Delta-8 THC is a psychotropic chemical found in the Cannabis sativa plant, of which marijuana and hemp are both forms. Delta-8 Tetrahydrocannabinol is one of approximately 100 cannabinoids generated naturally by the cannabis plant, however it is not present in substantial concentrations. As a consequence, high levels of delta-8 THC are often produced from cannabidiol obtained from hemp (CBD).
Consumers should be informed that the FDA has not examined or authorised delta-8 THC products for safe use in any setting. They may be promoted in ways that endanger public health and should be kept out of the reach of youngsters and pets in particular.
Here are five facts regarding delta-8 THC that you should be aware of in order to protect yourself and others you care about from potentially harmful products:
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.
The FDA is aware of the rising concerns about delta-8 THC products offered online and in shops. The FDA has not examined or cleared these items for safe use in any setting. Variability in product formulations and labelling, additional cannabinoid and terpene content, and fluctuating delta-8 THC concentrations are some of the issues. Furthermore, some of these items may simply be branded as “hemp products,” which may mislead customers who equate “hemp” with “non-psychoactive.” Furthermore, the FDA is worried about the growth of products containing delta-8 THC that are advertised for therapeutic or medicinal purposes despite the fact that they have not been authorised by the FDA. Selling unapproved drugs with unproven therapeutic claims is not only against federal law, but it may also endanger customers since these products have not been demonstrated to be safe or effective. This misleading marketing of untested remedies raises substantial public health issues because patients and other consumers may use them instead of recognised medications to address serious and even deadly ailments.
2. The FDA has received adverse event reports involving delta-8 THC-containing products.
Between December 1, 2020, and February 28, 2022, the FDA received 104 reports of adverse events in patients who used delta-8 THC products. Among the 104 adverse event reports are:
- 77% of the patients were adults, 8% were paediatric patients under the age of 18, and 15% did not indicate their age.
- In 55 percent of cases, intervention (e.g., examination by emergency medical services) or hospitalisation was necessary.
- Sixty-six percent reported unpleasant effects after consuming delta-8 THC-containing food items (e.g., brownies, gummies).
- The following adverse effects occurred: hallucinations, vomiting, tremor, anxiety, dizziness, disorientation, and loss of consciousness.
Between January 1, 2021 (the day 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 Tetrahydrocannabinol products. Among the 2,362 incidents of exposure:
- 58% of the patients were adults, 41% were paediatric children under the age of 18, and 1% did not indicate their age.
- Accidental exposure to Delta-8 Tetrahydrocannabinol was implicated in 40% of the cases, and 82 percent of these unintentional exposures impacted juvenile patients.
- 70% needed a health care institution review, with 8% needing admission to a critical care unit; 45 percent of patients requiring a health care facility evaluation were paediatric patients.
- One paediatric instance had a medical result of death coded.
3. Delta-8 THC has psychoactive and intoxicating effects.
Delta-8 THC is psychoactive and intoxicating, comparable to delta-9 THC (the component responsible for the “high” that individuals may feel while smoking cannabis). The FDA is aware of media claims that Delta-8 Tetrahydrocannabinol products are causing customers to get “high.” The FDA is particularly worried that Delta-8 Tetrahydrocannabinol products expose consumers to significantly greater doses of the chemical than exist naturally in hemp cannabis raw extracts. As a result, previous cannabis usage cannot be relied on to establish a degree of safety for these products in humans.
4. Delta-8 THC products often involve use of potentially harmful chemicals to create the concentrations of delta-8 THC claimed in the marketplace.
The naturally occurring level of delta-8 THC in hemp is relatively low, and extra chemicals are required to convert other cannabinoids in hemp, such as CBD, into Delta-8 Tetrahydrocannabinol (i.e., synthetic conversion). Among the issues raised by this procedure are:
- Through this chemical synthesis method, some firms may employ potentially hazardous household chemicals to produce 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 include potentially dangerous by-products (contaminants), and there is ambiguity about additional possible contaminants that may be present or created depending on the nature of the beginning raw material. These compounds, including those required to manufacture (synthesise) delta-8 THC and by-products formed during synthesis, may be dangerous if swallowed or breathed.
- Delta-8 THC products may be manufactured in unregulated or unsanitary conditions, resulting in the presence of hazardous pollutants or other potentially toxic compounds.
5. Delta-8 THC products should be kept out of the reach of children and pets.
Manufacturers are packaging and labelling these items in ways that youngsters may find appealing (gummies, chocolates, cookies, candies, etc.). These items may be bought online as well as through a number of merchants, including convenience stores and petrol stations, where there may be no age restrictions. As previously stated, there have been a number of poison control centre warnings involving juvenile children who have been exposed to Delta-8 Tetrahydrocannabinol -containing products. Furthermore, animal poison control centres have reported a significant rise in the unintentional exposure of pets to these products. Keep these items away from children and pets.
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Why is the FDA notifying the public about delta-8 THC?
The FDA has decided to disclose this information to consumers due to a number of circumstances. These elements are as follows:
- An increase in reports of adverse events to the FDA and the nation’s poison control centres.
- Marketing that is attractive to children, includes internet marketing of items.
- Concerns about contamination as a result of manufacturing procedures that may be employed in certain situations to manufacture marketed delta-8 THC products.
The FDA is actively working with federal and state partners to address these goods’ problems while also monitoring the market for product complaints, adverse events, and any new cannabis-derived products of potential concern. When FDA-regulated goods break the law, the FDA will provide warnings to consumers about public health and safety concerns and, if required, will take action.