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Health (OTC Drugs)

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Regulation/Legislation Explore this Topic

Set Alert for Regulation and Legislation {Health}

Latest From Regulation, Legislation & Health

FTC's Substantiation Expectations In Consumer Health Claim Guidance Aren’t ‘Out Of Nowhere'

“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.

Ad Complaints Consumer

Offset-Based Green Claims Like 'Carbon Neutral' Will Soon Be Banned In Europe

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. 

Europe Health

US FDA Electronic Drug Registrations Key For OTC Monograph Fees Plus Keeping Tabs On Products

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.

Warning Letters OTC Drugs

‘Akin To Junk Mail,’ FTC Notices Of Penalty Offense Don't Identify Health Claim Violations – Petition

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

Ad Complaints Dietary Supplements

Court Wants Defense Of Acetaminophen Pregnancy Warning, US FDA Provides Research Review

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.

FDA OTC Drugs

Akili Turns Heel, Goes ‘All In’ On OTC Model For ADHD Digital Therapeutics

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.

Commercial Business Strategies
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Business Explore this Topic

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Latest From Deals & Health

Flarin’s Philip Lindsell: UK ITV Backing Could Provide Springboard For International Expansion

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.

United Kingdom United States

Cipla Grows South African OTC Offering With Actor Acquisition

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.

South Africa Deals

Bayer CH Backs Digital Therapeutics With ‘Multimillion-Dollar’ Mahana Partnership

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. 

US States Health
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Latest From Business Strategies & Health

FTC's Substantiation Expectations In Consumer Health Claim Guidance Aren’t ‘Out Of Nowhere'

“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.

Ad Complaints Consumer

Over A Quarter Of EU Consumers Increase Supplement Intake But Financial Pressures Take Toll

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.

Europe Market Intelligence

People On The Move: Appointments At Norgine, Lonza, Sabinsa

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.

Executive Changes Europe
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Latest From Sales & Earnings & Health

Dermapharm Benefits From Supplements Demand And Arkopharma Acquisition

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.

Europe Health

OTC Brands In Hand, Perrigo Prepares To Pump More Revenue From Private Label Portfolio

“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.”

OTC Drugs Business Strategies

Chiesi Posts Higher OTC Sales As It Makes Leadership Changes

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.

Sales & Earnings Leadership
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Latest From Legal Issues & Health

‘Akin To Junk Mail,’ FTC Notices Of Penalty Offense Don't Identify Health Claim Violations – Petition

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

Ad Complaints Dietary Supplements

Court Wants Defense Of Acetaminophen Pregnancy Warning, US FDA Provides Research Review

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.

FDA OTC Drugs

Fast Start To Oral Phenylephrine Efficacy Complaints As US FDA Considers 'Any Action'

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.

Advisory Committees FDA
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Marketing Explore this Topic

Set Alert for Marketing {Health}

Latest From Launches & Health

Health And Wellness Weekly Trademarks Review: 19 September

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

OTC Drugs Trademarks

Health And Wellness Weekly Trademarks Review: 12 September

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

OTC Drugs Trademarks

UK's Maxwellia Offers Mid-Price Branded Levonorgestrel Alternative

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

United Kingdom Health
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Latest From Ad Campaigns & Health

Offset-Based Green Claims Like 'Carbon Neutral' Will Soon Be Banned In Europe

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. 

Europe Health

UK's Maxwellia Offers Mid-Price Branded Levonorgestrel Alternative

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

United Kingdom Health

Flarin’s Philip Lindsell: UK ITV Backing Could Provide Springboard For International Expansion

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.

United Kingdom United States
See All

Latest From Ad Complaints & Health

FTC's Substantiation Expectations In Consumer Health Claim Guidance Aren’t ‘Out Of Nowhere'

“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.

Ad Complaints Consumer

Offset-Based Green Claims Like 'Carbon Neutral' Will Soon Be Banned In Europe

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. 

Europe Health

‘Akin To Junk Mail,’ FTC Notices Of Penalty Offense Don't Identify Health Claim Violations – Petition

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

Ad Complaints Dietary Supplements
See All
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