FDA Issues Warning to Millennium Bioceutics

DELRAY BEACH, Fla.FDAs Public Health Service office, College Park, Md., issued a warning letter in mid-February to Millennium Bioceutics, based in Delray Beach, Fla., after the agency reviewed claims made online for the companys Caplex Supplement. According to FDA, online health claims for the ingredients in Caplex, such as capsaicin, included anti-tumor activity, anti-inflammatory properties and preventing cancer cell growth." Further, links from the company site and a related site, CaplexSupplement.com, direct consumers to a page with excerpts from research articles about ingredients used in Caplex, such as capsaicin is a potent anticancer agent."

The agency informed the company that such claims position Caplex as a drug, not a dietary supplement, as it is intended to cure, mitigate, treat or prevent disease. Further, as the product has not been recognized as safe and effective for its stated uses and does not carry appropriate labeling for use, it is a new and misbranded drug.