Cigars at The Daily Beast

My first contribution to The Daily Beast explains what’s at stake in the proposed FDA cigar regulations:

Ever since the FDA was given authority over cigarettes in 2009, cigar makers have been pushing a bill in Congress to keep stogies out of the agency’s purview. That an industry would try to protect itself from FDA regulation is not surprising. That the FDA might agree with them is. And given the agency’s record on cigarettes, keeping its hands off of premium cigars is the right idea.

Read the whole thing here.

What proposed FDA regulations mean for e-cigarettes and cigars

I had a relaxing morning planned until the FDA announced its proposed regulations extending its authority to more tobacco products, including e-cigarettes and cigars. Predictably most of the press is focusing on the former, but the proposals over cigars are also very interesting. The long PDF detailing the proposal is here. Since you probably don’t want to read that, read this post instead.

First, a little background on how the existing law works with regard to cigarettes. The most important power that the Tobacco Control Act gave the FDA was pre-market review. Before releasing a new cigarette, producers must now get explicit approval from the FDA. This created three classes of products:

1. Products that were already on the market as of February 2007 are grandfathered in and allowed to be sold without review, although the FDA could hypothetically order them off the market.

2. Products introduced between February 2007 and March 2011 are allowed on the market while under provisional review. Producers have had to submit applications, but they are allowed to continue selling while the FDA reviews them.

3. Since March 2011, all new products must receive FDA approval before being sold.

This has resulted in a freeze of the cigarette market since 2011. In the three years since then, only two new cigarettes have been approved for sale. The anti-competitive effect this has had on the cigarette market has been my primary criticism of the FDA’s handling of tobacco. It has been reviewing applications for four years, currently has more than 150 employees working on reviews, has received approximately 4,000 applications, and has managed to rule on only 34 of them. For more detailed information on this, see my coverage in The Atlantic and Reason. (Keep in mind, too, that the Tobacco Control Act was fully backed and negotiated by Philip Morris. They knew what they were doing.)

It’s also helpful to know what the FDA is looking for in new product applications. The law establishes two routes to approval. One is for completely new products (premarket tobacco applications) and requires extremely burdensome amounts of data; this is basically uncharted territory at this point. The other is “substantial equivalence.” To get approval by this route, a new product must demonstrate that it is substantially equivalent to a predicate product that was already on the market as of February 2007 or has since been approved by the FDA. “Substantially equivalent” is defined to mean having the same characteristics (materials, ingredients, design, composition, heating source, or other features) or raising no new questions of health. (To see why this is a huge obstacle to new producers, see my articles above.)

It’s been known for a long time that the FDA planned to extend its authority beyond cigarettes. The biggest concern is how the agency’s sluggish review process will affect these new products, especially e-cigarettes and cigars. These are both dynamic sectors of the market and applying the same standards that the agency uses for relatively commodified cigarettes is extremely problematic.

Impact on e-cigarettes: As mentioned above, substantial equivalence applications must specify a predicate product by which to compare the new product. That predicate product must have been on the market by February 2007. You can see the problem here. The market for e-cigarettes barely existed then. Thus the review process as it exists now is essentially a death sentence for e-cigarettes. As the agency notes in its proposal today, its hands are tied: “Because this date is written into the statute, we do not believe that we have the authority to amend it with respect to e-cigarettes or other products.”

Because of this, the FDA’s proposal gives e-cigarette companies two years after the date the rule goes into effect to submit a premarket tobacco application (PMTA). What happens after that is anybody’s guess. But unless the law changes, it looks like the substantial equivalence option is off the table for e-cigarettes and the variety of products that remain for sale will be extremely restricted. If any products successfully navigate the PMTA process, they will likely be those with lots of financial backing and perhaps the right connections.

Impact on cigars: The FDA’s proposals regarding cigars are intriguing. The agency offered two options. Option 1 is to treat cigars just like other tobacco products, subjecting them to all the same burdens of review. Option 2 is to carve out an exemption for premium cigars.

The first option, as I’ve been warning for a long time, would be disastrous. Hundreds of new cigars come out every year in distinct blends, shapes, and ages. Forcing them into a review process that has managed to approve only two cigarettes in four years would destroy the market as we know it. It would also require all cigars to be substantially equivalent to those already on the market in 2007, making the sector considerably more boring.

The fact that Option 2 is even being considered shows that the FDA is aware of this. Under this option, exemptions would be made for premium cigars. A cigar would be exempt if it:

(1) Is wrapped in whole tobacco leaf

(2) contains a 100 percent leaf tobacco binder

(3) contains primarily long filler tobacco

(4) is made by combining manually the wrapper, filler, and binder

(5) has no filter, tip, or non-tobacco mouthpiece and is capped by
hand

(6) has a retail price (after any discounts or coupons) of no less than $10 per cigar

(7) does not have a characterizing flavor other than tobacco**

(8) weighs more than 6 pounds per 1000 units.

