Commissioner Robert Califf says FDA has no firm plan but will “react to whatever happens” following the UK’s momentous decision to leave the EU. The European Medicines Agency also is taking a wait-and-see approach, while regulated industries brace for potential compliance, R&D and IP challenges in Brexit’s aftermath.
Nearly half of voting Brits and many millions more around the world continue to process their shock at the UK’s decision to withdraw from the European Union, with more questions than answers at present as to the momentous event’s ramifications.
The UK’s 52%-48% referendum result in favor of leaving the union now has far-right politicians in France and the Netherlands calling for similar plebiscites, while prevailing “remain” sentiment in Scotland and Northern Ireland has talk of
Testing conducted by the US Food and Drug Administration has found several cosmetic products on the market that contain high levels of methylene chloride, a banned ingredient.
Engaging with EU member state legislators, stressing the impact of national EPR systems on the accessibility, availability, and affordability of medicines, reformulating products to reduce their financial contribution, and lobbying for expanding the scope of EPR schemes to include other polluting industries are all ways that the European consumer health industry can try and influence the way that the revised Urban Wastewater Treatment Directive is transposed into national legislation, law firm Mason Hayes & Curran explains.
France's food safety regulator ANSES is proposing a reproductive toxicity category 1B classification for CBD under the EU's CLP regulation, which would mean an effective ban on CBD in cosmetics and foods. However, French hemp industry association UIVEC hopes that new evidence coming out of a European Commission review will put the issue to bed before it gets that far.
Two nail care ingredients included in the European Commission’s Omnibus VII, which includes about two dozen ingredients overall, are banned in Europe in September.
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.
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.
