IA#66-15 --- 2/18/88
BACKGROUND:
This product has been seized in three districts.
SAN-DO filed an injunction on November 9, 1987, enjoining the following three
firms from directly or indirectly importing, processing, packing, labeling,
distributing, promoting or advertising Padma 28:
George Weissman Inc.
Berkeley, CA
Padma Distribution Corporation
Berkeley, CA
Central Health Network
Berkeley, CA
Padma 28 Tibetan Herbal Food Supplement ("Padma 28") is purported to be a
combination of 22 herbs in tablet dosage form. The product is manufactured by
Padma A.G., Zurich, Switzerland, and is imported into the United States by
George Weissman, Inc., Padma Distribution Corporation, and Central Health
Network which share a common tie. George Weissman has in fact stated that he
holds exclusive rights to this product in North America.
Padma 28 enters the Country without literature. However, oral and written
claims for Padma 28 have subsequently been made by these companies.
Specifically the product has been promoted for use in the improvement of
cardiovascular circulation; reduction in levels of cholesterol and blood
lipids; reduction of platelet aggregation; normalization of immunological
responses; cure, mitigation, treatment and prevention of atherosclerosis;
bronchial asthma; skin allergies; acute and chronic viral and bacterial
infections; peripheral arterial occlusion; hepatitis; angina pectoris; chronic
coronary heart disease; hyperlipidemia; pyelitis; liver damage; hemorrhoids;
upper belly syndrome; depression; impaired intellectual function; lethargy;
myocarditis; pharyngitis; sinusitis; otitis media; bronchitis; pneumonia; and
chest pains.
GUIDANCE:
Although slight variations in the label may be found, any product bearing the
name Padma 28 should be considered the same drug.
Please inform your local U.S. Customs and Postal Service officials of our
interest in these types of products, especially mail entries.
When found, shipments of Padma 28 tablets, should be detained, charging: "The
article is subject to refusal of admission pursuant to Section 801 (a)(3) in
that it appears to be a new drug within the meaning of 201(p), without an
approved new drug application pursuant to Section 505(a) and is misbranded in
violation of Section 502(f)(1) in that its labeling lacks adequate directions
for its intended uses."
Contact Rod Chu, Compliance Officer, at FTS 556-1521 if any of the above firms
attempt to import Padma 28 into the U.S.
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