FDA

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.

Sen. Grassley’s Selective Crusade Against Conflicts of Interest

by Greg Conko on October 28, 2010

in Culture, Health and Illness, Nanny State, Politics as Usual, Precaution & Risk, Regulation, Zeitgeist

Sen. Charles Grassley (R-Ia.) has been on a tear lately, badgering the Food and Drug Administration about whether it’s doing enough to crack down on financial conflicts of interest among doctors who participate in clinical trials to test new medicines.  Grassley suggests that the payment of consulting fees to doctors could create a “potential bias that may compromise the reliability of data” generated to support the approval of drugs and medical devices.

While collaborative arrangements between medical products manufacturers and academic researchers has in fact been a huge boon for medical progress during the past half century or so, and financial connections are not the only source of relevant bias, it’s not entirely unreasonable to be alert to possible conflicts of interest.  What’s hypocritical about Grassley’s crusade is that he only seems to be concerned about financial conflicts of interest when they’re used to condemn products he doesn’t happen to like.

Take, for example, Grassley’s partnership with Cleveland Clinic cardiologist Steven Nissen and their joint campaign against the GSK diabetes drug Avandia.  There’s been a fair amount of news over the past couple of years describing the controversy over Avandia (see here, here, and here for examples).  The drug appears to work wonders for the treatment of Type II diabetes, but research conducted by Dr. Nissen indicates that it also leads to a significant elevated risk of cardiovascular events, such as heart attack and stroke.  Nissen was a key source for a February 2010 Senate Finance Committee report condemning Avandia, which was instigated by Grassley, and both men think that Avandia should be pulled from the market.  They would have gotten away with it too, except that lots of patients actually taking the drug have decided that the huge health benefits associated with controlling their diabetes far outweigh the higher cardiac risk.  They demanded to have continued access to the drug.  So, last month, FDA decided to keep Avandia on the market, but place heavy restrictions on its use.  Nissen said that “more than 99 percent of Avandia use in the U.S. will disappear” because of the restrictions.

So, where’s the hypocricy?  It turns out that Nissen just happens to be one of the investigators on a study purporting to show that Avandia’s closest competitor, Takeda Pharmaceutical’s drug Actos, is superior to Avandia because it doesn’t increase cardiac risk.  And, as it turns out, Takeda provided $25,000 in funding to Nissen’s Cleveland Clinic team to conduct the Actos study.  As my 5-year-old son, who is newly taken with episodes of the classic cartoon Scooby-Doo, might say … “Ruh-Roh!”  The golden boy, upon whose research Grassley’s crusade against Avandia has been built, has taken funding from a GSK competitor to conduct research that boosts Actos over Avandia.  Can you say “conflict of interest”, boys and girls?

Now, just to be clear, I want to explain that Steven Nissen is a highly regarded scientist, and there appears to be no good reason to believe his research on Avandia or Actos has actually been biased by the funding from Takeda.  (Although the kind of meta-analysis Nissen used to study Avandia has inherent methodological weaknesses that make the findings suspect.  But that’s an argument for another day.)  So, it’s not entirely inappropriate for either the FDA or Charles Grassley to listen to what Nissen has to say.  But, for someone like Chuck Grassley who’s been riding a hobby horse against financial conflicts of interest in the pharmaceutical industry, the arrangement ought to have come under a bit more scrutiny.

Antibiotics and Meat DO Mix

by Greg Conko on September 1, 2010 · 1 comment

in Agriculture, Culture, Environment, Health and Illness, Precaution & Risk, Regulation, Zeitgeist

CEI submitted comments this week on an FDA proposed guidance that “encourages” farmers and antibiotics manufacturers to stop using “medically important” antibiotics for livestock growth promotion purposes.  When I first started researching the topic, I was sympathetic to the view that at least some of the antibiotics that serve as essential human therapies probably shouldn’t be used in livestock.  Sure, I thought, cheaper meat is a huge consumer benefit, but why surrender our last line of defense in the war against germs?  I wasn’t as strident as this Los Angeles Times editorial (“Antibiotics and meat don’t mix”), but I did think that maybe a few limits couldn’t hurt.

Naturally, I was surprised to find out how much it really could hurt.  There’s actually a pretty large body of scientific research showing how much so-called sub-therapeutic doses actually contribute to consumer health by reducing pathogen loads in animal-derived foods and have a positive impact on human safety (see here, here, here, and here, for just a few examples).  Plus, when the European Union banned antibiotics for livestock growth promotion, the expected decrease in the incidence of resistant human pathogens did not occur.  In most cases, the number of resistant bacteria continued rising, and in some cases they rose dramatically.  Moreover, the incidence of foodborne illness also rose substantially.  This shouldn’t have come as much of a surprise, since it’s estimated that livestock uses account for as little as 10 percent of the problem with antibiotic resistant bacteria.

