FDA WARNING_LETTER - Scientific Botanicals Company, Inc. - May 19, 2014

On May 12, 14, 16, and 19, 2014, the FDA inspected Scientific Botanicals Company, Inc. and reviewed product labeling, including their websites (www.scientific-botanicals.com and www.licrogel.com). The inspection revealed serious violations of the Federal Food, Drug and Cosmetic Act.

The company's products, including "ANANABROM," "ANANACUR," and "Licrogel," are promoted with therapeutic claims (e.g., anti-inflammatory, cancer therapy, antiviral) that cause them to be unapproved new drugs under section 201(g)(1)(B) of the Act. These products are not generally recognized as safe and effective and lack FDA approval, violating sections 505(a) and 301(d). Additionally, many products are misbranded under section 502(f)(1) because they are intended for conditions not amenable to self-diagnosis, lacking adequate directions for layperson use.

Furthermore, all dietary supplement products are adulterated under section 402(g)(1) due to non-compliance with Current Good Manufacturing Practice (CGMP) requirements (21 CFR Part 111). Specific CGMP violations include: 1. Failure to conduct identity testing for dietary ingredients (21 CFR 111.75(a)(1)(i