The FDA’s Continuing Assault on the Principles of Justice

The Chairman of the Board

Eddie Gray, the owner of the online pipe-smokers’ boutique The Pipe Nook, reports in his latest YouTube video that the FDA has accused him of selling to a minor but refuses to provide the evidence. This is nothing less than a direct assault on a basic principle of Anglo-American justice: innocence until guilt is proved, which means that the government — exclusively — has the burden of proof and the accused has no burden whatever to provide evidence of his innocence. One obvious aspect of this principle is that the state has an obligation to present the evidence to the accused, who may then rebut it. This is how things should work because one cannot prove a negative, namely, that one is not guilty, especially when one is given no details about the alleged offense.

When will those in Washington who love to rail against regulation finally pull the plug on the FDA, which tramples individual rights wherever it treads?

See my other FDA posts here, herehere, and here.

The FDA’s Assault on Tobacco Consumers, Part 3

Updated Feb. 11, 2019

Early one morning last December, Jeff Gracik was heading to his southern California home garage-workshop where he makes his living when he heard a loud, hurried knock on his front door. Thinking it might be a rushed UPS driver, he quickly opened the door. But it wasn’t UPS. Standing on his doorstep were three badge-flashing inspectors from the U.S. Food and Drug Administration. They had come to inspect Jeff’s business.

Just what is Jeff’s business? Does he produce food? No. Does he produce drugs? No again. So why the unannounced visit by FDA inspectors?

Jeff makes pipes for tobacco pipe smokers. He doesn’t make tobacco, mind you, which (alas) Congress empowered the FDA to control, but pipes, most of which are made from wood (most commonly briar, but other varieties too), materials such as acrylic and vulcanized rubber for the mouthpieces, and wood stains, which Jeff buys but does not make.

In its wisdom, the FDA has deemed pipes “tobacco products,” a category of things it regulates under the Family Smoking Prevention and Tobacco Control Act (TCA) of 2009. Forgive the bureaucratese I’m about to shovel your way, but an FDA document states (pp. 257-58):

“The definition of ‘tobacco product’ …  includes all components, parts, and accessories of tobacco products (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product). FDA interprets components and parts of a tobacco product to include any assembly of materials intended or reasonably expected: 1) to alter or affect the tobacco product’s performance, composition, constituents or characteristics; or 2) to be used with or for the human consumption of a tobacco product. Both e-cigarettes and pipes meet this definition.”

You may find it odd that the FDA chooses not to regulate lighters, matches, ashtrays, humidors, and the like, but it has its reason: it deems such things to be accessories, not components and parts. Accessories, the FDA says, “do not contain tobacco, are not derived from tobacco, and do not affect or alter the performance, composition, constituents, or characteristics of a tobacco product.” Since pipes do those things, they are deemed regulated components rather than unregulated accessories.

Who knew the FDA personnel had the wisdom to make such fine distinctions?

Note the first word that I emphasized a couple of paragraphs earlier: interprets. The FDA admits it has no explicit statutory authority to regulate things not made or derived from tobacco even if they can be used to consume tobacco. Did the members of Congress who wrote and voted for the TCA (which amended the FD&C) deem non-tobacco products such as wooden pipes to be tobacco products? It appears not. The legislation states that 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 (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product).”

The word including would seem to limit the covered components, parts, and accessories to things “made or derived from tobacco,” of which the briar root Jeff Gracik uses is not an example. Briar comes from the root of the flowering plant called Erica Arborea, or tree heath.

To reinforce my point, note that the word pipe appears in the TCA only as a qualifier for the word tobacco. The statute’s authors wanted to assure that tobacco is understood to include pipe tobacco and not just cigars and cigarettes. But the legislation contains not one single reference to pipes per se. So Congress apparently did not intend to authorize the FDA to control anything other than tobacco or things derived from it, even things that are likely to be used to consume tobacco.

But no matter. The FDA has assumed the power to deem non-A to be A. Logic and common sense be damned.

UPDATE: What’s more, a federal district court judge says that’s just fine. 

At any rate, three FDA inspectors (two of them trainees) turned up unannounced at Jeff Gracik’s door to say that they had the authority under the TCA to enter his premises — right then — and inspect his home workshop. Actually, he had “consented” to inspections once every two years when he registered with the FDA as a pipe maker. Jeff had learned earlier that under the law, retailers could not sell his pipes unless he was registered, so he allowed a retailer to register him, saving him the trouble of doing the paperwork himself. He had no choice: he earns his living as a full-time pipe maker and wants to keep doing so.

