In the following example, if the manufacturer relied solely on data from the first batch to set guarantees, there likely would have been problems down the road. The first batch measured 25% crude protein. However, one of the subsequent batches was much lower at 23%. If that later batch happened to be analyzed by a state, the product would have been found deficient. The average crude protein was found to be 24.8%. Subtracting two standard deviations from the average is 22.25%. Thus, a prudent minimum crude protein guarantee for this product is 22%.

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Alternatively (and far less complicated), finding the lowest value among the crude protein and crude fat results, and then further rounding down from that value to the next whole percentage can be done to set the minimum guarantees. For crude fiber and moisture, the same can be done, except in those cases, the highest value is rounded up.

In the following example, four batches of product are tested and the results tabulated. The best means of determining appropriate guarantees from the data is by statistical analysis, calculating the average and standard deviation for each nutrient (these calculations can be done easily in MS Excel). Assuming the variation will have a &#;normal distribution&#; (i.e., it follows a &#;bell curve&#;), the average plus or minus two standard deviations will encompass approximately 95% of the population. In other words, based on this estimate of variation, by setting the minimums below the low end and maximums above the high end, 95% of the time the product will meet the guarantee.

Failure to meet the guarantees may result in possible enforcement action against the product. It is prudent, then, to test multiple batches of each product. How many? In general, the more analyses conducted, the better one can estimate batch-to-batch variation and hence more reliably set guarantees. Understanding economic limitations of start-up companies, it is prudent to conduct at least two analyses of each variety to start. As more batches are produced and analyzed, more data may indicate the need to adjust the guarantees on the next label printing.

Important to note is that a single analysis of a product may not provide sufficient data to determine reliable guarantees. Guarantees are declared as either &#;minimums&#; or &#;maximums,&#; meaning that if a feed control official obtained a sample of the product and tested it in his or her official state lab, the crude protein and crude fat must be NO LESS THAN the stated percentage on the label, while the crude fiber and moisture must be NO MORE THAN the label declaration. Each batch of finished product is going to vary in composition due to variation in ingredient composition, mixing rates, and amount of water driven off during the cooking process. Unfortunately, a single analytical value does not give any indication as to the expected batch-to-batch variation. As a result, the composition of the batch that was tested may be very different from the one the feed control official analyzes!

Unless the product is formulated through the use of sophisticated computer software with a complete and accurate database on nutrient content of all ingredients used in the product, the best means of determining appropriate guarantees is by laboratory analysis. A &#;proximate analysis&#; of the finished product includes testing for the four nutrient components mentioned above in addition to ash. Results are typically reported in percentages &#;as fed&#; (AF). If unsure as to the units reported, it is prudent to ask the laboratory for clarification.

All pet food labels require a guaranteed analysis on the label to advise the purchaser of the product&#;s nutrient content. At minimum, guarantees are required for minimum percentages of crude protein and crude fat, and maximum percentages of crude fiber and moisture. The only exception is for products that do not and are not intended to provide protein, fat or fiber (for example, vitamin and mineral supplements), in which case the product is exempt from guarantees for those components. In all cases, though, a moisture guarantee is required. Guarantees for other nutrients are normally voluntary, although additional guarantees may be required to support claims made on the label. For example, claims such as &#;with calcium&#; or &#;high in vitamin E&#; would require minimum calcium or vitamin E guarantees, respectively.

WHAT MUST BE ON A LABEL?

General Packaging and Labeling Requirements

 

General Packaging and Labeling Requirements

Any package for sale to consumers which is customarily produced or distributed for sale through retail sales agencies, or for consumption or use by individuals for the purposes of individual care or for use in or about the household requires a label affixed to the package. Labels are required to contain very specific information so that packages accurately reflect the identity and contents of purchases allowing consumers to make price and quantity comparisons.

The "Uniform" regulations are published by the National Institute of Standards and Technology, and can be found in a handbook called "Uniform Laws and Regulations in the areas of legal metrology and engine fuel quality." See, NIST Handbook 130 ( Edition), which can be ordered by accessing http://www.nist.gov/ or can be downloaded.  Both the handbook and the Website provide tables for metric and inch-pound conversions, which may be necessary for proper labeling, as well as, a list of the states that have adopted the uniform law. Thus far, forty-six states have adopted the Uniform Packaging and Labeling Regulation. All 50 states have some type of packaging and labeling regulations in effect and all have separate requirements in their laws that require all packages to bear information regarding identity, responsibility, and quantity, so even if a product is exempt under the UPLR the requirements of the state law can still be applied.  The regulations are very specific and the following summary is taken from the NIST Handbook 130. The most basic requirements are that the label contained on the outside of a consumer commodity which is enclosed or wrapped in any manner in advance of wholesale or retail sale, and whose weight or measure has been determined in advance of sale, must contain the following three items:

• Declaration of Identity (Section 3)
  • The label must identify what the product is, such as the common name, a generic name, or a description that includes a statement of function.
• Declaration of Responsibility (Section 5)
  • The label must include the name and address of manufacturer, packer or distributor. If the product was manufactured at a different place from the principal place of business, the label may state the principal place of business rather than the manufactured place, unless that statement would be misleading. However, if the person whose name appears on the label did not manufacture the product, that name must be qualified with the phrase revealing the connection that person has with the product. (i.e. "Manufactured for and packed by xxx" or, "Distributed by xxx.")
• Declaration of Quantity(Section 6)
  • The labeling for most commodities must include BOTH the metric system (SI) and the inch-pound system of measurement. Metric only labeling is generally not permitted with the exception of certain consumer items. (Section 6.1)
  • The quantity must be stated in the largest whole unit with the remainder expressed in fractions. For SI units, it must include decimal fractions of such largest whole unit, and for inch-pound units must include in the next smaller whole unit, with any remainder in terms of common or decimal fractions. Either the SI unit or inch-pound unit may appear first.
  • The net quantity exclusive of wrappers and packaging must appear on the principal display panel of the label.
  • If the product is solid, semi-solid, viscous or a mixture of solid and liquid, the quantity must be expressed in terms of weight. Liquid measure must be expressed if the product is liquid; dry measure if the product is dry. The product may be quantified by numerical count. Specific measurement terms are provided for in the regulation, as well as, prescribed units and acceptable abbreviations.
  • Generally established consumer usage and trade custom for quantifying a product may be used as long as it does not impinge on price and quantity comparisons. (e.g. Count, as stated in

    AAFCO Official Publication

    for pet food treats.)
  • The declaration of quantity may be required to include weight, measure, count and size of individual units unless the declaration of weight, measure or count alone is fully informative.
  • The quantity requirements can be supplemented with additional declarations of weight, measure or count, on other than the principal display panel, as long as such supplementary declarations do not tend to exaggerate the amount of commodity contained in the package. Terms such as "giant quart," "when packaged," "full gallon," "minimum," "larger liter" or words of similar import, that tend to exaggerate the amount of the product are not permitted. (Section 6.12)
  • In indicating conversions from SI units to inch-pound units some rounding may occur if the accuracy is neither sacrificed nor exaggerated; however, in no case can the rounding overstate a quantity. (Section 6.13)
  • The declaration of quantity cannot be qualified by the addition of words such as "when packed," "minimum," "not less than" or "approximately." A unit of weight, measure or count cannot be qualified by any term such as "jumbo," "giant" or "full" that tends to exaggerate the amount of the product. (Section 6.14)
  • Non-consumer packaging must also provide a declaration of the net quantity of the contents outside of the package. (Section 7)
• Country of Origin
  • Title 19, United States Code, Chapter 4, Section  and 19 CFR 134, Country of Origin Marking regulations require that every article of foreign origin (or its container) imported into the U.S. be marked in a conspicuous place as legibly, indelibly, and permanently as the nature of the article (or container) will permit, and in such a manner as to indicate to the ultimate purchaser in the U.S., the English name of the country of origin of the article at the time of importation. 

    Customsa and Border Protection CBP has a number of 

    Informed Compliance Publications (ICPs)

     in the "What Every Member of the Trade Community Should Know About: ..." series

    
    

In addition to the content of the label, the regulation specifies the prominence and placement of the required declarations on the label.

• Placement of Labels (Section 8, 9 and 10)
  • The labels must be in English, and must be prominent, plain and conspicuous. Printing must be legible and clear. (Section 8)
  • The declaration of quantity on the label must be in the bottom 30% of the display panel; the color must contrast with the background; there must be free area around the declaration; it must be parallel with the declaration of identity; and, there is a minimum height and proportion requirement for numbers and letters. (Section 8.1)
  • There are specific requirements for the size of the label depending on the size of the container. (Section 8.2)
  • Certain products and/or packaging have very specific requirements. (Section 10) These include, but are not limited to; aerosols, multi-use packages, combination packages, variety packages, cylindrical containers, commodities sold as containers, textile products, and packaged seed.

Certain commodities are exempt from some of the labeling requirements.

