FDA WARNING_LETTER - 7Seas LLC - March 31, 2010
Discuss this record with AI
On April 5, 2010, the FDA issued a Warning Letter to Mr. Norman Hem of 7Seas LLC, citing violations related to the marketing of several products on his websites: http://www.AlternateCancerCure.com, http://www.CureCancerSource.com, http://www.Treatallcancer.com, and http://www.ApricotPower-info.com.
The FDA determined that products including Jade Windscreen, Vitamin B17, Ultra-A+E, Apricot Seeds, and Miracle Mineral Supplement (MMS) are promoted with therapeutic claims that classify them as unapproved new drugs under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)]. Examples of claims cited include MMS for "Malaria, Hepatitis A, B, and C, Colds, Herpes, TB, Most cancer, Flu, Pneumonia," Ultra-A+E for "inhibitory effects...against leukemia and certain head and neck cancers," Jade Windscreen for "prevention for the H1N1 (Swine Flue) virus," and Apricot Seeds/Vitamin B17 for "attacks carcinogenic cells" and "prevention and treatment of cancer." These claims, along with personal testimonials and metatags, establish the products' intended use as drugs.
Since
ID · d5394ec8-f64d-4d58-bfe8-99dbf534772b
Full citation text and observation details available on the Dashboard.