This question has come up in almost every sourcing conversation this year, usually in the form of a rumour that the FDA is about to ban flavours and that terpenes are next. It is worth answering from the document rather than the rumour.
The document
On 11 March 2026 the FDA published a notice of availability at 91 FR 11980 for a draft guidance titled “Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications, Considerations Related to Youth Risk”.
The abstract states its purpose precisely. It:
“describes FDA’s current thinking and provides recommendations regarding evidentiary considerations for premarket tobacco product applications (PMTAs) for flavored ENDS submitted under section 910 of the Federal Food, Drug, and Cosmetic Act (FD&C Act).”
Three scope markers in one sentence: electronic nicotine delivery systems, premarket tobacco product applications, and section 910 of the FD&C Act.
What that scope means
The guidance addresses the evidence FDA expects to see in a PMTA for a flavoured nicotine ENDS product. PMTA is the authorisation pathway for tobacco products. It is not a pathway that hemp or cannabis vapour products travel, because they are not nicotine products and are not regulated as tobacco products.
So a hemp vape does not become subject to this guidance by virtue of being flavoured. The document is about a different product class going through a specific application process.
It is also draft guidance and a request for comment. Draft guidance represents an agency’s current thinking. It is not a rule, and it does not bind in the way a regulation does.
Where terpenes genuinely intersect
There is a real intersection, and it is narrower than the rumour but worth knowing.
Terpenes are used as flavouring compounds in nicotine ENDS products. Where that is the case, they form part of the flavour profile a PMTA has to characterise and justify. A supplier selling into nicotine ENDS manufacturing is therefore selling into a regulated application process, and buyers in that channel will ask for correspondingly detailed documentation.
That is a documentation and channel question rather than a restriction on the compounds themselves. The relevant preparation is having COA, SDS and TDS documentation in order, which is good practice regardless of channel.
The distinction worth holding
Inhalation attracts regulatory attention as a route of administration, across product categories and independently of any single guidance document. A compound with a long history of safe dietary or topical use has not thereby been evaluated for inhalation, and that is a genuine open question in this industry rather than a regulatory technicality.
Anyone formulating for inhalation should treat that seriously on its own terms. It is a better reason for care than a guidance document that does not apply.
The practical summary
The March 2026 draft guidance concerns premarket applications for flavoured nicotine ENDS. It does not regulate hemp terpenes, does not apply to cannabis vapour products, and is draft rather than final.
If you supply into nicotine ENDS manufacturing, expect documentation expectations to follow the PMTA process. If you supply into cannabis and hemp, this particular document is not the thing to plan around. The November hemp definition change very much is.
About this brief
Written 6 July 2026 and checked against the statute and the Federal Register rather than against secondary coverage. This is a summary for commercial planning, not legal advice. Where the answer depends on your product format, your state or your licence position, take the specific question to your own counsel.
