Dietary Supplements, Consumer Health & Non-Prescription

What's typically included

• U.S. regulatory framing — whether the product belongs in the dietary supplement frame under DSHEA, in the OTC drug frame, in the conventional food/functional food frame, or in a combination posture, and the implications of each.
• Claims feasibility — structured review of intended claims against the structure/function vs. drug-claim line, and the evidence that would be needed to defend them.
• Quality & specification expectations — senior read on what 21 CFR Part 111 expects of the product, the formulation, the contract manufacturer, and the brand owner.
• Scientific & evidence strategy — pragmatic recommendations on the evidence the product actually needs to support its U.S. claims and retailer requirements.
• Commercial positioning — how the product can credibly hold its place in U.S. retail and channel, including label, claims, and category framing.

When this is the right conversation

Global brands typically engage RGM here when a product that performs in another market is being readied for the U.S.; U.S. supplement companies when a new product concept needs an early read on whether it sits inside DSHEA or crosses into drug-claim territory; and consumer health innovators when claims, evidence, and quality need to be reconciled before a launch is committed.

Output you can use

A documented view of where the product fits in the U.S. regulatory landscape, what it can and cannot claim, what evidence and quality posture it needs to defend that position, and what changes (formulation, label, claims, manufacturing posture) are required to make the U.S. version viable. Written so it can drive a launch decision at the leadership table.