FDAnews Drug Daily Bulletin

Warning Letters Cite Disclaimers, Metatags as Inappropriate

June 5, 2008

Despite including disclaimers that products are not approved to treat disease on the same website that asserts people use the products for that purpose, the marketers of herbal supplements touted to cure cancer have received warning letters from the FDA.

The agency has sent four separate warning letters citing marketers for making claims on their websites that their products can treat disease, which would make them unapproved new drugs.

One warning letter cites a company for saying, “While historically, black salve and bloodroot salves have been used for melanoma, basal and squamous cell carcinomas … we at Best on Earth Products are not legally allowed to make such claims. Such claims made by companies would put these products into the category of new drugs based on the FDA definition. Again, we do not make such claims regarding our products.”

Besides the claims on the website that Best on Earth Products’ supplements can treat various forms of cancer, which resulted in unacceptable labeling and misbranding, the company was cited for its use of cancer-related metatags to bring consumers to the website through internet searches. Metatags are invisible hypertext markup language on web pages and are used, among other purposes, to tell search engines the subject of the page.

Another warning letter cited Generations Black Salve for website claims that its products can cure cancer, despite partial disclaimers. At the time of the letter, the website said, “No claims can be legally made about the Black Salve. The information has been prepared as narration of what users have reported to be the most effective way to use the products as an herbal remedy, and what some have reported as the results. It is not intended as a report of scientific studies, and it is not offered or endorsed by the AMA or the FDA.”

The warning letters can be accessed at www.fda.gov/foi/warning_letters/s6777c.htm (Best on Earth Products), www.fda.gov/foi/warning_letters/s6778c.htm (Teeter Creek Herbs), www.fda.gov/foi/warning_letters/s6776c.htm (Generations Black Salve) and www.fda.gov/foi/warning_letters/s6775c.htm (H&L Worldwide).