[civilized]

I'm seeing this amidst a lot of pundit complaints that the FDA and similar regulatory organizations are hopelessly restrictionist. Because of their incentives, because they only add new regulations and never remove old and ill-suited ones, etc.

I'm not saying the pundits are wrong in general, but this seems to be an exception. What went right here and why? Is there anything to learn?

[cushpush]

Plans for open-source hearing aids have also been developed and released, like happened on HN a few years ago (amazing work by the gentleman @zdw) https://news.ycombinator.com/item?id=20604566. So, I think like someone else said, this is gov't catching up to the fact that market alternatives exist and are undercutting an industry that has celebrated regulatory shielding for a long time. Really, the hardware is less complex as time goes on, right? It makes sense that low-cost alternatives will bring quality up for consumers and prices down for consumers. Question, Hearing aids are considered medical gear and therefore the regulation?

[14]

I always was told that the heating aids need to match the user. By that it means heating is tested and what frequency loss the patient has the hearing aid will then take that frequency and alter it to one the client can hear. It’s not a matter of higher volume. It seems now however a simple app on a phone could do the hearing test and then match up what the patient needs with an open sourced hearing aid.

[carlmr]

>It seems now however a simple app on a phone could do the hearing test and then match up what the patient needs with an open sourced hearing aid.

I would bet a lot of things could be done by regular people with proper software support. Having licensed gatekeepers raises prices for the service. Since you're excluding a lot of supplierd from the market.

The question is then why gatekeep at all?

With antibiotics for example, abuse and misuse can cause a lot of harm, so having someone gatekeep them, even if this raises the price of service makes sense.

But with a lot of licensed professions we're merely creating an artificial moat that increases prices in a market economy.

[rocket_surgeron]

>I'm not saying the pundits are wrong in general

The pundits are wrong. The FDA follows the instructions given to them by Congress.

What went right is that there was broad bipartisan support for the 2017 FDA reauthorization act which permitted them to do this.

What went wrong was that covid delayed the rule making process by about 18 months.

Every single rule/regulation in the Code of Federal Regulations can be traced back to a law that originated in Congress with the words "the Secretary shall..." in it, with the secretary being the head of a government agency.

Prior to 2017 the Congress said "the Secretary shall regulate medical devices" and under the definition created by Congress hearing aids were medical devices, so the FDA did.

After 2017 the Congress said "the Secretary shall regulate medical devices but also make a category for OTC hearing aids" so the FDA did.

Also, rule changes take a long time either because of changes in the laws telling federal agencies what to do or laws already in 5 U.S. Code that define the rule-making process.

There are many federal agencies that would like to wave their hands and create or eliminate rules but for better or worse (I think mainly better) they can't.

Many, though not all, pundits don't realize what the process is.

[armchairhacker]

Some things need to be over-regulated, like food (making sure companies don't put bad things in it or lie about what they're selling), or anything common for the matter. Some things ehh...like experimental drugs, which some argue need to be well-tested, but the alternative for some is dying or living in constant pain (personally, I think people should be able to sign up for anything as long as its, beyond doubt, under their own choice and they're fully aware of potential consequences)

I just don't see the reason to regulate hearing aids. It's not like they'll blow up in your ear or translate people's everyday conversations into conspiracy theories, and hearing aids which don't work well are better than none at all.

[geraldwhen]

As a counter example, sesame was recently made a major food allergen by the FDA, which caused many food makers to add sesame to their food.

Adding sesame was easier than following the regulations to assert their foods were sesame free, so now food that used to be safe is now dangerous for anyone with a sesame allergy.

https://www.fastcompany.com/90830854/sesame-seed-allergen-fd...

[bsder]

And for those with a mild sesame allergy, things improved dramatically as they don't have to play roulette with how much "undetectable" sesame is in their food anymore. The amount of sesame is known, quantified, and reliable. Once they establish that a food is "safe", they can buy it going forward.

What did everybody expect was going to happen? That companies were magically going to sterilize their production lines?

[Jochim]

My heart truly bleeds for companies who face the insurmountable task of printing "may contain sesame" next to the rest of their allergen information.

Wheat was already on the major allergens list, the regulatory burden of keeping aerosolised flour from contaminating other products doesn't seem to have been much of an issue.

