# FDA WARNING_LETTER - NaturesAlternatives.com - Unknown Date

Source: https://www.keypedia.com/records/warning_letter/naturesalternativescom/58ccabb7-1692-4870-be05-1e2f27bce120

> FDA WARNING_LETTER for NaturesAlternatives.com on Unknown Date. Product: Drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: WARNING_LETTER
- Company Name: NaturesAlternatives.com
- Product Type: Drugs
- Office Name: Los Angeles District Office
- Summary: On June 2, 2008, the FDA issued a Warning Letter to NaturesAlternatives.com following a review of their websites, www.naturesalternatives.com and www.essiacformula.com. The FDA determined that numerous products, including "African Pygeum Bark," "Native Essense? Plus," and various "Plus" formulas, were promoted with therapeutic claims that cause them to be unapproved new drugs under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act. Examples of claims included treating or preventing cancer, arthritis, diabetes, HIV, and inhibiting tumor growth. These products are not generally recognized as safe and effective for their intended uses, classifying them as "new drugs" under section 201(p), which require prior FDA approval per section 505(a). Additionally, the products are misbranded under section 502(f)(1) because their labeling lacks adequate directions for use. The letter emphasized that the listed violations were not exhaustive and that the firm is responsible for ensuring all products comply with the Act. NaturesAlternatives.com was instructed to take prompt corrective action, review all labeling and promotional materials, and respond in writing within fifteen working days detailing steps taken to correct the violations and prevent recurrence. Failure to comply could lead to enforcement actions, including product seizure and injunctions.

## Related Officers

- [Director](https://www.keypedia.com/people/alonza-e-cruse/650e3631-3f99-45f7-863e-3a35c44be485)

Company: https://www.keypedia.com/companies/naturesalternativescom/10f7ef1e-f0ca-46f5-82b6-791a3d4dc81b

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b