Jeff, who is 39, started making pipes in 2003. He sold his first one a year later and has since built a sterling reputation among pipe collectors. He makes 100 to 125 pipes a year, which sell for $800 to $3,000 apiece, under the name J. Alan Pipes. Jeff is an artisan; he makes pipes one at a time by hand. Each is unique, a thing of beauty, a dazzling collaboration of nature and human being. He and brother Jeremy have a second, lower-priced line of partially machine-made pipes under the name Alan Brothers.

Needless to say, Jeff was unaccustomed to having federal agents traipsing around his workshop. “I was so shocked,” he told me. He said the inspectors were friendly but firm — and apparently unsure what they were supposed to be doing. This might have been their first venture into unknown territory. (Other pipe makers are being similarly visited.) The inspectors started asking questions “most of which were not really relevant to pipe making. Things like: tell us about all the materials you use. Tell us about where they’re from. Do you have receipts for where they’re from? We need the names for all the distributors for all your materials. We need to know exactly the ingredients with which they’re treated; so, for instance, briar, how is it treated? Of course, I’m an artisan. I don’t have those kinds of records.”

That was just the beginning. “They had me demonstrate how to make a pipe. So I had to take a block of briar and chuck it in my lathe…. And as the day went on, they became more and more interested in what I was doing.” He said some of their questions suggested they were interested in the potential toxicity of materials and ingredient, but that’s as far as that went. They tested no materials or stains and took no sample with them. Jeff was not told to submit anything for approval.

The visit lasted six and a half hours, as if this small businessman had nothing better to do than entertain a group of FDA inspectors. “I got nothing done that day,” he said.

“They wanted to see written procedures,” he explained. “How do you do A to Z?” He told them that as a craftsman and unlike a factory, he has no written procedures As the hours went by he sensed he was almost gaining sympathy from the inspectors.

Jeff said he did his best to comply with all requests, including requests for documents going back to 2006. “If they shut me down because I failed to answer a question to their satisfaction,” he said, “then my kids don’t eat and we foreclose on our house.”

For the record, the TCA states that regulations “shall not impose requirements unduly burdensome to a tobacco product manufacturer or importer, taking into account the cost of complying with such requirements and the need for the protection of the public health ….” Decide for yourself if the FDA obeys that prohibition.

The FDA and those who support government control will point out that even though pipes are not made from tobacco, they are used to consume tobacco. That’s true. But Gracik points out that some people who buy his pipes, which can be as beautiful as any work of art, are collectors who don’t smoke. (Interestingly, his grandmother’s first cousin was Andy Warhol.)

It’s hard to say how many pipe makers we have in America. People connected with the industry and hobby estimate the number of full-timers at 25 to 30, with a few hundred more who make and sell pipes part-time. Jeff is afraid that the thicket of rules could persuade many of them to “throw in the towel.” He says: “It scared the hell out of a lot of pipe makers when we found out we were under this kind of scrutiny.”

The pipe makers certainly could use a trade association to protect them. But Gracik says they are, unsurprisingly, individualists and so discussions about forming an association have gotten nowhere.

So the FDA harasses — even if it’s with a smile — small-scale artisans who scratch out livings working by hand with wood and other harmless materials. To what end? It’s all part of a larger puritanical campaign to harass peaceful Americans who enjoy consuming tobacco via cigarettes, cigars, pipes, and smokeless tobacco and using non-tobacco nicotine e-cigarettes.

“Nothing so needs reforming as other people’s habits,” Mark Twain said.

Using tobacco is not risk-free, of course, but most things in life are not risk-free. In the real world, risk can be managed and minimized but never eliminated, and in a free society, individuals have the right to decide for themselves how to go about doing it.

Read part 1 and part 2.

This also appears at The Libertarian Institute.

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.

Traveling Man


I don’t travel much, but I’m flying today. Waiting for my connection in Atlanta, I sure miss the days when airports had smoking areas. My two-hour layover would go a lot quicker. I’ll have to content myself with sniffing the tobaccos I’m carrying: Amphora, Wild Atlantic, and Autumn Evening.

Oops! I found the area! Yay! Time for some Autumn Evening in a small black clay.

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