What You Need to Know About the FDA’s Delta-8 Warning

The Food and Drug Administration (FDA) released a consumer update about Delta-8 tetrahydrocannabinol (Delta-8 THC or D8) in mid-September. It warns that D8-containing products may pose a serious health risk to consumers, especially for children and pets. Here’s what you need to know about the FDA’s Delta-8 Warning.

What is Delta-8 THC and is it legal?

Delta-8 THC is a mildly intoxicating cannabinoid that can be manufactured from hemp CBD. It was initially considered to fit squarely through a ‘loophole’, since the Farm Bill legalized hemp products and Delta-8 THC is a hemp product. But many states have banned the substance, including California, which banned Delta-8 (9 and 10) THC in its recent hemp bill, AB 45. 

Read our article in MJ Biz Daily on the Delta-8 debate. 

What is the FDA’s Delta-8 Warning About?

The FDA’s Delta-8 warning highlights that the D8 THC has yet to be evaluated by the agency “for safe use in any context”, before going on to state that the warning was released following:

• An uptick in adverse event reports to the FDA and the nation’s poison control centers.
• Marketing, including online marketing of products, that is appealing to children.
• Concerns regarding contamination due to methods of manufacturing that may in some cases be used to produce marketed delta-8 THC products.

The agency pointed to 5 specific ‘things to know about’: 

Delta-8 THC products have not been evaluated or approved by the FDA for safe use and may be marketed in ways that put public health at risk.

The FDA identifies a wide range of concerns in its consumer update regarding the labeling and advertising of Delta-8 THC products, including that:

• Some D8-containing products are simply labeled as ‘hemp products’, which consumers may assume mean the product is non-intoxicating. 
• Certain products containing Delta-8 THC are being marketed as having therapeutic or medical uses, without having been approved by the FDA. 

The FDA has received adverse event reports involving Delta-8 THC-containing products. 

The FDA and National Poison Control Centers have received an increased number of adverse event reports since December 2020, including a rising number of individuals (children in particular) requiring treatment at a hospital, emergency room, or intensive care unit (ICU). These adverse reactions include vomiting, hallucinations, trouble standing, and loss of consciousness. 

Delta-8 THC has intoxicating effects.

The FDA is concerned that consumers are not able to rely on their historical use to establish a safe level of consumption for products containing Delta-8 THC. This is because the Delta-8-containing products contain higher levels of the substance than what naturally occurs in hemp cannabis raw extracts. As a result, these products may elicit a ‘stronger’ intoxicating effect than expected. 

Delta-8 THC products often involve the use of potentially harmful chemicals to create the concentrations of delta-8 THC claimed in the marketplace. 

The FDA warns that chemicals are used to convert other cannabinoids in hemp into Delta-8 THC because the natural levels are so low. This can be problematic because the process may result in the final Delta-8 THC product containing harmful by-products and contaminants. In turn, these may be consumed or inhaled, which can cause harm. 

Delta-8 THC products should be kept out of the reach of children and pets.

As outlined above, the poisons centers and the FDA are receiving more reports of adverse events involving children. This may be (at least partially) due to the packaging and labeling of many Delta-8 THC products appealing to children. Consumables, including gummies, chocolates, cookies, and candies, can be purchased at a variety of retailers and online, which means that there may not be age limits placed on who can purchase these products. 

Animal poison control centers have also reported an increasing number of pets ingesting products containing Delta-8 THC. 

If you need assistance navigating the cannabis or hemp landscape in California, reach out. Our cannabis attorneys would love to assist.