FDA: New York dietary supplement manufacturer enters into consent decree
For Immediate Release: June 30, 2011
Media Inquiries: Tamara Ward, 301-796-7567, [email protected]
Consumer Inquiries: 888-INFO-FDA
FDA: New York dietary supplement manufacturer enters into consent decree
Defendant agrees to cease distributing products with disease claims
The U.S. Food and Drug Administration has announced that Howard Sousa, doing business as the Artery Health Institute LLC, and DeSousa LLC, in New York, N.Y., has signed a consent decree of permanent injunction. The consent decree prohibits Sousa from distributing products with claims in the labeling to cure, treat, mitigate or prevent diseases.
Prior to entry of the consent decree, Sousa distributed Advanced Formula EDTA Oral Chelation capsules on his website, www.arteryhealthinstitute.com.
Although the capsules are represented as dietary supplements, they are promoted as drugs through claims made on the 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 are promoted and marketed for serious disease conditions, such as cardiovascular disease and kidney stones.
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, 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. 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.
“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 such 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.
The decree was signed on June 29, 2011, in the U.S. District Court for the Southern District of New York.
For more information:
FDA Warning Letter: Artery Health Institute LLC (10/12/2010)
Press release: FDA issues warnings to marketers of unapproved ‘chelation’ products
Podcast: FDA issues warnings to marketers of unapproved ‘chelation’ products
Consumer Update: FDA Warns Marketers of Unapproved ‘Chelation’ Drugs
Questions and Answers on Unapproved Chelation Products
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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