FDA Regulation of E-Cigarettes – Are You Prepared?
This article is reprinted with the permission of Vape Magazine. It first appeared in the August 2015 issue of Vape Magazine.
The U.S. e-cigarette industry, in particular open-system refillable e-liquid industry, has grown tremendously over the past several years, with some estimating total sales in the range of $3 to 4 billion in 2015. That rapid growth has largely taken place in the absence of regulation. That will soon change, however, as more states enact laws restricting how and where these products can be used, and as the U.S. Food and Drug Administration prepares to finalize its long-awaited “Deeming Regulation” that will capture many of these products as regulated “tobacco” products.
The first “cigalike” e-cigarette models began entering the U.S. from China around 2007-2008. As these products started to become more popular, FDA initially sought to regulate them as drug-delivery devices, arguing that they were intended to deliver nicotine, a drug, into the body and were not traditional tobacco products determined to be outside of the Agency’s authority in the Supreme Court decision Food and Drug Administration v. Brown & Williamson Tobacco Corporation, 529 U.S. 120 (2000). Since drugs can only be marketed after receiving FDA approval, the Agency’s position at that time was that all e-cigarettes that contain nicotine were unapproved drug products that could not be marketed without explicit FDA approval.
Based on this, FDA and Customs had several e-cigarette shipments from China seized at the border. Those e-cigarette companies filed a lawsuit against FDA arguing that their products were actually not unapproved drugs at all, but tobacco products under the new Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), which had just become law. The Tobacco Control amended the existing Food, Drug and Cosmetic Act (FDCA) to give FDA authority, for the first time, to regulate the manufacture, distribution, marketing of “tobacco products” in the U.S. Importantly, the term “tobacco product” is defined broadly in the new law to include anything made or derived for tobacco intended for human consumption, including the components, parts and accessories of the product. The argument that the court ultimately agreed to in Sottera, Inc. v. Food & Drug Administration, 627 F.3d 891 (D.C. Cir. 2010) is that if an e-cigarette contains nicotine derived from tobacco and is “customarily marketed” for recreational use and not for any intended therapeutic benefit (such as to treat nicotine addiction or for smoking cessation), then such e-cigarette is a tobacco product under the new law and subject to FDA’s tobacco authority.
The Tobacco Control Act
While the Tobacco Control Act defined tobacco products broadly to capture any products made or derived from tobacco, it did not give FDA the immediate ability to regulate all such products. Rather, the law only gave FDA the immediate authority to regulate four specific types of tobacco products, e.g., cigarettes, cigarette tobacco, smokeless tobacco and roll-your-own tobacco. But, the law also gave FDA the ability to use its rulemaking procedures to create a regulation that would “deem” other, currently unregulated tobacco products under its tobacco authority. On April 25, 2011, FDA published a letter to e-cigarette stakeholders on its website stating that it would not appeal the Sottera decision, and that e-cigarettes made with tobacco-derived nicotine would be deemed to be under FDA’s tobacco authority by the “Deeming Regulation”. Exactly three years later on April 25, 2014, FDA finally published the Notice of Proposed Rulemaking for the Deeming Regulation.
The Deeming Regulation
During the 105-day comment period following publication of the proposed rule, over 135,000 comments were submitted by consumers, advocates, industry and academics. FDA is legally obligated to review each comment and provide analysis in the final rule. In terms of next steps, once FDA finalizes the rule (hopefully taking into consideration many of the helpful comments) it will submit that final rule to the Office of Management and Budget (OMB) in the White House, who will consider the potential economic impact of the rule. Although FDA initially indicated that it expected the final rule to be published in June 2015, as of the time of this writing the rule has not yet been submitted to OMB. OMB typically takes at least 3 to 6 months to review new regulations. If the final rule gets to OMB this summer, some expect it will be published and become effective before the end of 2015.
What Requirements Will Apply to E-Cigarettes?
