Krave Nic Gummies Pose Risk of Nicotine Toxicity, Death For Children Due to Candy-Like Appearance: FDA

The FDA claims the manufacturer never applied for FDA approval for the gummies, which look like candy and could be a nicotine toxicity risk for children.

Federal regulators have issued a warning to the makers of “Krave Nic” nicotine gummies, indicating that the products pose a serious public health concern for children, since they resemble sweet food or candy products, and could cause severe nicotine toxicity or death.

VPR Brands received a warning letter about Krave Nic gummies issued by the U.S. Food and Drug Administration (FDA) on August 18, indicating that the product is not approved for sale, manufacture or distribution in the United States, since the company did not submit a Premarket Tobacco Product Application (PMTA) per new FDA guidelines.

The candy-like gummies contain 1 mg of nicotine, and have been marketed as a tobacco-free alternative to smoking or vaping. However, research has established that ingesting even 1 to 4 milligrams of nicotine can be severely toxic to children under 6 years old, and can lead to vomiting, abdominal pain, seizures, respiratory failure, coma and death.

“Nicotine gummies are a public health crisis just waiting to happen among our nation’s youth, particularly as we head into a new school year,” FDA Commissioner Robert Califf said in a separate press release issued this week. “We want parents to be aware of these products and the potential for health consequences for children of all ages – including toxicity to young children and appeal of these addictive products to our youth. The FDA will not stand by as illegal products infiltrate the marketplace.”

The gummies are sold in Blueraz, Cherry Bomb, and Pineapple flavors, which the FDA fears are particularly attractive to young children, teens and others without a pre-existing nicotine addiction. The FDA also warns that young children are likely to mistake the Krave Nic gummies for candy, posing a risk of nicotine overdose or toxicity.

In the warning letter, the FDA calls on VPR Brands to submit a PMTA and receive market authorization before selling the product in the US. Failure to do so and respond to the warning letter with intended corrective steps can result in further action, including civil money penalties, seizure, and injunction.

Teen Nicotine Addiction Epidemic

The warning comes amid increased efforts by the FDA in recent years to combat the growing number of nicotine products marketed toward teens and young adults, such as JUUL and other vape pens, which have caused a new generation of Americans addicted to nicotine.

JUUL in particular marketed their products aggressively through social media influencers, and designed their vape pens to resemble USB drives, to help children hide their vaping addiction. The company now faces a growing number of JUUL addiction lawsuits brought by parents and young adults, indicating that they were not adequately warned about high levels of nicotine in the products and the risk of addiction.

Research has found that JUUL vape pens are as addictive as smoking Marlboro cigarettes. More so, teens are especially vulnerable to nicotine addiction due to the design and marketing of JUUL ad campaigns.

Numerous lawsuits have been filed against JUUL, alleging the brand sparked the teen vaping epidemic and hooked youth on vape products, leading to a new generation of nicotine addiction.