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CDC, FDA report adverse events involving delta-8 THC products

2022-06-22 naturalproductsinsider

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Two U.S. health agencies on Tuesday warned about adverse events associated with the use of delta-8 THC products.

During the first seven months of 2021, the American Association of Poison Control Centers (AAPCC) recorded 660 delta-8 THC exposures, plus an additional exposure from October 2020, according to a health advisory issued by the Centers for Disease Control and Prevention (CDC).

The health advisory was targeted towards public health departments, healthcare professionals, first responders, poison control centers, laboratories and the public.

Eighteen percent of exposures reported by the AAPCC, or 119 cases, required hospitalization, while 39% of exposures, or 258 cases, involved pediatric patients who were less than 18 years old, CDC reported.

FDA, which also reported concerns Tuesday over delta-8 THC in a consumer update, said the hospitalizations above included children who required admission to the intensive care unit (ICU) after they were exposed to the products.

In cases reported by the Michigan Poison Control Center, two children who ingested a parents delta-8 THC-infused gummies purchased from a vape shop suffered deep sedation and slow breathing, according to CDC. The kids initial elevated heart rate progressed to a slowed heart rate and decreased blood pressure, and they were admitted to the ICU for further monitoring and oxygen supplementation, CDC said.

From December 2020 through July 2021, FDA reported, it received adverse event reports from consumers and law enforcement describing 22 patients who consumed delta-8 THC products.

Fourteen patients went to a hospital or emergency room for treatment after they ingested the products, and 19 patients suffered adverse events after ingesting delta-8 THC food products like brownies and gummies, FDA shared.

"Adverse events included vomiting, hallucinations, trouble standing and loss of consciousness," FDA stated.

Delta-8 THC products have proliferated over the last year in gummies, chocolates, tinctures, vapes and other forms, but they are often available to the public without any age restrictions or state regulations.

These products are increasingly found in hemp and marijuana marketplaces, some of which operate under state, territorial or tribal laws, according to CDC.

Delta-8 THC: FDA concerns 

In its consumer update, "5 Things to Know about Delta-8 Tetrahydrocannabinol – Delta-8 THC," FDA warned it has not evaluated or approved delta-8 THC products; and the agency said delta-8 THC products may be marketed in ways that endanger public health.

"Some concerns include variability in product formulations and product labeling, other cannabinoid and terpene content, and variable delta-8 THC concentrations," FDA explained. "Additionally, some of these products may be labeled simply as hemp products, which may mislead consumers who associate hemp with non-psychoactive."

Delta-8 THC products are sometimes marketed as "weed light" or "diet weed," according to CDC. And FDA described delta-8 THC as displaying "psychoactive and intoxicating effects," similar to the cannabinoid found in large quantities in marijuana, delta-9 THC.

FDA also raised concerns about potentially harmful chemicals needed to convert CBD, for example, into delta-8 THC. And the agency referenced products containing delta-8 THC and marketed for therapeutic or medical uses.

"Selling unapproved products with unsubstantiated therapeutic claims is not only a violation of federal law, but also can put consumers at risk, as these products have not been proven to be safe or effective," FDA cautioned. "This deceptive marketing of unproven treatments raises significant public health concerns because patients and other consumers may use them instead of approved therapies to treat serious and even fatal diseases."

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