23andMe warning letter won't decimate personalized nutrition trend, but will help shape boundaries, experts say

The appeal of the trend is obvious.  At a recent seminar put on by the United Natural Products Alliance (at which 23andMe executive Geoffrey Benton was a featured speaker), attendees were told that the advent of simplified genetic tests marks the dawn of an age in which the idea of personalized nutrition will be driven by hard data as opposed to answers on survey queries as was the case in the past.  And it means that that amassed data can be mined with statistical techniques—the so called Big Data scenario — to yield information that can drive product formulation and brand development strategies.

The lower costs and new delivery methods for these tests will transform the movement, said UNPA president Loren Israelsen.  Instant information available to consumers to drive immediate product decisions (my personal data tells me this product will work for me) will open up a new world, he said. 

“This will be the game-changer,”​ he said, while holding up a smart phone.

Are the tests actually medical devices?​

That’s the glittering vista.  FDA seems to be viewing this trend somewhat differently, as spelled out in the warning letter it sent to 23andMe​.  For $99 the company gathers genetic information from users via a saliva sample and supplies an array of results, including some personal genetic heritage information and insights into whether they are predisposed to certain diseases, or which types of nutrients might work best for their individual physiology. It can also help consumers understand which drugs might work best, such as certain classes of antidepressants, for example.

“We give you that piece you can use to help your doctor,”​ Benton said.

It’s the tone of that last bit of rhetoric that led FDA to view the company’s test as a medical device, subject to that statutory pre market approval process​.  In the warning letter, FDA said the test “​is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body.”​  As support for that view, FDA took cues from the company’s own marketing materials that showed the test was “providing ‘health reports on 254 diseases and conditions,’ including categories such as ‘carrier status,’ ‘health risks,’ and ‘drug response,’ and specifically as a ‘first step in prevention’ that enables users to ‘take steps toward mitigating serious diseases’ such as diabetes, coronary heart disease, and breast cancer.”​

Stalled negotiations​

23andMe founder Anne Wojcicki has said that her company is offering a technology that FDA doesn’t yet know how to regulate.  But she also acknowledged that 23andMe has not done a good enough job in working with the agency to allay its concerns. In the warning letter, FDA detailed its back-and-forth communications with the company, a dialogue that the agency says the company terminated in May of this year.

“We completely recognize we’re behind schedule; we failed to communicate proactively,” ​she said. “[The FDA is] a very important partner, and everyone is focused on resolving it,” ​Wojciki said.

Where does personalized nutrition go from here?​

So where does that leave the personalized nutrition sector?  New tests are coming on to the market at a steady pace.  For example, a company called Progene that markets a testosterone support dietary supplement is offering a saliva test that purports to measure a subject’s testosterone level.  And nutraceutical development firm Health Enhancement Products Inc. is test marketing a urine test that purports to measure ‘wellness’ via a series of oxidative stress markers.

“It’s pretty obvious to us that personalized nutrition is the wave of the future. Not only whether a particular nutraceutical works, but whether it works for you,”​ said HEPI CEO Andrew Dahl.

Privately, some companies have opined that 23andMe seemed to be playing by a different set of rules.  The company, founded in 2008, was finding great uptake in the marketplace (the company now boasts that it has completed more than 450,000 profiles) without having registered its test as a medical device.  Yet other companies seeking to bring tests to market were being given advice from counsel that the only safe way to go was to incur the expense of proving the tests work via the medical device approval process.

“It’s not that it can’t be done. It’s just that it has to go through the right channels,”​ said Ivan Wasserman, a partner in the Manatt law firm. “FDA was taking issue with certain types of claims [23andMe was]  making for certain diseases or markers for certain conditions.​ Even the claims they were making are not dead in the water.  They just have to complete the FDA process.”​

Accurate and reliable​

The concern on the part of the agency is that any test deemed to be a medical device be proved to be accurate and reliable, Wasserman said.  The extreme hypothetical example of the danger of an inaccurate test is given in the warning letter in which a woman might be moved to seek a prophylactic double mastectomy if the test showed a strong predisposition toward breast cancer.

“The agency’s approach to 23andMe goes to two points.  Can the test itself yield consistent, analyzable factors?  Can you get an adequate sample of out saliva?”​ said Jason Sapsin, an attorney in the firm Fox Rothschild.

“The second part is, either implicitly or explicitly, are the relationships that a company is looking at between those factors sufficiently well documented that they can be presented to consumers as fact? Can you derive results on which it is reasonable to ask consumers to rely?”​

How results are used matters​

Sapsin said another issue that is still being delineated as the personalized nutrition trend develops is what happens after the tests are completed.  How will the companies offering the tests expect that consumers will use the data, and with whom?  If an employee in a health food store helps consumers use their personal genetic profile to select or exclude certain products, does that amount to dispensing medical advice?

“What is it you are encouraging the consumers to do with the results? ​It’s like any other class of FDA-regulated products, what you tell people to do with them matters. If I give someone a glass of water and I tell them 'If you’re thirsty, drink it,’ it’s a beverage.  If I give them that same glass of water and tell them it will help with their cancer, it’s a drug,”​ Sapsin said.

In the end, even if some of these questions are up in the air, it doesn’t make a lot of sense to try to do an end run around FDA, Sapsin said.

“I advise clients to think of FDA as a potential partner in the development of the project,”​ he said.