Popping into the office on a recent Saturday, I overheard Alex Tabarrok practicing a talk, with fascinating details on FDA history. From FDAReview.org: Throughout the 1950s and 1960s, the FDA brought hundreds of court actions against nutrition manufacturers for making health-related claims for their products. Under threat of law, food manufacturers were even prevented from labeling the fat, cholesterol, or other nutritional content of their food! (Later such labeling was allowed, and with the
Robin, just to be sure: would you say that false advertising (claiming that a product can do something it can't) should be protected under the 1st amendment?
The vitamin thing seems to go like this. 1.)Observational - People who eat a diet rich is vitamin x don't get(fill in the blank),2.) Plausible explanation- Vitamin x in an anti- oxidant . Oxygen radicals cause(fill in the blank).3. People take mega-doses of vitamin x as recommended by popular guru such as Linus Pauling.4.) Mega doses are found to be toxic or harmful. For example,cancer cells love vitamins. Antioxidants prevents muscle conditioning.5.) Prospective ,long term studies are done and years later show no effect of vitamin x. 6.) Then, observational studies show that people who eat a diet rich in vitamin y, and so on ad nauseam.A good article in the NY Times a year ago summarized several recent studies.
No, I don't think there's NO point in food producers mentioning a given possible nutrition benefit. I DO think there's a policy case for regulating HOW or WHETHER it's mentioned, even if that means regulators sometimes err on the side of caution or enthusiasm. Food producers tend to err only on the side of enthusiasm, for obvious reasons.
I caution all readers to be on the look-out for cranks!
The health food business attracts cranks like flies to honey, a cursory persual of past supplement fads shows that about 90% or more of claims don't stack up, the media seems to move from one vitamin craze to the next.
In particular, megadoses of vitamins A,C and E, which were hyped as powerful antioxidants, have been demonstrated to be useless at best and actually slightly harmful at worst. Some initial studies did suggest that E might prevent health disease, but later bigger studies found this claim baseless.
Vitamins B and D do show some promise, but are still under investigation. Minerals Zinc, Magnesium and Selenium are also promising, but as above (still under investigation).
"FDA blunders" is probably not a helpful summary; "regulatory blunders" might be better. Remember that the FDA is a creature of its enabling legislation, and in my experience working in an FDA-regulated industry, the FDA is mostly driven by what it thinks the law requires. "Corrective" actions by Congress often amount to changing or clarifying the statutory requirements.
Of course, particular interpretations may not be correct, and sometimes a particular Commissioner has a particular agenda to advance (e.g. regulating tobacco).
I have never had a doctor advise me on nutrition. Many producers have and of course some of their claims turn out to be true, so I am glad they are able to advertise. I'm not sure such advertisements would be very useful before the Internet of course.
On the subject of consumer protection in general: if consumers are limited in their knowledge and want to hold someone accountable for product claims, isn't it more rational for them to demand accountability from producers and retailers than to vote for regulators to regulate? The later group seems to have less incentive to actually provide the goods the consumers are looking for, and probably has less knowledge too.
This seems to be how the vast majority of consumer protection works: we return stuff to the store we bought it from if it doesn't work. I'm wondering why the same can't be done with health products.
e.g., "I found a study showing this product's claims to be false. I want my money back!"
But food producers, unlike doctors, have an incentive to inflate (or outright fabricate) claims about the efficacy of their product.
Is it so dangerous to regulate the instances where conflicts of interest are likely or even guaranteed to occur, so long as the process has been shown to be responsive to advances in scientific understanding?
Is there evidence that the decisions you cite (and others like them) were wrong ex ante?
I fully expect that they were wrong ex ante, given the incentive structure faced by the regulators. But how would one go about testing this empirically? There is Peltzman's work. Is there more?
As a lawyer, and one who has represented food manufacturers, I would not be too critical of the FDA. Marketing types will go as far as they can regardless. A lot of claims have to be qualified or limited, but that is not the way a marketer works. Give me the bold words, and you can have the asterisk.
A case in point are some of the marketing programs on "nutri-foods", and industry story that began about 8 years ago.
Some of the improvements were so marginal it was a joke--but, people bought it, and paid more.
You would have been better off taking a vitamin twice a week. And, you would have saved a lot of money. Caveat emptor.
The FDA has a mandate to make sure that food advertising is correct, and that foods are safe. If food isn't safe, they get blamed, and they don't really have enough staff to analyze the claims in any depth. When you consider the way the agency's incentives are structured, it's no surprise that they lean toward a "permit nothing" approach.
"At some point, giving people a false sense of security becomes a public health hazard on its own."
Who do you think gives people more of a false sense of security, product manufacturers or federal agencies that are supposedly tasked with protecting us?
