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The Coalition for Smarter Regulation of Nicotine

The Coalition for Smarter Regulation of Nicotine was formed with the singular mission to modernize the U.S. Food and Drug Administration’s (FDA) Center for Tobacco Products to advance a comprehensive, common-sense approach to regulating nicotine products as intended by the Tobacco Control Act of 2009.

Our Priorities

We believe the time has come to fully modernize FDA’s Center for Tobacco Products and set a clear direction toward harm reduction.

That means adopting neutral, science-based regulation that focuses on authorization, education, and enforcement.

To establish a well-regulated marketplace, FDA should:

Accelerate and streamline the authorization process to provide adult consumers access to the less harmful smoke-free products they are moving to; and support rather than impede a transformation of the marketplace for the better.

Educate adult consumers on the benefits of authorized smoke-free options over conventional cigarettes – empowering them with the information to help them make better choices.

Nicotine Product Facts

26M+ innovative nicotine product applications filed since 2009, only 46 authorized by the FDA

Vaping is at least 95% less harmful than combustible cigarettes

Approximately 85% of vaping products sold in the U.S. are illicit or unauthorized by the FDA

15 years post Tobacco Control Act adult consumers deserve better choices. CTP has the opportunity to become a smarter, more efficient, and more effective regulatory agency.

Former Senator and Coalition Chairman Richard Burr

Learn more about the coalition

FAQ

What’s the goal of the Coalition for Smarter Regulation of Nicotine?

To advocate for a modernized FDA regulatory system that embraces harm reduction and science-based approach to regulating tobacco and nicotine.
What is the Tobacco Control Act?

The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) of 2009 granted FDA authority to regulate the manufacture, distribution, and marketing of tobacco products. It placed comprehensive restrictions on manufacturers’ marketing and manufacturing practices to protect youth and adults.
What’s the current regulatory process to review and approve new tobacco and nicotine products?

Any new tobacco product seeking an FDA marketing order, under section 910(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), must file a premarket tobacco product application (PMTA). A PMTA must provide scientific data that demonstrates a product is appropriate for the protection of public health. The Tobacco Control Act requires FDA to review premarket tobacco applications within 180 days of submission. In practice, FDA product reviews have taken far longer than this statutory time frame – often many years without resolution. Since 2009, applications for over 26 million tobacco and nicotine products have been filed, yet the FDA has only approved 46 to date.
Why are there so many illegal, Chinese-manufactured vaping products on store shelves?

FDA has authorized only a small fraction of the smoke-free products millions of adult consumers are moving to. With so few FDA-authorized products and limited enforcement, unregulated foreign manufacturers, mainly from China, have flooded the U.S. with vapor and other nicotine products, displacing the regulated marketplace [7]. Today, most vapor products U.S. consumers are buying are illicit, and lack the benefit of any FDA oversight on product quality and design, nicotine content, ingredients, or manufacturing practices.
How can the FDA make further progress in reducing underage use?

The biggest threat to bringing down underage use today is a marketplace filled with illicit products and manufacturers operating outside of FDA oversight and marketing products to underage users with youth-appealing flavors and youth-appealing components. It is critical that FDA take an enforcement approach that holds all manufacturers, distributors, and retailers accountable.

FAQ