FDA urges consumers not use certain hand sanitizer products

https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-hand-sanitizers-consumers-should-not-use#products

by bookofjoe • 6 years ago

103 82 6 years ago

Are These bring sold in the US? Are there repercussions for people importing or manufacturing them?

Yes and yes, but legal action takes time and the FDA wants to prevent adverse events rapidly. Expect legal action to follow in the future.

vikramkr3• 6 years ago

They mention that they are adding them to import alert in order to stop them from being legally imported into the US

leeoniya• 6 years ago

all but 1 are manufactured in Mexico, yet this is not directly stated in the headline, nor the abstract.

curious.

untog• 6 years ago

Why should it be?

If 90% of all sanitizers produced in Mexico were dangerous then it makes sense to include it in the headline: that’s useful information for the reader. But if it’s a tiny minority then knowing the country of origin doesn’t actually help the reader make a choice in the store.

In any case, this isn’t a new article, it’s an FDA dataset. It isn’t supposed to be editorialised.

vikramkr3• 6 years ago

Why is that "curious?" They clearly state they're putting these on import alert to prevent them from entering the country, it's not like they're hiding anything. If they put out a blanked statement it would impact all Mexican manufacturers, including the ones that aren't contaminated, while giving people a false sense of security with all non-mexican origin products, when the lack of listings from other regions may just be because the FDA prioritized first looking into sanitizers that shared a similar supply chain and simply haven't gotten around to testing enough others yet to determine how widespread the problem is.

rsynnott2• 6 years ago

It's a recall, so that doesn't particularly relevant. In fact, it could have two harmful effects if that narrative took hold.

a) It could cause people to avoid all hand sanitiser from Mexico. Given that supplies are still uncertain, this could lead people to avoid using hand sanitiser at all, with negative effects.

b) It could cause people to incorrectly assume it's only a problem with products from Mexico, causing them to ignore future recalls. Realistically, given the massive rampup in production of the stuff, there will be more recalls.

lemiffe• 6 years ago

Most of them seem to be from Mexico, is this a comprehensive list? Or are most of the sanitizers that are imported into the US produced in Mexico?

rsynnott2• 6 years ago

It's possible that there's common manufacturing involved, either of an ingredient or the whole product. That's fairly common for this sort of rather generic product, and can lead to extremely broad recalls. A while back, almost all hummus in the UK and Ireland was recalled; turns out practically all manufacturers shared one company in the supply chain.

Carioca• 6 years ago

A lot of them were recalled for containing methanol, which could be a characteristic of the original bulk alcohol. I'd imagine most plants are not set up to do the necessary separation

elliekelly• 6 years ago

I wonder if it’s related to the “counterfeit” Mexican alcohol that killed some resort-goers last summer.

rconti• 6 years ago

They were all Mexico, actually, except Tritanium Labs, which had this comment:

Product purported to be made at the same facility as Incredible Products SA de CV that produced methanol contaminated product; FDA recommended a recall on 7/30/2020

tyingq3• 6 years ago

I'm pretty sure the supply chain changed drastically when hand sanitizer went into high demand mode. Opportunistic companies that had access to methanol, ethanol, or isopropyl alcohol probably jumped in too quickly.

Purell, a popular brand, is made in Ohio and France.

dTal• 6 years ago

This may be an attempt to pander to US corn ethanol interests ahead of the election, in particular the swing state of Iowa which is a major corn ethanol producer and holds the first primary election. Note that it's not just a recommendation - the named products are now forbidden from import.

Circumstantial evidence:

* The very day before the import bans, Trump retweeted "President @realDonaldTrump is working to ensure that AMERICA produces the critical goods necessary to combat COVID-19 here" - along with a small speech about "restoring American manufacturing".

* The head of the FDA appears to be politically captured by the Trump administration, for example by ordering FEMA to distribute hydroxychloroquine to pharmacies nationwide.

* This administration has already attempted to pander to the Iowa ethanol demographic in the form of lobbying Brazil to lower ethanol import tariffs. Mexican ethanol is both cheaper and geographically nearer to Brazil, so discrediting its purity would make sense.

