FDA WARNING_LETTER - NaturesAlternatives.com

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.