§7.1 After Submission

• Jurisdiction: United States
• Publication year: 2022

§7.1 After Submission

§7.1.1 Acknowledgment¹

The 1996 proposal indicated that the day a notification is filed is its filing date.² For seventy-five days after the filing date, the manufacturer is not to introduce or deliver for introduction the dietary supplement containing the new ingredient. This allows the FDA time to determine whether there is a basis for concern about the supplement containing the new ingredient.³ One commentator proffered that as this provision was not contained in the act, it was unnecessarily restrictive; in essence the manufacturer should be permitted to market the supplement upon FDA's completion of the review regardless whether or not seventy-five days has expired.⁴ In not agreeing with the commentator, the FDA shed light on the review process of the notifications, saying that, "[b]ecause there is no requirement that the notification provide a comprehensive safety review of the new dietary ingredient, [the notification] is not likely to provide the agency with a basis to find that there is no concern."⁵

§7.1.2 Amendments⁶

In the event that additional information is submitted by the manufacturer in support of the notification, the filing date will be reset. This was done to allow the FDA an opportunity to examine all the newly submitted information.⁷ In response to a comment inferring the FDA should be more flexible when deciding when to reset the filing date, the final rule stated the filing date will be reset when amendments are substantial.⁸

§7.1.3 90-Day Publication and Trade Secret Protection⁹

Ninety days after the notification filing date, the notification will be placed on public display. Currently, this information is posted on the FDA database 95S-0316. An exception was made with regard to information that is a trade secret or confidential commercial information.

§7.1.4 Failure of FDA to Respond to Notification¹⁰

The FDA asserts that its failure to respond to a notification is not an indication that it believes the new dietary ingredient is safe.¹¹ The provision reflects the fact that the manufacturer makes the conclusion a supplement containing the new ingredient is safe, not the FDA. The FDA enunciated its position in the 1996 proposal as, ". . . the agency will not be in a position to make a determination that the supplement is safe, or that it is not adulterated under section 402 of the act."¹² To this provision, no comment was proffered and no further FDA statement was forthcoming in the final rule.

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