Food FAQ - What Issues Should Be Considered during the Application Process for New Health Food Products Containing Anthraquinone-based Ingredients?

Based on our years' of experience, we have collected frequently asked questions on health food/dietary supplements registration in China and translated them into English for your reference.

1. What are the current regulations? What raw materials are involved?

The current regulations mainly include: Regulations on the Application and Review of Health Food Products such as Amino Acid Chelates (Trail) (2005) - article 6; Notice on the Application and Review of Health Food Products Using Red Yeast and Other Raw Materials - section 4; and Notice on Strengthening the Supervision of Health Foods Containing Polygonum Multiflorum.

In addition to the raw materials already specified in these regulations, such as aloe, rhubarb, polygonum multiflorum, and cassia seed, senna leaf, which contains anthraquinone component, should also be managed according to these regulations. This applies to processed products, such as decoctions and extracts of these raw materials.

2. What should be taken into account during the application process other than the current regulations?

Labels and instructions should be prepared based on the recent scientific literatures and the formulation compatibility of the raw materials.

The current regulations only specify requirements for single anthraquinone-containing ingredients (hereinafter referred to as anthraquinone raw materials). When using two or more of such raw materials in a combination, the cumulative safety risks should be carefully considered.

When using extract-based raw materials, attentions should be paid to changes in the safe dosage due to variations in solvent concentration or purification.

3. When a health food containing two or more anthraquinone raw materials, what application documents should be provided regarding the formula compatibility and scientific safety evidence?

The theoretical basis and source of the product formula should be provided to explain the rationality and safety basis for their claimed health benefits in terms of formulation compatibility. Special attention should be paid if the total daily anthraquinone intake exceeds 30mg, as sufficient scientific evidence for long-term safety should be provided. If the formula contains more than two anthraquinone raw materials, greater attention should be paid to the rationality of the formula and the necessity of the combination.

4. When a health food containing two anthraquinone raw materials claims to aid bowel movement, what are the key aspects for its label instruction?

If there are no other raw materials in the combination: The necessity of the compatibility should be fully justified. In principle, the target population should be limited to “occasional constipation sufferers”. People who should avoid the product include “children, pregnant women, breastfeeding mothers, people with chronic diarrhea, elderly or weak individuals, and those with a cold constitution”. Warnings should include “This product cannot replace medicine. Individuals outside the recommended target population should avoid it. If diarrhea occurs, stop immediately. The product should not be taken in excess for long periods. Individuals with long-term constipation should consult a healthcare professional before use.”

If other raw materials are combined: Based on the compatibility theory and the formula composition, the target population should be more specifically defined. At a minimum, the product should not be recommended for “children, pregnant women, breastfeeding mothers, people with chronic diarrhea, elderly or weak individuals”, and warnings should include “This product cannot replace medicine. Individuals outside the recommended target population should avoid it. If diarrhea occurs, stop immediately. The product should not be taken in excess for long periods. Individuals with liver, kidney, or gastrointestinal issues should use it with caution. Individuals with long-term constipation should consult a healthcare professional before use.”

5. When a health food containing two anthraquinone raw materials claims other health functions (not related to bowel movement), what should the label instruction address?

In principle, the use of only anthraquinone raw materials is not recommended!

If other raw materials are combined: The label should incorporate compatibility theory, the health function claims, and define the target population more clearly. The product should not be recommended for “children, pregnant women, breastfeeding mothers, people with chronic diarrhea, elderly or weak individuals”. Warnings should include “This product cannot replace medicine. Individuals outside the recommended target population should avoid it. If diarrhea occurs, stop immediately. The product should not be taken in excess for long periods. Individuals with liver, kidney, or gastrointestinal issues should use it with caution. Individuals with long-term constipation should consult a healthcare professional before use.”

6. For health foods containing polygonum multiflorum, in addition to the above issues, what else should be considered?

If the formula contains only polygonum multiflorum as the anthraquinone raw material: The warning should be adjusted to “This product contains polygonum multiflorum. Those sensitive to this ingredient should use it with caution or consult a healthcare professional. The product should not be taken in excess for long periods. It cannot replace medicine, and it should not be used with hepatotoxic drugs. Liver function monitoring is advised.”

It is not recommended to develop health foods containing both polygonum multiflorum and other anthraquinone raw materials. If such a product is necessary, the formula's rationality and compatibility must be closely examined, and the target population should exclude "children, pregnant women, breastfeeding mothers, people with chronic diarrhea, elderly individuals, those with liver dysfunction, and those with a family history of liver disease”. Warnings should include “This product cannot replace medicine; individuals outside the recommended target population should avoid it. If diarrhea occurs, stop immediately. The product should not be taken in excess for long periods. Individuals with liver, kidney, or gastrointestinal issues should be cautious. For long-term use, consult a healthcare professional. This product contains polygonum multiflorum, and those sensitive to it should use it with caution or consult a healthcare professional. It should not be used with hepatotoxic drugs, and liver function should be monitored.”

7. What else should be considered when combining anthraquinone raw materials?

When developing health foods containing two anthraquinone raw materials, companies are advised to refer to domestic and international research progress and existing methods for measuring anthraquinone content. Measures to limit the high-dose intake of anthraquinone components should be established. It is not recommended to combine aloe glycosides or sennosides, if the daily intake exceeds 30mg, with other anthraquinone raw materials. From a safety perspective, the product’s technical specifications should set a high-limit value for total anthraquinone content, which will be used to calculate the daily intake. If the total daily intake of anthraquinones exceeds 30mg, scientific evidence supporting long-term safety should be provided, and the formula and target population should be carefully evaluated.

8. What application documents should be submitted if anthraquinone raw materials undergo ethanol extraction or purification processes like column chromatography?

Complete evidence should be provided to show the converted raw material dosage, and the composition of the raw material obtained through the extraction or purification process should be compared with the traditional water extraction method (including changes in free anthraquinone and total anthraquinone content). Additionally, documentation proving the change in the safety of the raw material due to variations in anthraquinone content should be provided. If the ethanol extraction or purification process results in a daily anthraquinone intake exceeding 30mg, safety literature supporting the long-term consumption of the extract should be included.

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