The FDA’s Assault on Tobacco Consumers, Part 2


bill introduced in the U.S. House last month would ban the flavoring of any “tobacco product.” The targets are vaping devices (vapes, e-cigarettes), but also cigars and pipe tobacco. (Flavored conventional cigarettes other than menthol have already been banned.) The Food and Drug Administration deems vaping devices “tobacco products” even though they contain no tobacco. Introduced without sponsors by Rep. Rosa DeLauro (D-CT), the bill would allow an exception for some vaping products, but it is one that would be all but impossible to qualify for.

The rationalization for the prohibition is that flavoring attracts underage consumers to the products. Yet this seems implausible because it suggests that without flavoring teenagers would be uninterested in e-cigarettes (not to mention conventional cigarettes). Yet kids have long been attracted to conventional unflavored cigarettes. (And unflavored marijuana has no troubling winning favor among the young.) After all, fruit, mint, and other flavors are readily available in unrestricted products like hard candy, chewing gum, and soft drinks. So if underage consumers want those flavors, why don’t they stick with products they can legally buy? Clearly, the attraction to e-cigarettes (and conventional cigarettes) is something other than flavors — the “coolness,” or maturity, factor perhaps.

DeLauro’s bill betrays a fundamental puritanism, which underlies all prohibitionism: since nicotine is a substance that provides pleasure and some people therefore use it habitually, it must be stamped out and its consumers, producers, and merchants demonized. (Human beings have long affirmed themselves by demonizing others and their preferences.) As H. L. Mencken told us: puritanism is the “haunting fear that someone, somewhere, may be happy.”

At any rate, DeLauro’s bill is redundant because the FDA under Trump appointee and putative deregulator Scott Gottlieb is already moving in that direction. Indeed, Gottlieb now threatens to yank vapes from the market and subject them to a lengthy and expensive regulatory review if “the youth use continues to rise.” (The anti-vaping hysteria is just getting started.) According to NBC News, Gottlieb told a meeting: “If … we see significant increases in [youth] use in 2019, on top of the dramatic rise in 2018, the entire category will face an existential threat. It will be game over for these products until they can successfully traverse the regulatory process.” (Emphasis added.) He reportedly accused the e-cigarette makers of marketing to young people. Yet when those makers label their products as for adults only, they are accused of enticing children. Damned if you do; damned if you don’t.

Welcome to America, the land (as Mencken put it) of the “theoretically free.”

In 2009 Congress and Barack Obama gave a virtual blank check to the secretary of health and human services to regulate “tobacco products” through the FDA and a soon-to-be-created Center for Tobacco Products. The result over the last few years has been a dizzying cascade of oppressive rules governing manufacturing, retailing, labeling, and other aspects of the business of producing and selling combustible and smokeless tobacco and nicotine-delivery products that don’t contain or are not made out of tobacco, such as e-cigarettes and pipes.

Among other things, the FDA has begun to move toward mandating that the nicotine in cigarettes be reduced to so-called “non-addictive” levels, the consequences of which would surely spill onto pipe and cigar smokers. (Nicotine users have always found ways to get the amount they want regardless of government restrictions.) The FDA’s most recent decree bans most flavored vape “e-juices” from general retail stores (as opposed to age-restricted vape shops), and prohibition of menthol cigarettes and flavored cigars are also in the works. Meanwhile, other tobacco products, such as pipe tobacco, that entered the market after Feb. 15, 2007, are being deemed “new” and are required by law to have “premarket authorization,” whatever that turns out to mean. Even a retailer’s blend of two long-available pipe tobaccos is deemed to be “new” and subject to testing. (Deadlines for submission for testing are in 2021 and 2022, depending on the product. The FDA’s procedures have yet to be worked out.)

The upshot is that adults are being harassed as they go about their peaceful consumption of combustible and smokeless tobacco and nontobacco nicotine products, which human beings have done in one way or another from time immemorial. (While some people find it easy to habituate themselves to nicotine, unlike inhaled tobacco smoke, it is not hazardous to health.) As noted, many of these bureaucratic violations of liberty are defended in the name of protecting children; however, we can address that issue without the blunt instrument of the state, and as mentioned, many intrusions have nothing to do with children. How many kids are shelling out for premium cigars, pipe tobacco, and briar pipes?