This is not a perfect definition, but it’s a start. The biggest drawback is that it would create a price floor of $10 per stick and this price would be adjusted (i.e. increased) every two years. It’s still possible to get pretty nice cigars for under $10, especially if one buys them a box at a time, so this would be a substantial imposition on cigar smokers. At this point, however, I’m just glad that the option to exempt premium cigars from the FDA’s pre-market approval process exists at all.

Impact on pipes: Pipe smokers, now few and far between, did not put a substantial lobbying effort into influencing the FDA’s new regulations. As a result, pipes get very little discussion in the proposal. However pipe tobacco will be subject to the full authority of the FDA and, if I am reading it correctly, pipes themselves would be subject to pre-market review as well. That seems potentially problematic for unique, handmade briar and meerschaum pipes. Pipe smokers, stock up now or prepare to order from overseas!

What’s next: There are seventy-five days to comment on the proposed regulations. The biggest fight will be over e-cigarettes, which are the hottest topic in the press. In my view it’s a mistake for the FDA to wade into this until it gets its review process under control or can provide a workable alternative to the substantial equivalence path. The upside is that it will take at least two years before it takes enforcement action, which will allow more studies on e-cigarette’s effectiveness as a harm reduction tool to be conducted.

(Note also that the law requires the FDA to examine health impacts on the population level, not on the individual user, so it could order e-cigarettes off the market even though they are unambiguously safer than cigarettes. Remember too that the head of the FDA’s Center for Tobacco Products, Mitch Zeller, came directly to the job from consulting for GlaxoSmithKline, which makes nicotine replacement therapies that compete directly with e-cigs. Might pharmaceutical companies use the new restrictive review process to develop nicotine vapor devices of their own? I would not be at all surprised.)

Cigars have been almost completely off the radar of press and anti-smoking groups, but expect that to change as the debate over exempting them unfolds. Cigar smokers will have to continue keeping the pressure on lawmakers and the FDA to not destroy the industry. It will be important to show that premium cigars are primarily enjoyed by adults and have different health effects than cigarettes for the typical user. (For a summary of the latter, see here.)

Regardless of which option the FDA takes, I expect black market sales of cigars to increase. If it takes Option 1, the variety of cigars available in the United States will suffer greatly. If it takes Option 2, the price will rise to $10 a stogie.* Cuban cigars are pretty alluring already! If you enjoy the company of your local tobacconist, savor the next few years you have together. Their store may not be around much longer.

* Update to add that cigars could escape the price floor by winning FDA approval, but given the agency’s record so far I would not expect many to achieve that. Cigars that were on the market before 2007 could remain available at a lower price too.

** Additional note: I’ve asked the FDA several times whether ageing tobacco in cedar wood, a traditional practice for many cigars, would run afoul of the rule against characterizing flavors. They have not been willing to clarify this.

New at Reason

After a long absence (my previous article was in 2008!), I’m back in the pages of one of my favorite publications today. Over at Reason I take a look at the FDA’s latest actions against tobacco, explain why they accomplish nothing for public health, and spell out what they imply for the future of cigars and e-cigarettes.

The article also updates the case of Hestia Tobacco, whose regulatory tribulations I profiled at The Atlantic one year ago. Unfortunately, they are no closer to coming to market than they were before. See that article for a more in-depth explanation of the laws that allow the FDA to keep new tobacco products in regulatory limbo.

Finally, be sure to check in at Michael Siegel’s blog, where he has been tearing apart the FDA’s action this week from a slightly different perspective.

Nicotine and regulatory capture

horsebrass 021

The FDA is expected to announce very soon new regulations governing chewing tobacco, cigars, and likely electronic cigarettes. If you’ve followed my writing on this, you know I don’t think this bodes well for the quality side of the tobacco market. The law giving the agency authority over tobacco products was brokered by an alliance of Philip Morris and anti-smoking groups, and the new head of the FDA’s tobacco division, Mitch Zeller, came to the job straight from consulting for GlaxoSmithKline on nicotine replacement therapies. The agency’s record so far has been distinguished much more by its anti-competitive effects than by any actual achievement improving public health.

