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Regulation/Legislation (Health)

Set Alert for Regulation {Health}

Regulation

Set Alert for Regulation {Health}

Latest From Health & Regulation

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
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Legislation

Set Alert for Legislation {Health}

Latest From Health & Legislation

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

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

OTC Monograph FY2024 Proposal Fees Published As FDA Anticipates Change Requests Starting

“The agency anticipates a greater likelihood of OMOR submissions compared to prior fiscal years,” CDER says. In fourth year of initial five-year authorization of OMUFA, FDA getting ready to receive OMOR submissions from drug firms and other industry stakeholders.

FDA OTC Drugs
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