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E Cigarette Legal Encounters

Wednesday, December 21st, 2011 at 6:55 pm  
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Potpourri of Other Legal and Quasi-Legal Considerations

For the e-cigarette community, legal issues other than those encountered by the cigarette, and to some extent the tobacco industry as a whole, may be relevant to the e-cigarette’s continuing legal encounters.

E-cigarettes and the Aviation Industry

e cigarette community
by eschipul under CC BY-SA
Taking Action On E Cigarettes

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For the e-cigarette community, the prohibited use of the e-cigarette on commercial airline flights, including non-American airlines, is growing worldwide, especially given the announcement by the FAA that in the spring 2012, e-cigarette use on airlines under its authority will be prohibited.  Even if the e-cigarette community could provide with no exceptions that the vapor produced by the c-cigarette contained nothing other than that which was originally in the atmosphere of a plane before the e-cigarette was used, it is doubtful that the trend against the use of e-cigarettes on commercial airline flights would significantly change.

What seems to be ignored, but possibly will become prohibited, is the possession of e-cigarettes, or any other e-tobacco use product on flights.  Such a prohibition on the bringing e-cigarettes on commercial airlines has nothing to do with the tobacco issues, or smoke versus vapor arguments currently facing the e-cigarette manufacturers. In the future, the ignition system within the e-cigarette itself might become the issue. With terrorists experimenting with ingenious methods of delivering their agents of violence, the e-cigarette is vulnerable to such a use, and consequent prohibition.

Potential Expansion of the No Smoking Zone

The most recent attack of the anti-tobacco coalition is on sports arenas.  However, given the fact that in many sports, the participants use tobacco products, this attack probably has many obstacles to overcome.  For the e-cigarette community, any expansion on smoking prohibitions needs to be monitored.

The Courts

To-date, the FDA has had little success in the courts in its attempts to enforce regulations on the e-cigarette manufacturers.  Even the more recent threat of the FDA regarding manufacturing defects and contaminated tobacco in e-cigarettes, and the newer law, the FDA has a substantial burden to overcome.

Turning Enemies into Allies

Being pro-active, instead of waiting for the legal system to legislate that the e-cigarette comes under the same laws and regulations as cigarettes or other tobacco products, the e-cigarette manufacturer and community  can “get to the courthouse first.”  Trying legally to separate the e-cigarette (and its progeny) from the tobacco products that are smoked is a tactic that could prevent e-cigarette inclusions.  Certainly, the e-cigarette industry would have to demonstrate that the vapor is not smoke, that the vapor contains no nicotine, and that the vapor itself is no different from any other steaming product which is not regulated or prohibited. Since second-hand smoke is currently as much a concern as the harm to the initial user, demonstrating that such a threat does not apply to e-cigarette vapor is imperative.

Conclusion

Although several of the e-cigarette NGO stakeholders would like law prohibiting the use of any nicotine product, that tactic seems improbable given the negative impact on the economy such an action would have.  Consequently, by providing a non-nicotine alternative to the traditional cigarette, the e-cigarette can provide an answer to the concerns of these NGO stakeholders while accommodating the e-cigarette users.

What Recent Legislation Means To The E Cigarette Comunity

Wednesday, December 14th, 2011 at 7:05 pm  
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For the e-cigarette community, recent legislation may possibly include the e-cigarette.

E cigarette legislationIn the two prior acts, the Cigarette Labeling and Advertising Act of 1965, and the Public Health Cigarette Smoking Act passed in 1979, were direct specifically at cigarettes, the e-cigarette industry, and e-cigarettes in particular, and were not included.  The obvious reason this lack of inclusion was that e-cigarettes did not exist, at least for the general public, at those times.

After the 2000 U. S. Supreme Court decision in FDA v. Brown and Williamson Tobacco Corp.,  when the Court ruled that the FDA had “overreached” its authority to regulate tobacco products as customarily marketed, stakeholders lobbied for additional tobacco control legislation.

In an attempt to protect the public health, in 2009 Congress passed and President Obama signed the Family Smoking Prevention and Control Act (Tobacco Control Act [TCA]).

