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                Rules, Regulations and Guidance

Rules, Regulations and Guidance

                        Rules and Regulations
          Guidance
          Center for Tobacco Products’ Regulation and Guidance Policy Agenda
          Family Smoking Prevention and Tobacco Control Act - An Overview Home
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          Rules, Regulations and Guidance
          CTP Letters to IndustryRules, Regulations and Guidance CTP Letters to Industry
  
  	
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    PrintCTP 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.

**Manufacturers, Importers, and Distributors**

	Official Information Requests per Section 904(b) (March 17, 2021)
		Request Letter to JUUL Labs, Inc. (September 9, 2019)
		Letters to JUUL Labs, Inc. and Altria Group Inc. (February 6, 2019)
		Letters to Manufacturers Regarding Tobacco Products that May Be Marketed Illegally (Oct. 2018 – Sept. 2019)
		Letters to Manufacturers Regarding Plans to Address Youth Access and Use (September 12, 2018)
		Official information requests per Section 904(b) (May 17, 2018, May 31, 2018)
		Official information request per Section 904(b): JUUL Labs, Inc. (April 24, 2018)
	**Retailers**

	Letters to retailers regarding illegal sale of tobacco products to minors (April 5, 2019)
		Letter to Walgreen Co. (March 4, 2019)
	**Archived CTP Letters to Industry (2014 – 2017)**Manufacturers, Importers, and Distributors

Official Information Requests per Section 904(b)

March 17, 2021: Request for Documents from [Aspire, Joyetech, Vaporesso, Voopoo]Letters to JUUL Labs, Inc.

**September 9, 2019**: FDA sent a letter to JUUL Labs, Inc., expressing concern and requesting documents and information about several issues raised in a recent Congressional hearing, including JUUL’s outreach and marketing practices, such as, those targeted at students, tribes, health insurers, and employers. This letter is accompanying a warning letter issued to the company for marketing unauthorized modified risk tobacco products by engaging in labeling, advertising, and/or other activities directed to consumers.

Request Letter to JUUL Labs, Inc.
	Exhibits A- OLetters to JUUL Labs, Inc. and Altria Group Inc.

**February 6, 2019**: FDA issued letters to the two companies regarding concerns related to the mounting epidemic of youth addiction to tobacco products, and specifically e-cigarettes, and to discuss the implication of Altria Group's recent acquisition of significant ownership in JUUL Labs, Inc.

Letter to JUUL Labs, Inc.
	Letter to Altria Group, Inc.Letters to Manufacturers Regarding Tobacco Products that May Be Marketed Illegally

FDA issues letters to tobacco product manufacturers requesting information within 30 days that will help the agency examine whether a product is 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.

June 11, 2020
	**June 11, 2020**
 

Bidi Vapor LLC
	California Grown E-liquids LLC
	Fuma Vapor Inc.
	HITT Vape
	Kenosha Tobacco Inc.
	Pop Vapor Co. LLC
	Romeo Vapors Inc.

February 13, 2020
	**February 13, 2020**
 

Aspire Vape Co.
	Cleopatra LLC
	HP Industries Inc.
	Medical Foods Rx LLC
	My Vape Bar LLC
	NicoSticks, LLC
	Perfection Vapes Inc.
	Shijin Vapor LLC
	Suck My Mod

September 30, 2019
	**September 30, 2019**
 

Aspen Mod Co., Inc.
	Crave Toothpicks, LLC
	Friday’s Vapor-ettes
	Fumizer LLC
	Good Guy Vapes
	Japan Tobacco International USA Inc.
	Kanger Wholesale USA
	Marshall IGA dba Harvard Distributing Corporation
	MH Global LLC
	Puf Cigs, Inc.
	Puff E-Cig
	Seditious Vapours, LLC
	Sky Distribution LLC
	Vape Organics dba VO Tech
	Walker Vapor Group, LLC

June 20, 2019
	**June 20, 2019**
 

Letter to Teardrip Holdings, Inc
	Letter to Clouds Vapors, LLC
	Letter to DripStop, LLC
	Letter to E-Alternative Solutions, LLC
	Letter to ECig Distributors, Inc
	Letter to Eliquidstop, LLC
	Letter to Eon Pods, LLC
	Letter to Juice Boy Vapors, LLC
	Letter to JUM Vapor, LLC
	Letter to J-Vapor, LLC
	Letter to  Liquid EFX, Inc
	Letter to Lucy Goods, Inc
	Letter to Medusa Distribution, LLC
	Letter to Monster Vape Labs
	Letter to Unishow USA, Inc
	Letter to Vape Plus Distribution Corp.
	Letter to VapeRanger Wholesale
	Letter to Vapetasia
	Letter to Vaping Swag
	Letter to VPRO Tech, LLC
	Letter to West Coast Vape Supply, Inc
	Letter to Wireless N Citi Vapor, LLC

