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The FDA & Deeming Regulations of E-cigarettes

NOTE: To see the actions CASAA has taken regarding FDA regulations prior to the date of this posting, click here.

03-03-2013

The passage of the Family Smoking Prevention and Tobacco Control Act of 2009 (FSPTCA) gave the Food and Drug Administration (FDA) the authority to regulate the manufacture, distribution and marketing of tobacco products to "protect public health." The FSPTCA defines the term “tobacco product,” in part, as any product “made or derived from tobacco” that is not a “drug,” “device,” or combination product.1


Between 2008 and 2010, the FDA tried to regulate electronic cigarettes as unapproved drug/device combination products and detained and/or refused admission to those offered for import by Sottera, Inc. and other manufacturers.  The companies sued the FDA to stop it from detaining their products. The U.S. Court of Appeals for the D.C. Circuit, in Sottera, Inc. v. Food & Drug Administration, 627 F.3d 891 (D.C. Cir. 2010), issued a decision with regard to e-cigarettes and other products “made or derived from tobacco” and the jurisdictional line that should be drawn between “tobacco products,” “drugs,” “devices” and combination products,  as defined in the Federal Food, Drug, and Cosmetic Act (FDCA).2  The court held that e-cigarettes and other products made or derived from tobacco can be regulated as  “tobacco products” under the FDCA and are not drugs/devices

 unless they are marketed for "therapeutic purposes." 3


Rather than appeal the court's ruling again, the FDA sent a letter to stakeholders regarding its intent to "propose a regulation that would extend the Agency’s “tobacco product” authorities in Chapter IX of the FDCA, which currently only apply to certain specifically enumerated “tobacco products,” to other categories of tobacco products that meet the statutory definition of “tobacco product” in Section 201(rr) of the Act." In the letter, the FDA specified electronic cigarettes and "other tobacco products" as products it intends to regulate. This is what is meant by "deeming regulations." The FDA will "deem" (ie. consider)  e-cigarettes and other new products not already specified in the FSPTCA to also be "tobacco products" which, unless the FDA choose to do otherwise, could subject e-cigarettes to the same regulations as other tobacco products that are already covered.


In January 2013, the FDA released its annual Regulatory Agenda, which states that the FDA should issue a Notice of Proposed Rulemaking (NPRM) no later than April of 2013. Upon issuing the rule making proposal, the public will have a period of time to comment on the proposed regulations.5


At this time we do not know which regulations the FDA intends to apply to e-cigarettes, but statements made by the FDA in its letter to stakeholders raises some concerns for electronic cigarette consumers and tobacco harm reduction advocates:


"Chapter IX also subjects “new tobacco products” (i.e., products that are first marketed or modified after February 15, 2007)  and “modified risk tobacco products”  (i.e., products that are “sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products”)  to pre-market review."


In theory, anything that wasn't on the market prior to 2007 could be banned until it was approved for sale by the FDA, unless it could prove that it is “substantially equivalent” to a “grandfathered” product that was being sold.6  Because electronic cigarette designs have changed and improved so dramatically since 2007 and many weren't even on the market in the U.S. prior to 2007, this regulation could deny consumers access to hundreds of existing products (leaving them access only to products on the market prior to February 2007) and put many electronic cigarette companies out of business - unless and until they can demonstrate their product does not raise different questions of public health compared to the approved products. The criteria to gain this approval is highly subjective and required documentation could be time consuming and extremely expensive. However, there is speculation that this provision could be altered to allow the technologies that exist as of the deeming in 2013 (or perhaps some date in between). This would obviously be better than limiting consumers to outdated, pre-2007 products, but the current environment of fast-paced development and release of new e-cigarette technology would be stopped in its tracks.


"Moreover, Chapter IX of the [FDCA] subjects “tobacco products” to general controls, such as registration, product listing, ingredient listing, good manufacturing practice requirements, user fees for certain products, and adulteration and misbranding provisions."


This statement is open to a lot of speculation. The FDA could choose to subject e-cigarette manufacturers and retailers to prohibitive registration paperwork, manufacturing requirements and user fees that could be unattainable for all but the largest companies. Manufacturing requirements and adulteration provisions could be reasonable or could severely limit the effectiveness of the products for consumers, such as prohibiting flavors other than tobacco and menthol, limiting nicotine content to extremely low levels and/or only allowing pre-filled, sealed cartridges to be sold. We simply won't know for certain until the FDA releases the actual proposed regulations.


