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Scott Gottlieb, MD 🇺🇸· @ScottGottliebMD · X·· 2026-08-11AI 评分50
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前FDA局长Scott Gottlieb就FDA拟议规则发表评论,认为该规则是FDA在缺乏国会新授权情况下,对“公认安全”(GRAS)食品成分能采取的最大限度监管举措。

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📝This is an important reform. FDA has generally lacked sufficient authority to meaningfully regulate these substances; and that lack of authority has stymied similar actions in the past. In this proposed rule, the agency appears to have gone as far as it can, without new Congressional action, to provide greater oversight of food ingredients that are “Generally Recognized as Safe" (GRAS).

The agency is relying on a new interpretation of existing statute, backing away from its prior finding from 2016 that it lacked express statutory authority to mandate GRAS notices. It's a 140+ page rule that has been carefully drafted (which explains the delay in its promulgation). Nonetheless, it’s likely this rule will be challenged in court if finalized.

Ultimately, the FDA needs a new set of authorities and more resources from Congress. The money to administer this new framework could be a bottleneck. This new rule requires notification, not pre-approval. But consumers will expect the FDA to review what’s in the notifications, and the FDA will try to do that. But the agency may not be properly resourced for that new mission.

https://www.washingtonpost.com/health/2026/08/10/rfk-jr-slated-unveil-plan-targeting-loophole-that-allows-chemicals-food-supply/

来源:Scott Gottlieb, MD 🇺🇸 · x.com