You really think doctors advising patients about nutrition is such an effective communication channel that there is no point in food producers also mentioning it?
FDA Blunders
this article seems a bit confusing.i think there is some problems with the information here.butt overall its a good post.
Robin, just to be sure: would you say that false advertising (claiming that a product can do something it can't) should be protected under the 1st amendment?
I couldn't get the link too to work The New York Times article is here:
http://well.blogs.nytimes.c...
The vitamin thing seems to go like this. 1.)Observational - People who eat a diet rich is vitamin x don't get(fill in the blank),2.) Plausible explanation- Vitamin x in an anti- oxidant . Oxygen radicals cause(fill in the blank).3. People take mega-doses of vitamin x as recommended by popular guru such as Linus Pauling.4.) Mega doses are found to be toxic or harmful. For example,cancer cells love vitamins. Antioxidants prevents muscle conditioning.5.) Prospective ,long term studies are done and years later show no effect of vitamin x. 6.) Then, observational studies show that people who eat a diet rich in vitamin y, and so on ad nauseam.A good article in the NY Times a year ago summarized several recent studies.
No, I don't think there's NO point in food producers mentioning a given possible nutrition benefit. I DO think there's a policy case for regulating HOW or WHETHER it's mentioned, even if that means regulators sometimes err on the side of caution or enthusiasm. Food producers tend to err only on the side of enthusiasm, for obvious reasons.
The FDA blew it with tryptophan, too.
I caution all readers to be on the look-out for cranks!
The health food business attracts cranks like flies to honey, a cursory persual of past supplement fads shows that about 90% or more of claims don't stack up, the media seems to move from one vitamin craze to the next.
In particular, megadoses of vitamins A,C and E, which were hyped as powerful antioxidants, have been demonstrated to be useless at best and actually slightly harmful at worst. Some initial studies did suggest that E might prevent health disease, but later bigger studies found this claim baseless.
Vitamins B and D do show some promise, but are still under investigation. Minerals Zinc, Magnesium and Selenium are also promising, but as above (still under investigation).
"FDA blunders" is probably not a helpful summary; "regulatory blunders" might be better. Remember that the FDA is a creature of its enabling legislation, and in my experience working in an FDA-regulated industry, the FDA is mostly driven by what it thinks the law requires. "Corrective" actions by Congress often amount to changing or clarifying the statutory requirements.
Of course, particular interpretations may not be correct, and sometimes a particular Commissioner has a particular agenda to advance (e.g. regulating tobacco).
I have never had a doctor advise me on nutrition. Many producers have and of course some of their claims turn out to be true, so I am glad they are able to advertise. I'm not sure such advertisements would be very useful before the Internet of course.
On the subject of consumer protection in general: if consumers are limited in their knowledge and want to hold someone accountable for product claims, isn't it more rational for them to demand accountability from producers and retailers than to vote for regulators to regulate? The later group seems to have less incentive to actually provide the goods the consumers are looking for, and probably has less knowledge too.
This seems to be how the vast majority of consumer protection works: we return stuff to the store we bought it from if it doesn't work. I'm wondering why the same can't be done with health products.
e.g., "I found a study showing this product's claims to be false. I want my money back!"
But food producers, unlike doctors, have an incentive to inflate (or outright fabricate) claims about the efficacy of their product.
Is it so dangerous to regulate the instances where conflicts of interest are likely or even guaranteed to occur, so long as the process has been shown to be responsive to advances in scientific understanding?
Marketing - http://www.xkcd.com/641/
Robin:
Is there evidence that the decisions you cite (and others like them) were wrong ex ante?
I fully expect that they were wrong ex ante, given the incentive structure faced by the regulators. But how would one go about testing this empirically? There is Peltzman's work. Is there more?
As a lawyer, and one who has represented food manufacturers, I would not be too critical of the FDA. Marketing types will go as far as they can regardless. A lot of claims have to be qualified or limited, but that is not the way a marketer works. Give me the bold words, and you can have the asterisk.
A case in point are some of the marketing programs on "nutri-foods", and industry story that began about 8 years ago.
Some of the improvements were so marginal it was a joke--but, people bought it, and paid more.
You would have been better off taking a vitamin twice a week. And, you would have saved a lot of money. Caveat emptor.
The FDA has a mandate to make sure that food advertising is correct, and that foods are safe. If food isn't safe, they get blamed, and they don't really have enough staff to analyze the claims in any depth. When you consider the way the agency's incentives are structured, it's no surprise that they lean toward a "permit nothing" approach.
"At some point, giving people a false sense of security becomes a public health hazard on its own."
Who do you think gives people more of a false sense of security, product manufacturers or federal agencies that are supposedly tasked with protecting us?
You really think doctors advising patients about nutrition is such an effective communication channel that there is no point in food producers also mentioning it?