Guidance to E Cigarette & E Liquid Industry (Non – PMTA) from the FDA

Guidance to E Cigarette & E Liquid Industry (Non – PMTA) from the FDA

The US Food and Drug Administration (FDA) deemed all “tobacco products” within its authority and subject to the Tobacco Control Act. FDA has issued a wide variety of information regarding tobacco products and the new regulations.

FDA has also been issuing guidance to assist the industry in understanding the new requirements and what FDA’s current policies are with regard to the regulations. They are also intended to help with compliance with all regulations and the law. While FDA guidance documents are only recommendations, unless specific regulatory or statutory requirements are cited, they provide great insight as to the agencies current thinking and policies.

FDA guidance publications include the following topics:

• Listing of Ingredients in Tobacco Products
• Civil Money Penalties and No-Tobacco-Sale Orders For Tobacco Retailers
• Civil Money Penalties and No-Tobacco-Sale Orders for Tobacco Retailers Responses to Frequently Asked Questions
• Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions
• Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments 
• FDA Deems Certain Tobacco Products Subject to FDA Authority, Sales and Distribution Restrictions, and Health Warning Requirements for Packages and Advertisements
• Health Document Submission Requirements for Tobacco Products
• Investigational Use of Deemed, Finished Tobacco Products That Were on the U.S. Market on August 8, 2016, During the Deeming Compliance Periods
• “Harmful and Potentially Harmful Constituents” in Tobacco Products as Used in Section 904(e) of the Federal Food, Drug, and Cosmetic Act
• Meetings with Industry and Investigators on the Research and Development of Tobacco Products
• Tobacco Product Master Files
• Requirements for the Submission of Data Needed to Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products

The e-cig/e-liquid attorneys at Brown & Charbonneau, LLP are up to date on all of the relevant issues affecting the industry, including the FDA’s deeming rule and related requirements, and are prepared to assist you. To learn more, call us today at 714.406.4397, or e-mail to set up a consultation. For more information about the e-cigarette, e-liquid and ENDS industry, please click here