Once the FDA has released its proposed regulations for e-cigarettes and other tobacco products to the public for comment, CASAA will review the legal and scientific implications of the proposal and identify points of concern and agreement.  We will then issue a Call to Action (CTA) asking members to submit comments to the FDA. The CTA will include recommended talking points and a link to the FDA comment form. It's extremely important that as many members as possible of CASAA and the e-cigarette community submit comments to the FDA when the time comes. This page will be updated as more information becomes known. 

To see the actions CASAA has taken regarding FDA regulations prior to the date of this posting, click here.

04-01-2013

FDA updated its agenda in early 2013 to reflect a new target date for issuing deeming regulations from April 2013 to October 2013.

04-05-2013

CASAA presents at FDA listening session in San Diego
The Office of Science in the Center for Tobacco Products held a public listening session, in conjunction with the annual meeting of the American Association for Cancer Research (AACR), this past Saturday.  Senior staff from the Office of Science was present to hear relevant presentations from members of the public.

CASAA director Elaine Keller attended the event with a presentation written by her and CASAA's Scientific Director, Dr. Carl Phillips, PhD.  Click the link above to see the transcript of the prepared presentation, with corresponding slides.

08-26-2013

CASAA gives presentation in FDA 'Listening Session'
Rockville, MD -- On August 26, 2013, CASAA had the opportunity to have a "Listening Session" with policy staff from the FDA's Center for Tobacco Products (CTP).  CASAA directors Elaine Keller, Carl V Phillips, Ronald A Ward, and Julie Woessner gave a presentation and answered questions for little over an hour.

Listening Sessions are an opportunity for stakeholders and others to communicate their views to FDA staff.  They primarily consist of one-way communication, though the staff typically ask questions.  They do not, however, answer questions or provide direct feedback, which would be inappropriate for government decisions-makers to do in a private meeting (consider what would happen if they gave information to a company and not its competitors).  Moreover, the participants are asked not to disclose information about the FDA's questions or any suggestions about the implications of their reactions.  Without such an agreement, FDA would not be able have sessions like this for obvious reasons.

CASAA focused on two messages:  (1) Consumers are the primary stakeholders in discussions of tobacco harm reduction (THR) and need a formal seat at the table, which they do not currently have.  (2) Specific insights we could offer about THR consumer preferences and behavior and the implications of these for making good and avoiding bad regulation.  CASAA advocates for consumers and potential consumers of all smoke-free alternativers, but the presentation was focused on e-cigarettes because regulation of this category is currently most in play.

We pointed out that formal consumer representation is mandatory in other health regulatory processes (patient group representatives, etc.), and the "nothing about us without us" principle has been accepted by the FDA for decades.  And yet, consumers' only voice in the CTP process is via mass protest, which is not terribly efficient and not enough.  The supposed consumer representatives are actually tobacco control special interests whose interests are actually diametrically opposed to those of consumers.  We pointed out that a formalized seat at the table allows effective two-way communication and is in everyone's best interest.  The alternative, with the consumer voice being entirely in the form of mass protest and everything that comes with it, makes it difficult to make good regulations and is more costly to the FDA.

We argued that we and most consumers see proper regulation of smoke-free alternatives as more similar to that for foods and cosmetics (which FDA also regulates) than drugs.  Consumers appreciate having an invisible regulatory process that ensures universal and accurate labeling of contents, along with the quality control needed to ensure general safety.  But once that is in place, individual consumers are the best judge of whether to consume the product, how much, and what particular varieties.

We pointed out the counter-productivity (in terms of serving the citizens they are supposed to be benefiting, including consumer benefits of public health) of restrictions on flavors or nicotine strengths.  In particular, we emphasized that any regulation that was (or appears) intentionally designed to lower the quality of the products in order to discourage use (a description of such policies as banning menthol in cigarettes) is inappropriate for low-risk alternatives and would likely lead to massive protest and organized resistance.

In terms of specific points about consumers, we emphasized the vapers are very motivated, and why and how this translates into mass political mobilization.  We explained how many e-cigarette users find "cig-a-likes" unsatisfying in terms of flavor, delivery, or purchase price.  Thus someone who does not have access to other products (or does not know their advantages) faces a major barrier to completely quitting smoking.  In particular, we emphasized that appealing flavors were the difference between continuing to smoke and quitting for many switchers (and, of course, that flavors appeal to adults, and there is not a shred of evidence they are attracting children to e-cigarettes).  Similarly, adequate delivery (in terms of not just nicotine concentration, but also sufficient batteries) is important. 

