Can Echinacea extract be used as a food supplement?

In China, Echinacea purpurea extract can currently only be used for "health food" or "medicine-food pilot" registration. It cannot be added to beverages, snacks, or dairy products as a regular food ingredient. Exports to Europe and the United States are permitted as dietary supplements, but must comply with each country's regulations on dosage and functional claims.

Current Chinese Regulatory Status

The 2020 "Medicine-Food Pilot Catalogue" lists Echinacea as one of nine pilot categories, but it is only permitted for "health food" registration. Functional claims may only include "helps maintain immune function" and may not include medical terms such as "treatment, antiviral, or anti-inflammatory."

Adding Echinacea to regular foods (beverages, candies, and biscuits) requires a "new food ingredient" registration. Currently, the National Health Commission has not yet approved this, so theoretically, this constitutes "exceeding the scope of use" and will fail random inspections. In June 2024, the State Administration for Market Regulation further clarified that for Echinacea raw materials registered as "health food," the recommended daily dose must be "chicoric acid ≥ 2.5 mg" or "echinacea polysaccharide ≥ 10 mg" as quality control indicators, and the label "Not suitable for infants, pregnant women, and lactating women" must be included.

Safe Dosage and Toxicological Red Lines

The US FDA OTC Monograph: Oral administration: 300–500 mg/dose (4% chicoric acid), no more than three times daily, for ≤10 consecutive days.

EFSA 2023 Opinion: No genotoxicity has been observed for daily doses of ≤1600 mg of dried root extract (3.5% chicoric acid) in adults; however, long-term safety data beyond 8 weeks is insufficient, and long-term consumption is not recommended.

For health food registration in China: "Chicoric acid 2.5–10 mg/day" is the functional range. Companies must conduct 30-day and 90-day subchronic toxicology studies and submit stability, total colony count, and mold counts <100 CFU/g for registration.

Five Compliance Scenarios for "Food Supplements" Available for Implementation in 2025

Scenario A: Health Food Hard Capsules/Tablets (Blue Cap)
Formula Example: Echinacea Extract(4% Chicoric Acid) 250 mg + Vitamin C 50 mg + Zinc 5 mg; Functional Claim: "Helps Maintain Immune Function." Filing period: 8–10 months, cost approximately 250,000 RMB.

Scenario B: Soft Candies Exported to Europe and the United States (Dietary Supplement)
Formula: Echinacea Extract (2.5% Chicoric Acid) 150 mg/capsule + Pectin Base + Erythritol; US labels may state "Support Immune Health," but must include "These statements have not been evaluated by the FDA."

Scenario C: Ready-to-Drink Oral Liquid (Cross-Border Export)
Formula: Echinacea Extract (1% Chicoric Acid) 500 mg/60 mL + Elderberry Juice Concentrate + Mogrosides; US GRAS Self-Affirmed, Directly Available on Amazon/iHerb, Ships from Domestic Bonded Warehouses.

Scenario D: Probiotic Powder "Dual Immune Benefit" Dual-Track Set
One 2g packet: Echinacea Extract (Water Extract) 100 mg + Lactobacillus Acidophilus La-14 5 billion CFU + Oligofructose 1g; Cross-Border Bonded, Domestic Live Streaming Can Claim "Originally Imported from Overseas"

Scenario E: Paste "Autumn Pear Echinacea Paste" (Pilot Local Medicinal and Food-Integrated Workshop)
Limited to pilot medicinal and food-integrated pilot parks in Shandong, Anhui, and Guangdong. Small workshop registration certificate and local standards required. Daily packaging: 10g. Chicoric acid control: 2.5 mg/10g. Sold in offline pharmacies/TCM clinics. Not for sale online to minors.

One-Stop Factory Installation Solution (Marketing Tips)

SOST Biotech has a partnered Echinacea GAP base, offering all-water extraction and low-temperature concentration. Echinacea Purpurea Extract Chicoric acid content can be customized from 1–4% in both water-soluble and oil-soluble grades. We have helped over 30 clients achieve US GRAS self-affirmation and EU NOVEL Food pre-submission.

Our Provides:

・Full health food filing (formula, toxicology, stability, and Blue Hat filing)

・Seamless scale-up from a 3 kg pilot test of cross-border soft candies/oral liquids to a 300 kg pilot test and 5 ton mass production

・Chinese and English label review and Amazon efficacy page compliance review

Minimum order quantity (MOQ) 1 kg, with included COA, heavy metals, pesticide residues, microbial analysis, and chicoric acid HPLC profile.

Contact Email : ericyang@xasost.com