The Food and Drug Administration (FDA) has sounded an alarm regarding the prevalence of products containing Delta-8 THC, a cannabinoid compound, expressing significant apprehensions about their potential dangers. The agency has outlined multiple areas of concern pertaining to such products:
1. Safety Evaluation: Delta-8 THC products have not been assessed or approved by the FDA for safe consumption. The unregulated marketing and distribution of these products pose a potential risk to public health.
2. Adverse Event Reports: The FDA has received reports of adverse events associated with products containing Delta-8 THC.
3. Psychoactive Effects: Delta-8 THC has psychoactive and intoxicating effects, which may have unintended consequences for consumers.
4. Concentration Processes: The FDA raises concerns over the methods employed to create and advertise the concentrations of Delta-8 THC present in these products.
5. Child Consumption Risk: The FDA is also concerned about the packaging and labeling of Delta-8 THC products, which could be appealing to children, leading to unintended consumption.
In particular, the FDA has taken action against two companies – one in California and another in North Dakota – for adding Delta-8 THC to their food products:
California Company
The FDA has raised concerns about the “Delta 8 Gummies” under the Koi brand and “Pot Rocks” under the Hemp Living brand, produced by a California-based company. The products were found to contain added Delta-8 THC. The FDA points out that there are no regulations permitting the use of Delta-8 THC as a food additive, and the substance is not generally recognized as safe (GRAS) for use in conventional foods. The FDA emphasizes that scientific procedures and data do not support its safety, with potential harm and adverse effects being indicated in published scientific literature. The FDA’s warning letter to this company can be reviewed for more details.
North Dakota Company
Another company in North Dakota, Northland Vapor Company, LLC, manufacturing ready-to-eat (RTE) human food products containing Delta-8 THC, received a warning letter from the FDA. The company’s “Death by Gummy Bears” and “Wonky Weeds” gummy bear products were found to be adulterated due to the presence of an unsafe food additive, Delta-8 THC. Furthermore, the RTE food products from the company were considered adulterated due to improper preparation, packing, or handling under unsanitary conditions. The FDA’s inspection of the company’s facility revealed deviations from proper practices, and a Form FDA-483 was issued outlining the discrepancies.
The FDA’s actions reflect growing concerns about the safety and regulation of Delta-8 THC in food products. The agency urges companies and consumers to be vigilant and prioritize public health and safety.
It’s important to note that the use of Delta-8 THC in food products requires premarket approval based on data demonstrating safety. The FDA emphasizes that introducing adulterated food products into commerce is prohibited.
As the debate on the safety and regulations surrounding Delta-8 THC continues, the FDA remains committed to ensuring consumer protection and the wellbeing of public health.