Will the Proposed FDA Ban On Flavored Vape Additives Include Hemp Terpenes?

This post was written by attorney Kamran Aryah with the Kight on Cannabis law firm.

Out of all the popular trends, the rise in popularity and notoriety of hemp “terpenes” has been one of the most promising developments  in the hemp industry. (We have previously written about the legal status of hemp terpenes in an article that you can read by clicking here.) This article will discuss whether terpenes are necessarily included within the definition of “flavorings” under the proposed federal ban on flavored e-liquids when they are added to vaping products. 

Terpenes are the smell and flavor molecules found naturally in plants of all varieties, including hemp. Terpenes from roses are distilled to make face spritzes and soaps, and extracts from lavender are used in all sorts of applications for their soothing aroma. Terpenes from hemp have been identified as particularly desirable by-products of hemp extract because they are not associated with any cannabinoids, and have a wide range of applications, particularly in the cosmetics sector.

Hemp terpenes can smell like mangoes, blueberries, and black cherries. They can be bright and piney, play on citrus notes, or have earthy tones. Terpenes can be lab produced, and have many other natural sources. Hemp terpenes are being explored because of the newly established hemp market, and because of the present marketing restrictions on cannabinoids such as CBD. Some online retailers are offering hemp derived terpenes for upwards of $3,000.00 USD / gallon.

One new and particular avenue for the use of hemp terpenes is potentially under threat: their use in vaporizable inhaled products (“vapes”). Amidst heightened concern following a spate of vaping induced lung injuries and hospitalizations (including six casualties), the FDA has indicated that it will take severe action toward flavored e-cigarette products. The FDA has the backing of the Trump administration, which may take executive action on the subject. Involving executive power can put restrictions in place faster than would otherwise be accomplished through the administrative process at the FDA. We may see a federal ban in place while the FDA determines how precisely to ensure the safety of vaporized products. How specific or generalized this ban might be remains to be seen. The FDA has been calling this an “epidemic”, and may seize this opportunity to include hemp extracted vape products under a larger federal ban. Several states, including Washington and Hawaii, have also taken action on the sale of flavored vapes. 

Unfortunately, several of the injuries to consumers have occurred from the use of black-market marijuana vaping devices. With e-cigarettes that deliver nicotine, there are some who argue that the benefits of these products as a method of harm reduction for cigarette smokers outweigh the risks that they might otherwise pose in creating new dependent nicotine users. Whether this argument is valid is currently the subject of contested debate in the public forum, as well as within the medical community. Regardless of the validity of the argument on harm reduction, this justification does not exist for marijuana e-cigarette products, which remain unlawful at the federal level. It is abundantly clear that products being sold as “marijuana” e-cigarettes (outside of a state-run dispensary in a marijuana legal state) are potentially extremely dangerous. 

As with many products in the hemp industry, vaporizable products containing hemp derived extracts do not fit squarely into either category. They are not e-cigarettes marketed as a smoking cessation aid, nor  are they marijuana vaporizables. They are unlike marijuana vapes in that they are legal, but similar in that they may contain cannabinoids, including, in some instances, THC. They are unlike e-cigarettes in that they do not contain nicotine, yet they are similar in that they may contain flavoring (depending on how the FDA ultimately defines a “flavoring”). It appears the FDA is most concerned with the flavors that may be attractive to minors, such as mango, strawberry etc… Recalling that some of the terpenes in hemp can mimic some of these flavors, it may be that the FDA would consider hemp terpenes a flavoring and that they would be included in the ban. 

An argument against this position would be that if the logic goes that we don’t want the attractiveness of flavorings to lure kids into getting hooked on nicotine, is to remind that hemp derived vape products do not contain nicotine. In addition, while hemp terpenes might smell naturally like pine, or citrus, or a fruit, we do not see such products targeted to minors in the same way that nicotine e-cigarettes are, with flavors like “Cotton Candy” and “Crazy Rainbow” and “Yellow Cake”. These flavors are particularly attractive to minors. Purveyors of hemp extracts by contrast have actively self-regulated to avoid selling hemp products to minors. While there is currently no federal regulation explicitly making it unlawful to sell hemp to minors, most actors are exercising due care to restrict the sale of such products to minors. 

Unfortunately as with so many aspects of this industry the impact of the FDA ban on flavored e-cigarettes on hemp derived vape products remains unclear. We’ll be tracking FDA action closely on this matter. 

September 21, 2019

This post was written by Kight on Cannabis attorney Kamran Aryah. Kight on Cannabis is a law firm founded by attorney Rod Kight that represents legal cannabis businesses. You can contact us by clicking here.