# FDA WARNING_LETTER - New Life Alternatives - July 19, 2010

Source: https://www.keypedia.com/records/warning_letter/new-life-alternatives/570801ce-4096-40ae-9b03-bfe09c6d3cf4

> FDA WARNING_LETTER for New Life Alternatives on July 19, 2010. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: New Life Alternatives
- Inspection Date: 2010-07-19
- Product Type: Food
- Office Name: New Orleans District Office
- Summary: On July 13 and 19, 2010, FDA investigators inspected New Life Alternatives in Hermitage, Tennessee, identifying the company as an own-label distributor and initial importer of "Tongkat Ali" or "Eurycoma Longifolia." The product is labeled as a dietary supplement.

The inspection revealed several violations:
1.  **Importation Violations:** New Life Alternatives failed to declare imported shipments of "Tongkat Ali" as required by Section 801(a) and (b) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 USC § 321(a) and (b)]. All food articles, including dietary supplements, require prior notice for import under Section 801(m) of the Act [21 U.S.C. § 381(m)], specifying the article, manufacturer, shipper, grower (if known), origin, shipment country, and anticipated port of entry. Failure to comply is a prohibited act under Section 301(ee) [21 USC § 331(ee)], rendering products subject to enforcement.

2.  **Unapproved New Drug:** A review of the company's website (http://www.newlifealternatives.com) on October 20, 2010, found "Tongkat Ali" promoted with therapeutic claims, specifically: "Tongkat Ali works naturally

## Related Officers

- [H.](https://www.keypedia.com/people/tyler-thornburg/611c288f-255c-4a1a-9914-14ff1363e7b3)

Company: https://www.keypedia.com/companies/new-life-alternatives/24da03a3-db54-4bf2-b5e5-307c8ffb14c5

Office: https://www.keypedia.com/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea