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Health (OTC Drugs)

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Regulation/Legislation Explore this Topic

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Latest From Regulation, Legislation & Health

Studies Find Oil, Topical And Transdermal Hemp Products’ Content Inconsistent With Labeling

JAMA study found 24% of 89 topicals or transdermals labeled correctly for amounts of cannabinoid in the products; JCR study found 54% of 80 CBD oils were accurately labeled, 15% had higher levels and 31% had lower.

FDA Cannabidiol CBD

OTC Sales Of Hearing Aids For Mild To Moderate Loss Allowed Under US FDA Final Rule

After requirement from Congress and push from President Biden, FDA establishes regulatory category for hearing aids to allow US consumers with mild to moderate hearing loss to purchase the devices without a prescription or prior exam.

Approvals FDA

UK Product Approvals: J&J Expands Sudafed And Nicorette Offerings

The UK's MHRA has approved the Rx-to-OTC switch of J&J's Sudafed Plus nasal spray (xylometazoline hydrochloride/dexpanthenol) and given the green light for the company to add new pack sizes to its Nicorette QuickMist and QuickMist Smart Track products.

Prescription To OTC Switch Launches

Mandatory Product Listing: Needed For US VMS Market, Not Mandatory In User Fee Bill – CRN

Establishing VMS products MPL as stated within legislation to re-authorize FDA user fee programs for drugs, biologics and medical device applications isn’t urgent enough to prevent passing user fee bill, says CRN chief Steve Mister.

Dietary Supplements FDA

Senate Cannabis Bill Could Torch US Hemp Market By Slashing THC Limit Below Farm Bill Level

Hemp Roundtable says Cannabis Administration and Opportunity Act’s limit of 0.001% THC per 100 g by dry weight for ingredients derived from cannabis to qualify as hemp “would impose a devastating setback to a thriving industry, and further limit opportunities for already struggling hemp farmers.”

Legislation Policy

Sunscreen Ecological Risk Assessment 'Teed Up' For US EPA

Lawmakers in Hawaii and other jurisdictions may be left wanting by the National Academies of Sciences' sunscreen report, but industry groups were pleased with the academy's findings and recommendations to the EPA. The Personal Care Products Council says it confirms that scientific data are insufficient at present to conduct “realistic” ecological risk assessments of UV filters or support their bans.

Ingredients FDA
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Business Explore this Topic

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Latest From Deals & Health

OTC Naloxone NDA In US Gets Fast Track Status

Nonprofit HRT reached a commercial supply agreement for a firm to produce its RiVive naloxone nasal spray still in development after FDA granted fast frack designation for its OTC switch NDA.

Prescription To OTC Switch FDA

Dermapharm Expands Natural Offering With France's Arkopharma

Germany's Dermapharm will pay €450m to acquire herbal specialist Arkopharma to expand its footprint in Europe's consumer health market in countries such as France, Spain and Italy.

Deals Europe

GSK Exits Consumer Health With Haleon Launch

The global market leader in consumer health is now Haleon following its separation from GSK after more than two years of planning.

Business Strategies Deals
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Latest From Business Strategies & Health

Dutch Firm TheOTCLab Gets EU MDR Approval For Dr. Yglo OTC Wart Device

Amsterdam-based TheOTCLab has received an EU CE mark for its new wart and verruca OTC freezing device Dr. Yglo. The firm plans to launch the product in Europe in Italy, Portugal, Estonia, Latvia, and Lithuania, and will separately look to take it further afield to the US and South Africa.

Europe Estonia

UK Product Approvals: J&J Expands Sudafed And Nicorette Offerings

The UK's MHRA has approved the Rx-to-OTC switch of J&J's Sudafed Plus nasal spray (xylometazoline hydrochloride/dexpanthenol) and given the green light for the company to add new pack sizes to its Nicorette QuickMist and QuickMist Smart Track products.

Prescription To OTC Switch Launches

Mandatory Product Listing: Needed For US VMS Market, Not Mandatory In User Fee Bill – CRN

Establishing VMS products MPL as stated within legislation to re-authorize FDA user fee programs for drugs, biologics and medical device applications isn’t urgent enough to prevent passing user fee bill, says CRN chief Steve Mister.

Dietary Supplements FDA
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Latest From Sales & Earnings & Health

Inflation, Supply Chain And Private Label Pressures: Consumer Health Leaders Talk ‘Big Picture’ Challenges

OTC drug and dietary supplement companies continue to face significant economic and competitive issues in what continues to be a highly volatile operating environment. Here we’ve culled takes from top execs at Sanofi, Bayer, J&J, P&G and other leading players, provided during recent sales and earnings presentations.