The Boston Globe recently interviewed Zeller to get some indication of where the agency may be headed. As expected, it appears likely that Zeller will pursue mandating the removal of nearly all nicotine from cigarettes:

1. Create a non-addictive cigarette. We have the authority given to us by Congress to reduce nicotine in cigarettes down to nearly zero,” Zeller said. Since nicotine is the addictive chemical in cigarettes, teens who start smoking products that are almost nicotine-free could, in theory, never get hooked in the first place. Researchers now have access to 9 million cigarettes with varying amounts of nicotine to start testing whether products with lower amounts will lead to less addiction among new smokers. But don’t expect an ultra-low-nicotine product for at least a few years, Zeller added, since the studies are just beginning.

A few notes on this:

1) This would obviously be good news for Zeller’s former client in the pharmaceutical industry. Removal of nicotine from cigarettes would leave smokers craving nicotine and many of them would likely turn to patches, gums, and the like. Zeller indicates in the same interview that the agency should perhaps remove warning labels from nicotine replacement therapies that discourage consumers from using them long-term, noting that using these products for life is healthier than smoking.

Even if this is good policy, Zeller’s previous job casts doubt on the FDA’s ability to consider the issue impartially. As many warned at the time of his appointment, his role as lead regulator of tobacco creates a blatant conflict of interest at the agency.

2) Mandated removal of nicotine could be good news for makers of electronic cigarettes, which now include the Big Tobacco companies. But it’s not clear that the FDA will turn a favorable eye to those, either. If the agency’s performance on cigarettes is any indication, e-cigarettes could be caught in a bureaucratic morass that keeps new products off the market with scant scientific justification.

3) Rather than turn to pharmaceuticals or e-cigarettes, at least some smokers will likely switch to cheap, low-quality cigars. Even if the FDA does not initially regulate nicotine levels in cigars, this will provide the impetus to extend the regulation. We’ve seen this before with bans on flavors or changes to tax policy when producers and consumers respond with products that technically qualify as cigars or pipe tobacco. Lawmakers and regulators then attempt to close the “loophole.” Makers of high-quality, traditional cigars would be caught in the crossfire. Whether or not one has any personal interest in cigarettes, if you enjoy an occasional pipe or cigar, then the FDA’s path should have you worried. There may be no way to produce a traditional cigar and comply with the FDA’s demands. This is the road that could lead to the complete destruction of the industry.

For more on how the FDA is getting tobacco regulation wrong, see my articles from the past year:
Who’s killing the electronic cigarette?
How the FDA is keeping new cigarettes off the market
The case against a smoke-free America

Two new cigarettes, now authorized for sale

This week the FDA sent out a press release boasting that its Center for Tobacco Products has finally issued a few decisions on new tobacco products:

For the first time since the Family Smoking Prevention and Tobacco Control Act of 2009 gave the U.S. Food and Drug Administration the authority to regulate tobacco products, the agency has authorized the marketing of two new tobacco products and denied the marketing of four others through the substantial equivalence (SE) pathway. [...]

“Today’s historic announcement marks an important step toward the FDA’s goal of reducing preventable disease and death caused by tobacco,” said FDA Commissioner Margaret A. Hamburg, M.D. “The FDA has unprecedented responsibility to protect public health by not allowing new tobacco products under FDA’s authority to come to market without FDA review.”

To put this into context, when I wrote about the FDA in March the agency had received about 3,500 new product applications. The most reasonable interpretation of the law giving the agency authority over tobacco implies that these reviews should take only 90 days, and certainly no more than 180, yet some of these have languished in a bureaucratic quagmire for years. Issuing only six decisions since 2009, with more than 100 employees at work reviewing them, is hardly an accomplishment worthy of praise.

(If you’re wondering, Hestia Tobacco, the brand I profiled for The Atlantic, remains tied up in the review process with no end in sight.)

It’s also worth emphasizing what these approvals don’t mean. They don’t mean that these two new cigarettes are any safer than products already on the market, only that they don’t raise any new questions of health. In other words, they’re just as lethal — though no more so, we are told to believe — as other cigarettes. New cigarettes like Hestia, which by any sensible standard also raise no new questions of public health, continue to be blocked. It’s difficult to see what good is accomplished by requiring them to go through this lengthy approval process.

And in the midst of this, the future of e-cigarettes remains unclear. As I explained at The Umlaut this week, this product that is indisputably safer than real cigarettes may soon fall under the same heavy-handed regulation that has brought the tobacco industry to a standstill. If that happens, the FDA will have even less to brag about that it does today.

Cato podcast on FDA tobacco regulation

While in DC this week I recorded a couple podcasts. Here’s the first, with the Cato Institute’s Caleb Brown. In it we cover FDA regulation of cigarettes, e-cigarettes, and cigars.

One minor correction: We were only discussing these inhalable products, so I misspoke when saying that current FDA regulations only cover cigarettes. The agency regulates smokeless tobacco too.

