FDA WARNING_LETTER - Lone Star Botanicals Inc. - April 21, 2023

The FDA inspected Tommy Kerzee's food manufacturing facility at 2001 Broussard St., Tyler, TX, from April 17-21, 2023, finding serious violations of the CGMP & PC rule (21 CFR Part 117) and labeling regulations (21 CFR Part 101). The facility manufactures and repackages ready-to-eat (RTE) seasoning blends.

The FDA determined that the RTE seasoning products are adulterated under 21 U.S.C. § 342(a)(4) due to insanitary conditions. Additionally, several "Dr. Botanical Health" products are deemed unapproved new drugs and misbranded drugs under 21 U.S.C. § 321(g)(1)(B) and 21 U.S.C. § 352(f)(1) due to disease treatment claims on labels, brochures, and the website (e.g., "Anti-inflammatory," "Helps Fight Colds & the Flu," "Reduces inflammation," "Stabilizes blood sugar," "Helps Combats Depression, Anxiety & Stress"). These products lack FDA approval and adequate directions for use.

Key violations include: - **No Food Safety Plan:** Failure to prepare and implement a food safety plan, including hazard analysis, preventive controls (allergens, environmental pathogens like Salmonella, bacterial pathogens, my