FDA WARNING_LETTER - genesis nutrition ultra slim - September 07, 2021

The FDA issued a Warning Letter to Ms. Gonzalez regarding "Genesis Ultra Slim Gold," sold on www.fastweightlossgarcinia.com and www.ketoultraslimplus.com, and promoted via social media. An FDA lab analysis confirmed the product contains undeclared sibutramine and phenolphthalein.

Sibutramine, an active pharmaceutical ingredient in the withdrawn drug Meridia, was linked to increased risks of heart attack and stroke. Phenolphthalein is a chemical not approved as a drug ingredient and poses a cancer risk.

The FDA determined "Genesis Ultra Slim Gold" is an unapproved new drug under sections 505(a) and 301(d) of the FD&C Act, as sibutramine was authorized for investigation as a new drug before being marketed as a dietary supplement. The product is also a misbranded drug under sections 502 and 301(a) because it lacks adequate directions for use, its labeling is false/misleading by not declaring sibutramine and phenolphthalein, and it lacks adequate warnings, making it dangerous to health.

The letter requires a written response within fifteen working days detailing corrective actions, steps to prevent recurrence, and supporting documentation. Failure to comply may result in legal action, including seizure or injunction. The FDA also noted other products marketed by the firm, emphasizing the firm's responsibility to ensure they do not contain undeclared