Democrats and anti-tobacco advocates are criticizing the FDA for not doing enough to regulate synthetic vaping companies and synthetic nicotine products. They say that the FDA’s failure to fully enforce the law and clear all unauthorized products from the market is putting America’s kids at risk.
In March, the house of congress passed a law giving FDA the power to regulate synthetic nicotine. Under the new regulation, companies that produce synthetic nicotine products must get FDA approval before marketing their products by 14th March. They also set 13th July as the deadline for companies to remove any unauthorized products from the market.
However, on the deadline day, several companies, such as AZ Swagg Sauce LLC and Electric Smoke Vapor House LLC, were still selling products without FDA approval, and consequently, FDA issued a warning to those companies.
Currently, FDA is processing applications for over 1 million products from over 200 manufacturers. Also, the regulatory institution is yet to the famous disposable vape Puff Bar. In its report, the FDA issued 107 warning letters to retailers in the past 14 days for illegally shelving nontobacco nicotine products such as e-cigarettes and vape juices to children.
In his statement, Brian King, director of the FDA’s Center for Tobacco Products, said the FDA remains deeply concerned about the proliferation of e-cigarette products that have not undergone FDA review and are illegally on the market. The FDA will take action against any company that unlawfully marketed its products in violation of the law.
However, even with the “Success” statements from the FDA, Myers was quick to point out that FDA’s inability to meet the set deadline for removing all unauthorized products from the market only goes on to put more American kids at risk.
The FDA’s actions come as no surprise to some lawmakers. In fact, Senators Dick Durbin (D-Ill.) and Susan Collins (R-Maine) had previously expressed their concerns that FDA might not be able to meet the deadline. They had even called on FDA Commissioner Robert Califf to immediately remove all unapproved products from the market.
Durbin and Collins were two of the key senators who strongly supported giving the FDA power to regulate synthetic nicotine and synthetic vaping companies. According to them, the FDA’s inaction on the issue puts Americans, especially children, at risk. They also noted that vape manufacturers with denied applications tried maneuvering the FDA’s approval process by switching to synthetic nicotine.
In his statement, Durbin expressed concerns that FDA was not doing enough to regulate e-cigarette manufacturers “The FDA is supposed to protect all Americans and particularly our children. I’m calling on FDA to finally come to its senses. Err on the side of public safety, on the side of kids, not tobacco companies. This free fall in the legal department at the FDA is unimaginable. It’s not safe for America. And it’s not safe for our future.”
And while the FDA tries to leave to the expectations, The American Vapor Manufacturers group stated that the FDA deadline was “Impossible to meet.” Amanda Wheeler, the group’s president, said, “It should not be surprising that some companies could not submit the robust data and evidentiary requirements in time. This latest crackdown shows that the FDA would rather pander to politicians who believe they know better than the millions of Americans who will now be forced back to cigarettes as more and more vaping products are banned.”
