§7.2 "Approval" Letter or "Rejection" Letter?

• Jurisdiction: United States
• Publication year: 2022

§7.2 "Approval" Letter or "Rejection" Letter?

The Congressional intent in passing the DSHEA and the FDA promulgated regulations contain numerous statements indicating the FDA shall not have the authority to approve or reject a dietary supplement containing new dietary ingredients.¹³ However, review of FDA communications in reply to notification submissions reveals the FDA may have established an approval or rejection process. The establishment of such a process may be against the intent of the statute and a shift from FDA promulgated regulations.

While this manual's intent is to be neutral in its analysis of regulation of dietary supplements, current FDA notices raise awareness to the point where the notices deserve further attention.

On October 20, 1994, a notice was published in the Federal Register for a public meeting to be held at the Center for Food Safety and Applied Nutrition (the division that handles food regulations).¹⁴ The public meeting was held to obtain comments from interested parties in regard to the new dietary ingredients.

Proposed issues to be commented on were put forth by the FDA. For example:

• "What changes in chemical composition to a dietary ingredient would cause it to become a substance that is not a dietary ingredient?"¹⁵
• "What types of chemistry information should be included to describe an NDI [new dietary ingredient] for purposes of the NDI notification? Please consider the following types of information . . ."¹⁶
• "What types of information should be included to describe a botanical NDI for purposes of the NDI notification? Please consider the following types of information: . . ."¹⁷
• "Is there other information that should be included in a botanical NDI notification due to unusual production conditions of the botanical? Please consider the following possible conditions . . ."¹⁸
• "Is there processing information that should be included in the description of a botanical extract in order to adequately describe the NDI? Please consider the following information . . ."¹⁹
• "What types of information should be included in an NDI notification in order to establish a reasonable expectation of safety based upon history of use? Please consider the following types of information . . ."²⁰
• "In considering the data and information necessary to establish reasonable expectation of safety, how would the following differences in the use of the NDI in the dietary supplement from historical use affect safety determinations?"²¹

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