Global Evolutions

Personalized Nutrition in the Wake of 23andMe's Warning Letter

<p>Personalized nutrition tests, such as those offered by 23andMe, could lead to more business for the supplement industry. The trick is staying legal with marketing claims.</p>

23andMe, a company that offers $99 DNA testing, is in hot water with FDA for marketing it's product as a devise that helps diagnose diseases. FDA sent the company  a warning letter saying the company must stop all marketing due to concerning marketing tactics. FDA pointed to marketing of DNA tests that report genetic risks for breast and ovarian cancers, as well as tests that report on drug responses.

FDA said it tried to work with 23andMe to hash out what marketing would be legal, but the company didn't respond. It's left FDA in the dark since May of this year, despite  "More than 14 face-to-face and teleconference meetings, hundreds of email exchanges, and dozens of written communications" from the agency.

Yet, the company kept their marketing strong. I've heard dozens of ads on my favorite podcasts, and FDA said in its warning letter that 23andMe was looking at entering TV advertising and expanding its health claims.

But FDA isn't the only one with a grudge against 23andMe. An article in Fast Company noted health insurance companies aren't too keen on it because the DNA results could lead consumers to request expensive medical tests. If a person finds out she has a gene that predisposes her to breast cancer, she may demand more mammograms than required, and health insurance companies would foot the bill.

It's interesting to look at this from the supplement and functional food industries. Say that same woman with the breast cancer gene looks into alternative/prevention strategies to help reduce her risk of breast cancer. She quits smoking, starts eating more broccoli, exercises more and adds soy, plant lignans and vitamin D to her daily multivitamin.  

This could mean bigger sales for the nutrition industry. Or, it could just mean different sales. Perhaps a supplement user will still spend the same amount, but on different products. That woman may perhaps skip out on her Coenzyme Q10 (CoQ10) supplement in favor of soy isoflavones.

It's up to industry to figure out how to market to these consumers, and how to do it legally.

As personalized testing and nutrition is getting more advance, the natural products industry is already taking notice. The United Natural Products Alliance (UNPA) recently hosted a seminar on personalized medicine, with its president Loren Israelsen noting, "To stay relevant, the natural health products industry must provide a patient-centered approach that addresses specific concerns."

I doubt any supplement company will be running to partner with 23andMe given their recent warning from FDA, but I'm sure supplements will be looking to working with DNA testing companies in the future. The legalities of the marketing supplement and foods to help healthy consumers stay healthy (even with their genetic predispositions) will have to be hammered out with a lawyer, but I bet these collaborations are on the horizon.

Maybe a solution is for a company to partner with a medical professional who can adequately evaluate a genetic test and offer possible lifestyle adaptations, including supplements and fortified foods. If this is the route you're exploring, this INSIDER slide show on hiring the right medical professional may be useful.

TAGS: Regulatory
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