On September 14, 2021, the FDA and CDC issued warnings to the public delta 8 pre rolls about Delta-8 products, many of which are marketed as hemp products and include references to other novel cannabinoids that may have similar effects and marketing. The notices state that most of the products on the market have been synthetically converted, but fail to address the question of legality. Adverse events following consumption, marketing to and use by children, and the presence of harmful by-products and unsafe manufacturing practices were the major concerns.
With increased state and federal attention on these products, there is an increased risk to industry participants beyond that of criminal liability, such as FDA/FTC enforcement, banking and insurance obstacles and civil liability claims. Some of these were discussed on the show.
FDA Consumer Alert
According to the FDA consumer alert, we may begin to see enforcement action taken against companies that market these products in deceptive ways. There are five things to know about the serious health risks of the drug.
Delta-8 products have not been evaluated or approved by the FDA for safe use, and may be marketed in ways that put public health at risk. The FDA has received reports of adverse events. The effects of Delta-8 can be felt. Potentially harmful chemicals are used to create the concentrations of Delta-8 THC claimed in the market. Children and pets shouldn’t be able to reach Delta-8 products.
More than a dozen hospital or emergency room visits and hundreds of calls to poison control were reported after the publication of the interim final rule of the Drug Enforcement Administration. Many of these incidents were preventable. More than 660 poison control calls resulted in hospitalization.
The FDA notes historical cannabis data cannot be relied upon for safety indicators because these products concentrate delta-8 THC in amounts much higher than found naturally. The FDA warned that some may be using potentially unsafe chemicals during the process, and that the result may contain potentially harmful by-products. Because of the lack of regulation, manufacturing may be taking place in unsanitary facilities that increase the risk ofContamination Many of these products are marketed in ways that appeal to children, and animal poison control centers have seen an increase in accidental exposure among pets.
CDC Health Alert
The public is put on notice by the CDC. The recent increases in adverse health events are being tracked and monitored. It provides lists of recommendations for consumers, health departments/poison control centers, retailers, and healthcare providers.
The CDC alert included a review of emergency room visits where delta-8 THC was mentioned in the primary complaint, as well as the poison control calls. Most of the visits were concentrated in southern states with no access to marijuana. In these regions, delta-8 THC products are often marketed as hemp products, which can be confusing to consumers under the impression all hemp products are not psychoactive.
According to the CDC alert, a lack of consistency in testing requirements may mean that some products may not be tested for harmful substances. The concern that health effects are unknown due to a lack of research is reinforced by the mention of the two cannabinoids.
The CDC recommends that the public be aware of these products.
- May be intoxicating;
- May only report Delta-9/CBD concentrations and leaves out the other cannabinoids that may make you feel good.
- Should be stored away from children.
Retailers are encouraged to be transparent with consumers about the potential for intoxication and include all forms of the drug on the labels.
For the healthcare industry, recommendations include:
- Increased awareness among healthcare workers about these products and their psychoactive qualities, including those in states that only allow the sale ofHemp.
- Encouraging the use of the newly-created poison center control codes.
- All forms of the drug should be listed on the labels.
- This data can be used by community-based organizations to raise awareness about the potential negative health effects of cannabis derivatives that may be of concern.
- Requesting healthcare workers ask about the exposure of patients to delta-8 when they are high.
- Toxicologists and local poison control can be consulted if necessary, as detection of use can be difficult and there is no antidote for intoxication with cannabinoids.
Final Thoughts & Takeaways
The reports of adverse health events are alarming and stakeholders should take heed. The health alert is being disseminated quickly and there may be an increase in regulation.
The health concerns over the products of the cannabis industry are not new. This is the first formal statement from a federal agency about Delta-8, and we got two in one day. After reports of health and safety concerns, it’s not surprising that these alerts came about, but it’s disappointing that the industry is largely unregulated and without uniform standards as we wait for action at the federal level. The industry needs to regulate in order to protect consumers.
The notices are carefully worded and refer to the products as “synthetically converted” as opposed to “synthetically derived”. The August 2020 Interim Final Rule of the Drug Enforcement Administration stated that all “synthetically derived” THCs are controlled substances no matter the THC concentration, which distinguishes them from “materials that are derived from the cannabis plant.” The challenge of categorizing products from a plant is highlighted by the precise choice of words.
Businesses working with delta-8 THC products are encouraged to analyze their risks and take appropriate measures which may include changes to manufacturing practices, testing methods and packaging. You can reach out to one of the authors.