FDA warns manufacturers of illegal flavored nicotine gummies
Time： 2022-08-22
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The company has not filed a premarket tobacco product application with the FDA, nor a marketing authorization order to manufacture, sell or distribute these products in the United States.
The FDA issued a warning letter on August 18 to VPR Brands, which does business as Krave Nic, for marketing illegal flavored nicotine gummies, the first warning letter of its kind.
According to the FDA, these types of gummies are of particular concern to the public because they are similar to kid-friendly food or candy products and can cause severe nicotine poisoning and even death in young children.
VPR Brands sells each 1mg nicotine gummy in three flavors - Blueraz, Cherry Bomb and Pineapple. The packaging claims that these products contain tobacco-free nicotine. The company has not filed a premarket tobacco product application with the FDA, nor a marketing authorization order to manufacture, sell or distribute these products in the United States.
The FDA called them a public health crisis waiting to happen and warned the manufacturer to pull its nicotine gummies from the market. The incident was notable because few people knew about the product's existence before the FDA's high-profile announcement, which included press releases, Twitter posts, and attaboy social media posts from tobacco control groups such as the Truth Initiative.
Gregory Conley of the American Vapor Manufacturers Association tweeted: The FDA has taken down a product that is often used in the United States. Fits the long and storied history of tobacco control of being distracted by bright, shiny new objects while cigarettes continue to be sold.
The FDA received authorization for synthetic nicotine earlier this year, and since July 14 it has been technically illegal to sell any synthetic nicotine product without authorization.
The warning letter was accompanied by a comprehensive press release from the FDA's Center for Tobacco Products, which included quotes from FDA Commissioner Robert Califf and Center for Tobacco Products (CTP) Director Brian King, suggesting that nicotine candies could be a serious public health threat.
"We remain steadfast in our use of compliance and enforcement resources to curb all illicit marketing of tobacco products, especially those that young people can easily confuse with things they regularly consume, such as candy," King said.
According to the FDA, Krave's nicotine gummies, which contain 1 mg of nicotine in boxes of 12, pose a significant risk to children.
"Studies have shown that, depending on the child's weight, nicotine intake of 1 to 4 mg may be severely toxic to children under 6 years of age," the official announcement said. "However, nicotine intoxication in young adults of any age can lead to nausea, vomiting, abdominal pain, increased blood pressure and heart rate, seizures, respiratory failure, coma and even death."
FDA-approved nicotine gums and lozenges, made by pharmaceutical companies and sold over the counter, contain more nicotine than Krave's gums. They also come in tantalizing flavors, are sold in larger packs, can be swallowed whole, and are available in tens of thousands of stores across the country.
"Nicotine gummies are a public health crisis waiting to unfold among our nation's youth, especially as we enter a new school year," FDA Commissioner Robert M. Califf said in a statement. Say. “We want parents to understand these products and the potential health consequences for children of all ages — including toxicity to young children and the appeal of these addictive products to our young people. The FDA will not stand idly by as illegal products seep into the market.”
The rhetoric is typical of an overkill institution that has lost all purpose and proportion and now swings wildly in the shadows. As explained in a recent article, the FDA, when faced with external pressure, tends to attack trivial threats with ludicrous ferocity.
"Today's action should serve as a wake-up call for manufacturers of these illegal products, and the FDA is actively working to identify violations and quickly seek corrective action," said CTP Director King King.
The warning letter gave Krave Nic 15 business days to respond "describe the actions you have taken to address any violations and bring your product into compliance."
According to Krave's website, it's not that hard, since these products have been discontinued.
It's unclear whether the gummies were phased out in response to the FDA letter or a lack of retail interest.
The following is the full text of the FDA's official announcement:
Today, the U.S. Food and Drug Administration issued a warning letter for the sale of illegal flavored nicotine gummies, the first warning letter for such a product. These types of gummies are of particular public concern because they are similar to kid-friendly food or confectionary products and can cause severe nicotine poisoning and even death in young children.
Manufacturer VPR Brands LP (operating under the name "Krave Nic") sells gummies containing 1 milligram (mg) of nicotine each and comes in three flavors - Blueraz, Cherry Bomb and Pineapple. The packaging claims that these products contain tobacco-free nicotine. The company has not filed a Premarket Tobacco Product Application (PMTA) with the FDA, nor has a Marketing Authorization Order to manufacture, sell, or distribute these products in the U.S.
"Nicotine gummies are an impending public health crisis among our nation's youth, especially as we enter a new school year," said FDA Commissioner Robert M. Califf, MD. "We want parents to know about these products. and the potential health consequences for children of all ages — including toxicity to young children and the appeal of these addictive products to our youth. FDA will not stand idly by as illegal products seep into the marketplace.”
The manufacturer states that each gummy contains 1 mg of nicotine, and each can of 12 gummies (12 mg). Studies have shown that ingesting 1 to 4 mg of nicotine may be severely toxic to children under 6 years of age, depending on the child's weight. However, nicotine toxicity in young adults of any age can lead to nausea, vomiting, abdominal pain, increased blood pressure and heart rate, seizures, respiratory failure, coma and even death. Nicotine is also highly addictive, and exposure to nicotine during adolescence can harm the developing brain.
In a recent study published in the Journal of Pediatrics External Links Disclaimer, researchers found that flavored non-tobacco oral nicotine products, including gummies and lozenges, were among the most commonly used tobacco products among young people in Southern California— second only to e-cigarettes. Use is particularly high among certain racial or ethnic, sexual or gender minorities, and people with a history of nicotine use. These flavored non-tobacco oral nicotine products pose an increased risk to adolescents because they are similar to child-friendly food or confectionary products (such as chewing gum or gum), have flavors that appeal to young adults, and adolescents are able to conceal their use from adults.
The warning letter issued today requires the manufacturer to provide a written response explaining how the company intends to address any violations and make its products compliant with the Federal Food, Drug and Cosmetic Act (FD&C Act). Failure to correct violations in a timely manner may result in further action such as civil fines, seizures and/or injunctions. In addition, companies may not sell or distribute offending products. Before selling or distributing products in the U.S., companies must submit a PMTA and obtain marketing authorization from the FDA
In response to the increase in non-tobacco nicotine content in tobacco products, including in some of the most popular e-cigarette brands among young people, Congress passed a federal law, effective April 14, 2022, that clarifies the FDA's response to regulation Tobacco products containing nicotine from any source. The law gives the FDA authority over products made with non-tobacco nicotine, including synthetic nicotine, and imposes requirements on manufacturers, importers, retailers, and distributors of non-tobacco nicotine products under the FD&C Act. To date, no marketing authorization orders have been received for non-tobacco nicotine products.
"We remain steadfast in our use of compliance and enforcement resources to curb all illicit marketing of tobacco products, especially those that young people can easily confuse with things they regularly consume, such as candy." MPH, Brian King, Ph.D., director of the FDA's Center for Tobacco Products, said. "Today's action should serve as a wake-up call for manufacturers of these illegal products, and the FDA is actively working to identify violations and quickly seek corrective action."
Efforts such as these support the FDA's commitment to using a science-based approach to protect teens from starting tobacco use. In addition to FDA's regulatory oversight, the agency recognizes the urgent need for targeted youth tobacco prevention efforts aimed at protecting America's children, including mass media campaigns. FDA also collaborates with the Centers for Disease Control and Prevention on the National Youth Tobacco Survey, the only national survey of middle school students dedicated to tobacco product use.
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