FDA

President Obama made a big show about cutting “red tape” government regulations that kill jobs and hurt the economy. In addition, members of the Obama administration, including his wife, Michelle, claim they want to improve the health and well-being of Americans. If these are genuine policy goals of the current administration then a good place to start would be to stop the FDA from instituting any new policies.

A news story today told the good news that the FDA approved a device for the iPhone that would combine a plug-in blood pressure monitor with an application purchased in the app store to monitor the health of the user. According to a two-year long study conducted by the Brookings Institution and the Kauffman Foundation, remote medical reporting such as blood pressure monitoring could save the nation nearly $200 billion in health care costs over 25 years.

According to remarks by economist Robert E. Litan, the study’s author, who is the Vice President for Research at the Kauffman Foundation and Senior Fellow at Brookings:

Widespread use of remote monitoring over broadband networks, located in both institutions and homes, to track vital signs of patients with chronic diseases such as congestive heart failure and diabetes is a critical and urgent development. “Remote monitoring can spot health problems sooner, reduce hospitalization, improve life quality and save money.”

Litans made his remarks earlier this year at a health forum sponsored by the Better Health Care Together coalition (BHCT). Participants at that forum suggested that the way to achieve wide-spread usage of devices like the cuff is to have larger insurance payouts for hospitals in order to fiscally incentivize their integration.

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CEI Senior Fellow Greg Conko has an excellent piece in today’s Wall Street Journal. Greg doesn’t think it’s right that the FDA is denying terminally ill patients access to potentially life-saving treatments.

The latest case in point is a drug called Avastin. It is approved for treating several types of cancer. But the FDA is moving to revoke its approval for treating breast cancer. This has, understandably, upset many breast cancer patients and their doctors.

The heart of the matter is who shall be in charge of treatment decisions. Should it be patients and doctors? Or should the FDA decide for them?

Greg thinks a decentralized approach is better. Different patients will react to the same drug in different ways. A doctor can see if Avastin works or not for a patient, and they can make the right decision from there. The FDA relies on averages and medians for making its approval decisions, ignoring individuals. The trouble with that is, as Greg points out, there is no such thing as an average cancer patient.

A few weeks ago, I interviewed Greg about Avastin and the FDA here.

Have a listen here.

Senior Fellow Greg Conko breaks down the fight over Avastin, a drug used to treat several types of cancer. The FDA is poised to rescind Avastin’s approval for treating breast cancer. It will retain its approval for other cancers. This will make life difficult, and possibly shorter, for some breast cancer patients. Conko believes this battle boils down to one question: who decides which treatments patients can use? Will it be the FDA, or doctors and patients?

Post image for Regulation of the Day 170: Kinder Eggs

Kinder eggs are a type of candy that enjoys worldwide popularity. They are chocolate eggs with a plastic shell underneath the outside layer of chocolate. After kids enjoy the chocolate, they can open up the plastic shell and find a toy inside. They are especially popular around Easter.

They are also illegal in the United States. The Consumer Product Safety Commission and the Food and Drug Administration have declared the toys to be a safety hazard. Children could choke on them.

A third agency, Customs and Border Patrol, confiscates about 25,000 kinder eggs per year. Most people know that kinder eggs aren’t actually a choking hazard, so they don’t know about the ban and think nothing of bringing some home from a trip.

NRO’s Mark Steyn recently had just such a run-in when he and his children returned from a trip to Canada:

My kids asked the CBP seizure squad if they could eat the chocolate in front of the border guards while the border guards held on to the toys to prevent any choking hazard — and then, having safely consumed the chocolate, take the toys home as a separate item. This request was denied.

As I noted in previous Regulation of the Day:

According to WebMD, 66 to 77 children under 10 die every year from choking on food in the U.S. That’s out of more than 42,000,000 children under 10, according to my calculations from U.S. Census data.

That means your child’s odds of choking to death on food are about 1 in 545,000. And that’s assuming 77 deaths, the high end of the range. Little Timmy is literally more likely to be struck by lightning (1 in 500,000) than choke to death on a hot dog.

I’m sure that SPSC, FDA, and CBP would love to credit their diligence in enforcing the kinder egg ban for those reassuring numbers. But common sense says they shouldn’t.

Lynne Nowick, a legislator in Suffolk County, New York, wants to ban energy drinks for anyone under the age of 19 years old. Why? She says it’s because the drinks “could potentially be dangerous to teens” and some parents don’t know the risks. She seems to believe that it is her duty to assess the risks and make the decision for teens and their parents. After all, nanny state knows best, right?

According to a “nutrition expert,” whatever that means, at the Cornell Cooperative Extension: ”Energy drinks can cause sleeplessness and high blood pressure in teens.”

Personally, government sticking its nose into my morning coffee gets my blood boiling and keeps me up at night; perhaps we can ban government bans for a while.

