Pointers at Glance
- The US FDA warns a maker of nicotine gummies to stop marketing an illegal product.
- The agency mentioned that these gummies cause severe nicotine toxicity or death if young children eat them.
The US Food and Drug Administration (FDA) warned a maker of nicotine gummies to stop marketing an illegal product.
The agency considers these gummies especially concerning since they resemble candy and can cause severe nicotine toxicity or death if young children eat them.
FDA Commissioner Dr. Robert Califf said in an agency news release, on the warning that, Nicotine gummies are a public health crisis just waiting to happen among their nation’s youth, specifically as they head into a new school year. They 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 the appeal of these addictive products to their youth.
VPR Brands LP (kravenic.com) made the gummies and had 1 milligram (mg) of nicotine in each gummy. They have been sold in three flavors, i.e., Blueraz, Cherry Bomb and Pineapple. The packaging mentions that the products contain tobacco-free nicotine. Still, the company does not have a marketing authorization order to distribute or sell such a product in the United States, the FDA said. The website of the company said the gummies had been discontinued.
The FDA, in its warning letter, tells the company that it must tell the agency how it plans to address any violations and bring products into compliance with the Federal Food, Drug, and Cosmetic Act. The agency said that the company could face seizure, fines, or injunction if it does correct violations within 15 days.
The FDA offers regulatory oversight of tobacco products and mass media tobacco prevention campaigns targeted at kids and partners with the US Centers for Disease Control and Prevention on the National Youth Tobacco Survey.
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