KANSAS CITY, Mo. — A Kansas City-based CBD producer received a warning letter from the U.S. Food and Drug Administration for several violations, including making products that could be considered appealing to children.
The FDA sent the letter on Nov. 16 to CBD American Shaman’s CEO Stephen Vincent Sanders II, KSNT reports. The extensive document points to the company’s CBD products and lists several violations it says need to be corrected.
Many products were listed as being adulterated because they contain an unsafe food additive. This is defined by uslegal.com as: “Adulterated means to make something impure by adding foreign or inferior ingredients. Adulteration can be done to edible goods or other commercial goods.”
These products include:
- CBD Suckers
- CBD Hard Candies
- Cookies [with] 10mg CBD per Serving
- CBD Sparkling Tea
- CBD Sparkling Water
- CBD Coffee
- CBD Honey Sticks
- CBD Honey
- Doggy Chews (all flavors)
- Soft & Tender Doggy Chews
- Horsey Chews
- Doggy Nugs
- Kitty Nugs
The FDA says it’s a prohibited act to introduce these products into interstate commerce.
However, the FDA reported in its letter it is “particularly concerned” over products sold by American Shaman that can be seen as appealing to children. These products include the CBD Suckers, CBD Hard Candies, various Cookies [with] 10mg CBD per Serving and various CBD Gummies products.
The warning letter also says such products have not been evaluated yet for safety, effectiveness and quality and could be unpredictable when used by vulnerable populations such as children.
Children may be at a greater risk for adverse reactions associated with certain drug products due to differences in the ability of children to absorb, metabolize, distribute or excrete such drug products or their metabolites, according to the FDA.
Other violations listed by the FDA include confusing marketing practices, selling the unapproved new drug “CBD + ZINC OXIDE Sunscreen” and the marketing of products containing CBD for pets that are unapproved new animal drugs.
The letter ends with the FDA requiring CBD American Shaman to respond within 15 working days with specific steps taken to correct the violations. An explanation of each step being taken to prevent the recurrence of violations along with copies of related documentation are required.