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Posts Tagged ‘e-cigarettes’

PHAI’s Gottlieb Comments on FDA Regulations’ Effect on Vaping Industry on All Things Considered

Wednesday, August 24th, 2016

On August 8, 2016, new regulations by the FDA went into effect that have a profound impact on a major segment of the electronic cigarette industry:  vape shops.  The shops that mix flavors for vaping products are now considered to be manufacturers and subject to the same requirements as manufactures owned by the companies that make Marlboros, Camels, and Newports.

The new rules will require each and every flavor variation of electronic cigarettes to be approved by the FDA as a new tobacco product.  The cost associated with each application is estimated by the agency to average over $300,000.  Vape shops had typically created many dozens of varieties of “e-juice” every month and, under the new rules, the revenues from these flavor varieties would account for only a small fraction of the cost for submitting new tobacco product applications. This has led some vape shops to close their doors.

WGBH’s Isaiah Thompson reported on these developments  for NPR’s All Things Considered (with an expanded written version). PHAI’s executive director, Mark Gottlieb, is quoted in the piece.

Vape Shop



PHAI Submits Comments on Proposed Mass AG Regulations for E-Cigarettes

Friday, May 1st, 2015

On April 23, 2015,  the  Public Health Advocacy Institute submitted the following written comments concerning proposed regulations for electronic cigarettes issued by Massachusetts Attorney General Maura Healey:


April 23, 2015

Amber Villa, Assistant Attorney General
Consumer Protection Division
Office of the Attorney General
One Ashburton Place
Boston, MA 02108

Re: Massachusetts Attorney General Proposed Regulations of E-Cigarettes Retail Sales

Dear Assistant Attorney General Villa:

On behalf of the Public Health Advocacy Institute at Northeastern University School of Law (PHAI), I am writing in response to Attorney General Maura Healey’s
request for comment on the proposed regulation of e-cigarettes sales. We at PHAI are dedicated to protecting and improving public health through law and legal policy. We enthusiastically support the proposed regulations to reduce youth access to e-cigarettes.

The three-fold increase in e-cigarette use among middle and high school age youth from 2011 to 2013 demands a response. [1]  Now a quarter of all high school age children and eight percent of middle school age children use e-cigarettes and do so regularly. [2]  We appear to be watching tobacco become ‘cool again’ among youth, and this time it is e-cigarettes.

This alarming trend sadly is not surprising. E-cigarette advertisements appear everywhere, promoting brands like Blu, which suddenly have become as recognizable as Marlboro and Camel. Additionally, candy and other exotic flavored e-cigarettes are contributing to the growing popularity among youth. Tobacco industry documents discovered through litigation tell us that manufacturers used such flavors in the past to target sales at children. [3] Today, e-cigarette  manufacturers may be doing the same thing with flavors like Cotton Candy, Sweet Tart and even Unicorn Puke. [4] Unicorn Puke is a mash-up of candy flavors.

PHAI applauds Attorney General Healey’s effort to stop the sale of e-cigarettes to children. Although some municipalities already established similar youth access
protections, many have not. [5]  The thousands of retailers in these municipalities can legally sell to children of any age. Unattended vending machines and self-services displays, which lead to youth acquisition of tobacco products, are allowed. Even online retailers do not need to verify a buyer’s age, if the product is delivered anywhere in these cities and towns. Attorney General Healey’s proposed regulation would stop these retail practices.

The leadership shown by Attorney General Healey also challenges others to join her and develop a more comprehensive public health response to e-cigarette use. Our state legislators, state agencies, and public health partners working at the municipal level must also respond in a coordinated and sustained manner. The e-cigarette industry appears to be acting just like tobacco manufacturers did decades ago. Partly, this similarity can be explained by the fact that many cigarette manufacturers also manufacture e-cigarettes. [6] Another, perhaps more important reason we appear to be reliving the tobacco industry’s past is because we are letting it happen through our own inaction.

Consider just some of the differences in regulatory oversight. E-cigarette advertisements are on television and cable. Other tobacco products are not because it would be illegal. The 1998 Master Settlement Agreement, which prohibits the use of cartoons in tobacco advertising and tobacco brand sponsorships at youth oriented events, is not applied to e-cigarettes. [7]  Candy and fruit-flavored cigarettes are prohibited, [8]  but exotic flavored e-cigarettes are heavily promoted and sold in Massachusetts. We tax tobacco products to dissuade use and help pay for tobacco prevention programs. [9] There is no tax on e-cigarettes. We passed smoke-free workplace laws to protect against secondhand smoke exposure and to de-normalize smoking. [10] Except for a few municipalities, [11] no such equivalent protection exists for e-cigarette emissions.

