May 13 2010
IOM Report on Supplement Regulation
The Institute of Medicine (IOM) is an organization of independent scientists and experts who are tasked with providing, “independent, objective, evidence-based advice to policymakers, health professionals, the private sector, and the public.” In my experience they generally do good work – those IOM reports I have read in areas that I have some knowledge seem to be thorough and objective.
They were recently tasked by the Food and Drug Administration (FDA) to prepare a report on the science behind health claims for food and drugs. Their report is now in, and the results are in accord with my own writings on the topic. They conclude, basically, that there should be a rigorous standard of evidence for not only drugs but also health claims made for food and supplements as well.
Their key points focus on the fact that many food and supplement claims are based upon basic science research – the use of biomarkers instead of clinical outcomes. They point out that extrapolation from biomarkers to health outcomes is problematic, and they outline methods the FDA can use to standardize the use of biomarkers. This is a valid point, but I am not sure why they focused as much as they did on this one point.
I have not read the whole report, but in their summary they did not mention the use of structure/function claims for supplements, which for me is a major problem. Essentially, companies can claim that any supplement supports a structure or function of the body without the burden of providing any evidence – they just cannot claim that it treats or cures a disease. But this, in practice, is a distinction without a difference. Companies can and do say, for example, that a product “boosts the immune system” and that the immune system fights off cancer, but they cannot say the product treats cancer. They can even have a doctor saying, “I give this product to my cancer patients.” It’s all a pointless game.
Other parts of the report were dead on.
“Many people naturally assume that the claims made for foods and nutritional supplements have the same degree of scientific grounding as those for medications, and this committee thinks that should in fact be the case,” said committee chair John Ball, executive vice president, American Society for Clinical Pathology, Chicago.
They call upon the FDA to regulate health claims for food and supplements better. Of course, they really can’t under current regulation, namely the Dietary Supplement Health and Education Act of 1994 (DSHEA). And recent efforts to reform DSHEA were quashed by the supplement industry and their stooges in the Senate. The IOM report does:
…calls for Congress to enhance FDA’s abilities to study how health-related information can be communicated more effectively to consumers to help them better understand the science behind claims they see on packaging.
Congress needs to do more than that – they need to abolish DSHEA and replace it with a rational science-based regulation. It’s not just about communicating the information to the public – that seems hopeless as industry will always have vastly more resources and incentive to spread misinformation to the public. Congress needs to give the FDA more power to actually regulate health products and their claims.
The IOM report is very welcome, but it does not go far enough. The problem really rests squarely in the lap of Congress – they hamstrung the FDA in 1994 at the behest of the supplement industry, and they continue to serve the interests of this industry over the consumer. I also don’t see this issue as being very much on the public’s radar – as the report notes, most people assume health claims for food and supplements are regulated already. The public is further kept nicely distracted from this issue by the frantic propaganda of the pushers of supplements and dubious health products and services. They seem to be dominating the discussion with anti-scientific nonsense and conspiracy-mongering.
For the time being, the con artists are winning.
18 Responses to “IOM Report on Supplement Regulation”
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Health claims for food should be supported by rigorous studies?
I suppose a million years of human diet isn’t enough for you, you need to have a lab test on healthy subjects peer reviewed for every edible plant and animal whilst you sit by eating chicken and chips?
I guess the standard of food in the US might explain your outlook. Over here in Europe we don’t wait for academia to catch up and tell us why we need to eat things, we listen to our stomachs…
john – they are not talking about nutritional claims, nor studying foods that are “generally recognized as safe” (GRAS), which is the current standard.
Rather they are talking about specific health claims that go way beyond common or historical knowledge. Once people start saying that their food product will prevent cancer or heart disease as a way to promote its consumptions, those types of claims should at least be based upon evidence.
Some companies even deliberately blur the lines. Have you ever heard of “medical foods” – these are basically products that sellers want regulated like food but still want to be able to make health claims for them.
Also – I am not sure how listening to your stomach will tell you whether or not certain foods will alter your risk for certain kinds of cancer.
It would be nice if we composed a form letter, for people to send to their Representatives. Because why shouldn’t they be cozy with industry if their constituents don’t complain? And maybe some linkies, put in your zip code and blam! There’s the email address of your Congressperson.
Cuz one of these days, we gotta get organizized.
shorter johnc: “Americans are stupid, it’s soooo much better here in Europe.”
This is why some of us don’t like some of you. Crummy attitude you got there.
JohnC-
I didnt know people in Europe all ate the same things. Or do the stomachs’ of people in europe say something different depending on which country they live in? In the US our stomachs don’t talk, but our mouths do, depending what our brains tell it to say. Its a pretty good setup to have a brain in charge.
The problem is that there is no simple way to address the nutrional supplement/ food health claim thing. We can’t require the same level of evidence that we do for drugs, because we don’t require the same studies for food or supplements as we do for drugs. All drugs must prove safety and efficacy for a specific indication at specific doses. Food does not have to treat anything to exist as a food (it just has to be edible and safe)… and currently there are very few true medical claims allowed by the FDA.
Everything else is fluff-language, because the claims that are made exist along a continuum. Free speech becomes an issue at one end of the spectrum… because most of these vague claims are medically meaningless (‘good for digestion’ for example). Also, where do we draw the line between saying something general&meaningless and someone making a medical claim?
