FDA and vaping

A global public health issue recently made its way to a US court. Vaping, which has gained popularity in recent years as an alternative to tobacco and cigarette smoking, is now under legal review after one major manufacturer was banned last week by the US Food and Drug Administration (FDA) from selling its e-cigarettes in the United States.

The issue appears procedural, however, and may not necessarily go into the pros and cons of vaping and its link to public health. Moreover, the US FDA last year approved the sale of e-cigarettes in the US, particularly those made by British American Tobacco and NJOY. But, in a surprising move, it also opted to ban Juul Labs’ products last week.

Surprising for the fact that Juul Labs is the industry’s 800-pound gorilla. CNBC reports that “Juul had been the market leader in e-cigarettes since 2018, according to Euromonitor International. As of 2020, the company held 54.7% share of the $9.38 billion US e-vapor market.” In the same report, CNBC quoted Juul as saying that “no other rival had their application denied for similar reasons.”

Juul Labs, a global producer of vaping products, thus asked a Washington DC appeals court to keep its temporary restraining order on the US FDA ban. It claimed the FDA ban was premature since the agency has yet to fully evaluate all of the company’s regulatory submissions for the approval of its e-cigarettes to be sold in the US. For now, Juul can continue to sell its products in the US. That is, unless the appeals court reverses itself on its stay order on the FDA ban.

The US FDA had claimed Juul failed to submit enough evidence on the “toxicological profile” of its e-cigarettes. Thus, the products’ ban. But Juul alleged that FDA “overlooked more than 6,000 pages of data that it provided about the aerosols generated by heating the liquid in its pods and that users ultimately inhale,” CNBC reported.

The crux of the matter is the “potential risks of using” Juul Labs products, and “whether potentially harmful chemicals could leak from Juul pods” or e-cigarettes while in use. The legal issue is whether FDA actually gave Juul a fair chance to prove the safety of its products by thoroughly reviewing its regulatory submissions.

In seeking remedy from the US District Court of Appeals for the District of Columbia Circuit, Juul claimed that “had FDA done a more thorough review (like it did for other applicants), it would have seen data showing that those [potential harmful] chemicals are not observable in the aerosol that JUUL users inhale,” CNBC reported. Juul also claimed that “taking its products off store shelves, even temporarily, would permanently damage its brand and that its customers would either use competitors’ products or return to traditional cigarettes.”

While the issue is not novel, if memory serves me, this is the first time that an e-cigarette company has gone to court to question the ban on its products. And considering that the legal suit involves the US market leader, the court decision on the matter will surely have implications not only on US sales but also on other Juul markets like the Philippines.

Assuming, for the sake of discussion, that the appeals court reverses itself and allows the Juul ban. Then this will practically validate the FDA claim that Juul has failed to prove the safety of its products. In short, allowing their sale will be detrimental to public health. What then will be the consequence and implication of this on Juul sales in the Philippines? Will local regulators follow suit?

At this point, I am already anticipating the vaping issue to also go to court here in the Philippines. The Supreme Court previously decided an 11-year-old case and upheld the authority of the Philippines’ Food and Drug Administration (FDA) to regulate cigarettes and tobacco products, noting it has the “technical authority over matters of public health.”

The Philippine Tobacco Institute, Inc., representing tobacco firms, argued that the industry should be regulated by the Inter-Agency Committee on Tobacco (IAC-Tobacco) as provided for by the Tobacco Regulation Act of 2003. But the Court ruled that this was “contrary to law and our international obligations,” noting that cigarette firms were part of IAC-Tobacco.

With the legality of FDA regulation of cigarettes now a settled issue, then the focus moves to vaping. Senate Bill No. 2239 and House Bill No. 9007, ratified in December 2021, transferred the regulation of vaping products from the FDA to the Department of Trade and Industry (DTI). While the bills have been passed, they have not been signed into law.

With the Supreme Court ruling on FDA’s authority over cigarettes, I am certain the vaping will also go to court. Other than taking the FDA out of the picture, the bills also lower the access restriction on vaping products from 21 to 18 years old; allow the sale of youth-appealing flavors other than plain tobacco and menthol; and, allow online sales of e-cigarettes.

As I have written previously, I don’t see any reason for vaping to be given more leeway than cigarettes. After all, given the Juul case in the US, it remains obvious that there are no guarantees that vaping is actually a “healthier” alternative to cigarette smoking. In this line, if the Senate bill on vaping is enacted, it should really be questioned in court.

The incoming administration and incoming legislators should also take note of international trends and developments in the tobacco industry as well as on global tobacco consumption and the sales growth of tobacco alternatives. This way, it can make better informed decisions on how to best regulate the production and sale of cigarettes and their alternatives.

The Philip Morris decision to end Marlboro sales in the UK in 10 years’ time is already indicative of the industry’s shift. Policies and regulations on tobacco and its alternatives like electronic cigarettes should recognize this shift and adjust to the times. To ensure a healthier, smoke-free future, we need to reassess present rules on taxation, advertising or marketing, and healthcare financing for smoking-related or vaping-related illnesses and diseases.