However, this most recent legislation, which became effective on June 22 2010, gave the FDA control over tobacco products in general. Included in the provisions of the act was to give prior FDA rules, if those rules were to protect the health of youth, legal enforceability. Hence, the TCA effectively negated the Supreme Court decision.  Potentially, that provision gives the FDA control over the e-cigarette as a smokeless tobacco.

If the e-cigarette is a “smokeless tobacco product,” then the FDA now has the control it attempted to get through the back-door of the courts, but was stopped.

While some stakeholder praised the TCA, others criticize it as ineffectual as it does not eliminate nicotine, and “gives the appearance of regulation without allowing regulation actual regulation,” according to Michael Siegel, a community health sciences professor.

For the e-cigarette manufacturer, the TCA has no provisions the ban the import of tobacco products, which the act might prohibit, for personal consumption.  Only is the product is imported for sale or distribution does it come under the act.  Therefore, if e-cigarette users choose to directly import e-cigarettes from e-cigarette companies then the TCA “oversight” applies.

Under Section 101(a)(1) of the act, “the term ‘tobacco product’ means any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product.” Does this section include the e-cigarette in the TCA?  Under Section 900(17), the TCA defines “smoke constituent” such that the e-cigarette would come under the TCA.

Missing in Section 900 is a specific definition of “tobacco product.”  While “tobacco product” is defined under Section 101, that section is titled “Amendment of the Federal Food, Drug and Cosmetic Act (FDCA).” So, under the general concept of where definitions apply, one could argue that “tobacco products” (such as e-cigarettes) only come under the FDCA, not specifically under more stringent TCA.

The TCA defines “cigarette” in Section 900(3)(A), but limits the definition to the that of the Cigarette Labeling and Advertising Act (“any roll of tobacco wrapped in paper or in any substance not containing tobacco, and any roll of tobacco…is likely to be offered to, or purchased by consumers as a cigarette”).  Additionally, Section 900(3)(B) is included as an “and”, which means the e-cigarette does not meet the definition of a cigarette under the TCA.

Nevertheless, will the FDA try to include it?  Probably yes.

Non-Governmental Organizations That Have Influenced the Legal System

Tuesday, December 6th, 2011 at 4:43 pm  
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While Non-Governmental Organizations (NGOs) can neither pass nor enforce laws, they can, and have, greatly influenced them.

Money up in smokeUsing federal grant monies, these entities have done, and published, research which reflected negatively on the effects of cigarettes. While e-cigarettes are technically not cigarettes, to these groups a “cigarette,” including the e-cigarette is bad, immaterial of the actuality. Not only have these organizations provided information to their members, they have publicized their works and advertised their opinions. For the e-cigarette to avoid the fate of the cigarette industry, the e-cigarette manufacturers need to exploit the differences between the e-cigarette and the cigarette.

Another way in which these groups influence the legal system is through extensive lobbying. The e-cigarette industry, while doing lobbying of its own, cannot compete on the same playing field as these groups.  One of the reasons is the proliferation of them. Another reason is the “respectability” they present. By arguing as health professionals and concerned citizens, the e-cigarette community might be outclassed.  But the e-cigarette industry has the opportunity to generate its own place in this arena.

These groups represent not only voters but also contributors.  Since legislative bodies, heads of government, some enforcement officials, and judges are elected, while others are appointed by elected officials, by courting these persons, the e-cigarette industry has an opportunity to be heard.

One thing that the e-cigarette industry must overcome is the period of years that have proven many of these groups’ predictions and research accurate.

Another way in which these groups have been very successful is in the courts. While filing amicus curie (friends of the courts) briefs, they have been instrumental in effecting court decisions. In fact, many of these groups have a vested interested in the outcome of the law suits, as they are, or are trying to be, a financial recipients of the court awards.

However, all the things that these groups have had success with in the past, the e-cigarette industry can use to its advantage.

An e-cigarette, while it looks like a cigarette, is not a cigarette.  As an alternative to, not a substitute for, cigarettes, the e-cigarette industry might be able to use some of these organizations to present the e-cigarette as a viable choice.

