FDA Issues 13 Policy Memos on Flavored E-Cigarette Review Methods

Nov.22.2024

FDA Issues 13 Policy Memos on Flavored E-Cigarette Review Methods

FDA has released 13 additional regulatory science policy memos related to the review of premarket applications, detailing the processes and prioritization methods for filing and reviewing PMTAs for flavored e-cigarettes and other products, as well as the basis for specific actions related to environmental assessments.

On November 21st, U.S. Food and Drug Administration (FDA) released additional regulatory science policy memos concerning its review of premarket applications. These memos aim to provide clarity on the agency’s methods and processes for evaluating applications.

The release includes thirteen memos developed between 2020 and 2023 and details FDA's approach to filing and reviewing PMTAs for flavored e-cigarettes and other products, including the criteria for prioritization. The memos also outline the agency's rationale for actions related to environmental assessments.

The memos posted today include:

Feb. 20, 2020: To Support the Efficient Filing Review of Premarket Tobacco Product Applications (PMTAs)

June 30, 2021: Updated Prioritization of PMTA Filing Reviews (includes an addendum from July 28, 2021)

Jan. 21, 2022: Filing Prioritization for PMTAs Received between Sep. 10, 2020, to Nov. 3, 2021 (with an addendum from Feb. 28, 2022)

July 9, 2021: ENDS Containing Non-Tobacco Flavored E-Liquid: Approach to PMTAs Not in Substantive Scientific Review (Phase III) (and five addendums from July 28, 2021, Aug. 18, 2021, Nov. 22, 2022, Dec. 7, 2022, and April 27, 2023)

July 16, 2020: Environmental Assessment Criteria to Support Refuse to Accept or Refuse to File Actions on Premarket Applications (with an addendum from May 27, 2021)

FDA notes that these science policy memos provide snapshots of its perspectives at specific times. Consequently, the information may evolve with changes in policies, regulatory frameworks, or regulatory science.

FDA reviews tobacco product applications based on the specific facts provided in each submission, with findings documented accordingly. As such, the regulatory science policy memos are not intended to serve as tools, guides, or manuals for preparing or submitting applications to FDA.

To support applicants seeking to market new tobacco products, FDA has issued final regulations, including the PMTA final rule. This rule specifies the required content, format, and review procedures for PMTAs and is supplemented by additional guidance documents. FDA also offers resources such as webinars and application tips, which are regularly updated on the CTP's website and social media platforms.

In April 2024, FDA resumed the publication of regulatory science policy memos. With the latest batch released today, the agency has published four sets of memos this year, totaling 26 memos in 2024.

#North America #United States #Open system e-cigarettes #Regulation

China Tobacco Regulation Shift：Policy Updates and Market Impact

China Tobacco Regulation Shift：Policy Updates and Market Impact

Florida Governor DeSantis Expands TANF Restrictions, Blocking Welfare Benefits From Buying Tobacco and Vapes

Florida Governor DeSantis Expands TANF Restrictions, Blocking Welfare Benefits From Buying Tobacco and Vapes

Florida Governor Ron DeSantis announced an expansion of Temporary Assistance for Needy Families (TANF) restrictions that would prohibit Electronic Benefit Transfer (EBT) funds from being used to purchase tobacco and vaping products. The state will amend its TANF State Plan and submit the changes for federal approval. Florida officials said the restrictions would not affect eligibility for temporary cash assistance or the amount of benefits received, but would change how funds can be spent.

Philippines BIR Steps Up Illicit Vape Enforcement Ahead of Christmas Shopping

Philippines BIR Steps Up Illicit Vape Enforcement Ahead of Christmas Shopping

The Philippines’ Bureau of Internal Revenue is intensifying enforcement against illicit vape and tobacco products ahead of the Christmas shopping season, directing regional and enforcement offices to strengthen monitoring of production sites, warehouses, distribution channels and retail outlets. The BIR destroyed 240,550 illicit vape products in August with an estimated tax liability of about PHP1.53 billion. A nationwide tax-compliance operation in July also inspected 3,590 businesses involved in tobacco and vapor products.

Sep.17 by 2Firsts Perspectives

$20 Million, a Permanent Injunction and Distributor Controls: Posh Deal Tightens Illinois Vape Compliance

$20 Million, a Permanent Injunction and Distributor Controls: Posh Deal Tightens Illinois Vape Compliance

An Illinois court ordered three companies tied to Posh vapes to pay $20 million and permanently restricted the sale, marketing and distribution in Illinois of products lacking required FDA authorization. The consent order also imposes downstream distributor controls, age-verification measures and social-media marketing limits, creating a new state-level compliance benchmark for disposable vape businesses.