Moreover, regulations that appear aimed at children, especially those regarding vaping, may discourage cigarette smokers from switching to that safer form of nicotine consumption. The warning that vaping is “not a safe alternative to cigarettes” almost sounds like an argument for sticking with cigarettes, although vaping is safer than inhaling cigarette smoke. (The reported rise in teen vaping has coincided with a drop in teen cigarette smoking.)

The intrusions simply hassle adults and make what they want to consume less abundant and more expensive. And they do something else: they entice teens, who will always be drawn to forbidden fruit. (What would Huck Finn be saying?)

Congress should repeal the Family Smoking Prevention and Tobacco Control Act (TCA) of 2009, which empowers the FDA to regulate “tobacco products” and to define what a tobacco product is. How can anyone continue to believe that the U.S. government is constitutionally limited when Congress and the president can authorize an executive department and a regulatory agency to define their own powers over peaceful, consensual conduct?

Make no mistake about it: the assault on manufacturers and retailers is ultimately an attack on consumers who indulge in what other people believe are vices. (See Lysander Spooner’s Vices Are Not Crimes: A Vindication of Moral Liberty.) This is shameful in a society that fancies itself free.

To be continued….

This also appeared at the site of The Libertarian Institute.

The FDA’s Assault on Tobacco Consumers


We’ve all heard horror stories about the run-amok regulatory state. Enabled by open-ended statutes passed by Congress and signed by presidents, regulatory agencies have acquired virtual carte blanche to write rules governing peaceful behavior. Even when a seemingly narrow purpose has been set out, regulatory rule-making has engaged in mission-creep with alarming regularity.

Here’s an example that gets little attention because it directly impinges on the freedom of only a small number of Americans. For the last 10 years the U.S. Food and Drug Administration has been writing draconian rules governing the makers, sellers, and ultimately consumers of cigars, smokeless tobacco, pipe tobacco, and even the pipes themselves (which of course are not made from tobacco) in what appears to be part of an effort aimed indirectly at eradicating these products from the marketplace. The fanatical campaign, reminiscent of America’s earlier crusade to prohibit alcoholic beverages, ought to concern everyone, including nonsmokers, because if it succeeds, other products could well be targeted on the grounds of public health. It is not just tobacco users who need to worry about the regulatory state’s tactics.

The assault on all forms of tobacco use, as well as the use of vaping devices, or e-cigarettes, which don’t use tobacco, is defended on public-health grounds, but we must not be fooled by this appeal. As Thomas Szasz showed throughout his career as the top critic of what he dubbed the “therapeutic state,” this assault is moral, cultural, and political, not scientific or medical. The anti-tobacco campaigners are not content merely with providing useful information, leaving people free to use it and the products as they wish. Instead, they support the use of state force to achieve their objectives; their advocacy of force is aimed not only at ostensibly protecting other people from smokers (which could be accomplished through contract and other consensual practices), but ostensibly at protecting smokers from themselves. (I should say “ourselves” because I’ve been a devout pipe smoker for over half a century.) Medical science can tell you what may happen to your body if you ingest a substance, but it cannot reasonably assert that in light of that information the state ought to prohibit or penalize the use of that substance. A physician qua physician has no special qualification to counsel when the use of force by the state or anyone else is justifiable.

Before describing the insidious campaign now underway (which will span a few of these columns), I want to establish a badly overlooked fact. The anti-smoking, or more generally, anti-tobacco, or more generally still, anti-nicotine campaign assumes that use of the relevant products entails costs but no benefits to “society.” Of course, that cannot be correct. We know this because individuals choose to consume the products; what’s more, they pay money (that is, they give up something of value) to do so. If consumers received no subjective benefit from the products, they would not buy or consume them. Lots of people have quit consuming them after deciding that the costs outweighed the benefits to them.

Among the benefits, which people of many cultures have enjoyed for centuries, are the well-known pleasant and useful effects of nicotine (as an aid to relaxation and concentration) and the palate-pleasing nature of the tobacco leaf. That those benefits can’t be quantified is no good reason to pretend that they do not exist. If tobacco products could effectively be banished (which they can’t be because of the robustness of black markets), the people who now enjoy them would be less well off in their own eyes; that is, the quality of their lives would be diminished. Why don’t those individuals count in the public-policy discussion? Are they lesser persons?

