April 20, 2010
MAITLAND, Fla.FDA issued a warning letter to 7Seas LLC, Hialeah, Fla., notifying the company that claims made for certain products on its Web sites position those products to be drugs, not dietary supplements; further, as the products have not been approved by FDA for the claimed purposes, they are unapproved drugs and subject to regulatory action.
7Seas promoted products including Jade Windscreen, Vitamin B17, Ultra-A+E, Apricot Seeds and Miracle Mineral Supplement (MMS) via Web sites including CureCancerSource.com, AlternateCancerCure.com and TreatAllCancer.com. Several products were promoted for their ability to inhibit cancer growth, prevent the H1N1 virus and attack carcinogenic cells; testimonials about the products usefulness in addressing cancer were also used on some sites. 7Seas also used metatagging for its sites, including cure cancer and treat cancer, to attract Web traffic.
FDA noted the products are not recognized as safe and effective for the claimed uses, making them new drugs, which may not be legally marketed without FDA prior approval. The products are also misbranded as their labels do not have adequate directions for use. The agency gave the company 15 days from receipt of the letter, dated April 5, 2010, to correct the violations; failure to do so, FDA noted, could result in regulatory actions such as seizure and/or injunction.
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