ACI’s Antiseptic Testing Continues Under Specter Of FDA Administrative Order

The American Cleaning Institute is preparing to submit a healthcare personnel hand wash study to the US FDA pending confidentiality discussions, along with results from a literature review on the topic of antimicrobial resistance. A progress report is due to the agency in October, which could stave off an administrative order under the reformed OTC drug review system.

Building icon with inscription FDA and flag of The United States over abstract background. - Illustration

While OTC drug review has changed in the US, there continues to be a spirit of collaboration between the US Food and Drug Administration and antiseptic industry stakeholders as testing advances to fill ingredient safety and efficacy data gaps identified under the former OTC monograph system.

According to James Kim, vice president of sciences and regulatory affairs at the American Cleaning Institute, ACI and its members recently completed a healthcare personnel hand wash study in support...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on HBW Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Regulation

EU’s Small, Medium Beauty Industry Pushing For Clarity In Revised CPR

French SME association COSMED will push the European Commission for a “clear checklist” and criteria on how substances in the Cosmetic Products Regulation are assessed by Member States, as well as more clarity on the exemption process and timelines.

US FDA Expert Panel Paints Bleak Picture For Future Of Talc In Cosmetics

 

The US FDA’s 20 May expert panel on talc discussed science behind the potential carcinogenicity of the cosmetic, food and drug ingredient, the importance of ‘good science’ in evaluating the substance and the need to find alternatives in each industry.

US FDA Finds Banned Cosmetic Ingredient Methylene Chloride In Gel Polish Removers

 
• By 

Testing conducted by the US Food and Drug Administration has found several cosmetic products on the market that contain high levels of methylene chloride, a banned ingredient.

Plenty For Industry To Do As EU Wastewater Directive Faces Legal Challenges

 
• By 

Engaging with EU member state legislators, stressing the impact of national EPR systems on the accessibility, availability, and affordability of medicines, reformulating products to reduce their financial contribution, and lobbying for expanding the scope of EPR schemes to include other polluting industries are all ways that the European consumer health industry can try and influence the way that the revised Urban Wastewater Treatment Directive is transposed into national legislation, law firm Mason Hayes & Curran explains.

More from Policy & Regulation

Beauty Industry Not Taking Advantage Of CBP’s Duty Drawback – IBA Conference

 

US Customs and Border Protection’s program allowing companies to recoup fees for imported goods that were destroyed or exported is applicable in the case of most of President Trump’s reciprocal tariffs. However, most cosmetic companies don’t make use of it.

Beauty Firms Confused By State EPR Laws Have New Resource: EPR Academy

 

Beauty and personal care companies are struggling with compliance with state Extended Producer Responsibility laws, given the outstanding number of stakeholders that have still not registered products with Oregon’s EPR law, the first to go into effect.

Supreme Court 1935 Ruling Limiting Executive Authority On Appointments ‘Unravels’ Today – DoJ

 

In complaint and response to motion to dismiss, Rebecca Kelly Slaughter’s and Alvaro Bedoya’s attorneys elaborate on Supreme Court ‘s 1935 decision, Humphrey’s Executor v. US. Administration attorneys, though, contend the ruling isn’t relevant to the current FTC.