Last updated : July 7, 2025
A few companies that sell delta-8 THC, a psychoactive cannabis product received warning letters from the U.S. Food and Drug Administration (FDA). Turns out they’ve been selling products illegally.
At the federal level, delta-8 THC is legal because it falls within the approved amount specified for hemp-derived products outlined in the 2018 Farm Bill. It’s in products such as cookies, gummies, candy, and tinctures.
That’s a problem though.
Not approved by FDA
Listed as one of over 100 cannabinoids produced in the Cannabis sativa L plant, delta-8 has psychoactive and intoxicating effects. The FDA hasn’t approved it for use. Companies that received the letters discovered they are illegally marketing the products with a promise of pain relief for varying medical conditions.
FDA Principal Deputy Commissioner Janet Woodcock said, “The FDA is very concerned about the growing popularity of delta-8 THC products being sold online and in stores nationwide. These products often include claims that they treat or alleviate the side effects related to a wide variety of diseases or medical disorders, such as cancer, multiple sclerosis, chronic pain, nausea, and anxiety.”
The letters also warned the companies that they didn’t feel there were adequate directions for use provided.
The companies that received the letters regarding the illegal sale of cannabis products are:
Several of these companies were also warned about CBD marketing.
Why won’t the FDA approve it?
In an article published on its website, the FDA warned that “delta-8 THC products haven’t been evaluated or approved by the FDA for safe use in any context. They may be marketed in ways that put public health at risk.”
In addition to the fact that the products aren’t approved by the FDA, the article listed other information the public needs to be aware of because products containing delta-8 THC could pose a serious health risk.
We’ll hit the highlights for you.
Mixed reports
Cannabis products are widely distributed in all but a couple of the states. However, the FDA received 104 reports of adverse events related to patients who consumed delta-8 THC products between December 1, 2020 and February 28, 2022. Adverse event reports provided the following information:
- 77% of the reports involved adults, 8% were related to pediatric patients, and 15% didn’t include an age
- 55% required emergency intervention or hospitalization
- 66% described adverse events after eating food products, such as brownies or gummies, that contained delta-8 THC
- Adverse events included but weren’t limited to: hallucinations, anxiety, vomiting, tremor, dizziness, confusion, and loss of consciousness
In addition to reports received by the FDA, national poison control centers received 2,362 exposure cases of delta-8 THC products between January 1, 2021 and February 8, 2022. Of those cases:
- 58% involved adults, 41% involved patients less than 18 years of age, and 1% didn’t report an age
- 40% of the reports involved unintentional exposure to delta-8 THC and 82% of the unintentional ingestion was by pediatric patients
- 70% required health care facility evaluation, of which 8% of those resulted in admission to a critical care unit; 45% of those patients were pediatric patients
- One pediatric patient case showed a medical outcome of death
The effects are intoxicating
The psychoactive and intoxicating effects of delta-8 THC are similar to those of delta-9 THC. It’s the component responsible for the “high” that people experience when they consume cannabis. The FDA is aware of the media reporting that delta-8 THC products cause impairment.
The FDA is concerned that the products in question are likely to expose consumers to much higher levels of delta-8 THC than naturally occur in hemp cannabis raw extracts. That said, looking back at the historical use of cannabis can’t be relied on to establish a safe level of consumption for humans regarding delta-8 THC.
Manufacturing involves chemicals
Some manufacturers use household chemicals to convert some of the cannabinoids in hemp, such as CBD, for instance, into delta-8 THC by means of synthetic conversion. That’s concerning because the final product may contain potentially harmful by-products when consumed or inhaled.
It’s also important to note that manufacturing of these products may occur in uncontrolled or unsanitary settings. This also leads to the presence of unsafe contaminants.
Stash your stash
The packaging and labeling of delta-8 THC products may appeal to children because they are likely candies, cookies, chocolates, or gummies. As we mentioned above, a large number of reports received from poison control centers involved pediatric patients. Moreover, animal poison control centers report a sharp increase in accidental exposure of pets to edible products containing delta-8 THC.
Store products in a place where kids and pets can’t reach them.
Another problem? Consumers can purchase products online and at retail stores alike—places like convenience stores and gas stations. That’s a concern because there may not be age limits on who can purchase the products.
If you experience adverse cannabis effects
If ever you feel you are in immediate danger after having taken a delta-8 THC—or any other cannabis product—contact 9-1-1 or head to your local emergency room.
The FDA urges healthcare professionals and patients to report complaints and cases of accidental exposure and adverse reactions to the FDA’s MedWatch Safety Information and Adverse Event Reporting program.
Call an FDA Consumer Complaint Coordinator to speak directly to a person about your problem. Otherwise, you can complete an electronic Voluntary MedWatch form online. You can also call 1-800-332-1088 to request a reporting form be sent to you.
You can report adverse reactions in animals to the FDA’s Center for Veterinary Medicine by submitting Form FDA 1932a.
We want safe medication
Cannabis products have long been touted as having amazing medical properties. People use them for a wide variety of ailments and conditions. However, there aren’t any formal guidelines for manufacturers to follow and that can be dangerous.
Reporting adverse reactions after ingesting products containing delta-8 THC, or any other cannabis products, can aid the FDA in its pursuit to ensure safe foods and drugs for public consumption.