During the Four Loko/alcoholic energy drink row of last month, some made “what next?” jokes, asking if the government would try to ban energy drinks altogether. It was a joke that I and most of my colleagues shied away from because we knew that it was a very real possibility. This is one reason we fight so vehemently against any kind of regulatory restriction on consumer products; once you have given government the power to regulate and ban products, it is difficult to draw the line.

First it’s alcohol, then it’s alcoholic energy drinks, then it’s energy drinks… what’s next? In a statement, the American Beverage Association, which represents energy drink companies, stated: ”To be consistent, coffeehouses would have to start carding customers before serving them coffee.”

They may have been facetious, but it isn’t out of the realm of possibility that the next step could be a limit on caffeine consumption for everyone. There is no science that shows energy drinks, when used in moderation, adversely affect the health of consumers. Once we let regulators limit how much of a “potentially dangerous” food item teens or anyone can ingest, we give away the right to make that decision for ourselves.

Even if a product does have some adverse side effect — whether it’s energy drinks, alcohol, or coffee — it should up to each individual to weigh the costs and benefits of the good and bad effects and decide for him or herself whether it’s worth it or not. This appears to be the bottom of a very slippery slope, but I assure you it can go further downhill from here.

Image credit: z3taa’s flickr photostream.

Have a listen here.

CEI Senior Fellow Greg Conko looks at the major provisions of the food safety bill that the Senate is voting on today. The bill would set in stone ever-evolving best practices. Changes to plant inspection and food recall policies are a mix of ineffectiveness and perverse incentives that could raise food prices. Overall, the FDA is too blunt an instrument to be effective on this sensitive issue.

If you saw the movie Beer Wars, which was released last year, you might remember one hard-working entrepreneur featured in the film named Rhonda Kallman. Rhonda, the co-founder of the Boston Beer Company (makers of Samuel Adams beer) and winner of Beer Business Daily‘s “Maverick” award, broke away from her very successful Boston-based brewery and risked it all to start her own craft brewing company, New Century Brewing Company, in order to sell a unique kind of beer she believed would be a hit: a caffeinated light beer.

As the movie Beer Wars shows, things got off to a shaky start for Rhonda, but the demand for alcoholic drinks with a caffeine kick eventually picked up. At just 4 percent alcohol, New Century Brewing Company’s flagship product Moonshot contains 69 milligrams of caffeine: less than half of the caffeine in a “tall” 8-ounce cup of coffee from Starbucks. Yet, that was enough to get her brewery on the short list of companies that the FDA issued warning letters this week telling them to reformulate their products. If the brewers choose to reformulate their products, they know that they will lose their competitive edge. As Rhonda Kallman put it:

I was fully hoping and optimistic that the FDA would create some standardization around what is safe in their mind in terms of caffeinated alcohol…The difficulty for me is if I remove the caffeine, there’s no real reason for Moonshot.

The FDA’s action will most likely result in a huge loss of market share for these small independent companies. Like New Century Brewing, Phusion Projects LLC, the maker of Four Loko, is also a small company run by three college friends. Energy drinks were a surprise hit on the market with consistently growing demand, adding pressure on big breweries.

By no means do I think the big breweries had a hand in FDA action, nor do I believe that they would consider the latest developments beneficial to their businesses in the long-run. However, FDA over-regulation does still have the effect of killing small business and keeping competition among a few large, well-established titans in the industry.  Small businesses simply cannot absorb the burdens of regulation as well as larger companies with many successful products can. For example, Miller Brewing Company was able to absorb the loss of its popular alcoholic energy drink Sparks.

It is highly unlikely that small fledgling brewing companies like Phusion Projects and New Century will be able to survive the loss of their most popular product lines. Currently, there are nearly 1,600 breweries in the United States (according to the Brewers Association). But if the FDA and other regulatory agencies continue to create hurdles that make competing with large brewers more difficult for entrepreneurs, we may find ourselves back in an environment where there are only 50 brewers throughout the country, as was the case in 1983.

Over the past few days, I’ve gotten plenty of angry e-mail from people critical of my defense of caffeinated alcoholic beverages like Four Loko, Joose, and Hard Wired.  Typical claims are that, “if it was [my] son or daughter ending up in emergency with a (sic) overdose of alcohol it wouldn’t be opposition to ban it,” and that “Your disgusting and your barely disguised right wing industry front is pathetic”.  My favorite, though, is, “I hope one of YOUR kids or family members dies from it, see how you feel.”

You might think that, boy, these products must really be awful to elicit that kind of a response — a message that the prohibitionists very definitely want you to get.  But just how potent IS a typical Alcohol-Energy Drink like Four Loko?  Let’s have a look.

A 23.5 oz can of Four Loko has 156 mg of caffeine.  You might think, “Wow!  What kind of caffeine-induced buzz is that going to get you?”  About the same as in a small/tall (8 oz cup) Starbucks coffee (160 mg).  By 7:30 this morning, I had already had nearly twice as much caffeine from my daily coffee.  The prohibitionists also like to point out that a 23.5 oz can of Four Loko has twice the caffeine as a can of Red Bull (76 mg).  But what they neglect to say is that Red Bull comes in 8.2 oz cans, which means that they’re just 1/3 the size and have about 50 percent more caffeine per unit volume.

