In the first two parts of this series, we provided an overview of the new US Food and Drug Administration regulatory requirements under the Modernization of Cosmetics Regulation Act of 2022 and the good manufacturing practices regulations FDA plans to establish. In Part III, we will review the new FDA draft guidance on the facility registrations and products listings as mandated by MoCRA.
In the first part of this series, A Legal Makeover Guide for Complying with New Cosmetic Regulations under the Modernization of Cosmetic Regulation Act of 2022 (MoCRA) Part I, we provided an overview of the new US Food and Drug Administration (FDA) ‘s regulatory requirements for cosmetics and their implementation deadlines. In this second part, we will delve into the details and look at the good manufacturing practices regulations the FDA plans to establish for cosmetic products.
Beginning 29 December 2023, the Modernization of Cosmetic Regulation Act of 2022, which was signed into law last year to establish a more strengthened US Food and Drug Administration regulatory framework to ensure the safety of cosmetic products, will begin to take effect. Like with cosmetic application, prepping for full coverage to comply with the new law is important.
On 3 April 2023, FDA issued a draft guidance for industry, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions, for manufacturers whose medical devices use machine learning technologies to improve patient care. Through the draft guidance, FDA intends to provide a least burdensome approach to support iterative improvements to machine learning-enabled device software functions or ML-DSFs through modifications, while continuing to provide a reasonable assurance that the device is safe and effective. In essence, manufacturers can proactively seek FDA’s concurrence with the intended modifications to the applicable devices without additional marketing submissions for each modification in the future.
On 24 March 2023, a notice was published in the Federal Register announcing that the Food and Drug Administration published a framework for the use of digital health technologies (DHTs) in drug and biological product development. DHTs are systems that use computing platforms, connectivity, software, and/or sensors for health care and related uses. FDA previously published draft guidance identifying considerations for the use of DHTs to support clinical investigations and relating to different aspects of DHT use. In the draft guidance, FDA particularly highlighted the importance of verification and validation to ensure the DHTs are for fit-for-purpose for use in the clinical investigation. Further, remote data acquisition through DHTs may raise issues including data privacy and confidentiality concerns.
On 13 March 2023, FDA issued a notice regarding guidance documents related to the COVID-19 pandemic, including which of the guidance documents will no longer be in effect after expiration of the declaration of the COVID-19 public health emergency (PHE). The notice followed a Department of Health and Human Services announcement on 9 February that it is planning for the declaration of the PHE to expire on 11 May 2023.
On 6 March 2023, FDA issued a Dietary Supplement Ingredient Directory. The Directory is hosted on the agency’s website and is intended to help the public quickly find what the FDA has said about a specific ingredient and whether the agency has taken any action with regard to the ingredient. Importantly, the Directory will replace the previous FDA Dietary Supplement Ingredient Advisory List, which listed ingredients identified by the agency as not lawfully marketed in dietary supplements.
The US Food and Drug Administration ensures the quality of drug products by carefully monitoring both domestic and foreign drug manufacturers’ compliance with its Current Good Manufacturing Practice regulations. With over 350 manufacturing establishments supplying the US drug market, China represents one of the two countries with the most foreign drug establishments subject to FDA inspection.
The US Food and Drug Administration ensures the quality of drug products by carefully monitoring both domestic and foreign drug manufacturers’ compliance with its Current Good Manufacturing Practice regulations. With over 350 manufacturing establishments supplying the US drug market, China represents one of the two countries with the most foreign drug establishments subject to FDA inspection.
On 24 January 2023, the US Food and Drug Administration issued draft guidance on action levels for lead in certain categories of processed foods intended for babies and children under two years of age. These action levels reflect levels of lead at which FDA may regard the food as adulterated within the meaning of section 402(a)(1) of the Federal Food, Drug & Cosmetic Act. FDA will consider these action levels when determining whether to bring an enforcement action.