Update 5/30/13: Or if you prefer video…

Tobacco news roundup

New FDA Center for Tobacco Products director Mitch Zeller tells Bloomberg to expect action from the agency soon and that he seeks to craft a “comprehensive nicotine policy.” What could that mean? Unmentioned in the article are Zeller’s ties to producers of pharmaceutical nicotine replacement products or his interest in reducing nicotine levels in cigarettes to near zero, a proposal he brings up in the most recent issue of Tobacco Control.

My friends the Stogie Guys have a couple recent posts that are worth reading. In the first, they explain how Big Tobacco has become the enemy of small, premium tobacco through its lobbying efforts. In the second, they examine what a new bill requiring online merchants to collect sales taxes may mean for the cigar industry.

Hestia Tobacco, the brand whose struggle to navigate the FDA’s approval process I documented for The Atlantic, is finally in business. Not selling cigarettes, of course, but rather filtered little cigars. Sale of their cigarettes must await greater competence at the agency. If the product interests you, go check them out.

Christine Quinn, a leader in polls to replace Bloomberg as New York City’s next mayor, appears to have embraced Bloomberg’s nannying legacy. She has proposed raising the legal age to purchase cigarettes within the city to 21. As J. D. Tuccille notes at Reason, this would be good news for black market sellers, who already claim more than 60% of the state’s cigarette market.

Evolving regulation of nicotine

If you’re using nicotine gums, lozenges, or patches to quit smoking, the FDA has good news for you. It’s also good news for the producers of these products, such as pharmaceutical company GlaxoSmithKline. The agency announced yesterday that it’s revising its labeling requirements for nicotine replacement therapy (NRT) as an aid to smoking cessation:

The Food and Drug Administration says smokers who are trying to quit can safely use over-the counter nicotine gum, patches and lozenges for longer than previously recommended in a move to help millions of Americans kick the habit.

Current labels suggest consumers stop smoking or using other products containing nicotine when they begin using the products to help them quit and that they should stop using nicotine replacement products after 12 weeks at most.

The federal agency said Monday that the makers of gum and other nicotine replacement products can change the labels that say not to smoke when using the products. The FDA also said the companies can let consumers know that they can use the products for longer periods as part of a plan to quit smoking, as long as they are talking to their doctor.

This is a sensible move. Nicotine, taken in small doses and divorced from the carcinogens produced by combusting tobacco leaves, is not particularly worrisome. And any small harms that could accrue from using these products certainly pale in comparison to the alternative of continuing to smoke. So this looks like a good decision from the FDA.

What’s interesting, though, is the timing. The FDA has indicated that this month it will announce new proposed rules expanding the reach of its tobacco authority, deeming additional items to be tobacco products covered by the Tobacco Control Act. Among these may be e-cigarettes, an increasingly popular alternative to smoking that delivers nicotine via vapor.

E-cigarettes haven’t been studied nearly as extensively as traditional NRT products, but evidence that consumers use them to reduce or quit consumption of cigarettes continues to grow. A new study to that effect came out last week, in fact. And though there have been some concerns about e-cigarettes, no reasonable person believes they even approach the dangers of the real thing.

The question is whether the FDA’s Center for Tobacco Products will allow e-cigarettes to continue as a viable approach to harm reduction or whether it will subject them to the full slate of regulations applicable to cigarettes. As I documented in my Atlantic article, the thicket of rules enforced by the CTP can be absolutely paralyzing, with the agency failing to rule on a single new product application in its three years of operation.

It’s at this point that one must mention the new director of the Center for Tobacco Products, Mitch Zeller. Zeller took over on March 4, stepping down from his pharmaceutical consulting position at Pinney Associates. His big client at Pinney? GlaxoSmithKline.

Neither Zeller nor the CTP are responsible for yesterday’s announcement about NRT labeling, which came from the FDA’s Center for Drug Evaluation and Research. However the relationship will be one to consider when and if the agency issues new rules regarding e-cigarettes. Hopefully the agency will take same the sensible approach to these potential competitors to traditional NRT as it has to GlaxoSmithKline’s own products.

Additional note: Buried at the end of Michael Felberbaum’s article linked above was this tidbit:

Meanwhile, the FDA said it is missing a Monday deadline to submit three tobacco-related reports to Congress, which the agency said are nearing completion. It also is missing another deadline to publish a consumer-friendly list of the levels of dangerous chemicals found in cigarettes and other tobacco products, as well as tobacco company testing and reporting requirements for ingredients and additives.

There are no penalties for forgoing the deadlines outlined in the 2009 law that gave the FDA authority to regulate a number of aspects of tobacco marketing and manufacturing.

Keep up the good work, FDA!

