FDA bans 19 different antibiotics in consumer products, 3 more under review

[Vekseid]

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm517478.htm

The US government has been surprisingly on point these past few weeks. I wonder if I woke up in bizarroland >_>

The U.S. Food and Drug Administration today issued a final rule establishing that over-the-counter (OTC) consumer antiseptic wash products containing certain active ingredients can no longer be marketed. Companies will no longer be able to market antibacterial washes with these ingredients because manufacturers did not demonstrate that the ingredients are both safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections. Some manufacturers have already started removing these ingredients from their products.

This final rule applies to consumer antiseptic wash products containing one or more of 19 specific active ingredients, including the most commonly used ingredients – triclosan and triclocarban. These products are intended for use with water, and are rinsed off after use.  This rule does not affect consumer hand “sanitizers” or wipes, or antibacterial products used in health care settings.

“Consumers may think antibacterial washes are more effective at preventing the spread of germs, but we have no scientific evidence that they are any better than plain soap and water,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER). “In fact, some data suggests that antibacterial ingredients may do more harm than good over the long-term.”

The agency issued a proposed rule in 2013 after some data suggested that long-term exposure to certain active ingredients used in antibacterial products — for example, triclosan (liquid soaps) and triclocarban (bar soaps) — could pose health risks, such as bacterial resistance or hormonal effects. Under the proposed rule, manufacturers were required to provide the agency with additional data on the safety and effectiveness of certain ingredients used in over-the-counter consumer antibacterial washes if they wanted to continue marketing antibacterial products containing those ingredients. This included data from clinical studies demonstrating that these products were superior to non-antibacterial washes in preventing human illness or reducing infection.

Antibacterial hand and body wash manufacturers did not provide the necessary data to establish safety and effectiveness for the 19 active ingredients addressed in this final rulemaking. For these ingredients, either no additional data were submitted or the data and information that were submitted were not sufficient for the agency to find that these ingredients are Generally Recognized as Safe and Effective (GRAS/GRAE). In response to comments submitted by industry, the FDA has deferred rulemaking for one year on three additional ingredients used in consumer wash products – benzalkonium chloride, benzethonium chloride and chloroxylenol (PCMX) – to allow for the development and submission of new safety and effectiveness data for these ingredients. Consumer antibacterial washes containing these specific ingredients may be marketed during this time while data are being collected.

Washing with plain soap and running water remains one of the most important steps consumers can take to avoid getting sick and to prevent spreading germs to others. If soap and water are not available and a consumer uses hand sanitizer instead, the U.S. Centers for Disease Control and Prevention (CDC) recommends that it be an alcohol-based hand sanitizer that contains at least 60 percent alcohol.

Since the FDA’s proposed rulemaking in 2013, manufacturers already started phasing out the use of certain active ingredients in antibacterial washes, including triclosan and triclocarban. Manufacturers will have one year to comply with the rulemaking by removing products from the market or reformulating (removing antibacterial active ingredients) these products.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by helping to ensure the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for helping to ensure the safety and security of our nation’s food supply, cosmetics, dietary supplements, and products that give off electronic radiation, and for regulating tobacco products.

[Lustful Bride]

It like actually competent people are running our government for a change! 0_0

I think I will stay with you in bizzaroland ^_^

[Missy]

Is there a bus a boat or a spaceship I have to hop on to get to this bizarroland?

[AmberStarfire]

There was a particular type of soap I used to get from the states that has Triclosan in it, because it keeps acne at bay better than just about anything else. If they're phasing it out then it sounds like time to stock up while I still can.

[Oniya]

Okay - for a while, I worked as a sub-contractor for the EPA, specifically in the field of germicides.  It's been long enough that I'm pretty sure the NDAs have expired. 

