FDA Issues Warning to Nicotine Gum Maker

The emergence and rapid success of nicotine gums among young people has prompted the FDA to call on one of their producers.

Since extending its prerogatives on March 15 to all nicotine products, whether synthetic or extracted from tobacco, the Food and Drug Administration (FDA) has been particularly attentive to new nicotine products developed by manufacturers. Among these products, nicotine gummies, which recently appeared on the market, were sold without having received prior marketing authorization. The FDA has therefore just written a warning letter to one of these producers (VPR Brands LP, marketing the Krave Nic brand) asking it to comply with the law, which was a first for this type of product. The agency has made this warning public[1].

In an information note relating to this letter[2], the FDA justifies its action by the great resemblance of these nicotine gums with other candies usually popular with children. It also fears that very young children could be poisoned, and even die, by ingesting this type of gum, which can contain between 1 and 4 mg of nicotine.

Study shows strong interest among young people in oral nicotine products

The FDA's concern is fueled in particular by a study recently published in the journal Pediatrics, which it cites. Conducted in California, this study indicates that, among the new nicotine products not containing tobacco, oral products (gummy gums, lozenges, tablets and non-therapeutic chewing gum) are the second most consumed and experimented with by middle school students, behind electronic cigarettes (disposable or not) but ahead of "pouches" (nicotine pouches resembling snus).[3]The study also found that these tobacco-free nicotine products are more commonly used by youth from ethnic minorities (primarily Hispanics and Asians), by girls and sexual minorities, and by adolescents who are already the heaviest smokers. Adolescent users thus include several of the vulnerable subgroups most likely to become or already be smokers.

The attractiveness of these products is due to their ease of use, their familiarity (sweet and evocative aromas, strong resemblance to other confectionery) and their discretion towards parents and adults, sometimes praised online by manufacturers. The perception that these products are less harmful than tobacco products may constitute other motivations for consumption. It would facilitate nicotine addiction, among young smokers even more than among non-smokers. The authors of the study conclude that this emerging market needs to be better regulated and that oral nicotine products should now be systematically included in health surveillance studies.

Manufacturers' strategy to offset decline in smoked tobacco

Faced, particularly in Western countries, with the decline in the consumption of smoked tobacco products, manufacturers have for several years been interested in developing new products, in parallel with the electronic cigarette and heated tobacco markets. Although officially banned in Europe, some of these products still manage to penetrate the markets of different countries, particularly through online sales. In France, the consumption of "pouches" by student athletes was recently reported in the Grenoble region.

The acquisition policy developed in recent years by the tobacco industry has led it to take over companies specializing in chewing gum and the " diamonds »[4], in the snus[5], THE cannabis and the CBD[6]. It can therefore be assumed that a major global offensive is underway to massively distribute nicotine products – or other substances – in all marketable forms.

Keywords: gummies, novel nicotine products, diamond, snus, cannabis, FDA Photo credit: Krave Nic manufacturer website

©Generation Without Tobacco

MF

---

[1] VPR Brands, LP d/b/a Krave Nic, Warning Letter, FDA, published August 18, 2022, accessed August 22, 2022. [2] FDA Warns Manufacturer for Marketing Illegal Flavored Nicotine Gummies, FDA, published August 18, 2022, accessed August 22, 2022. [3] Harlow A, Vogel E, Tackett A, Cho J, Han DH, PhD; Melissa Wong, Cockburn M, Sussman S, Unger J, Leventhal A, Barrington-Trimis J, Adolescent Use of Flavored Non-Tobacco Oral Nicotine Products, Pediatrics e2022056586, August 8, 2022. [4] Philip Morris acquires nicotine replacement specialist Fertin Pharma, Generation Without Tobacco, published July 5, 2021, consulted August 22, 2022. [5] Ongoing talks could lead to Philip Morris' acquisition of Swedish Match, Generation Without Tobacco, published on May 13, 2022, consulted on August 22, 2022. [6] Tobacco Industry Maneuvers in Cannabis and Pharmaceutical Markets, Generation Without Tobacco, published July 26, 2021, consulted August 22, 2022. National Committee Against Smoking |