FDA WARNING_LETTER - New Life Alternatives - July 19, 2010

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