FDA WARNING_LETTER - Citrus Fit

The FDA issued a Warning Letter to Citrus Fit Weight Loss and Detox Products, LLC, following a review of their website and analysis of their "Citrus Fit Gold" product. Laboratory tests confirmed the product contains undeclared sibutramine, an active pharmaceutical ingredient previously withdrawn from the U.S. market due to serious cardiovascular risks. The FDA determined that "Citrus Fit Gold" is an unapproved new drug under FDCA sections 505(a), 301(d), and 201(p), as sibutramine was authorized as a new drug before being marketed as a dietary supplement, and the product is not generally recognized as safe and effective. Furthermore, it is a misbranded drug under sections 502 and 301(a) of the FDCA. Specific misbranding violations include failing to bear adequate directions for use (502(f)(1)), having false or misleading labeling (502(a)) by not declaring sibutramine and making unsubstantiated safety claims, and being dangerous to health (502(j)). The company is responsible for ensuring products comply with federal law and do not contain undeclared ingredients. Citrus Fit must take prompt action to correct all violations and prevent recurrence, notifying FDA within 15 working days with documentation of corrective steps. Failure to comply may lead to enforcement actions like product seizure and injunctions.