The Role of FDA in Misleading the Public

According to a report by Filter on September 7th, Brian King, the director of the Center for Tobacco Products (CTP) at the Food and Drug Administration (FDA), recently stated in a commentary for the journal "Addiction" that nicotine e-cigarettes and other reduced-harm tobacco alternatives are safer than combustible cigarettes.

A recent study, conducted by Dr. Olivia Wackowski and others, was commented on by King. The research revealed that only 18% of surveyed adult smokers held the accurate belief that e-cigarettes contain fewer harmful chemicals than traditional cigarettes.

This research holds great value. However, over the years, a series of other surveys and studies have found that the American public has been disastrously misled in crucial comparisons regarding public health. It is only now that the head of CTP has stated, "There is an opportunity to employ evidence-based approaches in educating adult smokers about the relative risks of tobacco products, including e-cigarettes.

Actions speak louder than words. The FDA bears responsibility for its lack of regulation and its resulting chaos. While King's suggestions are encouraging, such as his immediate proposal for a warning against adolescent use and mentioning the FDA's infamous 'real cost' campaign, it is important that action is taken.

So far, the FDA has been criticized for a series of regulatory inaction and confusion. Without significant policy changes, mere verbal commitments will have no effect for the millions of American adults who could benefit from safer alternatives to smoking.

The FDA has long acknowledged, albeit not publicly, that all tobacco products (including nicotine consumer goods) carry "ongoing risks," with combustible cigarettes being the most harmful and other alternatives posing significantly lower risks. It is the smoke, not nicotine, that is the primary source of harm. However, misconceptions surrounding nicotine have become so deeply ingrained that the majority of American doctors (let alone the general public) believe nicotine directly causes cancer.

In 2017, then-FDA commissioner Scott Gottlieb unveiled an ambitious plan aimed at "striking the right balance between regulating and encouraging the development of innovative tobacco products that may be less harmful than traditional cigarettes." In a accompanying statement, the FDA highlighted that "a key part of the approach" is to demonstrate people's understanding of nicotine, namely that while highly addictive, it is delivered through products that represent a continuum of risk, with the most harm associated with smoke particles produced by combustible cigarettes.

In the years that followed, the organization consistently failed to convey this information.

The FDA's own inaction has resulted in the greatest harm, as it has allowed new products to reach the market through a cumbersome application process.

Perhaps this misunderstanding partly stems from the wording in the Tobacco Control Act (TCA). Section 46 of the 2009 legislation prohibits the FDA from "approving" tobacco products. The TCA states that if manufacturers were allowed to sell their products in a way that is "approved, inspected, or endorsed by the FDA," then consumers—understandably—may "likely be confused and misled.

Therefore, the FDA does not approve tobacco products, regardless of their relative safety, but it authorizes their sale.

This raises concerns among certain public health organizations heavily funded by billionaire Michael Bloomberg, suggesting that since the FDA has yet to approve any e-cigarette product for smoking cessation, they are not inherently safer than combustible cigarettes. These organizations are actively spreading misinformation, impeding the transformation of the US tobacco market into an industry offering a variety of safer nicotine products.

However, undoubtedly the biggest damage caused is the inaction of the FDA themselves. This lack of fluidity is due to the complex application process that new products must go through before being pushed into the market, regardless of whether or not they pose any harm.

Currently, there are two pathways to seek FDA authorization for tobacco products launched after February 15, 2007 (as determined by TCA predicate date): Substantial Equivalence (SE) and Pre-Market Tobacco Product Application (PMTA).

The SE pathway requires products to either possess the same characteristics as existing products or not pose any public health issues that differ from those of existing products. In other words, it provides quick authorization for products that maintain the current market status.

The FDA has thus far issued several hundred SE orders, including 421 marketing orders from 2019 to 2022. Among them, 127 are targeted towards combustible cigarettes; none of them are for safer alternatives to cigarettes.

The absurdity lies in the fact that this double standard makes it easier for conventional cigarettes to obtain authorization compared to e-cigarettes.

In contrast, the PMTA pathway requires the FDA to determine that a product is "appropriate for the protection of public health" (APPH) - a more rigorous standard that necessitates extensive scientific research, which only the largest companies can truly undertake.

Since 2015, the agency has denied millions of PMTA applications. Under the PMTA pathway, it has only authorized 45 different products, out of which only 23 are e-cigarette products, and they are produced solely by three different manufacturers.

For a federal agency that deals with the funding and regulation of tobacco sales, this is an unusual reality. The CTP is "fully funded by tobacco users," and this applies to six different types of tobacco products, including cigarettes, cigars, chewing tobacco, snuff, roll-your-own tobacco, and snus. The amount of fees is determined based on market share, with combustible cigarettes accounting for over 83% of the funds paid by tobacco users. Essentially, cigarettes (and the adults who smoke them) provide the financial resources for the CTP's operations.

To be fair, the FDA is still trapped in a state of ambiguity and near-impossibility when it comes to the basic regulations. The Tobacco Control Act (TCA) stipulates that the Agency should determine the risks and benefits of tobacco products for the entire population, including users and non-users, and consider the likelihood of their use. Although the TCA acknowledges the marketing targeted towards young people by tobacco companies, it does not provide a specific definition of what constitutes products appealing to the youth.

In this situation, the FDA continues to use youth e-cigarette use as an excuse to reject all sales orders of reduced harm tobacco products with flavors (which are crucial to many adult users of these products).

In 2021, the FDA made a significant move in the first of many seasoning e-cigarette liquid PMTA Marketing Denial Orders (MDOs). The FDA claimed that the applicants lacked sufficient evidence to prove that these products have enough benefits for adult smokers to outweigh the public health risks associated with smoking. The widespread usage of such products among young people is alarming, and there is substantial evidence to support this claim.

In May 2023, the FDA issued additional refusal orders, stating that the agency will assess "whether the products in the application demonstrate additional benefits to adult smokers… that may outweigh the known significant risks of flavored e-liquids and e-cigarette products for youth.

Both teenagers and adults use flavored e-cigarette products. However, young users do not widely cite the flavors as their reason for vaping. In 2021, the FDA banned the sale of flavored products largely due to concerns about youth usage. Currently, nearly half (43.4%) of American middle school students who vape claim they do so as a form of self-treatment for anxiety, depression, and/or stress. Only 13.2% stated that they use e-cigarettes specifically for the flavors.

The FDA has a clear starting point: to acknowledge its role in misleading the public and preventing people from smoking.

If the FDA ultimately wishes to correct public misconceptions about reduced harm tobacco products, it will face an uphill battle.

The organization needs to overcome language and definition challenges, accurately determine the reasons why young people use e-cigarettes, while not exaggerating its harm. It needs to clarify the reform process in order to communicate accurate information to consumers. It needs to simplify the authorization process for products that are deemed safer than traditional cigarettes and have a wider reach.

We can remain hopeful that the FDA will adhere to scientific evidence and the urgent need to save lives. However, if it desires to establish transparent and honest communication, it must begin by acknowledging its role in misleading the public and promoting smoking.