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

• Jurisdiction: United States
• Publication year: 2022

§6.3 A Description of the Dietary Supplement Containing the New Dietary Ingredient⁹

In the 1996 proposal, the FDA stated the description should include the level (amount) of the new dietary ingredient present in the dietary supplement, and the conditions of use of the supplement that are present in the labeling.¹⁰ In the final rule, the FDA supported this requirement, pointing to the fact that statute apparently states that an ingredient can be safe at some levels and unsafe at others. The rule was added to ensure that manufacturers have considered the level or amount of dietary ingredient in the supplement when concluding the supplement to be safe.¹¹

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Notes:

^[9] Code of Federal Regulations §190.6(b)(3)(I and ii).

^[10] Id.

^[11] 62 Fed. Reg. at 49887.