Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

FDA Should Ban Triclosan, House Democrats Urge

This article was originally published in The Tan Sheet

More Democratic House members are calling for a ban on triclosan use in personal-care products with a letter to FDA Commissioner Margaret Hamburg.

Claiming that the antimicrobial ingredient is "clearly a threat to [public] health," Reps. Louise Slaughter of New York, Betty McCollum of Minnesota and Raul Grijalva of Arizona issued their plea Nov. 16 in anticipation of FDA's review of triclosan due to Congress in April 2011.

"We urge FDA to consider the full weight of scientific evidence leading to this simple conclusion: Triclosan should be banned in consumer and personal-care products," they say.

The representatives assert triclosan poses human health risks because it may interfere with the body's hormonal and developmental processes and "can also influence the development of cancer."

Triclosan is marketed for antigingivitis/antiplaque benefits under a 1997 new drug application.

In March 2010, FDA asked for comment on adding the ingredient to the proposed monograph for oral health care products for antigingivitis/antiplaque and the acne products monograph (Also see "Environmental Group Opposes FDA Adding Triclosan To OTC Monographs" - Pink Sheet, 1 Mar, 2010.).

Following FDA's proposal to add triclosan to those monographs, Massachusetts Rep. Ed Markey wrote to 13 firms asking them voluntarily to stop the use of triclosan in soaps and toothpastes ("Markey Takes Triclosan Issue To Firms," "The Tan Sheet" April 19, 2010).

FDA recognized the ingredient's endocrine-disrupting potential in a February letter to Markey, who wrote the agency earlier in 2010 to request that triclosan be reevaluated.

In its response to Markey, FDA acknowledged that "existing data raise valid concerns about the effects of repetitive daily human exposure to these antiseptic ingredients" (Also see "Rep. Calls For Triclosan Ban, Approval Redo, Following FDA, EPA Response" - Pink Sheet, 12 Apr, 2010.).

Slaughter and her colleagues also maintain that "routine usage of medically important antimicrobials in over-the-counter consumer products" – including hand sanitizers, shaving gels, dishwashing liquids "and even socks, workout clothes and toys" – is a "significant contributor" to antibiotic resistance.

The scientific community supports that finding, they say.

Triclosan An Eco-Hazard, Legislators Say

The lawmakers also say triclosan presents possible hazards to the environment. They note that in a 2000 study by the U.S. Geological Survey, the substance was detected in 57% of sampled U.S. waterways "thought to be susceptible to agriculture or urban activities."

Investigators from Baylor University, which collaborates on research with the Environmental Protection Agency, also have concerns about triclosan in U.S. rivers. They characterized the antimicrobial as an ingredient that "appears to be more toxic" to aquatic life than others of interest (Also see "Cosmetic Substances Found In River Fish Have EPA Expanding Its Investigation" - HBW Insight, 6 Apr, 2009.).

The lawmakers maintain triclosan "can be highly toxic to different types of algae, thereby damaging specific organisms as well as potential destruction of larger ecosystem balance."

"Routine usage of medically important antimicrobials in over-the-counter consumer products" is a "significant contributor" to antibiotic resistance, the letter says.

Finally, they point to evidence suggesting that triclosan is no more effective than soap and water.

With FDA's review of triclosan not due to Congress until April 2011, the legislators ask to be informed about the status of the second, amended petition Food & Water Watch and Beyond Pesticides submitted in July 2009 asking for a triclosan ban. FDA has not yet responded to the petition.

Furthermore, they encourage FDA to finalize its monograph for topical antimicrobials and soaps.

Rep. Markey also has pressed the agency to finish its work with that monograph, maintaining that its failure to do so "has allowed the use of chemicals in everyday antiseptic agents that may be both ineffective and unsafe to human health and the environment" .

In July, the European Commission's Scientific Committee on Consumer Safety decided that due to gaps in available data, the microbial resistance picture remained unclear and it "[could] only recommend the prudent use of triclosan" (Also see "More Data Needed On Triclosan's Role In Triggering Microbial Resistance" - HBW Insight, 19 Jul, 2010.).

Slaughter and her co-signatories cite a recently released study from the Alliance for the Prudent Use of Antibiotics and Cook County Hospital, which estimates that antibiotic-resistant bacterial infections add between $16.6 billion and $26 billion in annual costs to the U.S. health care system.

By Ryan Nelson

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS104736

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel