FDA Issues Warning to Nicotine Gummy Maker

The letter to Krave Nic marks the first time the agency has put a company on notice for this type of product.

August 19, 2022

ALEXANDRIA, Va.—The U.S. Food and Drug Administration (FDA) issued a warning letter to VPR Brands LP dba Krave Nic for marketing illegal flavored nicotine gummies. This is the first time the FDA has sent a warning letter for this type of product.

Krave Nic markets gummies that have 1 milligram of nicotine each and are available in three flavors—Blueraz, Cherry Bomb and Pineapple.

The FDA said the firm has not submitted a premarket tobacco product application (PMTA) to the agency and does not have a marketing authorization order to manufacture, sell or distribute these products in the U.S.

“These types of 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 stated.

The FDA cited a recent study published in the journal Pediatrics in which researchers found that flavored nontobacco oral nicotine products, including gummies and lozenges, were among the most commonly used tobacco product among youth in southern California—second only to e-cigarettes. Use was particularly high among certain racial or ethnic, sexual or gender minority groups, and those with a history of nicotine use.

The warning letter issued requests a written response from the manufacturer describing how the firm intends to address any violations and bring its products into compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act). Failure to promptly correct violations can result in further action such as civil money penalties, seizure and/or injunction. Additionally, the firm must not sell or distribute violative products and must submit a PMTA and receive marketing authorization from FDA before selling or distributing the product in the U.S.

In response to the increase of non-tobacco nicotine in tobacco products, including in some of the e-cigarette brands that are most popular with youth, Congress passed a federal law that went into effect on April 14, 2022, clarifying the FDA’s authority to regulate tobacco products containing nicotine from any source. This law gives the FDA authority over products made with non-tobacco nicotine, including synthetic nicotine, and imposes requirements under the FD&C Act for manufacturers, importers, retailers and distributors of non-tobacco nicotine products. To date, no non-tobacco nicotine product has received a marketing granted order.