Business Strategies Supply Chain

Beiersdorf Is Having Record Year For Sun Care, Seeing China Recovery, But Full-Year Outlook Is Guarded

The Hamburg, Germany-based firm defied economic and political headwinds and China troubles in the fiscal 2022 first half to book organic net sales growth of 10.5% to 4.5bn worldwide. Despite optimism about China recovery, sun care, and its recent Chantecaille acquisition, Beiersdorf is projecting a slowdown in the second half in what remains a volatile operating environment.

Sales & Earnings Commercial

Perrigo Starts Supply Chain Overhaul After Filing OTC Birth Control NDA, Launching Nasonex Switch

Along with Q2 results including reported net sales up 14.3% to $1.12bn, Perrigo announces overhaul of its supply chain expected to generate $100m to $300m in net cost savings and creation of women's health, skin care business units.

Sales & Earnings Supply Chain
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Latest From Legal Issues & Health

First Recalls, Now Investors' Concerns Over Ranitidine Litigation Take Pharmas For Wild Ride

Host of complaints in US courts, seeking damages or alleging ranitidine caused various cancers, followed FDA’s 2020 findings of NDMA levels exceeding allowable limits in some samples provoked  Litigation is starting to come to trial, the first set for 22 August in Illinois and a bellwether case due to begin in California in February 2023.

Recalls OTC Drugs

J&J Pulls Plug On Talc Across Its Baby Powder Portfolio, Shifts To Cornstarch-Based Products

As it did when it halted sales in US and Canada in 2020, J&J’s latest announcement attributes its decision as coming from a “portfolio assessment” and stated it remains confident in using talc in baby powder and cosmetics.

Business Strategies Cosmetics

Benzene Suits Against US Personal-Care Firms Appear Headed In One Direction: Settlement

The latest in litigation against Unilever, P&G, Beiersdorf and J&J alleging violations for selling personal-care products contaminated with benzene.

Legal Issues Quality
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Marketing Explore this Topic

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Latest From Launches & Health

Dutch Firm TheOTCLab Gets EU MDR Approval For Dr. Yglo OTC Wart Device

Amsterdam-based TheOTCLab has received an EU CE mark for its new wart and verruca OTC freezing device Dr. Yglo. The firm plans to launch the product in Europe in Italy, Portugal, Estonia, Latvia, and Lithuania, and will separately look to take it further afield to the US and South Africa.

Europe Estonia

UK Product Approvals: J&J Expands Sudafed And Nicorette Offerings

The UK's MHRA has approved the Rx-to-OTC switch of J&J's Sudafed Plus nasal spray (xylometazoline hydrochloride/dexpanthenol) and given the green light for the company to add new pack sizes to its Nicorette QuickMist and QuickMist Smart Track products.

Prescription To OTC Switch Launches

Health And Wellness Weekly Trademarks Review: 2 August

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

Dietary Supplements OTC Drugs
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Latest From Ad Campaigns & Health

Less Than Four Weeks Remain To Enter The OTC Marketing Awards 2022

Entries to the OTC Marketing Awards are coming in thick and fast from industry players large and small across the 15 categories. With the entry deadline fast approaching on 29 August, don't miss out on your chance to win a prestigious trophy. 

Ad Campaigns Innovation

GSK Consumer Healthcare Celebrates Pain Release With UK Panadol Campaign

GSK Consumer Healthcare wants to “bring to life the emotional transformation” that UK pain sufferers experience when released from discomfort by analgesic brands like Panadol. 

United Kingdom Health

Bayer Undresses UK Vaginal Health Stereotypes And Stigmas Via Canesten Schools Program

Bayer Consumer Health in a new campaign for UK women's intimate health brand Canesten hopes to “move imagery of real vulvas away from a sexualised depiction and into an informative, educational space to equip young people with the essential information they need to better understand their bodies as well as normalise conversations.”

United Kingdom Health
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Latest From Ad Complaints & Health

Responsibility For Distributors’ Claims At Root Of Supplement Direct Seller’s Advertising Review

After the DSSRC recommended that Root Wellness remove health claims from its advertising in 2021, the direct seller has not made efforts to remove the claims that its ambassadors have made on social media.

Regulation Enforcement

Sanofi Appealing Findings In Review Of Zantac 360 Doctor-Recommended Claims Challenged By J&J

French pharma disagrees with NAD finding, following review of a claims made in online and social media ads, retailers' websites and a TV commercial, that the claim “#1 doctor recommended medicine” for Zantac 360 refers to the brand and not famotidine, also used in other OTC heartburn remedies, including Pepcid.

Ad Complaints OTC Drugs

Labs' High-Performance Chromatography Results Don't Help Dakota Nutrition's Elderberry Claims

NAD’s review was shorter than it might have been because Dakota Nutrition stopped using around 30 challenged disease claims, leaving a total of eight claims made on labels, its website and online retailers’ platforms about the amount of elderberry in its products.

Advisory Committees Ad Complaints
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