INDIANAPOLIS — As children return to school, the U.S. Food and Drug Administration is trying to stop what they are calling a public health crisis just waiting to happen.

On Thursday, the FDA issued a warning letter to VPR Brands LP for marketing illegal flavored nicotine gummies. This is the first warning letter for this type of product.

The company, doing business as Krave Nic, markets gummies that have one milligram of nicotine each. They are available in three flavors; blueraz, cherry Bomb, and pineapple.

The FDA says 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.

“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,” said FDA Commissioner Robert M. Califf, M.D. “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 FDA said the product’s packaging claims that the product contains tobacco-free nicotine. However, the firm has not submitted a premarket tobacco product application (PMTA) to the FDA, and does not have a marketing authorization order to manufacture, sell or distribute these products in the U.S.

The manufacturer states that each gummy contains twelve gummies per tin, with one milligram of nicotine per gummy. The FDA says research indicates that ingesting one to four milligrams of nicotine could be severely toxic to a child under 6 years of age, depending on the child’s body weight.

Nicotine toxicity among youth of any age may lead to nausea, vomiting, abdominal pain, increased blood pressure and heart rate, seizures, respiratory failure, coma and even death. The FDA says nicotine is also highly addictive and exposure during adolescence can harm the developing brain.

The FDA is also concerned because of the popularity of these types of products. A recent study published in the journal Pediatrics found that flavored non-tobacco oral nicotine products, including gummies and lozenges, were among the most commonly-used tobacco product in southern California among youth. They were second only to e-cigarettes.

Lawmakers have noticed the increased popularity of youth, and have been actively working to address the situation. This includes passing a federal law clarifying the FDA’s authority to regulate tobacco products containing nicotine from any source.

“We remain unwavering in our use of compliance and enforcement resources to curb all unlawful marketing of tobacco products, especially those that youth could easily confuse with something that they consume regularly – like candy,” said Brian King, Ph.D., M.P.H., director of the FDA’s Center for Tobacco Products. “Today’s action should be a wake-up call for manufacturers of these illegal products that the FDA is actively working to identify violations and to swiftly seek corrective actions.”

Under the warning letter, VPR Brands LP has 15 days to submit a written response describing their actions to address any violations and bring their products into compliance.