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Michigan Firm’s Nasal Spray Neither A COVID-19 Treatment Nor For Nasal Use

 
• By Malcolm Spicer

CofixRx and Sensory Cloud are latest OTC nasal spray marketers FDA warned about fraudulent COVID-19 claims. While the others’ violations were limited to violative claims, CofixRx also warned the active ingredient in its spray is limited to topical use.

• Source: Alamy

CofixRx LLC’s claims its nasal spray could prevent and treat COVID-19 caught US regulators’ attention, and its use of an ingredient intended for topical application, not inside the noise, added to the list of violations stated in a warning letter.

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More from Compliance

Over The Counter: Why OTC Firms Should Care About Rx Advertising, With AdverCheck’s James Walmsley

 
• By David Ridley

HBW Insight speaks to AdverCheck managing director James Walmsley about the rise of direct-to-consumer prescription drugs marketing in the UK, and its impact on the consumer healthcare industry.

ASA Files: ACME Vapes Case Shows Marketers Must ‘Know Their Audience’

 
• By David Ridley

A recent ASA case involving an ad for vape products shows that marketers shouldn’t assume that professional online networks like LinkedIn are any different to other social media platforms when it comes to UK advertising codes.

US Proposal To Remove Phenylephrine From OTC Monograph Could Stress-Test Streamlined Process

 
• By Malcolm Spicer

Proposed administrative order likely is first to prompt opposition from OTC industry or other stakeholders potentially delaying or deferring the agency’s expectation for moving its proposal to a deemed final order effective one year after it would be published.

Perrigo’s Formula To Drive Earnings Rebound Swings On Further Formula Business Recovery

 
• By Malcolm Spicer

“The infant formula business is recovering and we've taken actions to simplify and consumerize our business, but there's a lot more work to do,” says CEO Patrick Lockwood-Taylor as Perrigo’s announced latest results.

More from Policy & Regulation

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

 
• By Derrick Gingery

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.

EU Parliament Agrees To Postpone Due Diligence And Sustainability Reporting Rules

 
• By David Ridley

Speaking at a recent AESGP webinar, sustainability expert Onur Durmus called the the European Commission’s “Omnibus” proposals - designed to simplify ESG reporting rules and recently supported by EU Parliament - a “positive development” for the European consumer health industry.

Over The Counter: Evolving The UK Consumer Health Industry, With PAGB’s Michelle Riddalls

 
• By David Ridley

HBW Insight catches up with PAGB CEO Michelle Riddalls to chat about the association's new five year plan. Riddalls also reflects on the successes of the last five years, including relaunching the UK Reclassification Alliance, which has published a list of Rx-to-OTC switches the government would like to see applications for. Part one of two.