,Global Herbal Supplements Compliance Services - Overview
As the demand for herbal supplements continues to rise globally, navigating the complex regulatory landscape becomes increasingly crucial for manufacturers, brand owners, and private label entities. Each market presents a unique set of regulations, documentation requirements, and compliance standards, making it essential to have a thorough understanding of the global regulatory environment.
In the United States, herbal supplements are regulated under the Dietary Supplement Health and Education Act (DSHEA), which requires manufacturers to ensure product safety and proper labeling. In the European Union, herbal supplements must comply with the European Food Safety Authority (EFSA) guidelines, which require safety and efficacy evidence. In Asian markets like Japan, South Korea, and China, there are stringent regulations that require detailed documentation and testing, while Canada mandates compliance with the Natural Health Product (NHP) Regulations.
Key Herbal Ingredients and Their Global Regulatory Landscape
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Korean Ginseng (Panax Ginseng)
China: Classified as a novel food ingredient with strict guidelines on source, dosage, and population restrictions.
South Korea: Permitted in food and health functional foods without specific limits
United States: Approved as a dietary supplement under FDA regulations
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Red Ginseng (Panax Ginseng)
China: Similar to Korean Ginseng, it is tightly regulated under novel food guidelines.
South Korea: Widely accepted and used in health functional foods, often without limits.
European Union: Permitted as a food supplement.
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Siberian Ginseng (Eleutherococcus senticosus)
Russia: Extensively used in traditional medicine, and widely accepted without strict regulations.
United States: Marketed as a dietary supplement, requiring compliance with DSHEA under FDA oversight.
European Union: Accepted as a herbal supplement but must adhere to specific herbal monographs.
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American Ginseng (Panax quinquefolius)
United States: Protected under CITES (Convention on International Trade in Endangered Species) due to its status as a native species; compliance with FDA regulations is also required.
Canada: Approved as a Natural Health Product (NHP) under Health Canada regulations, with specific guidelines on dosage and labelling.
China: Highly valued and imported extensively, but subject to rigorous import regulations and quality standards.
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Turmeric
Widely used globally, with varying regulations, particularly in terms of curcumin content and health claims.
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Ashwagandha
Accepted in many markets, but with specific dosage guidelines and restrictions, particularly in the European Union and United States.
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Tulsi (Holy Basil)
Considered a traditional remedy in India, with growing acceptance in Western markets as a dietary supplement.
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Green tea
Globally recognized, but regulations focus on antioxidant content and allowable health claims.
How Freyr Can Help
At Freyr Solutions, we offer end-to-end regulatory Herbal Supplement Compliance services to help businesses navigate the complex global landscape of herbal supplement registration. Our services include:
- Regulatory Strategy and Market Entry: Developing tailored Herbal Supplements Market Entry strategies for new markets, considering the specific regulatory requirements of each country.
- Product Classification and Registration: Assisting in determining the correct Herbal ingredient compliance, Herbal supplement product classification, and completing the necessary Herbal Supplements registration processes with relevant Health Authorities (HAs).
- Labeling and Claims Compliance: Ensuring that all product labels and health claims meet Herbal Supplements Labeling requirements.
- Safety Assessments and Documentation: Conducting comprehensive Herbal Supplements Safety Assessments and preparing the required documentation, including scientific evidence and Certificates of Analysis (COAs).
- Regulatory Submissions: Managing the entire submission process, from compiling the necessary documentation to liaising with regulatory bodies on behalf of our clients.
- Herbal Supplements Regulatory Intelligence: Keeping clients informed of the latest regulatory updates and changes in the global Herbal Supplements Market, ensuring ongoing compliance and market access.
- Regulatory Training and Support: Offering training programs to help businesses understand and comply with regulatory requirements in their target markets.
Why Choose Freyr
- Cost-effective consultation services.
- End-to-end regulatory services for Herbal Supplements.
- Qualified team of experts with hands-on experience across all categories of health foods like health supplements, dietary supplements, nutraceuticals, health functional foods, health functional beverages, foods for special dietary use, etc.
- Support for region-specific regulatory complexities.
- Claims supporting data consultation and advice.
- Extensive partner network across the globe.
- A strong relationship with global HAs.
- A structured approach to ensure quick market access.
Freyr Solutions ensures seamless herbal supplement regulations compliance, enabling you to bring high-quality, compliant products to market with confidence.
Frequently Asked Questions (FAQs)
01. What regulatory standards apply to herbal supplements globally?
Herbal supplements must meet varying regulatory standards depending on the region. For example, the U.S. follows DSHEA under FDA oversight, the EU complies with EFSA guidelines, and countries like Canada, Japan, South Korea, and China have their own strict regulations.
02. Which key herbal ingredients are regulated differently across countries?
Ingredients like Korean Ginseng, Red Ginseng, Siberian Ginseng, American Ginseng, Turmeric, Ashwagandha, Tulsi, and Green Tea all face region-specific compliance requirements based on safety, dosage, labeling, and health claims.
03. What does Freyr Solutions offer for herbal supplement compliance?
Freyr provides end-to-end regulatory services, including regulatory strategy, product classification, registration, labeling and claims compliance, safety assessments, and regulatory submissions.
04. How does Freyr assist with herbal supplement registration?
Freyr helps determine the correct product classification, compiles required documentation and manages the entire registration process with health authorities in different regions.
05. How does Freyr ensure compliance for herbal supplement labels?
Freyr ensures that all product labels and associated health claims meet region-specific herbal supplement labeling requirements.
06. Can Freyr help with regulatory compliance in multiple countries?
Yes, Freyr supports businesses in navigating the regulatory complexities of global markets, including the U.S., EU, Canada, China, Japan, and South Korea.
07. What role does Freyr play in herbal supplements safety assessments?
Freyr conducts thorough safety evaluations and prepares essential documentation such as scientific evidence and Certificates of Analysis (COAs).
08. How does Freyr keep clients updated on regulatory changes?
Freyr provides Herbal Supplement Regulatory Intelligence services to keep clients informed about ongoing updates and market-specific changes.
09. Does Freyr provide training on herbal supplement regulations?
Yes, Freyr offers regulatory training and support to help clients understand and comply with local and international herbal supplement regulations.
10. How can Freyr help accelerate the market entry of my herbal supplement products?
Freyr develops tailored regulatory strategies, ensures accurate product classification, manages end-to-end submissions, and maintains strong relationships with global health authorities—streamlining the approval process and helping you achieve faster, compliant market entry.
