Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Saturday, September 3, 2016

FDA Orders Ban On Antibacterial Consumer Soaps


Body wash soap woman
FDA, Antibacterial Consumer Soaps, Antibacterial Soaps, Antibacterial Soaps ban

The "antibacterial" soaps that we usually buy in stores and groceries will no longer be sold. The Food and Drug Administration (FDA) has ruled that "antibacterial" soaps do little or nothing at all to make soap work any better and said the industry has failed to prove that they are safe for consumers.

The latest ruling by the FDA will effectively ban antibacterial soaps and body washes that has certain ingredients from being sold to the public since those questionable ingredients were not proved to be safe and effective for long-term daily use, the FDA said on Friday.

It applies on antibacterial soaps and washes that contain one or more of 19 active ingredients, which includes a chemical known as triclosan and triclocarban which we see in our regular soap. Soap manufacturers will have another year to negotiate over other, less commonly used ingredients such as benzalkonium chloride. However, this rule has no effect on consumer hand sanitizers or antibacterial wipes.

Triclosan used in 93% of liquid products labeled "antibacterial" or "antimicrobial" at least 2,000 different products, according to the FDA.

Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research said,

"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. In fact, some data suggests that antibacterial ingredients may do more harm than good over the long-term."

Soap companies will have one year to either remove the ingredients or no longer market their products before the final rule is effective (PDF).

The American Cleaning Institute released a statement in response in which it indicated that the FDA had data showing the safety and effectiveness of antibacterial soaps. Manufacturers plan to provide additional science and research to fill any data gaps, according to the statement:

"In the coming year, ACI and its member companies will submit additional safety and effectiveness data on the key ingredients in use in consumer antibacterial soaps today: benzalkonium chloride, benzethonium chloride and chloroxylenol. ... Consumers can continue to use antibacterial soaps with confidence as they have for decades in millions of homes, offices, schools, daycare centers and other commercial settings."

In 2007 a research published in the journal Clinical Infectious Diseases found that using antibacterial consumer soaps containing triclosan seemed to offer no additional health benefit over using regular soap and water. And continued use for a long period of time may be linked to the propagation of dangerous drug-resistant bacteria.



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Saturday, February 15, 2014

FDA Raises Safety Concern on Drugs Made in India

FDA, Drugs Made in India, medicine


FDA wants to keep the quality imported drugs from country like India in check, they will establish an Office of Pharmaceutical Quality that will enhance their inspection of brand-name, generic and over-the-counter drugs.

This was announced by FDA’s Center for Drug Evaluation and Research director Janet Woodcock at the Bloomberg Health care summit on Friday.

India is one of the major players in drugs, their drugs export to the US market is one of the largest. Many local pharmaceutical plants in India have been inspected by the FDA to make sure that they are following the guidelines and quality of the drugs they export.

FDA has been calling the attention of manufacturing plants in India regarding good manufacturing practices not being followed that includes Ranbaxy Laboratories and Wockhardt.

Japanese pharmaceutical Daiichi Sankyo took over Ranbaxy Laboratories but the quality and condition has not improved FDA has ban three facilities over the few years, and added another one this year.

One facility of Wockhardt Limited was banned by the FDA from selling their products in the US.

However, drug regulators in India do not see any reason to ban these companies they say that they are following good manufacturing practices. The do not agree with the FDAs reason.