CHAPTER 5 Pre-market Notification

• Jurisdiction: United States
• Publication year: 2022

CHAPTER 5 Pre-market Notification Chapter Contents

Introduction

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

§5.2 "A dietary supplement . . ."

§5.2.1 ". . . a vitamin; a mineral . . ."
§5.2.2 ". . . an herb or other botanical . . ."
§5.2.3 ". . . an amino acid . . ."
§5.2.4 ". . . dietary substance . . . to supplement the diet by increasing the total intake . . ."
§5.2.5 ". . . a concentrate, metabolite, constituent, extract, or combination of any ingredient described [in the above clauses] . . ."
§5.2.6 ". . . new dietary ingredient . . ."

§5.3 ". . . shall be deemed adulterated . . ."

§5.4 ". . . under Section 402(f) unless it meets one of the following . . ."

§5.5 First Scenario to Overcome Assumption of Adulteration: ". . . contains . . . dietary ingredients . . . which have been present in the food supply . . . in a form . . . [that] has not been chemically altered . . ."

§5.6 Second Scenario to Overcome Assumption of Adulteration: Premarket Notification Filing

§5.6.1 ". . . history of use or other evidence . . ."
§5.6.2 ". . . when used under the conditions recommended or suggested in the labeling of the . . . supplement . . ."
§5.6.3 ". . . reasonably be expected to be safe . . ."

§5.7 The Manufacturer's or Distributor's Conclusion

Introduction

As this manual focuses on the development of new dietary supplements, emphasis is given to the "New Dietary Ingredient" provision of DSHEA.¹ Below is an analysis of the provision. As mentioned in Chapter 4, Congress stated the Statement of Agreement was to be considered the only legislative history for DSHEA. However, other reports were made with reference to the Act, most notably Senate Report 103-410, which accompanied S. 784.² Whether such reports and documents are advisable in formal legal proceedings is a matter left to the judiciary, not to this handbook.³

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