FDA Regulation of Vapor Products – How We Got Here and What’s Coming Next

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By Azim Chowdhury

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 over $4 billion in 2016. 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 now that the U.S. Food and Drug Administration (FDA) has released its long-awaited “Deeming Regulation” that has officially regulated virtually the entire vapor industry as “tobacco” products.

But how did we get to this point? This article summarizes the timeline of how we got to where we are today, and what we can expect in the coming years.

The Early Years: 2003-2008

The modern e-cigarette “cigalike” product was developed around 2003 in China by Hon Lik, a 52-year-old pharmacist, inventor and lifelong smoker. Lik was inspired to invent the device, a less harmful method of inhaling nicotine, after his father, who was also a heavy smoker, died of lung cancer. Lik claims to have had a dream one night where he was engulfed by vapor. He presented the idea to his company, Golden Dragon Holdings, who began developing the device and changed their name to Ruyan, which means “like smoke.”

The first e-cigarettes began being exported to Europe around 2006 and to the U.S. around 2007. Almost immediately, health regulators around the world began assuming these products were just another form of harmful tobacco and began restricting their marketing and sale. In March 2008, for example, Turkey’s Health Ministry banned the sale and importation of e-cigarettes, falsely claiming that the products were just as

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harmful as regular cigarettes and that nicotine was the most dangerous chemical in cigarettes. The World Health Organization (WHO) soon followed suit, result in bans in New Zealand, Australia and Jordan.

2008-2009

What REQUIREMENTS Will Apply to E-Cigarettes?


As these products started to become more popular, the U.S. (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).

In March 2009, FDA added e-cigarettes to “Import Alert 66-41” and directed the U.S. Customs and Border Protection to reject the entry of electronic cigarettes into the United States because they were “unapproved drug-delivery devices.” 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.

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Based on this, FDA and Customs had several e-cigarette shipments from China seized at the border. Those e-cigarette companies (Smoking Everywhere and later NJOY (Sottera)) 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.

In June 2009, the Tobacco Control Act was signed into law by President Obama. This landmark legislation provided FDA, through the newly established FDA Center for Tobacco Products (CTP), with the authority to regulate the development, manufacturing, marketing, labeling, distribution, and sale of tobacco products deemed subject to the Tobacco Control Act’s authority. The Tobacco Control Act marked the first time that a regulatory agency in the United States was enabled to utilize science-based regulation in overseeing and addressing the use of tobacco by consumers. 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.

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The Sottera Decision – March 2010

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.

April 2011

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.”

The Deeming Regulation – April 2014

Exactly three years later on April 25, 2014, FDA finally published the Notice of Proposed Rulemaking for the Deeming Regulation, followed by a 105-day public comment period.

During the comment period, 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. Once FDA finalizes the rule (hopefully taking into consideration many of the helpful comments) it must submit that final rule to the Office of Management and Budget (OMB) in the White House, who will consider potential economic impact of the rule, as well as whether the public health concerns merit the level of regulation imposed by FDA.

October 2015

On October 19, 2015 we learned that FDA sent its final version of the Deeming Regulation to OMB. From November 2015 through January 2016, OMB has been meeting with industry stakeholders and members of the public health community to hear their concerns about the pending regulation. OMB typically takes at least 3 to 6 months to review new regulations. Some expected the new regulations could be published as early as the first quarter of 2016, but more likely later this year.

May 2016

The FDA officially released its Deeming Regulation for the vapor industry.

What Requirements Will Apply to Vapor Products?

The newly covered tobacco products subject vapor products to the same regulatory requirements that already applied 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) are 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.

With litigation already pending from NicoPure and trade organizations joining forces, it is possible that the regulations could see at least some changes moving forward.

Azim Chowdhury is a partner with the law firm Keller and Heckman LLP, which specializes in regulatory law.

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