HBW Insight

Manufacturers in the OTC drug, cosmetics, and dietary supplement sectors are encountering stricter regulations, increasing legal challenges, and a more competitive market every day. At the same time, the distinctions between these industries are diminishing, creating exciting growth prospects for innovative companies and allowing insights from one sector to benefit another. HBW Insight stands out as the comprehensive source for news and insights on regulations, legislation, legal matters, and market trends tailored for the OTC drug, cosmetics, and dietary supplement markets. Our team of knowledgeable analysts, equipped with extensive connections across industry, government, and legal realms, provides daily updates and thoughtful articles that analyze the latest changes. This ensures that stakeholders remain informed, strategically focused, and prepared for future developments.

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Articles

Capitol Hill Gridlock On Amending Federal Hemp Law Leaves States In Regulatory Driver’s Seat

Oct 14, 2024 | hbw.citeline.com | Malcolm Spicer

News Executive Summary Congress will be on Capitol Hill briefly after 5 November elections before current session ends. It hasn’t prioritized re-authorizing 2018 farm bill, which de-scheduled hemp as a controlled substance. Until changes come through farm bill re-authorization or other legislation, federal definition of lawful hemp will remain any part of the cannabis plant containing no more than 0.3% concentration of delta-9 THC.
People On The Move: Appointments At Dr Reddy's, Mayoly, NèreS

Oct 14, 2024 | hbw.citeline.com | Tom Gallen

News Executive Summary A round-up of the latest appointments in Europe's consumer health industry: Dr Reddy's hires UK head; Mayoly names CEE lead; NèreS adds director. Source: Shutterstock Existing Subscriber? Sign in to continue reading. New to HBW Insight? Start a free trial today!
New Era For CIR: Expert Panel Meets As Mandatorily Reported Ingredient Data Pours In From FDA

Oct 14, 2024 | hbw.citeline.com | Lauren Nardella

News Executive Summary Now that reporting of cosmetic ingredient use to FDA is no longer voluntary, the Cosmetic Ingredient Review is wading through a tide of data generated by MoCRA registration and listing deadlines. Source: Shutterstock Existing Subscriber? Sign in to continue reading. New to HBW Insight? Start a free trial today!
FAO/WHO Codex Alimentarius Committee: Harmonized Guidelines for Probiotics?

Oct 14, 2024 | hbw.citeline.com | David Ridley

News Executive Summary At its most recent meeting, delegates to the Food and Agriculture Organization of the United Nations and World Health Organization’s Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU) discussed international harmonization guidelines for probiotics as constituents in foods and dietary supplements, based on a proposal to align international regulatory frameworks with guidelines established by the FAO/WHO.
Washington State TFCA Violators Likely To Face Conversation Before Penalties - DOE

Oct 11, 2024 | hbw.citeline.com | Eileen Francis

Analysis Executive Summary The Washington State Department of Ecology will try to work with companies that violate the Toxic Free Cosmetics Act, rather than reflexively imposing the $5,000-per-violation fine for first-time offenders, says the law’s implementation planner.
US FDA’s Petition Procedures No Place For OTC Acetaminophen Pediatric Dosing Enforcement

Oct 11, 2024 | hbw.citeline.com | Malcolm Spicer

News Executive Summary Requests for “enforcement actions are not within the scope of FDA’s citizen petition procedures,” CDER says, rejecting petition dosing device firm Parenteral Technologies submitted as it prepares for workshop on Pediatric Research Equity Act requirements for OTC NDA sponsors. Source: Shutterstock Existing Subscriber? Sign in to continue reading. New to HBW Insight?
Private Equity Poised To Take Control Of Opella But Sanofi Will Retain Sizable Stake

Oct 11, 2024 | hbw.citeline.com | Tom Gallen

News Executive Summary Control of Sanofi Consumer Healthcare – recently rebranded as Opella – may soon pass to US private-equity firm CD&R but the French firm looks set to retain a substantial stake in a business which has some big Rx-to-OTC switches in the pipeline. Source: shutterstock Existing Subscriber? Sign in to continue reading. New to HBW Insight? Start a free trial today!
Adcomm Reform: Getting Needed Information More Important Than Vote Or Discussion

Oct 11, 2024 | hbw.citeline.com | Derrick Gingery

Analysis Executive Summary US FDA Office of New Drugs Director Peter Stein says review divisions have made the case that a discussion-only meeting would solicit the necessary input. Source: Shutterstock Existing Subscriber? Sign in to continue reading. New to HBW Insight? Start a free trial today!
Washington State TFCA Stakeholders: Don’t Hold Your Breath For Higher Lead Limit

Oct 10, 2024 | hbw.citeline.com | Eileen Francis

Analysis Executive Summary Toxic-Free Cosmetics Act planner Shari Franjevic acknowledges the Washington State Department of Ecology is authorized to use enforcement discretion regarding the new law’s 1ppm limit on trace lead in cosmetic products, effective 1 January 2025, or raise the ceiling via rulemaking. But it does not seem inclined to do either based on data known to the department at present.
De Novo Clearance For HealGen Flu/COVID-19 Test

Oct 10, 2024 | hbw.citeline.com | Elizabeth Orr

News Executive Summary FDA grants de novo authorization to Healgen Rapid Check COVID-19/Flu A&B Antigen Test, making it the first OTC flu test to be cleared outside the emergency use pathway. Source: Shutterstock Existing Subscriber? Sign in to continue reading. New to HBW Insight? Start a free trial today!