We pointed out the importance of the internet in giving consumers – most of who are not near an e-cigarette specialty store – access to better quality products.  As an aside, we pointed out that any regulations that favored low-quality devices over better ones, as well as imposed onerous mandatory requirements, would favor the cigarette companies' products – both their cigarettes, by making the alternative less appealing, and their e-cigarettes because they would be best able to comply with the regulations.

We addressed the common rhetorical point about "dual use" (and the related point about "gateway" effects) by reframing them more usefully as "transition."  We pointed out that there was nothing inherently harmful about dual use, of course, and that FDA officially agrees.  But we emphasized that anyone who is using e-cigarettes but still smoking should be thought of as one of the many switchers who used both for a while before quitting smoking.  With that, we could emphasize that making sure people have access to better e-cigarettes, as well as better communicating the comparative risks, is the key to helping complete the transition (and to ensure that no one makes the mistake of transitioning in the wrong direction).

We have every reason to believe that the FDA was interested in what we had to say and paid attention.  Their questions focused on what we presented.  We, of course, know nothing about how seriously they will take it.  We remain guardedly optimistic.  However, we believe we presented the best possible case for giving consumers a formal seat at the table.  If they do not move forward to making that happen, we can safely conclude that they are actively refusing to provide such a seat, in which case we will know that we need to fully mobilize for fighting from the grassroots level and pull out all the stops.

(Note: The FDA has stated its intent to issue its proposed "deeming regulations" for electronic cigarettes sometime in October 2013. After reviewing the proposed regulations, CASAA will issue a Call to Action, as needed. Please watch for future updates on this blog or via your email, if you are a registered CASAA member.)

09-24-2013

CASAA Press Release: E-Cigarettes: Rush To Regulate Could Destroy Effective Alternative

10-07-2013

CASAA Press Release: U.S. Government Officials Create False Crisis, Mislead Public About E-Cigarettes

01-04-2014

CASAA engages with US government to ensure consumer representation
This week, CASAA took two steps to help gain consumers better representation in tobacco product regulation.  First, we nominated our Scientific Director, Dr. Carl V Phillips, to serve on the Tobacco Products Scientific Advisory Committee (TPSAC) for FDA’s Center for Tobacco Products.  CTP has repeatedly assured the public that it intends to make sure consumers have a seat at the table.  (As you may know, consumers and those of us who organize to represent them have been relegated to supplicant status to date http://antithrlies.com/2013/12/10/dear-fda-ctp-nothing-about-us-without-us/ )  This will be a make-or-break test for their commitment, since it is difficult to imagine anyone more qualified to serve on that committee than Dr. Phillips.

We nominated him primarily for the consumer representative slot on the committee (which to date has been held by an extremist prohibitionist who is about as far from representing consumers as is possible), but also for any open slot, since he is also one of the most accomplished and broadly knowledgeable scientists in the area of the modern world of tobacco products (if you want more details on that, here is our nomination letter).  We believe he may be the only genuine consumer representative nominated this round, and know that he is among the most qualified scientists.  If his nomination is rejected, it can only be interpreted as the FDA not being honest about welcoming consumer participation in the process.

Second, we had a very successful meeting with the White House Office of Information and Regulatory Affairs (OIRA; part of the Office of Management and Budget), which is currently reviewing FDA’s proposed regulations of e-cigarettes.  (see: CASAA Testimony to OMB Office of Information and Regulatory Affairs January 2, 2014) As you know, FDA has written regulations that “deem” e-cigarettes to be tobacco products, and thus to be under the jurisdiction of their Center for Tobacco Products, and that contain other (as of yet, unknown) details about the regulation of e-cigarettes.  OIRA is the office responsible for reviewing all regulations to basically make sure they are not unnecessarily burdensome.  The testimony that CASAA (in the persons of Elaine Keller and Julie Woessner) delivered can be found here.

If you read that, you will notice that it is not just a generic broadside that says “e-cigarettes are great, and everything is fine, so regulation is bad.”  While that is often the right approach with politicians, dealing with different offices requires different approaches, and we realized that a generic plead would not be useful for persuading them or aiding their decision.  Thus, we based our analysis not on pleading about the wonders of the category, but on the regulatory economics arguments and other technical points that we believed would resonate with OIRA.  Apparently it worked, because they were attentive, asked a lot of questions, and kept us there well past our scheduled time so that they could continue to ask more.  We do not want to overstep by providing any details about what they said, but we will go as far as to say that they seemed to believe that the points had merit and did go to the basis on which they have to make their decision.

