Lucy Goods Submits Premarket Tobacco Product Applications for 42 Innovative Nicotine Products

LAS VEGAS, May 23, 2022 /PRNewswire/ -- Lucy Goods, Inc ("LUCY" or the "Company") is excited to announce its submission of Premarket Tobacco Product Applications ("PMTAs") to the U.S. Food and Drug Administration ("FDA") seeking marketing authorization of 42 of its modern oral nicotine products, including its innovative line of capsule pouches. LUCY's applications highlight key evidence demonstrating that the continued marketing of LUCY products is appropriate for the protection of the public health, and LUCY's timely submission of these PMTAs allows these products to remain on the market after the FDA's May 14, 2022 deadline for PMTAs of newly deemed tobacco products containing non-tobacco nicotine ("NTN").

LUCY is a developer, marketer, and distributor of next generation nicotine products 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 NTN.

The NTN 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. The low-waste manufacturing process does not require arable land or pesticides used in the cultivation of tobacco for tobacco-derived nicotine. According to the WHO, "tobacco growing and curing are both direct causes of deforestation, since forests are cleared for the tobacco plantations, and wood is burned to cure the tobacco leaves."¹ Deforestation is one of the largest contributors to global climate change and loss of biodiversity.

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. 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.

"LUCY's commitment to working with the FDA is essential to its goal of delivering innovative nicotine products for switching adult smokers," noted Dr. Willie Mckinney, CEO of McKinney Regulatory Science Advisors, LLC and a regulatory advisor to LUCY. "These PMTAs for LUCY's NTN 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 Renteln, the 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."

LUCY is an independently owned and operated nicotine alternative company formed with the mission of reducing tobacco-related harm to zero. The company does not sell any combustible or inhaled products, and its products include proprietary formulations of nicotine gums and pouches. LUCY's marketing communications are designed for, and directed to, existing adult tobacco consumers who are 21 and older. The company has always supported effective, appropriate, and evidence-based regulation of nicotine products.

To learn more about LUCY and its products, please visit www.lucy.co.

¹ Tobacco and its environmental impact: an overview. Geneva: World Health Organization; 2017, p. 5.

SOURCE Lucy Goods, Inc.

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