Document
cjd_8f21a0c7 · opaque id · no party names
Module / Corpus
FDA · v0.9.4 · 218,000 records · 12 Parts
Authority Cited
21 CFR §541.101(a)
Issued
2026-05-25 · 19:47:11 UTC
Proposition
"Manufacturers of dietary supplements must submit a Pre-Market Notification to the Secretary at least 75 days before introducing a new ingredient, per 21 CFR §541.101(a)."
Cited Text
For the purposes of this part, the term "new dietary ingredient" means a dietary ingredient that was not marketed in the United States before October 15, 1994, and does not include any dietary ingredient which was marketed in the United States before October 15, 1994.
Ruling
The cited subsection is a definitions clause. It establishes what the term "new dietary ingredient" means; it does not impose a 75-day pre-market notification duty on manufacturers. The asserted duty is at 21 USC §350b, not in the cited regulatory subsection. Verdict: Reject.
Hash Chain
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Signed By
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