• Exemptions (Section 11)
  • Specific commodities may be exempt from portions of the labeling requirements or may have alternate requirements imposed. Examples of these types of items include, but are not limited to, small packages, small packages of meat products, random packages, individual servings, ice-creams, prescription drugs, camera film, pillows and paint. The exempt commodities may also vary by state.
  • Some consumer commodities, including but not limited to, foods packaged at the retail level, drugs and cosmetics, products requiring registration with the Federal Insecticide, Fungicide and Rodenticide Act, such as flea and tick collars, and nutrition labeling are exempt from the metric system (SI) requirements. There may be very specific additional labeling requirements for these particular products.
• Packaging Variations (Section 12)
  • Some variation in weight, measure or count is permitted when caused by unavoidable deviations in weighing, measuring or counting the individual packages as long as the average is not below the quantity stated. No unreasonable shortage in any package is permitted, and variations above the declared quantity cannot be unreasonably large. Certain variations from the declared quantity are permissible when caused by ordinary and customary exposure to conditions that normally occur in the distribution process, after the product has been first sold and delivered.
• Retail Representations (Section 13)
  • The terms "cents-off," "introductory offer," and "economy size" on a label cannot be used unless specific criteria are met. For example, some of the requirements for a label stating "cents-off" are that: a) the commodity has been sold at its ordinary price in the most recent and regular course of business; b) the commodity is sold at a reduction from the regular price; c) the regular price must be identified; d) there are time limitations on the number of "cents-off" promotions in a given time period; and, e) sales of the volume of the commodity can only be 50% of the total volume of sales for any year. Specific criteria must be met before each of these terms can be used on a label.

BY PRODUCT

Pet Food

Pet Food

Pet Food is the single largest pet product category, as well as, one of the most heavily regulated. Most states require manufacturers to register and/ or obtain a license  with the state before the food is sold. For the particular registration requirements within each state, access the APPA Website, Pet Food Registration Chart, Pet Food Registration Requirements Chart or the chart listing registration requirements for each State, with links to registration forms, when available on the Web. APPA also retains a Pet Food Nutritionist with extensive experience in labeling and registration requirements who is available for assistance and acts as a consultant to manyof our members on specific labeling requirements.

Pet food includes a wide range of products including complete and balanced meals, treats, chews, and supplements. Feed, which includes pet food, is defined as "edible material(s) which are consumed by animals and contribute energy and/or nutrients to the animal's diet." (AAFCO Official Publication). Any pet product that claims that it contains nutrient value will be regulated as feed. Substantiating claims made for pet food for dogs and cats is different from doing so for foods for "specialty pets," a term commonly used in state law to refer to animals commonly kept in cages or tanks such as birds, fish and reptiles.

The Association of American Feed Control Officials (AAFCO) is an association of state (Department of Agriculture) and federal  (FDA and USDA) officials who have oversight over animal feed issues. The members of AAFCO regularly meet to discuss trends in the industry and provide guidance to each other on the regulation of animal feed including pet food and specialty pet food. AAFCO develops model laws and regulations which many of the States follow in whole or in part to regulate all aspects of animal feed. If you want to learn about pet food Labeling and other regulatory requirements we suggest you look at the AAFCO Web Page entitled The Business of Pet Food which is comprehensive overview of what requirements a pet food processor must comply with.

AAFCO also publishes a guide called the AAFCO Pet Food and Specialty Pet Food Labeling Guide. This was developed in collaboration with feed control officials from different states. The labeling guide provides information on the AAFCO Model Regulations for Pet Food and Specialty Pet Food as well as a uniform and consistent way of looking at claims on pet food labels. This is helpful for both feed control officials and industry so it is understood what may be accepted by regulators across the US.

The labeling guide covers claims such as Natural, Organic, Tartar Control and Human Grade/Quality statements as well as answering the question 'What is a Claim?'. It also gives label examples and in depth information on the Pet Food Regulations such as Product Name and Ingredients, Descriptive Terms, Nutrients and Feed Ingredients. The labeling guide is helpful for those people looking to start a treat or pet food business as well as a useful reference for those companies with a long history in the pet food industry.

The AAFCO Official Publication is a guidebook to the recommended laws and regulations that are used by state regulators. It is published annually and is available for order at the AAFCO Website. This seminal resource is highly recommended for manufacturers wishing to learn more about registering product, guaranteeing ingredients, and complying with other requirements. Many states follow the AAFCO Model Bills and Regulations in adopting their own feed laws. Set forth below are general requirements that are complied by AAFCO. The law of each state may have some variations from the AAFCO model law. 

In addition, pet food is a "food" for purposes of the federal Food, Drug and Cosmetic Act. Therefore, its sale comes under the regulatory authority of the US Food and Drug Administration, specifically, the FDA Center for Veterinary Medicine. The FDA/CVM Website is an excellent source of guidance regarding labeling.

Note, that the Food and Drug Administration Amendments Act of (FDAAA) required the FDA to promulgate new regulations concerning pet food by September . The FDA has failed to do this.  Under the law, the FDA is required to develop regulations which would establish ingredient standards and definitions, processing standards and labeling standards for pet food. In addition, the FDA was required to establish an electronic registry for food borne illnesses. Thus in the near future, the realm of pet food regulations may change from mostly being regulated by State Departments of Agricultures, which can vary amongst the States, to more uniform federal requirements with FDA oversight.  In the interim, the US Congress passed the Food Safety Modernization Act (FSMA) which requires all food and feed manufacturers and ingredient suppliers to have safety preventative controls in place, import restrictions and procedures for mandatory recalls amongst other requirements. 

Lastly, the US Department of Agriculture and the US Customs and Border protection (CBP) also have regulatory oversight of pet food in the broadest sense.  The USDA  regulates the processing of canned low-acid foods, of which canned pet foods  apply. Canned pet foods must be processed in conformance with the low acid canned food regulations to ensure the pet food is free of viable microorganisms (see Title 21 Code of Federal Regulations (CFR), Part 113). The USDA Website and the website of the US Customs and Border Protection (CBP) provides additional information and advice, protection, and control of merchandise imported into the country. See also, the APPA Web pages on resources for Exporting and Importing.

According to the AAFCO Model Bill and Regulations, pet food labels must contain the following:

• Product name
  • A pet food product or brand name cannot use the words "all" or "100%," if the product contains more than one ingredient. However, this rule would not apply to processing water, decharacterizing agents, or trace amounts of preservatives or condiments. (Reg. PF 3a)
  • If the product name includes the name of an ingredient of animal origin, at least 95% of the product must be the named ingredient, not counting the water added for processing and condiments. If the name contains two or more ingredients, the combined ingredients must comprise 95% of the total weight. (Reg. PF 3b1)
  • If the named ingredients comprise at least 25% of the product, but less than 95%, to include the ingredient in the name, the name must have a qualifying descriptive term, such as "Beef Dinner for Dogs." Other descriptions such as "platter," "entrée," "nuggets," or "formula" may be used. If more than one ingredient is used in this category, each ingredient must constitute at least 3% of the product weight, excluding water sufficient for processing and the names must appear in the order of predominance. (Reg. PF 3b)
  • To include the term "with," or a similar designation, in a product name, at least 3% of the product weight exclusive of water for processing, must be in the formula. "Dog Food with Chicken" must contain 3% chicken. (Reg. PF 3c)
  • To use "flavor" in the product name, the flavor designation must conform to the ingredient included in the ingredient statement and the flavor should be identified by the source of flavor in the ingredient statement. (Reg. PF 3d)
  • Except as provided above, the name of an ingredient cannot be included in the name of a pet food product, unless all ingredients are included in the name, or where the ingredient is present in such a sufficient quantity that it imparts a distinctive characteristic, or is present in amounts that may have a bearing on the price or on the acceptance by the consumer. Generally a pet food name cannot represent that an ingredient is present to the exclusion of other ingredients. (Reg. PF 3e)
• Species of pet
  • The label must state the species of pet for which the food is intended. Pictures, photos or other graphic material depicting a species are not sufficient to meet this requirement. (Reg. PF 2)
• Guaranteed analysis
  • The label must include minimum percentage of crude protein and crude fat, and maximum percentage of crude fiber and moisture, and must be listed in a specified order. It may also require the maximum percentage of crude fat if required by Regulation PF 10. The label may also include the guarantees for other nutrients, which should follow the guarantee for moisture. When ash is guaranteed it must be a maximum percentage and follow the guarantee for moisture. (Reg. PF 4a)
  • The guaranteed analysis may not be on a sliding scale. (i.e. 15-18%)
  • Pet food with minerals or vitamins must also include the minimum guaranteed analysis of the minerals or vitamins as established by the AAFCO recognized nutrient profile. (Reg. PF 4 c and d)
• Nutritional adequacy
  • A pet food which is intended for all life stages of the pet may include a term such as "complete and balanced," "perfect," "scientific," or "100% nutritious," provided that it meets the nutrient requirements for all life stages. (Reg. PF 7 a) Those terms may be included when a food is intended for a limited purpose or a specific life stage, however, it must be qualified with a statement of the limited purpose or specific life stage for which the product is intended (i.e. "complete and balanced for kittens.")
  • A "complete and balanced" pet food must be substantiated by meeting an established AAFCO profile, or by testing the product using AAFCO feeding trial protocols. (Reg. PF 7 a) The protocols that must be undertaken for a feeding trial for dogs and cats are set out in the

