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The largest wellness category in U.S. retail, the most crowded, and the one where the regulatory position is most often misunderstood by brands entering from abroad.
What's different here
FDA does not approve supplements before sale. Responsibility for safety and labeling sits with the company placing the product on the market — faster to enter, far less forgiving of error.
An ingredient not marketed in the U.S. before October 1994 may require notification well ahead of launch. This is the item that most often derails a schedule.
What you can say determines where the product sits and which buyer will take the meeting. Claims are a commercial decision before they are a regulatory one.
Specialty and drug buyers ask how the product already sells. Marketplace performance built deliberately is what makes a first meeting productive.
U.S. Market Assessment
Send us your product and your numbers. We come back with a written assessment of what entering U.S. retail would require and what it would realistically return.
