FDA WARNING_LETTER - South Texas Botanicals - October 06, 2017

On March 29, 2018, the FDA issued a Warning Letter to South Texas Botanicals following an inspection from September to October 2017. The inspection and subsequent review of product labels and a mail order catalog revealed serious violations of the Federal Food, Drug, and Cosmetic Act.

The FDA determined that several products, including Oral Health, LDMS Formula, and Diabetic Formula, were promoted with claims in the mail order catalog that established them as unapproved new drugs. These claims indicated intended use for the cure, mitigation, treatment, or prevention of disease, making them "new drugs" under Section 201(p) of the Act, requiring prior FDA approval. Additionally, some products were deemed misbranded under Section 502(f)(1) because they lacked adequate directions for use by a layperson, particularly those intended for conditions requiring professional supervision. This was a repeat observation from a January 2017 inspection, and the firm's response regarding ongoing labeling revisions was deemed inadequate.

Furthermore, all dietary supplements were found to be adulterated under Section 402(g)(1) due to non-compliance with Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 111). Specific CGMP violations included: 1. Failure to establish specifications for components and finished dietary supplements (21 CFR 111.70(a), (b)(1)-(3),