Understanding PMTA: The Vaping Industry’s Regulatory Challenge

Follow Us on Youtube!

Recent Posts

A PMTA, or Premarket Tobacco Application, is a critical marketing authorization application that all vape manufacturers must secure to introduce new vape products. This process, as we’ll explore, is riddled with challenges. Once the application is appropriately submitted, manufacturers await the FDA’s response, a process that can extend up to 180 days. Notably, each new product necessitates its own approval. In essence, if a company aims to offer 30 different products, it must navigate and successfully file 30 separate PMTAs. So, what steps is ALD, as a vape manufacturer, taking concerning PMTA?

To grasp the significance of PMTA, let’s start at the beginning. The Family Smoking Prevention and Tobacco Control Act (TCA), enforced on June 22, 2009, bestowed regulatory power upon the United States Food and Drug Administration (FDA) to oversee the production, distribution, and marketing of tobacco products within the United States.

One key mandate was that any tobacco product, subject to TCA regulations, introduced into the market or modified after February 15, 2007, must secure FDA approval before being marketed. While the initial TCA requirements primarily applied to cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco, the Act vested the FDA with discretion over other tobacco products’ inclusion within federal regulations.

Subsequently, the FDA issued the “Deeming Rule” in May 2016, officially extending TCA regulations to electronic nicotine delivery systems (ENDS) and e-liquids meeting the statutory definition of tobacco products.

So, what precisely is a PMTA? PMTA stands for Premarket Tobacco Application, a process initiated with the enactment of the Family Smoking Prevention and Tobacco Control Act in 2009. According to the Tobacco Control Act, any new tobacco product is one that was not in the market prior to February 15, 2007. The FDA’s “deeming rule,” issued on May 10, 2016, clarified that vaping products would be subject to tobacco product regulations in the United States. Consequently, vaping products fall under the jurisdiction of the Tobacco Control Act.

In 2007, vaping products had yet to debut in the United States market. Therefore, any vaping product available in the U.S. today does not possess prior approval. In accordance with U.S. vaping regulations, every device, tank, coil, flavor, and nicotine strength within an e-liquid is treated as a distinct product, necessitating its own marketing order. To continue selling vaping products within the United States, manufacturers must diligently submit PMTAs.

While on the surface, the U.S. legal compliance system for vaping products may seem comparable to the United Kingdom’s. After all, UK-based e-liquid manufacturers are required to register their products with the relevant authorities and subject them to emissions testing before market entry. However, the UK compliance process for new e-liquids is generally considered fair to small businesses. In contrast, the PMTA process, with estimates suggesting that generating a PMTA for a single product could cost between $117,000 and $466,000, poses a significant financial barrier. For a basic e-liquid line, the cost of securing PMTAs for each product could escalate into the millions.

The FDA’s rules for vaping products, set as part of the “Deeming Rule,” imposed a deadline of August 8, 2018, for manufacturers to submit premarket authorization applications for new tobacco products. This encompassed products existing in the market on August 8, 2016. Notably, products that failed to meet the submission deadline were barred from sale in the absence of FDA market approval.

In May 2017, the FDA proposed a three-month extension to the submission deadline and later indicated its intention to extend the deadline even further, affecting both combustible products like cigars and non-combustible products such as e-cigarettes. Subsequently, the FDA published a draft compliance policy in March 2019, shifting the enforcement dates for flavored ENDS to August 8, 2021.

Fast forward two years, and the U.S. District Court for the District of Maryland directed the FDA to require manufacturers to submit premarket applications for newly deemed tobacco products. This directive also granted a one-year grace period for these products, allowing them to remain available on the market provided applications were submitted by the May 12 deadline. Importantly, the FDA retained the authority to enforce premarket review provisions before the submission date and during the one-year grace period.

In February 2020, the FDA began prioritizing enforcement against flavored ENDS, particularly cartridge-based products not flavored with tobacco or menthol. These products, lacking FDA premarket approval, were effectively barred from sale in the United States.

The FDA sought a 120-day extension to the PMTA deadline in light of the extraordinary circumstances brought about by the COVID-19 pandemic. On April 22, 2020, the court granted this request, postponing the initial deadline to September 9, 2020.

Beyond this date, any products without premarket authorization were effectively prohibited from the U.S. market. Should manufacturers file applications by the deadline, submitted products typically gained a one-year grace period to continue sales. However, the FDA retained the authority to exercise enforcement discretion or take adverse action against products, even if a PMTA had been submitted, during this period.

The advent of full government regulation of vaping in the United States in 2020 ushered in a new era for the vaping industry. While it may seem that U.S. developments hold limited relevance for the U.K. vaping scene, this notion is far from accurate.

The Impact of U.S. Vaping Events on the U.K. Vaping Industry

The U.S. vaping landscape has a broader influence than one might initially assume. The United States boasts the largest vaping product market globally, and events occurring there reverberate across the world. Consider the vaping-related lung injury that swept through the U.S. last year as a testament to the ripple effect of American vaping events.

While over 2,700 individuals fell ill due to this outbreak, it was ultimately attributed to illicit cannabis vaping products. A significant issue arose when some U.S. media outlets reported the illness without distinguishing between cannabis vaping and nicotine vaping. Consequently, some vapers chose to return to smoking in the wake of this.

Popular Products