Science | International Experts Propose a New Smoking Cessation Pathway, Citing Higher Quit Rates With E-Cigarettes Than Nicotine Replacement Therapy

Science | International Experts Propose a New Smoking Cessation Pathway, Citing Higher Quit Rates With E-Cigarettes Than Nicotine Replacement Therapy

A new expert paper in JAMA urges U.S. clinicians to include nicotine e-cigarettes in smoking-cessation discussions, citing higher quit rates than nicotine replacement therapy. It also stresses that products must deliver enough nicotine to replace cigarettes, dual use should be brief, and complete switching is the goal. 2Firsts argues the recommendations matter beyond clinics: public-health professionals should reassess relative risk, regulators should preserve sufficient product appeal for adult smokers, and manufacturers should focus on helping users quit cigarettes more sustainably.

Aug.03 by 2Firsts Perspectives

Reuters Tracks Big Tobacco’s Shift Beyond Cigarettes as Nicotine Pouches Vie for the Next Growth Curve

Reuters Tracks Big Tobacco’s Shift Beyond Cigarettes as Nicotine Pouches Vie for the Next Growth Curve

As cigarette markets face long-term pressure, major tobacco companies are increasingly turning to nicotine pouches in search of growth beyond combustible tobacco. Reuters has examined whether nicotine pouches can become the next strategic growth platform for companies including Philip Morris International, British American Tobacco and Japan Tobacco. PMI strengthened its position through the acquisition of Swedish Match and its ZYN brand, while BAT and JTI continue expanding their own nicotine pouch portfolios. The category has gained attention because of its smoke-free, device-free format, but regulation, youth-use concerns and market scale will determine whether it can become a long-term growth engine.

Aug.18 by 2Firsts Perspectives

As FDA Reshapes PMTA Reviews and ENDS Enforcement Priorities, CTP Acting Director Bret Koplow to Keynote NATO Event for a Retail Network of 66,000-Plus Stores

As FDA Reshapes PMTA Reviews and ENDS Enforcement Priorities, CTP Acting Director Bret Koplow to Keynote NATO Event for a Retail Network of 66,000-Plus Stores

Bret Koplow, acting director of the U.S. Food and Drug Administration's Center for Tobacco Products, will deliver a keynote and participate in a fireside chat at the National Association of Tobacco Outlets' Sept. 29-30 conference in Washington. His appearance comes months after the FDA moved to accelerate PMTA reviews and introduced a more differentiated enforcement policy for certain unauthorized ENDS and oral nicotine pouch products. The agency also plans a public list identifying manufacturers and products it does not currently intend to prioritize for enforcement under the May guidance. NATO says its membership includes more than 66,000 retail stores, making product-status transparency and enforcement boundaries directly relevant to the retail sector.

Related Topics

HEADLINE News Regulation

Related Read

Florida Governor DeSantis Expands TANF Restrictions, Blocking Welfare Benefits From Buying Tobacco and Vapes

Florida Governor DeSantis Expands TANF Restrictions, Blocking Welfare Benefits From Buying Tobacco and Vapes

Philippines BIR Steps Up Illicit Vape Enforcement Ahead of Christmas Shopping

Philippines BIR Steps Up Illicit Vape Enforcement Ahead of Christmas Shopping

2Firsts Perspectives

$20 Million, a Permanent Injunction and Distributor Controls: Posh Deal Tightens Illinois Vape Compliance

$20 Million, a Permanent Injunction and Distributor Controls: Posh Deal Tightens Illinois Vape Compliance

Science | International Experts Propose a New Smoking Cessation Pathway, Citing Higher Quit Rates With E-Cigarettes Than Nicotine Replacement Therapy

Science | International Experts Propose a New Smoking Cessation Pathway, Citing Higher Quit Rates With E-Cigarettes Than Nicotine Replacement Therapy

2Firsts Perspectives

Reuters Tracks Big Tobacco’s Shift Beyond Cigarettes as Nicotine Pouches Vie for the Next Growth Curve

Reuters Tracks Big Tobacco’s Shift Beyond Cigarettes as Nicotine Pouches Vie for the Next Growth Curve

2Firsts Perspectives

As FDA Reshapes PMTA Reviews and ENDS Enforcement Priorities, CTP Acting Director Bret Koplow to Keynote NATO Event for a Retail Network of 66,000-Plus Stores

As FDA Reshapes PMTA Reviews and ENDS Enforcement Priorities, CTP Acting Director Bret Koplow to Keynote NATO Event for a Retail Network of 66,000-Plus Stores