FDA says nicotine gum is an ‘imminent public health crisis’



First there is flavored cigarettes Tastes like chocolate or grapes.Then came electronic cigarettes with similar flavors dad’s beard Or gummy bears. Now, there are flavored nicotine gums, which the FDA isn’t happy with.

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

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

Last month, the FDA sent a Warning Letter VPR Brands, one of the companies that made the nicotine gum, informed him that the products were being sold illegally.By law, the manufacturer Tobacco products must submit an application and be approved by the FDA before they can be legally sold in the United States.This The agency claims that VPR did not apply for such a “premarket authorization” for the gummies.

Each gummy contains 1 mg of nicotine and comes in a pack of 12. Depending on their weight, nicotine in doses of 1 to 4 mg can be severely toxic in children younger than 6 years old, as well as in older children, the FDA said.

This website For VPR’s Krave brand, the smoke-free product is designed to “give adult smokers the tools to use nicotine on their own terms.” But the bright colors and fruity flavors of gummies like “blueraz,” “cherry bomb,” and pineapple may also appeal to kids.

VPR Brands did not respond to CNN’s request for comment, and the site now says the fudge has been discontinued.

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

There is no clear data documenting the prevalence of gummies or any other candy-like nicotine products.But if a A recent study The use of nicotine in Southern California shows their popularity.

In this survey, 9th and 10th graders who reported nicotine use were more likely to use non-tobacco-flavored oral nicotine products. – Gummies, tablets, lozenges and gummies – than many traditional products such as cigarettes. They are second only to the wildly popular e-cigarettes. About 10 percent of the children surveyed used e-cigarettes, and more than 3 percent opted for oral nicotine products.

Nicotine gums and lozenges have been on the market for many years. Gummy products are relatively new, said Erica Sward, assistant vice president for national advocacy at the American Lung Association. This worried him.

She said the gummies had been on the market for about six to nine months before the FDA’s warning letter, suggesting there may be more nicotine gummies available for children in the future.

“The FDA isn’t regulating these products as quickly as it should,” Sward said. She was encouraged by the warning letter, but said it was not enough. “I think this will continue to be an issue until the FDA shows it’s serious about cracking down on the companies that are launching these products.”

It’s especially concerning, she added, that companies know they can’t launch products without FDA premarket approval, but do so anyway.

“It’s really very disturbing from the perspective of a parent or anyone who thinks if the product goes on sale, someone will look at it, and we know that’s not the case,” Sward said.

The FDA has only been allowed to regulate synthetic nicotine since Congress gave the agency authorization for non-tobacco nicotine products earlier this year.

In a statement to CNN, the agency said it is “firmly committed to addressing the ongoing public health concern about youth tobacco use” and that it “will continue to take appropriate enforcement actions supported by evidence.”

“Manufacturers of illegal products, including nicotine gum, should be aware that the FDA is actively working to identify violations and will require corrective action in a timely manner. It is important to note that the FDA has not approved any nicotine gum products and therefore currently sells All products are illegal,” the agency said this week.

For years, the FDA has cracked down on companies trying to sell certain types of nicotine products food for kids. In 2020, it restricts the flavors of vaping devices that are available in options like Charms cerealsCherry Lime Cola and Unicorn cake with heavy cream.

In 2019, FDA reprimanded e-cigarettes Giant Juul How she marketed her product, including a school presentation, the company said it was “completely safe” and that “the FDA would approve it at any time.” In June, he ordered the company to stop selling its products. But the court blocked the injunction, so the product is still on sale.

Several state attorneys general announced that after a two-year investigation found Juul knowingly marketed its products to children this week The company will pay $438.5 million in settlements to 34 states and territories.

Centers for Disease Control and Prevention E-cigarette use by children is still considered a serious public health problem.

During the pandemic, teen vaping has declined for the first time in years. But according to Matt Meyers, president of the Campaign for Tobacco-Free Kids, data from the CDC Foundation shows that sales of e-cigarettes skyrocketed when kids started going back to school.

Some 2.55 million students reported using some form of tobacco products in 2021 CDC investigation.

Disposable flavored e-cigarettes that use synthetic nicotine are particularly popular with children. The products come in flavors such as sugar cookies, mango, pound cake and sparkling lemonade.

Companies that make products containing synthetic nicotine argue that they do not need to follow the rules that apply to other nicotine products because their products do not contain tobacco. A 2009 law finally allowed the FDA to regulate nicotine products, but it regulated nicotine in tobacco.

In April, A new law clarifies that the FDA can regulate products that use synthetic nicotine. But many products are still on sale as the agency reviews manufacturers’ requests to stay on the market. The FDA has passed a court-imposed deadline to make a decision on the product.

Manufacturers must submit marketing applications to the FDA by May, and if products are not licensed by July, those products will be deemed illegal and withdrawn from the market.

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

Anti-tobacco experts say that while the FDA action on nicotine gummies is a good thing, the agency should do more.

“The nicotine gum proof—or just a reminder to us—is that the FDA hasn’t drawn a hard line in the sand. Our children are at greater risk of exposure to addictive nicotine products than they have been in a long time,” Myers said . “FDA enforcement is so sporadic that we will continue to see new kid-friendly nicotine products launched when companies think they can make a profit.”

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