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Food and Drug Law Articles by Eric F. Greenberg

RECENT ARTICLE
by Eric F. Greenberg

An interesting rulemaking, if you like that sort of thing

In today’s column, I try to persuade you that the way FDA has lately been making regulations is unusual, surprising, and interesting. Yes, I know how that sounds. But the regulations are crucially important to food companies, so it’s useful to watch them develop and perhaps even get involved.

The typical sequence for agencies making regulations (OK to call them “rules”) is, first, they issue a proposed regulation, inviting the public to comment on it. Second, they mull over all the comments, make changes to the proposal as they see fit, and third, issue the final regulation, revised perhaps in light of the comments, together with detailed explanations of why they did what they did. Fourth, the final regulation becomes effective at some date after its publication.

Watchers of the FDA’s seven separate proposed regulations growing out of the Food Safety Modernization Act were surprised in September, because FDA didn’t follow the typical sequence. They had been proposed, and had been commented upon by the public. But instead of issuing final versions of the regulations, which was the expected next step, FDA issued slightly revised proposed versions of four of them. Comments on the revised proposals are due by December 15. Final versions of the regulations are expected in 2015.

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