FDA NEWS RELEASEFor Immediate Release: Oct. 23, 2012
Media Inquiries: Pat El-Hinnawy, 301-796-4763, patricia.el-hinnawy@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
Dietary supplements, unapproved drugs seized in New York New York company claims products prevent or treat disease
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. 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.
The
FDA, an agency within the U.S. Department of Health and Human Services,
protects the public health by assuring the safety, effectiveness, and
security of human and veterinary drugs, vaccines and other biological
products for human use, and medical devices. The agency is also
responsible for the safety and security of our nation's food supply,
cosmetics, dietary supplements, products that give off electronic
radiation, and for regulating tobacco products.