FDA Blunders

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 Nutrition Labeling and Education Act of 1990 nutrition labeling became mandatory.)

The FDA actively prosecuted vitamin retailers that sold vitamins and other supplements in conjunction with books or pamphlets that extolled their use. … The FDA justified such practices, which many considered to be a violation of the First Amendment, under the theory that literature that was sold near a product was thereby converted into a product label. …

In 1973, the FDA published regulations … High-potency vitamins, by which the FDA meant vitamins sold in dosages as little as twice the federal recommended daily allowance (RDA) … were effectively made illegal by this ruling because they could not be sold without FDA approval, and the FDA would not approve supplements that it considered to be unnecessary. Vitamin manufacturers and consumers fought back, and in response Congress passed the Proxmire Vitamin Mineral Amendment of 1976. …

It is worth pointing out explicitly, although it will come as no surprise to anyone who follows today’s health news, that numerous scientific studies have since validated many of the health claims for vitamins and minerals that the FDA had earlier suppressed. The FDA suppression of information concerning vitamin E and heart attacks, for example, may rank alongside its suppression of information concerning aspirin as one of the most deadly regulations of the post–World War II era. …

In 1992, the federal Centers for Disease Control and Prevention (CDC) recommended that women of childbearing age take folic acid supplements. Studies showed that taking folic acid reduced risks of babies suffering neural-tube birth defects such as anencephaly and spina bifida. The FDA immediately announced, however, that it would prosecute any food or vitamin manufacturer that placed the CDC recommendation in its advertising or product labeling.  The public did not learn of the importance of folic acid until Congress passed the Dietary Supplement Health and Education Act of 1994, … Within only a few years of its ban on publicizing the CDC recommendation, the FDA made a complete turnabout. Since 1998, the agency has required manufacturers to fortify a variety of grain products with folic acid—that which is not prohibited is mandatory!

You might think these examples show that the system works – if the FDA screws up, Congress will jump in to fix things.  But if Congress hadn’t made these changes, when would you have heard of these mistakes?

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  • You only mention one side – how many misleading product claims were blocked by FDA? It’s always a matter of trade-offs, and if we hear only one side it’s fairly pointless exercise.

  • Michael Turner

    “Since 1998, the agency has required manufacturers to fortify a variety of grain products with folic acid—that which is not prohibited is mandatory!”

    What? You mean, before then, the FDA prohibited manufacturers from fortifying grain products with folic acid?

    Oh, no, wait, I see it now: it only prohibited them from using the CDC recommendations in advertising on product labeling. Well, why not, considering that CDC recommendations go on for pages of careful caveats, whereas product labels will necessarily oversimplify and exaggerate? (Rather as Alex Tabarrok seems to be doing here, come to think of it.)

    Check Google News Archive — press reports about folic acid and neural tube defects start as early as 1984 and mount continuously. 1992 was decidely not when people first started hearing about the benefits. A woman planning to get pregnant who hadn’t heard about it from her doctor was a woman who wasn’t seeing her doctor about a planned pregnancy — don’t get me started about the externalized social costs in that.

    By 1998, the FDA probably figured that the only way to further extend the benefits of folic acid wasn’t to educate the residual uneducatables, but to just get the stuff into their mouths from whatever crap white bread or oversugared cereal was already going in anyway. In other words, getting it to the kind of people who could think, “Oh, it’s OK to drink and smoke during my pregnancy, because I’m eating stuff with that folic acid stuff in it, and it prevents birth defects — it says so on the label of my favorite spaghetti!” Probably better that the Marching Morons not know how we’re helping them, if you’ll excuse my “statist maternalism.”

    “… Congress hadn’t made these changes, when would you have heard of these mistakes?”

    That’s assuming they are all mistakes. What the FDA is doing here is regulating manufacturers’ claims about their products, not suppressing information generally.

    Remember how oat bran was some kind of lifesaver because of some supposed cholesterol-reducing compound in it? It was all over the news, and then it was all over the products. But it turned out that 99%+ of the heart-health benefit of eating oatmeal was that you were filling up on something other than eggs and bacon in the morning …. yet the product labeling of oat bran for heart health benefit was relentless for a while there. (Ditto for olive oil.) At some point, giving people a false sense of security becomes a public health hazard on its own.

    • 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?

      • uselessheuristic

        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?

      • Grant

        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!”

      • Michael Turner

        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.

  • TheQuickBrownFox

    The FDA’s current diet recommendations are almost completely upside down. Wheat and agriculture destroyed human health when they were introduced 10,000 years ago yet it is the basis of a healthy diet according to the FDA.

    It has already been shown and widely accepted that eggs don’t cause heart disease. In fact, overall cholesterol levels are a very, very blunt measurement (but cheap and easy to do) and can tell you nothing about a person’s health or likelihood of heart disease. The nature of your cholesterol profile, i.e. the varying amounts of HDL, LDL, VLDL (and their subtypes) can begin to give you an idea of the associated risk of heart disease. There is no good evidence that dietary fat or cholesterol causes heart disease and in fact ingesting these things causes a change in cholesterol profile that reduces heart disease risk according to the most current research. The reason fat and cholesterol are vilified is that people had to make public diet policy in the 50’s without anywhere near the full information. Once they had decided fat was the cause of heart disease scientists found no end of weak statistical links that seemed to confirm their hypothesis. An obvious example of confirmation bias. Statistical observational studies of such complex systems (human beings) can lead to almost any conclusion if the results are framed in the right way.

    “The idea that saturated fats cause heart disease is completely wrong, but the statement has been “published” so many times over the last three or more decades that it is very difficult to convince people otherwise unless they are willing to take the time to read and learn what all the economic and political factors were that produced the anti-saturated fat agenda.”
    – Dr Mary Enig

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  • mrwiizrd

    “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?

  • Jay

    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.

  • Bill

    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.

  • 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?

  • Greg Lee

    “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).

  • mjgeddes

    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).

  • Mike

    The FDA blew it with tryptophan, too.

  • Dave

    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.

  • toto

    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?

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