The FDA double standard of food

The FDA’s 2020 FDA Investigations Operations Manual confirms pet food is allowed to violate law.

Each year the FDA compiles a “Investigations Operations Manual”. Per the 2020 manual’s foreword (bold added) “The Investigations Operations Manual (IOM) is the primary operational guide for FDA employees who perform field investigational activities in support of the agency’s public health mission. Accordingly, it directs the conduct of all fundamental field investigational activities. Adherence to this manual is paramount to assure quality, consistency, and efficiency in field operations.” In other words, this manual is the FDA’s official guide for it’s employees on how to properly handle investigations, how to regulate pet food/animal feed.

The 2020 Investigations Operations Manual provides it’s employees the legal definition of food, and as well as provides examples of food that includes pet food.

2.7.1.3.2 – FOOD

The term food as used in section 304(h) of the FD&C Act, is defined in section 201(f) of the FD&C Act, as follows: “(1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.” In addition, a dietary supplement, as defined in section 201(ff) of the FD&C Act, is deemed a food within the meaning of the FD&C Act.

Examples of food include, but are not limited to, fruits, vegetables, fish, dairy products, eggs, raw agricultural commodities for use as food or components of food, animal feed, including pet food, food and feed ingredients and additives, including substances that migrate into food from food packaging and other articles that contact food, dietary supplements and dietary ingredients, infant formula, beverages, including alcoholic beverages and bottled water, live food animals, bakery goods, snack foods, candy, and canned foods.

The 2020 Manual’s definition of food does not define pet food or animal feed any differently than any other food. Thus far, ‘food’ to FDA includes pet food, infant formula, bakery goods and even candy.

But then in Chapter 2 of the Manual – “Regulations” – things change. In sub-chapter 2.7, FDA explains to its employees “Detention Activities“: “Detention protects the public by preventing movement in interstate or intrastate commerce of a food, device, or drug that an authorized FDA representative has reason to believe is adulterated or misbranded…” Right after going into detail about all of the laws FDA should be guided by regulating ‘food’ (such as Federal Meat Inspection Act and the Poultry Products Inspection Act), the FDA manual then includes the section “SUBCHAPTER 2.8 – DENATURING”.

The FDA defines denaturing as:

Decharacterization of a product, whereby it is made unusable for its originally intended purpose.

The “Objective” of denaturing is defined as:

The basic purpose of denaturing is to prevent salvage or diversion of violative materials for human consumption.

Denaturing is to prevent illegal (violative – violating law) ingredients “for human consumption“. What happened to that definition of “food” that included pet food, infant formula and bakery goods?

Without directly stating there are exceptions of law enforcement with some foods, the FDA includes denaturing in their employee instruction manual because denatured foods are allowed to be diverted to pet food/animal feed. Under the same category (Denaturing):

2.8.2 – DIVERSION TO ANIMAL FEED

The indiscriminate use of contaminated food for livestock may constitute a hazard to such livestock, as well as humans. Due to this concern, all diversion request of this nature should be forwarded to Division Compliance for review and consultation with Center for Veterinary Medicine, Division of Compliance to determine if the product may be converted to animal feed.

The pet food/animal feed exceptions to law included in the 2020 manual are:

2.8.2.1 – Rodent or Bird Contaminated Foods

Diversion of rodent or bird contaminated foods for animal feed is authorized only when the contaminated product is treated by heat to destroy Salmonella organisms. In the case of wheat and other grains containing rodent excreta, a suitable heat process may be used or the product is examined bacteriologically and shown not to contain Salmonella.

2.8.2.2 – Moldy Food

If processors insist on salvage of moldy grain or foods for animal feed use, it must be done under proper supervision, and provide for:
1. Treatment by dry heating to destroy viable spoilage microorganisms (generally, this will result in grain having a toasted color and odor), and
2. Evidence it does not contain mycotoxins, and
3. Evidence, by animal feeding studies, the product is safe for animal use.

2.8.2.3 – Pesticide Contamination

Foods contaminated by pesticides residues should not be diverted to animal food use unless a determination is made which assures illegal residues will not result in the food animal or their food products, e.g., meat, milk, eggs.

Most significantly, the FDA approves denatured ingredients contaminated with rodent/bird excreta or mold or pesticides WITHOUT disclosing that information to pet owners. No pet food label/no pet food manufacturer is required to disclose to the consumer if the product was made with ingredients contaminated with any of these FDA’s exceptions to food.

Interestingly, the 2020 Investigations Operations Manual does NOT include the exception of diseased animals and animals that have died other than by slaughter allowed by FDA in pet foods/animal feeds (with no warning or disclosure to pet owners). FDA told us they allow this material in pet food; “we do not believe that the use of diseased animals or animals that died otherwise than by slaughter to make animal food poses a safety concern and we intend to continue to exercise enforcement discretion where appropriate.” But the 2020 Investigations Operations Manual does not address these exceptions to law in pet food. Perhaps the FDA doesn’t want to draw attention to this exception (as it is so horrendous and so illegal it could be foundation for a damaging lawsuit against the agency).

How can pet food be considered ‘food’ by FDA – exampled by FDA alongside of infant formula and bakery goods – yet at the same time be singled out, allowed to contain bird or rat poop, mold, and/or pesticides?

The ONLY food FDA allows to violate law is pet food/animal feed.

Pet owners can send FDA their opinions on denatured illegal ingredients allowed in pet food to: AskCVM@fda.hhs.gov

Wishing you and your pet(s) the best,

Susan Thixton
Pet Food Safety Advocate
Author Buyer Beware, Co-Author Dinner PAWsible
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