The effect of antibiotic resistance on human health is a complex problem that cannot be solved by superficially appealing solutions.  What we need to do is optimize the mix of long-term efficacy and near-term benefits from antibiotics use.  We ordinarily expect that market forces can do this kind of thing, and that government regulation would exacerbate problems.  The appropriate market forces are attenuated here, however, since the off-patent status of most antibiotics makes them a “commons”, with little incentive for anyone to maximize the net present value.  Add in cross-resistance issues (i.e. resistance to one antibiotic can, at times, make a pathogen resistant to another one in the same or similar chemical class), and the end result is that we have to become more creative about instituting the right incentive mechanisms.  But one thing is certain:  an FDA decision to cut off a whole category of uses because the agency is solely concerned with long-term efficacy is shortsighted at best.

Here at CEI, we have long observed that far too many governmental (and some private) efforts to limit exposure to certain risks unintentionally increases exposure to other, potentially more hazardous risks.  Whether you’re talking about human or animal use, banning beneficial uses today can have negative impacts on human and animal health just as surely as a lack of long-term drug efficacy can.  And it seems pretty clear that use of antibiotics for livestock growth promotion purposes can coexist with the optimal antibiotics use.

The Nanny Zone Episode 1

by Ryan Lynch on June 1, 2010

in Nanny State, Personal Liberty, Video, Zeitgeist

[youtube:http://www.youtube.com/watch?v=1_OJgLJZuwM 285 234]

FDA Salt Statement Leaves a “Mistaken Impression”

by Daniel Compton on April 28, 2010 · 2 comments

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

Some 80 years ago this month, Mahatma Gandhi led tens of thousands on a 240-mile march in protest against a British salt tax, inciting millions to engage in widespread acts of civil disobedience.  In a seemingly unintentional display of historic irony, the Food and Drug Administration made national headlines on April 20th for its efforts to forcibly restrict the amount of salt that can be added to processed foods.  The Washington Post was among the first to pick up the story, and was subsequently chastised for its efforts in a statement from the FDA, released later that day.  The FDA accused the Washington Post story of “[leaving] a mistaken impression” in the minds of readers.  But examination of the facts shows that The Washington Post got it right, and that it is the FDA statement itself which leaves the mistaken impression.

The event that triggered media interest was the release of a report by the Institute of Medicine urging the FDA to revoke salt’s GRAS (Generally Recognized As Safe) classification, thereby granting regulators the legal framework needed to mandate acceptable levels of salt for processed foods.

The Washington Post responded to the release by reporting that the FDA’s plans to clamp down on salt were already underway and that the initiative would be launched later this year, citing FDA insiders who spoke only on the condition of anonymity.  Within hours, the FDA responded with a statement that the Washington Post article leads readers to believe that the FDA “has begun the process of regulating the amount of sodium in foods.”  The statement went on to assert that “[t]he FDA is not currently working on regulations… to regulate sodium content in foods at this time.”

While it is true that the FDA has made no official announcements regarding their stance on salt regulation, the claims that they have not begun the process and are not currently working on it are demonstrably false.

For 30 years, the FDA had largely ignored calls to reclassify salt, voiced by groups such as the Center for Science in the Public Interest.  That all changed in October of 2007 when, in an abrupt about-face, the FDA announced in the Federal Register that they would hold a public hearing to consider a change in the regulatory status of salt.  The hearing was conducted that November, and the public comment period was closed in August of 2008.  Just a few weeks later, the IOM kicked off a 21 month project titled “Strategies to Reduce Sodium Intake”—a project sponsored by the FDA.  This project would ultimately lead to the creation of the recent IOM report, also FDA sponsored.

Over the course of 2009, 14 meetings and phone conferences were held discussing the project.  All but the first two of these meetings were entirely closed to the public.

At the first meeting, a representative of the FDA itself made a presentation explicitly discussing the regulatory status of salt, as well as its history as a GRAS substance.  The second meeting included a presentation addressing the legality of a reclassification of salt—concluding that the FDA has “ample legal authority” to do so—and one discussing how low salt reduction levels could be set.

But what of the science underwriting this new FDA push?  Also included in the first meeting was a presentation by the Department of Health and Human Services stating that “100% of adults exceed the [adequate intake] of 1,500 mg sodium/day”.  Presented with such a statistic, certain questions spring to mind.  For instance, if 100% of adults eat more than 1,500mg of salt, what research could possibly have been conducted that would lead them to conclude that 1,500mg is adequate?  One might assume that such research was conducted on residents of other countries, but the reality is that the average American consumes about 9% less salt than the worldwide average.

The only places in the world where you might find a significant population who eat so little salt are in countries so poor that people don’t have reliable access to food at all. In such a place, one might indeed find low rates of hypertension-related illness, but only because those who live under such tragic circumstances don’t enjoy the luxury of living to the age where high blood pressure starts to become a concern.

Decades of research, encompassing multiple lines of evidence, have shown that our bodies naturally self-regulate salt intake.  Not unlike the feeling of thirst we experience when we need more water, our bodies send us queues—though more subtle than thirst—that lead us to unconsciously adjust our diets to meet our salt requirements.  One recent study by nutritionists at the University of California at Davis examined data collected from over 19,000 individuals across 33 countries to find that the normal range of salt consumption is 2,700-4,900mg per day.  The study went on to conclude that, because of our natural ability to regulate salt intake, it is “unlikely to be malleable by public policy initiatives, no matter how well intended.”

A study conducted 12 years earlier coincides with these findings, concluding that most people are simply unable to reduce their consumption below about 2,700mg per day, even when receiving regular dietary counseling and instruction.  A third study, conducted the same year, demonstrates that people will unconsciously increase or decrease their dietary salt intake to stay within the normal range, even when they don’t know how much salt is in their food.  Neuroscientists have even successfully identified the specific neurological mechanism by which this unconscious salt-regulation occurs.

Grossly out of step with the current scientific understanding, the FDA clearly has begun the process of regulating the amount of sodium in foods, and has been working on it for several years.  Between the hearing in 2007, their sponsorship of—and participation in—the 21 month project specifically aimed at reclassifying salt, and their sponsorship of the report itself, there is little more that the FDA could have done to expedite the process.

It is true that the FDA has not yet formally proposed a rule, but that is the obvious next step on the new path it’s been taking for the past few years.

It is an outrage that the FDA would deign to censure The Washington Post for publishing an article informing readers about the shape of things to come.  Far from leaving a “mistaken impression”, The Washington Post’s article hit the nail squarely on the head.  If a mistaken impression is to be had, then readers need look no further than the FDA’s own statement.  And why would the FDA go to such lengths to deny that which is both obvious and confirmed by insiders?  It’s a safe bet that they want the unveiling of their plans to be timed just right, as whatever they are about to drop on us is bound to be damned unpalatable.

Menthol cigarettes aren’t cool to the FDA

by Fran Smith on April 1, 2010 · 2 comments

in Nanny State, Personal Liberty, Regulation

In what could be one of its most paternalistic moves, the Food and Drug Administration is considering banning menthol in cigarettes – not because menthol itself is considered dangerous but because too many African-Americans smoke menthol cigarettes, and menthol may be a “gateway” smoke for young people.  An FDA panel focused on these thorny issues relating to menthol this week, with a view toward taking possible future action.

So let’s get this logic straight: members of a particular race particularly like that cool menthol taste, so the FDA wants to keep them from enjoying their smokes.  The top government nanny also says that menthol — because it tastes good – is used by cigarette companies to lure young people to smoke.

Given the fact that the FDA has tight restrictions on cigarette marketing and sales to young people under new rules that go into effect in June, and companies aren’t distributing free menthol cigarettes in the schools, it sounds like any youth who is “lured” into smoking menthol cigarettes is bumming the smokes.  Here’s a summary of the FDA’s new rules from a medical website:

  • Bans sale of cigarettes or smokeless tobacco to anyone under age 18.
  • Forbids tobacco brand-name sponsorship of any “athletic, musical, or other social or cultural event, or any team or entry in those events.”
  • Bans sale of cigarette packs containing fewer than 20 cigarettes.
  • Bans sale of cigarettes via vending machines or self-service displays “except in very limited situations.”
  • Prohibits free samples of cigarettes and limits samples of smokeless tobacco.
  • Forbids gifts in exchange for buying tobacco products.
  • Allows only words — and no music or sound effects — in audio ads for tobacco products.
  • Bans the sale or distribution of gear, such as hats and T-shirts, with tobacco brands or logos.

