The FDA is very clear, food is not a drug. Food cannot make claims it treats or prevents a disease. That is, unless it is pet food.
According to federal regulations, “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals” is a drug. While some would argue food can treat or prevent disease, the FDA only considers drugs as the ‘thing’ that can actually cure or prevent disease. Drugs are subject to FDA approval through a lengthy and costly process. Drugs.com states “It takes on average 12 years and over $350 million to get a new drug from the laboratory onto the pharmacy shelf.”
But…we’re talking about pet food…which has its own set of rules. The FDA has just announced another of their (not so popular) Compliance Policies, this one in reference to “Labeling and Marketing of Nutritional Products Intended for Use to Diagnose, Cure, Mitigate, Treat or Prevent Disease in Dogs and Cats.” The Draft Compliance Policy isn’t favorable to pets.
Quoting…(bold added) “FDA does not generally intend to recommend or initiate regulatory actions against dog and cat food products that are labeled and/or marketed as intended for use to diagnose, cure, mitigate, treat, or prevent diseases… when all the following factors are present. Specifically:
(1) Manufacturers make the products available to the public only through licensed veterinarians or through retail or Internet sales to individuals purchasing the product under the direction of a veterinarian;
(2) manufacturers do not market such products as alternatives to approved new animal drugs;
(3) the manufacturer is registered under section 415 of the FD&C Act (21 U.S.C. 350(d));
(4) manufacturers comply with all food labeling requirements for such products (see 21 CFR part 501);
(5) manufacturers do not include indications for a disease claim (e.g., obesity, renal failure) on the label of such products;
(6) manufacturers limit distribution of material with any disease claims for such products only to veterinary professionals;
(7) manufacturers secure electronic resources for the dissemination of labeling information and promotional materials such that they are available only to veterinary professionals;
(8) manufacturers include only ingredients that are general regarded as safe (GRAS) ingredients, approved food additives, or feed ingredients defined in the 2012 Official Publication of the Association of American Feed Control Officials (AAFCO) for the intended uses in such products; 1 and
(9) the label and labeling for such products are not false and misleading in other respects.”
In other words, pet foods are allowed to be a drug. Without extensive clinical trials, pet foods are allowed to diagnose, cure, mitigate, treat or prevent disease. Just as with drugs, these pet foods are sold only through doctors (veterinarians) and the ‘cure this/prevent that’ marketing is provided only to veterinarians (not to pet food consumers). Prescription pet foods – sold to prevent, treat, or cure a disease – can be sourced from inferior waste ingredients (utilizing other FDA Compliance Policies). Prescription pet foods are not required to state actual protein, carbohydrate or fat contents. And prescription pet foods are allowed to include ingredients sourced from China with no statement for the consumer on the label.
Pet foods…the only FDA approved non-drug drug.
Wishing you and your pet(s) the best,
Pet Food Safety Advocate
Author, Buyer Beware
Co-Author Dinner PAWsible
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