On March 10, 2023, the U.S. Food and Drug Administration published a long-awaited proposed rule on Requirements for Tobacco Product Manufacturing Practice which sets forth proposed requirements for the manufacture, design, packing, and storage of tobacco products. The proposed requirements are essentially “good manufacturing practices” for tobacco products and are intended to minimize and prevent additional risks associated with such products and apply to both domestic and foreign manufacturers of finished and bulk tobacco products.

For vape shops the proposed rule clarifies that such establishments that only sell ENDS products and components and parts would not be considered manufacturers and would not be subject to the requirements in the proposed TPMP rule unless they also engage in the manufacture, preproduction design validation, packing, and storage of finished or bulk tobacco products within the meaning of the rule.

This rule would not affect “small businesses for 4 years after the effective date of the Final Rule” but it begs the question…. How many small vape shops do the FDA expect will still be in business in 4 years and why the delay specifically for these small businesses?  The FDA defines a small business as a product manufacturer that employs 350 employees or less.

FDA will host a public hearing on April 12, 2023, to gather comments from stakeholders, including industry, the scientific community, advocacy groups, and the public. FDA will also hold a meeting of the Tobacco Products Scientific Advisory Committee on May 18, 2023, to seek recommendations from FDA’s outside panel of experts on the requirements laid out in the proposed rule. As part of the TPSAC meeting, the public will have an opportunity to make oral presentations.

You can register for the public oral hearing here; the event will start at 9:30am and finish at 5:00pm ET. The “FDA aims to make this public hearing a transparent and inclusive opportunity to hear a range of ideas and perspectives from all interested parties.” So I highly recommend registering and requesting to verbally comment, those comments must be received by March 31, 2023 at 11:59pm. Registration for listen-only attendees will close April 12, 2023, at 3:00 p.m. ET.

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To hear more about the upcoming news and policies around vaping, vape shop owners can apply to WVA’s Ambassador Program. Door de WVA-ambassadeur te worden, hebben vape-winkels een unieke kans om lid te worden van een wereldwijd netwerk van vapers en in contact te komen met duizenden consumenten en activisten die hartstochtelijk vechten tegen schadelijk beleid dat een negatieve invloed zou hebben op hun rechten en bedrijven.

Vape-winkels zullen geen lid zijn van onze organisaties, maar als ambassadeurs kunnen ze onze gemeenschappelijke boodschap vermenigvuldigen: vapen redt levens.