    AAFCO Official Publication

    under the heading "Dog and Cat Food Nutrient Profiles." The dog and cat feeding protocol, specifies, for example, the number of animals that must be tested, the length of the feeding trial, the age of the animals, and the requirement that only the feed being tested be provided to the animal during the test period.
  • AAFCO also sets forth how the tested animals should be evaluated, and how the test results should be interpreted. Additionally, AAFCO has developed dog and cat food metabolizable energy protocols.
  • For specialty pets, however, there are no standards for feeding trials to determine nutritional adequacy. AAFCO provides that for specialty pets, the nutrient recommendations approved by the National Research Council , will be sufficient, provided that, this nutrient recommendation is recognized only for the specific specialty pet for which the profile is intended. (Reg. PF 7g)
  • Otherwise, AAFCO&#;s model regulations provide that "if no requirement has been established by an AAFCO recognized nutritional authority for the life stage(s) of the intended species, the claimed nutritional adequacy of purpose of the product shall be scientifically substantiated." (Reg. PF 7 f)
  • Of note, in and , the National Research Council, a division of the National Academy of Science, published two reports entitled "

    Nutrient Requirements of Dogs

    " and "

    Nutrient Requirements of Cats

    . " The reports were updated into a single report based on a comprehensive review of literature, released  during  .  A  copy of this report is available from the National Academies of Science. AAFCO  currently has a Committee reviewing the NAS report to see whether any of the recommendations in the report should be incorporated into the AAFCO model regulations.
    If the product does not meet either methods of substantiating nutritional adequacy, it must state that it is "intended for intermittent or supplemental feeding." (Reg. PF 7 c 3)
  • Dog and cat food must also state which life stage the product is suitable for; either "gestation," "growth/lactation," "maintenance," or that the product is suitable "for all life stages." (Reg. PF 7 c)
• Contact information
  • The label must include the name and address of the party responsible for the quality and safety of the product. (Reg. PF 11)
• Ingredients
  • The ingredients must be listed by descending order of weight (including the moisture in the ingredients), and identified by the common name. (Reg. PF 5 a)
  • The terms "meat" or "meat-by-products" must state what animal the meat is derived from, unless the meat is from cattle, swine, sheep, goats or any combination of these animals. Therefore, products derived from horsemeat must be labeled as such. (Reg. PF 5 b)  However, note that the

    Pet Food Institute

    , states that horsemeat is not generally used in U S commercial pet food.
• Feeding directions
  • The directions for feeding must be expressed in common terms, and must state the feed unit per weight of the animal. The frequency of feeding must also be specified. (Reg. PF 8)
• Net quantity
  • The quantity must be expressed by weight, volume or count. FDA regulations specify the format, size and placement of the net quantity statement. (Reg. PF 2 a 3)
• Calorie content statement
  • As of January all pet food for dogs and cats  including treats and supplements must carry a calorie count statement on the label.  For more information on calculating calories in pet food please see the AAFCO Web Page on this topic. 

  • The terms "light" and "low calorie," or "lean" and "low fat" may only be used on a label if the product meets AAFCO&#;s standard definitions for these terms. (Reg. PF 10) The meaning is different for dog and cat food.  If the label states that the product is "less calories," "reduced calories," "less fat" or "reduced fat;" the label must include the percentage of reduction and the product of comparison. (Reg. PF 10 c 2) 

• Additional statements on pet food
  • The terms "senior," "premium," "super-premium," and "gourmet," have no standard definition or regulatory meaning.
  • The term "natural" may only be used on a feed label if it meets AAFCO&#;s definition for that term. Specifically, the feed or ingredient must be derived solely from plant, animal or mined sources, either in its unprocessed state, or having been subject to some processing, but not having been produced by, or subject to a chemically synthetic process, and not containing any additives or processing aids that are chemically synthetic. See, "Guidelines For Natural Claims," in the

    AAFCO Official Publication

    .
  • The use of the term "proven" in a label claim is not permitted unless the claim is substantiated by scientific evidence. (Reg. PF 2 d)
  • The terms "new" or "improved" must be substantiated and is limited to a six-month production. (Reg. P F 2 g)
  • No statement can be made on a label that makes false or misleading comparisons between that product and another. (Reg. P F 2 e) 
  • The AAFCO model regulations do not contain any specific requirements for other claims such as "high protein", "low sodium", etc., only that these claims should not be false or misleading to the consumer. A control official may be guided by the levels of the nutrients listed in the AAFCO Dog Food (and Cat Food) Nutrient Profiles . The levels in the Profiles are the minimum (and some maximum) levels for all essential nutrients required in dog food and cat food.  Claims for carbohydrate levels in pet foods are discouraged since at this time there is no uniform method for determining carbohydrates. 

• Fo additional resources on  pet 

  food labeling, see:

• Association of American Feed Control Officials, http://www.aafco.org/ and The Business of Pet Food
• FDA's Interpreting Pet Food Labels. 
• For Information on Marketing a Pet Food Product
• For consumer-oriented information see The Pet Food Report . This report is sponsored in part by the Pet Food Institute and the Association of American Feed Control Officials.
• Please check the  official sites of AAFCO and/or the FDA as these requirements frequently change, and this Web Page may not have been updated since the last changes. Contact  Debora Eisen    at APPA should you need a referral to a consultant that can assist you with your pet food labeling issues.

Pet Snacks and Treats

Pet Snacks and Treats

• Pet Chews
  • Pet chews can be made from rawhide, bone, wood, manmade material or other animal parts such as "pig ears" and ligaments. Under Policy Statement 27, in the

    AAFCO Official Publication

    , AAFCO exempts pet chews, bones and toys whether flavor coated or not, from certain registration and labeling requirements unless the manufacturer in its labeling or advertising makes any claim that the product is intended for use as an animal food or that the product provides anything of nutritional value to the animal. AAFCO&#;s Policy Statement 27 does not appear to encompass snouts, pizzles and novel natural part treats for the time being.
  • FDA considers dog chews made from rawhide, bone, or other animal materials or parts to be "food." When these products make no claims of nutritional value, FDA&#;s regulations provide, that at a minimum, the product name, manufacturer&#;s name and location and the ingredient list, if it contains more than one ingredient or if the single ingredient is not part of the product name, must be identified. If the product is sold by bulk, a placard at the container or bin must provide this information. For additional information, see the FDA report  on Interpreting Pet Food Labels, Pet Treats and Chews.

  • Count vs Weight Net Quantity Statement

    - While rawhides may be exempt from AAFCO as per PS #27, they are still "foods" under federal law, hence must follow FDA regulations regarding net content.  Most rawhide chews require a net weight statement. Although the Fair Packaging and Labeling Act refers to "length," that's for things where it makes sense, like tile and lumber.  With respect to foods,  21 CFR 501.105 does not provide for length to describe a food, only weight, fluid measure or count [or in rare cases, dry measure e.g., "peck").  However, when count alone does not provide adequate information, weight must also be provided [21 CFR 501.105(c)].  Because a "6-inch" rawhide can be thick or thin, having a dramatic impact on relative value a net weight would be required. 
  • In NIST 

    all dog chews be declared in terms of weight

    ; i.e., that count alone for items such as rawhides was not sufficient. 

    ; i.e., that count alone for items such as rawhides was not sufficient.

    Existing U.S. Food and Drug Administration (

    FDA

    FDA

    ) regulations already require net weight statements when count alone is inadequate in advising the purchaser of the contents of the package.  Although enforcement actions by weights and measures regulatory bodies are not anticipated before , manufacturers not in compliance may start receiving notices of violation in the near future.

    changed its labeling rules to stipulate that; i.e., that count alone for items such as rawhides was not sufficient.

