September 9, 2024

The Honorable Brett Guthrie                                         The Honorable Anna Eshoo
Chairman                                                                       Ranking Member
Subcommittee on Health                                               Subcommittee on Health
House Committee on Energy and Commerce              House Committee on Energy and Commerce
2125 Rayburn House Office Building                            2125 Rayburn House Office Building
Washington, D.C. 20515                                               Washington, D.C. 20515

Dear Chairman Guthrie and Ranking Eshoo,

On behalf of the more than one million members and supporters of the Council for Citizens Against Government Waste (CCAGW), I am submitting the following statement for the record for the House Energy and Commerce Subcommittee on Health September 10, 2024, hearing on “Evaluating FDA Human Foods and Tobacco Programs.” 

CCAGW is concerned that the Food and Drug Administration (FDA) and the Center for Tobacco Products (CTP) have failed to adopt tobacco harm reduction policies that would encourage smokers to use less dangerous alternatives and result in better outcomes for smokers looking to quit.  CTP has had authority for nearly 15 years to assess and collect user fees and has collected $712 million in user fees annually paid by manufacturers of certain tobacco products since fiscal year 2019.  Yet, there is lack of accountability over the agency.  For example, it is unclear if CTP is using these funds to meet and comply with its statutory obligations under the Family Smoking Prevention and Tobacco Control Act of 2009 (“Tobacco Control Act”).  It is also unclear if CTP is performing as a fair, effective, and efficient product regulator when there is no review of the agency’s performance.

Congress made harm reduction a critical component of the Tobacco Control Act and established a process to allow manufacturers to bring products to market in a timely manner.  The directive that CTP deny or approve Premarket Tobacco Product Applications (PMTA) within 180 days after the application is submitted is not being met.  Currently, the application process is cumbersome and time-consuming, vague, and frequently changing, which adversely affects manufacturers’ ability to innovate and invest in harm reduction products. 

To date, the FDA has only authorized 45 products out of 26 million product applications.  In lieu of mitigating the problem, the FDA is more focused on talking about death due to tobacco-related illnesses, which would be mitigated by more timely approval of tobacco harm reduction (THR) products.  The government red tape contributing to the backlog of PMTAs has resulted in an influx of unregulated foreign-made products to meet consumer demand.  And even with the FDA’s crackdown on THR products, the number of unique e-cigarette devices sold in the U.S. has tripled to more than 9,000 since 2020. This increase is, unfortunately, driven mainly by unauthorized disposable vaping products from China. 

Additionally, efforts to ban menthol flavoring in cigarettes has negatively impacted state and federal budgets that rely on tobacco tax revenues, hurt small businesses, fail to reduce youth cigarette use even though youth cigarette use is currently at historic lows, and created a black market of unregulated menthol cigarettes.  According to the Centers for Disease Control and Prevention (CDC), menthol cigarettes are no more dangerous than any other cigarettes.  Banning the sale of menthol cigarettes will mean lost tax revenues at all levels of government, which have used this money to fund various programs for decades.  In 2019 and 2020, menthol-flavored cigarettes made up 37 percent of all cigarette sales in the U.S., according to the CDC.  If banned, the lost tax revenues will reduce government budgets and require either higher taxes or cuts in spending to make up for the financial loss.  A March 2, 2022, Tax Foundation analysis estimated that state governments would lose $4.7 billion, and the federal government would lose $1.9 billion annually if the FDA follows through on the proposed menthol ban.

The menthol cigarette ban will also have an adverse effect on public health and safety due to higher black-market sales and illegal smuggling.  Making a product illegal will not only fail to reduce demand, but also put smokers at increased risk by criminalizing smoking and enforcing strict penalties.  States with high tobacco taxes are already at risk for illicit cigarette sales, like New York, which has a thriving black market for tobacco products.  Imposing high tobacco taxes, which are intended to deter behavior, does not lead to less smoking.  Instead, consumers purchase unregulated products at a lower cost to avoid the high taxes. In 2015, New York lost $1.63 billion due to untaxed tobacco sales. If smokers can’t buy menthol products in a regulated market, they will find a way to purchase the products in an unregulated, dangerous market.

A January 23, 2020, Reason Foundation study found that youth menthol smoking is less popular than non-menthol smoking.  States with the highest rates of menthol smoking also had the lowest rates of youth smoking.  Banning menthol cigarettes is a solution in search of a problem.  It would be far more effective to enforce ID verification laws and hold retailers accountable for selling to minors instead of implementing an all-out ban that impacts everyone.

If the FDA proceeds to implement a menthol ban, the doors will open to an illegal, unregulated, and dangerous black market which increases the risk to public health and safety.  This ban will also drain local, state, and federal governments of tax revenue streams.  Small businesses that rely on tobacco sales will be subjected to lost revenues as a result of the menthol prohibition.

CTP should be evaluated on performance and the backlog of PMTAs should be addressed.  Millions of Americans utilize THR products each year to quit smoking and instead of using evidence-based data the FDA is using fear tactics to limit access, slow approvals, and overall harm Americans who use THR to quit.

Thank you for your consideration of our testimony for this hearing.

Sincerely, 

Tom Schatz 
President, CCAGW