More questions from the FDA

Good news: The FDA is once again taking action on the application of Hestia Tobacco, the aspiring start-up whose case I profiled in The Atlantic this week. Bad news: The agency returns with a new round of demands for information.

To recap, in order to bring their cigarettes to market, Hestia Tobacco and brand owner David Sley must prove that their product is substantially equivalent to a product that was already on the market before February 2007. Sley identified the original blend of Natural American Spirit as his chosen predicate and submitted a report demonstrating the very tight similarities between it and his product.

Natural American Spirit is an established brand, successful enough that its parent company was acquired by Reynolds American in 2001. Even if you don’t smoke, there’s a good chance you’re familiar with it. Yet Hestia Tobacco’s newest task is proving that this product really was for sale, as explained in an email Sley received this morning and in a phone call yesterday:

Dear Mr. Sley,

Thank you for taking the time to speak with CTP’s Office of Compliance and Enforcement today regarding your 905(j) submission. In follow-up to our conversation, please find below a summary of the information we requested.

1. Evidence demonstrating that the predicate tobacco product was commercially marketed in the United States as of 2/15/2007

Please provide evidence to demonstrate that the predicate tobacco product was commercially marketed in the United States on 2/15/2007. If you cannot provide evidence demonstrating the tobacco product was commercially marketed on 2/15/2007, per our discussion, we suggest that you provide evidence that your product was commercially marketed before and after 2/15/2007.

Examples of such evidence may include, but are not limited to, the following:
• dated copies of advertisements;
• dated catalog pages;
• dated promotional material;
• dated trade publications;
• dated bills of lading;
• dated freight bills;
• dated waybills;
• dated customer receipts; or
• dated distributor or retailer inventory lists.

2. Evidence Description

Please provide a brief statement or chart explaining and identifying any abbreviations (e.g. item number and/or product description) in the evidence and how it references the predicate tobacco product.

3. Package Description

Please provide a statement as to whether the cigarettes are sold as a soft pack or hard pack.

4. Statement that the predicate tobacco product was not in a test market as of 2/15/2007

As you stated in the teleconference, your predicate tobacco product is Original Blend Natural American Spirit and you do not own the product. Thus, in addition to providing a statement that to the best of your knowledge the predicate tobacco product was not in a test market only on 2/15/2007, please provide additional evidence to show that product was not in a test market only. Examples of this additional evidence can include but are not limited to: dated copies of U.S. advertisements, dated U.S. promotional materials, dated online U.S. product reviews, dated U.S. articles, etc.

We request that you provide the above information for the following 905(j) Report (SE0004644) as soon as possible.

You may receive additional requests if further information is needed. Please do not hesitate to contact me if you have any questions.

Thank you!

[Redacted]

Hestia Tobacco’s application was submitted in June of last year. As explained in my article, the law implies that these reviews should be complete within 90 days, or at most 180. Regardless of whether one considers this latest request for information legitimate, it’s rather late for the agency to be getting around to it. And the timing — arriving the first business day after my article ran — is something to ponder.

Markets not in everything

My article today at The Atlantic looks at the anti-competitive effects of the FDA’s regulation of tobacco:

David Sley wants to sell cigarettes. This, by his own admission, does not make him the most sympathetic person to feature in an article about excessive government regulation. Yet Sley, an aspiring entrepreneur who has spent more than two years trying to navigate the Food and Drug Administration’s new tobacco regulations, has legitimate cause to complain. The entire cigarette industry has been brought to a standstill by the FDA, forbidden from introducing any new products since March 2011. Tobacco companies contend that the agency’s actions rest on uncertain scientific and legal grounds — and, for once, they may be right.

In the article I document Sley’s attempt to launch a new cigarette brand, a process which has dragged on for more than two years without resolution. As you may remember, the Tobacco Control Act was backed and negotiated by Philip Morris, who just might have anticipated such a result.

The extremely slow approval process also bodes poorly for the premium cigar market, which is even more dynamic than that for cigarettes. Cigar lovers should pay close attention when the FDA issues its proposed rules for cigars later this year.

Read the whole thing.

115 employees, 3 years, 0 results

When the Food and Drug Administration was granted authority over tobacco products, many people (myself included) objected that this was an inappropriate field for the agency to be involved in. Among other reasons, it makes little sense for the FDA to approve products that are to some degree inherently dangerous. An excellent article from Michael Felberbaum of the Associated Press shows that the agency has failed to establish reasonable standards of review and has halted innovation in the parts of the industry it regulates:

Tobacco companies have introduced almost no new cigarettes or smokeless tobacco products in the U.S. in more than 18 months because the federal government has prevented them from doing so, an Associated Press review has found. [...]

