Lucy Goods has submitted Premarket Tobacco Product Applications (PMTAs) to the U.S. Food and Drug Administration (FDA) for its modern oral nicotine products, including its line of capsule pouches. In a May 23, 2022 press release, Lucy announced that it had submitted PMTAs for 42 of its products and each application highlights key evidence that demonstrates how the continued marketing of Lucy products will benefit public health. Lucy’s submission of these PMTAs will allow for the company’s products to remain on the market after the FDA’s May 14, 2022 deadline. PMTAs were required after the FDA was granted regulatory authority over non-tobacco nicotine (NTN) products earlier this year [read more here].
David Renteln, CEO of Lucy, commented: “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. 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.”
Lucy is independently owned and operated and was formed with the mission of reducing tobacco-related harm to zero. The company does not sell any combustible or inhaled products and its portfolio includes proprietary formulations of nicotine gums and pouches. Lucy specializes in next generation nicotine products that offer adult tobacco consumers alternatives to conventional tobacco. Lucy uses non-tobacco nicotine in its products which is manufactured using principles of green chemistry but is said to be chemically identical to tobacco-derived nicotine in other modern oral products on the market.
“Lucy’s recent filings represent the second round of FDA applications from the company and demonstrates our continued commitment to FDA compliance and public health,” the company wrote in a press release. “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 NTN products, the company had been engaged in serious efforts to prepare PMTAs for its suite of NTN products.”