Upsher Smith Laboratories, Inc. – FDA Warning Letter

The FDA issued a Warning Letter to Upsher Smith Laboratories, Inc. regarding their SLO-NIACIN® product, promoted on www.slo-niacin.com. The FDA determined that the product is marketed with therapeutic claims, classifying it as a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act).

Examples of violative claims include "Reduced risk of cardiovascular events* when combined with a statin," "Halted stenosis progression when combined with a statin," and "Niacin is clinically proven to help manage cholesterol levels, a major factor in heart health." The website's "References" and "In the News" sections also cite scientific articles, which, in context, imply disease treatment or prevention, further supporting the product's drug classification.

Since SLO-NIACIN® is not generally recognized as safe and effective for these uses, it is considered a "new drug" under section 201(p) of the Act. Marketing a new drug without prior FDA approval violates section 505(a) of the Act. Additionally, the product is misbranded under section 502(f)(1) of the Act because its labeling lacks adequate directions for use. The letter also notes that images on the website may be considered claims.

Upsher Smith Laboratories, Inc. must take prompt action to correct these violations and prevent recurrence. Failure to