Congress aims to give the FDA new powers over synthetic nicotine products, including a young favorite – Puff Bar e-cigarettes.

Congress aims to give the FDA new powers over synthetic nicotine products, including a young favorite – Puff Bar e-cigarettes.

The FDA already has jurisdiction over nicotine derived from tobacco plants. The new legislation would give the agency clear jurisdiction over nicotine produced in laboratories. In recent years, when the agency cracked down on e-cigarette manufacturers to stop juvenile consumption, some companies, including the popular Puff Bar brand, switched to synthetic nicotine to avoid regulation.

In 2020, sales of flavored disposable e-cigarettes at the Puff Bar increased after the FDA temporarily banned sweet and fruity e-cigarettes containing refilled cartridges. No restrictions applied to Puff Bar items as they cannot be refilled. Anti-tobacco advocates rejected what they called a “Puff Bar escape” after teens marched on the brand. In July 2020, the FDA ordered that the company’s products be cut off the market because they did not have the necessary authorization. According to the agency’s regulations, tobacco products imported after August 2016 must obtain FDA approval before being sold.

But last year, the puff bar resurfaced using a new synthetic nicotine formula that made it seem out of reach for the FDA regulators. Several other companies have taken similar measures and others are considering it, including those whose marketing applications for tobacco products have been turned down by the FDA.

Matthew L. Myers, campaign leader for tobacco-free children. “Some companies have announced they are using synthetic nicotine for this purpose.

Health groups say nicotine, which is addictive despite coming from nature, prevents young people from vaping and can lead to smoking if made in a laboratory. Vaping advocacy groups argue that e-cigarettes can help adults quit smoking dangerously.

The 2021 survey by the FDA and the Centers for Disease Control and Prevention showed that the Puff Bar, disposable vaporizers available in a variety of flavors such as Banana Ice and Blue Razz, was the most popular choice with 26.8% among high school and high school students who define themselves as current users of e-cigarettes. . Puff Stick. It was their “usual brand”. Juul, which has limited sales of vipers, ranked fourth with 6.8%.

The survey also showed juvenile evaporation declined last year, the second largest in a row.

According to the legislation in question, manufacturers of synthetic nicotine products will have to apply for approval from the FDA within 60 days of the law’s entry into force. Any product not authorized by the body within 120 days of entry into force will become illegal.

Industry officials say they suspect synthetic nicotine companies are asking the FDA for permission to sell their products. Some admitted they were trying to avoid FDA regulation. And they wondered if the companies would have the scientific data needed to meet the FDA’s standard for marketing authorization, if the product would be “related to public health.”

Frank Pallone Jr., chairman of the Congressional Energy and Commerce Committee. (DN.J.), said in a statement that “some malicious individuals have tried to circumvent FDA regulations by using synthetic nicotine in their products. It concludes with the adoption of this bill, which fills this gap and clarifies the FDA’s authority to regulate all tobacco products, including synthetic nicotine.

Erica Sward, vice president of national advocacy for the American Lung Association, said closing the Puff Bar loophole would hopefully end a float that has hampered FDA efforts to regulate e-cigarettes.

Vaping advocates have been harshly critical of the move by Congress.

“Like nearly all of our industry, we believe synthetic nicotine is a positive innovation that increases consumer choice and provides a crucial path for smokers to switch to steam,” said Amanda Wheeler, president of American Vapor Manufacturers based. in St. Louis. Prescott represents Ariz and the companies that manufacture steam appliances and electronic fluids.

Gregory Conley, president of the American Vaping Association, a nonprofit advocacy group, said the change has damaged the efforts of thousands of small VIP shops offering synthetic nicotine electronic fluids to their customers. The result, he said, will be increased smoking.

Pap Bar did not immediately respond to an email requesting comment. The company’s website, in addition to advertising its products, states that “this product contains nicotine without tobacco. Nicotine is a narcotic substance.

For more than a year, the FDA has faced the lengthy task of deciding which vaping products can remain on the market. (Items shipped before August 2016 had until September 2020 to receive FDA approval.) The agency ordered sales of many products to be suspended, but did not respond to requests from some major players, including Juul. And there were some companies Refusal to allow marketing is sued by the agency.

In recent months, the Subcommittee on Economic and Consumer Policy and the North Carolina Attorney General have launched an investigation into Puff Bar and other companies using synthetic nicotine, saying companies are undermining FDA efforts to end vaping among teenagers.

Rachel Rubin contributed to this report.

Source: Washington Post