At the request of the U.S. Food and Drug Administration, U.S. Marshals recently seized dietary supplements and unapproved drugs from Confidence, Inc., of Port Washington, N.Y. The products seized include Dr. Brain, pH Balance, Fe-Mon-9, Glucosamine Plus, and Prostate-7, all dietary supplements, and Full-Bloom, a drug. Confidence, Inc. claimed 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, dysuria and several types of cancer (e.g., lung, cervix and prostate).
To make a claim that a product prevents, treats, cures, or mitigates disease, companies generally must demonstrate to the FDA that the product is safe and effective for the particular claim. Confidence, Inc.'s products did not conform to any monograph, nor did the company file or receive approval of a New Drug Application, and the products are not generally recognized as safe and effective for their recommended uses. Therefore, the products are unapproved new drugs. In addition, the products are misbranded drugs under the Act, because their labeling failed to provide adequate directions for their use as drugs. Additionally, the products were not manufactured in accordance with the current good manufacturing practice (cGMP) regulations for dietary supplements.
The FDA has warned Confidence, Inc. that its products and manufacturing processes violate federal law. "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, FDA's acting associate commissioner for regulatory affairs. "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." No illnesses have been associated to date with Confidence, Inc.'s products.