FDA has released another revision to Ingredient Listing Guidance (found here), which clarifies some longstanding issues surrounding the listing requirements (previously created for traditional tobacco products) as applied to ENDS products. The first major point addressed in the new guidance is clarifying those items for which an ingredient listing entry is required.
Under the previous guidances, manufacturers were required to submit ingredient listings for all aspects of ENDS products including “components and parts” — a phrase which encompasses elements of ENDS devices such as heating coils, cartridges, and mouthpieces. Notably, these items do not contain any nicotine or tobacco but are instead comprised of metal, plastic, or glass, yet under the previous guidance, manufacturers were required to submit a listing of the “ingredients”. This process was a headache, to say the least, because it called upon manufacturers to provide breakdowns of alloys, constituents of glass and plastics.
Fortunately, FDA has since changed its tune, explaining that:
Examples of components or parts for which FDA does not intend to enforce the ingredient listing submission requirement of section 904(a)(1) at this time include, but are not limited to, the following:
- Electrical components including, but not limited to, batteries, charging systems, circuit boards, wiring, and connectors
- System software
- Digital display, lights, and buttons to adjust settings
- Connection adapters
- Cigarette filter that does not contain any ingredient that is burned, aerosolized, or ingested during tobacco use
While this revision may come as a relief to those manufactures trying to grapple with setting out the “ingredients” for parts such as heating coils or plastic mouthpieces, for others who have already submitted their listings in accordance with the previous deadline last November, it is too little too late.
The guidance further provides clarification as to how manufacturers should handle submissions for those items which are sold as part of multiple products–for example, a 30 ml container of e-liquid that is sold: individually, as part of a package including an ENDS device, and in a set. Rather than relist that ingredient each time, FDA now provides that:
tobacco product manufacturers or importers can satisfy the ingredient listing requirement under section 904(a)(1) by providing one listing that corresponds to multiple products if the tobacco product manufacturer or importer sells tobacco products that
- are identical in chemical composition to one another or
- are identical in chemical composition to one another except the quantities of propylene glycol (PG), vegetable glycerin (VG), and/or nicotine differ
To the extent, the nicotine content or the ingredient content per weight composition varies, or the purity of PG/VG differs separate listings are required.
In any event, this change is a positive indication that FDA is following through on its effort to better understand ENDS products to develop a regulatory scheme that properly fits the unique nature of the industry as compared to traditional tobacco products. For more on the evolution of the Deeming Rule since its implementation in August 2016, please see our prior blog articles:
As a reminder, the deadline to submit Ingredient Listings is May 8, 2018 (for non-small-scale manufacturers) and November 8, 2018 (for small-scale manufacturers).
For more information on the Deeming Rule please contact Tom Norby.