The campaign against tobacco and its consumers goes back several decades, but in 2009 it took a giant leap. In that year Congress and President Barack Obama enacted the Family Smoking Prevention and Tobacco Control Act, the statute empowering the FDA to regulate whatever it deems a “tobacco product.” Later, we will see why the word deems is important. That such authority would be given to the FDA should seem odd since tobacco is neither a food nor a drug in the pharmaceutical sense; people don’t eat it or treat (real or imagined) illnesses with it. If the issue were consumer welfare, regulation advocates might have wanted the authority given to the Consumer Product Safety Commission or the Federal Trade Commission. So why should the FDA have anything to do with tobacco? The answer lies in Szasz’s term the therapeutic state. The government can claim jurisdiction over virtually any peaceful behavior simply by playing the public-health card. What’s more, many people will accept it without question.

At any rate, the word family in the name of the legislation is meant to suggest that the goal of the legislation is to keep children from becoming cigarette smokers, a worthy goal, to be sure, if pursued without the help of government. The first “finding” listed in the act is this: “The use of tobacco products by the Nation’s children is a pediatric disease of considerable proportions that results in new generations of tobacco-dependent children and adults.” (We’ll leave aside the Szaszian question of how the use of a product can be a disease. Adults who habitually use tobacco and nicotine are similarly seen as suffering a disease. While behavior may lead to a disease, it is not in itself a disease. Interestingly, it is only unapproved behaviors that are regarded as diseases.)

While we can stipulate that smoking cigarettes constitutes a personal health risk (as many other legal things do), we may reasonably doubt that children are all that the bill’s supporters have in mind. (By the way, the danger in cigarettes lies not in nicotine, as Dr. Brad Rodu argues in For Smokers Only. Pipe tobacco and cigars, the smoke from which is rarely inhaled, pose a far lesser risk than chemical-laden cigarettes.) Children are unlikely customers for premium cigars, tobacco pipes, and premium pipe tobacco, which are not within a typical child’s means. (Government campaigns to keep children from doing something will likely be undercut by the forbidden-fruit phenomenon: if the government thinks an activity or substance is that much fun, then it must be tried. Better to leave such matters to families and voluntary associations.) Thus, it is hard not to see the act as part of the larger campaign to rid America of tobacco and non-tobacco nicotine products. Through this lens, the FDA’s actions since 2009 — the warning labels, taxes, restrictions on adults, the product-testing requirements — all have a certain logic, but it is a logic that is inimical to individual liberty and responsibility. We’ll explore other features of the anti-tobacco campaign in future columns.

This was originally posted at The Libertarian Institute website.

The Open Door

img_20180528_124658On a visit to Fayetteville, Arkansas, my wife and I dropped in at Open Door Cigars and Pipes, where we were warmly welcomed to this fabulous tobacco establishment, bar, and lounge. It reminds me of those great wood-paneled clubs of old. I picked up some G. L. Pease Haddo’s Delight and Cornell & Diehl Star of the East, both of which I enjoyed on first smoke. I also acquired an HIS black straight apple sandblast, which is now breaking in quite nicely. I’ll definitely be back.



Preliminary Court Win! But It’s Not Over Yet

This week a U.S. district judge ruled the FDA’s legal grounds insufficient for requiring local tobacco shops that blend pipe tobaccos to register as manufactures, a costly and onerous process that would destroy in-shop blending and other services traditionally rendered by tobacconists. However, the judge has given the FDA a chance to come up with stronger legal grounds, so this victory is not final.

This is from the website of the International Premium Cigar & Pipe Retailers (IPCPR):

Earlier this week, a Federal Judge seemingly rejected the FDA’s assertion that retailers who blend pipe tobacco in store must register as manufacturers and adhere to certain other compliance obligations. But what does this mean? What requirements and responsibilities must retailers now be aware of following this ruling? IPCPR attempts to provide some clarity below.

Brief Background:
In the Deeming Rule’s preamble, the FDA claimed that those retailer establishments that blend pipe tobacco are subject to and must comply with “all applicable statutory and regulatory requirements for ‘tobacco product manufacturers.” This would mean that retailers who blend pipe tobacco in store would have to annually register as manufacturers with the FDA, submit initial listings for their blended “products,” submit bi-annual updates for those product listings, and otherwise comply with a host of requirements applicable to tobacco product manufacturers, including the premarket review requirements and compliance policies applicable to “new tobacco products.”

