Document Type
Oral Presentation
Location
Oxford Conference Center, Oxford MS
Event Website
https://oxfordicsb.org/
Start Date
8-4-2025 3:00 PM
Description
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) became effective December 29th, 2023 and is the most significant expansion of FDA’s authority to regulate cosmetics since the FD&C Act was enacted in 1938. MoCRA expands the FDA's rulemaking and enforcement authority over cosmetics and creates new compliance obligations for manufacturers. There are six key areas of the legislation including Facility Registration, Product & Ingredient Listing, Safety Substantiation, Cosmetics Labeling, and Adverse Event Reporting and Record Keeping. Each of these areas has significant implications for manufacturers and cosmetic ingredients. Given the ubiquitous presence of botanical and other naturally occurring substances found in cosmetics, these ingredients will certainly be scrutinized for any present or emerging safety issues. FDA has issued guidance on product registration but guidance for other areas such as classification of serious adverse events has not been published. This is important as serious adverse events are defined differently from other FDA regulated products such as OTC-drugs or dietary supplements. Lastly, fragrance and flavor safety are specifically called out in the legislation, especially as to their role in allegedly contributing to SAERs. This requires manufacturers to pay particular attention to any alleged adverse events that might generate a safety signal for the product or its ingredients. This presentation/session is designed to review the first year of regulatory implementation and how manufacturers, regulators, lawyers and product safety experts are dealing with the new regulations. Three experts including an FDA cosmetics regulator, a prominent FDA attorney, and a clinical toxicologist whose healthcare firm is managing AEs on behalf of many of the largest and smallest cosmetic manufacturers in the world will share their views on where we’re at, where we’re going and future implications for natural product scientists.
Recommended Citation
Kingston, Rick, "Cosmetic Adverse Events and the Product Safety Landscape" (2025). Oxford ICSB. 27.
https://egrove.olemiss.edu/icsb/2025_ICSB/Schedule/27
Publication Date
April 2025
Accessibility Status
Screen reader accessible, Searchable text
Included in
Cosmetic Adverse Events and the Product Safety Landscape
Oxford Conference Center, Oxford MS
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) became effective December 29th, 2023 and is the most significant expansion of FDA’s authority to regulate cosmetics since the FD&C Act was enacted in 1938. MoCRA expands the FDA's rulemaking and enforcement authority over cosmetics and creates new compliance obligations for manufacturers. There are six key areas of the legislation including Facility Registration, Product & Ingredient Listing, Safety Substantiation, Cosmetics Labeling, and Adverse Event Reporting and Record Keeping. Each of these areas has significant implications for manufacturers and cosmetic ingredients. Given the ubiquitous presence of botanical and other naturally occurring substances found in cosmetics, these ingredients will certainly be scrutinized for any present or emerging safety issues. FDA has issued guidance on product registration but guidance for other areas such as classification of serious adverse events has not been published. This is important as serious adverse events are defined differently from other FDA regulated products such as OTC-drugs or dietary supplements. Lastly, fragrance and flavor safety are specifically called out in the legislation, especially as to their role in allegedly contributing to SAERs. This requires manufacturers to pay particular attention to any alleged adverse events that might generate a safety signal for the product or its ingredients. This presentation/session is designed to review the first year of regulatory implementation and how manufacturers, regulators, lawyers and product safety experts are dealing with the new regulations. Three experts including an FDA cosmetics regulator, a prominent FDA attorney, and a clinical toxicologist whose healthcare firm is managing AEs on behalf of many of the largest and smallest cosmetic manufacturers in the world will share their views on where we’re at, where we’re going and future implications for natural product scientists.
https://egrove.olemiss.edu/icsb/2025_ICSB/Schedule/27