As part of its enforcement efforts, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not published until weeks or months after they are sent. The employer must respond to her FDA warning letter within 15 days. Warning letters are often not issued until the company has had months or years to resolve the issue.
Discover Health, LLC dba Discover CBD and Curb the Snob
Colorado Springs, Colorado
A Colorado food company has been notified by the FDA over concerns that consumers may confuse its products with traditional foods. Therefore, there is a risk of unintentional ingestion of cannabidiol (CBD) and delta-8 tetrahydrocannabinol (THC) in these products.
In a warning letter dated November 16, 2023, FDA describes its review of the Discover CBD and Strain Snobs websites located at the Internet addresses “discovercbd.com” and “www.activecbdoil.com” from June to August 2023. did.
FDA review of Active CBD Oil Infused Coffee, Active CBD Oil Gummies, CBD Living Water, and Strain Snobs™ Delta-8 Plant-Based Gummies products sold on the company's webpage was determined to be contaminated with foreign matter. Contains or contains dangerous food additives.
Food additives that are not approved for use in food are considered unsafe and can lead to contamination of food. The introduction of adulterated food into interstate commerce is prohibited.
Some of the violations:
301(ll) and adulterated human food.
According to the company's product labels, its “Active CBD Oil – CBD Infused Coffee,” “Active CBD Oil Gummies,” and “CBD Living Water” products are food products spiked with CBD.
The FDA notes that the various benefits of “active CBD oil gummy” products appear to be promoted as conventional human foods. Specifically, the company promotes the gummies as “delicious, fruity candy.”
Based on the available evidence, FDA has concluded that the Section 301(ll) prohibition applies to CBD. There is an exception if the substance was sold as a food before the drug was approved or substantial clinical research began on the drug. However, based on the available evidence, the FDA concluded that this is not the case with his CBD. FDA is aware of evidence that calls into question the current conclusion that section 301(ll) of the FD&C Act, 21 USC 331(ll) prohibits the introduction into interstate commerce of foods to which CBD has been added. However, the company may present evidence to the FDA on this issue.
FDA is not aware of any other exceptions to the food additive definition that apply to CBD used as an ingredient in conventional foods. Therefore, CBD added to conventional foods is a food additive under Section 201 of the FD&C Act and is subject to the provisions of Section 409 of the FD&C Act. Under Section 409, food additives are considered unsafe unless their intended use is approved by the FDA before they are placed on the market. CBD is not approved for use in conventional foods. A food containing an unsafe food additive within the meaning of section 409 is adulterated. Therefore, the company's “Active CBD Oil Gummies,” “Active CBD Oil – CBD Infused Coffee,” and “CBD Living Water” products contain or contain unsafe food additives. Foreign matter is mixed in. These adulterated foods are prohibited from entering interstate commerce.
Additionally, the company's “Strain Snobs™ Delta 8 Plant-Based Gummies” products are edibles spiked with Delta-8 THC, according to the product label. There are no food additive regulations that allow the use of Delta-8 THC. FDA is not aware of any information indicating that Delta-8 THC is subject to prior sanctions (see 21 CFR Part 181). Furthermore, I am not aware of any basis to conclude that delta-8 THC is GRAS used in conventional edibles.
FDA is not aware of any basis for general acceptance of the safety of delta-8 THC based on scientific procedures or common use in foods prior to January 1, 1958. We do not provide existing data and information based on FDA's review of published scientific literature. Sufficient basis to conclude that the use of delta-8 THC in food meets the criteria for GRAS status. Some of the available data raises serious concerns about the potential harms of Delta-8 THC. A review of published scientific literature indicates that it may have adverse effects on the central nervous system and the cardiopulmonary system. Additionally, animal studies suggest that exposure to delta-8 THC during pregnancy may interfere with neurodevelopment. Therefore, based on FDA review, the use of Delta-8 THC in that product does not meet GRAS standards.
FDA is not aware of any other exceptions to the food additive definition that apply to delta-8 THC used as an ingredient in conventional foods. Therefore, delta-8 THC added to conventional foods is a food additive and is subject to the provisions of Section 409 of the FD&C Act. Under Section 409, food additives are considered unsafe unless their intended use is approved by the FDA before they are placed on the market. Delta-8 THC is not approved for use in conventional foods. A food containing an unsafe food additive within the meaning of section 409 is adulterated. Therefore, the company's “Strain Snobs™ Delta 8 Plant-Based Gummys” products contain or contain unsafe food additives and are therefore adulterated. This adulterated food is prohibited from entering interstate commerce.
View the full warning letter here.
(To sign up for a free subscription to Food Safety News, click here)