* Tiny methanol impurities, the cited reason for most of these recalls, pose virtually no contact risk in hand sanitizer. Even if you rubbed pure methanol on both your hands for a whole minute, you'd only absorb about 30 mg. That's about the same as you'd get from metabolizing a pint of diet soda (aspartame turns into 10% methanol by weight). Real hand sanitizer will contain tiny amounts of methanol, and will be in liquid form on the hands for considerably less than a minute. So I find the health justification for this rather suspect.

taf2• 6 years ago

Is there any easy diy way to test at home?

Consultant32452• 6 years ago

This site claims you may be able to test by scent and flame color. It's about testing alcoholic beverages, not hand sanitizer though, so assess your risk accordingly.

https://sciencing.com/test-ethanol-content-4598588.html

hlieberman• 6 years ago

I'm reallllly skeptical of their recommendations here, because of their two solutions for testing for the presence of methanol, one won't work for contaminated ethanol (which is what this is likely to be), and the other uses a toxic heavy metal with inhalation risks.

qqqwerty• 6 years ago

I have some small bottles of hand sanitizer from the manufacturer in question. It is unclear if the particular brand I have is on the re-call list (the list has dozens of brands with slightly different name variants).

Just now, I poured some out on a tin can and lit it on fire. The flame was mostly blue, with a very occasional flash of yellow. So not super clear what that means. But I think I will play it safe and throw them out.

UPDATE: I had a small amount from a target brand sanitizer. I saw a similar flame, mostly blue with an occasional flash of yellow. Regardless, best to play it safe and throw out the brand in question.

fencepost• 6 years ago

Basically no. I've discussed it with a friend with very relevant experience and it comes down to "it's easy if it's pure, but difficult once you have a blend or contaminants (like gelling agents)."

Flame color isn't reliable because you don't know what's burning.

dillonmckay• 6 years ago

Didn’t the FDA waive some regulations regarding production in March?

dawnerd• 6 years ago

That was more with the production of ethyl alcohol, not methanol.

vanattab• 6 years ago

Methanol is a byproduct in the production ethyl alcohol and has to be removed. The stories of people going blind drinking moonshine is do the methanol.

rtkwe• 6 years ago

They provided a series of rules and guidelines for companies not typically registered to produce it to be able to legally produce it yeah. There's some hiccup in these companies' ethanol source because if they were following the rules they'd be using existing food grade sources for their ethanol which wouldn't have methanol.

https://www.fda.gov/media/136289/download

cbg0• 6 years ago

Edit: apparently methanol is also absorbed through the skin through extensive exposure, so it's safer to stay away from it.

762236• 6 years ago

Your dangerous comment should be downvoted into oblivion. The whole point is that methanol is dangerous to handle.

aaronchall2• 6 years ago

There is methanol in all alcohol we drink. This study[1] proposes that up to 2% methanol would be fine in usual cases but .4% (the EU's limit) gives a greater margin of safety.

It is conceivable that this is a costly overreaction by the FDA - you'd have to use far more hand sanitizer to absorb enough methanol to hurt you. To what degree will loss of hand sanitizer further the spread of Covid19?

Reading the FDA press releases a little deeper, we find, of course, we are mostly concerned about the safety of those who might drink hand sanitizer.

Of course. Of course we should be concerned about this risk. Of course.

But at what cost?

[1] https://pubmed.ncbi.nlm.nih.gov/11926610/

surbas3• 6 years ago

This is not true. You will absorb the methanol into your skin.

refurb2• 6 years ago

Sure, but it would require prolonged contact over a high body surface area to reach toxic levels.

https://watermark.silverchair.com/29-7-734.pdf

0.192 mg/cm2/min. Toxicity starts at ~7mL for an adult male. 7ml = 5.6g.

So if you dunked an adult male with a body surface area of 1.7m2 (17,000 cm2) into a vat of methanol, it would take ~2 min to absorb a toxic dose.

Or you could soak your hands (~2% of body surface area) in 100% methanol for 100 min.

This ignores that fact that concomitant ethanol exposure protects against methanol toxicity.

bcl• 6 years ago

"Methanol, or wood alcohol, is a substance that can be toxic when absorbed through the skin or ingested and can be life-threatening when ingested."

https://www.fda.gov/drugs/drug-safety-and-availability/fda-u...

aarongough• 6 years ago

Methanol exposure through the skin can also cause a lot of issues: https://www.cdc.gov/niosh/ershdb/emergencyresponsecard_29750...

vikramkr3• 6 years ago

The EU banned the use of methanol in windshield washer fluid[1], and the sooner the US does the same, the better. Methanol is very toxic. You don't spread windshield washer fluid all over your hands and breathe in the vapors for a reason. That reason is that you will go blind and/or die if you do.

