Products marketed for cosmetic use but formulated with drugs are regulated as topical drugs and would be subject to potential OTC user fees, although the products have little similarity with oral or nasal delivery nonprescription drugs also available under FDA's monograph system, consultant David Steinberg says.
Personal care and cosmetic product manufacturers should take note that legislation on reforming FDA's OTC drug monograph program with a user fee program might regain momentum, says regulatory consultant David Steinberg.
Steinberg, president of Plainsboro, N.J.-based Steinberg & Associates Inc., a consultancy specializing in the OTC drug and personal care industries, acknowledges he's not a proponent of establishing user fees for...
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.
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.’
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.
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."
Fragrance companies and suppliers can draft contracts that ensure the cost burden of tariffs is shared, says attorney David Morrell of law firm Jones Day, during a recent panel discussion, ‘Tariffs in Motion: Insight for the Fragrance Industry.”
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.
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.
