The FDA & Deeming Regulations of E-cigarettes

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.

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.



For more information:

1. 
http://www.fda.gov/tobaccoproducts/guidancecomplianceregulatoryinformation/ucm246129.htm
2. http://casaa.org/FDA_vs.html
3. http://casaa.org/uploads/ct_app_opinion_on_injunction.pdf
4. 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