What happened
Original notice title
Lone Star Botanicals Inc. MARCS-CMS 659735, November 06, 2023
From the archived source record
During the inspection, the FDA investigator found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). Based on FDA’s inspectional findings, we have determined that the ready-to-eat (RTE) seasoning products manufactured in your facility are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)] in that they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health. In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the Preventive Controls provisions of the CGMP & PC rule (located in Subparts A, C, D, E, F, and G of Part 117) is prohibited by section 301(uu) of the Act [21 U.S.C. § 331(uu)]. Further, we found significant violations of the labeling regulations for foods, 21 CFR Part 101. These violations cause your seasoning blends and Dr. Botanical Health products to be misbranded within the meaning of section 403 of the Act (21 U.S.C. § 343). After reviewing the inspectional findings, response that your firm provided, product labeling collected during the inspection, and your website, we are issuing this letter to notify you of FDA’s concerns and provide detailed information describing our findings. Unapproved New Drugs and Misbranded Drugs FDA reviewed your website at the Internet address [see original source] in July 2023 and October 2023, and has determined that you take orders there for your Dr. Botanical Health Organic Elderberry Plant Based Superfood Powder o “Contains Ant-Inflammatory Properties” o “Helps Fight Infections Like Cold & Flu” o “Fights Harmful Bacteria” Dr.
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
- FDA closeout listed
- Source checked
- Jul 16, 2026
- Record revision
- f81bfe667709
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.
Sources, dates, and coverage →