February 28, 2019
	**February 28, 2019**
 

Letter to 7 Daze, LLC – ZOOR
	Letter to Access Vapor, LLC - Cali Pods and Delicious Pods
	Letter to Al Khalifa Group, LLC, d/b/a MK Vape - SMOK INFINIX and SMOK FIT
	Letter to All Access Vapor LLC - All Access Vapor E-liquids
	Letter to American Vapor Group - Airbender Pods
	Letter to Blue Dot Vapors - Nic Salts
	Letter to Cool Pods, LLC - COOL pods
	Letter to DripTip Vapes LLC - ATOM PODS and mngo PODs
	Letter to ECBlend, LLC - MATE1
	Letter to Eparticles.Co. - Salteez Pods
	Letter to ePuffer International Inc. – XPOD
	Letter to Ethos Vapors, LLC - Ethos Vapor Candy Treats
	Letter to Fronto King LLC - Fronto King Leaf and Fronto King Cigar and/or Cigarillo
	Letter to Fuma Vapor Inc. - FUMA Pods
	Letter to Ghost Pods LLC - Ghost Pods
	Letter to GRIPUM LLC - Skippermilk Pie
	Letter to Hold Fast Vapors Inc. - Air Factory E-liquids
	Letter to Holy Smokes - Holy Smokes Pods
	Letter to Ikrusher Inc. - ALD POD Systems
	Letter to Joyetech USA Inc.  – TEROS
	Letter to Kilo E-Liquids, Inc.  - Kilo E-Liquid 1K Device
	Letter to Lan & Mike International Trading Inc., d/b/a Vapor DNA - Vapor Storm Stalker
	Letter to LCF Labs, Inc. - Zalt Pods
	Letter to Limitless Accessories, Inc. - Unique Pods and NicoTech Pods
	Letter to Maduro Distributors Inc. d/b/a The Loon - Loon Pods and Loon Pod Starter Kit
	Letter to Madvapes Holdings, LLC - Madvapes E-Liquids
	Letter to Midwest Distribution Illinois US - Edge Pods, J-fit Pods, and Mr. Fog Pods
	Letter to MK Distributors, Inc. - SMOK Rolo Badge
	Letter to Modern Vapor Co. - Caesar Pods
	Letter to Mums Fantasy Factory, LLC - G10 PLUG and DELRIN PLUG
	Letter to Nicopure Labs LLC - Halo Nic Ultra Salts
	Letter to Parallel Direct LLC, d/b/a The Magic Mist - Magic Mist PODS
	Letter to Plus Vapor Co. - Plus Pods
	Letter to Pure Cigs LLC - JEMM Pods
	Letter to Purilum LLC - BANTAM Strawberry E-liquids
	Letter to Sigelei Vape, Inc. - KADO STEALTH
	Letter to Space Jam Juice LLC - THE BYRD
	Letter to Spark Industries, LLC., d/b/a Cig2O – STIK
	Letter to Texas Smoke Accessories/Luxury Lites - Carbon Pods
	Letter to Twist Vapor Franchising LLC - sea100 Pods
	Letter to Vapers & Papers, LLC - 3X Pods
	Letter to Vapor 4 Life Holdings, Inc. - Viv Pods and BOMBZ Pods
	Letter to Vaportronix, LLC - VQ Pods

October 12, 2018
	**October 12, 2018**
 

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.

Letters to Manufacturers Regarding Plans to Address Youth Access and Use

**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
	Letter to Reynolds American regarding Vuse
	Letter to Altria regarding MarkTen XL
	Letter to Fontem Ventures regarding Blu
	Letter to Japan Tobacco International, USA, Inc., regarding LogicOfficial information requests per Section 904(b)

**May 17, 2018 and May 31, 2018**: 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 LLCOfficial information request per Section 904(b): JUUL Labs, Inc.

**April 24, 2018**: Request for Documents from JUUL Labs, Inc.Retailers

Letters to Retailers Regarding Illegal Sale of Tobacco Products to Minors

**April 5, 2019**: FDA issued letters to twelve retailers asking each company to submit within 30 days plans describing how they will address and mitigate illegal sales to minors.

Letter to 7-Eleven
	Letter to BP
	Letter to Casey's
	Letter to Chevron
	Letter to Citgo
	Letter to Exxon
	Letter to Family Dollar
	Letter to Kroger
	Letter to Marathon
	Letter to Shell
	Letter to Sunoco
	Letter to Walmart

Letter to Walgreen Co.

**March 4, 2019**: FDA issued a letter to the corporate management of Walgreen Co. requesting a meeting to discuss whether there is a corporate-wide issue related to sales of tobacco products to minors, based on its stores’ high violation rate.

Letter to Walgreen Co.Looking for information about a Tobacco Retailer Warning Letter?

References

1. Guidance: Compliance Policy for Certain Labeling and Warning Statement Requirements for Cigars and Pipe Tobacco

                                                                                  Content current as of:
      03/17/2021
              
              
Regulated Product(s)
		 TobaccoRules, Regulations and Guidance

          
                        Rules and Regulations
          Guidance
          Center for Tobacco Products’ Regulation and Guidance Policy Agenda
          Family Smoking Prevention and Tobacco Control Act - An Overview
 
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