Lone Star Botanicals Inc.
FDA issued a warning letter to Lone Star Botanicals Inc. (doing business as Dr. Botanical Health) in Tyler, TX, citing serious CGMP violations at their food manufacturing facility, unapproved new drug claims across 11 botanical supplement products, and extensive food misbranding violations. The company's website, product labels, and brochures made disease treatment and prevention claims — including curing colds/flu, reducing anxiety and depression, fighting cancer, stabilizing blood sugar, and lowering cholesterol — that caused the products to be classified as unapproved new drugs under the FD&C Act. FDA demanded written corrective action within 15 working days and warned that failure to comply may result in seizure or injunction.
Flagged claims (31)
Ashwagandha powder can help reduce inflammation ….
Helps Fight Colds & the Flu
It's often used as a folk remedy for…the common cold and flu … helping allergies and sinus infections, treating diarrhea ….
[T]hese mushrooms lower cholesterol, reduce allergic reactions ….
This powerful supplement is proven to stabilize blood sugar…reduce inflammation….
Helps Fight Infections Like Cold & Flu
Ashwagandha. ...reduces anxiety and depression ….
Various studies have shown that it can be effective as a natural remedy for preventing and treating colds and flu … Not only can elderberry help prevent colds and flu, but it can also be used to treat allergies, including hay fever, and sinus infections.
It…reduces anxiety and depression ….
It also has anti-inflammatory properties, which makes it useful for treating allergies and sinus infections … scientifically proven to be effective at treating colds and flu, particularly at the onset of a cold or flu.
Helps Combats [sic] Depression, Anxiety & Stress
It's known to help reduce anxiety ….
Powerful Antioxidant
The phytochemicals found in elderberries are known to fight infection, particularly in the respiratory system. High in antioxidants, it lowers cholesterol ….
Marine Collagen is a powerful supplement proven to…reduce inflammation….
[T]his herb has been traditionally used to reduce anxiety, depression ….
The benefits of this adaptogen also extends to fighting inflammation.
It is known for aiding in…constipation, diarrhea, and diabetes!
Maca may also help…lower blood pressure ….
Acai also helps lower cholesterol levels ….
Rich in Vitamins & Nutrients
Anti-inflammatory
Lion's mane mushrooms have been used medicinally for…skin diseases…reduce inflammation…. They are also used to help treat skin conditions such as psoriasis and eczema, as well as mental health conditions such as depression and anxiety.
Reduces inflammation
Contains Anti-Tumor Properties
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 ….
The health benefits of these mushrooms…include…lowering cholesterol, blood sugar and blood pressure…and fight unhealthy inflammation.
The lions mane mushroom contains a variety of compounds… [that] have anti-inflammatory, anti-cancer…properties.
Fights Harmful Bacteria
Stabilizes blood sugar
Medicinally, Lion's Mane mushrooms are thought to protect from dementia, reducing mild depression and anxiety, and increase recovery from nervous system injuries.
Required actions (3)
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
The claims on your product labels, product brochure, and your website establish that certain of your 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. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
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