HBW Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Health (OTC Drugs)

Set Alert for Health (OTC Drugs)

Regulation/Legislation Explore this Topic

Set Alert for Regulation and Legislation {Health}

Latest From Regulation, Legislation & Health

FDA’s OTC Monograph User Fees Are Existential Threat To Small Contract Manufacturers, Cosmetics Brands

OMUFA reauthorization should include small business considerations for the US FDA’s OTC Monograph Drug User Fee Program, which established in 2020 a ‘one-size-fits-all’ facility and monograph order request user fee system which could lead to more contract manufacturer exits, a manufacturing bottleneck for OTC cosmetic products, and fewer product choices, says IBA.

FDA Regulation

US FTC Says It’s On ‘Solid Ground’ To Bring Cases Following Notices Of Penalty Offense

The US Federal Trade Commission is "fully prepared" to bring forward cases after issuing hundreds of penalty offense notices in April regarding health claims substantiation, and it is likely to seek injunctive and monetary relief, said Samuel Levine, director of the FTC’s Bureau of Consumer Protection, at the National Advertising Division’s annual conference in Philadelphia.

Advertising, Marketing & Sales Enforcement

FTC On AI And Consumer Vulnerabilities: ‘One Self-Regulatory Failure Is Begetting Another’

The US FTC’s Sam Levine, director of the Bureau of Consumer Protection, discusses the advent of AI and the compounding risks consumers face in today’s evolving, largely unregulated, profoundly uncertain digital age.

Artificial Intelligence Business Strategies

No End To US FDA Concerns About DEG And EG Testing, Or To OTC Firms Not Answering Its Calls

One of firms targeted in eight most recent warnings published since early September to OTC drug manufacturers, Zhao Qing Longda Biotechnology Co. in China, was dinged for both failing to respond to a request for records and for concerns about its production with DEG and EG.

FDA OTC Drugs

Bausch + Lomb Spreads Into US Cosmetics Market, Extends Lumify Brand With Eye Illuminations Line

Canadian firm launches US sales of Lumify Eye Illuminations 3-in-1 Micellar Cleansing Water and Eye Makeup Remover, Nourishing Lash & Brow Serum and Hydra-Gel Brightening Eye Cream. Each product contains hyaluronic acid, a fluid in eyes and joints which acts as a cushion and lubricant.

Cosmetics Launches

FTC Health Claims Guidance ‘Lacks Legal Basis,’ Conflicts With FDA’s Supplement Regulations – CRN

“There is no bright-line requirement that a company possess randomized, controlled clinical studies before making so-called ‘health benefit’ claims for dietary supplements,” CRN states in petition. FTC, however, says it “makes no bright-line distinctions between categories of health-related products or claims.”

Ad Complaints Consumer
See All

Business Explore this Topic

Set Alert for Business {Health}

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
See All

Latest From Business Strategies & Health

Message Clear For Xylitol Nasal Spray Firm Xlear: ‘Capitalize’ On FDA’s Oral Phenylephrine Doubts

“Pharmaceuticals have their place, and many do wonderful things for health, but the science of nasal hygiene is clear,” says marketing director Joel Melton.

Ad Campaigns FDA

Haleon Helps Pharmacists #ListentoPain As Social Stigma And Isolation Increases

Haleon finds in its latest global “Pain Index” that people are becoming less tolerant and more judgmental. To help remedy this situation, the firm has launched a training program to support pharmacists to “improve communication with patients and have a focused discussion on pain tailored to the individual.”

International Health

US Health And Wellness Executive Decisions: Perrigo, Nestle, Flexpower Health, Herbalife, More

NBA star Antetokounmpo invests in Flexpower; Perrigo changes Americas helm; Bündchen models healthy lifestyle for Gaia; Vit-Best appoints growth chief; Olympian Jennings works with Protein Puck; and more.

Executive Changes Consumer
See All

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
See All

Latest From Legal Issues & Health

Message Clear For Xylitol Nasal Spray Firm Xlear: ‘Capitalize’ On FDA’s Oral Phenylephrine Doubts

“Pharmaceuticals have their place, and many do wonderful things for health, but the science of nasal hygiene is clear,” says marketing director Joel Melton.

Ad Campaigns FDA

FTC Health Claims Guidance ‘Lacks Legal Basis,’ Conflicts With FDA’s Supplement Regulations – CRN

“There is no bright-line requirement that a company possess randomized, controlled clinical studies before making so-called ‘health benefit’ claims for dietary supplements,” CRN states in petition. FTC, however, says it “makes no bright-line distinctions between categories of health-related products or claims.”

Ad Complaints Consumer

‘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

Marketing Explore this Topic

Set Alert for Marketing {Health}

Latest From Launches & Health

Dutch Firm TheOTCLabs Enters UK Market With Kidsner Range

Amsterdam-based TheOTCLabs breaks into the UK consumer health market with Kidsner, a playfully marketed range of wellness products aimed at children aged 4 to 12 years old. 

United Kingdom Health

Bausch + Lomb Spreads Into US Cosmetics Market, Extends Lumify Brand With Eye Illuminations Line

Canadian firm launches US sales of Lumify Eye Illuminations 3-in-1 Micellar Cleansing Water and Eye Makeup Remover, Nourishing Lash & Brow Serum and Hydra-Gel Brightening Eye Cream. Each product contains hyaluronic acid, a fluid in eyes and joints which acts as a cushion and lubricant.

Cosmetics Launches

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
See All

Latest From Ad Campaigns & Health

Message Clear For Xylitol Nasal Spray Firm Xlear: ‘Capitalize’ On FDA’s Oral Phenylephrine Doubts

“Pharmaceuticals have their place, and many do wonderful things for health, but the science of nasal hygiene is clear,” says marketing director Joel Melton.

Ad Campaigns FDA

Haleon Helps Pharmacists #ListentoPain As Social Stigma And Isolation Increases

Haleon finds in its latest global “Pain Index” that people are becoming less tolerant and more judgmental. To help remedy this situation, the firm has launched a training program to support pharmacists to “improve communication with patients and have a focused discussion on pain tailored to the individual.”

International Health

Dutch Firm TheOTCLabs Enters UK Market With Kidsner Range

Amsterdam-based TheOTCLabs breaks into the UK consumer health market with Kidsner, a playfully marketed range of wellness products aimed at children aged 4 to 12 years old. 

United Kingdom Health
See All

Latest From Ad Complaints & Health

Message Clear For Xylitol Nasal Spray Firm Xlear: ‘Capitalize’ On FDA’s Oral Phenylephrine Doubts

“Pharmaceuticals have their place, and many do wonderful things for health, but the science of nasal hygiene is clear,” says marketing director Joel Melton.

Ad Campaigns FDA

FTC Health Claims Guidance ‘Lacks Legal Basis,’ Conflicts With FDA’s Supplement Regulations – CRN

“There is no bright-line requirement that a company possess randomized, controlled clinical studies before making so-called ‘health benefit’ claims for dietary supplements,” CRN states in petition. FTC, however, says it “makes no bright-line distinctions between categories of health-related products or claims.”

Ad Complaints Consumer

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
See All
UsernamePublicRestriction

Register