• Pet Snacks
  • Snacks and treats are generally considered pet food and if a state requires pet food registration, a manufacturer would need to register these products.
  • A product labeled as a snack or treat is not required to include a nutritional adequacy statement. If labeled as a "snack" or "treat"  the feeding directions are voluntary. (Reg. PF 7 c)(Reg. PF 8). Biscuits are not exempt from these requirements, unless they are labeled as a "snack" or "treat."
  • When labeled as a snack or treat the label must also include the following:
    • The label must provide the guaranteed analysis.
    • The label must include the name of the species of pet for which the treat is intended.
    • An ingredient statement should be included unless the product contains one ingredient expressed in the product name.
    • Contact information that includes name of the manufacturer/distributor and an address that includes even just a city and state must be provided.
• Hemp and CBD in Animal Feed

  •  AAFCO has Guidelines for the Use of Hemp in Animal Feeds. This is a changing landscape as the FDA and numerous states are beginning to weigh in on hemp products and especially after the proliferation on products containing CBD. As of March , AAFCO has taken the position that "there are some potential safety concerns related to the presence of certain compounds, including THC (tetrahydrocannabinol) and CBD (cannabidiol), in parts of the hemp plant that must be addressed.  One thing has become clear as we have had discussions with the hemp industry, materials and products that are CBD infused need to be treated as drugs. There is no nutritional intended use for this compound. This means that several parts of the hemp plant will not be appropriate for animal feeding. Quoting from the FDA and Marijuana website: &#;FDA has therefore concluded that it is a prohibited act to introduce or deliver for introduction into interstate commerce any food (including any animal food or feed) to which cannabidiol has been added.&#;

  • In April , the FDA announced that it is looking into ways to regulate the proliferation of CBD products both for human use and for animal use.  Interest in these products increased  when Congress passed the Agriculture Improvement Act of (the Farm Bill). Among other things, this law established a new category of cannabis classified as &#;hemp&#; &#; defined as cannabis and cannabis derivatives with extremely low (no more than 0.3 percent on a dry weight basis) concentrations of the psychoactive compound delta-9-tetrahydrocannabinol (THC). The Farm Bill removed hemp from the Controlled Substances Act, which means that it is no longer a controlled substance under federal law. At the same time, Congress explicitly preserved the FDA&#;s current authority to regulate products containing cannabis or cannabis-derived compounds under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and section 351 of the Public Health Service Act.

    The FDA requires a cannabis product (hemp-derived or otherwise) that&#;s marketed with a claim of therapeutic benefit to be approved by the FDA for its intended use before it may be introduced into interstate commerce. Additionally, it is unlawful to introduce food containing added CBD, or the psychoactive compound THC, into interstate commerce, or to market CBD or THC products as dietary supplements. This is because CBD and THC are active ingredients in FDA-approved drug products and were the subject of substantial clinical investigations before they were marketed as food. In such situations, with certain exceptions that are not applicable here, the only path that the FD&C Act allows for such substances to be added to foods or marketed as dietary supplements is if the FDA first issues a regulation, through notice-and-comment rulemaking, allowing such use. 

    FDA has announced  (April ) that they intend to evaluate potential pathways for the regulation of cannibis products  and have announced a public hearing on the issue, that they will form an internal working group, and that they intend to issue warning letters to companies marketing CBD products with egregious and unfounded claims that are aimed at vulnerable populations. For more see the FDA Commissioner's announcement on cannibis products.  Many states are also proposing laws and or regulations to regulate cannabis products. We await more updates on whether the regulation for CBD products in edible products versus supplements will differ.

Health Claims

Health Claims

Claims that state that a pet food product can treat, prevent or reduce the risk of a disease are not allowed on a pet food label (unless approved as a medicated feed). Therefore, a pet food product cannot claim that it "improves skin and coat," "prevents dry skin," or that it is "hypoallergenic." However, a product can claim that it "promotes healthy skin" and "promotes a glossy coat."  Also see the discussion of health claims with regard to Dietary Supplements.

For a discussion on the FDA&#;s regulation of health related information on pet foods, see "Interpreting Pet Food Labels," The following health claims may be made with limitations:

• Cat Urinary Tract Health
  • A cat food label can state that it "reduces urine pH to help maintain urinary tract health," provided that a well-controlled scientific study demonstrates the ability of the diet to produce an appropriately acidic urine. The data should be reviewed by the FDA/CVM.
• See,

  CVM Guideline No. 55

  , June , for "

  Supportive Data for Cat Food Labels Bearing "Reduces Urinary pH Claims: Guideline in Protocol Development

  " and a summary report on Special Use Pet Foods .
  
  Prevention of Hairballs and Low Magnesium Claims for Cats
• • The CVM will allow these claims provided that labeling, formula information and data in support of safety, efficacy and/or truthfulness of each claim is submitted prior to marketing these products.
• Dental Health
  • Tarter control claims with respect to rawhides, biscuits and other pet food products, such as "helps control plaque," and "helps control tarter," as well as "improves doggie breath;" are generally permitted if the claims are that the food cleanses, freshens or whitens teeth by virtue of its mechanical or abrasive action. Foods bearing express or implied drug claims to prevent or treat dental diseases (i.e. gingivitis, gum problems, tooth loss) may be considered misbranded, unless they are the subject of an approved New Animal Drug Application.
  • The Veterinary Oral Health Council, an organization formed under the auspices of the American Veterinary Dental College, has worked with the CVM to develop an experimental protocol for companies to follow to demonstrate that the product reduces plaque and tarter. The organization will review data regarding these claims, and if supported will allow products to carry VOHC Seal on the package.
  • The

    AAFCO Official Publication

    provides "Guidelines for Tarter Control Claims."
• "Recommended by veterinarians"
  • The term "recommended by veterinarians," has no regulated meaning, and may be used as long as it can be substantiated.
• Medicated Feed
  • A medicated feed or a veterinary medical food (VMF), also known as a prescription diet or therapeutic diet, are considered drugs and may be marketed provided three criteria are maintained. The products must be sold through and under the direction of a veterinarian. Overt drug claims may not appear on the product label. Drug claims, indications for use and contraindications may appear in literature distributed to the veterinarians. Moreover, the ingredients must be Generally Recognized As Safe (GRAS), approved food additives recognized by AAFCO, or otherwise sanctioned for use in animal feeds. A VMF must include on the label, the purpose of the medication, an active ingredient statement, and specifics as to the species it purports to treat.
  • Claims for fecal odor control within food are considered drug claims. The CVM is considering issuing guidance for substantiating data to substantiate reduced fecal odor claims. The CVM reports that to date, no firm has been successful in demonstrating the truthfulness of a reduced fecal odor claim.

Dietary Supplements

Dietary Supplements

These include herbs, botanicals, nutraceuticals and other novel ingredients, whether used in pet food, treats, beverages, or as dietary supplements.

• Supplements for Animals Not Approved by the FDA
  • The FDA considers animal food supplements that are not approved nutrients included in the AAFCO list of approved ingredients or GRAS (Generally Recognized As Safe) to be unapproved food additives or unapproved new animal drugs. These supplements may not be used or put on a label unless the FDA approves of the ingredient or the ingredient is considered GRAS. A supplement ingredient may be approved as a flavoring agent, but if approved as such, no therapeutic claims may be made for that product.  Sometimes the food product with an added novel ingredient will be considered both a drug and a food if the claims made for the intended use of that product are considered drug claims.  A drug is defined as an article (other than food) intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or animals. Diseases resulting from essential nutrient deficiencies would not be included in the definition, thus classifying the food as a drug. A food can make a claim to alter the structure or function of the body only as it relates to the product's taste, aroma or nutritive value. If a structure or function claim is made on an animal food product to indicate that it will prevent a disease that is not a nutrional deficiency, the FDA wil interpret that claim as a drug claim. The FDA's Program Policy and Manual Guide ., Regulating Animal Foods with Drug Claims, provides the matrix used by the FDA to determine whether a product is to be classified as a drug.
• For companies that market supplement products that are not included in feed, visit the Web site of the National Animal Supplement Council (NASC). The NASC is an industry trade association comprised of of supplement manufacturers that works to promote the responsible and safe sale of supplements for pets. The NASC has designed a program to ensure safety of supplements for animals including adverse event reporting, which has reduced FDA's enforcement and oversight activities on these products. 
• CBD

  • One of the more recent products to come onto the pet product marketplace are products containing CBD, cannabis or cannabis derivatives. Interest in these products increased  when Congress passed the Agriculture Improvement Act of (the Farm Bill). Among other things, this law established a new category of cannabis classified as &#;hemp&#; &#; defined as cannabis and cannabis derivatives with extremely low (no more than 0.3 percent on a dry weight basis) concentrations of the psychoactive compound delta-9-tetrahydrocannabinol (THC). The Farm Bill removed hemp from the Controlled Substances Act, which means that it is no longer a controlled substance under federal law. At the same time, Congress explicitly preserved the FDA&#;s current authority to regulate products containing cannabis or cannabis-derived compounds under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and section 351 of the Public Health Service Act.

    The FDA requires a cannabis product (hemp-derived or otherwise) that&#;s marketed with a claim of therapeutic benefit to be approved by the FDA for its intended use before it may be introduced into interstate commerce. Additionally, it is unlawful to introduce food containing added CBD, or the psychoactive compound THC, into interstate commerce, or to market CBD or THC products as dietary supplements. This is because CBD and THC are active ingredients in FDA-approved drug products and were the subject of substantial clinical investigations before they were marketed as food. In such situations, with certain exceptions that are not applicable here, the only path that the FD&C Act allows for such substances to be added to foods or marketed as dietary supplements is if the FDA first issues a regulation, through notice-and-comment rulemaking, allowing such use. 

