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

Source: https://www.globalkeysolutions.net/records/warning_letter/lone-star-botanicals-inc/76857d25-03df-4d1b-abd0-e3a5c00bc88c

> FDA WARNING_LETTER for Lone Star Botanicals Inc. on April 21, 2023. Product: Food. Access full analysis and detailed observations.

---

## Details

- Record Type: WARNING_LETTER
- Company Name: Lone Star Botanicals Inc.
- Inspection Date: 2023-04-21
- Product Type: Food
- Office Name: Division of Human and Animal Food Operations - East III
- Summary: 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

## Related Officers

- [Program Director](https://www.globalkeysolutions.net/people/edmundo-garcia/d47fc6d7-1ed9-4a65-bcaf-b3860041ca55)

Company: https://www.globalkeysolutions.net/companies/lone-star-botanicals-inc/42e59908-82a2-42ee-ac02-82b23dc744c9

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-iii/fe10072a-a5ee-4949-9781-1942c4334ab7