The U.S. Food and Drug Administration released final guidance on March 22 limiting how specialty vape shops that stock e-cigarettes can modify the devices before selling them to consumers, though some of the largest e-cigarette makers already recommend against tinkering with their products.
Vape shops cannot modify a pod-based e-cigarette with parts not manufactured specifically for that device, according to the agency's guidance, which finalizes draft rules first issued in 2017. Pod-based, or "closed," e-cigarettes use prefilled pods containing a nicotine-infused liquid that is heated to produce flavored vapor. The category includes products made by Juul Labs Inc., British American Tobacco PLC, Japan Tobacco Inc. and Imperial Brands PLC.
The guidance also applies to "open" systems, which are e-cigarettes that contain a refillable liquid reservoir. Shops cannot modify any component of the device or assemble custom devices from multiple prepackaged kits. Imperial Brands sells some open e-cigarettes under the blu brand name, according to the company.
E-cigarette companies, meanwhile, generally advise against changing their products.
Japan Tobacco's Logic e-cigarettes are not designed to be modified in "any way" by retailers or consumers, U.S. Head of Corporate Affairs Anthony Hemsley said in an email.
British American Tobacco subsidiary Reynolds American is still reviewing the guidance and has not formed an opinion on it, Vice President of Communications Lance Latham said March 22.
Imperial Brands and Juul did not return messages from S&P Global Market Intelligence seeking comment on the guidelines. Device warranties for both companies, however, do not cover e-cigarettes that have been modified to change how the devices work, according to the company.
While the guidance is nonbinding, vape shops that do not follow the rules would create new tobacco products subject to FDA pre-market review, requiring the stores to seek FDA authorization before selling a modified device, according to the agency.
The agency allows companies to sell e-cigarettes that were introduced on the market between Feb. 15, 2007, and Aug. 8, 2016, but those companies must submit their products for FDA review by 2022. E-cigarettes introduced after Aug. 8, 2016, must have FDA approval before they can be legally sold, according to the agency.
Vape shops are still free to show customers how to use e-cigarettes, clean a device or tighten fixtures, fix e-cigarettes using identical replacement parts and assemble an e-cigarette from parts included in a single prepackaged kit, according to the guidance.
"Today's final guidance is another example of our work to strike an appropriate balance between regulation and encouraging development of innovative tobacco products for currently addicted adult smokers that may be less dangerous than cigarettes," FDA Commissioner Scott Gottlieb said in a March 22 statement. Gottlieb is resigning from the agency in April.
The rules come just days after the FDA on March 13 issued separate draft guidance for e-cigarette manufacturers that, if enacted, would restrict the sale of most flavored products to vape shops or age-restricted sections of other stores as regulators try to keep the products away from minors.
The FDA warned that it could pull e-cigarettes off the market if they do not follow the guidelines, which also include quantity limits for online purchases and advance the deadline for e-cigarette makers to submit their products for FDA review to 2021. The draft guidance is open for comment through April 15, at which point the FDA will craft final guidelines.