Lucy Goods, Inc. announced the submission of a premarket tobacco product application to the U.S. Food and Drug Administration seeking marketing authorization for its 42 modern oral nicotine products, including its innovative line of capsules.

LUCY's application highlights key evidence that continued marketing of LUCY's products is appropriate to protect public health, and LUCY's timely submission of these PMTAs enables these products to be deemed to contain non-tobacco by the FDA's new PMTA deadline of May 14, 2022 Nicotine tobacco products.

LUCY is a developer, marketer and distributor of next-generation nicotine products, offering adult tobacco consumers an alternative to traditional tobacco. One of the key product innovations described in LUCY's recent PMTA submission is its use of NTN.

The NTN in LUCY products is manufactured using green chemistry principles, but is chemically identical to the tobacco-derived nicotine found in other modern oral products on the market. The low-waste manufacturing process does not require arable land or pesticides used in tobacco cultivation to obtain tobacco-derived nicotine.

LUCY's most recent filing, which represents the company's second FDA filing, demonstrates an ongoing commitment to FDA compliance and public health. In 2020, LUCY submitted a PMTA for its modern oral nicotine products containing tobacco-derived nicotine, which are currently under review by the FDA. Even before the FDA gained regulatory authority over NTN products, the company had been making serious efforts to prepare PMTAs for its suite of NTN products.

LUCY CEO David Renteln said: "Submission of PMTA for our non-tobacco nicotine products is an important 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 FDA as the process moves forward.

LUCY is an independently owned and operated nicotine replacement company with a mission to reduce tobacco-related harm to zero. The company does not sell any flammable or inhalable products, and its products include proprietary formulations of nicotine gum and sachets. LUCY's marketing communications are designed and targeted to existing adult tobacco consumers 21 years of age and older. The company has consistently supported effective, appropriate and evidence-based regulation of nicotine products.

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