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?
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.
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.
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.
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...
What did everybody expect was going to happen? That companies were magically going to sterilize their production lines?
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.
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.
> 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.
There's no government compulsion to make sesame free products and should not be in a free Society.
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.
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.
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.
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.
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.
Though it's weird that the FDA don't just allow a 'may contain traces' warning, many countries do.
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.
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.
they've added sesame where there was none before
If it was obvious it was none there wouldn't be an issue.
we don't know specifically which cases there was no sesame before but we do know there were a lot of them
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.
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.
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.
2. Yeah its may be unhealthy but people do all kinds of unhealthy things to themselves.
3. 35k subs on a subreddit that seen around 12 years is TINY. There's a sub about quitting porn that has over a million.
4. Even though you claim there are "no studies", here's a study from the WHO. Where they concluded that no action beyond "monitoring" was warranted based on current evidence.
https://www.who.int/publications/m/item/kratom-mitragynine-7...
I wonder if they will legislate on that soon.
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.
This is FDA starting to go with the flow.
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.
There is always a stock story available to explain whatever we currently don't like, but who knows what the facts are.
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.
IF there actually is a consensus by economists that bureaucrats won't regulate well then I'd believe them
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.
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.
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.
> Congress actually passed a law in 2017 ordering them to sell them over the counter.
There is no credit here, whatsoever, for FDA.
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