Lucy Goods has filed a Premarket Tobacco Product Application (PMTA) with the U.S. Food and Drug Administration seeking marketing approval for 42 of its modern oral nicotine products, including its innovative line of capsule bags.
Lucy is a developer, marketer and distributor of next-generation nicotine products that provide adult tobacco consumers with alternatives to traditional tobacco. One of the key product innovations described in Lucy's recently submitted PMTA is the use of non-tobacco nicotine.
According to Lucy Goods, the non-tobacco nicotine in Lucy's product is made using green chemistry, but chemically identical to tobacco-derived nicotine in other modern oral products on the market. The low-waste manufacturing process does not require arable land or pesticides used for tobacco cultivation to obtain tobacco-derived nicotine.
Lucy's most recent filing represents the company's second round of FDA filings. In 2020, Lucy submitted PMTA for its modern oral nicotine product containing tobacco-derived nicotine, which is currently under FDA review. Even before the FDA gained regulatory authority over non-tobacco nicotine products, the company had been working in earnest to prepare PMTA for its suite of non-tobacco nicotine products.
Willie McKinney
"Lucy's commitment to working with the FDA is critical to its goal of providing innovative nicotine products to transform adult smokers," Willie McKinney, CEO of McKinney Regulatory Scientific Advisors and Lucy regulatory advisor, said in a statement. "These PMTAS for Lucy's NTN [non-tobacco nicotine] modern oral product demonstrate the company's ability to responsibly drive such innovations."
"The submission of PMTA for our non-tobacco nicotine product is an important milestone for us as we continue to create the highest quality and most innovative products in the industry," said David Renteln, CEO of Lucy. "We are proud of the evidence we provided to the FDA in these PMTAS, and we look forward to working with the FDA as the process moves forward."
Lucy is an independently owned and operated nicotine replacement company whose mission is to reduce tobacco-related harm to zero.