The hallucinogenic chemical delta-8 tetrahydrocannabinol, often known as delta-8 THC, is present in the Cannabis sativa plant, of which marijuana and hemp are two types. Delta-8 THC is one of more than 100 cannabinoids produced naturally by the cannabis plant, however it isn’t found in large concentrations. As a result, cannabidiol produced from hemp is commonly used to produce concentrated levels of delta-8 THC (CBD).

Consumers should be informed that the FDA has not examined or authorised delta-8 THC products for safe use in any circumstance. They may be promoted in ways that endanger public health, and they should be kept out of the reach of youngsters and pets in particular.

Here are five things you should know about delta-8 THC to protect yourself and people you care about from potentially harmful products:

1. The FDA has not studied or authorised Delta-8 THC products for safe use, and they may be marketed in ways that endanger public health.

The FDA is aware of the growing concerns about delta-8 THC products that are now available for purchase online and in stores. The FDA has not examined or approved these products for use in any situation. Variability in product compositions and labelling, as well as additional cannabinoid and terpene levels and varying delta-8 THC concentrations, are all causes for worry. Furthermore, some of these items may simply be marketed as “hemp products,” thus misleading customers who equate “hemp” with “non-psychoactive.” The FDA is also worried about the growth of products containing delta-8 THC that are advertised for therapeutic or medical purposes despite the fact that they have not been approved by the agency. Selling unapproved products with unsupported therapeutic claims is not only illegal, but it also puts customers at danger because these products have not been demonstrated to be safe or effective. Because patients and other consumers may utilise experimental medicines instead of recognised medications to treat serious and even deadly conditions, this deceptive marketing of unproven treatments poses substantial public health issues.

2. The FDA has received reports of adverse events regarding products containing delta-8 THC.

Between December 1, 2020, and February 28, 2022, the FDA received 104 reports of adverse events in patients who took delta-8 THC products. The following are the 104 adverse event reports:

Adults were involved in 77% of the cases, children under the age of 18 were involved in 8% of the cases, and children under the age of 18 were not involved in 15% of the cases.

Intervention (e.g., evaluation by emergency medical services) or hospital admission were required in 55 percent of cases.

Sixty-six percent reported experiencing negative consequences after consuming meals containing delta-8 THC (e.g., brownies, gummies).

Hallucinations, vomiting, tremor, anxiety, dizziness, confusion, and loss of consciousness were among the adverse effects.

Between January 1, 2021 (the day when the delta-8 THC product code was introduced to the database) and February 28, 2022, national poison control centres received 2,362 exposure instances of delta-8 THC products. There were 2,362 cases of exposure:

Adults made up 58 percent of the study, while paediatric patients under the age of 18 made up 41%, and 1% did not specify their age.

Unintentional exposure to delta-8 THC was found in 40% of the cases, and 82 percent of these unintentional exposures impacted children.

70% required a health-care institution review, with 8% requiring admission to a critical-care unit; 45 percent of patients requiring a health-care facility evaluation were children.

A medical outcome of death was coded in one paediatric case.

3. Delta-8 THC possesses intoxicating and psychoactive properties.

Delta-8 THC possesses psychoactive and intoxicating properties, similar to delta-9 THC (the component that causes individuals to become “high” when they use cannabis). The FDA is aware of reports in the media that delta-8 THC products make people “high.” The FDA is particularly worried that delta-8 THC products expose consumers to significantly higher doses of the drug than are found naturally in hemp cannabis raw extracts. As a result, history cannabis consumption cannot be used to determine the safety of these products in humans.

4. To achieve the advertised amounts of delta-8 THC in the marketplace, several delta-8 THC products contain potentially dangerous substances.

The natural level of delta-8 THC in hemp is extremely low, necessitating the use of extra chemicals to convert other cannabinoids in hemp, such as CBD, into delta-8 THC (i.e., synthetic conversion). The following are some of the issues with this procedure:

Some producers may employ potentially hazardous household chemicals in this chemical synthesis procedure to create delta-8 THC. To modify the colour of the finished product, additional chemicals may be applied. Because of the chemicals utilised in the process, the final delta-8 THC product may contain potentially dangerous by-products (contaminants), and there is ambiguity about other potential contaminants that may be present or created depending on the nature of the beginning raw material. These compounds, including some utilised to manufacture (synthesise) delta-8 THC and the by-products created during synthesis, can be dangerous if swallowed or breathed.

Delta-8 THC products may be made in uncontrolled or unsanitary conditions, resulting in the presence of hazardous pollutants or other potentially toxic compounds.

5. Keep Delta-8 THC items out of the reach of youngsters and dogs.

These products are being packaged and labelled in ways that appeal to youngsters (gummies, chocolates, cookies, candies, etc.). These products are available for purchase online as well as in a number of merchants, including convenience stores and gas stations, where age restrictions may not apply. There have been multiple poison control centre alerts concerning juvenile patients who have been exposed to delta-8 THC-containing medications, as previously mentioned. Furthermore, animal poison control centres have reported a significant increase in the number of pets accidentally exposed to these items. Keep these items out of the reach of kids and dogs.

Why is the FDA issuing a public health alert regarding delta-8 THC?

The FDA has decided to disclose this information to consumers due to a number of factors. These elements include:

An increase in adverse event reports to the FDA and poison control centres around the country.

Children-friendly marketing, including product marketing on the internet.

Concerns about contamination from manufacturing procedures that may be used to make marketed delta-8 THC products in some circumstances.

The FDA is actively working with federal and state partners to address these concerns, as well as monitoring the market for product complaints, adverse events, and new developing cannabis-derived products of concern. When FDA-regulated items break the law, the FDA will send warnings to consumers about public health and safety concerns.

How to file a complaint or report an incident of accidental exposure or an adverse event:

If you suspect you’re suffering a major side effect that’s putting your health in jeopardy, dial 9-1-1 or go to your nearest emergency facility. The FDA’s MedWatch Safety Information and Adverse Event Reporting Program encourages health care providers and patients to report concerns, incidents of accidental exposure, and adverse events:

If you want to talk to someone about your situation, call an FDA Consumer Complaint Coordinator.

Request a reporting form by filling out an electronic Voluntary MedWatch form online or calling 1-800-332-1088, then returning it to the address on the form or faxing it to 1-800-FDA-0178.

Fill out a Voluntary MedWatch form on paper and mail it to the FDA.

Please download and submit Form FDA 1932a to the FDA’s Center for Veterinary Medicine at www.fda.gov/ReportAnimalAE to report adverse events in animals to the FDA’s Center for Veterinary Medicine.

Warning Letters from the FDA: The FDA has issued warning letters to companies selling CBD and Delta-8 THC products illegally.

Warning Letters and Test Results for Cannabidiol-Related Products: Warning Letters and Test Results for Cannabidiol-Related Products

CDC HEALTH ALERT NETWORK HEALTH ALERT NETWORK HEALTH ALERT NETWORK HEALTH ALERT NETWORK HEALTH ALERT NETWORK (HAN)

The National Poison Data System (NPDS) is maintained by the American Association of Poison Control Centers (AAPCC), and it contains de-identified case records of self-reported information collected from callers during exposure management and poison information calls managed by poison control centres across the country (PCCs). As more exposures may go unreported to PCCs, NPDS data do not reflect the whole universe of exposures to a specific chemical; as a result, NPDS data should not be considered to represent the complete incidence of U.S. exposures to any substance (s). Exposures do not always imply poisoning or overdosing, and the AAPCC is unable to verify the truth of every report. AAPCC does not necessarily agree with the findings based on NPDS data.