Experts talk about how the FDA's regulation of synthetic nicotine will affect the e-cigarette industry

Blue Hole New Consumption Report, March 29 news, according to foreign news reports, in mid-March, the U.S. Congress took action to fill the loophole in the use of synthetic nicotine in the U.S. electronic nicotine delivery system (ENDS) to make it consistent with tobacco-derived nicotine products. In this paper, Nveed Chaudhary, chief scientific and regulatory officer at Brudon, an independent life sciences contract research organization, explains what this regulatory change means for the next generation of nicotine delivery industry in the U.S. market.

What happened in the United States and when will these changes take effect?

Congress expanded the Food and Drug Administration's authorization of tobacco products to include synthetic nicotine in products such as e-cigarettes, heating products, and oral nicotine bags. This will align these products with tobacco-derived nicotine next-generation nicotine delivery products. The new regulations were passed as part of the U.S. Lawmakers' Long Spending Bill, which was signed into law by President Joe Biden on March 15. It takes effect immediately, and manufacturers of synthetic nicotine e-cigarettes and oral nicotine bags have 60 days to file a PMTA file starting March 15 to keep their products on the U.S. market.

Is the industry expecting such regulatory changes?

The e-cigarette industry has been paying attention to the interest of U.S. regulators on this issue for some time and is expected to change at some point. The speed at which it passed came as a surprise to the industry. It is included in a long-term spending bill that contains hot-button issues such as funding for Ukraine, Covid support and regular government operating expenses, allowing it to pass without debate or modification. That being said, U.S. lawmakers might argue that e-cigarette makers have been collecting data about their products for nearly two years since the PMTA regulations were issued.

What is synthetic nicotine?

Synthetic nicotine, also known as tobacco-free nicotine, is a synthetic form of nicotine that is extracted through a chemical process rather than from tobacco. Recent improvements in manufacturing processes have enabled producers to simulate the enantiomer proportions of tobacco-derived nicotine. Synthetic nicotine is not new, it was first synthesized in 1904, but mass production is relatively new. Most e-cigarette manufacturers do not use synthetic nicotine because it tends to be more expensive than tobacco-derived nicotine. There is also much less infrastructure for synthesizing nicotine from scratch compared to mature facilities that harvest nicotine from tobacco plant material.

Why are U.S. regulators now choosing to close the synthetic nicotine vulnerability?

Previously, the FDA defined "any product made or derived from tobacco and intended for human consumption, including any component, part, or accessory of a tobacco product" as a tobacco product.

According to this description, e-cigarettes containing tobacco-derived nicotine e-liquids are subject to the premarket tobacco product application (PMTA) regulatory framework, while e-cigarettes containing tobacco-free nicotine are not.

However, some U.S. lawmakers and nonprofit lobbyists have long discussed plugging the loophole because it enables manufacturers to bring tobacco-free nicotine products to market without regulatory oversight.

Following the recent release of data from the National Youth Tobacco Survey (NYTS), the FDA does not have the authority to regulate the use of synthetic nicotine disposable e-cigarette products, e-liquid flavors, and marketing by the FDA. As we've seen in tobacco-derived nicotine ENDS products, rigorous scrutiny of products that have been found to be attractive to young people has become an important area of political concern in the United States.

In fact, some manufacturers appear to be using loopholes that bypass regulatory controls that could speed up the pace at which lawmakers think they must act.

What can synthetic nicotine manufacturers do now?

If the product is already available in the United States, the manufacturer has 60 days to submit the PMTA. If a manufacturer is commercializing a new synthetic nicotine product in the United States, they have 30 days to launch the product and then 30 days to submit their PMTA. For most smoke-free nicotine ENDS manufacturers, this 60-day data submission deadline will be challenging, but not impossible. We are currently discussing the regulation with several customers and what they need to do to submit a PMTA within the allowable time frame.

Is it possible to prepare a PMTA file in such a short period of time?

We believe this is the case, but manufacturers need to act now, and success is not guaranteed. In particular, many manufacturers filing PMTA dossiers for their tobacco-derived nicotine ENDS products still do not know whether they have obtained marketing authorization through FDA requirements. The first question is how much data manufacturers of synthetic nicotine ENDS already have about their products, and then set up analytical studies to fill in the gaps in order to submit enough submissions within the available time frame. It is always possible for the FDA to shut down this NGP market area entirely, but this seems unlikely. They are more likely to want to ensure that tobacco-free nicotine products are regulated in the same way as tobacco-derived nicotine products.

What are the long-term effects of FDA authorizations on synthetic nicotine products?

For some time now, the industry has been debating how the government will respond to the regulation of synthetic nicotine products. It's not made from tobacco, but how else can lawmakers regulate it? This is the classic dilemma for regulators; industries that need to respond quickly to technological innovation, have less information than they regulate, and then rely on existing regulations to act quickly and fill gaps. This has always been a problem for the entire next-generation product category.

We believe that all nicotine-containing products, whether nicotine derived from tobacco or synthetic nicotine, should be treated in the same way. Regardless of where nicotine comes from, the impact on population health needs to be measured in a consistent manner. The manufacturing cost of synthetic nicotine is still not high, and due to patents on the manufacturing process, only a few companies currently produce synthetic nicotine.

It is estimated that synthetic nicotine is 13 times more expensive to manufacture than tobacco-derived nicotine.

It's interesting to see if ENDS manufacturers are now abandoning the use of synthetic nicotine or sticking with it because of regulatory changes. Much of this may depend on how the FDA evaluates the PMTA submissions they receive and whether there are any discrepancies in evaluating synthetic nicotine and tobacco-derived nicotine PMTA applications.