FDAnews Drug Daily Bulletin

FDA Issues Warning Letter to Supplement Firm for Promotional Claims

March 18, 2005
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The FDA has issued a warning letter to dietary supplement maker ABCO Laboratories, accusing the company of promotional activities that violate the Federal Food, Drug, and Cosmetic Act.

The letter states that the therapeutic claims made on ABCO's website for its Spirulina Powder establish the product as a drug because it is intended for use in the mitigation, prevention, cure or treatment of disease. Because Spirulina Powder has not been approved as a drug, the marketing of the product for these claims violates federal law, the agency said.

Among the specific claims cited by the FDA was language on the website touting Spirulina Powder as a "rich source of carotenoids and phycocyamin, which are associated with cancer preventative agents in the diet."

To view the warning letter, go to http://www.fda.gov/cder/warn/cyber/2005/CL127e.pdf (http://www.fda.gov/cder/warn/cyber/2005/CL127e.pdf).