What’s the Deal with H4 CBD?

While in the Netherlands this spring, I noticed cannabis products sold in smartshops (similar to smoke shops in the US) that contained the cannabinoid H4 CBD. I discussed these products with one smartshop owner, who informed me that sales of H4 CBD were increasing rapidly.

Shortly afterwards, a client of mine who was also traveling in Europe for business said that he was negotiating an H4 CBD supply contract. Over the past two months I have begun to see products containing H4 CBD for sale in the US. So what’s the deal with H4 CBD? Is it lawful?

What is H4 weed?

Hexahydrocannabidiol, commonly known as “H4 CBD”, is a synthesized form of CBD in which the two carbon-carbon double bonds on the cannabidiol (CBD) molecule are converted to single bonds by adding four hydrogen atoms. This is a common conversion, called “hydrogenation”, and it is widely used in foods. For example, margarine is created from vegetable oil by the process of hydrogenation. The cannabis plant does not naturally produce H4 CBD, and it is only produced synthetically.

The legal status of H4 CBD, like all cannabinoids, is properly analyzed by reference to the Controlled Substances Act (CSA) and, when marketed for human or animal use, by the Food, Drug & Cosmetic Act (FDCA).

Part 1: The CSA

H4 CBD is not a controlled substance under the CSA. This was recently confirmed in a letter by the DEA. In that letter, the DEA properly states: “Whether a cannabinoid product synthetically produced from non-cannabis materials is controlled depends on whether that product contains ‘any quantity’ of a synthetically produced tetrahydrocannabinol [(THC)].”

Notably, the DEA does not address whether a cannabinoid product synthetically produced from cannabis materials is controlled or not. This is because the DEA has stated on numerous prior occasions that such a product is not controlled if its delta-9 THC concentrations do not exceed 0.3% by dry weight (ie, the legal definition of “hemp”.)

Since pure H4 CBD does not contain any quantity of synthetically produced THC it is not controlled. Of course, if an impure form of H4 CBD, such as a distillate, contains trace amounts of synthetic THC, it is controlled.

Part 2: The FDCA

If H4 CBD is marketed for use by humans or animals it is subject to the FDCA and is regulated by the FDA. Whether it can be used in food or dietary supplements is less clear.

The FDA could argue H4 CBD is simply a form of CBD, making it subject to the drug exclusion rule. However, this would be incorrect — H4 CBD and CBD are distinct cannabinoids with different molecular structures and are not the same substance studied in Epidiolex trials.

Regardless of whether or not H4 CBD is captured by the drug exclusion rule, it has not been marketed in the US prior to 1994 and is thus a “new dietary ingredient” (NDI) and subject to the rules regarding NDI.

These rules include the requirement to submit a premarket notification to the FDA containing “information that is the basis on which you have concluded that a dietary supplement containing the new dietary ingredient will reasonably be expected to be safe.”

With respect to H4 CBD, safety is the primary issue. H4 CBD has been touted as having 100 times more binding affinity to the CB1 receptors than CBD. Although this could potentially be helpful in certain circumstances, at least one clinical study states that there are, “clear differences between consumption of natural CBD, and two synthetic derivatives on ALT and AST levels.” (Note, ALT and AST are enzymes that the body uses to remove synthetic cannabinoids from the body.)

The authors of this study contend that the elevated ALT and AST levels are due to the fact that “[t]he human body is not equipped with the tools needed to catabolize synthetic cannabinoids.” While this may be an overstatement, their results in this specific trial did show heightened levels of these enzymes after consumption of H4 CBD. Another study concluded that H4 CBD has “no cardiac issues.“

Part 3: Summary

H4 CBD is an intriguing cannabinoid that is similar to CBD, though potentially much more potent. The fact that the cannabis plant does not naturally produce H4 CBD means that it can only arise as a synthetic compound. In and of itself, this may or may not be an issue. H4 CBD is not a controlled substance provided that it does not contain any quantity of synthetic THC.

With respect to the FDCA as regulated by the FDA, H4 CBD also likely does not fall under the drug exclusion rule; however, since it is a new dietary ingredient, it is important to follow NDI premarket requirements before marketing it. The crucial issue is its safety, which I hope will be the subject of future clinical trials.

For more information on H4 CBD, contact us today.

August 3, 2023 – Updated May 19, 2026