Animal dietary supplement manufacturers and distributors beware of FDA warning letters

DOES FDA REGULATE DIETARY SUPPLEMENTS FOR ANIMALS?

 

Animal dietary supplement manufacturers and distributors can run afoul of FDA prohibitions against “drug” claims and receive an FDA warning letter, unless they understand how FDA regulates animal dietary supplements.

Does FDA regulate dietary supplements for animals?

With considerable clairvoyance, FDA answers this question directly on its website:

Yes. However, dietary supplements for animals are not recognized as a class of products. Under the Federal Food, Drug, and Cosmetic Act, products marketed as dietary supplements for use in animals are classified as either foods or drugs, depending on their intended use.

The basic regulatory categories to understand are:

  • foods
  • drugs
  • dietary supplements
  • cosmetics
  • medical devices

There are others (such as biologics), but these are the main ones that we typically see.

Animal Foods vs. Animal Dietary Supplements vs. Animal Drugs

The federal Food, Drug & Cosmetic Act defines defines food as “articles used for food or drink for man or other animals…”

According to FDA:

any article that is intended to be used as an animal feed ingredient, to become part of an ingredient or feed, or added to an animal’s drinking water is considered a “food” and thus, is subject to regulation.

Failure to meet the requirements of federal food regulations can result in a product being deemed adulterated or misbranded.

Although there are some specific legal rules applicable to animal feed, the main point here is to distinguish foods from dietary supplements from drugs.

Adulteration refers to such things as food packaged or held under unsanitary conditions.  This is serious.  The more common problem is “misbranding,” where the product’s overall labeling is considered false or misleading in any way, or fails to include the required information.

The place where may dietary supplements get into legal trouble with FDA is where they are essentially making drug claims for their supplements (including dietary supplements for animals, and therefore misbranding their products.

Adulteration includes, among other things, food packaged or held under unsanitary conditions, food or ingredients that are filthy or decomposed, and food that contains any poisonous or deleterious substance. A food may be considered misbranded if its labeling is false or misleading in any way or fails to include required information.

Food Additives

In addition to the above categories, there are also food additives, which are separately regulated.  Essentially food additives are added to or expected to become a component of animal food, either directly or indirectly.  FDA notes:

Typical feed ingredients such as forages, grains, and most minerals and vitamins are generally recognized as safe (GRAS) as sources of nutrients.

The legal definition for a food additive is found in Section 201(s) of the FFDCA.   In Section 409 of the FFDCA, a food additive is unsafe unless its use conforms to an existing food additive regulation.  Further, a substance that does not become a component of final animal food product but that is used, for example, in preparing an ingredient of the animal food to give it a different flavor, texture, or other characteristic may also be a food additive.

As we said, food additives have special rules.

Drug Claims for Animal “Supplements”

As with cosmetics, which can also be drugs if drug claims are made, animal feeds or foods can simultaneously be a food and a drug.

The key is the intended use of the product. Intended use can be shown by labeling claims, advertising matter, historical use, oral or written statements, and by the circumstances under which the article is offered and used, regardless of labeling or advertising.

Some clients come to us with an FDA warning letter in hand.  At that point, a full compliance review is advisable.  FDA can look at the company’s website once it has issued the warning letter and, if it still sees violations – even if there were not flagged in the original warning letter – initiate swift and severe enforcement without notice to the company.  Second-time violators typically do not fare well.

The better approach is to do the compliance review before getting to the point where a warning letter is issued.  Cleaning up claims is the best internal policy.

FDA’s CVM Policy & Procedures Manual has many useful pointers for those in the animal foods business. The misbranding danger, though, is that the manufacturer could be seen as marketing an unapproved animal drug. This is a “drug” that is:

  • intended for use in animals; and
  • meets the definition of “new animal drug” in the Federal Food, Drug, and Cosmetic (FD&C) Act; but
  • does not have legal marketing status, meaning FDA has not approved, conditionally approved, or indexed the drug.

A drug, according to the federal Food, Drug & Cosmetic Act includes: “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals.”

Yes, animals are included. But you have to learn more about major species (such as cattle, horses, pigs, chickens, turkeys, dogs, and cats) and minor species (such as ferrets, eagles, fish, and sheep), and about specific rules that apply to various species and uses.

Intended Use

We said before that FDA looks to “intended use” of the product to see whether it should be categorized as dietary supplement or drug.  This means FDA is looking to a company’s marketing (including the claims on its websites and brochures) for evidence of what use was “intended.”

FDA gives some helpful example:

  • When a company sells bottled water for people to drink as a beverage, the water is not a drug. But if the company sells those same bottles of water as a cure for cancer in dogs, then the water is a drug under the FD&C Act because the intended use is to cure a disease (cancer) in dogs….
  • When a company sells a product claiming it makes cows ovulate at the same time, the product is a drug. Although it’s not treating or preventing a disease in the cows, the product’s intended use is to change how their bodies function, which makes it a drug under the FD&C Act.

It’s similar to the way claims for a shampoo can make it a cosmetic (clean your hair) or drug (treat dandruff).

Off-Label Use

Veterinarians may recommend a particular dietary supplement to help treat a pet’s disease or condition.  In fact, this is quite common.  That in itself does not convert the supplement into a drug.

However, as FDA points out in I read online that a supplement can treat my dog’s illness, if the product itself makes claims to treat a disease (i.e., on the label itself or in the product labeling, which includes the company website), then the manufacturer is making a drug claim.  In such case, the manufacturer is likely to receive an FDA warning letter for marketing an unapproved animal drug.

No Structure/Function Claims for Animal Dietary Supplements

Unlike human dietary supplements, animal supplements cannot make structure/function claims.

So, for example, the manufacturer or distributor of an animal dietary supplement cannot say: “supports joint health”  — even if the product contains glucosamine and if the very same claim could be made for a similar human product.  FDA might decline to exercise enforcement discretion, given the panoply of pet products talking about joint health; but this does not insulate any given manufacturer from risk.

Similarly, if the manufacturer includes, on its website, references to scientific articles, or, testimonials from grateful customers that the company’s animal supplement cured the pet’s cancer, diabetes, arthritis, or any other disease or condition, FDA can flag these as drug claims.

According to recent FDA guidance, the only claims the animal supplement can make, are those that focus on nutrition, taste or aroma.

The Cascade of Legal Consequences

In law school we would talk about the “parade of horribles,” which referred to all the consequences that would ensue from a particular legal decision if the judge went a certain way on a ruling of law.  Here, the cascade of consequences is that once the company receives the warning letter, it is squarely within FDA cross-hairs. As suggested, this means the agency is likely to be less tolerant if it finds a second round of violations.

Further, FTC may initiate a CID (civil investigative demand).  Once FTC gets involved, it may ultimately that the company disgorge all profits the company has received from marketing the product.  Obviously this can tank a company financially and is much more severe than a warning letter.

Private plaintiffs may bring actions on the heel of FDA and/or FTC activity.  Class actions may ensue, seeking to extract a settlement from the company for product claims that cannot be substantiated.

Legal prevention is the best medicine.

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