FDA WARNING_LETTER - Herbs of Light, Inc.

On June 18, 2013, the FDA issued a Warning Letter to Herbs of Light, Inc. following an inspection from September 24-28, 2012, and a review of product labeling in April 2013. The FDA determined that numerous products, including Agrimony, Blood Root, and Himalayan Crystal Salts Capsules, were promoted with 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)]. These products are not generally recognized as safe and effective for their claimed uses and lack FDA approval, violating section 505(a) of the Act. Furthermore, many products were deemed misbranded under section 502(f)(1) due to inadequate directions for use for laypersons.

Beyond drug claims, the products were found to be adulterated under section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] for failing to comply with Current Good Manufacturing Practice (CGMP) requirements for dietary supplements (21 CFR Part 111). Specific CGMP violations included: 1. Failure to establish specifications for dietary supplement components, in-process materials, finished products, labels,