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Regulation/Legislation (Wellness)

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Regulation

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Latest From Wellness & Regulation

Over The Counter: Solving The Sustainable Pill Pack Puzzle, With PA Consulting’s Tony Perrotta

In this episode of the updated Over The Counter podcast, HBW Insight speaks to sustainable packaging expert Tony Perrotta about the complexities of replacing plastic pill packs in medicines packaging. Perrotta is a partner at PA Consulting, which set up the Blister Pack Collective alongside consumer health players Haleon, Bayer and Sanofi. They are working with PulPac, which has invented a dry molded fiber alternative to plastic, which the Collective hopes to commercialize within 12-24 months. We discuss whether regulators will accept such alternatives, given the safety and stability requirements for medicines, and the challenges of recycling, given the multitude of different frameworks and processes across the world. Perrotta also reveals that one of the partners in PA Consulting’s Bottle Collective, which hopes to replace plastic bottles in the food, personal care and consumer health industries, will soon launch its first market trial.

International Health

Without Additional Funding, US FDA's Inspections In Jeopardy – Regulatory Affairs Chief

Without additional funding, FDA’s ORA faces challenges in retaining and hiring staff, which will impact inspections, says office chief Michael Rogers. 

FDA Enforcement

Federal Judge Knows ‘Clear’ When He Reads It

The regulation “is clear, as is the Court’s order” rejecting CRN’s motion for preliminary injunction against imposition of the regulation, says US district Judge Andrew Carter in order denying the trade group’s request for clarification of New York regulation.

Litigation Dietary Supplements
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Latest From Wellness & Legislation

Over The Counter: Solving The Sustainable Pill Pack Puzzle, With PA Consulting’s Tony Perrotta

In this episode of the updated Over The Counter podcast, HBW Insight speaks to sustainable packaging expert Tony Perrotta about the complexities of replacing plastic pill packs in medicines packaging. Perrotta is a partner at PA Consulting, which set up the Blister Pack Collective alongside consumer health players Haleon, Bayer and Sanofi. They are working with PulPac, which has invented a dry molded fiber alternative to plastic, which the Collective hopes to commercialize within 12-24 months. We discuss whether regulators will accept such alternatives, given the safety and stability requirements for medicines, and the challenges of recycling, given the multitude of different frameworks and processes across the world. Perrotta also reveals that one of the partners in PA Consulting’s Bottle Collective, which hopes to replace plastic bottles in the food, personal care and consumer health industries, will soon launch its first market trial.

International Health

Supreme Court To Hear RICO Complaint Against CBD Firms As Hemp Regulation Remains AWOL

Litigation the court agreed to accept for its term beginning in October doesn’t allege CBD in a tincture purchased in 2012 contained an unlawful level of delta-9 THC but contained any THC at all. Also, FDA Commissioner Califf encourages Congress to authorize regulatory pathway for lawful use of CBD and other hemp ingredients in supplements and food.

Dietary Supplements Cannabidiol CBD

‘Clear’ Is In The Eye Of The Beholder, New York, CRN Argue In Age-Restricted Sales Litigation

CRN’s request for clarification, as it continues litigating complaint in US District Court for Southern New York, highlights what it contends is vague and overly general language in the legislation passed in October with a 22 April effective date.

Dietary Supplements Litigation
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