Supplement Maker Must Change Label, Feds Rule

The U.S. Food and Drug Administration has entered into an agreement with Howard Sousa, doing business as the Artery Health Institute LLC, and DeSousa LLC, to change the way he labels his dietary supplement products.

The consent decree prohibits Sousa from distributing products with claims in the labeling to cure, treat, mitigate or prevent diseases. Before reaching the agreement, Sousa distributed Advanced Formula EDTA Oral Chelation capsules on his website.

Sousa ran afoul of the FDA by promoting his supplements as drugs through claims on his website. Under the Federal Food, Drug, and Cosmetic Act (FFDCA), a product is a drug if it is intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease. The capsules have been promoted and marketed for serious disease conditions, such as cardiovascular disease and kidney stones.

The FDA has forced Sousa to remove the drug claims from his website. He has also agreed to hire an independent expert to review the claims he makes for his product and to certify that he has omitted all violative claims.

Can still sell the supplements

The order does not require Sousa to stop making and selling the product, only to change its label and marketing. However, under the decree the FDA can order Sousa to stop making and distributing any product if he fails to comply with any provision of the consent decree, the FFDCA or other FDA regulations.

“Products with unapproved disease claims are dangerous because they may cause consumers to delay or avoid legitimate treatments,” said Dara A. Corrigan, the FDA’s associate commissioner for regulatory affairs. “The FDA will continue to take actions against companies that do not meet federal standards for safety, effectiveness, and quality by placing unapproved products on the market.”

The FDA previously issued a warning letter to Sousa for violating the FFDCA by promoting and distributing his product as a drug. Sousa responded to the warning letter promising to remove all such claims from his website, but the FDA discovered during a subsequent inspection that he continued to make the claims.

The warning letter was one of eight issued by the FDA in October 2010 to companies promoting unapproved over-the-counter chelation products with claims to treat and diagnose a range of the serious disease.