The FDA sets targets for Delta-8

This article originally appeared on the Green Light Law Group and has been republished with permission.

On May 4, 2022, the Food and Drug Administration (FDA) sent out warning letters to five companies that distribute delta-8-THC (FDA Warning Letters). This is the first time the FDA has specifically addressed products containing hemp-derived delta-8.

In all but one of the letters, the FDA also warned against distributing products containing cannabidiol (CBD). Both Delta-8 and CBD can be derived from hemp. Hemp is a federally legal form of cannabis that has created a huge, quasi-legal market for these products. Up to this point, the FDA’s focus when it comes to cannabis has been CBD. Now it appears that the FDA is also targeting Delta-8.

Photo by Hector Roqueta Rivero/Getty Images

Each of the FDA’s five Warning Letters alleged the following violations:

  • Distribution of new unapproved drugs containing Delta-8
  • Distribution of false brand medicines containing Delta-8
  • Distribution of adulterated foods containing Delta-8

Delta 8 drugs

The FDA has not approved a drug containing Delta-8. The FDA warning letters indicate that the five recipients are distributing unapproved drugs containing Delta-8. The FDA regulates a variety of products and has a system for classifying those products under the Food, Drug and Cosmetics Act (FDCA). To determine if a product is a drug, the FDA looks at how the product is marketed to determine its intended use. If medical, health, or wellness claims are made about a product, regardless of what the product contains, then the product becomes a drug in the eyes of the FDA.

Here are some of the drug claims referenced in the FDA warning letters:

  • Facebook post stating “Delta-8 THC shows great promise as an antiemetic that may relieve nausea and vomiting in pediatric cancer patients undergoing chemotherapy.”
  • Instagram post captioned “Prevent vomiting . . . A small study suggested that Delta 8 THC is an effective option for treating vomiting during chemotherapy. . . Eliminates Fear”
  • A webpage titled “What is Delta 8 THC?” which reads: “In non-medical terms, researchers brought Delta 8 THC to anti-nausea (antiemetic), anti-anxiety (anxiolytic) and pain relief (analgesic) benefits, among others Connection . . . Thanks to its neuroprotective effects, it could also protect brain cells.”
  • A blog post titled “Let’s [sic] Introducing Delta-8 THC” with the following content: “Delta-8 THC flower is an ideal option for medical cannabis users who want to enjoy the benefits of THC without the sedative effects.”
  • A product website stating, “Delta-8 users report many of the same effects as THC. . . and relieving some symptoms such as pain. . . Delta-8 can also help with insomnia.”

These examples were chosen to illustrate that the FDA looks beyond a product’s labeling and packaging to determine whether or not it is a drug. The FDA reviews social media and websites to make their decision. Additionally, claims do not have to be explicit for the FDA to determine that a drug is involved. A blunt claim that Delta-8 can cure or treat a disease constitutes a drug claim, but even citing a study on Delta-8 will put a target on your back.

RELATED: Delta-8 THC Suffers From Misnames — Misname or Mismanagement?

In the FDA Warning Letters, the FDA also alleges that the Delta-8 drugs are mislabeled because they do not include proper instructions for use. At this point, the FDA Warning Letters state that adequate guidance cannot be written because there are insufficient studies on Delta-8. The lack of studies also prohibits Delta-8 manufacturers from determining a safe dosage up to the FDCA standard.

Getting FDA approval for a new drug is incredibly expensive, making it unaffordable for most companies. The FDA sets strict testing standards to determine a drug’s safety. There doesn’t seem to be a clear path for the FDA to approve Delta-8 as a drug.

Delta-8 in food

Both drugs and foods are subject to FDA pre-market approval, but the standards are not the same. The FDA requires food additives to be generally considered safe (GRAS) for use in human or animal foods. The FDA has not concluded that Delta-8 is GRAS, meaning it cannot be added to food. Contrary to claims that Delta-8 products are unapproved and mislabeled drugs, the FDA’s conclusion that the presence of Delta-8 adulterates food is based on the product’s ingredients and not how it is marketed.

RELATED: The FDA will use Reddit to learn more about cannabis-derived products, including CBD and Delta-8

smoking marijuanaPhoto by Inside Creative House/Getty Images

Comparison of CBD and Delta-8 in the FDA Warning Letters

In the FDA warning letters, the FDA alleges that four of the five recipients (one only distributes Delta-8 products) distributed unapproved drugs, misbranded drugs, and adulterated edibles containing CBD. Like Delta-8, a product containing CBD will be considered a drug depending on how it is marketed and if the product is a edible product the FDA will consider it adulterated since CBD is not GRASS ( i.e. “generally considered safe” for human consumption). .

Unlike Delta-8, CBD has been approved as a drug in the form of Epidiolex, which invokes the “drug exclusion rule.” The basic concept of the drug exclusion rule is that a substance that has been studied as a drug may no longer be added to food or a dietary supplement unless it was first marketed as a food or dietary supplement prior to drug testing. The FDA has concluded that the Drug Exclusion Rule applies to CBD because it determined that CBD was not marketed as a food or drug prior to the research that led to Epidiolex.

The fact that the drug exclusion rule does not apply to Delta-8 (or other cannabinoids that have not been studied as drugs) means that Delta-8 could potentially be considered a New Dietary Ingredient (NDI) that could potentially be added to dietary supplements. Unlike food and medicines, food supplements do not have to be approved before they are placed on the market. Distributors of dietary supplements may make limited health and health claims (e.g., calcium is good for bone development). However, manufacturers of dietary supplements containing Delta-8 would be required to notify the FDA of the NDI, including information used as a basis for concluding any claims about the product.

RELATED: How to Know if Delta-8 THC Is Right for You

Delta-8 and CBD also differ in how they interact with the human body and where they come from. CBD is a non-affecting cannabinoid found in the cannabis plant and is commonly present in hemp due to selective breeding. Delta-8-THC has an intoxicating effect but is not as potent as delta-9-THC, which is the compound that gets cannabis users high. Delta-8 is only found in trace amounts in the cannabis plant and is typically developed by converting CBD into delta-8 THC in a lab.

marijuanaPhoto by Kindel Media via Pexels

The fact that delta-8 THC is intoxicating and doesn’t occur naturally could prompt the FDA to take a more rigorous approach with delta-8 than when dealing with CBD. For the past eight years, the FDA has continuously issued warning letters to companies that distribute CBD products. The Federal Trade Commission (FTC) has also fined several CBD distributors for claims related to COVID-19. But aside from a few warnings and fines, CBD distributors have operated with little risk of FDA enforcement beyond warnings.

I believe the FDA took their “hands off” position in part because CBD is relatively safe and non-intoxicating. I expect the FDA will have less tolerance for Delta-8 as it is intoxicating and not generally found naturally in the cannabis plant. If the FDA takes a stand against Delta-8 CBD, it could seize and destroy products, bring civil lawsuits against manufacturers, and possibly even criminal charges against Delta-8 manufacturers.

If you are in the Delta-8 business, your attention is now being brought to the attention that the FDA has its goals for Delta-8. Now it’s time to examine the marketing material very carefully. We will continue to monitor the FDA’s position on all forms of cannabis on the Green Light Law Blog.

Daniel Shortt is a Seattle, Washington-based corporate and regulatory attorney who works extensively with entrepreneurs in the cannabis industry. You can reach him at info@gl-lg.com or (206) 430-1336.

This article originally appeared on the Green Light Law Group and has been republished with permission.

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