FDA WARNING_LETTER - Nutri Fusion Systems, Inc

The FDA and FTC issued a Warning Letter to Nutri Fusion Systems LLC regarding "HCG Fusion 30" and "HCG Fusion 43." The products are deemed unapproved new drugs and misbranded, violating sections 301, 505, and 503 of the Federal Food, Drug, and Cosmetic Act (the Act). The FTC also cited violations of the FTC Act for unsubstantiated advertising claims.

The products are marketed with claims like "reset its 'set point' to a new lower weight," "burn the abnormal fat for energy," and "Appetite Control & Detox," which classify them as drugs under section 201(g)(1) of the Act. They are "new drugs" under section 201(p) because they lack general recognition of safety and effectiveness for their intended uses and have no FDA-approved applications.

Although labeled as homeopathic, the products contain ingredients (HCG, Vitamin B12, L-Ornithine, L-Arginine, Acetyl L-Carnitine) not established as homeopathic in the Homeopathic Pharmacopoeia of the United States (HPUS). Therefore, they do not qualify for the enforcement policies outlined in FDA's Compliance Policy Guide (CPG 7132.15) for homeopathic drugs.

Furthermore, "HCG Fusion 30" and "HCG Fusion 43" are prescription