IOM wants just as rigorous science for food claims as for drugs
Buried in an Institute of Medicine report released today on, of all things, “biomarkers and surrogate endpoints in chronic disease” are some truly astonishing recommendations:
Rec. 3: The FDA should use the same degree of scientific rigor for evaluation of biomarkers across regulatory areas, whether they’re proposed for use in the arenas of drugs, medical devices, biologics, or foods and dietary supplements.
Rec. 4: The FDA should take into account a nutrient’s or food’s source as well as any modifying effects of the food or supplement that serves as the delivery vehicle and the dietary patterns associated with consumption of the nutrient or food when reviewing health-related label claims and the safety of food and supplements.
Translation: The FDA should require the same level of scientific substantiation for health claims as for pharmaceutical drugs, and not assume that a supplement has the same health effect as a food or diet.
As the press release states:
The FDA should apply the same rigor to evaluating the science behind claims of foods’ and nutritional supplements’ health benefits as it devotes to assessing medication and medical technology approvals…There are no scientific grounds for using different standards of evidence when evaluating the health benefits of food ingredients and drugs given that both can have significant impacts on people’s well-being.
The committee set out to recommend scientific criteria for evaluating the types of scientific data that companies use to convince the FDA to allow health and safety claims. Food claims got tossed into the mix.
The impact of these recommendations could be considerable. The IOM is saying that health claims need to have rigorous science to back them up, not least because the kinds of claims now used to market foods do not come close to meeting those criteria.
Here’s what the Wall Street Journal has to say about this report (it quotes me).
How right they are, as witnessed by the health claims on chocolate-flavored, sugar-sweetened Enfagrow.
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[...] This post was mentioned on Twitter by Marion Nestle, Helen Branswell. Helen Branswell said: RT @marionnestle: IOM wants as rigorous science 4 food claims as 4 drugs: Buried in Institut of Med report released 2day http://cli.gs/zjzYT [...]
Yeah science! Yeah evidence!
I assume this means that the claims of raw milk drinkers, and organic foodies, and organic foodies claims of harmful stuff, and homeopaths, and everybody now, right?
I am behind this 100%.
I hope they follow through on this, though I’m skeptical that it will happen: there is so much money in the food industry that will fight it. I am so sick of junk food being marketed as healthy. If people had real information to draw on I bet they’d be making much better decisions about their food.
This IOM recommendation would cut back sharply on advertising claims. Such claims presume that the marketers A) have real, scientifically valid information and that B) they are speaking truthfully. Both presuppositions are dubious (which is the point of Marion’s blog).
The current system is based so very heavily on the idea of caveat emptor (let the consumer beware). But the bulk of consumers are simply not well-informed (who can be in today’s busy world?). And we have the problem of asymmetrical information: the dentist has information about your teeth that you do not have (because s/he can look directly into your mouth and they have the expertise to know what to look for); but does your dentist have a child in college whose expenses have to be paid for? Do you know that your dentist is giving you accurate (i.e. truthful) information about the state of your mouth?
Of course this recommendation would have to be supported by clearly written regulations, which itself is a difficult job. I won’t hold my breath waiting for accurate advertising information.
Currently health claims for dietary supplements are required to meet the same level of scientific evidence as drugs. The FDA’s website is clear about this:
http://www.fda.gov/Food/LabelingNutrition/LabelClaims/ucm111447.htm
The FDA has approved health claims for these supplements only: calcium, fiber, folic acid, and soy protein.
The much weaker structure/function claims, e.g., calcium builds strong bones, do not require the same rigorous level of proof. Nor should they have to. All structure/function claims have to be accompanied by the FDA’s diclaimer that the substance is not intended to treat any disease.
Of course there are a few companies that make false or misleading claims. Those companies breaking the law are subject to prosecution initiated by the FDA. Unfortunately the FDA is very lax about enforcing these laws. This is an enforcement issue, not a problem with regulation.
The Alliance for Natural Health has a very sensible response to the IOM report:
http://www.anh-usa.org/u-s-institute-of-medicine-study-urges-new-approach-to-regulating-supplements-%E2%80%93-big-pharma-influenced-doctors-get-it-wrong-again/
Yes, please! And real science, please. And we have to promise to not reject the findings when they don’t support our preconceived notions. An we have to promise not to reject every study’s findings based on the funding source. Right now nutritional science seems to be quackery into the 21st century, and too many public health officials can’t give up their activism when the science shifts away from their beliefs.