October 23, 2012
PORT WASHINGTON, N.Y. Federal authorities have seized dietary supplements and unapproved drugs from Confidence, Inc. after the nation's food and drug regulator found the New York-based company was making unfounded claims that it could cure or treat such diseases as brain atrophy, kidney dysfunction and gangrene.
U.S. Marshals seized a drug, Full-Bloom, and a number of dietary supplements including Dr. Brain, pH Balance, Fe-Mon-9, Glucosamine Plus and Prostate-7, the FDA announced Tuesday.
FDA said Port Washington, N.Y.-based Confidence was marketing unapproved drugs and misbranding them because their labeling failed to provide adequate directions for use as drugs. The company also was found by the government agency to be violating current good manufacturing practice (cGMP) regulations for dietary supplements.
"This firm made unfounded claims to consumers. Products with unapproved disease claims are dangerous because they may cause consumers to delay or avoid legitimate treatments," said Melinda K. Plaisier, FDAs acting associate commissioner for regulatory affairs, in a statement. "The FDA is committed to protecting consumers from the dangers of unapproved products on the market. We will continue to take aggressive enforcement actions against companies that do not meet federal standards for safety, effectiveness and quality."
FDA disclosed no illnesses have been linked to Confidence's products, though the agency encouraged consumers to report any illnesses or serious side effects associated with them.
Confidence wasn't immediately available by phone Tuesday afternoon, and the company didn't immediately respond to an emailed request for comment.
Problems Date Back to 2010 Inspection
The seizure appears to have been years in the making.
In the fall of 2010, FDA inspected Confidence's dietary supplement facility in Port Washington, discovering a number of regulatory violations that included unfounded disease claims. Some of the other infractions included failing to make and maintain written procedures for various purposes, neglecting to establish certain specifications, and failing to collect and hold reserve samples for dietary supplements that are distributed.
FDA advised the company of the numerous violations of cGMP regulations in a letter submitted on July 7, 2011 to Confidence President Helen Chian. In the letter, FDA also acknowledged receiving a response from Confidence following its inspection. However, the agency declared the company failed to support its contentions that it would take corrective actions.
Company Claims on Website It's in Compliance
On its website, Confidence asserts that it "strictly follows Good Manufacturing Practices and FDA Manufacturing Practices to set an example as a model in the health supplement industry in terms of top quality, and the highest efficacy for better health." Confidence says it has more than 150 products marketed in about 21 countries with sales offices in nine different regions and countries.
Listed as the company's founder, chief herbal scientist and alternative medicine doctor, "Dr. Gin Harding is one of the first in the world to combine Chinese medicine and Western medicine to formulate highly effective nutritional supplements," according to Confidence's website.
The company's products range from those to help women fight the effects of aging to a supplement intended to assist the brain in functioning: Dr. Brain.
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