FDA WARNS HERBAL REMEDIES FIRM FOR SELLING UNAUTHORIZED DRUGS

The Cayenne Company must stop marketing its herbal products as drugs, the FDA said in a warning letter.

According to the FDA, product labeling in brochures and on the company's website claimed the remedies were for the treatment and prevention of disease, which means the agency considers them drugs. Cayenne says their products can strengthen the heart, improve blood flow to the brain, reduce tension and enhance male libido, among other benefits.

The FDA found all of Cayenne's products mislabeled during investigations June 15 and 19, the agency said in the Sept. 21 warning letter, which was posted to the FDA website Oct 10. Since the products are not recognized as safe or effective but claim to treat conditions, the FDA considers them new drugs. Companies promoting new drugs must have an approved new drug application, and Cayenne does not.

The mislabeling goes further, according to the warning letter. Even if Cayenne's products "did not contain disease claims in their labeling that cause them to be drugs, they would still be misbranded as dietary supplements," the letter said. Products that Cayenne calls dietary supplements do not have the proper nutrition labeling to satisfy FDA regulations.

The warning letter can be viewed at www.fda.gov/foi/warning_letters/g6040d.pdf (http://www.fda.gov/foi/warning_letters/g6040d.pdf).