As cosmetics manufacturers and suppliers have ‘a responsibility to ensure the safety of their products,’ industry members must understand the critical tenants of cosmetic safety substantiation under MoCRA. In this seminar, Dr. Paula Brock of EAS reviewed...
AHPA Director of Regulatory Affairs Robert Marriott discusses serious adverse event reporting (SAER) requirements, FDA’s upcoming proposed rule on labeling of fragrance allergens, and more to note in the months ahead.
SPL XForms are now an additional option for cosmetic companies for submission along with the Cosmetic Direct portal, FDA Electronic Submission Gateway (ESG), as well as paper Form FDA 5066 and Form FDA 5067.
It’s been a busy week for the US Food & Drug Administration, with the Agency publishing, issuing, launching, and releasing a raft of MoCRA-related updates.
Updated deadlines, the announcement of a newly developed draft submission portal, and the release of several different draft guidance documents are just some of the developments that have occurred this year regarding MoCRA’s implementation of cosmetic...
Manufacturers and suppliers to the cosmetics and personal care product industries can now adjust their strategies for MoCRA compliance following the FDA's recent announcement confirming a six-month extension of the facility registration and product...
Newly issued guidance on the intent to delay enforcement of these key regulatory requirements under MoCRA for six months will allow cosmetics and personal care product companies more time to enact compliance measures.
To glean the most important takeaways from the FDA’s latest recommendations outlined in the draft guidance document published earlier this week, CosmeticsDesign interviewed associate Kelly Bonner of Duane Morris LLP and partner Jessica O’Connell of Covington...
Manufacturing and cosmetics companies looking to best adhere to MoCRA regulations should consider digital support to achieve compliance, suggests Specright VP Tom Preston.
As the FDA continues to implement changes to begin enforcing some of MoCRA’s authorities and industry requirements by the end of this year, CosmeticsDesign checks in with Victor Mencarelli, Director of Global Regulatory Affairs at Orveon, to learn more...
The beauty and personal care industry must acknowledge weaknesses and address them, because the gap between industry and consumers continues to widen, plagued by poorly backed claims and a raft of misinformation online, warns a cosmetic claims consultant.
From the FDA’s new mandatory recall authority to reporting and record-keeping requirements for serious adverse events, we caught up with attorneys from Perkins Coie on the key aspects of the Modernization of Cosmetics Regulation Act.
The Long Read: What Industry Needs to Know about MoCRA
By the end of this year, US manufacturers, packers and distributors of cosmetics will be required to comply with new legal requirements under the Modernization of Cosmetics Regulation Act (MoCRA) and they need to be looking carefully at it now, says a...
Some cosmetic products sold in Europe still contain excessive levels of allergy-inducing fragrances when labelled and marketed as perfume-free, finds a study by the Council of Europe and its European Directorate for the Quality of Medicines & Healthcare...
The new data privacy law goes into effect in January 2020 and could mean a significant change in business practices for any cosmetics or personal care venture that conducts ecommerce with California residents. Late last month, Cosmetics Design spoke to...