Is This Herbal Capsule Legit? Food Inspection Numbers

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I recently found out that my mom bought a type of traditional Chinese medicine capsule that has a food inspection number 9405-0185-B02-SA-1 on it.
The ingredients listed are all traditional Chinese herbs, but I couldn't find any information about this food inspection number.
Thank you.

cc, 20~29 year old female. Ask Date: 2006/06/22

Dr. Huang Yicheng reply Pharmacology

If it is classified as traditional Chinese medicine or concentrated preparations, it must comply with the Good Manufacturing Practice (GMP) regulations for Chinese herbal medicines set by the Ministry of Health and Welfare in order to be sold domestically.
If it is classified as food, there is no requirement to label it with the so-called "Food Product Number" from the Ministry of Health and Welfare, as long as qualified manufacturers use legally sourced food ingredients, they can market it independently.
The manufacturers are responsible for self-management, but their products must comply with food hygiene regulations regarding hygiene, safety, labeling, and advertising.
Foods labeled with the "Food Product Number" simply indicate that the Ministry of Health and Welfare recognizes the product as food and not as a pharmaceutical, and it does not imply that it has passed laboratory testing.

For tablet and capsule forms of food, the ingredients used are food ingredients, designed for consumer convenience, resembling the form of pharmaceuticals.
Therefore, regulations require that the packaging clearly indicate "Food" to avoid misleading consumers into mistaking it for a drug.
Currently, there are two categories of food product numbers (the "official food product number" from the Ministry of Health and Welfare) available on the market: (1) Imported tablet and capsule foods - "This product has been verified and registered by the Ministry of Health and Welfare under Food Product Number ○○○○○○○○○○ as 'recognized as food'": The product form is similar to that of pharmaceuticals.
To prevent confusion at customs regarding whether it is food or a drug, such foods must apply for verification and registration with the Ministry of Health and Welfare, which reviews their ingredients, formulations, and sources to confirm they are food and not drugs.
After obtaining the approval document, the manufacturer can apply to customs to import it under the designation of "food." (2) Domestic formula inquiry for food review - "This product has been reviewed by the Ministry of Health and Welfare under Food Product Number ○○○○○○○○○○ as 'recognized as food'": This is for domestic manufacturers to understand whether the ingredients they intend to use for their products can be classified as food.
Manufacturers provide the ingredient formulations to the Ministry of Health and Welfare for inquiry, which conducts a review service for the formulation.
A formal document is issued confirming it as food to prevent the use of unsafe ingredients in food products.

These product numbers only prove that there has been correspondence between the manufacturer and the Ministry of Health and Welfare.
In the past, manufacturers believed that having a product number made it easier to persuade consumers to purchase, and consumers seemed to rely heavily on these "numbers." However, this often leads to consumer misunderstandings, so the Ministry of Health and Welfare has prohibited the labeling of "Food Product Numbers." Food is primarily intended to provide the nutrients and calories necessary for the human body, not for treating diseases.
Regardless of their form, they do not possess or claim therapeutic effects; otherwise, it would be illegal.
Medical efficacy must be evaluated and confirmed through comprehensive scientific testing and clinical trials.
As for health benefits, they must provide a health efficacy assessment report in accordance with the Health Food Management Act, which must be approved by the Ministry of Health and Welfare before any claims can be made.

If one must consume such foods, they should check for the presence of a "Drug Number"; if present, it is classified as a drug, not food.
For tablet and capsule foods, verify the presence of the word "Food"; check for Chinese labeling and its completeness; review the ingredient content, brand, manufacturer, etc.; and contact the manufacturer to confirm the labeling information, such as food product number and certificates.
If any product is found to be of unknown origin, lacks Chinese labeling, or has unclear or incomplete labeling (such as product name, ingredients, distributor and manufacturer name, address, phone number, etc.), or makes therapeutic claims with exaggerated terms like "super," "invincible," etc., for weight loss, enhancement, etc., it should be rejected for purchase.

Respectfully, Huang Yi-Cheng, Pharmacist, Hualien Hospital, Ministry of Health and Welfare.

Reply Date: 2006/06/22

More Info

When it comes to assessing the legitimacy and safety of herbal capsules or any dietary supplements, it's crucial to understand the significance of food inspection numbers and how they relate to regulatory standards. In your case, the food inspection number you mentioned (9405-0185-B02-SA-1) is likely a registration or inspection number that indicates the product has undergone some level of scrutiny by a regulatory body. However, the presence of such a number does not automatically guarantee the product's safety or efficacy.

In the United States, dietary supplements, including herbal capsules, are regulated by the Food and Drug Administration (FDA) under the Dietary Supplement Health and Education Act of 1994 (DSHEA). This act allows manufacturers to market supplements without prior approval from the FDA, provided they do not make false claims about their products. However, the FDA does have the authority to take action against any unsafe or misbranded products after they reach the market.

To determine if the herbal capsule your mother purchased is legitimate, consider the following steps:
1. Check the Label: Look for the product's label, which should include the name of the manufacturer, the ingredients, and the dosage. Ensure that the label is clear and not misleading. Ingredients should be listed in descending order by weight.

2. Research the Manufacturer: Investigate the company that produces the herbal capsule. A reputable manufacturer should have a history of compliance with good manufacturing practices (GMP) and should be transparent about their sourcing and production processes.

3. Look for Third-Party Testing: Some manufacturers voluntarily submit their products for testing by independent third-party organizations. These organizations verify the product's contents and ensure it meets safety standards. Look for seals or certifications from recognized third-party testing organizations on the product label.

4. Consult Regulatory Websites: You can check the FDA's website or other relevant regulatory bodies in your country to see if there are any warnings or recalls associated with the product. In the U.S., the FDA maintains a database of dietary supplements that have been reported for adverse effects.

5. Seek Professional Advice: If you have concerns about the herbal capsule, consider consulting a healthcare professional, such as a pharmacist or a physician, who can provide guidance based on your mother's health history and current medications.

6. Food Inspection Numbers: The food inspection number you mentioned may be specific to a local or national regulatory body. In some regions, such numbers indicate that the product has been inspected for safety and compliance with local food safety regulations. However, if you cannot find information about this specific number, it may be worth reaching out to the regulatory agency that issued it for clarification.

In summary, while the presence of a food inspection number can provide some assurance regarding the product's safety, it is essential to conduct thorough research and consult professionals to ensure that the herbal capsule is safe for consumption. Herbal supplements can interact with prescription medications and may not be suitable for everyone, so it is always best to err on the side of caution.

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