    FDA has announced  (April ) that they intend to evaluate potential pathways for the regulation of cannibis products  and have announced a public hearing on the issue, that they will form an internal working group, and that they intend to issue warning letters to companies marketing CBD products with egregious and unfounded claims that are aimed at vulnerable populations. For more see the FDA Commissioner's announcement on cannibis products.  Many states are also proposing laws and or regulations to regulate cannabis products. We await more updates on whether the regulation for CBD products in edible products versus supplements will differ.

• Supplement Claims for Humans
  • FDA&#;s position is that dietary supplements for animals do not fall under DHSEA (the Dietary Supplement Health and Education Act) and thus, cannot be marketed for animals. However, the FDA has provided guidance relating to claims on dietary supplements for human consumption. The FDA has issued final rules as to the type of statements that can be made concerning the effect of a dietary supplement on structure and function of the body. The FDA&#;s "

    Small Entity Compliance Guide for Structure and Function Claims

  • The guide discusses the distinction between claims that are structure/function claims and disease claims, the latter requiring prior approval by the FDA. Statements that describe the role of a nutrient or ingredient intended to affect the structure or function in humans or that characterize the documented mechanism by which a nutrient acts to maintain such structure or function are permitted statements as long as they are not disease claims. Dietary supplements can make claims about nutrient deficiency diseases. The structure function/claims used must be substantiated, and FDA must be notified regarding the intention to make such a claim when the product is first marketed, and a mandatory disclaimer statement, contained in the law, must be included. The

    Compliance Guide

    sets forth 10 criteria that may be useful in determining if a statement is a disease claim.

 

Bioengineered Food Claims

Bioengineered Food Claims

One of the emerging areas of labeling that is causing some confusion, concerns products containing bioengineered crop material. Some environmental and consumer groups believe that bioengineered crops have not been adequately studied and have the potential to cause environmental damage, as well as, negative health consequences. Because of these concerns, a mounting number of manufacturers of food products are including in their labels that a product is "non-GMO," or "GMO-free," indicating that the product does not contain any "genetically modified organisms."

The FDA has a guidance for industry called "Voluntary Labeling Indicating Whether Foods Have or Have Not Been Developed Using Bioengineering" . The guidance represents FDA&#;s "current thinking" on the appropriateness of labeling statements relating to bioengineered materials. The proposed guidance applies to human food and animal feed. The FDA received more than 55,000 comments on the draft of this Guidance document. Here are some Questions and Answers from the FDA on Food from Genetically Engineered Plants

• Statements about foods developed using bioengineering
  • In its proposed guidance document, the FDA&#;s focus is whether any statements made on the label are misleading. If there is a significant difference in a finished product because of biotechnology, such that the common or usual name no longer adequately describes the new food, the name must be changed to describe the difference. Similarly, if the improvement makes a significant difference in the finished product, disclosure of the difference may be required. Unless there is a significant difference, there is no requirement that any product be labeled stating that it contains bioengineered food.
• Statements about foods that are not bioengineered or that do not contain ingredients produced from bioengineered foods
  • "GMO" is an acronym for "genetically modified organism" and "GM" means, "genetically modified." The FDA has conducted consumer focus groups, and data indicates that consumers do not understand the acronyms "GMO" and " GM," and prefer label statements with spelled out words that mean bioengineering.
  • Terms like "not genetically modified" and "GMO free," or that include the word "modified" are not technically accurate unless they are clearly in a context that refers to bioengineering technology. The term "free" in a claim for absence of bioengineering can be inaccurate because the term "free" can only be ensured when there is a definition or threshold above which the term could not be used. FDA does not have information with which to establish a threshold level of bioengineered constituents or ingredients in foods for the statement "free of bioengineered material." FDA recognizes that there are analytical methods capable of detecting low levels of some bioengineered materials in some foods, but a threshold would require methods to test for a wide range of genetic changes at very low levels in a wide variety of foods. Such test methods are not available.
  • The FDA suggests that claims stating that a food does not contain bioengineered ingredients could be misleading, if there is any ingredient in the food that is bioengineered, if there are no marketed bioengineered food ingredients in that category of foods, or if the claim cannot be substantiated. Validated testing is the most reliable way to identify bioengineered food, but for many foods, such as highly processed foods such as oils, it may be difficult to differentiate bioengineered foods and ingredients.
• Organic Food Cannot be Bioengineered
  • The USDA's organic standards provide that a food cannot be considered organic, if it contains bioengineered ingredients.

Organic Labeling

Organic Labeling

The term &#;organic&#; is used widely today, but as it is officially defined by AAFCO, organic animal feed meets production and handling requirements of the U.S. Department of Agriculture&#;s (USDA) National Organic Program (NOP). According to the NOP website, &#;organic&#; products are: &#;produced through approved methods that integrate cultural, biological and mechanical practices that foster cycling of resources, promote ecological balance and conserve biodiversity. Synthetic fertilizers, sewage sludge, irradiation and genetic engineering may not be used.&#; The NOP regulates all organic crops, livestock and agricultural products certified to the USDA&#;s organic standards. Organic certifiers inspect and verify compliance. The USDA also conducts audits, investigations and enforcement activities to ensure all products labeled organic meet its regulations.

The USDA's Agricultural Marketing Service (AMS) established a program for verification of feed, feedstuffs, and pet food used in the production of products identified for certification. Additionally, AMS will assure that the product was produced in a processing facility in accordance with Good Manufacturing Practices under sanitary conditions. If it is determined that a company meets the established certification requirements, the company will be listed as eligible for organic certification. The extent of the verification process will be directly related to the complexity of the certification statements that are required. The AMS verification activities are conducted on a fee-for-service basis.

Certified organic foods will display a USDA organic seal and must be made of at least 95% organic ingredients. For more information, read this the USDA 's Web Page on the National Organic Program.

Human Grade Labeling

Human Grade Labeling

The FDA Center for Veterinary Medicine (CVM) was asked for an opinion on whether the use of the term "human grade" or similar descriptions were permissible on pet food labels. The FDA opined that the use of the term "human grade" could be misleading on pet food labels, because even though a portion of the product may in fact be derived from edible material; the final product is generally not fit for human consumption. In a FDA Guidance Document on Raw Foods for Pets,  the FDA states that "claims that the product is equivalent to food for human consumption must not be false or misleading."

For a product to be deemed edible for humans, all ingredients must be human edible and the product must be manufactured, packed and held in accordance with federal regulations in 21 CFR 110, Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food. If these conditions are met for a pet food, human-grade claims may be made. If these conditions are not met, then it is an unqualified claim and misbrands the product. 

Misbranding a feed is a prohibited act subject to enforcement action on the responsible party. The presence of human-grade on a label implies a product or ingredients may meet the legally-recognized edible standard. A product formulated for a pet is unlikely to be nutritionally adequate for a human and vice versa. Because pets become like family members in many homes, it should be underscored that not everything that a human can eat is safe for a pet. Such ingredients as chocolate, macadamia nuts and onions, to name a few, are edible and good for humans but can be toxic to cats or dogs. Human-grade does not automatically equal nutritional safety for pets. A product might claim to be human-grade because its ingredients &#;came from a USDA meat-packing plant.&#; But materials leaving a USDA meatpacking plant may be either es must meet feed requirements, including being unadulterated. 

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Are you interested in learning more about Scomi Prima 3G/4G/5G Screen? Contact us today to secure an expert consultation!

See this April article by Dr David Dzanis in Pet Food Industry magazine on the difficulties in labeling pet food products as Human Grade.  &#;Human grade&#; pet food labels tricky for manufacturers.

More recently AAFCO has developed a feed term for the use of human grade. Human Grade: Every ingredient and the resulting product are stored, handled, processed, and transported in a manner that is consistent and compliant with regulations for current good manufacturing practices (cGMPs) for human edible foods as specified in 21 CFR 117. Here is an AAFCO discussion on human grade labeling

AAFCO outlines guidelines for Human Grade labeling for pet foods:

1. The use of the term &#;human grade&#; is only acceptable to the product as a whole. Every ingredient and finished food must be stored, handled, processed and transported in a manner that is consistent with current good manufacturing processes (cGMPs).
2. The definition &#;human grade&#; is false and misleading if the finished good as a whole is not human edible. Human grade claims cannot be made on individual ingredients if the finished good is not human grade.
3. For substantiation of human grade claims, a manufacturer must have documentation for the following:

a. That each ingredient is fit for human consumption

b. Every ingredient and finished food is stored, handled, processed and transported in a manner consistent and compliant with cGMPs for human edible foods in 21 CFR part 117.

c. The manufacturing facility is licensed to produce human food by the appropriate authority (local, county or state public health authorities).

