Calling For FDA Reform: What Happens Next

Calling For FDA Reform:

What Happens Next

Congress mandated the U.S. Food and Drug Administration’s (FDA) Center for Tobacco Products (CTP) decide on premarket tobacco product applications (PMTAs) for new tobacco products within 180 days of receiving them.

Despite this, it takes years on average to make these decisions, leaving smokers with minimal options.

Here are the facts:

There are 28 million adults in the U.S. who continue to smoke cigarettes. They need the availability of FDA-authorized smoke-free options.

Since 2009, CTP has only authorized roughly 50 products out of the more than 26 million new tobacco product applications it has received.

The FDA must be reformed to create a well-regulated marketplace for scientifically substantiated smoke-free products.

Will you join us?

“Internal and external stakeholders expressed concerns about a lack of clarity, transparency, and communication regarding CTP’s priorities and its decision-making processes.

The lack of clarity about CTP’s direction, its priorities, and its near-term and longer-term goals and objectives, hinders CTP’s ability to effectively carry out its mission, establish efficient programs to accomplish its goals and objectives, and set appropriate metrics to assess outcomes.”

– The Reagan-Udall Foundation