[1] https://ec.europa.eu/growth/content/new-restriction-methanol...

marcrosoft2• 6 years ago

Keep in mind this list contains subpotent products which are not dangerous to use and should not be discarded or recalled, just mentioned that you didn’t get the protection you were looking for.

surbas3• 6 years ago

This is a list of products that you should NOT use. They all have been recalled by the FDA.

marcrosoft2• 6 years ago

Read the categories of products on the list!

tomxor2• 6 years ago

They are not "toxic", but they are certainly dangerous.

In the same way oven-gloves that do not insulate are dangerous, and sun lotion that has no UV protection is dangerous... i.e they are misleading, indirectly causing people harm.

tomxor2• 6 years ago

Can anyone backup the downvotes?

Comment is opposite of parent which is also downvoted, so which is it?

Wowfunhappy2• 6 years ago

My biggest concern when I read this—perhaps unnecessarily—is how do I know if the sanitizer dispenser at $random_grocery_store is safe? A lot of stores require that you use those upon entry (for perfectly well-intentioned reasons).

aaronchall2• 6 years ago

2 grams is a safe daily dose of methanol, according to this paper[1]. 2 cubic centimeters of water weighs about 2 grams.

These sanitizers are supposed to be mostly ethyl or isopropyl alcohol, around 70%.

So, supposing conservatively, if all of the alcohol is methanol instead, and you absorb all of it, about 3 cc's should be your maximum daily limit from such a dispenser.

Of course, most of the alcohol will be lost to evaporation instead of absorbed, thus I think a few small squirts here and there shouldn't hurt you - as long as you aren't drinking it.

[1] https://pubmed.ncbi.nlm.nih.gov/11926610/

Retric• 6 years ago

This is likely correct, the FDA is reasonably concerned for at the extreme end.

“Although all persons using these products on their hands are at risk for methanol poisoning, young children who accidently ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk.”

I would be more concerned if your using hand sanitizer 10+ times a day, but a single use from a random store is almost certainly harmless.

tyingq3• 6 years ago

Every one I've seen has the ingredients listed. Just avoid methanol. Ethanol is the same alcohol you drink, so I would guess that's relatively safe.

I also imagine a store employee wouldn't balk at you using your own sanitizer instead. Or even notice if you pretended to use it.

Edit: I missed the idea that these products have unintentional, and undocumented, methanol in them. Note that some hand sanitizers intentionally have methanol in them, and it's listed. Those, at least, are easy to avoid.

polalavik• 6 years ago

Early warnings from the FDA said “in most cases methanol did not appear on the product label”[1] or I remember reading something about methanol being mislabeled as ethyl alcohol

[1] https://www.fda.gov/news-events/press-announcements/coronavi...

loeg3• 6 years ago

Methanol is usually an accidental byproduct of ethanol production. If the ethanol is untested, the end product might be labelled "ethanol" and contain methanol.

triceratops• 6 years ago

I bought one of these at Target. It didn't have methanol listed as an ingredient. Didn't use much of it fortunately.

jennyyang3• 6 years ago

The boiling point for ethanol and methanol are close and methanol boils at a lower temperature, so if you distill your alcohol incorrectly, your end product could have both ethanol and methanol. Unless you test for it, you won't know that you have both which is why illegally made alcohol would cause blindness, hence the turn "drinking yourself blind".

loeg3• 6 years ago

The FDA primarily cares about methanol in hand-sanitizer because alcoholics (and teenagers) sometimes drink hand sanitizer. In a public grocery store, you're probably not drinking the stuff.

aaomidi2• 6 years ago

It can be absorbed through the skin.

gruez• 6 years ago

A lot of stores require that you use those upon entry

Is this actually a thing? None of the stores I’ve been to require you to use it.

Wowfunhappy2• 6 years ago

Yes. Just yesterday, I was in the glasses store to get my frames adjusted, and I missed the sign that asked you to sanitize your hands upon entering. The woman at the counter asked me to please go back and use the sanitizer dispenser.

