What happened
Original notice title
South Texas Botanicals MARCS-CMS 541782, March 29, 2018
From the archived source record
Based on the inspection, a review of the product labels collected and a review of your mail order catalog, we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. Unapproved New Drugs FDA reviewed your firm’s mail order catalog in November 2017, following our inspection of your facility. A drug is misbranded under Section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). Thus, the products are misbranded under Section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates of section 301(a) of the Act [21 U.S.C. § 331(a)]. Adulterated Dietary Supplements Even if your products did not have therapeutic claims which make them unapproved new drugs, these products, along with all your dietary supplements, would still be adulterated dietary supplements within the meaning of Section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] because the products have been manufactured under conditions that do not meet the Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements regulation in Title 21, Code of Federal Regulations, Part 111 (21 CFR part 111). During the inspection of your facility, the following significant violations of these CGMP requirements were observed: 1. Specifically, you failed to establish the following: an identity specification; specifications to ensure purity, strength and composition of dietary supplements manufactured using the components are met; and specifications that establish the limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(b)(1)-(3).
What the official notice says to do
Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice →Status and source details
- Status recorded in the archive
- Historical warning letter; closeout not established by annual index
- Source checked
- Jul 16, 2026
- Record revision
- 57c219174f24
This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
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