Those rules are pretty stringent, but Health and Human Services Secretary Kathleen Sebelius says they’re not enough where children are concerned.  She noted that somehow, some way, tobacco companies are getting to the kids:

“Despite a ban on direct marketing to young Americans, tobacco companies have still found a way to reach out to them,” Sebelius said at a news conference. “It’s no accident that Marlboro, Camel, and Newport, the three brands that spend the most on ads, are more preferred by children than by adults.”

The FDA panels this week are part of what is expected to be a year-long review of menthol, even though Dr. Joshua Rising, an FDA scientist, said that limited data “do not suggest that menthol cigarettes are associated with an earlier age of initiation.” And what words for adult smokers who like their menthol cigarettes?  Trust the FDA to protect you with a ban or a phase-out or an additional warning for menthol.

Human Achievement of the Day: e-Cigarettes

by Michelle Minton on March 19, 2010 · 1 comment

in Odds & Ends

Oh yeah, I’m going there. Cigarettes are a human achievement. Just like food items (i.e. chocolate) or beverages (i.e. wine) cigarettes are a consumable product that can enhance the enjoyment of the smoker’s life. Sure, it can cause a lot of problems for the smoker and irritate folks around him or her, but those are trade-offs that, as with many other things, one must account for when deciding whether or not to take a certain action. ecigs

All that said, quitting is a really good idea. The achievement this post seeks to praise is the device that shows great promise in helping smokers improve the quality of their lives while allowing them to continue behaviors that they find enjoyable.

Smoking in the modern age is not like it used to be. Gone are the days when you could light up anywhere, buy a pack for pennies, and expect the nonsmokers to “suck it up” so to speak. Almost anyone who has or continues to smoke understands that maintaining the habit is costly, time consuming, and hazardous to one’s health and psychology.

But quitting can sometimes be more difficult than living with the immediate frustrations of smoking. One major barrier to helping smokers quit is that most of them genuinely enjoy the act of smoking. Whether it’s the rush of nicotine or the habitual behaviors surrounding the process of lighting up, even those smokers who intellectually understand the dangers of smoking don’t want to stop.

The electronic cigarette, or e-cigarette might change all of that.

First developed in 2003 by a Beijing company now known as The Golden Dragon Group Ltd. the electronic cigarette is was approved by the FDA for sale in the US in 2008. These battery powered devices, which can look like cigarettes, cigars, or even pens, provide a dose of nicotine through the process of vaporizing a gel solution.

In addition to purported nicotine delivery, this vapor also provides a flavor and physical sensation similar to that of inhaled tobacco smoke, while no tobacco, smoke, or combustion is actually involved in its operation…They are battery powered, and create their effect by vaporizing nicotine which is dissolved in a solution of water and propylene glycol.

The question for some however, is whether or not these new electronic cigarettes really are safe. As one producer website noted, while the safety of the e-cigarette may not be exactly known, it is assuredly safer than smoking conventional cigarettes. For one, there is a definitive reduction in the risk of accidental fires as the e-cigs are battery powered and have no burning element.

E-smoking is almost identical to cigarette smoking. The major difference is that the e-cigarette is always “lit”. Most of them even have an LED on the end that lights up like a cigarette ember when you draw on it. You can put it down or pick it up at any time without worrying about burning anything. It is only on when you actually draw on it. How much you smoke is related more to how many puffs you desire rather than on the length of the cigarette.

But what about the health consequences of long-term e-smoking? Again, it isn’t exactly known how much safer e-cigarettes are than conventional smoking, but again, it is almost assuredly safer to smoke the vaporized nicotine solution than the tar-laced smoke of tobacco products.

Even if e-cigs are about ten times as harmful as smokeless tobacco, that still makes them about 1/10th as harmful as smoking. Smoking is just that bad.

First of all, there is no burning of any plant matter so all those combustion related carcinogens are no longer present. Of course, in most cases, nicotine is still present but, as we’ve written elsewhere, nicotine is one of the more benign elements in tobacco…All that remains is some uncertainty about the effects of propylene glycol with long term regular use.

Almost anything else that is not acutely toxic (and we know the e-cigs are not) will be safer. Even if e-cigs are about ten times as harmful as smokeless tobacco, that still makes them about 1/10th as harmful as smoking. Smoking is just that bad.

