KANSAS CITY, Missouri — A Kansas City CBD grower has received warning letter from the US Food and Drug Administration for several violations, including making products that could be considered attractive to children.
The FDA sent a letter on November 16 to CBD American Shaman CEO Stephen Vincent Sanders II. This is reported by KSNT. The extensive document points to the company’s CBD products and lists several violations it says must be corrected.
Many products have been listed as adulterated because they contain a dangerous food additive. Uslegal.com defines it this way: “To adulterate is to make something impure by adding extraneous or inferior ingredients. Adulteration may be committed with respect to edible goods or other commercial goods.”
These products include:
- CBD suction cups
- CBD hard candy
- Cookies [with] 10 mg of CBD per serving
- CBD sparkling tea
- CBD sparkling water
- CBD coffee
- CBD honey sticks
- CBD Med
- Doggy Chews (all flavors)
- Soft and tender chewing candies for dogs
- The horse chews
- Doggy Nugs
- Kitty Nags
The FDA states that the introduction of these products into interstate commerce is prohibited.
However, the FDA said in its letter that it is “particularly concerned” about American Shaman’s products, which could be seen as appealing to children. These products include CBD Suckers, CBD Hard Candies, various cookies [with] 10mg of CBD per serving and various CBD Gummies.
The warning letter also states that such products have not yet been evaluated for safety, efficacy and quality and may be unpredictable when used by vulnerable populations such as children.
According to the FDA, children may be at greater risk of adverse reactions associated with certain drugs because of differences in children’s ability to absorb, metabolize, distribute, or eliminate such drugs or their metabolites.
Other violations listed by the FDA include confusion in marketing practices, the sale of a new unapproved CBD + ZINC OXIDE sunscreen, and the marketing of CBD-containing pet products that are new unapproved animal drugs.
The letter ends with the FDA requiring CBD American Shaman to respond within 15 business days with specific measures to address the violations. An explanation of each step taken to prevent repeat violations is required, along with a copy of the relevant documentation.
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