# FDA WARNING_LETTER - MexHealth LLC d/b/a Al Natural E-Shop - September 03, 2024

Source: https://www.keypedia.com/records/warning_letter/mexhealth-llc-dba-al-natural-e-shop/d6bfa0c8-3ba0-45ff-a5a8-69aa3f5755c0

> FDA WARNING_LETTER for MexHealth LLC d/b/a Al Natural E-Shop on September 03, 2024. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: MexHealth LLC d/b/a Al Natural E-Shop
- Inspection Date: 2024-09-03
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: 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

## Related Officers

- [Director](https://www.keypedia.com/people/tina-smith/5d590654-a270-4f3f-833f-d6fe13ca8c05)

Company: https://www.keypedia.com/companies/mexhealth-llc-dba-al-natural-e-shop/702e100f-7c85-4a40-b991-ba44ef3d8e8a

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c