FDA WARNING_LETTER - Lose Fat Gain Life M&B - September 30, 2019

The FDA issued a Warning Letter to Mr. Villalobos following an inspection of his facility in Long Beach, CA, on September 24 and 30, 2019, and a review of product labeling and website content.

The "Skinny Pill" product was found to be adulterated under section 402(a)(2)(C)(i) of the Act because it contains 1,3-dimethylamylamine (DMAA), an unsafe food additive. DMAA is not a dietary ingredient, nor is it generally recognized as safe (GRAS). The firm voluntarily destroyed its inventory of "Skinny Pill" and removed it from its website.

Additionally, products including Reishi Coffee, Sugar Control, Blood Pressure Support, Fat Burner, Hear Clear Ear Health Formula, Hemp Oil, Liquid Gold, Omega 3, and Ovary Care, sold on the firm's website and social media, are deemed unapproved new drugs and misbranded drugs. Claims made for these products establish their intent for use in the cure, mitigation, treatment, or prevention of disease, classifying them as drugs under section 201(g)(1)(B) of the Act. They are not generally recognized as safe and effective for their intended uses, making them "new drugs" under section 201(p) of the Act, requiring prior FDA approval. Furthermore, these products are misbranded under section 502(f