FDA Issues Warning Against Nicotine Gum: A Growing Public Health Crisis

Nicotine Gum Receives Warning Notice.

Recently, the FDA has labeled nicotine gum as a "public health crisis waiting to happen" and has warned a manufacturer in Florida to remove its nicotine gum products from the market. Additionally, the FDA has sent a warning letter to VPR Brands for marketing illegally flavored nicotine gums. This marks the first warning letter received by any nicotine gum product.

Nicotine gum is a means of absorbing nicotine into the bloodstream through the mucous membrane of the mouth, with the aim of substituting nicotine. The gum typically contains 2 or 4 milligrams of nicotine, which is about one-sixth to one-third the amount in a cigarette. It is used as an aid in smoking cessation, but its appearance can easily be mistaken for candy by teenagers. In a press release, the FDA stated that "studies have shown that ingestion of 1 to 4 milligrams of nicotine depending on a child’s weight could result in serious toxicity effects and could be potentially lethal for children under six years of age. However, nicotine poisoning in young people of any age can lead to nausea, vomiting, stomach pain, increased blood pressure and heart rate, seizures, respiratory failure, coma, and even death.

The ban on nicotine gum has sparked widespread criticism, with some commenting that the FDA's actions are "typical of overreaction", and that "when facing external pressure, the FDA often responds with ridiculous aggression towards insignificant threats". Others have accused the agency of disregarding the human and economic consequences of their decisions to reduce harm.

According to Nielsen data, the FDA's crackdown on a single e-cigarette brand will only boost sales of other brands and will not make e-cigarette brands disappear. This was seen when the popular e-cigarette brand, Juul, was banned and Vuse replaced Juul as the best-selling e-cigarette brand in the United States.

Has FDA Regulation Gone Too Far?

The FDA's PMTA process aims to find a perfect solution to minimize any potential risks. This year, the U.S. Congress granted the FDA regulatory authority over all forms of nicotine, whether derived from tobacco or manufactured in a laboratory, filling a gap in its oversight that did not include nicotine derived from botanical extracts.

As of August of this year, the FDA has rejected over 88,000 applications for PMTAs for tobacco products and has issued marketing denial orders (MDOs) to 263 electronic cigarette companies, prohibiting their products from being sold within the United States.

This action has led over 40 e-cigarette companies to file appeals with the FDA, requesting a temporary suspension or revocation of the MDO. However, the FDA has scheduled the appeal review for 2025. Due to strict regulations, some companies have chosen to abandon the US market. For example, Chill Brands Group PLC announced that it will cease production and sales of e-cigarettes in the US due to the high cost of regulatory approval.

However, if electronic cigarette companies want to develop and sell new products, time will be their biggest cost. The product development process takes up to three years of PMTA testing, which includes two years of stability testing, time for planning, conducting and writing research, and an additional one to three years of CTP review before products can enter the market. This sounds like a fairly daunting investment, and it's no wonder the e-cigarette industry is drawn to the American market.

Suggestion and Reflection

There is a need to increase transparency in product reviews.

The related reviews also lack transparency. Although people can view the technical project reviews and some review criteria that CTP has posted on its website, few PMTA applicants know the progress of their applications. Apart from the initial pre-PMTA meeting and the only review results, applicants have little knowledge of the status of their applications. For example, Juul provided thousands of pages of data related to toxicology issues raised by CTP in the MDO, and after a court ruling, these issues should be addressed as soon as possible.

Simplify the review process for electronic cigarettes.

Most electronic nicotine delivery products can be determined solely based on chemistry, but currently the cost of materials and reviews are piled onto toxicology, human factors, pharmacokinetics, and behavioral research. Operational issues come from existing regulatory schemes which are too complex for tobacco products. The Tobacco Control Act specifies parameters/guardrails, but the CTP has leeway in how to implement the process. Comprehensive PMTA guidance and strong final rules require too much scientific depth. Using Juul as an example, reports show that Juul provided thousands of pages of data related to toxicology issues raised by the CTP in the MDO, which should be addressed as soon as possible after the court's ruling, rather than wasting time on a company.

How to develop and maintain long-term policies

This is extremely difficult, especially given the turnover of the U.S. government every few years. Nonetheless, policies related to harm reduction should and must form the cornerstone of tobacco regulation. If harm reduction is the top priority, regulatory agencies need to prioritize ways of reducing the introduction of harmful products into the market, incentivize innovation, and focus on providing more options for traditional tobacco users seeking to quit. While youth tobacco use is a crucial issue, the 1,300 smokers who die every day are just as important. It is necessary to develop balanced harm reduction policies, control access and exposure for youth, and simultaneously help traditional cigarette smokers quit entirely or transition to lower-risk products.

Outlook or Forecast. (Note: This is not a full sentence and cannot be translated into standard journalistic English without additional context.)

It is hoped that an external review will prove to be an effective measure in providing the FDA with a viable alternative solution. If the review is focused on the right areas, it could address fundamental issues that ultimately lead to a more reasonable and harm-reducing regulation of tobacco, giving smokers hope for the future.

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