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Source: FDA, 7/13/22
Recently, a growing number of
companies–including manufacturers of some of the e-cigarette brands most
popular with kids–began using synthetic nicotine to make their products in an
attempt to evade the U.S. Food and Drug Administration’s regulation. An
important new federal law went into effect in April clarifying FDA’s authority to regulate tobacco products containing nicotine from any source, including synthetic nicotine, and the agency continues to implement the law.Today, FDA issued its first two
warning letters to manufacturers for unlawfully marketing non-tobacco nicotine
e-liquid products without the required authorization. Collectively, these two
companies, AZ Swagg Sauce LLC and Electric Smoke Vapor House, have
listed a combined total of approximately 10,000 products with FDA. Neither
company submitted a premarket application for its non-tobacco nicotine products
by the May 14, 2022 deadline as required by the new law. In addition, FDA announced today
that it has issued 107 warning letters to retailers in the last
two weeks for illegally selling non-tobacco nicotine products, including
certain e-cigarette or e-liquid products, to underage purchasers. The law makes
it clear that tobacco products, including non-tobacco derived nicotine
products, cannot be sold legally to customers under age 21 following passage of
the new law. “FDA has been fully committed to actively implementing this critical new law regulating non-tobacco nicotine products since its passage, and the warning letters announced today are just the beginning of our compliance and enforcement actions” said Brian King, Ph.D., M.P.H., director of the FDA’s Center for Tobacco Products. “In the coming weeks, we will continue to investigate companies that may be marketing, selling, or distributing non-tobacco nicotine products illegally and will pursue action, as appropriate.” After today, July 13, 2022, any new non-tobacco nicotine product
that has not received premarket authorization from FDA cannot be legally
marketed. FDA is currently processing applications for approximately one
million non-tobacco nicotine products submitted by more than 200 manufacturers
by the May 14, 2022, deadline. FDA is preparing to issue refuse-to-accept (RTA)
letters soon for those applications that do not meet the criteria for
acceptance. FDA is engaged in the necessary work to pursue enforcement
action as swiftly as possible. When companies are found to be illegally
marketing non-tobacco nicotine products, the agency will typically first issue
warning letters to achieve voluntary compliance and will pursue enforcement actions,
as needed, including civil money penalties, no-tobacco sale orders, seizure, or
injunction. In addition, any unauthorized non-tobacco nicotine products
detected for import into the United States can be detained or refused
admission. “FDA is working diligently to process the substantial number of applications submitted and, as always, will make marketing decisions based on the best available science and will pursue compliance and enforcement actions when warranted,” said Dr. King. “We remain fully committed to taking whatever steps are necessary to protect the public health and to provide timely updates on our ongoing progress regulating non-tobacco nicotine products.” These efforts align with FDA's commitment to protecting youth from initiating tobacco use, including e-cigarettes. In addition to FDA’s regulatory oversight of all e-cigarettes and electronic nicotine delivery systems (ENDS), including the review of applications of millions of products, the agency has made a significant investment in a multimedia e-cigarette public education campaign aimed
at the nearly 10.7 million youth age 12-17 who have ever used e-cigarettes or
are open to trying them highlighting information about the potential risks of
e-cigarette use. Read More
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