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NDI Or GRAS? Supplement Label But A Drug Claim? Answers Unclear For Some Regulatory Questions

 
• By Malcolm Spicer

“We try to interpret the language that is given to us and if Congress would make it more clear to us, we would absolutely carry that forward,” ODSP's Cara Welch says about whether FDA regulations require NID notifications or self-GRAS submissions for dietary ingredients yet to be used in supplements.

The US Food and Drug Administration expects questions about problem products and companies in the dietary supplement sector could be answered not only from industry stakeholders’ input but also through congressional clarification.

“Clarification of statutory language is often helpful

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More from International

New Zealand Could Become First Country To Offer Gout Drug Allopurinol OTC

 
• By David Ridley

At the second attempt, New Zealand’s Medicines Classification Committee supported the Rx-to-OTC switch of allopurinol (100mg and 300mg) for people suffering from gout by specifically trained pharmacists.

Stada Expands Oilatum Range To Meet Saudi Arabia’s Skin-Care Needs

 
• By David Ridley

Stada launches nine new Oilatum products in Saudi Arabia including “rich moisturising creams for intense hydration, gentle body washes for daily cleansing, and baby-specific products like soothing bath bubbles and head-to-toe wash.”

Bayer And GSCF Paper Outlines ‘Practical Actions’ For Scaling Self-Care Globally

 
• By David Ridley

Bayer Consumer Health, the Global Self-Care Federation and the Business Council for International Understanding outline in a paper how industry can work with multilateral organizations, governments, financial institutions, and stakeholders to "recognize and champion self-care as a fundamental driver of global health progress."

UK Honors PAGB’s Riddalls And ISF’s Webber For Self-Care Service

 
• By David Ridley

PAGB CEO Michelle Riddalls and ISF president emeritus David Webber have been awarded OBEs for their services to consumer health and self-care.

More from Geography

Supplementation Unlikely To Help With Hereditary Hair Loss, Says German Agency

 
• By David Ridley

Germany’s Federal Institute for Risk Assessment says that there is "no evidence that people with androgenetic alopecia have special dietary needs or a special nutrient requirement.”

US Tariffs Pose ‘Existential Threat’ To EU Medical Devices Industry

 
• By David Ridley

AESGP, MedTech Europe and other associations representing medtech companies including manufacturers of self-care devices call for such products to be included in European Commission proposals for “zero-for-zero” trade in industrial goods between Europe and the US.

OTCs Are ‘Beacon Of Hope’ For Austrian Pharmacy

 
• By David Ridley

Just under half of Austrian pharmacists surveyed by Elpato Medien are “convinced that the OTC business will ensure the survival of their pharmacy.”