The article also seems to make the case that sesame allergens were making their way into foods, with presumably disastrous effects but that was fine because companies didn't have to think about it.

The preferred solution to the intentional adulteration of products should be to fine the companies and throw their executives in jail. It might make them more amenable to complying with the spirit of the law. In fact, society would be better off in general if executives went to jail more often.

[SloopJon]

> My heart truly bleeds for companies who face the insurmountable task of printing "may contain sesame"

The reason the regulation, and the commercial response to it, is controversial is that companies cannot simply print "may contain sesame" and be done with it.

"Statements such as 'may contain [allergen]' ... can be used to address unavoidable 'cross-contact,' only if manufacturers ... have taken every precaution to avoid cross-contact"

https://www.fda.gov/food/food-labeling-nutrition/food-allerg...

This is a counter-intuitive, and presumably unintended consequence of the regulation that sucks if you're allergic, but fining or jailing executives for complying with it is silly. Hopefully, enough other companies will see a competitive advantage in retooling their processes to deliver sesame-free products.

[Jochim]

My mistake. They're simply required to do the same thing the do to ensure their enriched breads do not cross contaminate unenriched breads with milk and eggs, or that gluten free breads aren't contaminated with wheat flour.

> This is a counter-intuitive, and presumably unintended consequence of the regulation that sucks if you're allergic, but fining or jailing executives for complying with it is silly.

They're not complying, they're skirting. People who play these kinds of games are a weight around society's neck. The purposefulness and agency over their actions is what should see them in jail. See the attempts of past Uber executives to obstruct the investigation of their illegal activities for an egregious, and relatively well known example of people who need a stern lesson on how to behave in society.

[s1artibartfast]

I think you need to take a step back and get some perspective if you are calling for Bakers who add Sesame to their ingredients to be jailed.

There's no government compulsion to make sesame free products and should not be in a free Society.

[sgtnoodle]

My understanding is that the recent law does not allow for compliance by simply labeling possible contaminants. If the recipe does not intentionally include seseme, the product must not list seseme as an ingredient, and must not contain any seseme.

So, the insurmountable task is either maintaining completely seseme free manufacturing lines, or cleaning manufacturing lines between recipes to the point of guaranteeing no seseme cross-contamination.

Does it really follow that executives should be jailed for adding seseme to their company recipes? I imagine many of the companies that made this change were previously voluntarily listing seseme as a possible contaminant, but had to stop because of the law.

[Jochim]

> My understanding is that the recent law does not allow for compliance by simply labeling possible contaminants. If the recipe does not intentionally include seseme, the product must not list seseme as an ingredient

My mistake. Since 2004, Major food allergens have come with a requirement that manufacturers take steps to avoid cross contamination. The addition of sesame to the list requires it to be treated in the same way.

> and must not contain any seseme.

The manufacturer must follow "current good manufacturing practices (cGMPs)"[0] as described by the FDA. These should already be in place to prevent cross contamination of the existing major allergens.

> So, the insurmountable task is either maintaining completely seseme free manufacturing lines, or cleaning manufacturing lines between recipes to the point of guaranteeing no seseme cross-contamination.

The insurmountable task is to do the same thing they're already required to do to make sure enriched breads, containing milk and eggs, were not cross contaminating merely leavened products or to make sure that wheat flour doesn't contaminate non-wheat products.

> Does it really follow that executives should be jailed for adding seseme to their company recipes?

Yes. Any executive that added sesame to their product in response to this law should be in jail. I'm tired of executives facing no consequences when they intentionally cause harm in their pursuit of profit.

> I imagine many of the companies that made this change were previously voluntarily listing seseme as a possible contaminant, but had to stop because of the law.

Presumably part of the reason sesame was added as a major allergen was because companies weren't doing a great job disclosing it as an ingredient.

[0] https://www.fda.gov/media/80337/download

[nitwit005]

No one is perfect. They sought to amend the rules after it became clear that would be an issue.

You can go to places where food is essentially unregulated, as even if there are laws, they aren't enforced. I guarantee people will warn you against eating the local food, and those warnings will be from experience.

[sitharus]

Your ‘counter example’ is exactly what we want to happen.