Did the Court settle this issue definitively?
No. In his ruling, Judge Mehta essentially told the FDA that the technical legal basis FDA cited to defend its decision that in-store blending triggered the section 905 registration and product listing requirements was lacking and struck down that decision. However, the Judge acknowledged that the FDA still may designate what retailer activities will trigger these requirements but must do so by applying the appropriate legal standard. So, in his ruling he sent the issue back to the FDA for reconsideration. If the FDA believes it can find a strong legal justification beyond what the Judge opposed, the Agency can double down on its previous approach to the section 905 requirements.

What about how FDA broadly defines manufacturing?
Judge Mehta’s decision expressly applied only to FDA’s position on application of the registration and product listing requirements.  It does not prohibit the FDA from enforcing other requirements applicable to “tobacco product manufacturers.” This includes required health warnings, ingredient listings, labeling and in some cases pre market approval.

However, IPCPR has previously released guidance on these issues and what retailers can do to try to avoid triggering these requirements.  These guidance documents can be found by visiting the IPCPR FDA Toolbox Compliance Hub.  The association recommends that retailers review this information.

Do Smokers Have Rights?


In 1994 I participated in a panel discussion at the Cato Institute on the question in the title. I did not mention pipe (or cigar) smoking because the fire of the anti-tobacco crusade back then was concentrated on cigarette smokers. As we know, inroads against cigarettes only set precedents for moves against pipes and cigars, as well as e-cigarettes, vaping, and smokeless tobacco. I’ve added links where appropriate.

I am offended by people in government who think that it’s their job to use television and the print media to tell me not to smoke. I have read the Constitution, and I cannot find authorization for government to hector us and pester us on issues of private conduct.

It’s not as if people don’t know that smoking entails some health risks. The term “coffin nail” was coined in the 19th century. People know that smoking carries risks. Those risks are not news to anyone, so I really can’t see a case for government’s hectoring us about it. I’m especially offended that kids are hounded in school from a very young age to take pledges that they won’t smoke, to go home and bug their parents about smoking, and to report their parents’ smoking and drinking habits to the social welfare agents who go to schools to talk to the kids. Government paternalism permeates society more than nicotine does, and it’s much more toxic, much more pernicious.

When we talk about regulating smoking, or most other behavior, we are talking about rights and liberty and people’s ability to conduct their lives the way they wish. In my view, civil liberties are always resolvable into property rights. All violations of civil liberties violate someone’s right to use and dispose of his property. I’m starting with the most basic property your self, your person, your body, and your personal resourcesÚand then going on to the external things that you justly acquire. Free speech violations, for example, interfere with the right to use one’s communications resources, starting with the mind and the larynx. Bona fide violations of privacy interfere with the use of one’s home, or papers, or place of business. Thus, civil liberties are property rights. Government smoking regulations, by their very nature, therefore, violate civil liberties and property rights. All such regulations dictate what people may do with their property.

Now I want to say something about the word “public.” The equivocation over the word is inexcusable and, I think, intentional in many cases. The Capitol is a public building, but the Cato Institute building is also a public building, in a sense, and a restaurant is a public building, in the sense that the public is able to come into it. A private home, however, is not “open to the public.” But, obviously, the Capitol and a restaurant are not public in the same way. So I suggest that we use three terms for the three kinds of property we’re going to be discussing: “government property,” for property that’s ultimately funded and maintained by the taxpayers; “commercial property,” for property that’s open to the public; and “private property,” for homes. My remarks are going to be about commercial and private property.

Let’s look at some violations of freedom of speech or the First Amendment in the name of making America smoke free. We’ve had since about 1970 or 1971 a ban on television and radio advertising, a clear violation of freedom of speech. In Baltimore, there’s a proposal to restrict youth-oriented, whatever that is, billboard advertising of cigarettes. A clear violation of freedom of speech. Why is that not being immediately laughed out of court? It’s compulsion.

In California and Massachusetts there are laws that require that cigarette taxes be used to fund anti-tobacco messages. The taxes sometimes go to nonprofit organizations that lobby for more restrictions. That is not so much a violation of free speech as it is an example of forced speech. People are being forced to finance speech with which they don’t agree and that they may not wish to hear broadcast.

We are faced with an ever-growing list of infringements of our rights. The Occupational Safety and Health Administration is proposing a rule to ban smoking in all workplaces. Washington has become the first state to ban smoking in commercial and state buildings. In Maryland the regulator of occupational safety and licensing has imposed a workplace smoking ban that is currently being held up in the courts. Los Angeles has banned smoking in outdoor cafes which, it seems to me, is overkill. And Rep. Henry Waxman (D Calif.) has introduced the Smoke-Free Environment Act in Congress to compel owners of nonresidential buildings that are open to the public and regularly frequented by more than 10 people to ban smoking or restrict it to a separately ventilated room.

