| Public Health Service Food and Drug Administration |
| Kansas City District Southwest Region 11630 West 80th Street Lenexa, Kansas 66214-3340 Telephone: (913) 752-2100 |
Department of Health and Human Services
November 23, 2011
HAND DELIVERED
WARNING LETTER
Ref. KAN 2012-02
Neil Thompson
President and CEO
Hill’s Pet Nutrition, Incorporated
400 SW 8th Street
Topeka, Kansas 66603
President and CEO
Hill’s Pet Nutrition, Incorporated
400 SW 8th Street
Topeka, Kansas 66603
Dear Mr. Thompson:
This letter concerns Hill’s Pet Nutrition’s marketing of the Science Diet® Healthy MobilityTM Adult Dry Dog Food (“the Healthy Mobility Diet”)[1]. The Food and Drug Administration (FDA) reviewed the label and labeling of this product, including statements made on your website at the Internet addresses www.hillspet.com and www.sciencediet.com. Based on claims made by Hill’s Pet Nutrition for this product, the Healthy Mobility Diet is a drug under section 201(g)(1)(B) of the Federal Food, Drug and Cosmetic Act (“FD&C Act”), [21 U.S.C. § 321 (g)(1)(B)], as it is intended for use in the mitigation and treatment of joint disease in dogs. As discussed below, this product is an unapproved new animal drug and your marketing of it violates the FD&C Act.
The Healthy Mobility Diet bears the following claims on its label:
- “Tested nutrition to enhance active mobility in just 30 days”
- “Improves joint flexibility in just 30 days”
- “Enhance active mobility in just 30 days
Vital fatty acids
Optimal levels of Omega-3 fatty acids to enhance overall mobility”
- “Improve joint flexibility in just 30 days
Omega-3 fatty acids plus Glucosamine & Chondroitin Sulfate
Natural key building blocks of healthy cartilage and joint function”
The product’s label also bears the statement, “For more information about our precisely balanced nutrition and about other Hill’s® Science Diet® pet foods visit www.sciencediet.com.” This link takes a consumer who accesses it to a page on the hillspet.com website: http://www.hillspet.com/products/science-diet.html?bmUID=1321892578734.
FDA acknowledges that the claims on the Hill’s Healthy Mobility Diet label – “enhance active mobility” and “improves joint flexibility” – appear to be claims that the product affects the structure or function of the body (“structure/function claims”), and the FD&C Act permits foods to make appropriate structure/function claims.
Some structure/function claims, however, imply that the product has an impact on disease. Although a food may make claims that refer to the product’s ability to maintain healthy structure or function, structure/function claims that imply the product is intended to diagnose, cure, mitigate, treat, or prevent disease are classified as “disease claims” and the product for which the claims are made is regulated as a drug.[2] FDA evaluates the context in which a structure/function claim is made to determine whether it is a disease claim. See 21 C.F.R. §101.93(g).[3]
The Hill's Pet Nutrition website provides ample context showing that the Healthy Mobility Diet is intended to treat or mitigate joint disease in dogs. The content on your website implies that the Healthy Mobility Diet has an effect on joint disease, including arthritis, by referring to identifiable characteristics of the disease. Reference to a characteristic set of signs or symptoms of a disease, even in the absence of the name of the disease, can be understood as a reference to the disease. See 21 C.F.R. 101.93(g)(2)(ii). The following lay terminology is used on your website to describe the “early signs of joint health issues”:
- “Slow to get up or down”
- “Lagging behind while walking”
- “Longer recovery time after play or exercise”
- “Less playful, running less or less active in general”
These signs are consistent with and indistinguishable from the characteristic signs and symptoms of arthritis, a broad spectrum of joint diseases with numerous etiologies. For instance, a page on your website entitled “Arthritis and Joint Pain” states that “If your dog has arthritis, the first thing you'll notice is that he or she finds movement difficult and is reluctant to walk, run and jump.”
Numerous other statements made on the Hill’s Pet Nutrition website to promote the Healthy Mobility Diet indicate that it is intended to mitigate or treat disease. FDA has defined “disease,” in reference to human foods, as “damage to an organ, part, structure, or system of the body such that it does not function properly”. See 21 C.F.R. §§101.14(a)(5), 101.93(g)(1). The Healthy Mobility Diet pages on your website describe the condition for which the product is intended to be used as “joint health issues,” a “joint health or flexibility issue,” “joint health issues or mobility problems,” or “quality-of-life changes due to mobility problems.” Use of the words “problems” and “issues” suggest a state in which joints do not function properly, and indicate that your product is intended for dogs with joint disease (e.g. arthritis), rather than dogs with normal or healthy joint function. Further, several web pages for the Healthy Mobility Diet describe or list the “early detection” or “warning signs” of joint health issues, terms that are generally used in reference to early identification of disease and are of questionable relevance to the maintenance of normal function in a healthy dog. The website’s assertion that one in five dogs has joint health issues or mobility problems is identical in magnitude to the estimated proportion of 20% of adult dogs one year of age or older that have osteoarthritis.[4] a search with the term “arthritis” on the home page of the Hill’s Pet Nutrition website returned direct links to the Healthy Mobility Diet products.
