Happy PMTAnniversary?

Published on September 9, 2024

Today marks the four year anniversary of the filing of the first Pre-Market Tobacco Applications.

Background: In 2009, Congress passed the Family Smoking Prevention and Tobacco Control Act (TCA). One of the principal goals of the TCA was to reduce smoking death and disease by getting less harmful tobacco products (i.e., anything with nicotine that doesn’t require combustion) into the market through the filing of pre-market tobacco applications (PMTAs). Sadly, not only are more Americans dying from smoking today than in 2009, but the trend will increase into the future, according to a recent study in the American Journal of Preventative Medicine.

Happy Anniversary? Today – September 9, 2024 – is the four-year anniversary of the filing of PMTAs for all new tobacco products. The U.S. Food & Drug Administration’s Center for Tobacco Products (CTP) claims it received applications for 26 million novel tobacco products, mostly electronic cigarettes or e-cigarettes. What has the FDA done to get these less harmful tobacco products on the market and into the hands of Americans who smoke? Virtually nothing.

By the Numbers: FDA leaders have repeatedly admitted that, “as a category” e-cigarettes are much less harmful and much less toxic than combustible cigarettes, and yet, the FDA proudly states that it has rejected more than 99% of all PMTAs for these less harmful alternatives to cigarettes. To be clear, the FDA/CTP have approved a mere 8 ten millionths of a percent of PMTAs submitted.

Instead of authorizing less harmful non-combustible products, since September 9, 2020, according to the FDA’s own publicly available database, the FDA has authorized an incredible 6,670 new combustible tobacco products to be sold in the U.S.:

3,232 new cigars;
1,291 new pipe tobacco products;
1,073 new hookah tobacco products; and
973 new cigarettes.

829 of those 973 new cigarettes have been ushered into the market under the current FDA leadership of Commissioner Robert Califf, with more than 700 authorized by Director Brian King himself during his brief tenure as CTP Director. In fact, in 2023 alone, Director King rushed to market 662 new cigarettes for Americans to smoke.

By comparison, CTP Director Brian King has only authorized just four vaping devices for 30 million Americans to use as alternatives to cigarettes.

All told, Director King has authorized 1,270 combustible products and only 14 non-combustible products, an absurd 91:1 ratio. In both categories, the overwhelming majority of products approved for the market are owned by Big Tobacco.

The E-Vaporating Youth Epidemic: Director King has justified his nearsighted and steadfast refusal to widely authorize virtually every flavored e-cigarette that are being widely used by American adults, claiming in virtually every product rejection that he was doing so to “protect youth.” But, just last week, the US Centers for Disease Control (CDC) just announced another dramatic decline in youth vaping, which now sits at the lowest level in more than a decade. According to the CDC’s National Youth Tobacco Survey for 2024, the youth vaping rate (users who say they’ve used an e-cigarette at least 1 time in the last 30 days) is now down to 5.9%. Even more importantly, despite the hysteric and repeated claims of widespread youth “addiction,” the number of youth who use e-cigarettes daily has dropped to 1.56%. These cratering youth use rates are now dramatically lower than the rampant and increasing rates of underage drinking, cannabis, fentanyl and opioid which, in many cases, lead directly to the death of our young people.

Taking Credit? Director King tried to take credit for the youth decline, saying his recent “enforcement” actions to remove e-cigarettes from the legal adult marketplace had something to do with declining youth use even though the declining trend had started long before he got to the FDA and long before he took any enforcement actions. In reality, before Director King took the helm at CTP, youth vaping rates had already begun dropping steeply in this country from the height of the JUUL epidemic in 2019. Without question, this dramatic downward youth trend is due much more to Congress raising the age in 2019 to buy tobacco products (a decision that VTA championed with Congress and the White House) rather than any recent enforcement actions by CTP. All told, youth vaping has plummeted 71% since 2019.

The Upshot: Even with these historic lows, Director King still maintains a zero-tolerance nicotine policy, stating that he will not change the FDA’s current approach of effectively banning all flavored and other vaping products – thus continuing to deprive American adult smokers access to less harmful flavored e-cigarettes – so long as any youth continue to use e-cigarettes.

The Bottom line: The number of American adults who die from cigarettes continues to increase. Since September 9, 2020, 1,930,000 Americans have died from smoking cigarettes (480,000 each year), and approximately 64 million Americans suffered from smoking-related disease (16 M each year), according to the CDC, at a cost of hundreds of billions of dollars to the U.S. health care system and gross domestic product. In this time, the FDA has only allowed the purveyors of these deadly combustible products to strengthen their grip on the market. Meanwhile, more and more Americans die from smoking, making this anything but a happy anniversary.