[setgree]

Perhaps silly to ask, but: why does the FDA regulate this?

It’s not a food, it’s not a drug, if it’s purely a saliva swab it is non-invasive — so where does the FDA come in?

In a university context, there is often a blanket IRB exemption for certain kinds of research where the risks are self-evidently minimal, such as taste tests.

If the FDA’s role here is to provide a stamp of approval indicating “this test ‘works’ according to an accepted standard,” then I would think something closer to how food supplements are monitored would be a better fit, for example, the test could come with text saying “this language has NOT been approved by the FDA” or equivalent for approval.

I am failing to see risks here besides the risks of misdiagnosis, but I just didn’t think it was the FDA’s mandate to approve or not approve based on efficacy.

[mjcl]

The legislation that created the FDA (the Food, Drug & Cosmetic Act) defines drugs to include "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals". See https://www.law.cornell.edu/uscode/text/21/321, section 321 (g)(1)(B).

[sk5t]

The FDA maintains it is within the administration's purview to regulate tests--including laboratory-developed tests, or LDTs--although the current state is that the FDA often elects to exercise its discretion to permit LDTs sans regulation-as-medical-device provided the lab adheres to CLIA and has any required accreditation in order.

Dietary supplements are more or less unregulated, as long as they don't claim to diagnose or treat a disease. This is not exactly a great situation for consumers. Also, the current administration has taken sort of a "safety over efficacy" tack, but I don't know, therapeutic failure seems pretty bad, so maybe there isn't that much meaningful difference between the two.

Back to the testing concept, if not for the FDA to come down on operations like Theranos, then who?

[glenra]

> if not for the FDA to come down on operations like Theranos, then who?

Theranos was committing fraud - selling investors a product that didn't exist. You don't need the FDA for fraud to be illegal, ordinary civil and financial law covers this.

If Theranos weren't defrauding investors and actually had a product that worked, it'd be up to the market to determine if that product were worth paying for. Since different customers have different risk profiles there's no one-size-fits-all best balance between safety, efficacy and cost - let people buy different products that choose different tradeoffs.

[IvyMike]

Theranos was in fact testing people, who received both false negative and false negative results.

From the article I link below:

> At its height, Theranos operated 40 “Wellness Centers” in Walgreens stores in Arizona and a single location in California, which were the source of much of its revenue. USA Today reported the metro Phoenix-area centers alone sold more than 1.5 million blood tests, which yielded 7.8 million tests results for nearly 176,000 consumers.

https://www.darkdaily.com/previously-high-flying-theranos-pr...

[sk5t]

> Theranos was committing fraud - selling investors a product that didn't exist

Well, the FDA is not the SEC--and Theranos was also providing patients with erroneous lab reports! This is more than a bit worse than wasting the time, money, and reputation, such that it may be, of Tim Draper, George Shultz, Henry Kissinger, et al.

[akiselev]

> You don't need the FDA for fraud to be illegal, ordinary civil and financial law covers this.

The FDA was literally made as the arbiter of what is and isn't fraud in medicine.

[smooth_remmy]

> Dietary supplements are more or less unregulated, as long as they don't claim to diagnose or treat a disease. This is not exactly a great situation for consumers.

If dietary supplements were regulated, they would probably 1) cost 10x as much 2) be prescription-only 3) only be affordable through health insurance 4) there would be 1/10th the innovation compared to what we see now.

I'm a consumer who consumes a basic set of supplements (vitamin d, vitamin k2, magnesium, multivitamin) and I'm very happy with how things are now.

I'm glad that the extreme level of waste, red tape, and corruption that affects the rest of the medical industry does not affect dietary supplements.

[ebg13]

> I'm a consumer who consumes a basic set of supplements (vitamin d, vitamin k2, magnesium, multivitamin) and I'm very happy with how things are now.

Fundamentally, no you aren't. What you are is a consumer who thinks they consume a basic set of supplements naively without oversight. Without a regulatory body verifying the safety and efficacy of the products, you actually have no idea that they contain what they claim and that they aren't tainted by e.g. lead or arsenic.

[smooth_remmy]

There are regulatory bodies overseeing generic prescription drugs and those still have quality control problems: https://www.npr.org/sections/health-shots/2019/05/12/7222165...

[ebg13]

> There are regulatory bodies overseeing generic prescription drugs

This is also sadly wrong. There are regulatory bodies overseeing only a very tiny fraction of generic prescription drug production (ask how often they inspect and test batches) because of a systemic drive to dismantle and defund regulatory oversight exactly as championed by the person I was replying to.

Oversight in the face of rampant fraud requires testing continuously, not once every few years, not sometimes after something goes wrong, and it requires funding to hire overseers.