FDA WARNING_LETTER - Drs. Foster and Smith, Inc.

This FDA Warning Letter, dated MIN 08-17, addresses Drs. Foster and Smith, Inc. regarding the marketing of "Joint Care Primary 1," "Joint Care Primary Plus 1," "Joint Care Advanced 2 with MSM," "Joint Care Premium 3," "Joint Guard Treats," and "Premium Plus Omega-3 Gel Caps."

The FDA determined these products are unapproved new animal drugs under the Federal Food, Drug, and Cosmetic Act. This classification is based on statements on the firm's website (http://www.DrsFosterSmith.com) and metatag keywords, which indicate the products are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in dogs and cats. Examples of such claims include "manage the crippling effects of osteoarthritis," "healing the damage," "builds cartilage," "reduce pain," "reducing the signs of feline arthritis," "treat arthritis in dogs," and "decrease inflammation in arthritic dogs and cats." Metatag keywords like "arthritis dog treatment" and "cat arthritis treatment" further support this intended use.

Since these products are not generally recognized as safe and effective for their intended uses and lack approved New Animal Drug Applications (NADAs), they are considered unsafe under section 512(a) and adulterated under section 501(a)(5) of the Act. Introducing adulterated drugs into interstate commerce is unlawful under section 301