§8.3 Affect of "Rejected" Notification on Dietary Supplement with New Dietary Ingredient Importation

• Jurisdiction: United States
• Publication year: 2022

§8.3 Affect of "Rejected" Notification on Dietary Supplement with New Dietary Ingredient Importation

Section 801 of the Federal Food Drug, and Cosmetic Act relates to the importation of articles under the Act. Paragraph (a) sets forth that the Secretary of the Treasury shall deliver to the Secretary of Agriculture a sample of imported article if requested to do so.²⁷ After examination, if it appears that the article is adulterated under the Act, then the article will be denied admission.²⁸ The examination may occur by evaluating the entry documents.

In a case of importing a dietary supplement containing a new dietary ingredient, if the FDA has made the determination that the supplement is "adulterated" under Section 4 of DSHEA,²⁹ the supplement may be refused entry.

In the event an imported supplement containing a new dietary ingredient is denied entry, suit may be filed against the entry denial in the jurisdiction where the entry denial occurs. As entry denial is based on Section 4 of DSHEA, the FDA "shall have the burden of proof"³⁰ to show that the supplement contains a new dietary ingredient where there is ". . . inadequate information to provide a reasonable assurance . . ." that the ingredient ". . . does not present a significant or unreasonable risk of illness or injury."³¹

In October 2003, interim final rules requiring prior notice of imported foods were published in the Federal Register.³² Under the interim rules, in order to implement the Public Health Security and Bioterrorism Act of 2002,³³ importers will be required to submit prior notification of imported food in addition to meeting admissibility under Section 801.27. The information should be submitted electronically, and should be received by the FDA no more than 5 days and no less than 8 hours before receiving water shipments, no less than 4 hours before receiving air or rail shipments, and no less than 2 hours before receiving road shipments.³⁴

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Notes:

^[27] 52 Stat. L. 1058 at sec. 801(a) (1938).

^[28] Federal Food, Drug, and Cosmetic Act, 52 Stat. L. 1040, sec. 801(a)(3).

^[29] Id.

^[30] Id.

^[31] 108 Stat. L. 4328 at sec. 4.

^[32] 68 Fed. Reg. 58,974 (2003).

^[33] Pub. L. 107-188 (2002).

^[34] Id.