Import Alert 66-15
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(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).
Import Alert # 66-15
Published Date: 03/18/2011
Type: DWPE
Import Alert Name:
"Detention Without Physical Examination of Padma 28 Tablets"
Reason for Alert:
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.
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, may be detained without physical examination.
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, may be detained without physical examination.
Product Description:
Padma 28 Tibetan Herbal Food Supplement
Charge:
"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)" OASIS Charge Code - UNAPPROVED and "is misbranded in violation of Section 502(f)(1) in that its labeling lacks adequate directions for its intended uses."
OASIS Charge Code - DIRECTIONS
OASIS Charge Code - DIRECTIONS
SWITZERLAND
Padma A G
Date Published : 09/10/2009
unknown , Zurich, SWITZERLAND
66 - - - -- Human and Animal Drugs
Date Published: 09/10/2009
UNITED STATES
Alta Wellness Systems Inc
Date Published : 09/10/2009
1654 University Ave # C , Berkeley, CA 94703-1455 UNITED STATES
66 - - - -- Human and Animal Drugs
Date Published: 09/10/2009
George Weissman, Inc
Date Published : 09/10/2009
unknown , Berkeley, CA 00000 UNITED STATES
66 - - - -- Human and Animal Drugs
Date Published: 09/10/2009
Padma Marketing Corp
Date Published : 09/10/2009
2490 Channing Way # 402 , Berkeley, CA 94704-2210 UNITED STATES
66 - - - -- Human and Animal Drugs
Date Published: 09/10/2009
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