While the e-cigarette industry might find that some in the American Cancer Society, American
Heart Association, AMA (American Medical Association) might be available to research the e-cigarette, other organizations such as Campaign for Tobacco Free Kids, ANR (Americans for Nonsmokers’ Rights), ASTHO (Association for State and Territorial Health Officials) would not be inclined to even listen to the e-cigarette industry representatives.

Since the advent of e-cigarettes is recent, the manufacturers do not have historical and empirical data. However, the issue which the e-cigarette industry has is that the e-cigarette is not the same as smoking. Vapor is not smoke. In law, each word has discrete meanings.

Virtually everything that is hot produces vapor.  For the e-cigarette industry, showing that the vapor is no more harmful than the vapor produced by any hot substance, and having these organizations concur, will go a long way to nip the legal issues in the bud.

Another issue, and a major legal hurdle which must be fully addressed, is the presence or absence of nicotine.  To the e-cigarette community, the absence of nicotine, which many consider an additive drug, is the key to the success of their arguments.

The Alphabet Soup of Federal Governmental Stakeholders

Wednesday, November 30th, 2011 at 4:26 pm  
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For the e-cigarette community, knowing the governmental stakeholders, along with the missions of each stakeholder, can provide a basic insight into the complexities of governmental intervention.

FdaBy getting an understanding about some of these stakeholders, the e-cigarette community can better understand not only the obstacles which the e-cigarette industry must overcome but also identify allies to help overcome or mitigate those obstacles.

Federal Governmental Agencies

Before going into each individual agency, the e-cigarette community can depend that, on the whole, these agencies fall into the obstacle category.

For the e-cigarette industry, the governmental stakeholders theoretically have unique missions, but, as with governmental entities, the actuality where one entity begins and another ends is so unclear that distinguishing which entity the e-cigarette falls under is, at best, described as convoluted.

Just as it began the attack on cigarettes, the Office of the Surgeon General will expand its anti-tobacco commitment to include the e-cigarette.

The Food and Drug Administration’s (FDA) mission, as stated by the head of the FDA in its “Strategic Priorities 2011-2015,” is to “protect and promote the public health.”  Under the assumption that “there is no known safe tobacco product,” the e-cigarette community has already won one big battle with the FDA.

To-date, use of the e-cigarette on commercial airlines has been at the discretion of the airline company.  According to recent information, the Department of Transportation will be issuing a regulation, going into effect in the spring 2012, prohibiting the use of the e-cigarette on all airlines.

Part of Alcohol, Tobacco, Firearms, and Explosives’ (ATF) mission is “to prevent criminal encroachment of the legitimate . . . tobacco industries organizations.” Basically, ATF is a law enforcement agency, not a policy making agency as is the FDA.  Consequently, in many ways the ATF protects the e-cigarette industry, as long as the taxes are paid.

For the e-cigarette industry, the Tobacco Tax and Trade Bureau (TTB), which is responsible for all inquiries in regards to regulating the . . . tobacco industries . . . and for the collection of taxes, seems to be one of those seldom referenced but possibly problematic governmental bureaus.  Depending on how TTB approaches is regulating ability; it can be either an ally or an obstacle for the e-cigarette manufacturer.

Another governmental entity that the e-cigarette community would probably readily name is the USDA (United States Department of Agriculture).  However, how many e-cigarette users would know the AHRQ (Agency for Healthcare Research and Quality), EPA (Environmental Protection Agency), FTC (Federal Trade Commission), HIS (Indian Health Service), OSHA (Occupational Safety and Health Administration), or SAMHSA (Substance Abuse and Mental Health Services Administration), just to name the most acknowledged.

Not To Be Overlooked

Nevertheless, the e-cigarette community must not forget to whom these governmental entities, and any other governmental entity that enters the e-cigarette discussion, depend; specifically, the USC (the United States Congress, both the Senate and the House of Representatives), the EB (Executive Branch, headed by the President), and the Judiciary.   While many of the e-cigarette community may consider these overseers as an obstacle, time has shown that pragmatism may prevail, especially where federal revenue is concerned.

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E cigarette Message

Monday, November 14th, 2011 at 6:19 pm  
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What the e cigarette Industry Tries to Convey to the Public May Become a Legal Boomerang

E cigarettes FDAWhat message does the e cigarette community want to project to expand, yet avoid or minimize legal complications?

