COVID-19

A report by AESGP and IQVIA Consumer Health finds that self-care medical devices account for a significant proportion of Europe's OTC market, and as a category is growing rapidly. However, only by “retaining the same favorable market conditions, notably in terms of efficiency, transparency, predictability and innovation” as under previous medical device regulations can this category continue to thrive, they argue. 

German consumers are “generally willing to accept price increases from OTC manufacturers” when it comes to core categories like cough, cold & flu, finds Sempora, and are increasingly willing to shell out for trending gut health products like probiotics.

Precision Patient Outcomes' compliance costs from settlement with FTC “are not onerous,” says New Civil Liberties Alliance attorney John Vecchione. Settlement requires firm to notify customers and resellers about lawsuit and preserve all scientific evidence for health claims made for its products.

Test is among first of a wave of products initially authorized for emergency use by FDA now pursuing traditional approval pathways to stay on market. 

US International Trade Commission found patents had mixed effect on consumer access to diagnostics and therapeutics during COVID-19 pandemic. Trade group AdvaMed says findings demonstrate patent waiver programs aren’t needed for COVID-19 diagnostics.

New York business partners continued false advertising for “The 1 Virus Buster Card,” to be worn around the neck or clipped onto clothing, on their website and social media platforms after receiving a warning from in July 2020.

During COVID-19 public health emergency FDA “became aware of reports of fatal methanol poisoning of consumers who ingested alcohol-based hand sanitizer products that were manufactured with methanol or methanol-contaminated ethanol,” agency says in guidance introduction.

Kantar data shows a slow but steady expansion of the UK vitamins, minerals and supplements market driven largely by digestive health products, especially probiotics, and women's health products, in particular those supporting women experiencing the menopause. 

In this episode, HBW Insight talks to BSS Consulting’s Birgit Schuhbauer about her stellar career in consumer health. Until recently, Schuhbauer was global vice president of Johnson & Johnson’s Self Care franchise and president of the Association of the European Self-Care Industry. Now running her own consulting business, Schuhbauer reflects in this first part of a two-part exclusive interview on her career highlights, what it takes to be a leader in OTC and on her role as the AESGP’s first female president during a time of unprecedented change.

“I think that is a value creating opportunity for us as well. We have incredible consumer reach in the US,” says CEO Patrick Lockwood-Taylor. Few companies can say, in “certain categories 80% of the units sold come from us.”

Two firms in India, two in South Korea manufacturing toothpastes and hand sanitizers available in US didn’t respond to FDA’s repeated records requests. Six others in those two countries and Canada and Turkey making sanitizers and toothpastes, including products for children, as well as sunscreens were warned about GMP failures after providing records at agency’s request.

A strong winter cough and cold season, demand for gut health products and price rises have all contributed to a good first six months of 2023 for Germany's OTC market, according to the latest Sempora data. 

Like other big global OTC players, Bayer Consumer Health is stepping up its investment in digital self-care. In the first part of an exclusive interview, HBW Insight catches up with the company's head of R&D and chief scientific officer David Evendon-Challis to dig deeper into the rationale for setting up a new 'prescision health' business unit, including why a holistic and personalized approach to digital self-care increases trust in long-loved and science-backed brands. 

Japanese curcumin specialist Theravalues claims to have found via a randomized clinical trial that its Theracurmin and Theracurmin Super dietary supplements can help alleviate some symptoms of the common cold. “However, the level of evidence is weak,” they warn. “Additionally, because the study was based on the reporting of subjective cold-like symptoms, it is was unclear whether the symptoms were actual subjective symptoms caused by an upper respiratory tract infection.”

FDA’s first premarket approval of OTC test for any respiratory illness went to first firm to receive an EUA for at-home molecular COVID-19 test, Cue Health, which had received $481m from agency to spur its diagnostics development.

The New York-based firm recorded 24% growth in fiscal 2023 first-quarter net sales to $311.7m. The performance reflects growth across all regions as consumers continue to splurge on more expensive fragrances in larger sizes, a trend that arose at the height of the global pandemic.