31 January 2011

Unhealthful News 31 - Will anyone figure out it is not about the caffeine?

Those of you who read this blog before the start of Unhealthful News will recall me writing about the stupidity that surrounded the regulation of alcoholic energy drinks like Four Loko, that appeal to young people seeking uppers and cheap alcohol that tastes like bad soda.  The upshot was (a) it was fairly stupid to think that banning these drinks was worthwhile (it is trivial to make them yourself: energy drink + vodka) and (b) all of the discussions, and the ultimate bans, completely missed what might be worth regulating.  They all focused on how these drinks contain caffeine, a well-studied, approximately harmless drug that is mixed with alcohol in any number of ways.  Both the news stories and the regulations ignored that what is different about these drinks and might have made them more dangerous to mix with alcohol are the various other less-well-studied stimulants in the drinks.  The bans ended up forbidding the caffeine-alcohol combination (except in drinks that wealthier people buy, like Kahlua) but allowing the energy drinks with alcohol to continue to exist with the removal of just the caffeine (so you need to drink some coffee to complete the cocktail).

A new proposed regulation in a large county in New York has the merits of addressing this problem, by banning sales of energy drinks to young people, though in a way that seems to hold little promise (even if you think it is a good idea).  But it was the critics of the proposal who managed to get the issue even more wrong.  The latter is quite disappointing to me.  I generally oppose regulations that restrict people's right to make informed autonomous choices about their health.  But that does not mean we should misrepresent efforts that, despite being bad in their details, are based on concerns that people are not actually informed about a particular set of risks (the first sentence of the statement proposing the law emphasizes the goal, "to alert consumers to the health risks associated with energy drinks", not a restriction on autonomy, though a restriction is, unfortunately, where the law's teeth lie).

The county government released this statement (pdf) about the proposed ban – sorry for the pdf link but it was not exactly big news and I only heard of it because critics were touting this critique of it.  The proposed ban would require merchants to post a warning about energy drinks, which you can read in the county's statement.  The warning suffers from the common problem of leaving the consumer thinking "might" means "is", and has a few badly chosen emphases, but is really not a terrible bit of advice.  The proposed law would also prohibit sales to anyone under age 20, which is what makes it a target of criticism.  As always, the devil is in the details, especially the definition, in this case:

an Energy Drink is defined as "a soft drink that is classified as a dietary supplement not regulated by the Food and Drug Administration and that contains 80 or more milligrams of caffeine per 8 fluid ounces and generally includes a combination of methylxanthines, B vitamins and herbal ingredients and other ingredients which are advertised as being specifically designed to provide or increase energy."
Let's unpack that a bit.  The emphasis on  caffeine is just as misguided as it was with Four Loko.  If such a rule were widely adopted (beyond just a few local governments), manufacturers would presumably lower the caffeine content of energy drinks to below that threshold (few are actually much above it) or produce a "lite" version, differing only in the lower caffeine content, that would now appear like the government said it was safe for the kiddies.  If they did that, it is not clear that the drink would meet the conditions of the law no matter what else it contained, if I am reading the word "and" correctly.  The rest of it is even more of a mess.  Methylxanthines are a class of chemicals that include caffeine and some other stimulants, so just adding this word to the already-listed caffeine seems content-free, whether or not some of the other methylxanthines are included, as they are in many energy drinks.  Merely having B vitamins (good for you in moderation, perhaps of concern in the megadoses found in some energy drinks) and herbal ingredients (like orange juice?) is a pretty useless way of creating a legal definition of energy drinks, though not as useless as "other ingredients".  As for how they are advertised, perhaps one or two of them actually say "designed to provide energy", but even if they say they provide energy, they seldom say anything about how they were designed.  And does it count the ads that say "Red Bull gives you wings"?

I think the best thing we can conclude from this is that county governments are probably in over their heads a bit trying to regulate food and drugs.  Health regulators at higher governmental levels often know how to better define substances and advertising regulators at those levels are better at characterizing statements.

That said, I have to admit some sympathy with the underlying goals.  There are a few stimulants we know a lot about, enough to be confident that they pose some minor risks but no substantial threat to users who are teens or older.  There are others that might pose greater risk, especially in combination, enough that better regulation is warranted (at least some warnings and perhaps limits on concentrations).  Caffeine is one of the well-understood stimulants, which is a huge problem with the way the legislation was written.  Nicotine is another.  The latter makes this proposed ban much more sensible than New York's proposed ban on e-cigarettes, since it is an attempt to cover other stimulants which we know disquietingly little about.

