FDA Halts Sale of Chelation Capsules for Disease Claims

WASHINGTONHoward Sousa, doing business as the Artery Health Institute LLC, and DeSousa LLC, signed a consent decree of permanent injunction that prohibits him from distributing Advanced Formula EDTA Oral Chelation capsules because they were promoted and marketed for serious disease conditions, such as cardiovascular disease and kidney stones, according to an FDA announcement. Dietary supplements are not allowed to be labeled as cures, treatments or preventers of diseases under the Federal Food, Drug, and Cosmetic Act (FFDCA).

Under the terms of the consent decree, Sousa will 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. Under the decree, 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. Sousa is also required to pay $1,000 per violation and twice the retail value of each shipment of product in the event he fails to comply with the consent decree. The decree was signed on June 29, 2011, in the U.S. District Court for the Southern District of New York.

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 such claims. 

Prior to entry of the consent decree, Sousa distributed Advanced Formula EDTA Oral Chelation capsules on his website, ArteryHealthInstitute.com, where he represented them as dietary supplements. However, FDA said they are promoted as drugs through claims made on the website per the FFDCA.

"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," said Dara A. Corrigan, the FDA's associate commissioner for regulatory affairs.

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