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

• Jurisdiction: United States
• Publication year: 2022

§6.4 Submission of Information Showing History of Use or Other Evidence of Safety¹²

The nature of the information to be submitted (kind, quality, quantity) is apparently at the discretion of the manufacturer.¹³ The information should form the basis on which he concludes the supplement containing the new ingredient is reasonably safe.¹⁴ In the final rule, one comment suggested the FDA provide regulation as to the quality and quantity of information submitted, that new dietary ingredients to be required to be GRAS, and that manufacturers be required to provide summary of studies and scientific data.¹⁵ In rejecting these suggestions, the FDA reiterated the procedural nature as opposed to substantive nature of DSHEA and stated "the agency, however, in deciding what information needs to be provided, is bound by the standard of the act. It is not free rewrite the law . . ."¹⁶

In responding to establishing GRAS status for new dietary ingredients, the FDA set forth manufacturers have the first determination of safety for a dietary supplement containing a new ingredient in comparison to GRAS articles:

". . . there is a fundamental difference between who is to make at least the initial judgment of safety . . . GRAS is based on the judgment of 'experts qualified by scientific training and experience to make' . . . a notification . . . for a new dietary ingredient provides . . . the manufacturer . . . is to determine whether . . . [the dietary supplement] . . . will reasonably be expected to be safe."¹⁷

The 1996 proposal stated that in addition to the list of references, copies of the references should be submitted, along with English translations when necessary.¹⁸ This was deemed necessary for the efficiency of the Notification process.¹⁹ This rule was continually supported in the final rule, with reasons being many cited references were not available in the United States or online, and English translations of foreign documents were sometimes not available.²⁰

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Notes:

^[12] Code of Federal Regulations §190.6(b)(4).

^[13] Note 11 at 49888: ". . . the statute does not specify or limit what evidence a manufacturer or distributor may rely on in determining whether the use of the ingredient will reasonably be expected to be safe."

^[14] See, 108 Stat. L. 4321 at sec. 2.

^[15] Id., note 2 at 49887-49889.

^[16] Id., at 49888.

^[17] Id.

^[18] 61 Fed. Reg. at 50775.

^[19] Id.

^[20] At 49889.