FDA WARNING_LETTER - Professional Botanicals, Inc. - October 11, 2016

On October 4-11, 2016, the FDA inspected Professional Botanicals, Inc.'s manufacturing facility and reviewed its websites, identifying serious violations of the Federal Food, Drug, and Cosmetic Act.

Several products were deemed unapproved new drugs due to claims on labels and websites indicating intent for disease treatment, prevention, or affecting body structure/function (e.g., "INF-D" for inflammatory syndrome, "Kidney Support" for kidney stones, "Candida-X2" for yeast infections). These products are not recognized as safe and effective for these uses and lack FDA approval.

The company's dietary supplements were found to be adulterated due to cGMP violations, including: 1. Failure to establish adequate product specifications for identity, purity, strength, and composition of finished batches (21 CFR 111.70(e)). 2. Failure to identify and quarantine returned dietary supplements until quality control review and disposition (21 CFR 111.510), and lack of documentation for destroyed returned products. 3. Failure to establish and follow written procedures for holding and distributing operations (21 CFR 111.453), a repeat deficiency from a 2013 inspection.

Additionally, numerous products were misbranded under 21 CFR Part 101, including: - Misleading labeling for "meal drink" products also labeled as "dietary supplements