Inspections, Compliance, Enforcement, and Criminal Investigations
Forever Young Products, Inc. 21-Dec-01
DEPARTMENT OF HEALTH AND HUMAN SERVICE
Food and Drug Administration
New Orleans District
6600 Piaza Drive, Suite 400
New Orleans, Louisiana 70127
December 21, 2001
WARNING LETTER NO. 2002-NOL-18
Mr. Earl J. Washington, President
Forever Young Products, Inc.
119 West Mayes Street
Jackson, Mississippi 39213
Dear Mr. Washington:
On August 28, 2001, an investigator with the U.S. Food and Drug Administration (FDA)
conducted an inspection of your firm, located at 119 West Mayes Street, Jackson, Mississippi. The inspection was conducted to determine compliance with FDA?s Current Good Manufacturing Practice (CGMP) regulations for Finished Pharmaceuticals, Title21, Code of Federal Regulations, Parts 210 and 211 (21 CFR 210 & 211). The investigator found that your firm distributes and promotes "Sportif Arthritis Pain Relief," "Forever Young Maxim Heal Antiseptic Cream, "Sportif Sports Injury Pain Relief Triple Action Formula," and "For Ever Young Pure Natural Emu Oil."
This letter is specifically written in reference to the marketing of these products by your firm. Your product labeling, including accompanying brochures, claims that: "Sportif Arthritis Pain Relief? is useful in keeping arthritis pain under control, "Forever Young Maxim Heal Antiseptic Cream" is an antiseptic, antibacterial, and antifungal cream, "Sportif Sports Injury Pain Relief Pure Natural Emu Oil" is useful in treatment of dermatitis, arthritis, hemorrhoids, diaper rash, and psoriasis. Based on these claims, these products are drugs within the meaning of Section 201(g) of the Federal Food, Drug, and Cosmetic Act (the Act).
"Forever Young Maxim Heal Antiseptic Cream" and "For Ever Young Pure Natural Emu oil" are subject to final rules covering topical acne drug products (21 CFR 333.301-350), topical anti-fungal drug products (21 CFR 333.201-280), anorectal drug products (21 CFR 346.1-52), and drug products for control of dandruff, seborrheic dermatitis, and psoriasis (21 CFR 358.701-750). These products fail to meet the requirements of these final rules, and thus, are "new drugs" [Section 505(a) of the Act]. Further, we are not aware of any evidence that the combination of ingredients in "Sportif Arthritis Pain Relief? and "Sportif Sports Injury Pain Relief Triple Action Formula" are generally recognized as safe and effective for the indications contained in their labeling. Thus, "Sportif Arthritis Pain Relief,"" Forever Young Maxim Heal Antiseptic Cream,"
"Sportif Sports Injury Pain Relief Triple Action Formula," and "For Ever Young Pure Natural Emu Oil" are "new drugs" not be marketed as such, since they are not subject to an approved New Drug Application [Section 505(a) and (b) of the Act]. Additionally, these products are misbranded [Section 502(f)(l) of the Act] because their labeling fails to bear adequate directions for the uses for which they are being offered. These products are further misbranded [Section 502(0) of the Act] because the products have not been listed as drugs as required [Section 510(j) of the Act and 21 CFR 207].
You should be aware that drugs must comply with all existing labeling requirements of Section 502 of the Act and in 21 CFR 210 & 211; they must be manufactured by a registered facility and listed with FDA (21 CFR 207); and, they must be manufactured, packaged, labeled, and stored according to CGMP?S (21 CFR 210 & 211).
In addition, we found your products currently are being promoted on an Internet web site
http://www.4everyoungproducts.com. This web site includes statements and representation
similar to those listed on the product labels for "Sportif Arthritis Pain Relief," "Forever Young Maxim Heal Antiseptic Cream, " "Omega Plus Arthritis Formula," "Sportif Sports Injury Pain Relief Triple Action Formula," and "For Ever Young Pure Natural Emu Oil" along with others. The statements represent or suggest these products are intended to be used in the curing, mitigation, treatment, or prevention of disease. Such claims on the Internet may cause these products to be misbranded.
It is your responsibility to assure that all your products are in compliance with federal laws and regulations of marketing of drugs, cosmetics, and dietary supplement products.
This letter is not intended to be an all-inclusive list of deficiencies at your facility. It remains your responsibility to ensure adherence to all requirements of the Act and regulations. You should take prompt action to correct these violations. Failure to correct these violations may result in regulatory action, including seizure and/or injunction, without further notice.
We are aware that at the close of your inspection, on August 28,2001, you made a verbal
commitment to correct observed deficiencies. You should notify this office in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to correct these violations, including an explanation of each step taken to prevent the recurrence of similar violations. If corrective action cannot be completed within 15 working days, please state the reason for the delay and the time by which the corrections will be completed.
Your written response should be directed to the attention of Ms. Rebecca A. Asente, Compliance Officer, at the address above.
Richard D. Debo
Acting District Director
New Orleans District