As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems.
Discover Health, LLC dba Discover CBD and Strain Snobs
Colorado Springs, CO
A food firm in Colorado is on notice from the FDA for concern that consumers may confuse their products with traditional foods; therefore, with these products, there is a risk of unintended consumption of cannabidiol (CBD) and Delta-8 Tetrahydrocannabinol (THC).
In a Nov. 16, 2023, warning letter the FDA described a June to August 2023, review of Discover CBD and Strain Snobswebsite at the internet addresses “discovercbd.com” and “www.activecbdoil.com.”
The FDA’s review determined that their “Active CBD Oil Infused Coffee,” “Active CBD Oil Gummies,” “CBD Living Water,” and “Strain Snobs™ Delta-8 Plant-Based Gummies” products offered for sale on their webpages are adulterated because they bear or contain an unsafe food additive.
Any food additive that has not been approved for its intended use in food is deemed to be unsafe and causes the food to be adulterated. Introduction of an adulterated food into interstate commerce is prohibited.
Some of the violations:
301(ll) and Adulterated Human Foods
According to the firm’s product labeling, their “Active CBD Oil – CBD Infused Coffee,” “Active CBD Oil Gummies” and “CBD Living Water” products are foods to which CBD has been added.
The FDA notes that the various strengths of “Active CBD Oil Gummies” products appear to be promoted as a conventional human food. Specifically, they promote these gummies as “delicious, fruity candy.”
Based on available evidence, the FDA has concluded that the prohibition in section 301(ll) applies to CBD. There is an exception if the substance was marketed in food before the drug was approved or before the substantial clinical investigations involving the drug had been instituted. However, based on the available evidence, the FDA has concluded that this is not the case for CBD. FDA is not aware of any evidence that would call into question its current conclusion that section 301(ll) of the FD&C Act, 21 U.S.C. 331(ll), prohibits the introduction into interstate commerce of any food to which CBD has been added, but the firm may present FDA with any evidence bearing on this issue.
FDA is not aware of any other exception to the food additive definition that would apply to CBD for use as an ingredient in a conventional food. Therefore, CBD added to a conventional food is a food additive under section 201(s) of the FD&C Act and is subject to the provisions of section 409 of the FD&C Act. Under section 409, a food additive is deemed unsafe unless it is approved by FDA for its intended use prior to marketing. CBD is not approved for use in any conventional food. Food containing an unsafe food additive within the meaning of section 409 is adulterated. Therefore, the firm’s “Active CBD Oil Gummies,” “Active CBD Oil – CBD Infused Coffee,” and “CBD Living Water” products are adulterated because they bear or contain an unsafe food additive. Introduction of these adulterated foods into interstate commerce is prohibited.
Further, according to their product labeling, their “Strain Snobs™ Delta 8 Plant-Based Gummies” product is food to which Delta-8 THC has been added. There is no food additive regulation that authorizes the use of Delta-8 THC. FDA is not aware of any information to indicate that Delta-8 THC is the subject of a prior sanction (see 21 CFR Part 181). Furthermore, we are not aware of any basis to conclude that Delta-8 THC is GRAS for use in conventional foods.
FDA knows of no basis for general recognition of safety for Delta-8 THC based either on scientific procedures or common use in food before Jan. 1, 1958. Based on the FDA’s review of published, scientific literature, existing data and information do not provide an adequate basis to conclude that the use of Delta-8 THC in food meets the criteria for GRAS status. Some of the available data raise serious concerns about potential harm from Delta-8 THC. Our review of published scientific literature identified potential for adverse effects on the central nervous and cardiopulmonary systems. In addition, studies in animals have suggested that gestational exposure to Delta-8 THC can interfere with neurodevelopment. Therefore, based on the FDA’s review, the use of Delta-8 THC in their product does not satisfy the criteria for GRAS.
FDA is not aware of any other exception to the food additive definition that would apply to Delta-8 THC for use as an ingredient in a conventional food. Therefore, Delta-8 THC added to a conventional food is a food additive and is subject to the provisions of section 409 of the FD&C Act. Under section 409, a food additive is deemed unsafe unless it is approved by FDA for its intended use prior to marketing. Delta-8 THC is not approved for use in any conventional food. Food containing an unsafe food additive within the meaning of section 409 is adulterated. Therefore, their “Strain Snobs™ Delta 8 Plant-Based Gummies” product is adulterated because it bears or contains an unsafe food additive. Introduction of this adulterated food into interstate commerce is prohibited.
The full warning letter can be viewed here.
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