The relative nature of the standards for proof of safety: a review of FDA's safety standards for various consumer products.

Autor: Burdock GA; Burdock Group a Safety and Regulatory Consulting Firm, Orlando, FL, USA. gburdock@burdockgroup.com., Hedrick E; Burdock Group a Safety and Regulatory Consulting Firm, Orlando, FL, USA.
Jazyk: angličtina
Zdroj: Archives of toxicology [Arch Toxicol] 2024 Oct; Vol. 98 (10), pp. 3209-3214. Date of Electronic Publication: 2024 Jul 17.
DOI: 10.1007/s00204-024-03816-0
Abstrakt: Are all food ingredients, dietary supplement ingredients and even foods, required to meet the same safety standards? Are they all equally safe? If so, then why do the various categories have different expressions describing their safety, such as "reasonable certainty of no harm" for food ingredients and "reasonable expectation of no harm" for dietary supplement ingredients? The basis for these different expressions is that they are not standards of safety, but standards of proof of safety. Just as in criminal vs. civil courts, the threshold for proving guilt or fault is different, so too are there differences between various categories of consumer products regulated by the US Food and Drug Administration. This manuscript describes the threshold requirements for each standard, as well as to the identity of the decision makers on what is safe, their credentials as decision makers and the databases mandated for their use.
(© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)
Databáze: MEDLINE
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