Damn, I guess that blows my thought that states will make better health policy than counties.  Perhaps the rule should simply be to not let an individual legislator propose line-item health regulations, especially when she basically admits (in the case of New York and e-cigarettes) that their attempt to deprive tens of millions of people of a potentially life-saving choice is based on the extensive expertise that comes from having done something once herself.

Returning to the energy drink law, it is unfortunate that the critics seem to completely miss the point of the regulation.  They first focus on the caffeine, probably because it is the only concrete part of the proposed definition.  But they suggest that the concern about energy drinks is about caffeine (this is clearly not in the intent of the law, but its author did leave herself open to the representation by emphasizing caffeine) and use that as a source of ridicule by comparing the (higher) caffeine content of a decent cup of coffee.  When they briefly address the other ingredients that are the greater source of concern, they emphasize that one ingredient common in energy drinks is a required ingredient in baby formula.  With this, they not only ignore the fact that the dose is what makes the poison, but they employ the same anti-chemical tactic often used by those calling for unjustified regulation (e.g., the "it is in anti-freeze!!!" rhetoric that is frequently used to imply that the major inactive ingredient in electronic cigarettes is unhealthy).  Someone reading the critique would think that the new proposal is as absurd as the U.S. FDA's choice of how to respond to the Four Loko hype, which it is not.  Whatever you might think about its actual net costs and benefits, the proposed law is not without merit.

The critics go on to express worry about convenience stores having to pay the cost of putting up a warning sign, though by my reading of the proposal they could print out the specified paragraph on a half-sheet of paper and tack it to the wall somewhere (and I am sure that the local Red Bull distributor would supply signs if color printing, cardstock paper, lamination, or some other great expense is required).  They also seem to worry about the burden of c-store clerks having to check the age of their patrons, perhaps not realizing that c-stores make most of their money selling products that already require carding (cigarettes alone are how those stores make a profit, and in New York they also sell alcohol).  Finally they argue at some length that this will damage teenagers by depriving them of the opportunity to make their own decisions:
One of the worst things about this bill — and other laws like it — is the disservice it does to youngsters. Young adults need to learn how to make their own decisions about nutrition and moderation. Almost any substance or product can be abused — even water can be consumed in fatal quantities. 
Really?  That is what we are using for anti-regulation arguments these days?  We should be just as worried about someone drinking gallons of water as we are about downing the pint of concentrated stimulants that might lead to cardiac arrhythmia?  And should we do nothing to reduce the chance of the latter just because the former might happen and because kids need to be responsible enough to do their own epidemiology before getting amped to study or party?  It is one thing to argue that the science shows that there is no reason to worry about these drinks (and then actually tell us what the science says), but responding with trumped-up concerns about implementation costs and the loss of personal responsibility just undermines legitimate criticisms of regulations.  Just because one county's ban of Happy Meals is simplistic and infantilizing does not mean the same is true of an attempt by a county on the other side of the country to regulate drugs that have not been well studied and seem to have some bad effects.  One-size-fits-all works no better for anti-regulation than it does for regulation.

I agree with the critics' main conclusion, that this would be an ill-formed law.  If for no other reason, banning 19-year-olds from consuming something seems to be among the least sensible ways to act on concerns about these minimally-regulated stimulant products.  However, assessing whether warnings and quantity limitations, and maybe age limits, are warranted seems worthwhile.  Unfortunately, without regulating specific stimulants by name, and without the involvement of scientifically-expert regulators who can understand the research on the chemicals and demand more if needed, regulation is unlikely to be effective.  County lawmakers are not in a good position to do this, and it is very frustrating that we cannot trust the FDA to play that role sensibly, so it is tempting to condemn all attempts at regulation.

But the debate over ill-formed health proposals is not improved by responding to legitimate concerns with aggressive condemnation.  This is especially true when the same essay could be used to condemn most any regulation with the substitution of only a few words.  The reader of the critique will be misled, both about the fact that the proposal has some reasonable motivation and, if he thinks about it, about the nature of opposition to public health interventions.  Some readers will conclude they should resist any such regulation because they are all a threat to autonomy and, besides, the water will kill you.  But others might go another direction:  The tone of the critique plays into the hands of those who would declare all opponents of regulation to be mere pro-industry spokesmen who just object to any restrictions on commerce.  When authors employ blanket condemnation, readers cannot recognize the difference between indefensible regulation (e.g., New York e-cigarette ban) and sloppy and perhaps-unwise, but sensibly motivated regulation.   As a reader you can be wary:  If it sounds like almost the same argument could be used to, say, argue that anyone should be able to sell any drug they want, without a warning label, until it is proven to be deadly, then perhaps you should doubt the authors' claims.  Their criticism might be correct, but you will not know that from what you are reading.

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