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Regulation of E-Cigarettes_ - UNC School of Government

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Regulation of E-Cigarettes:
Federal and state activityAnna Stein, JD, MPHLegal Specialist, Community Transformation Grant ProjectNC Division of Public HealthApril 17, 2013
How E-Cigarettes Work
Battery poweredWhen user inhales on the mouthpiece, vaporizer turns on and coverts liquid in cartridge into a vapor by heating itThe end lights up when the device in is use to mimic a cigaretteUse often referred to as “vaping”
Legacy Foundation
What is Inhaled by the User?
Nicotine and other chemicalsManufacturers are currently not required to list the ingredients of the e-cigaretteliquidA variety of nicotine levels are advertised by manufacturersSome varieties claim to be nicotine freeOffered in a variety of flavors, such as vanilla, chocolate, menthol, and fruit flavors
Americans for Nonsmokers Rights,
2009 Study by the FDA
FDA’s Division of Pharmaceutical Analysis analyzed the ingredients in a small sample of cartridges from two leading brands of e-cigarettesFound detectable levels of toxic chemicals and known carcinogens, including nitrosaminesIn one sample, FDA detecteddiethyleneglycol, a chemical found in antifreeze
Legacy, 2009
2009 Study by the FDA, cont’d
Testing suggested that quality control processes in manufacturing are inconsistent to non-existentThree different e-cigarettes with the same label emitted a markedly different amount of nicotine with each puffAll of the e-cigarette cartridges tested that were labeled “no nicotine” contained low levels of nicotine except one
Legacy, 2009
February 2013 publication,Indoor Air
Researchers found thatexhalinge-cigarettevaporreleases measurableamounts of carcinogens and toxins into the air, including nicotine, formaldehyde, andacetaldehydeEmissions from the e-cigarettes were a fraction of the emissions from the conventional cigarette used as a comparisonConclusion: “The e-cigarette is a new source of volatile organic compounds (VOCs) and ultrafine/fine particles in the indoor environment. Therefore, the question of ‘passivevaping’ can answered in the affirmative. However, with regard to a health-related evaluation of e-cigarette consumption, the impact of vapor inhalation into the human lung should be of primary concern.”
Attempted Federal Regulation ofE-Cigarettes
In 2008 FDA attempted to regulate e-cigarettes as a drug or drug delivery device under the Federal Food, Drug, and Cosmetic Act (FDCA) ; blocked shipment of e-cigarettes into the USIn 2009,Sottera, distributor of NJOY e-cigarettes, sued for an injunction to allow the entry of their e-cigarettes, claiming that e-cigarettes cannot be regulated under the FDCAThe US DistrictCourt of the District of Columbia ruled that e-cigarettes cannot be regulated as a drug or drug delivery device and so FDA lacked authority to block the shipmentThe FDA appealed to the US Court of Appeals
Sotterav. FDA, 627 F.3d 891 (D.C. Cir. 2010)
The Federal Food, Drug, and Cosmetic Act (FDCA) gives the FDA authority to regulate articles that are “drugs,” “devices,” or “drug/device combinations”“Drugs”are defined as:Articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of diseaseArticles intended to affect the structure or any function of thebodyThe FDAsought to regulate e-cigarettes as a drug/device under the “intended to affect the structure or any function on the body” provision of the FDCA
Sotteracourt looks toBrown & Williamson
The DC Circuit Court looked to the US Supreme Court’s decision inFDA v. Brown & Williamson(2000), wherein the FDA hadattempted beginning in 1996 toregulate cigarettes and smokeless tobacco under the same provisionThe Supreme Court inBrown & Williamsonsaid that FDA’s role under the FDCA is to approve only products that are safe and effective for their intended useSince tobacco products are clearly not safe when used as intended, they do not fit under the regulatory scheme set forth in the FDCA
Supreme Court’s analysis inBrown & Williamson, cont’d
If the FDA banned tobacco under the FDCA, it would be going against Congress’s clear intent that tobacco be a legal product (as demonstrated by its passage of six statutes relating to tobacco since 1965 and its declaration that “[t]he marketing of tobacco is one of the greatest basic industries of the United States”)Furthermore, the FDA until that time had repeatedly claimed it did not have the authority to regulate tobacco productsThus,the Supreme Court concludedthat the FDA did not have authority to regulate tobacco products under the FDCA
Sotteraexamines Congress’sresponse toBrown & Williamson
In response to the regulatory gap exposed byBrown & Williamson, Congress passed the Family Smoking Prevention and Tobacco Control Act of 2009 (TCA)The TCA allows the FDA to regulate “tobacco products,” which it defines as:“any product made or derived from tobacco that is intended for humanconsumption”
The FDA argued inSotterathatBrown & Williamsononly stood for the proposition that the FDA couldn’t regulate tobacco products under the FDCA that had been the subject of specific federal legislationat the time of that decision (namelycigarettes and smokeless tobacco); e-cigarettes had not been the subject of any legislation and thus could be regulated under theFDCATheSotteracourt opined that the Supreme Court inBrown & Williamsondid not intend to include only cigarettes and smokeless tobacco when it held that tobacco products may not be regulated under the FDCA and that the Supreme Court’s decision would encompass e-cigarettes aswellThus, the FDA must regulate e-cigarettes under the TCA
Interesting concurrence inSottera
Judge Garland wrote:I do not believe the Supreme Court intended its use of the term “tobacco products” to extend to products that do not contain tobacco.He continued:On its face, the natural meaning of the term “tobacco product” is a product—like cigarettes or chewing tobacco—that contains tobacco. Although it is true that the liquid nicotine in NJOY’s electronic cigarettes is derived from tobacco, it seems less natural to regard that fact as sufficient to transform NJOY’s plastic cartridges—which contain no tobacco—into a tobacco product. As NJOY acknowledges, its reading leads to the counterintuitive conclusion that a syringe filled with injectable nicotine is a tobacco product as well.
