Lucy Goods has submitted premarket tobacco product applications (PMTAs) to the U.S. FDA seeking marketing authorization of 42 of its modern oral nicotine products.

Boxes of Lucy Chew nicotine gum
Lucy’s recent filings represent the second round of FDA applications from the company. In 2020, Lucy submitted PMTAs for its modern oral nicotine products containing tobacco-derived nicotine, which are currently under review by the FDA. Even before the FDA was granted regulatory authority over non-tobacco nicotine products, the company had been engaged in serious efforts to prepare PMTAs for its suite of non-tobacco nicotine products.

“Lucy’s commitment to working with the FDA is essential to its goal of delivering innovative nicotine products for switching adult smokers,” said Willie McKinney, CEO of McKinney Regulatory Science Advisors and a regulatory advisor to Lucy, in a statement. “These PMTAs for Lucy’s NTN [nontobacco nicotine] modern oral products demonstrate the company’s ability to drive such innovation responsibly.”

“Submitting PMTAs for our non-tobacco nicotine products is a key milestone for us as we continue to create the highest quality and most innovative products in the industry,” stated David RenteIn, CEO of Lucy. “We are proud of the evidence we have provided to the FDA in these PMTAs, and we look forward to working with the agency as the process moves forward.”

Innovation for Next-Gen Nicotine Products

Lucy is a developer, marketer and distributor of next-generation nicotine products, including its innovative line of capsule pouches, that offer adult tobacco consumers alternatives to conventional tobacco.

One of the key product innovations described in Lucy’s recently submitted PMTAs is its use of non-tobacco nicotine.

The non-tobacco nicotine in Lucy products is manufactured using principles of green chemistry but is otherwise chemically identical to tobacco-derived nicotine in other modern oral products on the market, according to Lucy Goods. The low-waste manufacturing process does not require arable land or pesticides used in the cultivation of tobacco for tobacco-derived nicotine.

Customized Product Testing Plan and PMTA Application Assistance

McKinney RSA worked closely with Lucy on this project to deliver a customized product testing plan and application filing strategy that balanced risk and cost.

Learn more about how we work with clients on testing plans and PMTA application strategy.