Since June 2009, when the law allowing the agency to regulate tobacco went into effect, the tobacco industry has submitted nearly 3,500 product applications, according to data obtained by the AP under a Freedom of Information Act request. While none have been ruled upon, the vast majority of these products are already being sold.

A grandfather clause in the law allows products introduced between February 2007 and March 2011 that are similar to those previously on the market to be sold while under review. They can be removed from store shelves if they don’t pass muster with the agency. But 400 products submitted for review since March 2011 are being kept off the market.

The reviews, which are supposed to take 90 days, have dragged on for years in some cases. About 90 percent of applications have lingered for more than a year.

Nearly 3,500 applications over three years and zero rulings. Perhaps the agency is understaffed? Not exactly:

The [FDA's Center for Tobacco Products] has an annual budget of more than $450 million, funded by the industry, and more than 365 employees, about 115 of whom work on the application reviews.

One hundred fifteen employees and zero rulings. One wonders what they do all day.

Part of the problem is that the agency evaluates products not merely on their physical characteristics, but also on whether they may entice new smokers or discourage current smokers from quitting. Since any new product is intended to appeal to someone, it’s not clear to me how applicants can decisively prove to hostile regulators that their products meet this requirement.

Perhaps one does not feel much sympathy for the tobacco companies. But note that the FDA has signaled that it will likely soon be regulating cigars too, and imagine giving the lumbering agency veto power over all new cigar blends. If Philip Morris and Lorillard can’t push new products through the approval process, how will boutique cigar makers fare? As demonstrated by the FDA’s handling of tobacco thus far, regulation could be devastating to the premium cigar industry.This is a topic I’ll be covering in greater depth next week.

Update 12/14/12: Michael Siegel weighs in too:

The rest of the story is that the Tobacco Act is working exactly as I predicted it would: as a way to protect the existing cigarettes on the market and block any real possibility of competition from what could be truly safer products.

Calorie counts everywhere!

My newest Examiner post covers the FDA’s draft rules for calorie labeling, which may extend not just to restaurants, but also to convenience stores, movie theaters, and supermarket salad bars — all without much evidence that they’ll do any good.

On a related note, last summer I wrote about how technological change will make these laws superfluous:

Improvements in information technology are another reason to doubt the merits of forcing restaurants to post calories directly on menus. Websites like Calorie Lab already provide databases of the nutritional information from more than 500 restaurants. As far as I know they don’t have a phone app yet, but they could easily make one (one competitor already has). As smart phones proliferate it will be easier than ever for consumers to access calorie counts in addition to much more thorough nutritional information about the foods they eat. Yet these archaic laws will still be on the books forcing unneeded clutter on printed menus.

Even better than smart phones, this week Eater takes a look at how iPads are replacing printed menus in a few restaurants. The devices are durable, interactive, can hold a lot more information than a printed menu, and can work with a restaurant’s point of sale system. If desired, an electronic menu could offer extensive nutritional information at the push of a button. They’re cost-prohibitive right now for most restaurants, but in the future we can expect the price to go down and electronic menus to become more common.

It will be interesting to see how the law is adapted for electronic menus. Will calorie counts have to be displayed prominently like they are now, or will it be enough to have them easily available on the device for interested consumers? If the former, that will be another sign this law is intended more to nag people than to provide them with desired information.

Two quick links

OK, one quick post from Tales with a couple links. I’m at the Washington Examiner today with a post about why the FDA’s menthol hearings are asking the wrong questions. Then at the Portland Examiner, Hoke Harden has a great (and way too flattering!) write-up of the Brewing Up Cocktails event. If you’re curious about the drinks we served, go check it out.

Toward a blander future!

The Institute of Medicine has released its report on salt in the American diet and, as expected, it recommends that the FDA mandate reduced sodium content in packaged foods and chain restaurants. Here’s a short summary from The Washington Post of how this would work:

In a complicated undertaking, the FDA would analyze the salt in spaghetti sauces, breads and thousands of other products that make up the $600 billion food and beverage market, sources said. Working with food manufacturers, the government would set limits for salt in these categories, designed to gradually ratchet down sodium consumption. The changes would be calibrated so that consumers barely notice the modification.

As Jeff Ely notes, the idea is that this is a coordination problem. We might all be better off if we reduced our salt intake, but in order to calibrate our tastes to a lower level we have to gradually reduce the salt in all foods at the same time. (For what it’s worth, the FDA has stated it’s not currently planning salt regulations.)

