Dietary supplements sold or imported into the U.S. must comply with strict FDA labeling regulations under 21 CFR Part 101. Non-compliant labels can lead to import refusals, product recalls, warning letters, and enforcement actions. Our Dietary Supplement Labeling Compliance Services ensure your product labels meet all regulatory requirements, helping you avoid costly mistakes and ensuring seamless market entry.
The U.S. Food and Drug Administration (FDA) closely monitors dietary supplement labels to ensure products are safe, accurately represented, and compliant with legal standards.
Common labeling mistakes that result in regulatory penalties include:
Our Dietary Supplement Labeling Compliance services provide comprehensive label reviews, ensuring your products meet all FDA labeling requirements for smooth importation and distribution.
Our expert label PCQIs will conduct a comprehensive review of your product labels and offer support to ensure full compliance with FDA dietary supplement labeling requirements.
The Supplement Facts panel is a critical component of dietary supplement labeling. We ensure serving sizes, nutrient amounts, and daily value percentages are accurate and properly formatted.
The FDA requires accurate ingredient lists and allergen disclosures for dietary supplements. We review your labels for ingredient safety and allergen compliance.
Structure-function claims describe how a product supports normal body functions . The FDA regulates these claims, and non-compliance can lead to misbranding violations.
Certain dietary supplements require FDA-mandated warnings based on intended use, ingredient risks, or health concerns. We ensure all necessary warnings and disclaimers are included.
Expanding to global markets requires meeting UK Trading Standards and EU food supplement labeling regulations. We ensure international compliance for smooth cross-border sales.
We focus exclusively on FDA dietary supplement regulations, ensuring labels meet all legal requirements.
From Supplement Facts panel creation to international labeling compliance, we provide complete labeling support.
We help you avoid costly delays, detentions, and recalls due to labeling mistakes.
Our services ensure compliance across U.S., UK, and EU markets, accelerating global distribution.
Read what our clients have to say about our services and how we have helped them export product.
A Supplement Facts panel provides information about:
Yes, but claims must be:
Under FALCPA, dietary supplements must declare the presence of:
Non-compliant labels can result in:
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Accurate and compliant labeling is essential for FDA approval, market success, and risk mitigation. Our Dietary Supplement Labeling Compliance Services ensure your labels meet all U.S. and international regulatory requirements, avoiding costly detentions and protecting your brand reputation.
Our friendly team is always happy to help and will reach out as soon as possible.
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