US Supplement Industry Pushes FDA for Broad Dietary Substance Definition
US supplement manufacturers and brand owners advocate for a broad interpretation of 'dietary substance' under DSHEA, emphasising innovation and clear science-based criteria for ingredient identity.
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Washington D.C., United States — The US supplement industry is pushing the Food and Drug Administration (FDA) to adopt a broad, innovation-centric definition of 'dietary substance' under the Dietary Supplement Health and Education Act (DSHEA). Industry groups contend that the FDA should recognise ingredients beyond those historically found in the food supply, fostering product development.
Key manufacturers and brand owners argue that manufacturing methods alone should not alter an ingredient's identity or create new regulatory compliance hurdles. Instead, the focus should remain on documented safety and verifiable characteristics. This stance aims to prevent the reclassification of established ingredients, which could trigger significant reformulation costs and market disruption.
Multiple industry associations, including the Council for Responsible Nutrition (CRN) and Natural Products Association (NPA), are calling for the FDA to establish precise, science-backed criteria for ingredient identity and 'sameness'. This is particularly crucial for complex ingredients such as novel proteins, specialty fibres, and probiotic strains, where subtle processing variations can lead to regulatory ambiguity. Transparent labelling practices are also advocated to differentiate between traditional and contemporary production methods, ensuring consumer clarity without impeding innovation.
The prevailing industry view, as reported by NutraIngredients Global, confirms that regulatory oversight should prioritise ingredient safety and scientific evidence. This approach would permit innovation within the supplement sector while leveraging DSHEA's established mechanisms for rigorous safety assessments and post-market surveillance.
What this means for United States
US manufacturers face potential disruption if the FDA does not adopt a flexible 'dietary substance' interpretation. A restrictive view could force significant reformulation efforts for 15-20% of current product lines, incurring substantial R&D expenditure. Procurement teams should monitor FDA guidance updates closely for specific ingredient classifications, while brand owners must prepare agile new product development pipelines to capitalise on accepted novel ingredients. Regulatory affairs teams need to engage with industry coalitions to influence policy, ensuring clarity reduces long-term compliance costs and maintains market access for advanced formulations.
Brand owners increasingly rely on contract-manufacturing partners such as Supplement Factory to navigate these requirements.