The writing on the wall

The writing on the wall

The FDA’s treatment of tobacco provides clues about what the vapor industry can expect, post-regulation.

By Patricia Kovacevic

These past couple of months the Food and Drug Administration (FDA) Center for Tobacco Products, which is the primary regulator of tobacco products in the United States, has been perhaps more active than ever in enforcement against tobacco products manufacturers, as well as with respect to rulemaking and issuance of guidance documents.

Why should we in the vapor industry care? In the immediate future the FDA will assert its authority over vapor products (and, possibly, vapor devices) containing tobacco-derived nicotine. Vapor products will be covered by the same regulatory regime as cigarettes, barring a successful challenge to some or all of the FDA’s authority to regulate such products. Thus, the FDA’s current behavior and thinking vis-a-vis conventional, regulated tobacco products (such as cigarettes) will be consistent with the FDA’s future actions on vapor products, once these are deemed tobacco products. While we may disagree vigorously that e-cigarettes or e-liquids are tobacco products—they are, after all, anti-tobacco products by definition—the FDA has no choice but to act within the legal framework Congress provided through the 2009 Family Smoking Prevention and Tobacco Control Act (TCA) amendment to the Federal Food, Drug and Cosmetic Act.

What are some of the recent the FDA developments that should concern vapor products manufacturers and importers in the United States?

On July 1, 2015, the FDA issued an advance notice of proposed rulemaking (ANPRM) and opened the docket for public comment to obtain information related to the regulation of new “tobacco products” subject to the TCA and restrictions regarding the sale and distribution of such tobacco products. Specifically, this ANPRM is seeking comments, data, research results or other information that may inform regulatory actions the FDA might take with respect to nicotine exposure warnings and child-resistant packaging for liquid nicotine and nicotine-containing e-liquid(s) that are made or derived from tobacco and intended for human consumption, and potentially for other tobacco products including, but not limited to, novel tobacco products such as dissolvables, lotions, gels and drinks. This FDA ANPRM comes before the FDA has had the opportunity to finalize regulation, which will bring (“deem”) additional products, including vapor products, under the TCA and thus subject to the FDA’s regulatory authority.

An ANPRM is an early rulemaking stage, but it’s important in collecting scientific and other types of information the FDA will use in issuing its proposed or even, directly, its final rule on nicotine exposure warnings and child-resistant packaging. There the FDA lags behind other foreign and even domestic (state level) U.S. legislation, at least with respect to child-resistant packaging, which is certainly an important feature of a product.

The FDA cannot require nicotine warnings or child-resistant packaging on vapor products before such products are brought under the FDA’s regulatory authority through the deeming rule. Also, the FDA will likely exercise caution in issuing a specific nicotine warning requirement because the FDA’s nicotine warnings, like any warnings, must be science-based and must withstand a possible First Amendment challenge. As you may know, to date the FDA’s attempt to impose certain graphic health warnings to cigarette products was challenged successfully on First Amendment freedom of speech grounds, on an “as applied” basis. Both the United States District Court for the District of Columbia, in R.J. Reynolds Tobacco Co. v. Food and Drug Administration (845 F. Supp. 2d 266 (D.D.C. 2012)), as well as the United States Court of Appeals for the District of Columbia Circuit, in R.J. Reynolds Tobacco Co. v. Food and Drug Administration (696 F.3d 1205 (D.C. Cir. 2012)) determined that the actual graphic health warning images chosen by the FDA violated the First Amendment.

Later this summer, on Aug. 27, the FDA issued warning letters to three cigarette manufacturers that describe their cigarettes on product labeling as “additive-free” and/or “natural.” The FDA found that this labeling represents explicitly and/or implicitly that the products or their smoke do not contain or are free of a substance and/or that the products present a lower risk of tobacco-related disease or are less harmful than one or more other commercially marketed tobaccos. Thus, the warning letters are for violations of Section 911 of the TCA, a section that addresses modified-risk tobacco products (MRTPs). The FDA has determined that these products, described as “natural” and “additive-free” on their labeling, need an MRTP order from the agency before they can be legally introduced as such into interstate commerce. MRTPs can only be introduced into interstate commerce after scientific evidence to support them has been submitted to the FDA and the FDA has issued an order permitting their marketing. To date, the FDA has not issued any orders that would permit label claims of reduced risk or harm to users and nonusers. The costs to submit an MRTP application are likely—and easily—in the millions of dollars per product, because the FDA MRTP guidance suggests extensive studies are needed, and are therefore prohibitively expensive for the vast majority of the vapor industry, and with unknown commercial benefits.

