FDA WARNING_LETTER - Suprimo Imports - June 22, 2023

The FDA issued a Warning Letter to Humberto Cecena regarding the sale of "AK Forte" and "Bob Marley CannaKing" on suprimoimports.com, following website reviews in January and April 2023, and laboratory analysis of "AK Forte."

"AK Forte" was found to contain undeclared active pharmaceutical ingredients: diclofenac, dexamethasone, and methocarbamol. These ingredients pose significant health risks, including cardiovascular events, gastrointestinal damage, adrenal suppression, and sedation. The product is marketed as a dietary supplement but is excluded from this definition because diclofenac and dexamethasone were approved as new drugs before being marketed as supplements.

Both "AK Forte" and "Bob Marley CannaKing" are deemed unapproved new drugs under sections 505(a) and 301(d) of the FD&C Act, as they are intended for disease treatment or to affect body function and lack FDA approval. "AK Forte" is also misbranded under section 502(a) because its labeling is false and misleading due to the undeclared drug ingredients. "Bob Marley CannaKing" is misbranded under section 502(f)(1) for lacking adequate directions for use, as it addresses conditions not amenable to self-diagnosis.

The letter also noted the sale of "Artri Ajo King," previously linked to undeclared diclofenac and adverse events