FDA Shares “5 Things to Know” about Delta-8 THC

Silver Spring, MD—The Food and Drug Administration (FDA) has issued an updated consumer update titled 5 Things to Know about Delta-8 Tetrahydrocannabinol – Delta-8 THC. The agency said the notification is in response to an increase in adverse event reports to FDA and poison control centers, online marketing that appeals to children, concerns regarding contamination. On the 5 things to know list:

  1. “Delta-8 THC products have not been evaluated or approved by the FDA for safe use and may be marketed in ways that put the public health at risk.” Concerns noted include variability in product formulations, other cannabinoid and terpene content, variable delta-8 THC concentrations, and product labeling, including products labeled as “hemp products,” which FDA noted may mislead consumers who associate “hemp” with “non-psychoactive.”
  2. “The FDA has received adverse event reports involving delta-8 THC-containing products.” The agency said it has received 104 reports of adverse events related to delta-8 THC products between December 1, 2020, and February 28, 2022, and offered a breakdown of the reports.
  3. “Delta-8 THC has psychoactive and intoxicating effects.” The agency said it is concerned that delta-8 THC products “likely expose consumers to much higher levels of the substance than are naturally occurring in hemp cannabis raw extracts.”
  4. “Delta-8 THC products often involve use of potentially harmful chemicals to create the concentrations of delta-8 THC claimed in the marketplace.” Among the concerns: That some manufacturers may use potentially unsafe household chemicals to make delta-8 THC through a chemical synthesis process.
  5. “Delta-8 THC products should be kept out of the reach of children and pets.”

As WholeFoods has previously reported, industry views on delta-8 are varied. Helping to guide the industry, the American Herbal Products Association (AHPA), adopted a guidance policy in June 2021 that points out that “hemp” is defined by federal law as “the plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent (0.3%) on a dry weight basis,” and notes that no other cannabinoid is subject to the same quantitative limit that delta-9 is. AHPA “discourages the marketing of goods for consumption by any route that both consist of or contain any amount of synthesized cannabinoids (including delta-8 THC) and are labeled as hemp products.” Another AHPA guidance policy recommends that any product (food or supplement) derived from hemp should comply with all applicable FDA regulations. AHPA encourages its members and non-member companies to adopt these policies to establish consistent and informed trade practices.

Read more industry perspectives here.

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