On November 26, 2023, the FDA issued a Warning Letter to Lone Star Botanicals, Inc. following an inspection of the company’s manufacturing facility, which found the company’s products to be adulterated because they were prepared, packed, or held under conditions that do not meet Current Good Manufacturing Practices (CGMP). Violations noted by the FDA included failure to prepare and implement a safety plan with elements required by the FDA, failure to have controls in place for allergen cross-contact, and failure to identify and evaluate bacterial pathogens such as Salmonella.

In addition, the agency’s review of the company’s website, company brochure, and product labels found statements about the company’s products, including Dr. Botanicals Health products Organic Ashwagandha Plant Based Superfood Powder, Organic Elderberry Plant Based Superfood Powder, Organic Lion’s Mane Mushroom Based Superfood Powder, Marine Collagen, Organic Cordyceps Mushroom Based Superfood Powder, 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 to be drug claims.

For example, Dr. Botanical Health Organic Ashwagandha Plant Based Superfood Powder products were promoted with statements such as, “Anti-inflammatory” and “It…reduces anxiety and depression…” Dr. Botanical Health Organic Lion’s Mane Mushroom Based Superfood Powder products were promoted with statements such as, “Rich in medicinal properties, Lion’s Mane mushrooms are thought to guard against dementia, reduce mild depression and anxiety, and help speed up recovery from injuries to the nervous system. Our extract powder can also help to regulate diabetes…”

Dr. Botanical Health Marine Collagen products were promoted with statements such as, “This powerful supplement is proven to stabilize blood sugar…reduce inflammation…”

See ConsumerLab’s Reviews of Collagen Supplements, Ashwagandha Supplements, and Lion’s Mane and Chaga Supplements for tests of related products.

Also see: What are the best supplements for depression and anxiety?

Do any supplements, foods or lifestyle modifications help with brain function, like memory and cognition?

Which supplements and foods can help lower or control blood sugar?

Dr. Botanical Health Organic Elderberry Plant Based Superfood Powder products were promoted with statements such as, “It’s often used as a folk remedy for…the common cold and flu … helping allergies and sinus infections, treating diarrhea…”

See ConsumerLab’s Review of Elderberry Supplements for more information and tests of related products.

Also see: Do any supplements help prevent or treat a cold?

Do any supplements help for flu?

Which supplements are best for seasonal allergies?

Dr. Botanical Health Organic Açaí Plant Based Superfood Powder products were promoted with statements such as, “Acai also helps lower cholesterol levels ….” Dr. Botanical Health Organic Reishi Mushroom Based Superfood Powder products were promoted with statements such as, “[T]hese mushrooms lower cholesterol, reduce allergic reactions…”

See ConsumerLab’s Reviews of Acaí Berry and Reishi Mushroom Supplements for more information and tests of related products.

Also see: Which supplements or foods can help lower cholesterol and keep my heart healthy? Are there any to avoid?

The FDA also stated in its letter that it considers most of these products to be “new drugs” because they are not recognized as safe and effective for their intended use. Additionally, most products were also found to be misbranded because the labels failed to include adequate directions for their intended use.

The company must respond to the FDA in writing within 15 days of receipt of the warning explaining the specific steps taken to address these violations.

For more information, use the link below.

Warning: Lone Star Botanicals Inc.

See related recalls and warnings:

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