To summarize our testimony, we presented the great benefits and limited costs created by the current e-cigarette market, and argued that therefore almost any restrictive regulation would have a poor cost-benefit performance.  We emphasized how the current Center for Tobacco Products regulatory process was already overburdened, with a huge backlog of applications awaiting action, and that e-cigarettes would dramatically complicate this process even more.  In particular, we pointed out that the MRTP process (by which a product can get approval to enter the market and/or make health claims on the basis of being low risk) is currently nonfunctional.  Thus, while it might appear on paper that particular FDA regulations were reasonably flexible, in practice requiring these approvals was functioning as a de facto ban.  We did not suggest that the FDA’s motives or goals were bad, just that the combination of workload, decisions to date, and the constraints of the Tobacco Act make it almost impossible for them regulate e-cigarettes in a way that is beneficial rather than harmful.

OIRA seemed genuinely pleased to hear from real consumer representatives (in contrast with some decision-makers we have dealt with) and especially pleased that we brought them a cogent and fact-based analysis that focused on the decision criteria that they need to use, rather than just expressing opinions about what a perfect world would look like.  Before the meeting, we did not really think there was much hope that OIRA or the White House would intervene to change what might be some bad proposed regulations.  While it is far from certain that it will happen, we are now optimistic that they are seriously considering doing so.

04-24-2014

FDA releases e-cigarette rules
On its face, it appears that it is not as bad for consumers as it might have been, but there are still serious concerns. The FDA approval process is very complicated, and the details matter. Unlike some commentators, we are not prepared to say much more until we have a chance to examine them and consider them in the context of existing institutions.

It's important to remember that the recently published rules are only proposed rules at this time.The next step for the FDA will be to open a docket for public comments, which will last for 75 days. After analyzing the 240-page document, CASAA will issue a Call to Action for its members detailing any consumer concerns, instructions for submitting public comments and possible talking points.7

To download a copy of the rules: Click Here

04-25-2014

CASAA's Assessment of FDA Deeming Regulation

04-28-2014

CASAA press release: FDA regulation of e-cigarettes: huge costs, little or no benefit, says CASAA

05-08-2014

CASAA's Basic Background for Understanding FDA Regulation of E-Cigarettes

Overview of CASAA's Action Plan Regarding Proposed FDA Regulations 

05-11-2014

First Call to Action for FDA Proposed Regulations - Consumer Request for an Extension of Comment Period

05-14-2014

CASAA Submission to U.S. Senate Committee on Health, Education, Labor, and Pensions Regarding 5-15-14 Hearing on E-Cigarettes

05-21-2014

Second Call to Action for FDA Proposed Regulations - Consumer Comment on Paperwork Reduction Act

05-26-2014

CASAA's Comment to OMB/OIRA regarding Paperwork Reduction Act and FDA Deeming Regulation 

06-13-2014

Third Call to Action for FDA Proposed Regulations - Demand Congressional Hearings Investigating FDA and CDC's Actions

07-09-2014

CASAA's Second request for extension of FDA's comment deadline

07-14-2014

First Call to Prepare for FDA Proposed Regulations - Prepare Draft Comment
This is the first Call to Prepare in CASAA's Action Plan.  This Call to Prepare is your opportunity to begin laying the groundwork for your formal, substantive comment to the FDA.  Consistent with our earlier instructions, we are asking consumers to continue to wait to file substantive comments for a few more days, but now is the time to prepare part of your comments in earnest.  For now, write up a few paragraphs on each of these three points so it is ready to assemble into your final comments.

07-23-2014

Second Call to Prepare for FDA Proposed Regulations - Prepare/Refine Draft Comment
This second Call to Prepare is your opportunity to add to that content. Instructions on actually filing your comment to the FDA will be contained in the Fourth Call to Action that will be issued tomorrow, July 24, 2014. 



For more information:

1. Overview of the Family Smoking Prevention and Tobacco Control Act: Consumer Fact Sheet: http://www.fda.gov/tobaccoproducts/guidancecomplianceregulatoryinformation/ucm246129.htm
2. Sottera vs. FDA lawsuit:  http://casaa.org/FDA_vs.html
3. Sotter vs. FDA opinion:  http://casaa.org/uploads/ct_app_opinion_on_injunction.pdf
4. Stakeholder Letter: Regulation of E-Cigarettes and Other Tobacco Products: http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm252360.htm
5. http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201210&RIN=0910-AG38
6. http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM239021.pdf
7. CASAA FDA Actions: http://blog.casaa.org/search/label/FDA