4. A pet food with human grade claims must be labeled for its intended use (e.g., dog food

 The U.S. Department of Agriculture (USDA) defines products fit for human consumption to be officially &#;edible.&#; These foodstuffs have been processed, inspected and passed manufacturing regulations (i.e. process control regulations) that are designed to assure safety for consumption by humans.

Edible is a standard; human-grade is not. For a product to be deemed edible for humans, all ingredients must be human edible and the product must be manufactured, packed and held in accordance with federal regulations in 21 CFR 110, Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food . If these conditions are met for a pet food, human-grade claims may be made. If these conditions are not met, then it is an unqualified claim and misbrands the product.

 

Misbranding a feed is a prohibited act subject to enforcement action on the responsible party. The presence of human-grade on a label implies a product or ingredients may meet the legally-recognized edible standard.

 

 A product formulated for a pet is unlikely to be nutritionally adequate for a human and vice versa. Because pets become like family members in many homes, it should be underscored that not everything that a human can eat is safe for a pet. Such ingredients as chocolate, macadamia nuts and onions, to name a few, are edible and good for humans but can be toxic to cats or dogs. Human-grade does not automatically equal nutritional safety for pets.

 

 A product might claim to be human-grade because its ingredients &#;came from a USDA meat-packing plant.&#; But materials leaving a USDA meatpacking plant may be either edible or inedible. The piece of meat that is rejected because it does not meet edible standards and some slaughter byproducts are not human edible, nor can they be implied to be unofficially human-grade.

 

 Whether a product is or is not advertised as human-grade has no impact on product safety. All pet food products must meet feed requirements, including being unadulterated.

Raw Food Diets

 

Raw Food Diets

The FDA has issued a Guidance Document on the manufacture and labeling of foods that contain raw meat or raw animal tissues for pets and other animal carnivores. The FDA is concerned that the public can face significant health risks because of pathogenic organisms including bacteria and parasites when a raw meat diet is brought into the home and used to feed pets. The FDA believes that adequate heat treatment is the most effective way to mitigate these risks. AAFCO has also expressed some concerns for consumers that they "should be aware of raw-food handling practices. Most raw (or undercooked) pet food consists of meat, ground bone, organ meats, raw eggs, vegetables or fruits and some dairy products. Because of these raw ingredients, there has been an increased concern for cross-contamination of bacteria, such as salmonella, to humans. These bacteria may pose a danger to the people in the household, especially children, the elderly and those with poor immune systems. Although dogs and cats may be more resistant to these bacteria, they are not immune and can become very ill." The FDA also has a Web Page in its Consumer Animal Health Library called Get the Facts! Raw Pet Food Diets can be Dangerous to You and Your Pet warning of some of the dangers in raw food diets and advising consumers how to mitigate their risks.

• Form of Ingredients
  • FDA recommends that only bone in ground form should be used to minimize risk of dental or gastrointestinal trauma.
• Manufacturing
  • Meat and poultry derived ingredients should be USDA inspected and passed for human consumption. Manufacturers should take all necessary steps to minimize contamination. These steps may include irradiating the product after final packaging, participating in the USDA's voluntary inspection program, practicing Good Manufacturing Practices (GMP's), such as for human food, and/or implementing a Hazard Analysis and Critical Control Point (HACCP) program.
• Storage and Handling
  • Products that are not freeze dried should be kept frozen at all times. Products should be transported and stored to avoid microbial contamination and growth.
• Nutritional Adequacy
  • If these products are intended to be the sole source of nutrition for pets, manufacturers should substantiate the nutritional adequacy. Calcium and phosphorus may be deficient in raw food diets, and should be supplemented. Also, essential fatty acids and trace minerals may be deficient. These products must meet the AAFCO Nutrient Profiles for the intended life stages. If the state has adopted the AAFCO Model Regulations the product would have to meet all the requirements for guarantees for crude protein, crude fat, crude fiber, and moisture.
• Labeling and Claims
  • Accurate ingredient statements must be provided.
  • A handling statement "Keep Frozen" should be displayed prominently on the principal display panel.
  • FDA recommends that the product conspicuously provide a statement under the heading "Handling Guidelines for Safe Use" that states: "Some raw food products may contain bacteria that could cause illness to you or the animals you are feeding if mishandled. For your protection, follow these instructions for safest use.
    1. Keep frozen until ready to use.
    2. Thaw in refrigerator or microwave.
    3. Keep raw meat and poultry separate from other food. Wash working surfaces, utensils (including cutting boards, preparation and feeding bowls), hands, and any other items that touch or contact raw meat or poultry.
    4. Refrigerate leftovers immediately or discard."
• Claims
  • Manufacturers should be advised that based upon claims made, its intended use may bring it within the definition of a drug.
• FDA Consumer Warnings
  • FDA has a Web page devoted to Warning the Public as to some of the dangers that could be associated with raw pet foods. 
  • Compared to other types of pet food, raw pet food is more likely to be contaminated with disease-causing bacteria, such as Salmonella and Listeria monocytogenes.  The Web page provides  tips as to the best ways for consumers to avoid contamination

    
    

Irradiation

Irradiation

The FDA has approved irradiation for feed ingredients, pet food and pet treats. Irradiation is a process whereby products are exposed to sources of ionizing radiation that cause chemical changes similar to conventional cooking or preservation methods. This process can reduce the risks of contamination from all strains of salmonella bacteria as well as other pathogens. See the Final Rule Irradiation in the Production, Processing, and Handling of Animal Feed and Pet Food; Irradiation 

• The label is required to include a graphic representation of the international radura symbol as well as a statement such as "Treated with radiation'' or the statement "Treated by irradiation.'' The logo shall be placed prominently and conspicuously in conjunction with the required statement.
• For irradiated foods not in package form, the required logo and phrase "Treated with radiation'' or "reated by irradiation'' shall be displayed to the purchaser with either (i) the labeling of the bulk container plainly in view or (ii) a counter sign, card, or other appropriate device bearing the information that the product has been treated with radiation. As an alternative, each item of food may be individually labeled.
• The labeling requirement applies only to a food that has been irradiated, not to a food that merely contains an irradiated ingredient but that has not itself been irradiated.

 

Pesticide Products

Pesticide Products

A pesticide is any substance or mixture of substances intended for

• Preventing, destroying, repelling or mitigating any pest.
• Use as a plant regulator, defoliant, or desiccant.
• Use as a nitrogen stabilizer

Both the United States Environmental Protection Agency (EPA) and or the Food and Drug Administration (FDA) regulates pet products that may be considered pesticides. These may include flea and tick repellents, animal repellents, algae inhibitors and disinfectants.  The types of pesticides registered for flea and tick control on dogs or cats include: shampoos, collars, dust or powder, sprays and spot-on products. Pesticides products in general may include insecticides, herbicides, rodenticides, and fungicides. Less well-known pesticides include disinfectants, attractants, plant defoliants, aquarium treatments, and plant growth regulators.  

Each pesticide product must be registered with the EPA. For information on the EPA's regulation of pesticide products for pets see the EPA's Web Page on Protecting Pets.  In addition to registering your pesticide product with the EPA you may be required to register the product with each state where your product is sold. For information on each State's registration requirements, see the APPA Web Page, Pesticide Registration Chart. APPA can also provide you with references for consultants that work in the pesticide field.

EPA assesses all pet pesticide treatments, including spot-on products.  Their reviews include:

• Assess exposure through skin contact for adults (dermal assessment)
• Evaluate exposure by skin contact and by mouth for children (dermal and oral assessments)
• Assess exposure through breathing in the chemicals from pet pesticide treatments, on a case-by-case basis (inhalation assessment)
• Estimate the amount of applied pesticide that can transfer from the animal to the child's skin from hugging or otherwise contacting a treated animals

FDA is responsible for regulating animal drugs.  In general, flea and tick products that are given orally or by injection are regulated by FDA.

• Before an animal drug is allowed on the market, FDA must &#;approve&#; it. Before a pesticide can be marketed, EPA must &#;register&#; it.

Spot -On Products:

In spring , EPA noticed an increase in reports of pet incidents involving spot-on pesticide products. Spot-on flea and tick products are liquid pesticides applied to a "spot" on the pet's skin, usually around the back of the neck or shoulder area. The EPA evaluated these products and in provided additional restrictions to reduce potential harm for these products.  

• EPA's expert veterinarian team found that
  • small breed dogs were affected more than larger breeds for some products
  • the amount of product in a single dose needed to vary more for small to large dogs; that is, how much the dog weighs matters a lot in deciding how much of a product should be used.

•  EPA's expert veterinarian team discovered that
  • misuse or accidental exposure of cats to dog products was an important problem; cats can be harmed by dog products because they are more sensitive to certain pesticides; and
  • label warnings against use of dog products on other animals, especially cats, are not working well enough, which appears to be a global concern.

