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

IF 4.8 2区 医学 Q1 TOXICOLOGY Archives of Toxicology Pub Date : 2024-07-17 DOI:10.1007/s00204-024-03816-0
George A. Burdock, Erik Hedrick
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Abstract

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.

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安全证明标准的相对性:食品和药物管理局对各种消费品安全标准的审查。
是否所有食品成分、膳食补充剂成分甚至食品都必须符合相同的安全标准?它们是否都同样安全?如果是,那么为什么不同的类别有不同的描述其安全性的表述,如食品成分的 "合理确定无害 "和膳食补充剂成分的 "合理预期无害"?这些不同表述的依据是,它们不是安全标准,而是证明安全的标准。正如在刑事法庭和民事法庭中,证明有罪或过错的阈值不同一样,美国食品药品管理局监管的各类消费品之间也存在差异。本手稿介绍了每种标准的阈值要求,以及决定什么是安全的决策者的身份、他们作为决策者的资质和规定使用的数据库。
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来源期刊
Archives of Toxicology
Archives of Toxicology 医学-毒理学
CiteScore
11.60
自引率
4.90%
发文量
218
审稿时长
1.5 months
期刊介绍: Archives of Toxicology provides up-to-date information on the latest advances in toxicology. The journal places particular emphasis on studies relating to defined effects of chemicals and mechanisms of toxicity, including toxic activities at the molecular level, in humans and experimental animals. Coverage includes new insights into analysis and toxicokinetics and into forensic toxicology. Review articles of general interest to toxicologists are an additional important feature of the journal.
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