Department of Health and Human Services' logo Department of Health and Human Services

Public Health Service
Food and Drug Administration
Dallas District

 

3310 Live Oak St
Dallas, TX 75204-6191
Telephone: 214-655-5317

June 18, 1998
WARNING LETTER
VIA FEDERAL EXPRESS

Philip A. Duterme, PhD, CEO
Ayurvedic Concepts, Ltd.
6950 Portwest Dr #170
Houston, TX 77024

Ref. No. 98-DAL-WL-38

Dear Dr Duterme:

This letter follows inspections of your firm on February 2, and March 9, 1998, by investigators of the Food and Drug Administration, and is in reference to the promotion, marketing, and distribution of products by your firm.

Promotional literature for your products make the following claims:

Your promotional literature "Ayurvedic Medicine Ancient Roots, Modern Branches" and "Companion Guide" contain numerous disease claims and third-party references that also make disease claims for your products. An example of such claims are those made in "Ayurvedic Medicine" for "Indian Madder": "treat tumors, kidney stones, heart disease, hepatitis and urinary problems", "cancer treatment … similar to the effects of the chemotherapeutic drug 5-fluorouracil", and "treating several types of cancer, including lung, blood (leukemia) and skin (melanoma)."

Some of your products are subject to 21 CFR 330 regarding Over-The-Counter (OTC) Human Drugs. Examples include, but are not limited to, "GastriCare" and "Gasex" which are subject to the "Final Rule for Antacid Products for OTC Human Use" which became effective June 4, 1974 (21 CFR 331). "MindCare" and "Mentat" are subject to the "Final Rule for Stimulant Drug Products for OTC Human Use" which became effective February 29, 1988 (21 CFR 340).

Based on the claims made for these products and their intended uses, these products are drugs [Section 201(g) of the Federal Food, Drug, and Cosmetic Act (the Act)]. They are also new drugs [Section 201(p) of the Act] and may not be legally marketed in the United States without approved New Drug Applications (§505).

These drugs are also misbranded [Section 502(f)(1)] because the labeling fails to bear adequate directions for use and is false and misleading as it suggests that the products are safe and effective for their intended uses when this has not been established [502(a)].

In addition, the promotional literature contains numerous references to "Himalaya Drug Company", "… holistic system of diagnosis and treatment", "herbal medicine", "…truly amazing 'understanding of pharmacology", "…a return to natural products in … pharmaceuticals…", and "consistency that only modern pharmaceutical technology can provide", which could cause the products to be considered to be drugs.

Furthermore, the promotional literature "Companion Guide" includes, in addition to numerous disease claims, a section titled "Pharmacology of the Major Components Used in Ayurvedic Concepts' Natural Formulas". The use of the word "Pharmacology" is not appropriate for dietary supplements because the word is defined as "the science of drugs". The section also makes extensive disease claims for your ingredients.

This letter is not intended to bean 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 the 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 proceedings 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 James R. Lahar, Compliance Offiicer, at the above letterhead address.

Sincerely,
/s/
Elaine R. Crosby for
Joseph R. Baca
District Director

This page was posted on August 20, 2006.

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