SeniorLife Health Inc. – FDA Warning Letter

On August 21, 2008, the FDA issued a Warning Letter to SeniorLife Health, Inc., following a review of their website, www.seniorlifehealth.com. The FDA determined that six products—"Green Tea Extract," "Healthy Heart Essentials," "Men's Multi 45 Plus Daily Essentials," "Omega 3-6-9 Complete," "Prostate Health Essentials," and "Women's Multi 45 Plus Daily Essentials"—were promoted with therapeutic claims that classify them as unapproved new drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)].

The products are marketed for conditions such as the cure, mitigation, treatment, or prevention of various diseases, including multiple types of cancer (ovarian, esophageal, prostate, breast, colon) and enlarged prostate. Examples of claims cited include "High Antioxidant Value Reduces Cancer Risk," "Assists in the Protection Against Prostate Cancer," "Lower PSA & Defend against Prostate Cancer," and "Shown to Shrink Enlarged Prostate." Testimonials also supported these claims.

These products are considered "new drugs" under section 201(p) of the Act [21 U.S.C. § 321(p)] because they are not generally recognized as safe and