Does the FDA regulate dog treats?

The FD&C Act defines the term “food” as “articles used for food or drink for man or other animals...and articles used for components of any such article." Courts have interpreted this to mean products or components of a product that are used mainly for nutrition, taste, or aroma.

Furthermore, for purposes of this document, pet food is used to mean food for pets and includes treats and chews for pets. The policies in this guidance apply to finished animal feed and pet food and the ingredients used to manufacture these products.

As opposed to an animal drug, food for animals doesn’t need FDA’s pre-market review to be legally marketed (unless the substance is a food additive ). However, the FD&C Act still requires that food for animals, like food for people, be: Safe to eat; Produced under sanitary conditions; Free of harmful substances; and Truthfully labeled.

All pet foods, including snacks, treats, cookies, chews, rawhides, supplements, and complete and balanced products are regulated by the states under the state’s feed law and pet food regulations, if the state has adopted such legislation.

You must register your facility under this subpart if you are the owner, operator, or agent in charge of either a domestic or foreign facility, as defined in this subpart, and your facility is engaged in the manufacturing/processing, packing, or holding of food for consumption in the United States, unless your facility qualifies for one of the exemptions in § 1.226

Facility means any establishment, structure, or structures under one ownership at one general physical location, or, in the case of a mobile facility, traveling to multiple locations, that manufactures/processes, packs, or holds food for consumption in the United States. [...] The private residence of an individual is not a facility.

Retail food establishment means an establishment that sells food products directly to consumers as its primary function. [...] A retail food establishment's primary function is to sell food directly to consumers if the annual monetary value of sales of food products directly to consumers exceeds the annual monetary value of sales of food products to all other buyers.

Examples of food include: Fruits, vegetables, fish, dairy products, eggs, raw agricultural commodities for use as food or as components of food, animal feed (including pet food), food and feed ingredients, food and feed additives

Requirements that Apply to All Food Businesses In-home Business On-Farm Business Other Businesses/Industry Adulteration yes yes yes Ingredients and Additives yes yes yes Labeling and Marketing yes yes yes State Regulations yes yes yes Food Facility Registration Requirement no no yes

Is your product made in a commercial facility rather than your own home? If you make your product in your own home, then you are exempt. If you do any of the above, you must register your facility with the FDA in compliance with the Bioterrorism Act.

This part does not apply to establishments, including “farms” (as defined in § 1.227 of this chapter ), that are not required to register under section 415 of the Federal Food, Drug, and Cosmetic Act.

The above FSMA requirements apply to companies that must register as an animal food facility because they manufacture, process, pack, or hold animal food for consumption in the United States. Besides having to follow the requirements under FSMA, registered animal food facilities must also comply with current good manufacturing practices (unless an exemption applies).

Very small business means, for purposes of this part, a business (including any subsidiaries and affiliates) averaging less than $2,500,000, adjusted for inflation, per year, during the 3-year period preceding the applicable calendar year in sales of animal food plus the market value of animal food manufactured, processed, packed, or held without sale

Qualified facility means [...] a facility that is a very small business as defined in this part, or a facility to which both of the following apply: [...] ( 2 ) The average annual monetary value of all food sold during the 3-year period preceding the applicable calendar year was less than $500,000, adjusted for inflation.

Except as provided in subpart D of this part , subparts C and E of this part do not apply to a qualified facility. Qualified facilities are subject to the requirements in § 507.7 .

If you are a very small business you must submit a qualified facility attestation to be exempt from certain requirements of the Preventive Controls for Animal Food during your initial food facility registration and subsequent biennial renewal.

The operation of a facility that manufactures, processes, packs, or holds animal food for sale in the United States if the owner, operator, or agent in charge of such facility is required to comply with, and is not in compliance with, section 418 of the Federal Food, Drug, and Cosmetic Act or subparts C , D , E , or F of this part and § 507.7 is a prohibited act

The principal display panel of a food in package form shall bear as one of its principal features a statement of the identity of the commodity.

Ingredients required to be declared on the label of a food [...] shall be listed by common or usual name in descending order of predominance by weight on either the principal display panel or the information panel in accordance with the provisions of § 501.2 .

The label of a food in packaged form shall specify conspicuously the name and place of business of the manufacturer, packer, or distributor. [...] The statement of the place of business shall include the street address, city, state, and ZIP Code; however, the street address may be omitted if it is shown in a current city directory or telephone directory.

