FDA WARNING_LETTER - Health Research Laboratories LLC - September 30, 2014

The FDA issued a Warning Letter to Health Research Laboratories, LLC/New World Health after reviewing their websites, www.hrlsupplements.com and www.rejuvaliferx.com, in September 2014. The FDA determined that the products "AtheChel Advanced," "Betarol," "BioTherapex," "Omega-3 Cardio Plus," "RejuvaLifeRx," and "Ultimate Health Formula" are promoted with therapeutic claims that classify them as drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(1)(B)].

The websites, a reorder letter, and a flyer titled "Don't Just Take Our Word" contain claims indicating the products are intended for the cure, mitigation, treatment, and/or prevention of disease. Examples of such claims include reducing prostate inflammation, lowering cholesterol, unclogging arteries, preventing heart disease, regenerating organ tissue, and providing relief from arthritis.

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 effective for their claimed uses. Introducing new drugs into interstate commerce without prior FDA approval violates section 505(a) and 301(d