It seems that the vaping industry is on the verge of a major transition. This follows a recent statement by Bret Koplow, the Acting Director of the FDA’s Center for Tobacco Products (CTP), that the FDA is set to approve new vaping products in the near future.

These kinds of comments, presented in a public speech during a conference on tobacco and nicotine policy sponsored by the Food and Drug Law Institute (FDLI), signal what seems to be a new course of action by the FDA. For a long time, the FDA had received criticism for having a rather rigid policy towards vaping products, thereby denying adults in the US access to healthier alternatives of smoking. It seems that the FDA is slowly recognizing the place of tobacco harm reduction as indicated in these quotes of FDA consultant Daniel Koplow.

A Shift in the FDA’s Tone Toward Harm Reduction

As stated in reports summarized by Cliff Douglas, a longtime advocate of tobacco control, Koplow stated that the FDA is in favor of a “tobacco harm reduction strategy to reduce cigarette smoking.” This is not typically how the FDA has addressed vaping in the past.

As a further point, Douglas observed that Koplow seemed to agree that flavored vape products had a possibility of getting authorized for sale. This is nearly unprecedented in any FDA policy until this point in time. At this time, there is only a small hand full of authorized vaping products approved by the FDA that come in a variety of tobacco flavors.

This shift in tone could signal that they are ready to assess a wider range of products maybe even popular flavored disposables and juice brands that are used in large numbers across North America. Indeed, if this strategy comes to fruition, this will be much more representative of the Canadian vape industry, where adult smokers enjoy greater access to regulated nicotine products via reputable retailers.

The Push for a Legal and Regulated Vape Marketplace

In his report to Douglas, Koplow identified the need to ensure a legal market that is underpinned by effective enforcement as one of the key considerations. This is according to a report where he stated that FDA needs to “streamline, simplify, and accelerate” the approval process of products.

This particular stance identifies a problem arising as a result of the FDA’s continued delay in approvals of various legitimate businesses, as illegitimate disposable vapes enter the U.S. market in bulk. This particular issue not only affects adult nicotine consumers in a negative way, impacting overall public policy considerations in matters of public health.

As a point of reference, there is already a successful regulated marketplace in place in Canada that allows online purchases of vape products directly from licensed retailers that follow strict packaging standards, labeling, and age verification standards. Popular online retailers, display hundreds of authorized vape products that ensure that adults purchase high-quality products.

“If the FDA is serious about this proposed transition, the U.S. marijuana market could soon look more like that in Canada, where access is regulated to benefit adult use, as well as protecting youth, in a fair balance of those considerations."

Policy Contradictions and Commissioner Makary’s Enforcement Agenda

Despite the positive coverage of his comments, there seems to be a conflict between what Koplow is saying and what FDA Commissioner Martin Makary is doing in aggressively enforcing his crackdown on the independent vapor industry. As a whole, Commissioner Makary has characterized vaping as a menace by pointing to youth usage numbers, referring to imported vapor products as “national security issues.”

Under his leadership, the FDA has already handed out dozens of marketing denial orders (MDOs) to small to medium vape businesses in the US, effectively prohibiting them from selling flavored eliquids as well as pod products. At least 40 MDOs appeared in public records until the FDA decided not to release updates anymore. Furthermore, Makary has led large-scale raids on vape distributors as well as retailers in various states, leading to the confiscation of over two million vape products. This ranged from illegitimate vape disposables to bottled e-liquids from small American manufacturers, including those awaiting FDA review.

This is doing the industry a great disservice, as many lawful businesses are being chased out of the industry, leaving the public with fewer trustworthy sources. It is submitted that this is doing the contrary of what is purported to be done in the field of public health, as many adult vaporizers will be forced into black markets that a preceding comment warned against.

The Industry’s Response to XBRL, The importance of a balanced approach

Nevertheless, a certain optimism has characterized the reaction of the vaping community to these new developments. This is a double-edged sword in that, on the one hand, industry advocates are encouraged by any mention of tobacco harm reduction by a representative like Koplow, as well as his openness to further approvals of flavored e-cigs.

Under the Trump administration, the commitment to a simpler approval process by the FDA had barely moved, while under the Biden administration, delays and rejection of PMTAs had increased, leaving thousands of applications unresolved.

As a consumer as well as a small business, this has led to a certain amount of frustration as well as confusion. However, if the FDA is planning to develop a robust vapor industry, this is what needs to be done.

At the same time, Canadian vape stores offer a way in which regulatory balance can be reached. Canadian vape stores comply with the Vape Product Regulations of the Canadian federal government in that they must follow certain guidelines in labeling, ingredient disclosure, as well as in marketing. Nevertheless, flavored juices can be sold in Canadian vape stores.

What a Broader Authority Could Mean to the Market

A further FDA approval of vaping products, especially flavored open systems, is expected to radically change the vaping industry in North America. It will give adult smokers increased access to reduced risk nicotine products, leading to a faster decline in conventional cigarette use.

As a result, businesses, particularly small retailers and manufacturers may see new doors opened through wider approval that include everything from refillable vape kits to nicotine salts as well as portable disposables.

This model of conducting vape-related businesses has already been successful in the Canadian environment. Brands and retailers in the Canadian marketplace operate under a clean, legal environment that gives consumers confidence in the businesses. Some of the successful vape businesses operating in this jurisdiction.

A safer, more competitive marketplace will benefit American consumers if a regime of this sort gains acceptance in the United States, while a new weapon in the struggle against smoking will be added to the arsenal of public health authorities.

Conclusion:

These comments represent a long-overdue first positive change in FDA policy towards vaping in years, as suggested by Acting FDA Director Bret Koplow. It remains to be seen if positive change will come about as a result of FDA speed in approving new products.

As things stand, the divide between what is intended through regulations and what is enforced in practice is large nonetheless. While leaders such as Koplow urge a legal, harm reduction-based marketplace, there are those in the FDA who continue to zero in on harsh crackdowns in this sector.

For the international vaping community in general, as well as Canadian vape stores that operate in a regulated framework, the U.S. discussion is a timely reminder that the best approach is one of balance thus a regulated policy that secures the safety of the user while not denying them access to healthier alternatives. 

It is only time that will tell if the FDA will be able to effectively evolve in its position. Until that happens, those adults in the US looking to use high-quality products that meet legal standards will be able to purchase vape products online from Canadian retail stores, that lead the way in terms of safety, convenience, innovation, and quality within the industry.