There’s some disagreement about the benefits of reducing salt consumption across the entire population and about whether our “bliss point” for salt content is really that malleable; John Tierney writes on this topic here and here. But for now let’s grant the plausibility of both of those claims. It’s one thing to say we should all reduce our salt consumption. It’s quite another to say that a government agency is capable of gradually and imperceptibly reducing the amount of sodium in the nation’s food supply over the course of a decade and stopping at the “correct” level. The IOM report’s introduction hints at the scale of this endeavor:

… if strategies to reduce sodium intake in the United States are to be successful, they must embrace an approach that emphasizes the entire food system and emphasizes sodium intake as a national concern. This report recommends the use of regulatory tools in an innovative and unprecedented fashion to gradually reduce a widespread ingredient in foods through a well-researched, coordinated, deliberative, and monitored process. [...] the approach must be supported by a strong federal government commitment to sodium reduction and leadership from the Department of Health and Human Services (HHS) in cooperation with other agencies and groups to ensure coordination with all stakeholders including the food industry and consumers.

Monitoring! Deliberation! Coordination! This is bureaucracy porn for technocrats. It’s a safe bet that the people at the IOM aren’t reading Hayek on their lunch breaks, because if you have read Hayek the success of this enterprise starts to sound very far-fetched. You begin to wonder how the people making these decisions could possibly have all the information they need to pull this off. How gradual is gradual? What percentage of salt should be taken out of each product each year? Is it the same for bread, pretzels, spaghetti sauce, pickles?

This knowledge problem is exacerbated by the fact that salt’s impact on taste is complex. It doesn’t just make things taste salty. It can make food seem like it has greater body and reduces the perception of bitter elements (recall the way a tiny bit of salt can reduce the bitterness of bad coffee). As food companies compensate for reduced salt in their foods, they may have to make them richer in other ways or use more sweeteners. Similarly, as Tierney points out, if anti-salt advocates are wrong and consumers do have an inflexible satiation point for salt, they may eat more food just to keep their salt intake constant. To some extent we may end up trading salt for calories, hardly an unequivocal good given our current excess.

It’s doubtful whether a government agency could accurately gauge consumer preferences. The FDA is not in the food-selling business and so has little incentive to care about taste. The IOM report repeatedly stresses keeping food “acceptable” to consumers. But what if you don’t want acceptable, you want delicious? Don’t expect the FDA to care. As demonstrated by its actions against unpasteurized dairy and its threat to ban menthol cigarettes, the agency places little value on consumers’ choices when they conflict with regulators’ own assessments of acceptable risk. There’s no reason to believe the interests of regulators and consumers will be aligned on salt levels either.

FDA bans product for tasting good

No, the headline is not an April Fool’s joke. This week the FDA began its inquiry into whether it ought to ban the sale of menthol cigarettes:

A scientific advisory panel that will advise the Food and Drug Administration on regulating tobacco opened a two-day meeting Tuesday and began reviewing hundreds of published studies on menthol cigarettes. The panel, largely made up of scientists, physicians and public health experts, has a year to make a recommendation to the FDA on menthol cigarettes, which are used by about 26 percent of smokers and make up almost one-third of the $70 billion U.S. cigarette market.

Throughout this process there will be allegations from anti-tobacco groups that menthol cigarettes are more addictive, more dangerous, and more likely to hook teenagers than unflavored cigarettes. These scare tactics neglect to mention that menthol itself is harmless. It’s not habit-forming like nicotine. It’s not dangerous and is used widely in medicinal, dental, and food products. Tobacco companies don’t put it in cigarettes as part of a dark conspiracy to addict people. They use it because it tastes good, is soothing, and consumers want it.

Because of these effects it’s possible that some of the charges against menthol cigarettes are true, statistically speaking. The FDA’s going to spend a lot of time and money sorting this out, but there’s no mystery as to why this is: When a product is pleasant, people consume more of it. They’ll smoke more of them or smoke each cigarette more intensively. They’ll have less reason to quit. Some teenagers will prefer them to unflavored cigarettes, just as about one third of legal adult consumers do. This doesn’t mean that menthols are especially toxic, it just means that people like them.

If this is accepted as a legitimate reason to ban menthol cigarettes there’s no limit to what the government could do next. It could ban other forms of flavored tobacco in cigars, pipes, chew, and hookahs — in fact, New York City has already passed a low doing almost exactly that. It could force cigarette producers to make their products so bland and heavily filtered that no one wants to buy them. It could kill premium pipe and cigar companies entirely, an industry whose purpose is to make tobacco that tastes good and is pleasant to smoke.

And that’s just tobacco. If menthol and other flavors can be banned for “masking” the harsh taste of cigarettes, why not ban flavors that “mask” the harshness of cheap vodka? Or the barrel aging that turns hot white dog into mellow whiskey? Or hops in beer, condiments in fast food, milk and sugar in a venti Frappuccino? As individual health increasingly becomes the public’s business, there’s no end to the unhealthy things we can reduce the consumption of by simply making them unpalatable.

