Under the Federal Food, Drug, and Cosmetic Act, it is a violation to market or sell products that claim to prevent, diagnose, treat, mitigate, or cure diseases without first demonstrating to the FDA that the products are safe and effective for their labeled uses.
Specifically, the companies were found to make unproven claims regarding the product’s ability to prevent, reverse, or cure cancer; kill or inhibit cancer cells or tumors; or other similar anti-cancer claims, the FDA notes.
In one case, the FDA sent a letter to AIE Pharmaceuticals, Inc.
For example, the FDA claims that AIE made claims on its website that its Cevrogin product included dandelion root, which has “also been shown to have potential for fighting cancer,” and that its ImmunPro product is “proven to still be effective against cancer.” The FDA notes that because it did not provide approval of these products, they are considered “new drugs,” and can not be “legally introduced or delivered introduction into interstate commerce without prior approval from the FDA.” The agency requested responses from the 14 companies stating how the violations will be corrected.
Stearn, director of the Office of Enforcement and Import Operations in the FDA’s Office of Regulatory Affairs, said in a statement.