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PCPSA's 'No Harm' Standard Would Set High Bar For FDA Ingredient Review

 
• By Ryan Nelson

Regulatory consultants have concerns about the draft Personal Care Products Safety Act's proposed standard for FDA ingredient review – reasonable certainty of no harm. The standard's de facto application in FDA's review of new dietary ingredients in the supplement space has resulted in a fail rate of around 75%.

The draft Personal Care Products Safety Act proposes that FDA review cosmetic ingredients against a standard that has proven challenging for the dietary supplement industry and could set unrealistically high consumer expectations, experts suggest.

The bill would require FDA to evaluate the safety of five cosmetic ingredients or non-functional constituents annually, considering whether evidence is adequate "to support a reasonable certainty among competent scientists that the ingredient is not harmful under the recommended or suggested conditions of use,

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No Longer Voluntary, MoCRA Drives Drastic Increase In Registered Companies, Products

 
• By Lauren Nardella

Preliminary registration data released by FDA offers a first glimpse of the Modernization of Cosmetics Regulation Act’s impact on information the agency has at hand.

WA Regulators Open Rulemaking On Cosmetic Lead Limits; Provide Safe Harbor Under TFCA

 
• By Eileen Francis

The Washington State Department of Ecology publishes ‘Interim Policy on Lead in Cosmetics’ which provides safe harbor options for cosmetic products struggling with the 1ppm limit under the state’s Toxic Free Cosmetics Act, while the department gathers information under a newly opened rulemaking to ‘identify a feasible approach to regulating lead in cosmetic products.’

WA State Regulators Haven’t Softened Stance On Preservatives, Provided Clarity On Penalties As TFCA Effective Date Nears

 
• By Eileen Francis

The Washington Department of Ecology hasn’t backed down on its targeting of formaldehyde-releasing preservatives under the state’s Toxic-Free Cosmetics Act, as industry still awaits a draft final rule. In a recent webinar, attorney Angela Deisch of Amin Wasserman Gurnani, LLP said the department has also not provided clarity on penalties under the law, which goes into effect 1 January.

Industry Support Key To US FDA’s Prospects Under Trump – Califf

 
• By Sue Sutter

The FDA's current leader, whose term will end with Donald Trump’s second inauguration, also described three qualities the agency’s next commissioner will need to succeed, including "believing that there is such a thing as expertise."

More from Policy & Regulation

US Fragrance Firms Should Identify Domestic, Non-Tariff Sources Now – Fragrance House CEO

Firms in the US facing tariff costs should identify US-based, non-tariff sources and lobby local government officials and DC when foreign-sourced ingredients cannot be substituted in the US.

Cosmetics Consortium Shares Studies With FDA To Build Confidence In Animal Testing Alternatives

 
• By Lauren Nardella

By guiding regulators through case studies and mock dossier examples of how to utilize new approach methodologies, the International Collaboration on Cosmetics Safety hopes to counter hesitations in replacing animal tests.

Stakeholders Hope US FDA’s Proposed Animal Test Phase-Out For Drugs Will Extend To OTCs, Cosmetics

 
• By Eileen Francis and Lauren Nardella

The US Food and Drug Administration has released a roadmap to adopt new approach methodologies in lieu of animal testing for monoclonal antibody therapies and other drugs, which may include OTC drugs though the proposal does not specifically include cosmetics.