FY2023 OTC monograph user fee target facility fee revenue is $25.4m from manufacturers’ fees of $26,153 and contract manufacturers’ fees of $17,435, all due by 1 June. OMOR fees are $517,381 for Tier 1 requests and $103,476 for Tier 2.

Commissioner Califf underscores need to keep inspections systems ‘tuned up’ to prevent manufacturers from ‘losing their edge’ on quality.

Three of seven businesses warned since February 2022 about noncompliance with FDA drug reporting requirements have been marketers of OTC cough/cold/congestion formulations made with dextromethorphan or guaifenesin.

Change noted without elaboration in update to FDA announcement on Nonprescription Drugs Advisory Committee meeting. CHPA also notes change, saying it’s best for Industry and for consumers.

“There’s no one company, government, person or technology who is positioned to ‘solve’ the health of the world,” notes Haleon's Nick Tate. Which is why OTC companies are partnering with tech firms large and small to create the next generation of consumer healthcare products and services. In the first part of an exclusive interview on the future of digital consumer health, Tate – who heads up the firm’s incubator business, Haleon NEXT – discusses some of the complications of tech innovation that make such collaboration attractive.

Marketers of copies of national brand OTCs are required under FDA regulations to use the same labeling as the brand, a rule that in effect has limited complaints in California state court alleging Prop 65 violations with nonprescription drug labeling to targeting branded product marketers.

In this episode, HBW Insight catches up with IQVIA Consumer Health’s vice president of global consulting services, Amit Shukla, to find out how the global consumer healthcare market is performing as it comes out of the pandemic. It’s good news, Shukla reveals, based on the firm’s latest intelligence. The market grew double digits in 2022 and is predicted to expand by 5-6% per year in the future - even faster if some of the innovative switches currently in the pipeline succeed. Shukla points to artificial intelligence, sustainability and popular wellness ingredients as trends to watch that will drive future market growth.

European consumers can now buy Futura Medical's Eroxon erectile dysfunction gel without a prescription online, and in person via Belgian pharmacies. Further country launches, supported by advertising and promotional campaigns, remain on track during the coming months, Futura says. However, the US launch, expected for Q1 this year, has been delayed while the firm answers questions posed by the FDA.

Day after releasing Q4 and full-year results, Perrigo announced launch of next chapter in its “3/5/7” makeover strategy. It reached annual growth of 3% for top line revenues in phase 1, aims for 5% operating income and 7% earnings per share growth in phase 2.

FY2023 OTC monograph user fee target facility fee revenue is $25.4m from manufacturers’ fees of $26,153 and contract manufacturers’ fees of $17,435, all due by 1 June. OMOR fees are $517,381 for Tier 1 requests and $103,476 for Tier 2.

A round-up of the latest appointments in the consumer health industry: the Global Self-Care Federation elects J&J's Raghunandanan as its chair; Bayer Consumer Health makes changes to its medical leadership; and Shop Apotheke hires ex-DocMorris CEO to lead company.

Haleon's partnership with Microsoft to include 1,500 of the former's products in the latter's Seeing AI application – which reads aloud information on packs for the visually impaired – is an example of how digitalization can help to make healthcare more inclusive, according to vice president and global head of healthcare professionals and health influencer marketing Tess Player.

Day after releasing Q4 and full-year results, Perrigo announced launch of next chapter in its “3/5/7” makeover strategy. It reached annual growth of 3% for top line revenues in phase 1, aims for 5% operating income and 7% earnings per share growth in phase 2.

The growth of its nine power brands helped Haleon outstrip its sales guidance in 2022. While operating profit also improved, the firm was unable to hit its margin guidance, a miss it blamed on adverse transactional foreign currency.

Reckitt recorded a £152m impairment charge for Biofreeze in 2022 after the topical pain relief brand underperformed in the first half of the year. Despite issues for Biofreeze, Reckitt's Health business as a whole had a strong showing over the 12 months, with sales jumping by 19%.

Marketers of copies of national brand OTCs are required under FDA regulations to use the same labeling as the brand, a rule that in effect has limited complaints in California state court alleging Prop 65 violations with nonprescription drug labeling to targeting branded product marketers.

Whether California court finds Zantac, when marketed containing ranitidine, should have had a Prop 65 label warning could be influenced by dismissal in federal court of class action complaints due to faulty research behind claims that ranitidine causes a carcinogenic substance to form post-production.

Sales authorized for first test providing at-home results including differentiating flu from COVID. Lucira gets EUA for its COVID-19 & Flu Test two days after filing for Chapter 11 bankruptcy protection, indicating it would seek buyer.

Trademarks are registered and published for opposition with the US Patent and Trademark Office and are published weekly in the agency's Official Gazette.

Trademarks are registered and published for opposition with the US Patent and Trademark Office and are published weekly in the agency's Official Gazette.

Color of the toothpaste, which P&G North America oral care chief says is “only one of its kind on the market today,” changes from blue to pink after two minutes of brushing.

Color of the toothpaste, which P&G North America oral care chief says is “only one of its kind on the market today,” changes from blue to pink after two minutes of brushing.

European consumers can now buy Futura Medical's Eroxon erectile dysfunction gel without a prescription online, and in person via Belgian pharmacies. Further country launches, supported by advertising and promotional campaigns, remain on track during the coming months, Futura says. However, the US launch, expected for Q1 this year, has been delayed while the firm answers questions posed by the FDA.

Bayer hopes its innovative Aspirin-branded Heart Risk Assessment Tool will reach 100m in the US and its planning an international roll-out, the firm's general manager and vice president of pain and cardio, US, Kelly Fanning tells HBW Insight in an exclusive Q&A. Fanning also explains what Bayer is doing to manage the current surge in demand for Aspirin in the US, UK and Europe.

FTC proposes order to settle administrative complaint requiring Bountiful Company to pay $600,000 monetary relief for consumers. Order prohibits the Nestle business from using “variation” relationships in e-commerce ads, when positive reviews posted for one product may be confused with a different but similar product.

The UK's advertising regulator has ruled that government health statements cannot be used to support smoking cessation claims for unlicensed e-cigarettes.

Manufacturers of UK personal care products watch out, the Competition and Markets Authority is on the look-out for false, exaggerated and/or vague sustainability claims, and may be targeting bigger players to make an example for the rest of the sector. And consumer health might be next. HBW Insight returns to advice from marketing expert Jo Stephenson on how to avoid greenwashing, based on the CMA's own extensive Green Claims Code.