§5.6 Second Scenario to Overcome Assumption of Adulteration: Pre-market Notification Filing

• Jurisdiction: United States
• Publication year: 2022

§5.6 Second Scenario to Overcome Assumption of Adulteration: Pre-market Notification Filing

Manufacturers or distributors of supplements containing new dietary ingredients may choose to overcome the assumption of adulteration by filing a Pre-market Notification. As laid out in the provision, a notification process was created wholecloth ". . . at least 75 days before being introduced or delivered for introduction into interstate commerce, the manufacturer or distributor provides the Secretary with information . . ."⁷⁶ The procedures for pre-market notification of dietary supplement comprising new dietary ingredients are discussed in Chapter 6. Below is a substantive analysis of the information that should be submitted with the pre-market notification filing.

§5.6.1 ". . . history of use or other evidence . . ."

As "history of use" is not defined in the Act or the accompanying report, the phrase ". . . common use . . ." as used in the Food Additives Amendment of 1958 to show a food additive to be GRAS⁷⁷ may help in defining "history of use." In one bill put forward to create the food additives amendment, "prolonged use" was used; however, in the final bill that was enacted, "common use" was substituted.⁷⁸ This was apparently done to emphasize the nature of the usage as opposed to the length of time it was used. Use of the phrase "history of use" may indicate an intent by Congress to emphasize the past use of the ingredient but perhaps not the length of time that it was used.

Information qualifying as "common use" was an issue addressed by the courts. One case held that information obtained from another country was suitable as evidence of "common use."⁷⁹

Regarding "other evidence of safety," the '58 Amendment allowed GRAS status to food additives that were shown to be safe through "scientific procedures."⁸⁰ As it was Congress' intent that dietary supplements would not be regulated as food additives, and Congress used the phrase "other evidence" as opposed to "scientific procedures," "other evidence" may be any information that shows safety, including but not exclusively scientific procedures.

§5.6.2 ". . . when used under the conditions recommended or suggested in the labeling of the . . . supplement . . ."

An example of "conditions of use" given in the report accompanying S. 784 was "take with meals."⁸¹ "Take one tablet three times per day" was given as an example of directions for use.⁸² It was Congress' stated intent that the labeling possess...