The keyword is community, as it includes not only the business elements of e cigarettes —e cigarette manufacturers, e cigarette distributors, e cigarette suppliers, e cigarette sellers— but also the e cigarette consumers and future consumers.

As the theory behind the e cigarette expands to include e-cigars and e-pipes, the initial messages about the e cigarette should be consistent.  Once one member of the e cigarette community says one thing, while another says something contradictory, the governmental legislative and enforcement communities are provided different evidentiary elements to pursue.

Any inconsistency in the messages sent by any responsible member of the e cigarette community to the general public generates avenues that government regulations might pursue.

E cigarette is one Airline Passenger’s Choice

Even an action by an e cigarette user on an airline flight generated negative publicity for the e cigarette.  Although the actions of the passenger subsequent to his being requested to extinguish the e cigarette were the reason for his “eviction” from the airplane, people tend to recall only the passenger’s presumed attitude toward being told to extinguish the e cigarette.

Currently, the trend of the airline industry is prohibiting the use of e cigarettes on flights, just as it limits cigarettes, pipes, and cigars.  Given the closed environment and the necessity of recirculating air, it is doubtful that the airline industry would reverse the decision on e cigarette usage on flights.

Is the e cigarette community as a whole responsible for the actions of one passenger? No.  Will this incident have a negative impact on the e cigarette community?  Possibly, as it brings to the forefront the use of e cigarettes is restricted smoking areas, not just on an airliner.

Be aware of what is advertised, even if the advertiser is a competitor

One of the major arguments used by e cigarette manufactures is that no smoke is emitted, just a vapor.  Based on this issue, any legislation which references smoke would theoretically not be applicable to e cigarettes’ use and e cigarette manufacturers.

However, by virtue of some e cigarette manufacturers’ advertising, this plus for e cigarettes appears to be negated.  One e cigarette manufacturer is Green Smoke.  Either an e cigarette is vapor producer, not smoke, or the e cigarette is a smoker, immaterial of the environmental impact the advertiser is attempting to convey.  The e cigarette industry cannot be both.

By including smoke in advertising, whether it is actual smoking, or a sensation of smoking, or a simulation of smoking, or whatever a manufacturer wants to advertise, the product (namely e cigarette) may come under smoking bans —bans that the e cigarette industry seems to want to avoid.

Do e cigarettes emit smoke or a vapor?  Many people not familiar with the distinction between smoke and vapor do not distinguish, nor would want there to be any distinction.   Any appearance of smoking is enough.

What are the reasons for smoking bans and/or limitations? Do e cigarettes overcome them?

One of the most publicized reasons for smoking bans is second hand smoke.  Since e cigarettes emit vapor instead of smoke, is there second hand vapor?

Another concern of the public, which eventually influences the legal process, is what the vapor emitted by e cigarette usage and what that vapor actually contains.  If e cigarette vapor does not contain any traces of nicotine, then releasing test results that prove that might minimize restrictions on e cigarettes, as the environment would not be polluted by nicotine.

Smell emitted by burning tobacco or smoke from the user also generates negative comments. If there is no smoke, does the vapor have any odor?  If e cigarettes generate any odor, then what might be pleasing to one person might be unpleasant to another.  To minimize legal intervention, no odor in the vapor is be preferable

While the law limits additives in cigarettes to menthol, e cigarettes have no such restrictions.  Although many might think additives enhance the vapor of e cigarettes, if such additives when added emit an aroma, albeit pleasant to many, it becomes an odor to others.

Certainly advertising serves the need of the e cigarette community to advance usage of its products.  However, what might appear to be an innocuous advertising statement might become the club that governmental agencies trying to control the e cigarette industry need.   It only takes one word to make a huge change in tenuous balance of the legal skirmish between the e cigarette manufacturers, e cigarette users, and the governmental intervention which a court might uphold.

E cigarette FDA Status

Thursday, November 10th, 2011 at 5:00 pm  
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How Did the E Cigarette and the Current Status of the Federal Law Evolve?