Attorney General Healey takes a strong first step in establishing at least some proportionality in e-cigarette regulation compared to other tobacco products. Although initial research suggests that e-cigarettes are a less harmful alternative to traditional cigarettes, scientific research also tells us that e-cigarettes are not safe. Just last week, CDC Director Dr. Thomas Frieden stated that e-cigarettes are not safe, in part, because “research had found that nicotine harms the developing brain.” [12]  In addition to a lifelong addiction to nicotine, exposing the young, developing brain to nicotine acts as a ‘gateway’ to other drug addictions. [13]

Additionally, e-cigarettes emit other constituents that should raise concerns for the public’s health. Monitoring of e-cigarette emissions has found varying levels of toxins and carcinogens in different brands and product types. [14] The range is broad. Some brands emit trace amounts of carcinogens, while other e-cigarette products, like refillable tank systems for example, can produce levels of formaldehyde comparable to combusted tobacco products. [15] Currently, there is no regulation of liquid or gel solution in e-cigarettes or how they are vaporized. Put simply, e-cigarettes are not a cessation product designed to end the harm caused by tobacco use or nicotine addiction.

PHAI would recommend one technical change in the proposed regulation. The regulations should not set “18 years of age” as the minimum sales age. Instead, the proposed regulations should use the minimum sales age set by the Legislature.  Currently, that age is 18, but proposed state legislation would raise it to 21. [16]  Several municipalities have already taken this step. [17]

 
Respectfully submitted,
/s/
Christopher Banthin, Esq.,
Program Director

REFERENCES
1  Intentions to Smoke Cigarettes among Never-Smoking U.S. Middle and High School Electronic Cigarette Users, National Youth Tobacco Survey, 2011-13, Nicotine & Tobacco Research, April 2015.
2  Id.
3 United States v. Phillip Morris, Inc., RJ Reynolds Tobacco Co., et al., 449 F.Supp.2d 1 (D.D.C. 2006).
4 Sabrina Tavernise, Use of E-Cigarettes Rises Sharply Among Teenagers Report Says, New York Times, April 17, 2015.
5  Donald Wilson, Municipal Tobacco Control Technical Assistance Program, Mass Municipal Ass’n (March 2015).
Big Tobacco Companies are Putting Big Warning Labels on Their E-Cigarettes, Washington Post, Sept. 29, 2014.
7   http://www.naag.org/naag/about_naag/naag-center-for-tobacco-and-public-health.php, visited on April 19, 2015.
8  21 U.S.C. § 387g.
9  Mass Gen Law. Ch 64C.
10 Mass. Gen Law. Ch. 270, Sec. 22.
11 Donald Wilson, Municipal Tobacco Control Technical Assistance Program, Mass Municipal Ass’n (March 2015).
12  Tavernise, supra, n. 4.
13 Eric Kandel, et al., A Molecular Basis for Nicotine as a Gateway Drug, New England Journal of Medicine, Vol. 371, Pp. 932-41 (2014).
14  US Food and Drug Administration. Final Report on FDA Analyses, May 4, 2009, available at  http://www.fda.gov/downloads/Drugs/ScienceResearch/UCM173250.pdf
15  Matt Richtel, Some E-Cigarettes Deliver a Puff of Carcinogens, New York Times, May 3, 2014.
16 House Bill 2021, An Act Further Regulating the Sale of Tobacco Products to Teenagers, 189 General Court 2015.
17  Wilson, supra, n. 5.


 



PHAI Submits Comments to FDA on Deeming Rule Focusing on E-Cigarettes

Friday, August 8th, 2014

Today the Public Health Advocacy Institute submitted comments  to the U.S. Food and Drug Administration on its proposed rule to include cigars, little cigars, electronic cigarette products, and tobacco for hookah smoking among the products for which it can legally issues rules and regulations.  This is known as a “deeming rule.”  The deeming rule is a first step toward regulating tobacco products beyond the cigarettes, smokeless tobacco, and roll-your-own products that the agency now regulates through its Center for Tobacco Products.

The Center for Tobacco Products solicited a wide range of comments and posed many questions to stakeholders and the public in its proposed rule.  PHAI focused its comments on the question of how best to regulate electronic cigarettes once they have been deemed tobacco products and are regulated by the FDA.

PHAI found that the vast majority of the American public believes that electronic cigarettes are a reduced risk product and that manufacturers and sellers of electronic cigarettes have marketed their products directly and indirectly as safer products.  Only tobacco products that are approved as “modified risk tobacco products” are permitted to advertise and market their products as posing a reduced risk to users.  As a result, electronic cigarette advertising focuses on other sorts of appeals such as sex appeal and conceptual themes that may attract new users and result in youth initiation. Electronic cigarettes are supposed to be an alternative to the most dangerous tobacco product, cigarettes, not a new pathway to addiction and eventual cigarette use for young people.

Electronic cigarette companies are benefiting from the perception that these are reduced risk products without going through the necessary approval process to attain that status from the FDA.

