fda regulation

An Alcohol-Caffeine Ban Won’t Work

by Michelle Minton on October 28, 2010 · 1 comment

in Health and Illness, Nanny State, Personal Liberty, Precaution & Risk, Regulation

The genie is out of the bottle.

Mixing energy drinks and distilled spirits has become a popular trend in the U.S., particularly, among college age students. However, a few isolated incidents in which alcohol-energy drinks (AEDs) were implicated in the alcohol poisoning of some students, has prompted the FDA to consider a ban on the sale of AEDs while others are calling for a ban on all mixing of alcohol and caffeine (no more rum and Cokes). In particular, the drink Four Loko has become the focal point of those calling for a ban.  But removing the drinks from the market will not stop people from drinking alcohol and caffeine together. But that is just one of many problems with the proposal to ban AEDs.

First, the research that draws a link between alcoholic energy drinks and health risks is limited and dubious. Second, a ban will not stop people from mixing alcohol and caffeine at home and the results of that could be worse than a pre-mixed AED which states the amount of caffeine and alcohol on the can. Third, even if risks are associated with the consumption of alcohol and caffeine it should be up to the individual to make that decision, not a government agency.

Research: Under the Influence

The mix of caffeine and “stimulants” with alcohol supposedly allows imbibers to achieve intoxication while maintaining energy levels that allow them to continue partying long into the night. Those pushing for a ban on AEDs argue that stimulants mask the effects of liquor on drinkers who then continue to consume alcohol putting them at risk for alcohol poisoning, physical harm, and victimization. However, most of the research cited by the anti-AED camp is the product a small number of university studies, wherein participants were surveyed on the internet or upon exiting nightclubs and asked to report on their drinking behavior and its effects. The problem with these surveys, as Baylen Linnekin noted in his paper, is that they do not differentiate between pre-mixed AEDs:

The most widely cited study in the war on AEDs, an Internet-based survey of college students conducted by researchers at Wake Forest University, has nothing to do with pre-mixed AEDs targeted by the FDA’s current action. Instead, the study examined the consumption of any “alcohol mixed with energy drinks.” The study methodology does not mention pre-mixed AEDs in any way, making it impossible to distinguish between pre-mixed drinks and the consumption of cocktails…

Still, the distinction between the known (AEDs) and the unknown (self-mixed energy drink cocktails) seems not to matter to Mary Claire O’Brien, primary author of the Wake Forest study… She told the anti-alcohol Marin Institute in 2008 that she would “like the federal government to immediately ban all alcoholic energy drinks and the adding of caffeine to all alcoholic beverages.” Such a ban would not only eliminate the AED market, it would also threaten a host of venerable traditional cocktails that contain caffeine, including Irish coffee and rum and Coke. [Emphasis added.]

It Says So on the Can:

The fact of the matter is that the alcohol and stimulant contents of Four Loko and other AEDs are printed right on the can for anyone to read. This makes it easier to determine the amount of alcohol one is consuming over time. However, if consumers mix the drinks themselves, they are more likely to imbibe greater amounts of alcohol accidentally. When compared ounce for ounce to the popular cocktail known as a Jägerbomb (a shot of Jägermeister and a can of red bull) the Four Loko actually has less alcohol per ounce.

Jägerbombs per ounce: Alcohol= 35% abv Caffeine = 8.24 milligrams

Four Loko per ounce: Alcohol= 18% abv Caffeine= 5.7 milligrams

For reference, the average domestic beer in the U.S. will be served in a 12-16.5 ounce serving and have between 4 percent and 6 percent abv.

The likelihood of over-consumption of alcohol and caffeine is more likely when the drinks are mixed at home because, unlike the pre-mixed canned drinks, the alcohol content is more difficult to calculate.

Caffeine is Not the Problem:

The issue with Four Loko is not that combining caffeine and alcohol is dangerous, as most anti-AED folks claim. The problem is that a few of the people choosing to drink Four Loko and other pre-mixed alcoholic energy drinks are behaving in a manner that is dangerously irresponsible.

While the product is not inherently dangerous, it does contain a large quantity of alcohol per can, about as much as four light beers. However, if a person drinks one can over the course of an hour or two the average person would experience no serious effects beyond mild intoxication. But that is not what we are talking about. A small group of college students are pounding back many cans of Four Loko over a short period of times (less than a couple of hours), knowing that it contains a high amount of alcohol per can.

There is nothing new in this. College students have been hazing and partying for decades. Their irresponsible behavior is no justification for banning a product that the majority of consumers use responsibly.  It is understandable that reporters, parents, and drinkers themselves want to blame their over-consumption and the resulting behavior on the drink itself; It’s easier to blame an uncontrollable outside force than to face the responsibility and consequences of bad decisions.  However, Four Loko and other AEDs are just the latest implement in age-old story of young adults acting dumb, taking risks and screwing up; this year it’s Four Loko, next year it might be water.

For a thorough look at FDA involvement in the alcohol-energy drink market I highly recommend reading Baylen Linnekin’s complete study: Extreme Refreshment Crackdown:
The FDA’s Misguided Campaign Against Alcohol Energy Drinks.