If the Deeming Regulation becomes effective as drafted, the newly covered tobacco products, including e-cigarettes (and e-liquids) that contain nicotine derived from tobacco, will be subject to the same regulatory requirements that currently only apply to regulated tobacco products: a one-size-fits-all approach (with the possible exception that “premium cigars” may be exempted, but that is another story). These requirements include:
- Manufacturing facility registration under Section 905(b)
- Product and ingredient listing under Section 904
- Harmful and Potentially Harmful Constituents (HPHC) Testing and Reporting under Section 904(a)(3)
- Good Manufacturing Practices (GMPs) under Section 906
- Premarket authorization under Section 910
In addition, all products that contain nicotine will be required to include the following warning on their labels, “WARNING: This product contains nicotine derived from tobacco. Nicotine is an addictive chemical.” Sales to minors (under 18) would be banned, as well as distribution of free samples (which could greatly impact how vape shops do business) and vending machine sales except in adult-only facilities. Claims of “modified risk” (i.e., that your product is less risky than other tobacco products or contains fewer harmful substances) would be prohibited as well.
The biggest hurdle for e-cigarettes will be getting through the premarket authorization process. This means that new products will first have to be authorized by FDA before they can be sold. There are two main premarket pathways set forth in the Tobacco Control Act – the Substantial Equivalence (SE) Report and the Premarket Tobacco Product Application (PMTA). The less onerous of the two is the SE Report, which requires demonstrating that a new product is “substantially equivalent” to a product that was on the market as of the “Grandfather Date” set forth in the statute: February 15, 2007. The substantial equivalence standard requires showing that any characteristics of the new product that are not identical to the grandfathered predicate product do not raise “different questions of public health”. Unless FDA uses a new Grandfather Date for e-cigarettes, the SE Report process will not be available for these products, since it does not appear that there were any e-cigarettes on the market on February 15, 2007.
The PMTA process, on the other hand, does not require comparison to a predicate product. Where a new tobacco product is not substantially equivalent to a tobacco product commercially marketed in the United States as of February 15, 2007, and is not exempt from the requirement to obtain a substantial equivalence determination pursuant to regulation, the manufacturer must submit a PMTA under section 910(b) of the Act and receive a marketing authorization order prior to marketing the product. A PMTA must include quite a bit of supporting data, such as:
- full reports of all investigations of health risks;
- a full statement of the components, ingredients, additives and properties, and principles of operation of the tobacco product;
- a full description of methods of manufacturing and processing;
- an explanation of how the product complies with any applicable tobacco product standards;
- samples of the product and its components;
- specimens of proposed labeling; and
- other information that FDA may require.
FDA has issued a PMTA Guidance document that further details the types of non-clinical, clinical (human), consumer perception studies, mathematical modeling, etc. that will likely be needed to meet the very high standard for PMTAs. That standard requires that applicants be able to demonstrate that their new product is "appropriate for the protection of the public health". To date, no tobacco products have received a marketing authorization via the PMTA process.
Recognizing that e-cigarette and e-liquid manufactures would not be able to rely on the Grandfather Date and would have to submit PMTAs to stay on the market, FDA proposed in the Deeming Regulation a “compliance policy; that would delay enforcement of the premarket authorization requirements. Under this policy, FDA would allow any deemed product marketed after February 15, 2007 through two years after the effective date of the Deeming Regulation to remain on the market provided: 1) a PMTA for the product is submitted by the two-year anniversary of the effective date of the regulation, and 2) until such time as FDA denies the premarket submission. For products not on the market at the end of the two-year compliance period, manufacturers will need to first obtain premarket authorization from the Agency before introducing such products into commerce.
What Will the Final Regulation Look Like?
It remains to be seen whether the final version of the Deeming Regulation will incorporate any of the ideas submitted in the public comments, or stick with its "one-size-fits-all" approach. Many industry advocates submitted comments urging FDA to consider e-cigarettes separate from traditional tobacco products and to develop regulations that better fit the product category. For example, many comments were submitted suggesting that FDA use a new Grandfather Date for e-cigarettes to capture the existing market. Other comments were submitted arguing that based on the growing body of available scientific evidence, FDA could determine that, as a product category, e-cigarettes are "appropriate for the protection of the public health" because they provide a less harmful alternative to combustible cigarettes for smokers and have contributed to the declining smoking rate (while there does not appear to be any evidence of the "gateway" phenomenon). Still other comments were submitted providing alternative frameworks for regulation based on the "Continuum of Risk" of tobacco products. Those comments argued that regulations should be tailored to the tobacco product type based on how harmful the product is. In other words, the regulatory burden for a product should be commensurate with its level of harm (i.e., cigarettes should be subject to a higher degree of scrutiny compared to smokeless tobacco and e-cigarettes).