Let’s think for a second what would the FDA do if a vapor product, once regulated as tobacco product, made a claim such as “tobacco smoke free” or “no tobacco-specific nitrosamines” or, better yet, “no carbon monoxide” (all of which are harmful features of conventional cigarettes or their emissions). Even if such a claim were absolutely true—after all, e-cigarettes do not emit tobacco smoke or carbon monoxide—the FDA, according to its strict views, could still issue a similar warning letter to the respective e-cigarette manufacturer based on the fact that the product labeling represents that the product or its smoke “does not contain or is free of a substance“ (such as, for instance, carbon monoxide). The list of comparative claims that would thus be barred could be vast. While consumers would rightfully benefit from accurate information, the TCA’s Section 911 appears to prevent manufacturers from incorporating factually accurate information about their products in labeling or advertising. One can see a potential First Amendment issue here as well—to date unchallenged, but to be watched.

Substantial equivalence

Another interesting development is the issuance this past September of a final guidance (second edition) titled “Demonstrating the substantial equivalence of a new tobacco product: Responses to frequently asked questions” (which I will refer to as the SE FAQ Guidance). This is the third iteration of a 2011 draft guidance that was updated in March 2015 and subsequently challenged in court by several tobacco product manufacturers. The FDA suspended the application of its March 2015 version of the guidance, and the respective lawsuit was withdrawn without prejudice, meaning it could be refiled at any time. There was hope that the FDA would issue a revised guidance actually based on the statutory language, which requires manufacturers to file substantial equivalence reports with the FDA for changes in the product, not product packaging or product count. That did not happen, and the FDA’s SE FAQ Guidance reinforces the FDA‘s own interpretation of a “change” to a product to mean also a change in the product packaging, which, again, does not appear supported by the language in the TCA.

This guidance describes the FDA’s current thinking on whether and when a change to a tobacco product’s label, product quantity in the package, additives or specifications renders that later product a “new tobacco product” subject to premarket review (whether or not the new tobacco product replaces the original tobacco product). It explains that a manufacturer may submit streamlined SE reports for certain modifications to labels and changes to product quantity. The guidance also explains the FDA’s plans and processes for review of the streamlined SE reports. Finally, this guidance responds to several questions that have been raised about the SE process more generally.

While in the FDA’s own words, guidances describe the FDA’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited, the FDA acts and enforces the law according to its guidance documents. Why should vapor product manufacturers care? Well, if the FDA’s upcoming deeming rule remains unchallenged, or survives potential legal challenges, all guidance documents published to date by the FDA regarding tobacco products will be applicable to vapor products, including this one.

There are many issues with this SE FAQ Guidance. I will only focus on the most glaring issue, the very definition of tobacco product. First and foremost, in the SE FAQ Guidance Section B, the FDA concludes, correctly, that a label (i.e., packaging, but could also be an insert or certain other types of communications about the product) is “not a part of a tobacco product.” Yet substantial equivalence reporting requirements are currently applicable to tobacco products only, as provided in the TCA and as currently enforced by the FDA. (Ingredients of tobacco products could be required to undergo premarket review, but at present the FDA does not intend to enforce this requirement.) The FDA then proceeds to justify why label changes still require a substantial equivalence report, in spite of a label not being a part of a tobacco product as per the statutory definition, and as agreed by the FDA itself. One would inevitably ask, where is the logic, and is the FDA making new laws and circumventing the legislator? Why do we need an SE FAQ Guidance for something (such as product labels) that is not supposed to undergo the substantial equivalence reporting and review process?

This matter is certainly of interest to vaping products manufacturers. According to this SE FAQ Guidance, at a date as of yet unknown in the near future all vapor products and their packaging would remain virtually “frozen in time,” and no change, line extension or rebranding would be possible without filing a substantial equivalence report with the FDA, at a non-negligible cost and effort. And, given the FDA’s track record of protracted yet diligent review (think years!) and challenges to the content of substantial equivalence reports, there is little hope that changes to products, even cosmetic changes to packaging, would be permitted by the FDA without extensive and costly filings, or at least that the respective “streamlined” substantial equivalence reports would be reviewed in a time that is realistic from a commercial/competition point of view to enable progress and innovation in the industry.

On Sept. 30, Imperial Tobacco Group, Reynolds American and Altria filed a new lawsuit against the FDA in the U.S. District Court for the District of Columbia, stating that the updated SE FAQ Guidance violates their commercial speech rights under the First Amendment and exposes manufacturers to civil or criminal penalties. Although the guidance is described by the FDA as nonbinding, it creates legal obligations. The FDA appears to have failed to follow the necessary rulemaking procedures required for substantive measures. Plaintiffs are seeking an order to enjoin the FDA from enforcing the SE FAQ Guidance, declare the SE FAQ Guidance unlawful and vacate it.

I strongly urge you to read this and other FDA guidance documents. The SE FAQ Guidance can be found at

The docket for this guidance is open for comments indefinitely. The FDA must read and consider your comments and will appreciate science-based, well-reasoned submissions. In the words of Mitch Zeller, the director of the Center for Tobacco Products, referring to the industry’s ability to educate the FDA through written, formal docket comments, “This is not a spectator sport,” so stay engaged!


Patricia Kovacevic is general counsel and chief compliance officer for Nicopure Labs, a leading U.S. e-liquid and vaping device manufacturer.