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.
- Letter to American Vapor LLC
- Letter to Baton LLC
- Letter to Black Mountain Fulfillment LLC
- Letter to ECS Global LLC
- Letter to Eonsmoke LLC
- Letter to Fontem USA Inc.
- Letter to Kandypens Inc.
- Letter to Kretek International Inc.
- Letter to Logic Technology Development, LLC
- Letter to Magellan Technology Inc.
- Letter to Maja Flava Vape Den
- Letter to MMS ECVD Distribution LLC
- Letter to Myle Vape Inc.
- Letter to Reynolds American Inc.
- Letter to Sutra Vape
- Letter to SV3 LLC
- Letter to Vertigo Vapor LLC
- Letter to VGOD Inc.
- Letter to VMR Products LLC
- Letter to Xfire Inc.
- Letter to ZLab S.A.
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.
- Letter to JUUL Labs, Inc., regarding JUUL (PDF)
- Letter to Reynolds American regarding Vuse (PDF)
- Letter to Altria regarding MarkTen XL (PDF)
- Letter to Fontem Ventures regarding Blu (PDF)
- Letter to Japan Tobacco International, USA, Inc., regarding Logic (PDF)
Official Information Requests, per Section 904(b)
- Request for Documents from J Well (and MMS ECVD LLC), Liquid Filling Solutions LLC (and Myle Vape Inc), SVR Inc., and YGT Investment LLC, and 7 Daze LLC (PDF)
05/17/18 and 5/31/18
- Request for Documents from JUUL Labs, Inc. (PDF)
- Request for Submissions Related to Research on Effects of pH of Smokeless Tobacco Products (PDF)
- Cigar Warning Plan Requirements (PDF – 111KB)
- Additional Tobacco Products Now Regulated by the Food and Drug Administration (PDF – 109KB)
- Searchable Databases of Establishment Registration and Tobacco Product Listing Information (PDF – 90KB)
- Other Media Notifications (PDF – 40KB)
- Certain Tobacco Products Found to be Not Substantially Equivalent (PDF – 105KB)
John Castle is a contributing writer and news contributor for VAPE News Magazine. Contact him at firstname.lastname@example.org.