One recent vitamin commercial that stands out in my mind stated that the product contained extra vitamin D because recent studies have demonstrated that it “supported breast health.” This of course is a meaningless statement, and I assume they are referring to epidemiological studies between Vitamin D levels and breast cancer rates. What level of evidence should be required for what level of claim? Since both evidence and claims exist along a continuum its a tough thing to handle. Legislators have enough trouble with more black-and-white problems, how can they address these gray areas? Now that DSHEA has been around for sometime, I can’t wrap my head around a satisfactory solution.
johnc: Thank you for making all us Euro’s sound totally ignorant and arrogant. I hope you simply misunderstood Novellas posting.
As for the EU-US differences it seems the situation over here is very similar (albeit the usual mixed bag of national legislation).
cc – you are correct, it is a continuum. But that does not mean it is hopeless (that is the “false continuum” logical fallacy – that because there is a continuum, we cannot meaningfully deal with extremes).
Lawyers and legislators are used to deal with gray continua. That is what they do.
I agree that we cannot and should not require the same level of evidence for food as for drugs. That is pointless. I think it is reasonable to require three levels of evidence – drugs (but I would include herbs taken as drugs), true supplements, and food. This scheme would obviously need a great deal more detail, but this is a quick overview.
For supplements, in addition to dose an purity, and specific health claims should require prior review and approval by the FDA. We should get rid of the “structure/function” nonsense.
For food, vague claims like “milk does a body good” should get a lot of leeway, but claiming that Cheerios reduces heart risk should be subject to review.
There will be a lot of splitting hairs, but that’s how such things work. It doesn’t mean we should throw up our hands and just let the buyer beware.
@ccbowers
Just require evidence to support health claims. If a company wants to put on their product labeling/advertising that their stuff “supports digestion”, then they should be able to show that their product does support digestion, defining what they mean by “support” and “digestion”. If they don’t want to do those studies, then they can’t put that claim on their product.
And, regarding free speech issues, this isn’t one. An exception to the First Amendment is commercial language. A company cannot simply claim whatever the hell they want. Misleading or outright incorrect claims constitute fraud and are not protected.
Methinks Johnc read too fast and used his jump-to-conclusions mat at the same time.
I thought congress was currently considering a bill to require evidence for vitamin/supplement claims? Did it already die?
We can deal with extremes, but that isnt the problem. The problems exist in the grays since most of what we are talking about is gray. And I am not commiting any logical fallacy… I just have little confidence that legislators will get this right, but hope they do. Of course it is easy to improve upon DSHEA, any piece of crap would… but I think we need to get this right if we are going to make a change now. It doesnt have to be perfect.
‘defining what they mean by “support” and “digestion”.’
We cannot have a manufacturer both making the claim and defining what it means to make the claim. Language is important in that it should have a well defined meaning if the FDA is going to allow these as medical claims. To say that free speech is not an issue is incorrect..a bit of a strawman to say that fraud is the speech I was referring to.
Don’t get me wrong.. in my ideal world I would get rid of 90+% of all vitamins/supplements on the OTC market, since there is no clinical evidence for most of them. There are even some OTC medications that I would get rid of. I would remove all claims that are meaningless or that have no evidence (which is most of them). But this is unrealistic and I struggle with a real world solution.
“I thought congress was currently considering a bill to require evidence for vitamin/supplement claims? Did it already die?”
Probably. McCain, who introduced the ‘Dietary Supplement Safety Act of 2010′ removed his support for the bill in March. It would have been a significant improvement to DSHEA (of course), but now will likely fizzle witheout his support…if it hasnt already. They are coming up with a watered-down version I’m sure.
What you’re saying about needed regulation makes a lot of sense.
Congress seems a bit busy at the moment (for the first time in my lifetime perhaps). But such changes take a long time to get through. Is there a PAC working on this?
johnc:
“Health claims for food should be supported by rigorous studies?
I suppose a million years of human diet isn’t enough for you.”
Just a side point, world average life span (including Europe) didn`t go above 35 until science based medicine came along.
Classical Greece 28
Classical Rome 28
Pre-Columbian North America 25-30
Medieval Britain 30
Early Modern Britain 40+
Early 20th Century 30-45
Current world average 67.2
Are you really claiming this million of years as evidence against using science?
Dr. Novella would have been dead before finishing his Neurology specialisation if people never bothered to see if things actually work.
Finally, I live in Japan. Which has both the longest life expectancy and probably respects science more than any other country.
cc – we don’t have to draw those lines at all. Plenty of administrative law is done through case by case adjudications. They can have a requirement like, “Advertising and labeling on food shall not contain health claims not supported by substantial evidence” and then anytime a company tries something that seems to be crossing the line the administration begins adjudication proceedings against them. After this has happened a bunch of times people begin to see clearly where the line is.
I wonder what would happen if the FDA just took out a full page ad in the NYT’s and Washington Post,calling out specific products and their misleading claims? They could hit the biggest offenders 1st, and work their way down the list. Now the idea isn’t that the ad’s would immediately reach enough readers, but that the unusual tactic would cause a media stir that might go “viral’ with it’s controversial nature, and get people’s awareness. Apparently the average person is somewhat ignorant of the problem, or otherwise that type of advertising claim wouldn’t be as effective.
banyan – Case by case adjudications as you describe are problematic because they require alot of resources and would be very inefficient. Maybe I’m wrong but anyone on charge of enforcing such vague guidelines would be quickly overwhelmed. That is similar to how things are done now, but hopefully with more authority to do something about it. I think we need something stronger, but I think thats wishful thinking