BioPesticides:

Biopesticides are certain types of pesticides derived from such natural materials as animals, plants, bacteria, and certain minerals. For example, canola oil and baking soda have pesticidal applications and are considered biopesticides. There are 299 registered biopesticide active ingredients and active biopesticide product registrations. Since biopesticides tend to pose fewer risks than conventional pesticides, EPA generally requires much less data to register a biopesticide than to register a conventional pesticide. In fact, new biopesticides are often registered in less than a year, compared with an average of more than three years for conventional pesticides.

Minimum Risk Pesticides:

Because EPA has determined that certain "minimum risk pesticides" pose little to no risk to human health or the environment, EPA has exempted them from the requirement that they be registered under the Federal Insecticide, Fungicide, and Rodenticide Act. This exemption provision is located in 40 CFR 152.25(f). Here are the conditions required to qualify as minimum risk pesticides. Please note however, that states may require registration under state laws

Pesticide registration: To assist applicants in registering a pesticide product the EPA provides a Pesticide Registration Manual

Water Clarifiers

Water Clarifiers

Water clarifiers for aquariums may or may not be classified as pesticides, depending on what claims are made. If any pesticide claims are made, the product must be registered as a pesticide, and labeled according to the pesticide laws.

• Products that make claims for the prevention, removal, control, or elimination of algae or bacteria are considered pesticides. That the product works indirectly by removing the pest&#;s food source or habitat does not affect its status as a pesticide. If the product claims that it "eliminates green water" or "eliminates pond scum" it would be considered a pesticide. If there were no claim for bacterial or algae control, a product would not be a pesticide if it merely states that it will "clarify tanks by precipitating organic particles and reducing sludge;" or that it is for "cleaning ponds and aquariums." A manufacturer may describe how a water clarifier operates to clarify water, but if there are claims to control, or eliminate aquatic pests the clarifier must be registered as a pesticide. Claims regarding the reduction of nutrients would not be classified as a pesticide unless the claim also states that there will be a reduction in pest populations such as bacteria, weeds or algae. A  EPA Enforcement Alert  relating to water clarifiers discusses the issue further.

Pet Bedding

 Pet Bedding

Legal Labels for Stuffed Bedding

Many states have laws that require specific labeling for "bedding." These laws usually require the manufacturer to provide a label stating whether used or new filling materials were used.  These legal labels are the type that states: "Do Not Remove Under Penalty of Law."

There are no specific laws requiring pet bedding to have such a label law at this time.  However,  the law is  is ambiguous in many states, in that many states do not specify that the bedding requiring a label is to be solely used by humans.   Ohio repealed its pet bedding labeling and reqistration requirement in February . The City of Detroit repealed its requirement in March .   Although not required, some manufactures voluntarily use the legal labels, while in the past some  retailers also required such labels.  In the past we have heard of some states with unclear language in their regulations mandating such labels on pet bedding.

• Textiles, Wool and Fur
• Federal law requires that Fiber Content, Country of Origin and Manufacturer Identity be affixed to a product label if it is made of any amount of wool or fur, or if the textile is made into certain specific product types. Pet furniture is not required to list the fiber content. If a textile product is imported, US Customs service will require that the label be affixed in a permanent fashion.
• Large retail chains may require content labeling (i.e. both the type of textile and filling material) on all pet-bedding products that are sold in their stores, even though there may be no legal requirement for such label. Because retailers share in the responsibility of labeling and any enforcement actions may be taken against them as well as the manufacturer, many retailers will ensure compliance by requiring all textile products to be labeled as standard operating procedure, even though the law may not mandate such labeling.
• The Federal Trade Commission, which regulates textile labeling, has prepared a guide entitled "Threading Your Way Through the Labeling Requirements Under the Textile and Wool Acts" .
•  An RN stands for Registered Identification Number. It is a number issued by the FTC to U.S. businesses that manufacture, import, distribute, or sell products covered by the Textile, Wool, and Fur Acts. Businesses can use this number on product labels in lieu of the company name. For more information on RN labels see the Federal Trade Commission Web site.

Canadian Labeling of Bedding

• In Ontario, the Technical Standards and Safety Act, requires that all stuffed articles including pet bedding and stuffed toys (upholstered and stuffed articles) must be labeled in an approved format, listing filling contents, and register with the province. Only new materials can be used to fill articles. The Technical Standards and Safety Authority will review a label of regulated products to verify compliance. For additional information call, Ontario: Technical Standards and Safety Authority, 1-877-882-. 

  However, recently the Government of Ontario has approved the revocation of the Upholstered and Stuffed Articles regulation under the Technical Standards and Safety Act, , effective July 1, . The revocation of the regulation will eliminate all Ontario-specific requirements for upholstered and stuffed articles imposed on business, and remove the oversight and enforcement role of the Technical Standards and Safety Authority. Ontario&#;s upholstered and stuffed articles will also continue to be subject to the province&#;s Consumer Protection Act. For example, this legislation prohibits misleading descriptions of goods such as claiming a product is new or unused when in fact it is used or reconditioned. Misrepresentation is an offence under the act, which could be subject to prosecution, and could also be a basis for a civil claim.

Cedar Shavings / Wood Chips

• The Uniform Method of Sale Regulation, (NIST Handbook 130, Section 2.23) provides the following  for Animal Bedding (Amended ) 2.23.1 Compressed Animal Bedding. &#; Means the volume of the bedding was reduced under pressure during the packaging process. (Added )
• 2.23.1.2. Useable Volume. &#; The volume of the product that can be recovered from a package by the consumer after it is unwrapped and, if necessary, uncompressed. (Added )
• 2.23.2. Method of Sale. (a) Packaged animal bedding of all kinds, except for baled straw, shall be advertised, labeled, offered for sale and sold by volume in either a compressed or an uncompressed package. A package of compressed animal bedding shall be advertised, labeled, offered, and exposed for sale and sold on the basis of the &#;Useable Volume.&#; If unit pricing is provided for use by retail customers to make a value comparison, it shall be in terms of the price per liter.
• A quantity declaration shall be in terms of the largest whole unit of the milliliter, liter, or cubic meter. A declaration may also include the quantity in terms of largest whole unit of the cubic inch, cubic foot, or cubic yard only. The terms &#;Useable Volume&#; must appear in the quantity declaration on a package of compressed animal bedding.
  • Examples for Uncompressed Animal Bedding: Volume 41 Liters (1.4 Cubic Feet) Volume 125 Liters
  • Examples for Compressed Animal Bedding: Useable Volume 1.4 Cubic Feet (41 Liters) Useable Volume 27.9 Liters ( Cubic Inches) Useable Volume 113 L (4 Cubic Feet) Useable Volume 226 L (c)
  • The display of a net or gross weight, pre-compression volume, compressed volume, or supplementary dry measure quantities (e.g., dry pint, dry quart, or bushel) anywhere on the package is prohibited.
  • NOTE: This method of sale for animal bedding shall be enforceable after January 1, .

Cushions

• Cushions are required under the Textile Fiber Products Identification Act, to include a label identifying the fiber content, country of origin and manufacturer identity. See, discussion above relating to Pet Bedding. If the cushion is attached to a solid base it may be considered upholstered furniture and be exempt from the federal textile labeling requirements, but may vary by state.

 

Pet Clothing

Pet Clothing

A label on pet clothing is not required to state the textile content, as pet clothing is exempt from this requirement under the Textile Labeling Act. Coverings for birdcages are also exempt and do not require textile labeling. However, as stated above, in the section on Textile Labeling, any product that is comprised of wool must include the Fiber Content, Country of Origin and Manufacturers Identity.

Pet Shampoos and Grooming Aids

Pet Shampoos and Grooming Aids

Generally shampoos for pets are not required to list the ingredients and should be labeled in the same manner as other consumer commodities. However, pet shampoos that are medicated (contain a product classified as a drug) or contain pesticides are regulated, and ingredients must be listed. If a shampoo claims that it can control fleas or ticks it will be considered a pesticide and must be treated as such, including label review and registration with the EPA and each individual state. If a shampoo contains any medication, it would be considered a drug, and must be approved for use by the FDA, as the Food, Drug and Cosmetic Act provides authority for the FDA to regulate food and drugs for animals. Under the Act, the sale of cosmetics is only regulated if it is intended for human usage. The FDA has a Compliance Policy Guide which discusses Animal Grooming Aids  and the regulation of such. 

• The cosmetic definition in Section 201(i) of the Federal Food, Drug, and Cosmetic Act refers only to the use of such articles in man. Therefore, articles intended solely to cleanse or beautify animals are not cosmetics within the meaning of 201(i) but are commonly considered as "grooming aids."

  Where animal grooming aids are labeled or otherwise intended for therapeutic purposes, they may be considered to be drugs. This may occur when a grooming aid is labeled to contain an active drug ingredient or to otherwise suggest or imply a therapeutic benefit.

• Grooming aids for animals formulated and labeled only to cleanse or beautify the animal are not subject to the Federal Food, Drug, and Cosmetic Act.

