With a projected U.S. market size of over $300 billion by 2030, the dietary supplement category has never presented more opportunities for brand success.
At the same time, competition is fierce as companies get more niche with competitive claims, innovative formulations, and new ways to address the top health concerns driving shoppers to the supplement aisle.
Our team can help to prepare regulatory notifications for new dietary ingredient submissions and/or structure-function claim notifications. We can evaluate your claims portfolio, or develop a clinical research strategy to support new or innovative claims to strengthen your competitive position in the market. Our team can recommend strategic pathways which you may not have considered, and can liaise with the FDA on your behalf. We can also provide creative and packaging services to strengthen your brand image while staying compliant.
Our U.S. dietary supplement compliance services include:
- Product development consulting and strategic planning
- Liaising with FDA
- Regulatory feasibility assessments
- Health claim validation
- Structure Function Claim Notifications to the FDA
- Dietary supplement label compliance (and Supplement Facts Panels)
- Dietary supplement clinical trials
- New Dietary Ingredient (NDI) Notifications to the FDA