Lone Star Botanicals Inc.

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

You did not prepare, or have prepared, and implement a food safety plan, as required by 21 CFR § 117.126(a)(1).

Passage 2

You did not identify and evaluate allergens as a known or reasonably foreseeable hazard to determine whether allergens are a hazard requiring a preventive control.

Passage 3

You did not identify and evaluate contamination with environmental pathogens, such as *Salmonella*, as a known or reasonably foreseeable hazard to determine whether it is hazard requiring a preventive control, to comply with 21 CFR § 117.130(c)(1)(ii).

Passage 4

You did not identify and evaluate bacterial pathogens, such as Salmonella, as a known or reasonably foreseeable hazard to determine whether they require a preventive control.

Passage 5

You did not identify and evaluate mycotoxins as a known or reasonably foreseeable hazard to determine whether they require a preventive control.

Passage 6

The claims on your website, product labels, and product brochure establish that the products are drugs under section 201(g)(1)(B) of the Act [21 U.S.C. 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease.

Passage 7

your Dr. Botanical Health Organic Ashwagandha Plant Based Superfood Powder, Organic Elderberry Plant Based Superfood Powder, Organic Lion’s Mane Mushroom Based Superfood Powder, Marine Collagen, Organic Acai Plant Based Superfood Powder, Organic Inulin Prebiotic Fiber Superfood Powder, Organic Chaga Mushroom Based Superfood Powder, Organic Maca Plant Based Superfood Powder, Organic Reishi Mushroom Based Superfood Powder, and Organic Rhodiola Rosea Plant Based Superfood Powder products fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)].

Passage 8

your John Paine’s Steak Beast Unleashed All Purpose Rub product is misbranded within the meaning of 403(w) of the Act [21 U.S.C. § 343(w)] in that the finished product label fails to declare the major food allergen “milk” as required by section 403(w)(1) of the Act.

Passage 9

Your John Paine’s Steak Beast Beasty Bird is misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] in that the product label fails to bear the common or usual name of the food.

Passage 10

Your John Paine’s Steak Beast Beasty Bird, Chop Beast Pork Rub, Steak Seasoning, and Unleashed All Purpose Rub products are misbranded within the meaning of section 403(k) of the Act [21 U.S.C. § 343(k)] because the products bear or contain an artificial coloring but do not bear labeling stating that fact.

Passage 11

Your John Paine’s Steak Beast Beasty Bird, Unleashed All Purpose Rub, Steak Seasoning, and Pork Rub products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the products are fabricated from two or more ingredients and each ingredient is not declared on the label in descending order of predominance by weight in the finished food.

Passage 12

Your John Paine’s Steak Beast Beasty Bird, Chop Beast Pork Rub, Steak Seasoning, and Unleashed All Purpose Rub products are misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that they fail to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5

Passage 13

Your John Paine’s Steak Beast products (Beasty Bird, Chop Beast Pork Rub, Steak Seasoning, Unleashed All Purpose Rub), and Dr. Botanical Health Organic Elderberry Plant Based Superfood Powder and Dr. Botanical Health Organic Lion’s Mane Mushroom Based Superfood Powder products are misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition information (e.g., Nutrition Facts label, “NFL”) is not in accordance with the requirements under 21 CFR 101.9.

Passage 14

Your John Paine’s Steak Beast products (Beasty Bird, Chop Beast Pork Rub, Steak Seasoning, and Unleashed All Purpose Rub) are misbranded within the meaning of section 403(e)(2) [21 U.S.C. § 343(e)(2)] because the labels fail to declare the net quantity of contents on the principal display panel, as required by 21 CFR 101.7(a).

Passage 15

Even if your Dr. Botanical Health Organic Elderberry Plant Based Superfood Powder and Dr. Botanical Health Organic Lion’s Mane Mushroom Based Superfood Powder products were not unapproved new drugs and misbranded drugs, they are misbranded within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C. 343(r)(1)(A)] because the product labels bear nutrient content claims, but the products do not meet the requirements to bear such claims.