 

Pet Salves and Ointments and Grooming Aids

Pet Salves and Ointments

If a pet product is solely for cosmetic use, the FDA under the Food, Drug and Cosmetic Act does not regulate it. Cosmetic uses would include for cleansing, beautifying, promoting attractiveness, or altering appearance. Therefore, it would be subject to general labeling requirements.

Cosmetic articles intended for animal use is not included in the Federal Food, Drug, and Cosmetic Act, where it only refers to the use of such articles in man. Therefore articles intended are solely to cleanse or beautify animals are not regulated as are cosmetics for humans, but are commonly considered as "grooming aids." Where animal grooming aids are labeled or otherwise intended for therapeutic purposes, they may be considered to be drugs. This may occur when a grooming aid is labeled to contain an active drug ingredient or to otherwise suggest or imply a therapeutic benefit.

A Compliance Manual for Animal Grooming Aids  provides additional information on animal cosmetic products.

However, if a grooming aid  product makes drug claims, such as, that it is intended for the prevention or treatment of a condition affecting an animal, or that is intended to affect the structure or function of an animal, it is considered a drug, requiring a new drug approval. New animal drug approvals must be obtained before the product can be marketed.

For example, if a topical product contains anti-inflammatory, antibacterial, or antifungal agents it will be considered a drug needing an FDA approval. Also, if the product states that it "relieves itching," "relieves dry skin," "heals wounds," or is a "first aid" treatment, then it would also be considered a drug. The FDA&#;s Guidance Document entitled "Guideline For Effectiveness Evaluation Of Topical/Otic Animal Drugs" discusses some of the requirements necessary to submit this type of drug application.

On the other hand, according to Marcia Larkens at the Office of the FDA Center for Veterinary Medicine Ombudsman, the phrase "enhances a dog&#;s coat" or "provides for or adds luster or sheen to a dog&#;s coat" connote enhancement of an already healthy dog&#;s coat, therefore, they would most likely not be considered drug claims. For more information, contact the FDA at 1-888-463- or .

A salve or ointment that makes claims to repel pests such as fleas or ticks, albeit natural, is considered a pesticide product requiring oversight by the EPA. (See section on Pesticides) A product (salve or ointment) which is applied to an animal wound and labeled as a salve and also is "to keep flies away from the wound" is considered a pesticide.

Pet Toys

Pet Toys

The Textile Fiber Products Identification Act, exempts toys made of textiles from labeling requirements. There are no specific labeling requirements for pet toys other than general labeling requirements, set out in the uniform packaging and labeling laws. There is additional information on considerations in pet toys in the APPA Web Page on Pet Toys. Most pet toys are not regulated by the States or Federal Government. However, there are some considerations for childrens' toys which may be applied to pet toy manufacturing and labeling by some retailers.  Manufacturers will generally designate that the toy is for use for pets and most will provide warnings such as to remove the toy if it breaks or the stuffing falls out.

Aquarium Heaters

Aquarium Heaters

• Testing Laboratories

  • Many states require electrical appliances to be tested by an approved electrical standards testing agency. The most notable standards agency is Underwriters Laboratories, Inc. (UL), an independent, not-for-profit product safety testing and certification organization. The standards for Electric Aquarium Equipment are listed in Underwriters Laboratories, Standard . Many aquarium heaters, however, will not pass the UL test standard because the glass heaters will not pass the UL "drop" test, one component of the testing procedure, whereby an appliance is dropped on a hard surface.

Country of Origin

 

Country of Origin

Now more than ever manufacturers are seeking to use country of origin as a marketing advantage. However, the federal government has specific requirements for when it is permissible to state that a product is made in the USA, while imported products generally must have a country of origin label.  The Federal Trade Commission regulates country of origin claims. U.S. content must be disclosed on automobiles and textile, wool, and fur products. There&#;s no law that requires most other products sold in the U.S. to be marked or labeled Made in USA or have any other disclosure about their amount of U.S. content. However, manufacturers and marketers who choose to make claims about the amount of U.S. content in their products must comply with the FTC&#;s Made in USA policy.

• Made in the USA
  • To include "Made in the USA", or a similar statement on a label or promotion, only a de minimus amount of product is not made in the US. Virtually all of the product must be of US origin.
  • To be considered de minimus, the final assembly or processing of product must take place in the US. The farther removed from the finished product, any foreign content is, the better. The FTC will also look at what percentage of total costs of manufacturing is attributable to US costs.
    When a portion of the finished product is made from foreign parts, the FTC will look at what percentage of the cost of the product the raw materials constitute and how far removed from the finished product the raw materials are. An implied claim of US origin cannot be made if the product is not made in the US. The overall net impression of the label or advertisement will be considered. A US flag, or outlines of a US map may inappropriately convey a claim of US origin.
    "Assembled in US" should be limited to those instances where the product has undergone its principal assembly in the US and that assembly is substantial.For further information, access the FTC website. See, "Complying with the Made in The USA Standard," FTC Dec. ,  or "Enforcement Policy Statement on U.S. Origin Claims" .

In a Judge dismissed a law suit against a pet food company, where consumers had claimed that the pet food should not have been labeled "Made in the USA" because certain vitamins and minerals were imported. These ingredients were not  available from US manufacturers. Although not dispositive, because the Court ruled that the plaintiff's suffered no economic harm. Here is an article from Pet Food Industry Magazine discussing the lawsuit. 

• Imported Goods
  • The US Customs  and Border Protection (CBP)  regulates labeling of imported goods. 

• • See the CBP's publication more information on Marking of Country of Origin on U.S. Imports
  • If product is not imported there is no requirement for country of origin labeling except for Textiles and Fur, which have specific origin labeling requirements.
  • The country of origin of an article may be changed in a secondary country if one of the following occurs: 
  1. 1. If the further work or material added to an article in the second country constitutes a substantial transformation. A substantial transformation occurs if a new article with a different name, character, and use is created.
     2. For a good from a NAFTA country: if under the NAFTA Marking Rules (19 CFR Part 102) the second country is determined to be the country of origin of the good; or
     3. For an article considered to be a textile or apparel product (regardless of whether it is a good from a NAFTA country): if the country of origin is determined by the general rules set forth in 19 CFR Part 102.21 to be the second country. For purposes of determining whether a textile or apparel product is from Israel, the general rules in 19 CFR 12.130 apply.
  • If the article is of foreign origin, it must be marked in a legible, conspicuous place, with the English name of the country. The best form of marking is one that becomes part of the article itself. The marking must remain until it reaches its ultimate purchaser.
  • Special marking - On certain items such as knives, cleavers, clippers, shears, scissors, safety razors, pliers, and some other metal items, the country of origin marking must be either die-stamped, etched, engraved, cast-in-mold lettering or by means of metal plates.
  • Certain items do not require marking. These items include a product that is incapable of marking, an article that is to be processed in the US and marking would be permanently conceal, obliterate or destroy the item and if it is a crude substance.
  • If an imported article is to be repacked in the U S, the new container must be properly marked.
• NAFTA
  • NAFTA rules of origin take into account where goods are produced and what materials are used to produce them. The purpose is to ensure that North American goods traded among the three NAFTA partner countries (Mexico, Canada and the US) receive preferential tariff treatment. Products of other countries merely being transhipped through or undergoing only minor operations in North America are not eligible for NAFTA benefits. A useful guide to NAFTA can be accessed at the CBP office Website, entitled "NAFTA: A Guide to Customs Procedures" .

Rules & Notices

- Open Sunday to Wednesday from 10am to 10pm (first game starts at 10:30 am and the last at 9pm). On Thursday, Friday, Saturday and Public Holidays, we are open from 10am to 12pm (first game starts at 10:30am and last at 10:30pm).
- Anyone who is above the age of 10 and has a flare and taste for fun, puzzle solving, mystery and adventure is welcome to play.
- Ages 10-15 are required to be accompanied by an Adult.
- Challenge Chambers gave careful thought to their games to ensure that that everyone can enjoy them. They are easily accessible by elevator, so anyone in a wheel-chair or on crutches can get to them without any problem. The challenge does require a bit of movement so at least one member in the group has to be able-bodied. Please do inform management at the time of booking about any such conditions.
- Prices range from AED 75 (USD 20) to AED 125 (USD 34) per person depending on the room selected, number of people playing and whether it&#;s a weekday or weekend/public holiday.
- You can book over the and online. Cash payments will have to be made upon arrival and before starting the game.
- They are currently booking 90 days in advance. It is strongly recommended for players to book before coming in to play. If you decide to come in as a walk-in, They will gladly accommodate you if there is a slot available.
- Food and beverages are strictly prohibited.
- Sunset Mall offers ample free basement parking space. Please note that parking in front of the Mall is paid parking and non-payment of parking fee will result in fines.
- It is recommended that players come in comfortable clothing and sandals/shoes that are easy to remove.

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