Q&A on the FDA’s New E-Cigarette Rules

After years of waiting and fighting, the new rules put forth by the U.S. Food and Drug Administration (FDA) on electronic cigarettes and other non-cigarette products go into effect Monday, August 8th, 2016. The rule change, purportedly to protect public health, sets new restrictions on packaging, sales, and marketing of vaping products in addition to requiring compliance with Agency filing and approval processes. With upwards of 35,000 vape-related businesses and thousands of popular products at risk, people are understandably anxious about what the changes mean. This post sums up the major effects of the rule change.

1. What gives FDA the authority to regulate vaping in the first place?

Powerful as it is, the FDA is limited to administering statutes enacted by Congress. There are two ways the agency can expand its purview: either Congress can enact new statutes granted the agency new authority, or the FDA itself can reinterpret existing law to give itself previously unrecognized authority. The latter strategy is how the agency established control over vaping products. They claim that the Tobacco Control Act of 2009—enacted by Congress to allow FDA to regulate cigarettes—also gave them the authority to regulate vaping, under the assumption that such items meet the definition of “tobacco products.” That is what the agency did with its 2014 “deeming rule.”

2. What is the “Deeming” Rule?

In 2009, the FDA directed U.S. Customs to reject the importation of electronic cigarettes into the United States, insisting it could do so under its authority to regulate “medical devices.” As the FDA tried in the 1990s with traditional cigarettes, the agency claimed that e-cigarettes were medical drug-delivery devices (with nicotine being the drug) and that it could regulate or even ban such products. Manufacturers sued, and in 2011 the courts agreed with them, telling the FDA it could only regulate vapes as tobacco products under the Tobacco Control Act (except those marketed as cessation devices). Three years later, FDA issued proposed rules to do just that: deem tobacco-less nicotine containing products, like e-cigarettes, tobacco products.  

As of today, the final rule subjects vaping devices (what FDA calls Electronic Nicotine Delivery Systems or “ENDS”), along with other non-traditional tobacco products, to the regulations under the Tobacco Control Act.

 ENDS include

 Component Parts include

 E-cigarettes

 E-liquids

 E-cigars

 Atomizers

 E-hookah

 Batteries (with or without variable voltage)

 Vape pens

 Cartomizers (atomizer plus replaceable fluid-filled  cartridge)

 Personal  vaporizers

 Digital display/lights to adjust settings

 Electronic pipe

 Clearomisers, tank systems, flavors, vials that  contain e-liquids
 

 Programmable software

3. What will the rule change do to the market?

Deadlines will roll out on a staggered basis with some rules requiring compliance beginning Monday, August 8th, while manufacturers, distributors, and retail shops may have up to two years to comply with other rules.

Beginning Monday, the new rules: 

  • Ban sales of vapes, hookahs, pipe tobacco, or cigars to customers under 18 years of age (all but two states already passed their own laws limiting vape sales to those under 18 or 19 by 2015)
  • Require ID age verification for purchase of these products for anyone under 27 years.
  • Prohibit selling tobacco products in vending machines (unless offered in facilities where minors are neither present nor permitted at any time).
  • Ban free samples of e-cigarettes and other tobacco products

By May 2018 the rules require:

The premarket approval application process is long and expensive and companies will have to file one for every single component part of their product, as well as one for every flavor and nicotine level of e-liquids. The FDA estimates that preparing a single PMTA takes 5,000 hours and about $330,000 per application, but industry analysts believe it’ll be much more expensive. For all but the largest companies, even $300,000 is an unsurmountable hurdle. By some estimates, 99 percent of current vaping products won’t even apply for approval.

The other way vape companies could get approval is by filing a “substantial equivalence exemption request,” if they meet the requirements to be “grandfathered” in. In order to qualify, they must prove that their products are substantially similar to “predicate” products that were on the market before February 2007.

4. What is the predicate/grandfather clause?

As discussed, the grandfather clause—or predicate date—would allow products that were on the market or are substantially similar to products that were on the market before February 15, 2007 to bypass premarket approval. As noted, however, there were no e-cigarettes on the market prior to this date against which existing vaping products could measure themselves. In the FDA’s opinion, no vaping products will qualify for this exemption.

Since the new rules were proposed, many have asked the FDA to push the predicate date back—from 2007 to August 2016—when the new rules go into effect. Moved to 2016, even though it will be virtually impossible for new vape products to enter the market, at least those already present would have a better chance at remaining available for consumers. But the FDA claims it doesn’t have the authority to change this date, despite the fact that the TCA explicitly gives FDA “flexible enforcement authority to ensure that there is effective oversight of the tobacco industry's efforts to develop, introduce, and promote less harmful tobacco products.”

To address that issue, lawmakers have proposed legislation that, if passed and signed by the President, would amend the TCA, setting the predicate date at 2016.

5. What does all this mean for the public?

The reason the FDA wanted to regulate the vaping market is, ostensibly, to protect public health. E-cigarettes and e-liquids are new products and the long-term effects aren’t really known. However, we have unfortunately robust data about how deadly traditional cigarettes are, killing fifty percent or more of long-term users. There is also good data to support the estimate that vaping is 95 percent less harmful than cigarette smoking. So, what does this mean for the public? More expensive vaping products with less availability and variety means that fewer smokers will switch and more people—perhaps millions—will continue with their deadly tobacco habit and ultimately die because of it.