FDA has a few questions for makers of hand sanitizer

[nageov3t]

I'll be interested to see how this shakes out.

I work for a hospital, so purell dispensers are everywhere, even in the non-clinical areas of the building (ie: I work on the IT floor; I've never actually seen a hospital patient IRL inside the building except the one time that I myself as a patient as well)

I've gotten into the habit of using it every time I leave the bathroom after washing my hands, and/or before sitting down at my desk, just because everyone else does.

 

[Brainonska511]

He's the one that said you shouldnt try to fix a broken system. He neglected to mention there is no system in place for supplements.

There used to be greater regulation until he stepped up to the plate with the DSHEA.

https://www.sciencebasedmedicine.org/supplements-lies-and-a-lengthy-transcript/

For their part, Dr. Kessler and other FDA officials present at the hearing tried to warn the committee about the dangers of supplements and the lack of evidence of their efficacy. Their points:

• Many products sold as dietary supplements – amino acids, herbs and botanicals, and other non-vitamin and non-mineral products, have no established role in nutrition, have been associated with serious adverse reactions, and frequently bear unsubstantiated claims to prevent or treat disease.
• If no scientific standard is imposed, the market will be filled with unsubstantiated claims, putting the public’s health at risk, including diverting people from proven medical treatments.
• The lack of reported adverse events doesn’t mean they don’t happen, because there is no system for reporting them.
• Although some botanicals are derived from well-known culinary herbs, most are not and have no known nutritional value or history of use as foods. Dietary supplements containing herbs and botanicals are not standardized, making testing them for efficacy or safety problematic. The FDA’s testimony specifically discussed the risks of germander, comfrey, chapparal, yohimbe, lobelia, Jin Bu Huan, Stephania/Magnolia, Ma Huang (ephedra), and willow bark.

And, finally, in Dr. Kessler’s own words,

The proposed legislation would permit companies to make the initial judgment. A claim could be made as long as it accurately described the state of the scientific evidence, which under the bill as written could include a complete lack of evidence. Thus, a claim could be based on mere belief or on one small preliminary study that in no way established the nutrient-disease relationship, as long as the label statements accurately portray the state of the evidence.​

And wouldn't you know it, the market is filled with tons of confusing and unsubstantiated claims with respect to supplements and pseudo-medicines.

 

[buckshot24]

Do you really lack the cognitive capacity to understand why what he said is a problem?

I don't think my cognitive capacity is the issue. It isn't as if there is constant exposure to these hand sanitizers. The "bugs" who survive will become the minority once reintroduced to a normal population.

 

[Brainonska511]

I don't think my cognitive capacity is the issue. It isn't as if there is constant exposure to these hand sanitizers. The "bugs" who survive will become the minority once reintroduced to a normal population.

Not necessarily. That would only be the case if whatever resistance mechanism they had used to survive was detrimental to their fitness in a non-antiseptic environment.

 

[buckshot24]

Not necessarily. That would only be the case if whatever resistance mechanism they had used to survive was detrimental to their fitness in a non-antiseptic environment.

Those bacteria wouldn't have been .01% of the population if this was the case.

 

[piasabird]

I remember a study that was done on this a while back in Korea. They tested getting hands dirty and then washing them. They concluded for the most part that washing your hands for 20 seconds in luke warm tap water works just as well as any anti-bacterial soap or hand sanitizer.

 

[buckshot24]

I remember a study that was done on this a while back in Korea. They tested getting hands dirty and then washing them. They concluded for the most part that washing your hands for 20 seconds in luke warm tap water works just as well as any anti-bacterial soap or hand sanitizer.

With regular soap or just water?

 

[Brainonska511]

Those bacteria wouldn't have been .01% of the population if this was the case.

That's not necessarily true either. Without an evolutionary influence, the trait will simply be at some equilibrium in the population, until an evolutionary pressure is exerted on it. It says nothing as to whether carrying the gene is detrimental or not under normal circumstances. Not all resistance mechanism are the same or have the same effect on normal cellular metabolism and survival under ambient conditions.

Hell, it's even been shown that you can have resistance in genetically identical cells, simply due to heterogeneous gene expression profiles of some intrinsic resistance traits.

Edit: granted, this is applies for antiseptic compounds, like triclosan. Things like bleach, ethanol, and isopropanol are not going to lead to resistance.

 

[nickqt]

its funny the FDA worries itself about hand sanitizers when they are neither food nor drugs, but they completely ignore all nutritional supplements.

If you're using alcohol to kill bacteria, it is most definitely a drug in the classical sense.

Ethanol does not exert its effects on microorganisms the same way that antibiotics do. Ethanol fundamentally messes up the lipid membrane and proteins, essentially it is an antiseptic chemical for most living cellular life (and viruses) on Earth. Developing resistance to ethanol isn't the same as developing resistance to an antibiotic, cells would have to fundamentally alter their cellular membranes and proteins to develop resistance. This would mean the barrier to resistance to ethanol is quite high, and there has not been a report of an acquired resistance to ethanol to date. Certainly there are cellular structures (like spores) that are resistant to ethanol, but this is not really an option for growing and dividing organisms.

For anyone interested in the activity, resistance, safety of various products used in hand sanitation, see:

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC523567/

Kampf G, Kramer A.Epidemiologic background of hand hygiene and evaluation of the most important agents for scrubs and rubs.Clin Microbiol Rev. 2004 Oct;17(4):863-93.

Yes, this.

Antibiotics inherently lead to resistance as bacteria with genes that provide for resistance to those antibiotics become the majority member of their specific habitat.

Alcohol, on the other hand, doesn't inherently lead to resistance as it functions to kill all cells, not just specific cells such as bacteria.

As a recommendation, use soap and water if you have access to soap and water, and especially if you have actual "stuff" on your hands.

If you don't have "stuff" on your hands, hand sanitizer, aka 70% alcohol, is fine.

To use sanitizer correctly, use enough to cover the surfaces of both hands while continuously rubbing all of the surfaces of your hands together until it dries.

Make sure you hit your fingers and fingertips, as that is what we use the most when touching things.

 

[shortylickens]

What's even more disgusting is the push for making people like 'naturopaths' licensed and attempting to give them legitimacy in the practice of their pseudoscience.
https://www.sciencebasedmedicine.or...and-the-licensing-of-naturopaths-in-michigan/
https://www.sciencebasedmedicine.or...-gives-naturopaths-a-broad-scope-of-practice/




This doesn't surprise me. Antiseptics, even if chemically distinct from antibiotics, can give rise to antibiotic resistance, as general resistance genes become favored by the local bacterial populations.

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I think this is pretty relevant with respect to those hand sanitizers:

 

[Eli]

It's pretty well established that the alcohols kill.. just about everything, at high concentrations. How effective it is likely depends far more on how the user implements its use. Probably takes ~60 of continuous saturation to really kill everything...

I think there should be concern about the other chemicals though. I keep a gallon of 99.5% isopropyl alcohol at the shop and I use that to sanitize everything. It's cheaper than hand sanitizers, without all the unnecessary fragrance and such.

I think those Clorox and the like sanitary wipes are a far bigger problem. People DO NOT understand that you're not supposed to touch them......