DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
St. Louis Branch
12 Sunnen Drive, Suite 122
St. Louis, MO 63143-3800
(314) 645-1167
(314) 645-2969 (FAX)
December 16, 1998
WARNING LETTER
Dear Sir: This letter is in reference to your firm's marketing and distribution of the product, "Arthaffect." Promotional material (labeling) for this product makes therapeutic claims that causes the products to be a drug as defined in Section 201(g) of the Federal Food, Drug, and Cosmetic Act (the Act).
Examples of the claims include the following:
The product is a "new drug" because there is no evidence that it is generally recognized as safe and effective for its intended use [Section 201 (p) of the Act]. Therefore, it may not be legally marketed in this country without an approved new Drug Application [Section 505(a) of the Act].
It is also misbranded because its labeling fails to bear adequate directions for use for the condition for which they offer it [Section 502(f)(l) of the Actl. Its labeling is false and misleading as it suggests that the product be safe and effective for its intended use when, in fact, this has not been established [Section 502(a) of the Act].
This letter is not intended to be an all-inclusive review of all labeling and products your firm markets. It is your responsibility to ensure that all products marketed by your firm are in compliance with the Act and its implementing regulations.
We request that you take prompt action to correct these violations. Failure to promptly correct these violations may result in enforcement action being initiated by the Food and Drug Administration without further notice. The Federal Food, Drug, and Cosmetic Act provides for the seizure of illegal products and for an injlmction against the manufacturer and/or distributor of illegal products.
Please notify this office in writing within fifteen (15) working days of receipt of this letter as to the specific steps you have taken to correct the stated violations. You should also include an explanation of each step being taken to identify and make corrections to assure that similar violations will not recur. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which you will carry out the corrections.
Send your reply to the attention of Andrew H. Paeng, Compliance Officer, 12 Sunnen Drive, Suite 122, St. Louis, MO 63143-3800..