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Posted October 24, 2012

FDA Seizes Many Supplements from New York Company Due To Drug Claims

On October 23, 2012, U.S. Marshalls, acting on behalf of the FDA, seized dietary supplements and unapproved drugs from Confidence, Inc., a supplement manufacturer in Port Washington, N.Y. The products included dietary supplements Dr. Brain, pH Balance, Fe-Mon-9, Glucosamine Plus, and Prostate-7, which were promoted as treatments for diseases and conditions such as senile dementia, atherosclerosis, kidney dysfunction, osteoarthritis, and several types of cancer. The company's Full Bloom product was found to be an unapproved drug.

The supplements, which did not conform to any monographs and were not approved as new drugs, were also found to be misbranded because the labels did not provide adequate directions for use as drugs.

In addition, the products were not manufactured according to Current Good Manufacturing Practices for dietary supplements.

Dr. Brain contains huperzine A, phosphatidyl serine and Ginkgo biloba extract. It was promoted for the prevention and treatment of dementia.

(See's Reviews of Huperzine A Supplements and Ginkgo Biloba Supplements for tests of related products.)

pH Balance contains tea polyphenols, fenugreek extract, bilberry extract, Gymnema sylvestre extract, spirulina extract and bitter melon extract, plus zinc, selenium, vanadium and chromium picolinate. It was promoted for weight loss and blood sugar and cholesterol support.

(See's Reviews of Green Tea Supplements, Chromium Supplements and Zinc Supplements for tests of related products.)

Fe-Mon-9 contains red clover extract, black cohosh extract, damiana leaf extract, lycopene, dong quai root extract, hyaluronic acid, pregnenolone, dehydroepiandrosterone, soy isoflavones, L-arginine and L-lysine. It was promoted for sexual, menstrual, skin and bone health.

(See's Reviews of Menopause Supplements, Lycopene Supplements, and L-Arginine Supplements for tests of related products.)

Glucosamine Plus contains glucosamine hydrochloride, chondroitin sulfate, hyaluronic acid, curcumin extract, boswellia extract and white willow bark extract. It was promoted for joint and immune health.

(See's Review of Glucosamine and Chondroitin Supplements for tests of related products.)

Prostate-7 contains pine bark extract, Cistanche tubulosa, L-arginine, saw palmetto extract, pumpkin seed extract, American wild yam extract, lycopene and zinc. It was promoted for testosterone health and prostate function.

(See's Review of Saw Palmetto Supplements for tests of related products.)

Full-Bloom contains fenugreek extract, kudzu extract, fennel seed extract, dong quai root extract, pregnenolone, dehydroepiandrosterone, blessed thistle extract, hops extract, saw palmetto extract, chromium picolinate and zinc. It was promoted for growth and maintenance of breast tissue.

(See's Review Article on Breast Enhancement Supplements for more information about some of these ingredients.)

Confidence, Inc.received a warning letter from the FDA in September 2011 for manufacturing violations and promoting Dr. Brain with Huperzine A, ph Balance, Glucosamine Plus, and Full-Bloom Topical Breast Cream as drugs.

Find more information on the FDA's website by using the link below.