Sotteraconcurrence, cont’d
Thus,Garlanddid not believeBrown & Williamson’s holding that tobacco products cannot be regulated under the FDCA would extend to e-cigarettesNevertheless, he found that the Tobacco Control Act has a very broad definition of “tobacco product” which includes “any product made or derived from tobacco”Since the nicotine in e-cigarettes is “derived from tobacco,” e-cigarettes were intended by Congress to be regulated under the Tobacco Control Act
Thus, in regulating “tobacco products” the FDA is limited to the authority given in the Tobacco Control Act, such as:To impose restrictions on their saleTo impose restrictions on their advertising and promotionTo regulatetheirmode ofmanufactureTo require ingredient listingTo subject “new tobacco products”(those 1stmarketed or modified after 2/15/07)and “modified risk tobacco products” to pre-market reviewNote: The FDA can still regulate tobacco products marketed for “therapeutic purposes” under the FDCA
Where does FDA regulation of e-cigarettes under the Tobacco Control Act stand today?
In an April 2011 letter, the FDA informed the public that it would not appeal theSotteradecisionThe Tobacco Control Act immediately placed only certain categories of “tobacco products” under the general control and premarket review requirements of the FDA:CigarettesCigarettetobaccoRoll-your-owntobaccoSmokelesstobaccoThus, the FDA does not have immediate authority to regulate e-cigarettes
The Tobacco Control Act permits the FDA, by regulation, to extend its controls to other categories of “tobacco products”The FDA announced in its April 2011 letter that it intends to issue “deeming regulation” to extend its authority to e-cigarettes and other new “tobacco products”In January 2013, the FDA released itsannual Regulatory Agenda,whichstatedthat the FDAplanned toissue a Notice of ProposedRulemaking on these other tobacco products in April 2013Uponissuing therule-makingproposal, the public will have a period of time to comment on the proposedregulations
Regulation of E-Cigarettesat theState and LocalLevel
Regulatory gaps identified by the Tobacco Control Legal Consortium:TaxationThe TobaccoControl Act preserves the authority of state and local governments to levy taxes on tobaccoproductsE-cigarettes are not taxed beyond sales tax in NCLocal governments in NC do not have the authority to levy their own taxes
Regulatory gaps, cont’d
Point-of-SaleWarnings, Marketing Restrictions & Broad SalesProhibitionsNCGS 14-313(e): Preempts local regulation concerning “the sale, distribution, display or promotion of tobacco products”“Tobacco product” is defined as “[a]nyproduct that contains tobacco and is intended for human consumption”; not clear that this would include e-cigarettesBill has been introduced in both the NC House and Senate to amend NCGS 14-313(e)’s preemption to include e-cigarettes
Regulatory gaps, cont’d
YouthAccessCurrently, NCGS 14-313 bans the sale of“tobacco products”to people under the age of 18Arguably, e-cigarettes are not covered bythe definition of “tobacco products”Proposedamendment to NCGS 14-313by House and Senate bans the saleof “tobacco products, tobacco-derived products, or vapor products” to minorsAmendment clarifies that “the term [tobacco product] does not include a tobacco-derived product or a vapor product”
“Tobacco-derived product” isdefined in the amended version of NCGS 14-313 as“[a]nynoncombustible product derived from tobacco that contains nicotine and is intended for human consumption, whether chewed, absorbed, dissolved, ingested, or by other means. This term does not include a vapor product….”“Vapor product” is definedas“[a]nynoncombustible product containing nicotine that employs a mechanical heating element, battery, or electronic circuit, regardless of shape or size and that can be used to heat a liquid nicotine solution contained in a vapor cartridge. The term includes an electronic cigarette, electronic cigar, electronic cigarillo, and electronic pipe.”
Regulatory gaps, cont’d
UserestrictionsS.L. 2009-27 (House Bill 2) allows local governments to regulate “smoking” in government buildings,grounds,and vehicles, and in public places“Smoking” is defined as “’[t]he use or possession of a lighted cigarette, lighted cigar, lighted pipe, or any other lighted tobacco product”Arguably, as discussed above, e-cigarettes are not “tobacco products”In any event, theyare not“lighted”Therefore, S.L. 2009-27 (House Bill 2) does not address local regulation of e-cigarettes
However, state preempting legislationpassed prior to S.L. 2009-27 (House Bill 2) onlypreempted local regulation of “smoking”; see NCGS 143-601Other types of regulation have never been preempted by the state; e.g.,regulation of smokeless tobaccoThe same authority to regulate, for example, smokeless tobacco in parks (basic police power authority of local governments) would coveruse restrictions on e-cigarettes
Final Note about Regulation
Other states are adding youth access restrictions for e-cigarettes and other tobacco products, while also adding provisions regarding the taxation of these products (e.g., Oklahoma)New definition of “vapor products” and “tobacco-derived products” in North Carolina’s youth access law opens the door for other state laws regarding e-cigarettes and other nicotine products such asdissolvables





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Regulation of E-Cigarettes_ - UNC School of Government