The U.S. Food & Drug Administration’s Center for Tobacco Products, or CTP, has dispatched a total of 21 letters to manufacturers of vapor products, or Electronic Nicotine Delivery Systems.

These letters solicit information from the contacted manufacturers which the CTP says will help it determine if those manufactuers’ products are being illegally marketed to underage consumers. Recipients of CTP letters include but are not limited to American Vapor, Eonsmoke, Fontem Ventures, Kandypens, Maja Flava Vape Den, Myle Vape, Reynolds American, Sutra Vape, Vertigo Vapor, VGOD, and ZLab. The recipients of the CTP letters have 30 days to deliver the requested information; the FDA has stated that the letters should be taken as an indication that the agency believes the recipients may have engaged in marketing which violates the Federal Food, Drug, and Cosmetic Act, but that the letters are intended only to seek information and not to communicate that the FDA is considering enforcement action at this time.

The FDA’s previous dispatch of letters occurred on September 12th, addressed to five manufacturers — JUUL Labs, regarding JUUL; Reynolds American, regarding VUSE; Altria regarding MarkTen XL; Fontem Ventures regarding Blu; and Japan Tobacco International regarding Logic — and concerned the question of how those manufacturers plan to combat underage consumers acquiring and using their products.

CTP sends letters to industry to provide updates, help industry understand FDA regulations and policies, and request information, per Section 904(b) of the Federal Food, Drug, and Cosmetic Act, among other reasons.


Letters to Manufacturers Regarding Electronic Nicotine Delivery System Products

October 12, 2018: FDA issued letters to 21 e-cigarette companies requesting information within 30 days that will help the agency examine whether the products are being illegally marketed. These letters indicate that regulated industry may be promoting a tobacco product in a manner that potentially violates the Federal Food, Drug, and Cosmetic Act and its implementing regulations, and are not intended to communicate that FDA is considering enforcement action.

September 12, 2018: FDA issued letters to five manufacturers asking each company to submit within 60 days plans describing how they will address the widespread youth access and use of their products.


Official Information Requests, per Section 904(b)


Notifications

John Castle is a contributing writer and news contributor for VAPE News Magazine. Contact him at johncastle@vapemz.com.