Upcoming Webinars Archived Webinars Training Vitals Host A Webinar About Get Updates Contact

FDA Asks For Safety And Effectiveness Of Active Ingredients In Hand Sanitizers

XTALKS VITALS NEWS

Hand Sanitizer

Recent studies have suggested that systemic exposure for some antiseptics – where the ingredient can be detected in the blood or urine – is more common than previously thought.

Share this!

Tweet: 90 percent of consumer hand sanitizers use ethanol or ethyl alcohol to kill bacteria http://ctt.ec/678GF+90 percent of consumer hand sanitizers use ethanol or ethyl alcohol to kill bacteria.

Tweet: Systemic exposure for some antiseptics is more common than previously thought http://ctt.ec/z17YF+Systemic exposure for some antiseptics is more common than previously thought.

July 4, 2016 | by Sarah Massey, M.Sc.

Amid increased use of over-the-counter (OTC) antiseptic hand sanitizers, the US Food and Drug Administration (FDA) is requesting more scientific data from manufacturers on the products’ safety and effectiveness. According to the agency, it does not believe that the products are ineffective or pose a safety risk, but it would like to be made aware of any presently unknown safety and efficacy concerns.

Antiseptic rubs are intended to be used in the absence of soap and water, however millions of Americans use hand sanitizers multiple times a day to control bacteria levels on their hands. The Centers For Disease Control and Prevention (CDC) recommend that consumers use an alcohol-based sanitizer containing a minimum of 60 percent alcohol.

“Today, consumers are using antiseptic rubs more frequently at home, work, school and in other public settings where the risk of infection is relatively low,” said Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. “These products provide a convenient alternative when hand washing with plain soap and water is unavailable, but it’s our responsibility to determine whether these products are safe and effective so that consumers can be confident when using them on themselves and their families multiple times a day. To do that, we must fill the gaps in scientific data on certain active ingredients.”

The FDA’s decision to request additional information on active ingredients in antiseptic rubs, was motivated by the release of new scientific evidence and on the advice of a medical advisory committee. Manufacturers of these products are being asked to provide data on the three most commonly used active ingredients in hand sanitizers: alcohol (ethanol or ethyl alcohol), isopropyl alcohol and benzalkonium chloride.



According to the FDA, 90 percent of all consumer hand sanitizers use ethanol or ethyl alcohol to kill bacteria present on the skin. Of particular interest to the FDA is the absorption data for these active ingredients.

Recent studies have suggested that systemic exposure for some antiseptics – where the ingredient can be detected in the blood or urine – is more common than previously thought. Because of this, the FDA is seeking out information related to the safety of repeated, long-term exposure to these products.

While the FDA has yet to finalize this rule, companies marketing their antiseptic products under the OTC Drug Review will be required to provide the FDA with additional safety data for their hand sanitizers. For now, the agency is not requiring the removal of any antiseptic products from the market.


Keywords: FDA, Drug Safety, Active Ingredient


| NEXT ARTICLE | MORE NEWS | BLOGS | VIDEOS | POLLS & QUIZZES | WEBINARS |

Share this with your colleagues!

MORE NEWS
Lavazza Acquires Controlling Stake in Canada’s Kicking Horse Coffee

May 26, 2017 - Italian coffee company Lavazza, has secured an 80 percent equity stake in Canadian organic and fair-trade coffee company Kicking Horse Coffee, in a deal worth CAD$215 million.

Featured In: Food News


FDA First: Keytruda Approved for Cancer Treatment Based on Biomarker Alone

May 25, 2017 - For the first time, the FDA has approved a cancer treatment for solid tumors based on the presence of a biomarker, as opposed to specifying a tissue of origin.

Featured In: Biotech News


One Year of Medically Assisted Dying in Canada

May 25, 2017 - In June of 2016, the federal government of Canada passed legislation to legalize medically assisted dying.

Featured In: Life Science News


LEAVE A COMMENT
 
  
THE XTALKS VITALS INDUSTRY BLOG

Top 5 Most Impactful Tweets in Life Sciences During the Last Week

REGISTER FOR THESE WEBINARS

EU IVD Regulation: Top Five Changes for Medical Device Manufacturers to Consider


Thermal Processing Systems for the Food Industry: A Guide to Selecting Thermal Equipment and Technology


Rare Disease & Orphan Drug Development: Cost-Efficient Trial Design to Minimize Cash Burn


eTMF Workflows: Active eTMF to Improve the Quality of Clinical Trials


Copyright © 2016-2017 Honeycomb Worldwide Inc.