It’s not that they’ve added sesame where there was none before, it’s that they’re having to declare that sesame might be there. It’s great news for people with sesame allergies and has no effect on those that don’t.

[brookst]

That was my first thought, but look at other well-documented comments here. It sure looks like "may contain" is a certification that every possible avenue to avoid "contamination" had been pursued. Which is an open-ended liability. Easier to just add 1% and definitively say it does contain sesame.

[BoorishBears]

No, they added sesame where there was none before.

The law requires you either have no sesame contact at all (as in not even having sesame based products travel on the same belts), or you list sesame as an ingredient.

But you can't just list ingredients that aren't in your food: "travelled on the same belt as sesame" isn't enough. So they actually went and added sesame.

[sitharus]

Yes. Before there may have been sesame, it was a lottery. Now there definitely is or is not sesame, which is what's important to people with allergies.

Though it's weird that the FDA don't just allow a 'may contain traces' warning, many countries do.

[dotancohen]

> Though it's weird that the FDA don't just allow a 'may contain traces' warning, many countries do.

The reason is that such information is useless. If someone has a sesame allergy, they can not eat the food that "may contain traces" anyway. So actually having a definitive boolean _hasSesame is far more useful information, and will lead to less accounts of confusion.

Just as an example, my son's friend is allergic. Can I, as a parent of a friend, give to this child food with the "may contain traces" label? Will every parent of a friend make the same decision? With the new labeling, the answer is much clearer.

[BoorishBears]

> It’s not that they’ve added sesame where there was none before, it’s that they’re having to declare that sesame might be there

They added it where there was none before. People with allergies to sesame were eating bread at Olive Garden and Chick-Fil-A just fine before this legislation and now they can't.

> Though it's weird that the FDA don't just allow a 'may contain traces' warning, many countries do

The FDA always allowed that. But by naming it a major allergen the "Contain" statement becomes mandatory, and the "May Contain" statement doesn't satisfy that.

[kragen]

this is incorrect

they've added sesame where there was none before

[maxerickson]

The thing driving the regulation is that there is an (small or trace but) unknown amount of sesame.

If it was obvious it was none there wouldn't be an issue.

[s1artibartfast]

So the solution to comply is to intentionally add Sesame to the manufacturing process has the most effective way to meet the regulation. This means that products that previously may have had occasionally low PPM levels of sesame now have a much greater amount intentionally added in larger but known quantities

[kragen]

in some cases there were trace amounts, and in others there weren't, but the absence of sesame couldn't be guaranteed

we don't know specifically which cases there was no sesame before but we do know there were a lot of them

[janeerie]

Poorly calibrated hearing aids actually can damage your hearing (even worse than it was). It’s sending highly amplified noise directly into your ear drum.

[eh9]

Hearing aids are generally calibrated for an individual’s specific frequency loss (usually done by a medical professional). We’re already seeing devices that simply amplify all frequencies, and while I’m no doctor, I can imagine boosting all frequencies for prolonged periods of time could lead to additional hearing loss.

[cdot2]

Given the current state of common food I don't think I would agree that it's currently over-regulated.

[markdown]

The opposite is true. Most Americans are eating food that isn't what the label says it is (eg. fish). This sort of scam is completely legal and the FDA allows it to happen. More regulation needed.

Then you have dietary supplements which is a complete wild west. There's a 3 billion dollar kratom industry, for example. You can buy this dangerously addictive drug at your nearest 7-11 or gas station.

[vinaypai]

So how many people have been seriously harmed by this 3 billion dollar industry? I'm particularly interested to know how many people who weren't taking the drug but were harmed by someone who was?

[markdown]

I don't have figures because nobody has done the studies. Like I said... Completely unregulated.

R/quittingkratom has tens of thousands of members. So hundreds of thousands of people have had their lives seriously affected by it (every addict ruins multiple lives... Family and friends). That's to say nothing of the many dead from kratom.

[vinaypai]

If there are no studies and you're implying that kratom is a big problem, so what are you basing that on?

There are many subreddits related to quitting various things. If that's your metric for “lives ruined" there are dozens of other things that have ruined dozens of times more lives.

[porkbeer]

Count the obese people you see, that is your answer.