Audio/visual segments on the Healthy Mobility Diet product-specific webpage reinforce the implication that the Healthy Mobility Diet is intended for use in dogs with joint disease. For instance, one segment contains a dramatized testimonial from a veterinarian that shows a dog exhibiting signs and symptoms consistent with joint disease and seeking treatment from the veterinarian, who states that she recommends the Healthy Mobility Diet for dogs that are “starting to have trouble getting around.” The segment goes on to suggest that 30 days after the veterinarian recommends the Healthy Mobility Diet for the dog, the dog returns to the clinic with improved flexibility and mobility as evidenced by the dog running and jumping over another dog and jumping up on the veterinarian with its front legs on her shoulders.
Because Science Diet® Healthy Mobility TM Adult Dry Dog Food is intended to mitigate or treat joint disease in dogs, it is a drug within the meaning of section 201(g)(1)(B) of the FD&C Act, [21 U.S.C. § 321 (g)(1)(B)]. The product is also a new animal drug under section 201(v) of the FD&C Act, [21 U.S.C. § 321(v)], because it is not generally recognized among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling. It is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing under sections 512, 571, and 572 of the FD&C Act [21 U.S.C. §§ 360b, 360ccc, and 360ccc-1]. Therefore, the product is unsafe within the meaning of section 512(a) of the FD&C Act, [21 U.S.C. §360b(a)], and is adulterated under section 501(a)(5) of the FD&C Act [21 U.S.C. §351(a)(5)]. Introduction of an adulterated drug into interstate commerce is prohibited under section 301(a) of the FD&C Act [21 U.S.C. §331(a)].
This letter is not intended to be an all-inclusive review of Hill’s Pet Nutrition’s products and their promotion. FDA has significant concerns about the promotion of other pet foods marketed by your firm. We strongly encourage you to contact Eric Nelson, Director of the Division of Compliance, at the FDA’s Center for Veterinary Medicine to arrange a meeting to discuss these concerns. It is your responsibility to ensure that all of your products are in compliance with the FD&C Act and its implementing regulations. Failure to promptly correct the violations specified above may result in enforcement action without further notice. Enforcement action may include seizure of violative products and/or injunction against the manufacturers and distributors of violative products.
You should notify this office, in writing, within fifteen (15) working days of the receipt of this letter of the steps you have taken to bring your firm into compliance with the law. Your response should include any documentation necessary to show that correction has been achieved. If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the date by which the corrections will be completed. Include copies of any available documentation demonstrating that corrections have been made.
Please send your response to Eric Nelson at the address below and copy me at the address above.
Eric Nelson
U.S. Food and Drug Administration
Center for Veterinary Medicine
Division of Compliance
7519 Standish Place
Rockville, MD 20855
Tel: (240) 276-9201
Sincerely,
/S/
John W. Thorsky
District Director
Kansas City District
[1] This letter covers any products marketed under the Healthy Mobility name, including Science Diet® Healthy Mobility™ Original, Science Diet® Healthy Mobility™ Large Breed, and Science Diet® Healthy Mobility™ Small Bites.
[2] Foods are also permitted to make claims to prevent diseases resulting from essential nutrient deficiencies. This exception does not apply to the Healthy Mobility Diet because glucosamine, chondroitin sulfate, and Omega-3 fatty acids are not recognized as essential nutrients for the production of healthy cartilage or joint function.
[3]Although 21 C.F.R. §101.93 applies to claims for dietary supplements, FDA advised in the preamble to the rule
“that for consistency, the agency is likely to interpret the dividing line between structure/function claims and disease claims in a similar manner for conventional foods as for dietary supplements.” 65 FR 1000 at 1034. We are applying the rule’s principles, as appropriate for animal food, to determine whether the claims you make for the Healthy Mobility Diet are implied disease claims.
[4]Roush, J.K., et al., Multicenter veterinary practice assessment of the effects of omega-3 fatty acids on osteoarthritis in dogs. J Am Vet Med Assoc, 2010. 236(1): p. 59-66.
No comments:
Post a Comment