FDA WARNING_LETTER - Sunergized LLC

The FDA issued a Warning Letter to Sunergized LLC on May 18, 2018, following a March 2018 review of their website, www.sunergeticproducts.com. The FDA determined that the product "Sunergetic" is an unapproved new drug under sections 201(g)(1)(B) and 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. §§ 321(g)(1)(B), 321(p)].

The product is deemed a drug because its website and product label claims indicate it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Examples of drug claims include: "repairing sun damage," "joint pains especially in the morning has lessened," "oral sunscreen," "useful for people who have had skin cancer, are at risk for skin cancer," "protect me from the harms of radiation," and "Take an additional capsule if exposed to excess sunlight."

Since Sunergetic is not generally recognized as safe and effective for these uses, it is an unapproved new drug. Introducing or delivering such a product into interstate commerce without prior FDA approval violates sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d),