NJOY ACE 2.0 PMTA Submission
Regulatory Compliance:
NJOY, a subsidiary of Oceania, has submitted a PMTA for the NJOY ACE 2.0 device and resubmitted PMTAs for blueberry and watermelon flavored pods to the FDA.
Underage Prevention Measures:
The NJOY ACE 2.0 device incorporates Bluetooth connectivity for user authentication, aiming to prevent underage use while offering a range of flavor options for adult smokers and vapers.
Addressing FDA Concerns
Marketing Denial Orders (MDOs):
NJOY previously received Marketing Denial Orders (MDOs) for its blueberry and watermelon flavored pods. The company believes that the new applications adequately address FDA concerns about underage use by implementing robust access restrictions based on device age and identity verification.
Preventing Underage Use:
NJOY’s stringent access restrictions effectively prevent underage use in almost all cases, addressing FDA concerns and demonstrating the company’s commitment to responsible marketing practices.
Preventing Underage Use:
NJOY’s stringent access restrictions effectively prevent underage use in almost all cases, addressing FDA concerns and demonstrating the company’s commitment to responsible marketing practices.
Altria’s FDA Authorization and Expansion Plans
FDA Authorization:
Altria’s products, including the NJOY ACE device and select pods, received FDA authorization through the Premarket Tobacco Product Application (PMTA), showcasing the company’s compliance with regulatory standards.
Expansion Initiatives:
In the first quarter of 2024, NJOY expanded its distribution network to cover approximately 100,000 retail locations by the end of the year. The company also launched a retail trade program to enhance visibility and product display space, further solidifying its presence in the market.
