Beth & Atlas
Member Since 2010
The FDA’s Center for Veterinary Medicine has issued a draft compliance policy guide outlining how the agency intends to handle pet dietary products that claim to treat specific disease conditions.
The guide is titled “Labeling and Marketing of Nutritional Products Intended for Use to Diagnose, Cure, Mitigate, Treat or Prevent Disease in Dogs and Cats.” As the guide is currently in draft form only, the FDA is asking for people to submit written comments to the address listed at the top of the guide.
According to the FDA, the agency has observed a concerning rise in the number of products marketed as cures for pet disease conditions. These products used to be sold by licensed veterinarians and used under their exact orders, but now any pet store, grocery store, or Internet company can market them directly to the consumer.
The trouble lies in the fact that many of the products are targeted toward specific needs, and some pets may not tolerate the products as well as others.
One example offered by the FDA is how owners might misinterpret a product that claims to control blood glucose. Pet owners might think that the dietary product is all they need to maintain the health of diabetic cats and dogs, when the animals might actually require insulin therapy or other treatment methods.
The draft compliance policy guide lays out the FDA’s considerations when determining whether to take enforcement action if a product is sold or marketed inappropriately. According to the guide, the four main factors that could trigger FDA enforcement action are products that:
Are marketed as alternatives to approved animal drugs.
Contain unapproved food additives, unless the use of that unapproved food additive conforms to uses as listed in the 2012 Official Publication of the Association of American Feed Control Officials.
Include words or vignettes on the label of the product(s) that explicitly or implicitly indicate diseases for which the product is to be used.
Are made directly available to the public circumventing the role of a licensed veterinarian for provision of directions for use, supervision of treatment and evaluation of the treatment outcome.
The guide is titled “Labeling and Marketing of Nutritional Products Intended for Use to Diagnose, Cure, Mitigate, Treat or Prevent Disease in Dogs and Cats.” As the guide is currently in draft form only, the FDA is asking for people to submit written comments to the address listed at the top of the guide.
According to the FDA, the agency has observed a concerning rise in the number of products marketed as cures for pet disease conditions. These products used to be sold by licensed veterinarians and used under their exact orders, but now any pet store, grocery store, or Internet company can market them directly to the consumer.
The trouble lies in the fact that many of the products are targeted toward specific needs, and some pets may not tolerate the products as well as others.
One example offered by the FDA is how owners might misinterpret a product that claims to control blood glucose. Pet owners might think that the dietary product is all they need to maintain the health of diabetic cats and dogs, when the animals might actually require insulin therapy or other treatment methods.
The draft compliance policy guide lays out the FDA’s considerations when determining whether to take enforcement action if a product is sold or marketed inappropriately. According to the guide, the four main factors that could trigger FDA enforcement action are products that:
Are marketed as alternatives to approved animal drugs.
Contain unapproved food additives, unless the use of that unapproved food additive conforms to uses as listed in the 2012 Official Publication of the Association of American Feed Control Officials.
Include words or vignettes on the label of the product(s) that explicitly or implicitly indicate diseases for which the product is to be used.
Are made directly available to the public circumventing the role of a licensed veterinarian for provision of directions for use, supervision of treatment and evaluation of the treatment outcome.