Review of the standards of proof (of safety) for FDA regulated consumer products and how the generally recognized as safe criteria could be applied to cosmetics.
Regul Toxicol Pharmacol
; 149: 105603, 2024 May.
Article
in En
| MEDLINE
| ID: mdl-38494042
ABSTRACT
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) amends the Food, Drug and Cosmetic Act (FDCA), elevating the standard of proof of safety (better known as a "safety standard") for cosmetics to the standard of a "reasonable certainty
[of]
safe."a standard equal to that of food ingredients. The standards of the proof of safety differ for various classes of FDA-regulated product categories e.g., cosmetics, dietary supplements, food ingredients and food itself. This manuscript describes the various standards of proof, the essential differences between the standards, key elements required to achieve a particular standard and, compares the standards to more familiar legal terms such as "a preponderance of the evidence" or "beyond reasonable doubt." The standards of proof for these product categories are also ranked according to increasing threshold for achievement of "safe" status. Lastly, this manuscript suggests how the requirements for the high standard of a "reasonable certainty of safe" (or "reasonable certainty of no harm") might be met.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
United States Food and Drug Administration
/
Consumer Product Safety
/
Cosmetics
Limits:
Animals
/
Humans
Country/Region as subject:
America do norte
Language:
En
Journal:
Regul Toxicol Pharmacol
Year:
2024
Document type:
Article