MexHealth LLC d/b/a Al Natural E-Shop – FDA Warning Letter, Sep 3, 2024

The FDA issued a Warning Letter to Mr. Travis Bunch regarding the product "Ossos-Sans" sold on alnaturaleshop.com. FDA website reviews in April and July 2024, and subsequent laboratory analysis of "Ossos-Sans" samples, revealed the product contains undeclared diclofenac and methocarbamol.

Diclofenac, an NSAID, carries risks of cardiovascular events and serious gastrointestinal damage. Methocarbamol, a muscle relaxant, can cause sedation, dizziness, and impaired abilities. The product is marketed as a dietary supplement but is excluded from this definition because diclofenac was approved as a new drug (Voltaren) before being marketed as a supplement or food.

"Ossos-Sans" is deemed an unapproved new drug under sections 505(a) and 301(d) of the FD&C Act, as its labeling claims (e.g., "Artritis," "Osteoporosis," "Dolores Musculares") indicate intended use as a drug, and it is not generally recognized as safe and effective. No FDA-approved applications exist for this product.

Furthermore, "Ossos-Sans" is a misbranded drug under sections 502(a) and 301(a) of the FD&C Act because its labeling fails to declare the presence of diclofenac and methocarbamol, rendering it false