HBW Insight reached out to suppliers of microplastic alternatives for cosmetics use to discuss their offerings and preparedness for demand surges under phased REACH prohibitions.

The DTx company’s revenue grew some 500% to $702,000 in the fiscal 2023 third quarter, reflecting its direct-to-consumer launch of EndeavorOTC to adult ADHD patients in June under a US FDA enforcement policy established for digital health devices during the COVID-19 public health emergency. That policy has since sunset, and Akili has submitted a 510(k) application to the agency for review.

The DTx company’s revenue grew some 500% to $702,000 in the fiscal 2023 third quarter, reflecting its direct-to-consumer launch of EndeavorOTC to adult ADHD patients in June under a US FDA enforcement policy established for digital health devices during the COVID-19 public health emergency. That policy has since sunset, and Akili has submitted a 510(k) application to the agency for review.

New leadership overseeing the US Food and Drug Administration’s Office of Cosmetics and Colors has kickstarted a long-sought rulemaking to address formaldehyde and formaldehyde releasers in hair straightening products, with a proposed ban in mind.

In comments on FDA draft guidance released in August, industry members raise questions about the agency’s capacity to deal with an anticipated flood of facility registrations and product listings. Confidentiality and international trade also figure among concerns.

Cosmetic product/ingredient listing required by new cosmetics regulations will be a boon for CIR, which has conducted its ingredient reviews to date based on limited, voluntary data reporting. Adding new product classifications and subcategories to the US FDA’s listing system could provide needed insight into dry shampoo and other product formats and help identify potential for incidental inhalation risks.