Guidance is due within one year and the new rule applies at once
What the document says“Section 505(j)(3)(H) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), applies beginning on the date of enactment of this Act, irrespective of the date on which the guidance required by subsection (b) is finalized.”
Subsection (b) of section 6703 requires the Secretary to issue or update draft guidance within one year of enactment on how the sameness determination will be made, including how pH adjusters are assessed, to allow at least 60 days for comment, and to publish final guidance within one year of the comment period closing. Subsection (c) provides that the new rule applies from enactment, whether or not the guidance is final.
What the document actually says“Section 505(j)(3)(H) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), applies beginning on the date of enactment of this Act, irrespective of the date on which the guidance required by subsection (b) is finalized.”
The new rule starts on the day this law passed. It does not wait for the guidance to be finished.
Draft guidance is due within a year, with 60 days for comment. The final version comes a year after that. The rule runs the whole time.
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