Without evidence of benefit, an intervention should not be presumed to be beneficial or safe.

- Rogue Medic

FDA bans useless, possibly dangerous, antibacterial soap ingredients

antiseptic soaps safe - qm - WSJ and FDA logo
 

As of September 6, 2017, The FDA (Food and Drug Administration) will ban manufacturers from selling antiseptic soaps over the counter to consumers because the manufacturers could not provide evidence that they work and that they are safe. The list of ingredients is in the footnotes.[1],[2]

In 2013, the FDA gave manufacturers a deadline to provide information about the products they sell to consumers. After decades of use, the manufacturers finally needed to provide evidence that the ingredients in their products are GRAS/GRAE. What does GRAS/GRAE mean?

GRAS = Generally Recognized As Safe
GRAE = Generally Recognized As Effective
GRAS/GRAE = Generally Recognized As Safe and Effective

As a consumer, do we want to spend our money on something that is not safe, is not effective, or is both unsafe and is ineffective?

Does the absence of evidence prove that the ingredients are unsafe or that they are ineffective? No.

The failure to provide evidence shows one of the following –

A. The manufacturers cannot show that the ingredients are safe.
B. The manufacturers cannot show that the ingredients are effective.
C. The manufacturers cannot show that the ingredients are safe and effective.

Those three are the most obvious possibilities, but there are several more possibilities. For example –

D. The manufacturers don’t care enough to find out if the ingredients are safe or effective.

Is it a business decision that the amount of money to be made in this multi-billion dollar market is not worth the amount of money that would be lost, but would any money be lost? Is the failure to provide evidence essentially an admission that the antibacterial soaps are just a marketing gimmick? Have the manufacturers avoided providing evidence? No.

Is there an absence of information? No. There is plenty of evidence, but the evidence does not show benefit or safety.
 

Both sides in the debate have submitted reams of evidence to the FDA supporting their stance, offering up conflicting studies that make it a challenge for the average consumer to make informed decisions.[3]

 

The more conspiratorial would add some other possibilities –

E. The manufacturers can show that the ingredients are not safe.
F. The manufacturers can show that the ingredients are not effective.
G. The manufacturers can show that the ingredients are not safe and not effective.

These are not impossible, but should we assume that manufacturers are intentionally and maliciously marketing dangerous and useless products? Hanlon’s razor addresses this –

Never attribute to malice that which is adequately explained by stupidity.

Stupidity does not appear to be the right word for this situation. There is another version of Hanlon’s razor that seems to be written just for the those who think that a lack of evidence of harm is the same as safety and efficacy.

Don’t assume bad intentions over neglect and misunderstanding.
 

How different is this from medical treatments that have no evidence of efficacy or safety? We stopped using backboards to stabilize the spine, atropine for cardiac arrest, furosemide for CHF, . . . , and we may no longer be able to justify using amiodarone.

Footnotes:

[1] FDA issues final rule on safety and effectiveness of antibacterial soaps – Rule removes triclosan and triclocarban from over-the-counter antibacterial hand and body washes
FDA (Food and Drug Administration)
For Immediate Release
September 2, 2016
FDA News Release

[2] Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use
A Rule by the Food and Drug Administration on 09/06/2016
Final rule.

What ingredients are banned?

Thus, the following active ingredients are not GRAS/GRAE for use as a consumer antiseptic wash:
    *Cloflucarban
    *Fluorosalan
    *Hexachlorophene
    *Hexylresorcinol
    *Iodophors (Iodine-containing ingredients)
○ Iodine complex (ammonium ether sulfate and polyoxyethylene sorbitan monolaurate)
○ Iodine complex (phosphate ester of alkylaryloxy polyethylene glycol)
○ Nonylphenoxypoly (ethyleneoxy) ethanoliodine
○ Poloxamer—iodine complex
○ Povidone-iodine 5 to 10 percent
○ Undecoylium chloride iodine complex
    *Methylbenzethonium chloride
    *Phenol (greater than 1.5 percent)
    *Phenol (less than 1.5 percent)
    *Secondary amyltricresols
    *Sodium oxychlorosene
    *Tribromsalan
    *Triclocarban
    *Triclosan
    *Triple dye
Accordingly, OTC consumer antiseptic wash drug products containing these active ingredients are misbranded, and are new drugs for which approved new drug applications are required for marketing.

IV. Ingredients Not Generally Recognized as Safe and Effective

[3] Are Antibacterial Soaps Safe? Companies say there’s no cause for alarm, but studies suggest they may be dangerous. Now the FDA is preparing to rule.
Wall Street Journal
By Laura Landro
Updated Feb. 15, 2016 11:01 p.m. ET
Article

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