I would like to look ahead slightly. It seems to me that the nonresidential criterion is surely only a temporary distinction and that if we get a ban on smoking in workplaces, it won’t be long before we begin to see regulation, perhaps creeping, of the home. Why not? Repairmen come into people’s homes. Don’t those workers have a right to be in a smoke-free environment? And what about children? They are more vulnerable than adults. The issue has already come up in custody cases, and John Banzhaf, head of Action on Smoking and Health, has said, “The same protection as in custody battles will eventually be extended to children in ongoing marriages through child neglect proceedings.”

Our rights of association and contract are being violated as well. All-smoking flights are banned; in other words, the government won’t even allow airlines to have designated flights for smokers, or set up an all-smoking airline. Now, let me point out a violation of freedom of contract on the other side. We’re seeing actions against employers who want to discriminate against smokers, either refusing to hire smokers or requiring, as a condition of employment, that employees not smoke, even in their own homes. Smokers and the tobacco companies don’t like that, but it is perfectly within the rights of an employer to specify terms of employment. I don’t think I’d like to work under those conditions but the employer has the right to lay down that condition. Such bans have been passed, I think, in 28 states and the District of Columbia. Smokers have even gotten some protection from the Americans with Disabilities Act, because nicotine is being claimed to be addicting, and, therefore, smoking is a disability.

The Food and Drug Administration is considering regulating nicotine as a drug, which presumably will mean limits on nicotine content. That is a violation of freedom of contract between tobacco companies and customers. It’s also an extension of the drug war and will have the predictable results. When we argue against drug prohibition, we like to say that people don’t shoot each other over cigarettes; that happens only in the black market. Well, if the FDA gets its way, people will be shooting each other over cigarettes, the illegal high-nicotine cigarettes that you will have to buy on the street.

The bottom line in all these cases is that the government presumes to dictate the terms of association between adults. I’d like to point out that the validity of the alleged hazard of secondhand smoke is irrelevant to what I’ve been saying; even if secondhand smoke does present a health risk, that does not justify the regulations. The official in Maryland who presumed to ban smoking said that if nerve gas were wafting through a restaurant, it would certainly be appropriate for the government to protect people. Obviously, that’s a very bad comparison. When you walk into a restaurant and take your first whiff of cigarette smoke, you are perfectly capable of leaving. Try that in a room full of nerve gas. Competition for customers and for employees may induce private no-smoking rules or less severe regulations, but that’s a separate issue, having nothing to do with civil liberties except that it’s within the rights of an employer to set such rules. The key point here is that there’s no right to be on someone else’s property on terms other than those set by the property owner. That’s really the bottom line.

In his book Cigarettes Are Sublime, Richard Klein said that life means choosing your poisons. I think that was a fancy way of saying that life is risk, that risk is inherent in life. It follows from that maxim that the rules we’ve been discussing interfere with a fundamental right and civil liberty, namely, the right to choose your own poison. In 1990 the Tobacco Free America Coalition, consisting of the American Cancer Society, the American Heart Association, and the American Lung Association, published its “Blueprint for Success: Countdown 2000, 10 Years to a Tobacco-Free America.” It was not a blueprint for a campaign of persuasion; no, it called for enactment of legislation to make America smoke free by the year 2000. All of that stands on the flimsy foundation of what the EPA itself calls “the a priori hypothesis that a positive association exists between exposure to environmental tobacco smoke and lung cancer.”

Liberty is under assault. I am not a cigarette smoker, most people are not smokers, but it is perilous for us to ignore this assault merely because it is aimed at someone else. Let’s not have to say years from now, “When they came for the smokers, I didn’t speak out because I wasn’t a smoker.” How long before something you do is singled out by the health fascists? The cigarette may be an unfortunate symbol of today’s struggle for freedom in the United States of America, but those of us who value liberty over security, and even over health, must now rally round it.

More to read
“Put That in Your Pipe,” by Rick Newcombe
“The FDA’s Unauthorized War on Pipes and Cigars,” by Rick Newcombe
“Anti-Smoking Paternalism Infantilizes Adults,” by A, Barton Hinckley
“FDA’s New Tobacco Rules Will Be Terrible for Cigar Smokers Too,” by Jacob Sullum