Baptist-Bootlegger Alliance on Tobacco

by Hans Bader on April 8, 2009

in Economy, Healthcare, Legal, Personal Liberty, Politics as Usual, Precaution & Risk, Regulation

In today’s Washington Examiner, Tim Carney has an excellent column on how the bill to place tobacco under FDA regulation would reduce competition in the tobacco industry and enrich the biggest company — Philip Morris — at the expense of consumers and competitors alike. Although the bill is supported by leading anti-smoking groups (which indirectly receive money from Big Tobacco through the $246 billion Master Settlement Agreement), the bill’s “most important ally” is “Philip Morris, the largest cigarette maker in the world.” As Carney notes,

“There’s a metaphor popularized by economist Bruce Yandle that is useful in explaining efforts to regulate anything from energy to toy safety. Call it the Tale of the Baptist and the Bootlegger.

“Picture a small-town Southern politician after Prohibition’s repeal. Call him Jones. Jones’ campaign needs both cash and a winning issue. The state’s most prolific bootlegger comes and offers Jones both. ‘I can bankroll your entire campaign. You just need to outlaw alcohol in the county. If you close down the bars and clear the liquor out of the corner stores, the men will all have to come to me for their fix.’

“Jones, with newly heavy pockets, walks down to the Lady’s Temperance Hall and declares, ‘Ladies, I’m running to end the scourge of alcohol in this town, and I’m asking for your support.’ At his campaign kickoff the next week, Jones has the entire Temperance Union and the local preacher onstage endorsing him, and of course, he’s got the pipeline of alcohol cash from the rumrunner who will get even richer when the county goes dry again.

“Philip Morris is the ‘bootlegger’ today — the undisputed giant of the industry. The company controls more than half of the U.S. cigarette market. . .Parent company Altria has hired three new lobbying firms so far this year, bringing its army to 19 different lobbying firms plus a powerful in-house shop. . .

“Philip Morris stands to benefit from this regulation in many ways. First, all regulation adds to overhead, and thus falls more heavily on smaller firms. Second, restrictions on advertising help Philip Morris’ Marlboro, a brand everyone already knows, by keeping lesser-known brands in the shadows. (Existing restrictions on advertising have already helped Philip Morris in this regard, with an added benefit spelled out in Altria’s annual report: ‘Marketing and selling expenses were lower, reflecting regulatory restrictions on advertising and promotion activities. … ‘) Finally, if the bill passes and the FDA gets added control over the industry, Philip Morris, more than any of its competitors, will have access to those bureaucrats and agency heads making the decisions.”

We wrote earlier about how FDA regulation might actually undermine public health by making it harder to market to smokers other tobacco products, like snus, that are not as lethal as cigarettes.

Federal regulation often backfires. A classic example is the 2007 child-safety law, the CPSIA, which was based on junk science. It shut down countless thrift stores and entire industries, resulting in children’s books being thrown out and pulled from library shelves by the thousands. It harmed poor people and special-needs kids. It rendered many ordinary bicycles illegal and made motorcycles more dangerous to children.

But it is now being used by Congress as a blueprint for a misguided law, the Food Safety Modernization Act of 2009, that would put small food producers and farmers’ markets out of business in the name of food safety.

Speaking of Baptists and bootleggers, a large coalition of religious leaders who know nothing about how regulation works in the real world have endorsed FDA tobacco regulation. Most of them are from liberal religious denominations, like the Unitarian Universalists and Religious Action Center of Reform Judaism, but the signatories also include Dr. Richard Land of the Southern Baptist Convention.

I wrote earlier about the Religious Left, including its claims that Sarah Palin is not really a woman (because she’s a Republican), that Ronald Reagan was “Pontius Pilate,” and its rants about the “Taliban-like American male,” who should “shut up for a milennium.” The Religious Left also believes that God hates secret ballots in the workplace, and falsely accused former Interior Secretary James Watt of publicly stating that all trees should be cut down in light of the imminent return of Jesus Christ.

Supreme Court Considers Tort Preemption for Medicines

by Greg Conko on November 3, 2008

in Healthcare, Legal, Nanny State, Personal Liberty, Precaution & Risk

Diana Levine suffered from chronic migraine headaches for many years. So, in April 2000, when she went to a local clinic to get treatment, she knew what to expect. She’d received the same treatment several times before: an injection of Demerol for the pain, and an injection of an antihistamine called Phenergan to treat the nausea that accompanies both migraine headaches and Demerol itself. Everything was normal — except for how the drugs were actually administered. The physician’s assistant who gave her the drugs accidentally injected the Phenergan into an artery, instead of a vein, causing tissue death and gangrene. Ms. Levine, a professional musician, eventually had to have her arm amputated.

Levine naturally sued the physician’s assistant, the supervising physician, and the clinic for malpractice. After all, Phenergan’s FDA-approved label specifically warned against injection into an artery, precisely explaining the likely, tragic side-effects. But Levine also sued the pharmaceutical company that manufactures Phenergan, Wyeth, arguing that the warnings were not clear enough. Despite Wyeth’s defense that the drug had been on the market since 1955, FDA had known about the gangrene risk since 1967, and the agency had explicitly approved the warning that was included on the label, a Vermont jury awarded Levine $6.8 million dollars.

Wyeth appealed the jury verdict, arguing that, because it had complied with FDA regulations on both product safety and labeling, and because there was no new information about Phenergan’s risks that would supersede FDA’s judgment about the warning language, FDA regulation should preempt the state tort claim. And FDA agreed. Nevertheless, the Vermont Supreme Court affirmed the verdict, and Wyeth further appealed to the U.S. Supreme Court, which hears oral argument in the case today.
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