If you read the press coverage of this debate in The Post for example, you’ll see quotes from anti-tobacco activists explaining why menthol needs to be banned. You’ll even see quotes charging that not doing so would be racially discriminatory on the grounds that menthols are relatively more popular among blacks than whites. What you won’t see are quotes from any of the millions of consumers who currently smoke menthols and may soon have that choice taken away from them. The opinions of smokers do not matter; they are assumed to be dupes or addicts incapable of making their own decisions. By portraying them as victims of the tobacco companies anti-smoking activists dodge the consumer rights aspect of this issue. They avoid answering the hardest question asked in opposition to their plan: If a consenting adult wants to purchase a flavored cigarette, why shouldn’t he be allowed to do so?

This is a dangerous road. It’s one thing to forbid sales to minors, to tax tobacco, to require warning labels, and to restrict the sorts of places where one can light up. It’s quite another to take a product off the market simply because many people prefer it. That is pure paternalism; take individual agency out of the picture and it’s a much smaller step to banning tobacco entirely.

This issue is going to drag on for a long time. I’m sure I’ll be writing more about it here, but be sure to also follow the excellent coverage of Brooke Oberwetter starting with her most recent blog post.

Authoritarian attitudes at the FDA

Yesterday’s Wall Street Journal featured a good article about the FDA’s renewed crackdown on raw milk sales. In it we get confirmation that the agency may indeed tighten its rule allowing sale of raw milk cheeses after 60 days of aging. It also includes a few quotes from John Sheehan, the media-shy director of dairy food safety:

“Raw milk is inherently dangerous and should not be consumed by anyone, at any time, for any reason,” says John Sheehan, director of the FDA’s division of plant- and dairy-food safety.

This is a completely unscientific statement. What does “inherently dangerous” mean? Pasteurization has been widespread for only about a century. Was the unpasteurized milk that humans drank for thousands of years before that “inherently dangerous” or simply less dangerous than modern pasteurized milk? Should it not even be consumed so a person can discover for himself if the benefits outweigh the costs? Sheehan’s conclusion has no scientific basis and ignores diversity of tastes and risk tolerances.

There’s a lot of hype about the health benefits and safety of raw milk put out by its advocates, much of it not very scientific. The FDA could play a constructive role by informing consumers of the risks involved. But to do so it needs to stop alienating them by driving them into underground markets of true believers. Potential raw milk consumers might be more trusting of the agency if it wasn’t denying them their freedom and seeking to have their suppliers thrown into jail.

[Via ColdMud.]

Update: In the comments, Barzelay says it much better than I did:

This binary way of looking at food as either risky or not risky is never going to work because everything carries a risk, it’s just that risks are greater, or at least different, for different things. Moreover, it’s not as simple as pasteurizing food, because other risk factors can come into play: your pasteurized milk, if stored at improper temperatures, can have a much higher risk than raw milk. We need to embrace a more complex view of food-borne illness risks that puts more of the onus on the consumer. People need to be aware of the risks of what they’re eating.

Instead the FDA wants to be able to proclaim that all the food in the US is safe, or at least all the food available from typical big-business retailers. They should be doing the opposite! All food is risky! Now tell people how to manage those risks.

They’re coming for your cheese

In much of Europe, fresh, raw milk cheeses are available and loved by cheese connoisseurs. In the US the FDA requires raw milk cheeses to be aged for at least 60 days prior to sale, which limits our options but is better than nothing. David Gumpert reports that now even that option may be taken away from us:

According to a report in an industry publication, Cheese Reporter, a top dairy official at the FDA, Stephen Sundlof, director of its Center for Food Safety and Applied Nutrition (CFSAN) believes that the 60-day aging period “is not effective in reducing pathogens in raw milk cheeses.” There needs to be “some other risk management steps” that could be applied. Sundlof said at a dairy conference last month. What makes him think that the 60-day period isn’t effective in reducing pathogens? A little birdie must have told him so.

A change in the aging period regulation could put a crimp on production of a number of raw milk soft cheeses like brie and camembert, among others. Some producers already struggle with the 60-day aging requirement, since certain cheeses are best sold sooner than that, and letting them age for 60 days simply reduces their viable shelf lives.

Moreover, the FDA isn’t proposing to extend the aging period, but rather to require processing of the milk, including pasteurization of milk for certain cheeses.

Unfortunately the Cheese Reporter story is no longer at the link so I have few details, but this looks like another overreaction from the FDA.