FDA WARNING_LETTER - Flexcin International, Inc.

The FDA issued a Warning Letter to FLexcin International, specifically Ms. Simpson, on May 25, 2010, after reviewing their website, www.flexcin.com. The FDA determined that the products "Flexin with CM8?", "Cal-Flex Calcium Pure," and "Flexpet" are promoted for conditions that classify them as unapproved new drugs under the Federal Food, Drug, and Cosmetic Act (the Act).

The therapeutic claims on the website for "Flexin with CM8?" and "Cal-Flex Calcium Pure" establish them as drugs intended for human use in the diagnosis, cure, mitigation, treatment, or prevention of disease, making them new drugs under section 201(p) of the Act [21 U.S.C. § 321(p)]. Examples of claims include "Joint Pain Remedy Treatment," "Arthritis, Gout & Fibromyalgia are eliminated," and "prevent[s] degenerative disease." These products are also misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] for failing to bear adequate directions for use.

Similarly, "Flexpet" is deemed a new animal drug under section 201(v) of the Act [21 U.S.C. § 321(v)] due to claims like "Flexpet will