CHAPTER 6

• Jurisdiction: United States

CHAPTER 6 Filing Pre-market Notifications—FDA Procedural Regulations (Henceforth "Manufacturer")

Chapter Contents

§6.1 Name and Complete Address of Manufacturer or Distributor (Henceforth "Manufacturer")

§6.2 The Name of the New Dietary Ingredient and the Latin Binomial Name (Including Author) of Any Herb or Other Botanical

§6.3 A Description of the Dietary Supplement Containing the New Dietary Ingredient

§6.4 Submission of Information Showing History of Use or Other Evidence of Safety

§6.5 Signature of Person Designated by Manufacturer

§6.6 Method of Filing Pre-market Notifications—COSM

The FDA proposed regulations regarding new dietary ingredient filings in 1996.¹ After a comment period, the regulations were made final on year later.² To be submitted at least 75 days before being introduced or delivered into interstate commerce,³ notifications should contain:

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Notes:

^[1] 61 Fed. Reg. 50774 (1996).

^[2] 62 Fed. Reg. 49886 (1997).

^[3] 108 Stat. L. 4321 at sec. 413(a)(2).