§5.1 "Pre-market Notification" for New Dietary Ingredients

• Jurisdiction: United States
• Publication year: 2022

§5.1 "Pre-market Notification" for New Dietary Ingredients

Section 8 of DSHEA, entitled "New Dietary Ingredients,"⁴ apparently requires a notification process to inform the FDA a dietary ingredient is to be marketed. The second paragraph of Section 8 requires the manufacturer of the ingredient to provide the Secretary with information relied upon by the manufacturer when the ingredients were determined safe.⁵ The Secretary is required to keep the information confidential for a period of time and then place the information on public display.⁶

In comparison, new drugs under the '38 Act require the filing of an application for review by the FDA.⁷ The Secretary has the right to postpone the effective date of the application in order to study and investigate the application's subject matter.⁸ The Secretary may also refuse to permit the application to become effective if he is not satisfied with the application.⁹

Under the '58 Amendment, food additives not considered GRAS required a petition to be filed with the Secretary.¹⁰ Actions required by the Secretary include establishing a regulation or denying the petition.¹¹ The Secretary's action was based on his determination that the additive is safe.¹²

Therefore, comparing the filing procedure for dietary supplements with new dietary ingredients and the procedures for new drugs or food additives, the bar necessary to be met for new dietary ingredients is significantly lower than that of new drugs or food additives.

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Notes:

^[4] 108 Stat. L. 4331.

^[5] Id.

^[6] Id.

^[7] Pub. No. 717, 52 Stat. L. 1040 (1938).

^[8] Sec. 505(c).

^[9] Sec. 505(d).

^[10] Pub. L. 85-939; 72 Stat. L. 1784 (1958).

^[11] Sec. 409(c)(1).

^[12] 104 Cong. Rec. 17416 (1958).