Dietary Supplements, Unapproved Drugs Seized in New York
The company claims the products prevent or treat disease
Sunday, October 28, 2012
U.S. Marshals -- at the request of the U.S. Food and Drug Administration (FDA) -- recently seized dietary supplements and unapproved drugs from Confidence, Inc., of Port Washington, NY.
The products seized include Dr. Brain, pH Balance, Fe-Mon-9, Glucosamine Plus, and Prostate-7 -- all dietary supplements, and Full-Bloom -- a drug. The company claimed 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.
No FDA interaction
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, they 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.
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.