FDA WARNING_LETTER - Health Research Laboratories LLC

The FDA reviewed Health Research Laboratories, LLC/New World Health's websites (www.hrlsupplements.com and www.rejuvaliferx.com) in September 2014 and determined that products like "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).

The websites, a reorder letter, and a flyer contain claims indicating the products are intended for the cure, mitigation, treatment, and/or prevention of diseases, such as reducing prostate inflammation, lowering cholesterol, unclogging arteries, preventing heart disease, and providing relief from arthritis. These products are considered "new drugs" under section 201(p) of the Act because they are not generally recognized as safe and effective for their claimed uses. Introducing new drugs into interstate commerce without FDA approval violates section 505(a) and 301(d) of the Act.

Furthermore, these products are misbranded under section 502(f)(1) of the Act because they are offered for conditions not amenable to self-diagnosis and treatment, meaning adequate directions for layperson use cannot be provided. Introducing misbranded drugs into interstate commerce is a