“Choosing which claims to make,” an advertiser “affects the amount of substantiation required. A structure function claim, supports digestive health, may require a different level of substantiation than if you choose to make the claim prevents diarrhea,” says FTC attorney Christine DeLorme.

The Green Claims Directive has moved one step closer to becoming European Union law. Once passed, within 24 months CO2 offset-based claims like "carbon neutral" will be banned altogether, claims like “environmentally friendly” will require substantive backing and sustainability labels in general will need to be approved beforehand by certification schemes or public authorities. 

FDA drug user fee program chief tells OTC industry stakeholders accurate information in electronic Drug Registration and Listing System is key to setting annual facility registration user fee rates. CDER publishes warning letters to US retailer and a South Korean manufacturer noting noncompliance with eDRLS requirements.

Trade group ask FTC to withdraw notices, arguing it is attempting to impose substantiation standard prohibited under FDA regulations for supplement manufacturing and marketing and are inconsistent with its own as well as FDA guidance

Review makes clear FDA’s thinking on safety acetaminophen use during pregnancy, but likely won’t sway federal judge from her conclusion that a warning about risks of in utero exposure could be added to drug containing the ingredient and available under an OTC monograph without violating FDA regulations.

The Boston, MA-based company says the pivot away from Rx will enable it to pursue a significantly larger market and remove “key friction points” that have prevented patients from accessing its game-based digital ADHD treatment. The company is targeting year-over-year cost savings of $8m-$18m after investments to juice up its direct digital marketing program.

Flarin Holdings recently secured £5m ($6.2m) investment from UK television company ITV's Media for Equity fund in return for a minority stake in the company, which markets analgesic brand Flarin in the UK. The investment could be a springboard for international expansion, including in the US, Flarin's managing director Philip Lindsell tells HBW Insight in an exclusive in-depth interview.

Cipla has signaled its commitment to expanding its OTC offering with the acquisition of South Africa's Actor Pharma and its diversified consumer health portfolio.

A multimillion-dollar partnership will bring together Bayer Consumer Health's digestive health brand equity with Mahana's cutting edge digital therapeutic technology for treating irritable bowel syndrome. 

“Choosing which claims to make,” an advertiser “affects the amount of substantiation required. A structure function claim, supports digestive health, may require a different level of substantiation than if you choose to make the claim prevents diarrhea,” says FTC attorney Christine DeLorme.

Research from Stada shows that while a quarter of European consumers increased their dietary supplement intake compared to last year, one in five have cut back spending on such products. These are among the findings of the Stada Health Report 2023 which asked 32,000 people more than 30 questions covering topics such as health prevention and satisfaction with national healthcare systems.

A round-up of the latest appointments in Europe's health and wellness markets: Norgine names former L'Oreal exec as COO; Lonza appoints chairman to interim-CEO role; and Sabinsa hires head for new French office.

Germany's Dermapharm said strong global demand for dietary supplements, in combination with its acquisition of herbals specialist Arkopharma, had helped drive up sales in the first half of 2023.

“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.”

Italy's Chiesi reported special care and consumer healthcare unit sales up by 20% in the first half as it named Alessandro Chiesi as its new chair.

Trade group ask FTC to withdraw notices, arguing it is attempting to impose substantiation standard prohibited under FDA regulations for supplement manufacturing and marketing and are inconsistent with its own as well as FDA guidance

Review makes clear FDA’s thinking on safety acetaminophen use during pregnancy, but likely won’t sway federal judge from her conclusion that a warning about risks of in utero exposure could be added to drug containing the ingredient and available under an OTC monograph without violating FDA regulations.

Two days after FDA advisory panel’s meeting to discuss whether oral phenylephrine is effective for nasal congestion, complaints filed in federal court in multiple states alleging manufacturers knowingly misled public about ingredient’s efficacy. FDA’s potential response to NDAC’S finding wouldn’t come as soon.

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.

UK consumers will soon be able to purchase at an "accessible" price branded levonorgestrel-based emergency contraceptive, LoviOne, marketed by switch specialists Maxwellia. 

The Green Claims Directive has moved one step closer to becoming European Union law. Once passed, within 24 months CO2 offset-based claims like "carbon neutral" will be banned altogether, claims like “environmentally friendly” will require substantive backing and sustainability labels in general will need to be approved beforehand by certification schemes or public authorities. 

UK consumers will soon be able to purchase at an "accessible" price branded levonorgestrel-based emergency contraceptive, LoviOne, marketed by switch specialists Maxwellia. 

Flarin Holdings recently secured £5m ($6.2m) investment from UK television company ITV's Media for Equity fund in return for a minority stake in the company, which markets analgesic brand Flarin in the UK. The investment could be a springboard for international expansion, including in the US, Flarin's managing director Philip Lindsell tells HBW Insight in an exclusive in-depth interview.

“Choosing which claims to make,” an advertiser “affects the amount of substantiation required. A structure function claim, supports digestive health, may require a different level of substantiation than if you choose to make the claim prevents diarrhea,” says FTC attorney Christine DeLorme.

The Green Claims Directive has moved one step closer to becoming European Union law. Once passed, within 24 months CO2 offset-based claims like "carbon neutral" will be banned altogether, claims like “environmentally friendly” will require substantive backing and sustainability labels in general will need to be approved beforehand by certification schemes or public authorities. 

Trade group ask FTC to withdraw notices, arguing it is attempting to impose substantiation standard prohibited under FDA regulations for supplement manufacturing and marketing and are inconsistent with its own as well as FDA guidance