FDA, CDC Release Statements On Delta-8 THC

The United States Food and Drug Administration (FDA) and the Centers for Disease Control (CDC) have released advisory statements warning of potential risks associated with delta-8 tetrahydrocannabinol (D8) use.

On Tuesday, September 14, the CDC issued an official health advisory, and the FDA published 5 Things to Know about Delta-8 Tetrahydrocannabinol – Delta-8 THC.

While THC exists naturally and abundantly in cannabis plants, D8 is not as plentiful.

The D8 currently sold comes from a conversion process that begins with the non-psychoactive cannabinoid cannabidiol (CBD).

“CBD can be synthetically converted into delta-8 THC, as well as delta-9 THC and other THC isomers, with a a solvent, acid, and heat to produce higher concentrations of delta-8 THC than those found naturally in the cannabis plant,” says the CDC. “This conversion process, used to produce some marketed products, may create harmful by-products that presently are not well-characterized.”

The FDA has not evaluated or approved D8 for safe use but is aware of growing concerns surrounding its use and says it may be marketed in ways that put public health at risk.

Among FDA concerns are variability in product formulations, product labeling, and inconsistent cannabinoid and terpene content.

The FDA also says that some D8 products may be labeled as hemp products, which may mislead consumers into thinking they are non-psychoactive.

According to the FDA, selling unapproved products with unsubstantiated therapeutic claims violates federal law and can put consumers at risk.

The FDA says deceptively marketing unproven treatments raises significant public health concerns because people may use them rather than approved therapies for serious or fatal diseases.

Adverse Reaction Reports

The FDA says that it received adverse event reports regarding D8 use from consumers and law enforcement between December 2020 and July 2021.

According to the FDA, of 22 patients who consumed D8, 19 had adverse reactions, and four went to hospitals or emergency rooms for treatment.

Adverse reactions included vomiting, hallucinations, difficulty standing, and loss of consciousness.

The FDA also reports that national poison control Centers received 661 reports of D8 exposure between January 2018 and July 21, 2021.

Of the 661 cases, 41 percent were unintentional exposures, 77 percent of which involved pediatric patients under 18 years of age.

Eighteen percent required hospitalization, including minors who needed intensive care admissions following D8 exposure.

Chemical Production of D8

While natural production of D8 in cannabis plants is low, additional chemicals are required to convert CBD to delta-8 THC.

The FDA says that some manufacturers may use potentially unsafe household chemicals to manufacture D8 and additional chemicals to change the color of the final product.

As a result, the FDA says D8 products may have potentially harmful contaminants.

“…and there is uncertainty with respect to other potential contaminants that may be present or produced depending on the composition of the starting raw material,” says the FDA. “If consumed or inhaled, these chemicals, including some used to make (synthesize) delta-8 THC and the by-products created during synthesis, can be harmful.”

The FDA warns that because manufacturers package and label products in ways that may be appealing to children, consumers should store D8 products where children and pets cannot access them.

According to the FDA, animal poison control centers have indicated a sharp increase in accidental pet exposure to D8 products.

FDA Response

The FDA says that its release of D8 information is in response to an increase in adverse event reports, marketing that appeals to children, and concerns regarding contamination of products due to manufacturing methods.

The FDA reports that it is working with state and federal partners to further address D8 product-related concerns and monitor the market for complaints, adverse events, and other emerging cannabis-derived products of potential concern.

The CDC Weighs In

According to the CDC, the rise of D8 products in cannabis and hemp marketplaces has increased psychoactive product availability in states, territories, and tribal nations where adult-use cannabis is not permitted.

The CDC says that variations in product content, manufacturing practices, labeling, and potential misunderstanding of D8’s psychoactive properties can lead to unexpected effects in consumers.

The CDC recommends that consumers be aware of potential limitations of THC and CBD product labeling, even from approved cannabis and hemp retailers.

According to the CDC, the reason is that products that only list their delta-9 THC concentration, but not total THC, may underestimate their psychoactive potential for consumers.

The CDC also says consumers should be aware of the evolving cannabis marketplace as other products of potential concern that contain delta-10 THC and THC-O acetate have emerged.

The CDC says more research is needed to understand the health effects of products containing those compounds.

For cannabis retailers, the CDC recommends providing information for consumers about D8’s psychoactive properties and reporting total THC content on product labeling.