The U.S. dietary supplement and functional food market continues to grow rapidly, but regulatory compliance remains a critical factor for success. Companies entering or expanding in the United States must pay close attention to evolving requirements from FDA (Food and Drug Administration) and FTC (Federal Trade Commission).
FDA Oversight on Dietary Supplements
The FDA regulates dietary supplements under DSHEA (Dietary Supplement Health and Education Act). This requires strict compliance with cGMP (21 CFR Part 111), accurate labeling, and scientifically supported structure/function claims. Recently, the FDA has increased inspections on imported supplements and raw materials, especially focusing on:
- Quality documentation (COA, testing reports, third-party certifications)
- Ingredient safety (GRAS status, New Dietary Ingredient notifications)
- Label transparency (non-GMO, allergen statements, organic claims)
FTC Guidance on Advertising & Claims
The FTC closely monitors marketing claims for dietary supplements, natural sweeteners, and functional ingredients. Any health-related claims must be supported by competent and reliable scientific evidence. This means that exaggerated claims or unverified clinical benefits can lead to enforcement actions.
Trends in Key Ingredients
- Minerals & Vitamins: Remain core to the U.S. nutrition market, but must meet USP standards.
- Amino Acids: Widely used in sports nutrition, requiring purity and safety validation.
- Sweeteners: Natural and high-intensity sweeteners such as Stevia, Monk Fruit, Neotame, Advantame, NHDC, and Trilobatin are under increasing consumer and regulatory attention, especially regarding “clean label” positioning.
- OEM/Private Label Supplements: Contract manufacturing must comply with FDA’s cGMP, ensuring product consistency, safety, and traceability.
How Nu-Activ Supports Compliance
At Nu-Activ, we not only supply premium minerals, vitamins, amino acids, sweeteners, and food additives, but also provide nutraceutical OEM solutions that align with U.S. regulatory requirements. With complete documentation (COA, MSDS, Non-GMO, allergen statements) and professional support, we help our clients confidently enter the U.S. market.
Staying informed about U.S. regulatory updates ensures product safety, consumer trust, and long-term business success.
