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OTC Homeopathic Market Could Shrink Under US FDA Risk-Based Oversight, Trade Groups Say

 
• By Eileen Francis

US FDA’s draft guidance for homeopathic products could result in consumer confusion, force sales of the products largely online and create a three-year backlog in review of products that have a safe track record, industry trade tells the agency. Agency plans to replace the existing compliance policy guide that largely delegated oversight to the Homeopathic Pharmacopeia of the US with risk-based enforcement by FDA.

US FDA’s draft guidance on OTC homeopathic products will confuse the industry, consumers and retailers and lead to the products being sold online only, the American Association of Homeopathy Pharmacists says in comments to the agency.

“Deleting the relative certainty in the current guidance would mean that many mass market sellers might find it difficult to...

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More from Regulation

EU Proposal To Simplify Hazardous Chemical Rules For Cosmetics ‘Step In Right Direction’ - Industry

 
• By Eileen Francis

The European Commission’s Simplification Omnibus published July 8 is ‘step in right direction’ for streamlining processes and providing more legal certainty and predictability for regulations addressing cosmetics, says Cosmetics Europe.

Cloudy Tariff Conditions Expected To Linger In US

 
• By Malcolm Spicer

White House announces president extends deadline he set in April for other countries to make new tariff deals from July 9 to Aug. 1, when the administration will start sending letters warning other countries that higher tariffs could take effect.

ECHA Adds Two Cosmetic/Personal Care Silicones To REACH Candidate List

 
• By Eileen Francis

ECHA has added two silicone ingredients used in cosmetics and personal care products to the REACH Candidate List as they are persistent and have bioaccumulative properties, requiring companies to notify customers and update safety data sheets if concentrations exceed 0.1%.

MoCRA Implementation Delay Creates More Legal Exposure For Stakeholders – Attorney

 
• By Eileen Francis

The delay in implementation of MoCRA is seen by many companies as a temporary reprieve, but it does create more legal uncertainty, says attorney Marissa Alkhazov of law firm Buchalter.

More from Policy & Regulation

Cloudy Tariff Conditions Expected To Linger In US

 
• By Malcolm Spicer

White House announces president extends deadline he set in April for other countries to make new tariff deals from July 9 to Aug. 1, when the administration will start sending letters warning other countries that higher tariffs could take effect.

US FDA’s Tough Talk On Talc: Regulating In An Echo Chamber

 
• By Michael McCaughan

An FDA “expert roundtable” on talc produced a new talking point on a potential drug safety risk, but the basis of that claim is difficult to determine.

ECHA Adds Two Cosmetic/Personal Care Silicones To REACH Candidate List

 
• By Eileen Francis

ECHA has added two silicone ingredients used in cosmetics and personal care products to the REACH Candidate List as they are persistent and have bioaccumulative properties, requiring companies to notify customers and update safety data sheets if concentrations exceed 0.1%.