The principal display panel of a food in package form shall bear a declaration of the net quantity of contents. This shall be expressed in the terms of weight, measure, numerical count, or a combination of numerical count and weight or measure.

All information appearing on the principal display panel or the information panel pursuant to this section shall appear prominently and conspicuously, but in no case may the letters and/or numbers be less than 1 ⁄ 16 inch in height unless an exemption pursuant to paragraph (f) of this section is established.

Pet food labeling is regulated at two levels. The current FDA regulations require proper identification of the product, net quantity statement, name, and place of business of the manufacturer or distributor, and proper listing of all the ingredients in the product from most to least, based on weight. Some states also enforce their own labeling regulations.

FDA considers a pet food to be adulterated under section 402(a)(1) of the FD&C Act (21 U.S.C. 342(a)(1)) when it is contaminated with Salmonella and will not subsequently undergo a commercial heat step or other commercial process that will kill the Salmonella. The following are some examples of pet food: Dog and cat food, aquarium fish food, raw meat and raw poultry formulations for pets

Pet treats or chews (e.g., dog biscuits, rawhide, pig ears) Vitamins, minerals, and other nutritional supplements intended for dogs, cats, and other pets Pet food ingredients such as animal products, plant protein products, grain products, vitamin and mineral products.

Of the 196 raw pet food samples analyzed, 15 were positive for Salmonella and 32 were positive for L. monocytogenes (see Table 1). [...] Raw pet food 196 15 32 Dry exotic pet food * 190 0 0 Jerky-type treats † 190 0 0

(j) The term “ meat food product ” means any product capable of use as human food which is made wholly or in part from any meat or other portion of the carcass of any cattle, sheep, swine, or goats

under the Federal Food, Drug, and Cosmetic Act (FFDCA), FDA is responsible for ensuring that pet food is safe for animals, produced under sanitary conditions, contains no harmful substances, and is truthfully labeled. [...] Individual States also regulate and inspect pet food, which also minimizes the need for FSIS's program.

Many types of pet foods that were developed in the last few decades are thus not eligible for FSIS certification (e.g., pet jerky, pet treats, pet rawhides, raw pet food, freeze-dried pet food, and prescription pet food). Likely for these reasons, no firms are participating in the FSIS certified pet food program.

AAFCO does not regulate, approve, certify or endorse animal feed or pet food in any way, and AAFCO does not review an individual company’s label or labeling. It is the states, and their designated regulatory officials, which have the legal authority to review a feed or pet food label and approve or disapprove products for distribution in their state

The state will either require registration of labels of products or will require a feed license for the firm that makes the pet food products. [...] The registration scheme involves a fee for each product, either annually or bi-annually, filling out an application with the company contact information, sending in a list of products to be registered and their labels.

Update, August 8, 2024: The FDA-AAFCO MOU will expire on October 1, 2024. The FDA has released a set of documents regarding the transition period after the expiration of the MOU.

steps FDA intends to take in the transition phase after our longstanding Memorandum of Understanding (MOU) with the Association of American Feed Control Officials (AAFCO) expires on October 1, 2024. The relationship between FDA and AAFCO is not ending, but it will be evolving.

AFIC is an interim process providing an additional way for firms to consult with the FDA regarding animal food ingredients and for the FDA to identify potential safety concerns associated with such ingredients, to help support firms developing animal food ingredients for which they may have otherwise utilized the AAFCO ingredient definition process.

Order the 2026 Printed OP AAFCO Digital Publication Package The AAFCO Digital Publication Package is a one-year subscription that includes digital access to: The most current AAFCO Official Publication (Cannot be downloaded) [...] Order the 2026 Paper Copy Members – $85 [...] Non-Members – $150

State Regulations In addition to meeting federal requirements, your animal food business may also have to follow certain state regulatory requirements. The AAFCO webpage has detailed information about your state’s regulatory requirements for animal food.

many states require pet food and specialty pet food registration and/or distributor licensure before offering distribution into that state. [...] Therefore, shipping product into a state in response to an internet purchase constitutes “distribution”.

.01 Scope and Purpose. This chapter establishes the requirements for registering pet food and specialty pet food prior to distribution in Maryland.