ShakataGaNai• 6 years ago

Last time I went to Trade Joes (a few weeks ago), there was a guy standing out front squiring hand sanitizer into your hands before you could even get in the door.

supernova87a2• 6 years ago

I just ran into that recently at my local $ethnicity grocery store. The bottle at the entrance looked like a bulk bottle of Purell/etc brand (though unlabeled), but then I squirted it out and it was a thick, slimy liquid that smelled of lavender. Instantly grossed out and mistrusting the grocery store's hygiene after that.

edit: I find it amusing that people are downvoting me for saying "ethnicity". As if I'm privileged and looking down on some ethnicity.

I'm of that ethnicity, you dolts. I thought I made that clear with the $ sign, following on the OP's use of it. But I guess that was too subtle.

diN0bot• 6 years ago

why point out "ethnicity" at all? all it shows is that you personally were predisposed to be less trusting of something different. and that probably you're white and don't view whiteness as an ethnicity.

your readers may not be the same race as you. maybe to them "different less-trustworthy ethnicity" is white.

or maybe you only wanted to talk to other white people so you could reconfirm to yourselves that "ethnic" cultures are "backwards" and "exotic" and "less trustworthy."

celticninja2• 6 years ago

Pointing out the ethnicity make it appear as if you think that is the root cause of the problem.

renewiltord• 6 years ago

Interestingly, this is a language phenomenon where applying a restrictive adjective in front of a noun is generally perceived as ascribing importance to it. That's just how English is read by most people. I suspect that it applies even if you use a variable to denote absence of importance.

Just trying it out for myself: "My $k-wheeled car in San Francisco is much better than public transit", I automatically read that the number of wheels as having some importance and also assume that the number of wheels is not 4.

Of course, this may seem unusual in that k is a free variable and I may be implying that it doesn't matter what its value is, but it doesn't read that way.

I think this comes from a natural form of information compression. Very cool.

Another fun example of implicit information is: "They met on the streets of San Francisco. She was homeless and he was homeless and dirty." Does this imply that she wasn't dirty? Yes. But that's actually unknown.

ardy42• 6 years ago

My biggest concern when I read this—perhaps unnecessarily—is how do I know if the sanitizer dispenser at $random_grocery_store is safe? A lot of stores require that you use those upon entry (for perfectly well-intentioned reasons).

I haven't personally encountered a store where hand-sanitizer use is required, but I usually wear a pair of nitrile gloves anyway, so I guess this is another reason to continue to do that.

timbit42• 6 years ago

Any place I've gone to that required it has let me use my own I carry with me when I'm out.

lazyeye• 6 years ago

There is a business opportunity here for someone to sell test strips that indicate the presence of methanol plus maybe some rough color indication (70+% ?) for ethanol.

Edit: This already exists for home distillers etc.

aaron695• 6 years ago

I remember drinking fridge cleaner with friends in college.

Had the producers lied about their product we'd have been badly hurt.

Had they changed the contents and we didn't carefully re-check every thing we'd be badly hurt.

This is what we are fighting here.

It's not about getting it on your hands.

Camillo2• 6 years ago

drinking fridge cleaner
in college

I don't know if I should be inspired or horrified.

throwaway_pdp09• 6 years ago

This seems curious. Methanol is toxic bit it's not novichok https://en.wikipedia.org/wiki/Methanol_toxicity

"Methanol has a high toxicity in humans. As little as 10 mL of pure methanol when drunk is metabolized into formic acid, which can cause permanent blindness by destruction of the optic nerve. 15 mL is potentially fatal,[1] although the median lethal dose is typically 100 mL (3.4 fl oz) (i.e. 1–2 mL/kg body weight of pure methanol[8]). Reference dose for methanol is 0.5 mg/kg/day.[9]"

I've been using methylated spirits (~10% methanol IIRC, rest ethanol) as a hand sanitiser (on my hands, not as a flipping mouthwash) for months with no problems and I'm going to dig around and check its skin permeability tomorrow, but I wonder if the FDA is doing a bit of major just-in-case butt-covering here.

Edit: some links

https://chemistry.stackexchange.com/questions/24036/methanol...

Quite long.

https://link.springer.com/article/10.1007/BF00378331

"Methanol absorption rate through the human skin has been examined by the use of a modified direct method, and a value of 0.192 mg/cm2/min was determined."

FDA urges consumers not use certain hand sanitizer products

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