E cigarette federalThe definitive interpretation of a law, statute, or regulation is the judiciary.  Whether it be a court of original jurisdiction (a court designated to be the first court that hears the case), or a court of appeals (a court that reviews the record and makes a determination to approve, overturn, or remand —send the case in whole or in part to the previous lower court).  In the US, when the Supreme Court makes a ruling, only new legislation or an amendment to the constitution can change the decision.

Currently, the legal status of the e cigarette as it pertains to governmental oversight occurred in the spring of 2011 when a three-judge panel of the U. S. Court of Appeals in Washington ruled that the FDA had overstepped its authority and that e cigarette and other similar products are not drugs/devices unless they are marketed for therapeutic purposes.

Why is the Federal Government Even Concerned about E Cigarette Usage?

Until January 11, 1964, the United States government’s control of the tobacco industry was limited to collection of taxes.  On that date, the Office of the Surgeon General of the U. S. released a report on the harmful effects of cigarette smoking. This report acted like a detonator on a bomb, with the e cigarette and e cigarette manufacturers eventual victims of the explosion.

However, the constitution of the US enumerates the powers of Congress as to category of laws it can pass.  Trying to include e-cigarettes as protecting the health of the citizenry, which is what the concern of the Office of the Surgeon was, is not on that list.  The problem of including e-cigarettes being covered is by using the tactic of the Commerce Clause…once something is transported across state lines, then Congress can legislate.  E cigarette distribution crosses state lines.

During the intervening years, the federal government, fuelled by additional information provided by the Office of the Surgeon General has engaged literally a war against cigarette smoking, or anything that could be considered similar to cigarette smoking.  The e cigarette falls into the latter category.

Several laws were passed by Congress with the goal of thwarting cigarette sales—the 1965Cigarette Labeling and Advertising Act, followed in 1970 by the Public Health Cigarette Smoking Act.   Interestingly, although passed in 1970, this act did not go into effect until January 1972 so that tobacco companies could advertise during the telecasts of the college football bowl games.

Developed by Hon Lik, a Chinese pharmacist, the e cigarette avoided coming under either of these laws both by intent and definition.

The FDA Decided to Extend Existing Law to Cover the E-Cigarette

Since the available cigarette laws did not cover the e cigarette or the manufacture of e cigarettes, the Food and Drug Administration (FDA) determined to extend the Federal Food, Drug, and Cosmetic Act (FD&C) to cover the import of the e cigarette by designating them as drug delivery devices.  The misplaced logic the FDA used to justify the attack strategy against e cigarette manufacturers was that e-cigarettes should be regulated as a nicotine replacement failed.

In its April 25, 2011 Letter to Stakeholders, (http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm252360.htm), the FDA announced that it would not appeal the court’s decision regarding e-cigarettes.

The FDA, not to take defeat easily, is not done using the FD&C. Most recently, the FDA is attacking e cigarette manufacturers alleging producing defective products and contaminated tobacco.

What will come of this newer approach against e cigarette manufacturers? As long as the e cigarette manufacturers make a quality product, the FDA will probably not succeed.  If e cigarette manufacturers make an inferior product, the public will buy alternative brands of e cigarettes.  In either instance, the e cigarette consumer will be the ultimate adjudicator on the quality of the product, not FDA legal gyrations.

Other Elements that Affect Control of The E-Cigarette

Thursday, November 3rd, 2011 at 5:35 pm  
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Since the e-cigarette is relatively new in the tobacco users’ choices, many of the already enacted laws are not applicable.

FDA regulations e cigaretteSince the e cigarette is covered neither in the scope nor in the definitions in the law. Again, this can easily change by a court decision, which as yet has not occurred.

Another element of law which helps the e cigarette manufacturer is the tobacco industry’s successfully prevention of several types of tobacco use not being legislated against.  Specifically, the FDA has exercised minimal control of pipe tobacco, cigars (other than small cigars), chewing tobacco, snuff, and the liquid form tobacco used in the hookah.

One may speculate on the reasons for such an apparent oversight. Cigarette smoking has received much negative notoriety. The proportion of the population that uses cigarettes significantly outnumbers the other forms of tobacco usage. With limited budgets, the government has to focus on the “most bang for the buck” approach.

