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New York Dietary Supplement Manufacturer Prohibited from Distributing Products
FDA has announced that Howard Sousa, dba Artery Health Institute LLC, and DeSousa LLC, in New York, NY, is prohibited from distributing products that make claims in the labeling to cure, treat, mitigate, or prevent diseases, under a consent decree of permanent injunction signed by Sousa. As explained in an FDA news release, prior to entry of the consent decree, Sousa distributed Advanced Formula EDTA Oral Chelation capsules on his Web site. FDA notes further that “Although the capsules are represented as dietary supplements, they are promoted as drugs through claims made on the website.” The capsules Sousa distributed were promoted as treatment for serious disease conditions, such as cardiovascular disease and kidney stones. Dara A. Corrigan, the FDA’s associate commissioner for regulatory affairs, stated, “Products with unapproved disease claims are dangerous because they may cause consumers to delay or avoid legitimate treatments.” More information about this FDA action is available in a news release on the FDA Web site.
