FDA WARNING_LETTER - Mountain Health Line

On December 15, 2009, the FDA reviewed Mountain Health Line's website, http://www.mountainhealthline.ecrater.com, and found it was offering "Living Streams Flora PM" for sale, claiming it could diagnose, mitigate, prevent, treat, or cure the H1N1 Flu Virus. The FDA determined this product is unapproved, uncleared, and unauthorized for such uses, violating the Federal Food, Drug, and Cosmetic Act (FFDC Act), specifically 21 U.S.C. §§ 331, 351, 352.

Examples of violative claims included: "Scientific studies have shown that it impairs the attachment of the HIV-1 virus... Another study examined influenza viruses, including the swine flu, with the same results... There is every reason to expect that its antiviral properties are broad spectrum, meaning it may have usefulness against the Asian or bird flu pandemic."

Given the public health emergency declared for H1N1, the FDA is taking urgent measures against unauthorized products. The letter demands immediate cessation of marketing unapproved H1N1-related products. Mountain Health Line must email FDAFLUTASKFORCECFSAN@fda.hhs.gov within 48 hours, detailing corrective actions. Failure to comply may result in enforcement actions like seizure, injunction, or criminal prosecution. The firm will be added to a public FDA list of non-compliant companies, which