Impact of Missing Science on FDA-CTP Decisions – R Street Institute

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of US Food and Drug Administration Center on Tobacco Products (FDA-CTP) was established in 2009 to regulate the production, distribution and marketing of tobacco products. Family Smoking Prevention and Tobacco Control Act. Between the years 2009 and 2023, the government Assumptions FDA-CTP collects and disburses $8 billion in user fees directly from manufacturers and importers of tobacco and nicotine products. However, the impact of this fee collection and expenditure is unclear: in 2009, it was An estimated 437,400 Americans died. Due to smoking-related diseases and this number has changed slightly Reporting to the Centers for Disease Control and Prevention In the year 480,000 tobacco-related deaths by 2022.

Over the 14-year history of the FDA-CTP, manufacturers and public health officials have scrutinized the establishment of regulatory policies and measures, resulting in Court case. While the FDA-CTP sets forth some guidelines and procedures for applications, many of these are lacking. Common standards and practices Included in other regulatory guidelines. The result of these flaws is confusion in the application process with many unsuccessful applications even before being evaluated. The net effect of this activity is to have Hundreds of flammable products Only 45 reduced risk products are approved for sale They have been accepted By FDA-CTP, reviewing six electronic nicotine delivery systems, one heat-resistant, and a few tobacco/nicotine products on the legal U.S. marketplace. Millions of applications They have been submitted and rejected at various stages of review, and thousands remain in regulatory purgatory, far beyond the required 180-day legal review period.

There are two clear outcomes from FDA-CTP activities over the past decade and a half. The first large amount of money was spent (out of the pockets of American citizens) and the results still reflect nearly half a million tobacco-related deaths in our country. The second is the often used excuse for the lack of marketing orders for tobacco and nicotine products More scientific interest. FDA-CTP continues to ignore the need to develop scientifically enforceable standards for the development of new products that significantly reduce the health burden associated with the use of traditional combustible tobacco products.

If there are gaps in the science, what has FDA-CTP done to help try to close these gaps?

In the year In 2013, the FDA and the National Institutes of Health collaborated to establish the Centers for Science in Tobacco Control.TCORS). In the first series of awardsTCORS 1.0), 14 academic and independent institutions received a total of $273 million in grants distributed over a 5-year award period. The stated goal of the first series of projects was to generate critical research to inform tobacco control. In 2018, the second waveTCORS 2.0) received $151 million in funding for nine additional institutions to advance science on tobacco product-related behaviors and marketing. Finally, the current round of 2023 awards (TCORS 3.0) will provide another seven grants of 140 million dollars to support further research Eight scientific domains High priority is given to FDA-CTP.

With these major awards, hundreds of other non-TCORS grants, and peer-reviewed publications by industry and independent investigators, FDA-CTP says there are still significant gaps in the science with reduced-risk products. These gaps are the primary reason for FDA-CTP not to issue marketing orders for new nicotine delivery products. Their use has been shown to significantly reduce the effects on health. (compared to burnt cigarettes).

FDA-CTP recently announced several new grants focused on “filling the gaps” in tobacco and nicotine science. The first two grants were awarded to two investigators to determine how menthol inhibition may affect cessation rates or switching behavior and its role in modulating the behavior of flavored and electronic nicotine delivery systems (ENDS, also known as e-cigarettes or vapes). .

of First study ($3.9 million) is listed as having a May 2023 start date and April 2028 completion date. The proposed objectives were: 1) to determine the effect of menthol products on usage patterns; and 2) to determine how the availability of these products affects changes in tobacco use. In addition, the lead investigator he said. The data from the study shed light on how any ban on menthol products would affect consumers who use menthol products. What is interesting about this award is that the studies must be completed within five years, but the FDA-CTP is in. The final stages of establishing a national ban on menthol. So it seems counterintuitive to create a national ban on an area that has been labeled as lacking sufficient scientific background, and where the FDA-CTP is currently funding scientific research to avoid that issue. As a science-driven organization, it would make more sense for the FDA-CTP to hold off on any activity on menthol until data collection is complete.

of Second study ($3.9 million) will also begin in May 2023 and end in April 2028. This study focuses on ENDS product acceptance, changes in demand for traditional cigarette products, and whether use of ENDS products leads to sustained and complete switching behavior. This is one of the longest studies evaluating both the role of taste and how consumption of ENDS products (with and without flavor) affects participant health. Scientists are awaiting new results to clarify the importance (or lack thereof) of flavored ENDS products and to provide this information to the FDA-CTP to help consumers make informed decisions about the use of risky products. It guides them in controlling such products. In this case, there are many studies that show many studies in the last decade Effectiveness of reduced risk products Also, the importance of alternatives (flavors, etc.) in helping smokers to avoid using cigarettes. So, while many agree that replication is a necessary step to prove scientific principles, the continued delay in granting marketing orders for potentially life-saving products seems too great a sacrifice to continue.

The overall adoption of uncertainty best describes FDA-CTP actions and activities. Over a decade, very little has changed in the health outcomes associated with tobacco use. The agency has spent billions with almost no return on investment. Of particular concern is the fact that there are numerous published reports showing how reduced risk products can help smokers and improve their health in doing so, yet the FDA-CTP is still delaying these products from entering the US market. This lack of effective regulatory oversight has led to confusion among consumers, reduced competition and innovation in the industry, and would have continued to die if there had been proper educational messaging and widespread risk exposure products. America. It is alarming to think that there could be another half million preventable deaths every year until the FDA-CTP is notified.



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