[55555]

Kratom users make other people obese? Now that’s a novel theory. (I think you misread the post you replied to.)

[orwin]

The US baby food contains so much heavy metal, that's not even funny anymore.

I wonder if they will legislate on that soon.

[carlmr]

>It's not like they'll blow up in your ear

I mean there is still product safety laws for this, which I would hope are enforced. But they should be just as strict as for your earphones.

[Tuna-Fish]

There has been very significant pushback against such restrictionism for more than a decade, and it has steadily won over support especially among doctors.

This is FDA starting to go with the flow.

[civilized]

By this do you mean that doctors are changing their minds, and since doctors do things like run advisory boards at the FDA, that causes the FDA to behave less restrictively?

In other words, why would the FDA bother to go with any flow? On the view of some economists, bureaucrats should never deregulate because there's no incentive for them to, and mere cultural pressure shouldn't really be an incentive.

[dragonwriter]

> On the view of some economists, bureaucrats should never deregulate because there’s no incentive for them to

Well, so economists models of things outside their notional specialty aren’t any more connected to reality than those inside. That’s…to be expected, I guess.

[concordDance]

Economists model incentive structures, I'd expect them to actually model things that aren't traditional economics quite well.

IF there actually is a consensus by economists that bureaucrats won't regulate well then I'd believe them

[the88doctor]

Traditional economists model traditional economic incentives. Behavioral economists try to understand all the gaps in traditional economic models such as why people don't steal as much as they can when there is 0% chance of getting caught or why people who choose In-and-Out when given an option between McDonalds and In-and-Out suddenly choose McDonalds when just asked to pick a restaurant for lunch.

Humans are motivated by emotional incentives at least as much as economic incentives, and humans also have cognitive and memory constraints that aren't considered by traditional economists.

All of which is to say that while there may not be an economic incentive for government regulators to de-regulate, that conclusion fails to consider that many government regulators actually have an emotional desire to feel like they are doing good in the world and that emotional incentive can sometimes be stronger than the traditional economic incentive to keep regulations in place.

[brundolf]

Cultural pressure means political pressure and eventually that works its way through the system. It may be blunt and slow, but it gets there eventually.

[civilized]

I'm realizing that you can always spin a story either way. If regulation is restrictionist, you talk about the ratchet and the overriding aversion of the regulator to being blamed for anything. If regulation is lax and ineffective, you talk about the revolving door with industry and the reluctance of regulators to piss off companies they could later get lucrative consulting jobs at.

There is always a stock story available to explain whatever we currently don't like, but who knows what the facts are.

[elliekelly]

I feel like there are a lot of similar examples they just don’t get a lot of press. Naloxone was recently approved for OTC and they also recently approved allowing Mifepristone prescriptions by mail. They’re considering allowing a new birth control to be sold over the counter. Maybe a decade or so ago Plan B was prescription only but they allow that to be sold over the counter now, too.

And a lot of other drugs have made the jump in my adult memory: allergy drugs like Claritin and Flonase used to be prescription only as did just about every major antacid like Prilosec and Nexium. There’s a new topical NSAID for arthritis that recently made the switch to OTC too, I think.

[loeg]

> There’s a new topical NSAID for arthritis that recently made the switch to OTC too, I think.

Diclofenac did, if that's the one you're thinking of. I was prescribed it for joint pain a few years ago and was pleasantly surprised when I was able to buy it OTC after a while.

[vlovich123]

I think only in topical cream form vs as a pill right?

[thaumasiotes]

https://news.ycombinator.com/item?id=35846202

> Congress actually passed a law in 2017 ordering them to sell them over the counter.

[voxic11]

https://en.wikipedia.org/wiki/Over-the-Counter_Hearing_Aid_A...

[zosima]

FDA was pushed for, I think, over six years by laws to allow over-the-counter hearing aids. I don't know why they even started regulating them.

There is no credit here, whatsoever, for FDA.

[AbrahamParangi]

Congress passed a law that made them do this - in 2017! The FDA has been going slow on implementation till the Biden admin gave them another kick in the pants.

[stainablesteel]

federal bureaucracy is slow to move, definitely

afaik older hearing aids actually posed some harm to folks if they got the wrong kind

new models basically make this kind of problem non-existent