FDA WARNING_LETTER - Metagenics

The FDA issued a Warning Letter to Metagenics, Inc. following a review of its website, www.metagenics.com, in August 2013. The letter identifies several products, including UltraClear, UltraClear Plus, and UltraInflamX, which are marketed as "medical foods." The FDA determined these products are misbranded under Section 403(a)(1) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. § 343(a)(1)] because their labeling is false and misleading. They fail to meet the statutory definition of a medical food in the Orphan Drug Act [21 U.S.C. § 360ee(b)(3)] or the criteria in 21 CFR 101.9(j)(8), specifically lacking distinctive nutritional requirements for the conditions they claim to manage. Additionally, the products are promoted for conditions such as chronic fatigue syndrome, fibromyalgia, and Type 2 Diabetes, which causes them to be considered drugs under Section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)]. As they are not generally recognized as safe and effective for these uses, they are deemed "new drugs" under Section 201(p) of the Act [21 U.S.C. § 321(p)]. Introducing these unapproved new drugs into interstate commerce violates Sections 505(a) and 301(d) of the Act [21 U.S.C. §§ 355(a), 331(d)]. Metagenics must promptly correct these violations and prevent recurrence, notifying the FDA within fifteen working days with documentation. Failure to comply may result in regulatory actions, including product seizure and injunctions. The firm is advised to review all its labeling and promotional materials for compliance.