FDA WARNING_LETTER - Bethel Nutritional Consulting, Inc - September 01, 2014

The FDA issued a Warning Letter to Bethel Nutritional Consulting, Inc. following reviews of their website (www.bethel30.com) in June 2013 and September 2014. The FDA determined that numerous products, including "15 Day Detox Diet," "Alpha Lipoic Acid," "Black Cohosh," and "Yohimbe," are promoted with therapeutic claims (e.g., preventing Alzheimer's, lowering cholesterol, treating depression, combating obesity, regulating blood pressure, treating erectile dysfunction). These claims cause the products to be unapproved new drugs under sections 201(g)(1)(B) and 201(p)(1) of the FD&C Act. The introduction or delivery of these unapproved new drugs into interstate commerce violates sections 301(d) and 505(a) of the Act. Furthermore, these products are considered prescription drugs under section 503(b)(1)(A) and are misbranded under section 502(f)(1) because their labeling lacks adequate directions for use, as no FDA-approved application exists. The introduction of misbranded products into interstate commerce violates section 301(a) of the Act. The FDA noted that previous discussions in June 2013 regarding some claims did not result in corrective action by September 2014. The company must promptly correct all violations and respond within fifteen working days, detailing corrective steps and prevention measures, or face potential legal action like seizure and injunction. The firm is also reminded of its responsibility to comply with 21 CFR part 111 if involved in dietary supplement operations.