PHAI recommends:

1. Electronic cigarettes should not be approved as “new tobacco products” because the public already believes that they are reduced risk products.

2. Electronic cigarette manufacturers should apply for approval by FDA under the “modified risk tobacco product” category and demonstrate that their products will be a real benefit to public health.

3. FDA should require a statement in all electronic cigarette advertising stating that the agency has approved the product as a “modified risk tobacco product.”  If electronic cigarettes were approved only as “new tobacco products,” they could not advertise because they could not carry the statement required on all advertising.  This would ensure that there would only be advertising for electronic cigarettes that were demonstrated to be beneficial to public health and drive consumers to purchase those products that carry the proposed required FDA statement.

4. In addition, PHAI urged the agency to include premium cigars in its regulatory authority by deeming them to be tobacco products.  Even if there is no need to impose new rules on premium cigars at this time, if the need did arise, having already deemed these tobacco products as “tobacco products” for regulatory purposes would allow the FDA to issue rules and regulation should evidence indicate such a need.

and

5. PHAI urged the FDA to develop comprehensive regulations for flavors in all newly deemed tobacco products.  Candy flavors should be banned and any other flavors proposed to be retained by manufacturers should only be approved upon a showing that the flavor contributes to improving public health.

You can download PHAI’s comment here.



Sottera, Inc. v. Food & Drug Admin.

Monday, July 8th, 2013

In April of 2009, Sottera, Inc., an importer and distributor of electronic cigarettes (“e-cigarettes”), sought a preliminary injunction barring the FDA from denying their products entry into the United States. E-cigarettes are “battery powered products that allow users to inhale nicotine vapor without fire, smoke, ash, or carbon monoxide.”[1] The nicotine in each e-cigarette is derived from tobacco plants. The FDA denied Sottera’s e-cigarette shipments entry into the U.S., asserting that e-cigarettes were unapproved drug-device combinations subject to their authority under the Federal Food, Drug, and Cosmetic Act (“FDCA”).[2] The FDCA gives the FDA authority to regulate drugs, devices, or drug/device combinations.

In 2000, the Supreme Court decided in FDA v. Brown & Williamson, that the FDA did not have the FDCA authority to regulate tobacco products as customarily marketed, meaning tobacco products marketed without claims of therapeutic effect.[3] In 2009, the Family Smoking Prevention and Tobacco Control Act (“Tobacco Act”) finally gave the FDA the authority to regulate customarily marketed tobacco products. The Tobacco Act defines tobacco products to include “all consumption products derived from tobacco except articles that qualify as drugs, devices, or drug-device combinations under the FDCA.”[4]

Sottera relied on Brown & Williamson to argue that e-cigarettes should be considered customarily marketed tobacco products such that the FDA has no authority under the FDCA to deny their products entry into the United States.[5] The FDA asserts that Brown & Williamson barred the FDA from regulating only those tobacco products that existed at the time the case was decided, and that e-cigarettes are properly regulated by the FDCA as a drug/device combination.[6]

The United States District Court for the District of Columbia granted a preliminary injunction barring the FDA from regulating e-cigarettes as drug/device products.[7] The Court held that Brown & Williamson precluded the FDA from treating e-cigarettes as a drug/device combination because e-cigarettes were customarily marketed tobacco products.

The D.C. Court of Appeals affirmed the District Court’s injunction barring the FDA from regulating e-cigarettes under the FDCA. The court held that e-cigarettes should be regulated as tobacco products under the Tobacco Act. The Court of Appeals stated that the holding in Brown & Williamson extended to all customarily marketed tobacco products.[8] Additionally, the court noted that the Tobacco Act specifically states that it does not “affect, expand, or limit” the FDA’s jurisdiction under the FDCA.[9] The Court of Appeals stated that,

 Together, Brown & Williamson and the Tobacco Act establish that the FDA cannot regulate customarily marketed tobacco products under the FDCA’s drug/device provisions, that it can regulate tobacco products marketed for therapeutic purposes under those provisions, and that it can regulate customarily marketed tobacco products under the Tobacco Act.[10]

 Thus, the Court of Appeals sided with Sottera, holding that e-cigarettes are customarily marketed tobacco products subject to FDA authority under the Tobacco Act, not the FDCA.

The FDA indicated it will not appeal the decision and will move forward with e-cigarette regulation through the Center for Tobacco Products.

Summary by Katelyn Blaney


[1] Sottera, Inc. v. Food & Drug Admin., 627 F.3d 891, 893 (D.C. Cir. 2010).

[2] Id.

[3] Food and Drug Admin. v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 126 (2000).

[4] Sottera, 627 F.3d at 894.

[5] Id. at 893.

[6] Id. at 895.

[7] Online Link to District Court Decision: https://ecf.dcd.uscourts.gov/cgi-bin/show_public_doc?2009cv0771-54.

[8] Id. at 895.

[9] Id. at 894.

[10] Id. at 898.




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