Of course, there’s also the alcohol.  Four Loko is 12 percent alcohol by volume, which amounts to the equivalent of four to four-and-a-half typical American-style pilsner beers, such as Budweiser, Coors, and Miller, with approximate 4.8 to 5 ABV.  Still, ounce for ounce, you get about 50 percent more caffeine and about the same amount of alcohol in a vodka and Red Bull cocktail (8.2 oz of Red Bull plus a 1.5 oz shot of 80 proof spirits).  And you get about three times as much caffeine and about the same amount of alcohol in a cup of Irish coffee made by mixing a tall Starbucks coffee with a 1.5 oz shot of 80 proof spirits.

In order to conclude that AEDs are worse, you have to buy the notion that your typical partying teenager or young adult would stop at just one or two vodka and Red Bulls.  But actual observation of the wild college partier or young professional in his natural setting indicates that that’s a pretty far-fetched assumption.  So, it’s not remotely clear that there is anything uniquely unsafe about AEDs.  Nor do I believe that a ban on AEDs will do anything at all to stem the genuine problem of alcohol abuse among teenagers and young adults.  Indeed, to the extent that some AED consumers may revert to the vodka and Red Bull alternative, the AED ban could have negative public health consequences because the far higher level of caffeine in those self-mixed or bartender-mixed cocktails would be more likely to mask the effects of intoxication.

Perhaps more serious, in my view, is the fact that many of the activist organizations intimately involved with the movement to ban AEDs (led by the Center for Science in the Public Interest) began this fight to regulate caffeine, long before there was an AED market, by attacking non-alcoholic energy drinks like Jolt Cola, Red Bull, Monster, and Rock Star.  They’ve even been highly critical of Starbucks coffee for its caffeine content.  And the exact same legal rationale that the FDA used to ban AEDs (i.e., that FDA has not approved caffeine used as a food additive as GRAS for any use but in “cola type drinks,” making the addition of caffeine to malt beverages presumptively unsafe) could just as easily be applied to non-alcoholic energy drinks.  I fear, and with good reason I would argue, that we haven’t seen the last of FDA’s enforcement activity against caffeinated beverages.

Image credit: The Wisest Wizards’ flickr photostream.

So, it looks as though the FDA is now set to ban the small but growing market for so-called alcohol-energy drinks, such as Four Loko and Joose. CEI wrote about the issue back in May of this year and explained that the move is an arbitrary extension of FDA authority based on irrelevant science at the behest of grandstanding state attorneys general and pro-regulation activist groups.

As food and beverage law expert Baylen Linnekin wrote in a CEI OnPoint, “The agency’s campaign against alcohol energy drinks (AEDs) … is based on research unrelated to AEDs and targets products the FDA should classify as generally recognized as safe. With more than 100 years of historical evidence that consumers can safely consume caffeine and alcohol together, the FDA should not stand in the way of adults’ drink choices.”  Most of the scare stories and essentially all of the research on the alleged abuse of caffeine-alcohol drinks are based, not on commercial pre-mixed AEDs, but on self-mixed or bartender-mixed drinks like vodka-and-Red Bull or JaegerBombs (see here, here, here, and here, for example).  Nanny State activists are simply extrapolating the findings of this research to pre-mixed AEDs because, as commercial products, they are more susceptible to regulation.

As it turns out, the FDA’s central legal objection to AEDs, and the source of its authority to ban the products, is not merely the mixture of alcohol and caffeine, but the addition of caffeine to nearly any food or beverage at all.  Currently, it is legal for the makers of commercial products to add caffeine only to “cola type beverages”, which means that the FDA could use its authority to ban countless other, much more common products, from Mountain Dew and Dr. Pepper to an array of popular candies and snacks that currently contain added caffeine.  Worse still, one of the lead campaigners against commercial pre-mixed AEDs has also suggested forbidding bartenders from selling their own caffeine and alcohol concoctions, which would wipe out not only vodka and Red Bull mixes but even the popular Rum-and-Coke and Irish coffee.

Of course, it’s easy to single out a small, politically incorrect product class.  But it’s pretty clear that young adults aren’t going to stop getting their kicks from the combination of caffeine and alcohol as long as those other products are so freely available.  So, the ban on Joose and Four Loko won’t solve any of the alleged problems associated with caffeine’s tendency to mask the intoxicating effects of the alcohol.  It is not reasonable to believe that banning AEDs would have any measurable effect on drinking or drunkenness, especially given the ubiquity of self-mixed cocktails combining alcohol and energy drinks.  The campaign against AEDs is therefore wasteful and misguided, and our national nanny will simply be removing one beverage option that some consumers seem to enjoy.

As my colleague Michelle Minton put it last week, “Product Bans Are More Dangerous than Four Loko.”

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