International Regulatory and Compliance Guide for Nutraceutical Companies

The global nutraceutical market is USD 500.62 billion in 2025 and is projected to reach USD 986.85 billion by 2032 with a CAGR of 10.18%, driven by growing consumer demand for wellness solutions, immunity boosters, and functional foods. But here’s the catch—while market opportunity is booming, cross-border compliance is becoming more complex than ever.

Whether you're launching herbal capsules in the US, protein powders in Europe, or Ayurvedic blends in Southeast Asia, your product needs to meet country-specific standards on everything from permissible ingredients to labeling and shelf-life stability. And one misstep—say, a missing allergen warning or an unapproved health claim—can lead to fines, bans, or even full recalls.

So how do successful supplement brands stay ahead?

This blog explores key international nutraceutical regulation from the FDA in the U.S. and EFSA in Europe to evolving frameworks in Asia-Pacific—and shows you how to build a compliance roadmap that scales with your business.

Let’s break it down country by country.

What Are FDA Regulations for Nutraceutical Companies in the U.S.?

In the United States, nutraceuticals—commonly known as dietary supplements. are regulated by the Food and Drug Administration (FDA) under the Dietary Supplement Health and Education Act (DSHEA) of 1994.

Unlike pharmaceuticals, nutraceuticals are classified as a category of food, which means they are not subject to FDA pre-market approval. Instead, manufacturers must ensure the safety and proper labeling of their products before they reach consumers.

What Are the FDA’s Key Compliance Requirements for Nutraceutical Manufacturers?

To comply with FDA regulations, nutraceutical companies must follow Current Good Manufacturing Practices (cGMPs) as specified in 21 CFR Part 111. These guidelines require manufacturers to:

• Establish quality control systems to guarantee the identity, purity, strength, and composition of dietary supplements.
• Maintain detailed documentation, including master manufacturing records and batch production records.
• Implement rigorous quality control operations to ensure consistent product quality.
• Ensure accurate and compliant labeling of supplements according to FDA standards.

How Does FDA Labeling Regulation Impact Nutraceuticals?

FDA labeling regulations mandate that nutraceutical products include:

• A statement of identity clearly declaring the product as a dietary supplement.
• The net quantity of contents on the packaging.
• A Supplement Facts panel detailing active dietary ingredients and their quantities.
• A list of other ingredients such as fillers and binders.
• The manufacturer’s name and contact information.

All claims on labels must be truthful, not misleading, and substantiated with evidence. While the FDA does not approve labels before marketing, it actively monitors compliance and can take enforcement action against false or deceptive labeling.

What Should International Nutraceutical Companies Know About FDA Compliance?

For companies exporting nutraceuticals to the U.S., compliance with FDA regulations is critical. International manufacturers must:

• Adhere to cGMP requirements ensuring product safety and quality.
• Register their manufacturing facilities with the FDA.
• Ensure all product labeling meets FDA standards.
• Be prepared for possible FDA inspections to verify compliance.

How Are Nutraceuticals Regulated in the European Union?

In the European Union (EU), nutraceuticals—commonly referred to as food supplements—are regulated under food law, not as pharmaceuticals. The primary legislation governing these products is Directive 2002/46/EC, which harmonizes the rules for vitamins and minerals used in food supplements across EU Member States. This directive outlines:

• Permitted vitamins and minerals: Annex I lists the vitamins and minerals that can be used in supplements.
• Authorized sources: Annex II specifies the substances that can serve as sources for these vitamins and minerals.
• Labeling requirements: Ensures that consumers receive clear and accurate information about the supplements they consume.

For ingredients beyond vitamins and minerals, such as botanicals or other bioactive substances, regulations may vary. These ingredients might be subject to national rules or other specific EU legislation, depending on their nature and history of use.

What Are the Key EU Regulations Impacting Nutraceutical Manufacturers?

Several EU regulations influence the manufacturing and marketing of nutraceuticals:

• Regulation (EC) No 1925/2006: Addresses the addition of vitamins, minerals, and certain other substances to foods, ensuring consumer safety and preventing misleading information.
• Regulation (EU) 2015/2283 on Novel Foods: Governs the authorization of foods and ingredients not consumed to a significant degree in the EU before May 1997. Manufacturers must obtain approval before marketing such products.
• Regulation (EC) No 1333/2008: Pertains to food additives, stipulating that only authorized additives can be used in food supplements, ensuring they are safe and not misleading to consumers.

How Does the EU Ensure the Safety of Food Supplements?

The European Food Safety Authority (EFSA) plays a pivotal role in safeguarding public health concerning food supplements. EFSA provides scientific opinions to support the evaluations carried out by the European Commission, especially when assessing:

• New ingredients: Substances without a history of safe use in the EU are evaluated under the Novel Foods regulation.
• Health claims: EFSA assesses the scientific substantiation of health claims made on supplement labels.
• Maximum and minimum levels: While Directive 2002/46/EC envisages setting maximum and minimum amounts for vitamins and minerals in supplements, these levels are determined in consultation with Member States and stakeholders. As of now, binding levels have not been established due to the complexity of the issue.

