Botanical Be – FDA Warning Letter, Dec 26, 2023

The FDA issued a Warning Letter to Mr. Felix regarding products sold on botanical-be.com, specifically "Kuka Flex Forte," "Reumo Flex," and "Artri King Reforzado con Ortiga y Omega 3." An FDA review in July 2023 and subsequent laboratory analysis confirmed these products contain undeclared diclofenac, an NSAID.

The FDA determined these products are unapproved new drugs under sections 505(a) and 301(d) of the FD&C Act, and misbranded drugs under section 502 and 301(a). Diclofenac, approved as Voltaren in 1988, is excluded from the dietary supplement definition, making "Kuka Flex Forte" and "Reumo Flex" mislabeled as supplements.

The products are considered drugs due to therapeutic claims like "powerful anti-inflammatory properties," "relieve joint pain," and "100% Effective Formula Against Pain." As they are not generally recognized as safe and effective, they are "new drugs" requiring FDA approval, which they lack.

The products are misbranded because their labeling fails to declare diclofenac, a material fact given its serious health risks (cardiovascular events, gastrointestinal damage, liver toxicity). The FDA requires a written response within fifteen working days detailing corrective actions and prevention measures. Failure to comply may result in legal action, including seizure and injunction