The FDA’s Continuing Assault on the Principles of Justice

Sinatra
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

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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

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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.

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.

McClelland: Sadly, It’s Official

Updated Feb. 4 & 5

Note the sentence “Without the supportive infrastructure our government used to provide [see Update 2 below], a small company such as ours cannot continue.” This is an obvious reference to the pending FDA rules — “deeming regulations” — that would regulate — read: stifle — pipe tobacco manufacturers and retailers. When (if?) the rules take effect, “new” blends would be very costly to introduce. And “new” wouldn’t even mean actually new, but blends that went on the market after some arbitrary past date. The original date specified was Feb. 15, 2007, though this could be changed to Aug. 8, 2016. Think of the effect on smaller companies! Moreover, retail tobacconists would be treated as manufacturers whenever they mixed two or more tobaccos already on the market and would effectively be stopped because the cost would be prohibitive. Blending might even include scooping 2 ounces from a larger bag of bulk tobacco. Other draconian rules are in the offing — such as treating pipes like tobacco products rather than accessories — unless Congress, a court, or the FDA itself scraps these outrageous rules. The compliance date is now set for 2021. This change from August of this year has been interpreted as portending a softening of the FDA’s attitude. We can hope so, but nothing short of repeal could make me feel confident that pipe and cigar smokers are safe.

More on this madness in future posts. Many in the YouTube Pipe Community are keeping up with this. On last year’s hopeful developments, see Derek Tant’s video here.

UPDATE 1: For background, see this article at Pipes and Tobacco Magazine. Pipes Magazine radio has more.

UPDATE 2: According to a statement read by Bradley at StuffandThings, the McNeils are closing McClelland not only because of the lack of quality red Virginia and the FDA threat but also because the government ended subsidies to tobacco growers (some time ago). For the record, the government never should have supported tobacco growers or any other crop or industry. Why should anyone be forced to support business people?