Final answer:
The FDA must be notified by a dietary supplement manufacturer or distributor when a new dietary ingredient is added to a product at least 75 days before marketing the supplement in the United States. The notification should include evidence that the new ingredient is reasonably expected to be safe. This is as per the DSHEA of 1994.
Step-by-step explanation:
A manufacturer or distributor must notify the Food and Drug Administration (FDA) about a dietary supplement it intends to market in the United States in certain circumstances. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), responsibility for determining the safety of the dietary supplements shifted from the government to the manufacturer. As a result, dietary supplements do not require approval from the FDA before they are marketed unless they contain a new dietary ingredient that was not sold in the US in a dietary supplement before October 15, 1994.
When a new dietary ingredient is added to a supplement, the FDA must be notified at least 75 days before the product is introduced to the market. The notification must include information that demonstrates that the new ingredient is reasonably expected to be safe for consumption. If the FDA does not raise any objections or concerns within 75 days, the supplement can be legally marketed.