FDA seizes N.Y. company's products over disease claims
U.S. Marshals, acting at FDA’s behest, seized products that the agency says were claimed to treat or cure diseases such as senile dementia, brain atrophy, ahtersclerosis, kidney dysfunction, depression, osteoarthritis, gangrene, dysuria and several types of cancer (e.g., lung, cervix and prostate).
The seized products included Dr. Brain, pH Balance, Fe-Mon-9, Glucosamine Plus, and Prostate-7, all dietary supplements, and Full-Bloom, a drug which purported to stimulate breast growth.
FDA said that the products did not conform to any drug monographs, nor was any the subject of a New Drug Application, meaning the products are classified as unapproved new drugs under the 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."
Confidence Inc. received a warning letter dated July 7, 2011 that detailed a host of GMP violations. The letter also detailed many of the illegal drug claims for which the products were seized.
