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Global Evolutions

FDA: Pet Supplements Can't Claim to Treat Diseases

The vet recommended my dog Donkey start taking glucosamine and chondroitin.My Donkey has  hip dysplasia and osteoarthritis. She's my loving puppy, but I must realize that at 9 years, she not the youngest puppy. A couple of weeks ago, she stopped jumping on her favorite chair and would not jump up to cuddle on the couch.

She and I took the next vet appointment we could, and after X-rays, the vet told me she just isn't as young in the hips as she used to be. My vet recommended I give her glucosamine and chondroitin supplements. My vet said I could just give her a smaller dose of a human supplement, but being the supplement-savvy consumer I am (the Council for Responsible Nutrition [CRN] calls me an AlphaWELL), I wanted to go with a supplement that's designed for her.

I'm quite familiar with claims that can be made for human supplements, but was just getting into the pet supplement territory. "Just what is legal here?" I thought.

As scary as it is to think the government can read my mind, FDA seemed to respond to my request by releasing a guide on the marketing of pet nutritional products.

Like human supplements, pet supplements are regulated under the "food" section of FDA. This week, the agency released a new guide on pet nutritional products, basically saying that dog and cat foods (including supplements) are not allowed to say they diagnose, cure, mitigate, treat or prevent diseases, unless they are distributed under a veterinarian's supervision. (It reminds me of the regulatory nature of medical foods.)

The draft compliance policy guide (CPG), Labeling and Marketing of Nutritional Products Intended for Use to Diagnose, Cure, Mitigate, Treat or Prevent Disease in Dogs and Cats," lets FDA staff and industry know how the agency intends to enforce the animal drug provisions of the Federal Food, Drug and Cosmetic Act (FD&C Act).

FDA said nutritional products or therapeutic diets are pet foods that are specially formulated to address specific disease conditions (for example, urinary tract disease in cats). The products were originally only sold through licensed veterinarians, but now the agency said it noticed these products are also being sold directly to pet owners over the Internet, in supermarkets and in pet stores. "This shift in marketing directly to pet owners without veterinary direction, concerns FDA because these products are formulated for specific needs and may not be tolerated by all animals," the draft guidance said.

In the draft guidance, FDA said it does not intend to initiate regulatory actions against these therapeutic  dog and cat food products when all the following factors are present:

  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;
  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 GRAS (generally recognized as safe) ingredients, approved food additives or feed ingredients; and
  9. The label and labeling for such products are not false and misleading in other respects.

Like all other draft guidances, it represents FDA's current thinking; it does not create any laws. But still, according to FDA any joint health products I buy for Donkey at my health food store should not say the words "osteoarthritis" or "hip dysplasia;" they can carry claims, such as "supports healthy joints." If I want foods or supplements for her that specially address osteoarthritis, I should be making another vet appointment.

Find out more about advertising to humans at SupplySide West in the education session, " Truthfully Advertising Your Dietary Supplements: Advertising Claims, Evidence and Self-Regulation ," with speakers Rend Al-Mondhiry, Esq., regulatory counsel, (CRN); and Kathleen Dunnigan, Esq., senior staff attorney, National Advertising Division, Council for Better Business Bureaus, on Wednesday, Nov. 7 at noon to 12:50 p.m.

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