Nicotine gum is a ‘public health crisis just waiting to happen,’ says FDA



CNN

First there were flavored cigarettes with chocolate or grape flavor. Then came e-cigarettes with flavors like cotton candy or gummy bears. Now there are flavored nicotine gums, and the US Food and Drug Administration isn’t happy about them.

The agency has warned parents to keep an eye out for products that may look like typical candy but are actually nicotine-based. He says they could be very dangerous for children.

“Nicotine gum is a public health crisis just waiting to happen among our nation’s young people, especially as we approach a new school year,” said FDA Commissioner Dr. Robert Califf. notified last month.

Last month, the FDA sent a warning letter to VPR Brands, one of the companies that makes nicotine gum, saying the products were being sold illegally. By law, manufacturers must submit an application and have it approved by the FDA before a tobacco product can be legally marketed in the United States. The The agency claims that VPR did not seek this “pre-marketing clearance” for the gummies.

Each of the gummies contained 1 milligram of nicotine and they were 12 per pack. The FDA says 1 to 4 milligrams of nicotine could be seriously toxic to children under 6 as well as older children, depending on their weight.

The website for VPR’s Krave brand of tobacco-free products aimed to “give adult smokers the tools to use nicotine on their own terms.” But the bright colors and fruit flavors of gummies like “blueraz”, “cherry bomb” and pineapple might also appeal to kids.

VPR Brands did not respond to CNN’s request for comment, and the website now says the gummies have been discontinued.

But nicotine products from other companies that look like candy are still available, along with lozenges, sachets, and gum.

There is no clear data documenting how ubiquitous gummies or any other candy-like nicotine products have become. But if a recent study of nicotine use in Southern California is any indication, they’re popular.

In this survey, 9th and 10th graders who reported using nicotine were more likely to use oral nicotine products without tobacco flavor. – gummies, tablets, lozenges and gummies – than many more traditional products like cigarettes. They were second only to the ever-popular e-cigarettes. About 10% of children surveyed used e-cigarettes and more than 3% chose oral nicotine products.

Nicotine gum and lozenges have been on the market for years. Gummy products were relatively new, said Erika Sward, assistant vice president for national advocacy for the American Lung Association. This worries him.

The gummies were on the market for about six to nine months before the FDA sent out its warning letter, she said, and that’s a sign that there will likely be a lot more gummies. of nicotine suitable for future children.

“The FDA’s oversight of these products isn’t going as fast as it should,” Sward said. She was encouraged by the warning letter, but says it’s not enough. “I think until the FDA shows it’s serious about cracking down on these companies that offer these products, it’s going to continue to be a problem. »

She added that it’s particularly worrisome that companies know they can’t introduce a product without premarket approval from the FDA, but do so anyway.

“It’s really, really disturbing from the perspective of parents or anyone in general thinking that if a product is on the market, someone takes a look at it, and we know that’s just not not the case,” Sward said.

The FDA has only been allowed to regulate synthetic nicotine since earlier this year, after Congress gave the agency authority over non-tobacco nicotine products.

The agency said in a statement to CNN that it is “deeply committed to addressing public health concerns about youth smoking” and “will continue to take appropriate enforcement actions supported by evidence.” “.

“Manufacturers of illegal products, including nicotine gum, should know that the FDA is actively working to identify violations and will promptly request corrective action. It is important to note that no nicotine gummy products have been cleared by the FDA and therefore all products currently sold do so illegally,” the agency said this week.

For years, the FDA has cracked down on companies trying to sell certain types of kid-friendly food-echoing nicotine products. In 2020, it limited vaping device flavors, which were available in options such as Cherry Lime Cola Cereal Charms and Heavy Cream Unicorn Cake.

In 2019, the FDA reprimanded e-cigarette giant Juul for the way it marketed its products, including a school presentation in which the company said the product was “completely safe” and that the “FDA would approve it.” any day “. In June, he ordered the company to stop selling its products. But a court blocked the ban, so the products are still on sale.

After a two-year investigation found Juul was deliberately marketing its product to children, several state attorneys general announced this week that the company will pay a $438.5 million settlement to 34 states and territories.

The United States Centers for Disease Control and Prevention still considers e-cigarette use by children a serious public health concern.

During the pandemic, teen vaping rates have plummeted for the first time in years. But data from the CDC Foundation showed that e-cigarette sales surged just as kids started going back to school, according to Matt Meyers, president of the Campaign for Tobacco-Free Kids.

In 2021, about 2.55 million college students reported using some form of tobacco product, according to CDC surveys.

Disposable flavored vapes, which use synthetic nicotine, are particularly popular with children. These products come in flavors such as sugar cookie, mango, pound cake, and sparkling lemonade.

Companies that make products containing synthetic nicotine have argued that they don’t need to follow the rules that apply to other nicotine products because theirs don’t contain tobacco. A 2009 law finally allowed the FDA to regulate nicotine products, but it specified tobacco nicotine.

In April, a new law clarified that the FDA could regulate products using synthetic nicotine. But many products are still on sale as the agency reviews manufacturers’ requests to stay in the market. The FDA has exceeded the court’s deadline to make a decision on the products.

Manufacturers had until May to submit marketing applications to the FDA, and if the products did not gain clearance by July, the products were supposed to be deemed illegal and pulled from the market.

“The law gives the FDA the tools to act quickly,” Myers said, but she doesn’t use them often.

Anti-tobacco experts say that while it’s good that the FDA has taken action on nicotine gummy products, the agency should be doing a lot more.

“What nicotine gum proves – or simply reminds us of – is the absence of the FDA drawing a hard line in the sand. Our children are at greater risk of being exposed to addictive nicotine products than they have been in a very long time,” Myers said. “FDA enforcement has been so sporadic, and when companies believe there are profits to be made, we will continue to see the introduction of new kid-friendly nicotine products. »

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