U.S. Marshals recently seized dietary supplements and unapproved drugs from Confidence, Inc, a Port Washington company, at the request of the U.S. Food and Drug Administration.
The products seized include Dr. Brain, pH Balance, Fe-Mon-9, Glucosamine Plus, and Prostate-7, all dietary supplements, and Full-Bloom, a drug. According to the FDA, Confidence had maintained that these products could be used to treat or cure specific diseases or conditions, such as senile dementia, brain atrophy, atherosclerosis, kidney dysfunction, gangrene, depression, osteoarthritis, and dysuria as well as several types of cancer, including lung, cervix and prostate.
Officials say that when companies make the claim that a product prevents, treats, cures, or mitigates disease, they must demonstrate to the FDA that this product is safe and effective for the particular claim.
However, according to the FDA, Confidence’s products "did not conform to any monograph." What’s more, Confidence had not filed or received approval of a new drug application. Officials say the products are not generally recognized as safe and effective for their recommended uses. For these reasons, the FDA says the products are unapproved new drugs. The agency also maintains that the products are misbranded drugs as their labeling does not provide adequate directions for their use as drugs.
"This firm made unfounded claims to consumers," said Melinda K. Plaisier, FDA’s acting associate commissioner for regulatory affairs, in a statement. "Products with unapproved disease claims are dangerous because they may cause consumers to delay or avoid legitimate treatments."
Request for comment was not immediately returned.
According to the company’s website, it maintains offices on Haven Avenue, corporate headquarters upstate New York, and conducts research and production in New Jersey.
Officials also say that products were not manufactured in accordance with the current good manufacturing practice (cGMP) regulations for dietary supplements.
The FDA had warned Confidence, Inc. that its products and manufacturing processes violate federal law.
"The FDA is committed to protecting consumers from the dangers of unapproved products on the market," Plaisier said. "We will continue to take aggressive enforcement actions against companies that do not meet federal standards for safety, effectiveness and quality."
On its website, Confidence states that it “strictly follows Good Manufacturing Practices and FDA 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.”
No illnesses have been associated to date with Confidence, Inc.’s products. Illnesses or serious side effects related to the use of these products should be reported to the FDA at CAERS@fda.hhs.gov or by calling 240-402-2405.
