US Still Rinsing Out OTC Sanitizer Warnings

Of GMP warnings for OTC hand sanitizers, 114 have been submitted by FDA since pandemic began, with first sent in late April 2020, and another 12 for false COVID-19 claims, with first sent on 1 April. One GMP warning for hand sanitizer product is listed in both 2018 and 2019.

• Source: Shutterstock

Production of alcohol-based OTC hand sanitizers remains a US regulatory gift that keeps on giving a year after the deadline to distribute any made under relaxed guidance the Food and Drug Administration allowed for two years.

More from Regulation

Melatonin And Buccal Acyclovir On German Switch Committee Agenda

 
• By 

An application for melatonin as an OTC medicine is on the agenda for the next German switch committee meeting, despite the hormone being widely available in food supplements. Acyclovir as a buccal tablet and second-generation antihistamine rupatadine are also up for discussion.

Over The Counter: Brands, Brexit And New Self-Care Business Models, With PAGB’s Michelle Riddalls

 
• By 

HBW Insight catches up with UK OTC industry association CEO Michelle Riddalls to talk about digital self-care and the unrealized promise of Brexit - part 2.

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.

US FDA Allows Telework For Reviewers As Companies Detail Layoff-Related Problems

 

The new telework policy returns to the pre-COVID-19 pandemic standard, but still requires reviewers to be at White Oak for sponsor meetings and divisions to have an in-office presence every day.

More from Policy & Regulation

Over The Counter: Brands, Brexit And New Self-Care Business Models, With PAGB’s Michelle Riddalls

 
• By 

HBW Insight catches up with UK OTC industry association CEO Michelle Riddalls to talk about digital self-care and the unrealized promise of Brexit - part 2.

US FDA User Fee Collection Safe In Preliminary Trump 2026 Budget Plan

 
• By 

The preliminary White House 2026 budget plan cuts agency funding, but not so sharply that user fees are excluded from collection.

Congress, Researchers Highlight Security Risks At DNA Testing Services

 
• By 

Congress launched an inquiry into 23andMe amid privacy concerns following its bankruptcy, particularly regarding the potential sale of sensitive user data. Additionally, a Cybernews report gave 40 DNA testing firms an average cybersecurity grade of D, citing widespread vulnerabilities and data breaches, along with inadequate public information about their security practices.