The FDA cited Lone Star Botanicals, Inc. after a facility inspection in the spring of 2023. The company manufactures seasoning blends as well as dry superfoods under the name Dr. Botanical Health. The warning letter listed several infractions, but we are going to focus on the misbranding of Dr Botanical Health superfoods as conventional foods when the claims are in violation of that classification.
The FDA reviewed their product labels, marketing material, and website at the Internet address https://drbotanicalhealth.com/. The claims made on the product labels, product brochure, and website 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.
The FDA has very strict guidelines when making claims regarding conventional foods. Structure/function claims for conventional foods focus on effects derived from nutritive value, while structure/function claims for dietary supplements may focus on non-nutritive as well as nutritive effects.
Claims found on the packaging, website, and marketing included the following:
- “Helps Fight Colds & the Flu”
- “Helps Combats [sic] Depression, Anxiety & Stress”
- “Anti-inflammatory”
- “Ashwagandha. …reduces anxiety and depression ….”
- “Acai also helps lower cholesterol levels ….”
- “The health benefits of these mushrooms…include…lowering cholesterol, blood sugar and blood pressure…and fight unhealthy inflammation.”
- “[T]hese mushrooms lower cholesterol, reduce allergic reactions ….”
The rest of the letter makes it clear that the company was manufacturing and labeling under the classification of conventional foods (CFR part 117/ Nutrition Facts Panels) which would cause the claims above to be in violation of the Act.
When you are manufacturing products for interstate commerce it is important that you are classified properly and are mitigating risks when it comes to claims and marketing. We have seen in recent years an increase in enforcement and companies hit with warning letters no matter the size of the brand. Claims such as the above are often the main infraction found in warning letters. Assuring you and your brand are compliant should be a top priority in the earliest stages of commercialization. To read the letter in full, click HERE.
If anything in the letter sounds familiar from your facility, or you would just like to be better prepared for your own FDA inspection when the time comes, let us know. In addition to label compliance reviews, we do facility audits and consulting on following cGMPs. Contact us today to discuss your needs and get a free quote.