There are boundary line issues between mere general purpose healthy cooking and food preparation, and genuine quasi-medical health programs, of course, which is why this mostly hasn’t been done so far. Defining what constitutes a “diet” isn’t easy. And, of course, there are free speech issues associated with regulating the dispensing of information that is factually true, but which comes a gloss of opinion that is currently viewed as unreasonable or unsubstantiated but isn’t really a fact.

This concern about CYP450 isn’t troubling at all from a regulatory perspective because that information gets evaluated through the screen of a medical doctor or nurse practitioner or psychologist with additional special certification and training pertinent to prescribing psychiatric drugs, and continuing education requirements for all of those professions (the details of who can prsecribe vary from state to state, but almost all such professions have some continuing education requirements) provide a ready means to quickly disseminate to the pertinent medical professional communities any problems with relying on outfits like 23andMe that have emerged.

From the point of view of outfits like 23andMe, I suspect that the issue is less one of liability (it is easy enough to include sufficient disclaimers and warnings to avoid that as a consequence of the First Amendment), than it is one of marketing – being able to say that you are the only consumer genomic test approved by the FDA for medical use, even others do the same thing within a few months, is a great way to boost your credibility and is probably more of a marketing plus than a regulatory cost minus over the several years period that it takes to get approved and earn back the regulatory costs. It probably pays for itself within a year or two of getting approval.

Witness the huge economic success of the handful of diet programs that have received FDA approval for comparison sake.

This is a comparison that I have little doubt has been made in the disclosures made to the investors who are financing this one time, moderately expensive, time consuming expense that comes with ongoing albeit modest regulatory costs that require it to do things like keep of file of published academic journal articles that support each of its medical effect claims that is subject to inspection on short notice by government regulators, establish a quality control regime at their lab, put in place a system to alert customers if a mistake is discovered, implement a privacy policy, designate privacy and record keeping officers, and put a lawyer on retainer to review any changes in the relevant regulations every year or so. For them, FDA approval is closer to Sarbanes-Oxley than it is for a typical pharma company.

Why does FDA approval have marketing value? Because the fairly smart consumers who are interested in purchasing test results recognize that 23andMe is a for profit company and that there are incentives for unregulated for profit companies providing services that customers are in a poor position to monitor to cut corners, just as there was in the bad old days of snake oil salesmen, and government regulation puts a third party that is harder to buy off than a private certification company with no track record of its own to reassure customers (Underwriters Laboratories if one of the only credible ones out there and this isn’t exactly its thing) monitoring the company with inspectors who are qualified to build trust. Unregulated industries can be subject to product liability after the fact, but the right to sue a small company with one or two products and few assets after it provides you with a defective product or an inaccurate result or an unsubstantiated medical opinion when it has probably done the same thing to thousands of other people is cold comfort once you’ve already relied on the inaccuracy and suffered some kind of harm.

However 23andMe released a new SNP report for Hemochromatosis just this week that was of interest.

I’ve known for a few years that in the HFE Gene linked to Hemochromatosis, my father and one sister carry one positive allele:

rs1800562 C282Y G to A AG

Now I find that my mother and a different sister carry a different positive allele:

i3002468 S65C A to T AT

I myself am NOT positive for either. But now I feel I should reach out to my other 4 siblings who are not tested and inform them of these results.

23andMe test 3 SNP’s as follows:
rs1800562 – high risk
rs1799945 – low risk
i3002468 – low risk

You are in danger of developing Hemochromatosis – much of which goes undiagnosed – if you carry either:
2 x high risk alleles
1 x high risk + 1 x low risk

So any of my other 4 untested siblings would have a reasonable high risk of developing Hemochromatosis.

That’s the first negative results of interest for me/family so far!

BTW, my father’s mother used to have very painful joints, especially knees, which was attributed to Arthritis – and which inadvertently caused her death, when she stumbled and fell – but now I wonder if she actually suffered from Hemochromatosis, as that is also a symptom.