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  1. Rules, Regulations and Guidance

CTP Letters to Industry

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.



Manufacturers, Importers, and Distributors

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.

Letters 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.


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.



February 28, 2019



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.


Official information requests per Section 904(b)


Official information request per Section 904(b): JUUL Labs, Inc.


Retailers

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 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.


Looking for information about a Tobacco Retailer Warning Letter?