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Public Health Service
Food and Drug Administration

 

Center for Drug Evaluation and Research
Office of Compliance (HFD310)
Metropark North I, 7520 Standish Pl
Rockville, MD 20855

June 13, 2002
WARNING LETTER

President & Owner,
Herbtech
204 Grandview
Church Hill, TN 37642

Ref. No. 02-HFD-312-15

Dear Sir or Madam:

This letter. is written in reference to your firm's marketing of various products, some of which purport to contain ephedra. or ma huang, that are promoted on your Internet website, www.rxherbstore.com, as alternatives to illicit street drugs.

Your Internet website, from which these products may be ordered, promotes these products with brand names or claims, or both, indicating that they are useful as street drug alternatives, as follows:

ENERGIZING HERBS:

RELAXATION HERBS:

LIQUID HERBS:

MIND EXPANDING HERBS:

FDA is aware that some street drug alternatives are being marketed as dietary supplements. FDA does not believe that street drug alternatives are intended to be used to augment the diet, to promote health, or to reduce the risk of disease. Accordingly, street drug alternatives are not intended to supplement the diet and are not dietary supplements. In March of 2000, FDA made available the document, "Guidance for Industry Street Drug Alternatives". This document is available at the Internet website, http://www.fda,gov/cder/guidance/index.htm.

Based on, the claims cited above, the products are "drugs" as defined in Section 201(g) of the Federal Food, Drug, and Cosmetic Act (Act). Moreover, they are also "new drugs" (Section 201(p) of the Act) because there is no evidence that these products are generally recognized as safe and effective for their intended uses. Under Section 505 of the Act, a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved new drug application (NDA) is in effect for such drug. Since these products are not the subjects of approved NDAs, they may not be marketed in the United States and their continued marketing violates Section 505 of the Act.

This letter is not intended to be an all-inclusive review of your Internet website nor all labeling and products your firm markets. The violation described above is not intended to be an all-inclusive list of violations concerning your firm and its products. You are responsible for ensuring that all products marketed by your firm are in compliance with applicable United States laws.

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 seizure of illegal products and for an injunction against the manufacturer and/or distributor of illegal products.

You must notify this office in writing within fifteen (15) working days of your receipt of this letter as to the specific actions you have taken to correct the stated violations. You should also include an explanation of each step you have taken 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 made.

Address your reply to the Food and Drug Administration, Division of Labeling and Nonprescription Drug Compliance (HFD-310), 7520 Standish Pl, Rockville, MD 208515, Attn: Joel Aronson.

Sincerely
/s/
David J. Horowitz, Esq.
Acting Director,
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration

This page was posted on May 4, 2006.

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