What Should International Nutraceutical Companies Know About EU Compliance?

For companies aiming to enter the EU market, understanding and adhering to the regulatory landscape is crucial:

• Product notification: Some Member States require manufacturers to notify competent authorities before placing a supplement on the market.
• Labeling: Supplements must be labeled in accordance with EU regulations, providing clear information about ingredients, usage, and any health claims.
• Safety assessments: Ingredients not previously used in the EU may require safety evaluations and authorization under the Novel Foods regulation.

By ensuring compliance with these regulations, international nutraceutical companies can confidently market their products within the EU, meeting consumer expectations and legal requirements.

How Are Nutraceuticals Regulated Across the Asia-Pacific Region?

The Asia-Pacific (APAC) region presents a complex and varied regulatory environment for nutraceuticals. Each country has its own set of guidelines, reflecting diverse cultural practices, health priorities, and regulatory frameworks.

For businesses aiming to enter or expand within these markets, understanding these nuances is crucial.

Australia: Enhanced Labeling Requirements for HCA Supplements

Effective March 1, 2025, Australia's Therapeutic Goods Administration (TGA) mandates that complementary medicines containing Garcinia gummi-gutta or other hydroxycitric acid (HCA) ingredients include warnings about potential liver harm. These products must also advise against use by children, pregnant, or lactating women.

China: Revisions to Import Regulations

China's General Administration of Customs is revising its food import regulations, potentially easing market access for foreign nutraceutical manufacturers. However, businesses must stay informed about the evolving compliance requirements.

India: Addressing Regulatory Ambiguities

India's Food Safety and Standards Authority (FSSAI) is working to clarify the distinctions between food and drug regulations, particularly concerning health supplements and nutraceuticals. A Joint Parliamentary Standing Committee has been established to assess and recommend updates to existing laws.

Japan: Implementation of PRISMA 2020 for Functional Claims

Starting April 1, 2025, Japan requires companies making Foods with Function Claims (FFC) to adhere to PRISMA 2020 guidelines when submitting systematic review evidence. This move aims to enhance the transparency and reliability of health claims.

South Korea: Launch of Customized Health Functional Food System

In January 2025, South Korea officially launched its Customized Health Functional Food System. This program allows companies to offer personalized nutrition solutions based on individual health assessments, marking a significant step toward personalized healthcare.

What Should Nutraceutical Companies Consider When Entering APAC Markets?

• Regulatory Compliance: Stay updated with each country's specific regulations, as non-compliance can lead to product recalls or bans.
• Cultural Sensitivity: Understand local consumer preferences and traditional health practices to tailor products effectively.
• Market Research: Conduct thorough market analysis to identify demand, competition, and potential barriers to entry.
• Partnerships: Collaborate with local entities to navigate regulatory landscapes and establish distribution channels.

How to Create a Country-Specific Compliance Roadmap for Nutraceuticals?

Expanding your nutraceutical brand globally requires a meticulous approach to regulatory compliance. Each country presents unique challenges, making a one-size-fits-all strategy ineffective. Here's how to craft a country-specific compliance roadmap:

1. Conduct Comprehensive Regulatory Research: Begin by thoroughly understanding the regulatory frameworks of your target markets. This includes identifying the governing bodies, such as the FDA in the U.S., EFSA in the EU, or FSSAI in India, and their specific requirements for nutraceutical products.
2. Engage with Local Regulatory Experts: Collaborate with local consultants or regulatory affairs professionals who possess in-depth knowledge of regional regulations. Their insights can help navigate complex approval processes and avoid common pitfalls.
3. Develop Customized Compliance Checklists: Create detailed checklists for each country, outlining necessary documentation, labeling standards, permissible ingredients, and health claim regulations. This ensures all aspects of compliance are addressed systematically.
4. Implement Robust Post-Market Surveillance: Establish mechanisms to monitor product performance and consumer feedback post-launch. This proactive approach aids in early detection of compliance issues and facilitates timely corrective actions.
5. Stay Updated with Regulatory Changes: Regulations are dynamic; hence, subscribing to updates from official regulatory bodies and industry news sources is crucial. Regularly reviewing and updating your compliance strategies ensures ongoing adherence to current laws.

By following these steps, nutraceutical companies can effectively navigate the complex regulatory landscapes of different countries, ensuring successful market entry and sustained compliance.

Conclusion

If there’s one thing the most successful nutraceutical brands get right, it’s this: they treat regulatory compliance not as a hurdle, but as part of the product itself. Every label claim, every imported ingredient, every country you want to sell in—it all runs through a maze of rules that can either slow you down or set you apart.

Whether you’re a startup building your first supplement or an established brand planning to scale globally, understanding how to work with—not around—regulatory systems is what separates short-term wins from long-term success.

At Abha Biotechnology, we help supplement brands do just that. From formulation to export, we ensure every product checks the right boxes—FSSAI, FDA, EFSA, and more.

Need a reliable partner to navigate compliance?
Let’s talk about how we can help you launch smarter, faster, and globally ready.