Inspections, Compliance, Enforcement, and Criminal Investigations
Twin Lab Corporation 31-Jul-01
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
Denver District Office
Bldg. 20-Denver Federal Center
P.O. B0X 25087
6th Avenue & Kipling Street
Denver, Colorado 80225-0087
July 31, 2001WARNING LETTER
RETURN RECEIPT REQUESTED
Ross Blechrnan, President
Twin Lab Corporation
150 Motor Parkway, Suite 210
Hauppauge, New York 11788
Ref # DEN-01-44
Dear Mr. Blechman:
This letter concerns your firm?s marketing and distribution of "Cholesterol-Power," a product promoted as a cholesterol lowering agent. Labels and production batch records collected during our inspection of your firm on February 21, 2001, show this product to be a drug.
"Cholesterol-Power" contains lovastatin, a prescription drug that is not approved for Over-The-Counter (OTC) use and requires monitoring by a physician. The presence of lovastatin in your product is demonstrated by:
- your label list of ingredients that includes "Red Yeast Extract (Monascus Purpureus) and Red Yeast Powder (Monascus purpureus) fermented on rice" which indicates the intended production of lovastatin;
- the "Materials Requirement List FRIDAY OCTOBER 27, 2000 5:35 PM Job: 55273" lists "RED YEAST EXTRACT .4% LOVASTATIN ," as an ingredient; and
- the "Power Herbs In Process Certificate of Analysis" for the product "Cholesterol-Power Bulk," lot number 55273 and batch number 55273, denotes a specification range for "Lovastatin O.157%" and a result of "0.21%."
In its dismissal of the law suit brought against the Food & Drug Administration by Pharmanex, Inc., the U.S. District Court for the District of Utah?s decision of March 30, 2001, case number 2:97 CV262K, affirmed that red yeast rice products which contain lovastatin are subject to regulation as drugs and are not dietary supplements.
In addition, the name "Cholesterol-Power" maybe considered a drug claim in that it implies the product affects the structure/function of the body by the regulation of cholesterol levels, as well as the claim "helps maintain healthy cholesterol levels."
Therefore, "Cholesterol-Power" is a "drug" under section201 (g) of the Federal Food, Drug, and Cosmetic Act (the Act). Moreover, "Cholesterol-Power is a "new drug" [section 201(p) of the Act] because there is no evidence that this product is generally recognized as safe and effective for its intended use. Since this product is a "new drug", it may not be marketed in the United States without an approved new drug application [section 505(a) of the Act].
Furthermore, this drug is misbranded [section 502(f)(1) of the Act] because its labeling fails to bear adequate directions for use for the conditions for which it is offered. The drug is also misbranded because the labeling is false and misleading as it suggests that the product is safe and effective for its intended use when this has not been established [section 502(a)].
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 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 injunction 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 the corrections will be implemented.
Your reply should be sent to the attention of Ms. Shelly L. Maifarth, Compliance Officer, at the above letterhead address.
Thomas A. Allison
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