Nicotine gums are ‘public health crisis to come’, says US agency

First, there were chocolate or grape flavored cigarettes. Then came electronic devices in flavors like cotton candy or gummy bears. Now, there are flavored gummies made with nicotine. THE Food and Drug Administration (FDA), a body similar to the National Health Surveillance Agency (Anvisa), in the United States, is not happy about this.

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

“Nicotine gum is a public health crisis waiting to happen among our nation’s youth, particularly as we approach a new school year,” warned FDA Commissioner Robert Califf last month.

In August, 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 agency says VPR did not apply for this “pre-marketing authorization” for the gummies.

Each of the gummies had 1 milligram of nicotine and came 12 in a packet. The FDA says that 1 to 4 milligrams of nicotine can be severely toxic for children under age 6, as well as older children, depending on their weight.

VPR’s Krave brand website says the tobacco-free products were made to “empower adult smokers with the tools to use nicotine on their own terms.” But the bright colors of the gummies and fruit flavors like “blue raz”, “cherry bomb” and pineapple can also appeal to children.

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

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

There is no clear data documenting how widespread gummies or any other candy-like nicotine product has become. But if one study recent report on nicotine use in Southern California is an indication, they are popular.

In that survey, 9th and 10th graders who reported using nicotine were more likely to use tobacco-free flavored nicotine products—gums, pills, lozenges, and gum—than many traditional products, such as cigarettes. They were second only to the ever-popular e-cigarettes. About 10% of young people surveyed used e-cigarettes and more than 3% chose oral nicotine products.

‘Truly, truly troubling’

Nicotine lozenges and gums have been on the market for years. Gum products were relatively newcomers, said Erika Sward, assistant vice president for national defense at the American Lung Association. It worries her.

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 are likely to be a lot more nicotine products for kids to come.

“FDA oversight of these products is not going as fast as it needs to be,” Erika said. She approved the warning letter, but says it is not enough. “I think until the FDA shows that they are serious about cracking down on these companies that are releasing these products, it will continue to be an issue.”

She added that it is especially concerning that companies know they cannot introduce a product without FDA pre-market approval, but they do it anyway.

“This is really concerning from a parent’s perspective or anyone in general who thinks that if a product is on the market, someone is taking a look at it, and we know that’s not the case,” Erika said.

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

The agency said in a statement to CNN which is “deeply committed to addressing the ongoing public health concerns around youth tobacco use” and “will continue to take appropriate enforcement actions that are supported by evidence”.

“Manufacturers of any illegal products, including nicotine gum, should be aware that the FDA is actively working to identify violations and will quickly seek corrective action. sold are doing so illegally,” the agency said this week.

FDA application

For years, the FDA has been cracking down on companies that have tried to sell certain types of nicotine products that seem child-friendly. In 2020, the agency restricted flavors in vaping devices, which came in options like Charms cereal, lemon cherry cola, and cream unicorn cake.

In 2019, the FDA chided e-cigarette giant Juul for the way it marketed its products, including a school presentation in which the company said the product was “totally 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 revealed that Juul deliberately marketed 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 US Centers for Disease Control and Prevention (CDC) still considers e-cigarette use by young people to be a serious public health issue.

During the pandemic, vaping rates among teenagers have dropped for the first time in years. But data from the CDC Foundation showed that e-cigarette sales increased once young people 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 some form of tobacco product, according to CDC research.

Disposable flavored vapes, which use synthetic nicotine, are especially popular with young women. These products come in flavors like sugar cookie, mango, pound cake, and fizzy lemonade.

Companies that make synthetic nicotine products 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 allowed the FDA to regulate nicotine products, but specified nicotine from tobacco.

In April, a new law clarified that the FDA could regulate products that use synthetic nicotine. But many of the products are still for sale as the agency reviews manufacturers’ requests to stay on the market. The FDA has exceeded the court-mandated deadline for making a decision on the products.

Manufacturers had until May to submit marketing requests to the FDA, and if products didn’t get authorization by July, they had to be considered illegal and withdrawn from the market.

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

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

“What nicotine gums prove – or just remind us of – is the absence of the FDA drawing a hard line in the sand. Our children are more at risk of being exposed to addictive nicotine products than they have been in a 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 nicotine products that appeal to children.”