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- CHAPTER 6 Filing Pre-market Notifications FDA Procedural Regulations (Henceforth "Manufacturer")
§6.2 The Name of the New Dietary Ingredient and the Latin Binomial Name (Including Author) of Any Herb or Other Botanical
Jurisdiction | United States |
Publication year | 2022 |
§6.2 The Name of the New Dietary Ingredient and the Latin Binomial Name (Including Author) of Any Herb or Other Botanical7
In the 1996 proposal, the FDA indicated this information was necessary so that the new dietary ingredient will be known and the agency will be able to determine if the information submitted in support of the ingredient is appropriate. While no example was given in the proposal, the 1997 final rule contained an example of the Latin binomial and author for a botanical.8
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Notes:
[7] Code of Federal Regulations §190.6(b)(2).
[8] Id.
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Request your trial- Title
- CHAPTER 6 Filing Pre-market Notifications FDA Procedural Regulations (Henceforth "Manufacturer")
- CHAPTER 6
- §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
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