§6.5 Signature of Person Designated by Manufacturer

• Jurisdiction: United States
• Publication year: 2022

§6.5 Signature of Person Designated by Manufacturer²¹

In the 1996 proposal, the signature of an authorized official of the manufacturer was required to ensure the accuracy, completeness, and understandability of the notification.²² In response to a comment about this provision, the FDA asserted it did not intend the manufacturer designate a particular person to prepare the notification, rather it intended the person who signs the notification be familiar with the filing and be available to answer questions about the filing.²³ To make the intention clear, the final rule changed the proposal so that a "person" as opposed to an authorized official" be required to sign the notification.²⁴

Ensuring the accuracy, completeness, and understandability of the notification was not meant to "certify" the notification.²⁵ Signing the notification is to ensure the information submitted is a fair and accurate representation of the information used by the manufacturer when concluding the dietary supplement containing the new dietary ingredient is safe.²⁶ Intentionally omitting information may be violation of 18 U.S.C. 1001.²⁷

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Notes:

^[21] Code of Federal Regulations §190.6(b)(5).

^[22] Id., note 1 at 49889.

^[23] Id.

^[24] Id.

^[25] Id.

^[26] Id.

^[27] Buckman Co. v. Plaintiffs' Legal Committee, 531 U.S. 341, 348 (2001); 18 U.S.C. 1001: ". . . whoever, in any matter within the jurisdiction of the executive, legislative, or judicial branch of the Government of the United States, knowingly and willfully."