FDA Deals Death Blow to the Nicotine Gummy Market

Calling them a “public health crisis waiting to happen,” the FDA has warned a Florida manufacturer to remove its nicotine gummies from the market. The event is notable because few people were aware the product existed before the FDA’s splashy announcement, which included a press release, Twitter thread, and attaboy social media posts from tobacco control groups like Truth Initiative.

“The FDA has taken down a product that 23 people in the U.S. use regularly,” tweeted Gregory Conley of the American Vapor Manufacturers Association. “Fits into tobacco control's long and storied history of being distracted by bright and shiny new objects, all while cigarettes continue to be sold.”

The manufacturer of the gummies, Florida-based Krave Nic (owned by VPR Brands), was cited by the FDA for selling the synthetic nicotine-containing candy without submitting a premarket tobacco application (PMTA) or receiving marketing authorization from the agency. The FDA gained authority over synthetic nicotine earlier this year, and since July 14 it has technically been illegal to sell any synthetic nicotine product without authorization.

The warning letter was accompanied by a full-blown press release from the FDA Center for Tobacco Products, including quotes from FDA Commissioner Robert Califf and Center for Tobacco Products (CTP) Director Brian King suggesting nicotine candy could be a serious public health threat.

“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 King.

According to the FDA, Krave’s nicotine gummies—which contain one milligram of nicotine each, and come in a box of 12—pose a major risk to children. “Research indicates that ingesting 1 to 4 milligrams of nicotine could be severely toxic to a child under 6 years of age depending on the child’s body weight,” says the press release. “However, 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.”

FDA-approved nicotine gum and lozenges, made by pharmaceutical companies and sold over the counter, contain more nicotine than Krave’s gummies. They also come in attractive flavors, are sold in larger quantities per package, can be swallowed whole, and are available in tens of thousands of stores across the country.

“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 Califf. “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 rhetoric was typical overkill from an agency that has lost all sense of purpose and proportion, and is now swinging wildly at shadows. As we explained in a recent article, the FDA, when faced with outside pressure, tends to attack insignificant threats with comical ferocity.

“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,” said CTP Director King.

The warning letter gives Krave Nic 15 working days to respond, “describing your actions to address any violations and bring your products into compliance.” That won’t be difficult, since the products have already been discontinued, according to Krave’s website.

It isn't clear whether the gummies were eliminated in response to the FDA letter or lack of retail interest.