FDA WARNING_LETTER - Life Support Development Ltd - December 30, 2014

On September 17, 2015, the FDA issued a Warning Letter to Life Support Development Ltd. following an inspection from December 16-30, 2014, and subsequent review of product labeling and website. The letter identified serious violations of the Federal Food, Drug, and Cosmetic Act.

The product "Life Support Hangover Relief" was deemed an unapproved new drug under section 201(g)(1)(B) of the Act, due to therapeutic claims like "Hangover Relief" and "protect the liver and brain from damage," which indicate intent for disease treatment or prevention. As it's not generally recognized as safe and effective for these uses, it's considered a "new drug" requiring prior FDA approval.

Even if not an unapproved drug, the product is an adulterated dietary supplement under section 402(g)(1) due to significant Current Good Manufacturing Practice (CGMP) violations (21 CFR Part 111). Deficiencies include: 1. Failure to establish identity, purity, and strength specifications for components and finished products (21 CFR 111.70). 2. Failure to prepare and follow complete Master Manufacturing Records (MMRs) (21 CFR 111.210). 3. Failure to follow written procedures for manufacturing operations (21 CFR 111.353). 4. Failure