It reminds me of Theranos because it meets the 'visionary founder(s) + unproven yet promising sounding scientific premise + extensive backing from prominent individuals = really great story to read/write about'. The caveat there is, as I mentioned, the significant scientific backing behind this.
I am very skeptical of dietary supplements (esp. when they aren't something like niacin, or iron, which have permitted claims). I am not a lawyer, but it would seem to me like their marketing might run close to afoul of FDA guidance on dietary supplement claims. See here (http://www.fda.gov/food/guidanceregulation/guidancedocuments...).
Here are a couple examples of them artfully avoiding making seriously problematic claims:
--- "Basis is designed to optimize NAD+ levels and sirtuin function in our cells to support our most critical metabolic processes like cellular detoxification, DNA repair and energy production." https://www.elysiumhealth.com/basis. Note the careful language use of 'support', which doesn't actually mean that it does it, according to the FDA guidance document cited above.
"It is closely related to resveratrol, a compound found in grapes and red wine, but more bioavailable, or easier, for the body to incorporate. Research has shown that pterostilbene, like NAD+, stimulates enzymes called sirtuins. They relate to critical cellular processes, from aging to circadian clocks to energy production." https://www.elysiumhealth.com/basis Note that they mention the critical cellular processes as related to it, without directly saying that consuming more of pterostilbene actually helps. ---
The claims themselves aren't direct enough to probably merit a warning letter (in my amateur opinion), but it certainly doesn't mean that they do anything. They aren't actually making any claims as to the product's efficacy, but if they were to, you'll also note that all of the research cited(https://www.elysiumhealth.com/basis, at the bottom) probably wouldn't actually substantiate any claims per FDA guidance, because the studies don't actually come close enough to testing the supplement itself.
I say all of this under the caveat that I am not a lawyer, just a regular human being who is skeptical of any miracle pills.
It is much more profitable in the short-term to make a supplement and sell it to millions without prescriptions than to make a drug and sell to thousands with Rx.
If they spend money on trials and subtantiate their hypotheses, they have to stop selling it as a supplement because now they know it is a drug... but as long as they don't run the trials and don't know it's a drug, they can keep going.
Stands in contradiction with this (in the article).
>The company stresses that it is using only compounds supported by hundreds of peer-reviewed papers, that it enforces high manufacturing standards, and that it is conducting a human trial (currently 120 people between the ages of 60 and 80 are participating)
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Your overall point about how it's a profit seeking venture first and foremost is accurate. Personally, I find it ethically wrong to imply that your product will help people without knowing for sure that it will. There's always the edge case where the less savvy consumer goes for the ineffective supplement instead of consulting with their doctor.
Couldn't they continue to do both even after it's certified as a drug?
Instead of a supplement, perhaps they could make a lower dose over-the-counter version of the same drug. They could still sell millions without prescription.