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.

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.

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.

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.

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.

“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.”

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. 

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

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.”

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.

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.

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

“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.”

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

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. 

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.

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

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

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.”

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. 

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

“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.”

“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.