Predictably, the FDA sought to prevent the sale of e-cigarettes in the states, claiming that the effects had not been thoroughly studied. However, in January of this year Federal Judge Richard Leon ruled in favor of plaintiffs Smoking Everywhere and Njoy who filed a jurisdictional lawsuit against the FDA. In his concluding remarks Judge Leon commented:

This case appears to be yet another example of FDA’s aggressive efforts to regulate recreational tobacco products as drugs or devices under the FDCA. Ironically, notwithstanding that Congress has now taken the unprecedented step of granting FDA jurisdiction over those products, FDA remains undeterred. Unfortunately, its tenacious drive to maximize its regulatory power has resulted in its advocacy of an interpretation of the relevant law that I find, at first blush, to be unreasonable and unacceptable

According to Matt Salmon, president of the Electronic Cigarette Association (ECA) and former congressman, in the two short years since the product was introduced in the US there’s an estimated 300,000 e-smokers now.

Regulation of the Day 123: Donating Blood

by Ryan Young on March 4, 2010 · 1 comment

in Health and Illness, Healthcare, Precaution & Risk, Regulation, Regulation of the Day

If you’re gay, you can’t donate blood. It’s illegal. The ban was put in place in 1983, during the early days of the HIV/AIDS scare. It may have made some sense in those days, when HIV testing was less than trustworthy. But it sure doesn’t now, with modern screening technology.

Obviously, keeping HIV-positive blood out of circulation is a wise policy goal. But most gay people don’t have HIV/AIDS.  Rather than screening donors for sexual preference, they should be screened for blood-borne diseases. Straight people already are. And it works quite well. Current policies are keeping healthy, willing donors out of the system.

The outdated ban could soon be coming to an end. Sen. John Kerry and 15 of his colleagues, usually more prone to passing regulations than repealing them, are urging the FDA to repeal this one. You can read their letter here.

The one disconcerting thing about the letter is that every single one of the signees is Democratic. Not one Republican joined in. That could be because Sen. Kerry and the others deliberately excluded them for political reasons. But the GOP is famously behind the curve on gay rights issues. So maybe Republicans were asked, and said no. I don’t know.

Republicans should send their own letter supporting Sen. Kerry’s position. Enlarging the pool of eligible blood donors is an unabashed good. It’s a classic gay rights issue. It’s also a health issue. Blood would be more readily available for patients who need it. Economists would add that increasing the supply of blood will lower its price – a good thing in this age of rapidly rising health care costs.

Why does everybody think BPA is safe but us?

by Michael Fumento on January 20, 2010

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

Regarding the ubiquitous plastic ingredient bisphenol A (BPA), my colleague Angela Logomasini blogged that “The greens are rejoicing today because the Food and Drug Administration has softened its stance on the safety of” the chemical and gave some reasons why it’s folly. But here’s what I find striking.

In 2006 the European Union’s Food Safety Authority conducted a risk assessment focusing on the threat to infants. It ultimately raised the Tolerable Daily Intake by a factor of five, which is to say it found BPA much safer than was first believed. Mind you, this is the same EU that has placed advisory warnings on cell phones and whose residents run in terror at the sight of a grain of genetically modified corn.

Two years later the EU conducted an update and as Trevor Butterworth of STATS has documented, since then there’s been:

• A review by Japan’s National Institute of Advanced Industrial Science and Technology (2007)
• An examination of claims of neurotoxicity by the Norwegian Scientific Committee for Food Safety (2008)
• An evaluation by the French Food Safety Agency (2008)
• A risk assessment by NSF International, a World Health Organization collaborative center (2008)
• A review of new data by the German Federal Institute for Risk Assessment (2008)
• A survey of canned drink products by Health Canada (2009)
• A risk assessment by Food Standards Australia/New Zealand (2009)
• A modeling study of BPA in humans by the German Federal Institute for Risk Assessment (2009).

None of these prompted any warnings or restrictions on BPA use.

There’s only one conclusion to draw from all this folks. Apparently Americans are uniquely vulnerable to the horrors of BPA. But (pssst . . . ) don’t try telling that to a geneticist.

Regulation of the Day 98: Gastrointestinal Drugs

by Ryan Young on January 8, 2010

in Deregulate to Stimulate, Health and Illness, Healthcare, Personal Liberty, Precaution & Risk, Regulation, Regulation of the Day

Did you know that the federal government has a Gastrointestinal Drugs Advisory Committee? It’s true. If you don’t believe me, you can attend their upcoming meeting on February 23. The topic of the day will be a new drug application to treat hepatic encephalopathy.

Hopefully some hepatic encephalopathy sufferers will be there. They can ask the Committee why the FDA takes as long as a decade (and as much as $800 million!) to approve medications that could be helping people and saving lives right now.

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