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August 06, 2012


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Michelle Meyer

Thanks for highlighting this case. I tweeted about this case in late April, and I think “wildly overbroad” about sums it up. The statute is bad enough, but things get really bizarre in the Board's guidance interpreting it. I’m all for clamping down on those who defraud (and potentially endanger) others by holding themselves out to be something they aren’t. But Cooksey never held himself out as licensed or in any other way as an expert or trained in nutrition. To the contrary, on each page of his blog, he warns readers that he possesses no such training, and that his views about diet are based on his own experience. Nor does the statute draw sharp lines on the legality of behavior depending on whether one is compensated for said behavior or not. Instead, the statute has the effect of controlling who gets to produce and communicate knowledge (thus my interest in the case).

Even if the statute didn’t run afoul of the First Amendment, from an innovation/information policy perspective, it’s troubling. The statute and guidance unwisely fetishize "expert" scientists in a way that’s on a collision course with trends towards citizen science, quantified self, post-publication "peer" review, and other checks against conventional wisdom and the risks to the public health (and general knowledge base) that *it* can create once it becomes dogma.

To wit, under the Act and the Board’s guidance, non-licensed individuals may "provide" safe, non-fraudulent, non-misleading "nutrition information." But the guidance then provides that "if a person provides nutrition information referencing a report or study, this information must be based on . . . research . . . by experts . . . using randomized controlled trials" or “studies published in peer-reviewed . . . journals.” One of the things that Cooksey did on his blog was to engage in n of 1 experiments in which he varied his diet and recorded the results online. See, e.g., and The Act, as interpreted by the Board, seems to prevent him from discussing or even referring to these non-expert, non-RCT, non-peer review-published studies. The guidance is here: (pdf) and the Act is here: (pdf).

That's quite a high bar. Neither journalists nor academic or other experts are bound by any such rule when they discuss, well, anything. Instead, they can and do refer to observational studies, non-peer reviewed popular "science," and so forth (though perhaps they should think twice about doing so in NC). For instance, since the Act defines "dietetics/nutrition" as "the integration and application of principles derived from [the food sciences] and from behavioral and social sciences to achieve and maintain a healthy status," North Carolinians may wish to be cautious in referencing, say, Nudge's discussion of placing fruit at the beginning of cafeteria lines and desserts at the end. For that matter, I'd bet that a good deal of the government's own "expert" advice about nutrition is based on less than peer reviewed RCTs. If I wanted to make the case for the importance of "expert" versus lay knowledge, I wouldn’t start with the field of nutrition.

Moreover, an independent requirement is that said nutritional information -- even if peer reviewed and/or based on a RCT -- must be intended for healthy populations, not for healthy or unhealthy individuals nor to address any medical condition, even at the population level. So, apparently, no talking about good diets for diabetics w/o a license, *even if* you're referencing the peer reviewed literature.

Finally, while the guidance notes that "does not regulate the collection of information or data in and of itself, or standing alone," they don’t bar collecting data, per se (a nice concession), the guidance provides: "A person must be licensed . . . in order to interpret results of any analysis, assess and determine nutritional needs, recommend appropriate nutrition intake, counsel, and integrate any analysis results to help a client establish priorities, goals, and objectives that meet nutritional needs. Thus, if an unlicensed person uses collected data to then assess an individual’s diet, whether this assessment is completed through the use of software or by the person him/herself, this would be a violation of the Dietetics/Nutrition Practice Act." The Act never mentions the word "client," and the guidance fails to define it. It's quite clear, though, both from the guidance and from the investigation into Cooksey's blog, that whether the speaker is paid
for her thoughts or not is moot. So it's at least conceivable that Cooksey himself counts as a "client" such that the Act and Board guidance prevent Cooksey (and other members of the increasingly popular Quantified Self movement) from interpreting their own n of 1 data. (This isn't as crazy an interpretation as it may seem; past directors of OHRP, the federal agency with oversight over human subjects research and IRBs, have insisted that researchers' n of 1 self-experiments are subject to the relevant regs, including IRB review.)

Oh, and the statute defines each act of unlicensed practice of nutrition as a Class 1 misdemeanor, such that Cooksey actually faces jail time. Oy.

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