Nicotine gummies are a “public health crisis waiting to happen,” the FDA says



CNN

Before, there were chocolate or grape flavored cigarettes. Then came e-cigarettes flavored like cotton candy or gummy bears. Now, there are gummies made with nicotine, and the US Food and Drug Administration is not happy.

The agency has warned parents to be on the lookout for products that may look like typical candies but are actually nicotine-based. He says they can be very dangerous for children.

“Nicotine gummies are a looming public health crisis among our nation’s youth, particularly as we head into a new school year,” FDA Commissioner Robert Califf warned last month.

The FDA last month sent a warning letter to VPR Brands, one of the companies that makes nicotine gummies, advising that the products were being sold illegally. According to the law, manufacturers an application must be submitted and approved by the FDA before a tobacco product can be legally marketed in the United States. The the agency says VPR did not apply for such “premarket authorization” for the gummies.

Each gummy contained 1 milligram of nicotine, and came in a pack of 12. The FDA says that 1 to 4 milligrams of nicotine can be very toxic to children under 6 and even infants, depending on their weight.

The website for VPR’s Krave brand says the tobacco-free products were intended to “empower adult smokers with the tools to use nicotine on their own terms.” But the bright colors and fruity flavors of the gummies, such as blueraz, cherry bomb and pineapple, can also appeal to children.

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

But other companies’ nicotine products that look like candy are still available, as well as lozenges, pouches and gum.

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

In that survey, ninth- and 10th-grade students who reported using nicotine were more likely to use flavored tobacco-free oral nicotine products. – gummies, pills, lozenges and gums – than many traditional products like cigarettes. They were second only to electronic cigarettes. About 10% of the 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, vice president of national advocacy for the American Lung Association. That worries him.

The gummies were on the market for about six to nine months before the FDA sent its warning letter, he said, which is likely a sign of more children’s nicotine products to come.

“FDA oversight of these products is not going fast enough,” Sward said. He was encouraged by the warning letter, but says it is not enough. “I think until the FDA shows that they’re serious about dealing with these companies that are coming out with these products, it’s going to continue to be a problem.”

He added that it’s particularly troubling when companies learn they can’t introduce a product without FDA premarket approval, but do it anyway.

“This is really concerning from a parent’s or anyone’s point of view, if a product is on the market, someone is taking a look at it, and we know that’s not the case,” Sward said.

The FDA was authorized to regulate synthetic nicotine only 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 “strongly committed to addressing the ongoing public health concerns surrounding youth tobacco use” and will “continue to take appropriate enforcement actions that are supported by the evidence.”

“Manufacturers of any illegal product, including nicotine gummies, should be aware that the FDA is actively working to identify violations and will seek immediate corrective action. It is important to note that the FDA has not authorized any nicotine gummy products, and therefore the products currently being sold are illegal. they are doing,” the agency said this week.

For years, the FDA has cracked down on companies that have tried to sell certain types of nicotine products that sound like baby food. In 2020, it limited flavors in vaping devices to options like Charms cereal, cherry lime cola, and Heavy Custard Unicorn Cake.

In 2019, the FDA penalized 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 “would be approved by the FDA any day.” In June, he ordered the company to stop selling its products. But a court blocked the ban, so the products are still available for sale.

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

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

During the pandemic, evaporation rates among teenagers fell for the first time in years. But data from the CDC Foundation showed that sales of e-cigarettes spiked when kids started going back to school, according to Matt Meyers, president of the Campaign for Tobacco-Free Kids.

In 2021, about 2.55 million students reported using tobacco products, according to CDC surveys.

Disposable flavors, which use synthetic nicotine, are particularly popular with children. These products come in flavors like sugar cookies, mango, pound cake and lemonade soda.

Companies that make products with synthetic nicotine have argued that they did not have to follow the rules that apply to other nicotine products because theirs did not contain tobacco. A 2009 law finally allowed the FDA to regulate nicotine products, but specified nicotine as coming from tobacco.

In April, a new law clarified that the FDA can regulate products that use synthetic nicotine. But many of the products are still for sale as the agency reviews manufacturers’ applications to stay on the market. The FDA broke the court-ordered 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 receive approval by July, the products had to be deemed illegal and removed from the market.

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

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

“What nicotine gummies prove — or simply remind us — is that the FDA isn’t drawing a hard line in the sand. Our children are more at risk of becoming addicted to nicotine products than they have been in a long time,” Myers said. “FDA enforcement has been so timely, and when companies think there’s a profit to be made, we’ll continue to introduce new nicotine-laced products that appeal to kids.”