• by Steve Ellwanger , August 23, 2022

The U.S. Food and Drug Administration has issued its first-ever warning letter for the marketing of flavored gummies infused with nicotine.

The FDA issued the warning last week to Florida-based VPR Brands LLC—which does business as Krave Nic and whose BlueRazz, Cherry Bomb and Pineapple gummies each contain one milligram of nicotine.

“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 Dr. Robert Califf said in a statement.

Flavored, nicotine-infused gummies are of particular public concern “because of their resemblance to kid-friendly food or candy products and the potential to cause severe nicotine toxicity or even death among young children,” the FDA warning letter states.

The agency said that VPR Brands has not submitted a premarket tobacco product application and, in the absence of filing one and gaining approval, “does not have a marketing authorization order to manufacture, sell or distribute these products” in the United States.

The FDA noted that nicotine “is also highly addictive and exposure during adolescence can harm the developing brain.”

VPR Brands “must not sell or distribute violative products.”

As of this morning, a notice on the company’s website stated “Product Discontinued,” and no gummies were displayed.

According to Mary Hrywna, assistant professor at the Rutgers Biomedical Health Sciences Center for Tobacco Studies, nicotine gummies are a rapidly evolving segment of the oral nicotine market.

“These products are relatively low in nicotine and use among adolescents is still quite rare,” Hrywna tells Marketing Daily.

“That said, FDA has a responsibility to ensure compliance with the law—including requiring deemed products to obtain the necessary premarket authorization to market their products.

“And as with all tobacco or nicotine products, manufacturers and retailers should be doing everything they can to restrict minors’ access to these products.”

VPR Brands could not be reached for comment.