There are certain very specific standards that have to be met when they say that a product is both safe and effective.  'Disinfectants' have to kill a certain percentage of the target microorganism.  'Sanitizers' have to kill a certain percentage of the target microorganism.  'Sterilants' have to kill a certain percentage of the target microorganism.  'Hospital grade', 'virucide', and 'fungicide' all have their correlating tests.  Otherwise, the label isn't approved and they have to go back to reformulate.  When a product has information on it about toxicity (including oral toxicity, skin contact toxicity, skin sensitization - which is a different thing, eye irritation, and corrosiveness), that's also based on specific standards.  My group didn't cover 'long term exposure' - sensitization was measured as an increase in reactions with exposures at different times measured in days or weeks.

Using germicides improperly helps create superbugs, by the simple process of natural selection.  This includes the contact time and the concentration of the product.  If Product X says that you need to leave it on the surface for 5 minutes to kill Staphylococcus aureus, and you spray down the surface and it's dry a minute later, then the S. aureus bacteria that survived are already predisposed to survive longer against Product X.  They will multiply, and form a greater portion of the population because the weaker ones have been killed off.  If it says 'contact time 5 minutes', then you need to reapply the product to make sure it stays wet for five minutes.

In addition, the article speaks about things like hormonal effects.  The Mayo Clinic has an article up that indicates

Research has shown that triclosan:

    Alters hormone regulation in animals
    Might contribute to the development of antibiotic-resistant germs
    Might be harmful to the immune system

When you use a product containing triclosan, you can absorb a small amount through your skin or mouth. A 2008 study, which was designed to assess exposure to triclosan in a representative sample of U.S. children and adults, found triclosan in the urine of nearly 75 percent of those tested.

A recent (2014) study published by the National Academy of Sciences (http://www.pnas.org/content/111/48/17200.short ) indicates that long-term exposure to triclosan can increase the likelihood of liver tumors.  (The 'correction' noted on the article was a mistyped grant number.)

Believe it or not, the government doesn't discontinue or ban products just to inconvenience people.  If you are using these products for a medical reason, you should talk with a professional about alternatives.

[Beguile's Mistress]

Long term side effects can only be determined by long term use of a product.  Once a product is approved by the FDA testing continues to determine if test subjects being administered the product are experiencing adverse side effects.  In addition, new users are, or should be, monitored by their physicians and any changes in physical aspects collated and reported to the manufacturer.

For example:  Physical side effects such as dry mouth, dry eyes or skin irritation that occurs following taking a newly prescribed medication or using an over the counter product for the first time should be reported.  A physician will monitor these side effects, sometimes discontinue use and reintroduce the medication to determine it is the cause.  A consumer should stop using an over the counter product if harmful side effects occur and report them to the manufacturer. 

This is the source of the information on the warning labels that accompany all products.  It is mandatory that a manufacturer report all conditions associated with a product even if they only fall under the "may cause..." heading.

It doesn't matter how effective a product is, if it causes harmful side effects in even one subject after long term use it becomes suspect.

[AmberStarfire]

Okay. Oniya, that makes sense about what you're saying about natural selection. I guess that's why antibiotic over-usage is such a problem. Triclosan used to be in so many things. They even put it in toothpaste.

[Oniya]

Okay. Oniya, that makes sense about what you're saying about natural selection. I guess that's why antibiotic over-usage is such a problem. Triclosan used to be in so many things. They even put it in toothpaste.

Both overprescription and under-usage.  There are people here that will take their antibiotics 'until they feel better' and then save the rest of the pills for when/if they get sick again under the assumption that they are 'better' and this will save money.  This falls under the same problem as not leaving a surface disinfectant 'wet' for long enough.  Prescribing antibiotics for things that they don't work on, like the common cold, which is a rhinovirus, damages the good bacteria (Ladies, you all know about some of the consequences, even when antibiotics are used properly) and clears the way for the 'bad' bacteria that are already antibiotic resistant, including one that is known for causing fatal diarrhea in small children.

Treating antibiotic resistant infections can get really expensive, since you have to use even stronger drugs, some of which haven't been released in generic form yet.  Plus, you have to find the one that works - which can take time and lead to more complications.

[RedRose]

I wonder if that will have any effect in my country. France is antibiotic-land. Seriously. Kids (and many adults) are on them at least a couple times a year if not 5+ times/winter. You still have docs prescribing them "just in case".