How do I calculate the Guaranteed Analysis in my pet treats?
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.
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.
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!
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.
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.
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, 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%.
Example: Calculating guarantees from proximate analysis data
NOTE: Ash guarantee not required on pet food labeling, but is typically included in “proximate analysis” lab reports
WHAT MUST BE ON A LABEL?
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 (2019 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:
AAFCO Official Publication
for pet food treats.)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.
Certain commodities are exempt from some of the labeling requirements.
BY PRODUCT
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 2007 (FDAAA) required the FDA to promulgate new regulations concerning pet food by September 2009. 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:
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.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 2006. 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.Pet Food Institute
, states that horsemeat is not generally used in U S commercial pet food.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)
AAFCO Official Publication
.Fo additional resources on pet
food labeling, see:
Pet Snacks and Treats
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.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.all dog chews be declared in terms of weight
; i.e., that count alone for items such as rawhides was not sufficient.Existing U.S. Food and Drug Administration (
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 2021, 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.
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 2017, 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 2019, 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 2018 (the 2018 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 2018 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 2019) 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
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:
CVM Guideline No. 55
, June 1994, 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 .AAFCO Official Publication
provides "Guidelines for Tarter Control Claims."Dietary Supplements
These include herbs, botanicals, nutraceuticals and other novel ingredients, whether used in pet food, treats, beverages, or as dietary supplements.
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 2018 (the 2018 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 2018 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 2019) 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.
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
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
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.
See this April 2016 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:
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
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.
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
Pesticide Products
A pesticide is any substance or mixture of substances intended for
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:
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 2009, 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 2010 provided additional restrictions to reduce potential harm for these products.
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 1401 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 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.
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 2017. The City of Detroit repealed its requirement in March 2017. 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.
Canadian Labeling of Bedding
However, recently the Government of Ontario has approved the revocation of the Upholstered and Stuffed Articles regulation under the Technical Standards and Safety Act, 2000, effective July 1, 2019. 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
Cushions
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
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
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 1-888-463-6332 or AskCVM@fda.hhs.gov.
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
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
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 1018 . 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
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.
In 2017 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.
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