How does all this affect the e cigarette?  The answer is “only time will tell.”  That is not avoiding the issues, but being aware of the changing goals of governmental agencies.

Office of the Surgeon General On The E Cigarette

One of the more significant departments that have affected the government’s public face on the tobacco industry is the Office of the Surgeon General, part of the Office of the Assistant Secretary of Health in the Office of the Secretary, U. S. Department of Health and Human Services. Theoretically, the purpose of this office is to provide the American public the best scientific information available on how to improve their health and reduce the risk of injury and illness (http://www.surgeongeneral.gov).  Historically, the Surgeon General has been in the forefront of influencing controls on tobacco industry, cigarettes in particular.

The advantage that the e cigarette industry has is, as it is relatively new in the market place, that scientific research and information is not available. The manufacturers of e cigarettes are not currently faced with overcoming any attack by the Office of the Surgeon General.  How long this silence remains is an unknown. Why?  One does not know what funding the Office of the Surgeon General is providing on obtaining scientific research on the e cigarette.  Research takes time, not only for the research to be done, but the information must be gathered over substantial time, using various factors.  One important factor which will impede any study is finding the right subjects, as any study on e cigarettes must not include anyone who smoked cigarettes, or possibly used tobacco in any form before using e-cigarettes.

Unavailability of Research Information On The E cigarette

Given that virtually everyone who uses the e cigarette have used tobacco products previously, research on the long-term, even short-term, effects of e-cigarettes on its users will be a hard to overcome obstacle.

Can the FDA force legislation on controlling the e cigarette absent scientific research and information to justify said control.  Undoubtedly the FDA will try.

The unknown in this scenario is what testing and research the manufacturers of e-cigarettes have done.  If such research has been done, the government will obtain it. If such research is currently being done, the government will somehow try to involve itself. However, where the research is being done might mitigate the Office of the Surgeon General obtaining what information the e cigarette manufacturer has or will have.

Alternatives

Another avenue that the Surgeon General has is to use information on similar devices, if similar devices exist, and the research would have to show a significant relationship between the e cigarette and the similar device.

The law and the e cigarette

Thursday, October 27th, 2011 at 9:25 am  
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First In A Series Of Legal Battles About The E Cigarette

E cigarette legal battleBefore delving into the on-going conflict between the Food and Drug Administration (FDA) of the United States and e cigarette manufacturers, one should have an understanding of the different elements of a law. Although most people think of a law as what can or cannot be done, there are several other parts of a law that are often overlooked, but essential to its understanding.

The first part of a law, even before it is enacted by any legislative body, is the intent or scope, why the law was passed and what it covers.  For the e cigarette, intent is often what eliminates it from being covered by the law.  Since the earliest laws passed relating to smoking specifically addressed cigarette advertising and labeling, in response to the reports from the Surgeon General, e cigarettes were not included in the intent of the coverage of the law.  Therefore, the law could not be extended to include them.

Another essential element of a law is the definitions; the words in a law that could be subject to dispute are defined, and often limited the scope of the law.  Definitions can appear in the beginning of a law or throughout the law’s various sections.  If the definition is in a section and, since definitions may vary from section to section, the definitions are only applicable within the section in which the definitions occur.  Again, the e cigarette comes out the winner in the earlier laws, as these laws were passed before the advent of the e cigarette.  Consequently, the e cigarette does not appear in any definition, nor can the existing definitions be extended to include them.

Unless something satisfies both the intent and definitions, one usually need go no further into the law as nothing in that law can apply. However, the courts have somewhat modified the issue by extending definitions beyond what the legislative body might have meant.  The easiest way to understand this change of definition by a court is exemplified by the tomato.  Although a tomato is a fruit, the Supreme Court ruled it was a vegetable.  Therefore, laws stating “vegetable” could also encompass a tomato.  If the FDA decided to attempt this method of  extension of definition to cigarettes to e cigarettes, then  e cigarette manufacturers would probably have to defend why their product is not a cigarette, but a different product altogether.

We will continue this discussion on the e cigarette in subsequent articles posted here.

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