the Differences Between Drug and Food Labeling in Taiwan - Pharmacology

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The difference between the usage of the "Drug" and "Food" labels by the Department of Health?


Hello, I would like to ask the following two questions:
1.
A friend who works in a hospital gave me a bottle of combined vitamin C and calcium tablets, which contains ascorbic acid 250 mg and calcium pantothenate 5 mg.
Is the vitamin C dosage too high for an average person? Because the Centrum vitamin C only contains 60 mg!
2.
The Centrum multivitamins I regularly take and the vitamin C my friend gave me both have the Ministry of Health and Welfare drug registration number xxx.
Are they safe to use? Are there any specific restrictions or differences in usage compared to food products?
Thank you!

stacey, 20~29 year old female. Ask Date: 2003/05/05

Dr. Hou Fangmin reply Pharmacology


Hello: 1.
General multivitamins typically contain lower amounts of vitamin C.
For treating deficiencies, a daily intake of 100mg to 500mg is recommended if needed, while for prevention, 50mg to 100mg per day is sufficient.
For urinary acidification, a dosage of 4g to 12g should be taken in divided doses every 4 hours.
2.
The difference between the drug registration number and the food registration number is that the drug registration number pertains to products that are more strictly regulated as pharmaceuticals, while the food registration number refers to health foods, which are regulated less stringently.
Health foods can generally be purchased in supermarkets, whereas pharmaceuticals are only available at pharmacies and hospitals.

Reply Date: 2003/05/05

More Info


In Taiwan, the distinction between drugs and food, particularly in the context of dietary supplements and health foods, is crucial for understanding their labeling and regulatory status. The classification of a product as a drug or food can significantly affect its safety, efficacy, and the claims that can be made about it.


Understanding the Classification
1. Drugs vs. Foods: In Taiwan, drugs are substances used to diagnose, cure, mitigate, treat, or prevent diseases. They undergo rigorous testing and approval processes by the Ministry of Health and Welfare (MOHW) before they can be marketed. On the other hand, foods, including dietary supplements, are primarily intended for nutrition and general health maintenance. They do not require the same level of scrutiny as drugs and cannot claim to treat or prevent diseases.

2. Health Foods: Health foods, often referred to as dietary supplements, can include vitamins, minerals, and herbal products. In Taiwan, these products must be registered with the MOHW and assigned a health food registration number (衛署健食字). This registration indicates that the product has been evaluated for safety and quality but does not imply that it has been proven effective for treating specific health conditions.


Your Questions Addressed
1. Vitamin C Dosage: The vitamin C content in the supplement you received (250 mg) is higher than that found in many multivitamins, such as Centrum, which contains around 60 mg. For most adults, the recommended dietary allowance (RDA) for vitamin C is 90 mg for men and 75 mg for women. While 250 mg is above the RDA, it is generally considered safe for most people, as vitamin C is water-soluble and excess amounts are typically excreted through urine. However, excessive intake (over 2000 mg per day) can lead to gastrointestinal disturbances, such as diarrhea or stomach cramps. Therefore, while the dosage in your supplement is higher than that in Centrum, it is not excessively high for most individuals.

2. Safety of Registered Products: Both the multivitamin you regularly consume and the vitamin C supplement your friend provided are registered with the MOHW, which means they have been evaluated for safety and quality. However, it is essential to note that the safety of these products does not guarantee that they are suitable for everyone. Individual health conditions, allergies, and interactions with other medications should always be considered.

Differences in Labeling and Usage
- Labeling: Products labeled as drugs will include specific claims about their therapeutic effects and must provide detailed information about their active ingredients, dosages, and potential side effects. In contrast, health foods or dietary supplements can only make general health claims and must include a disclaimer stating that the product is not intended to diagnose, treat, cure, or prevent any disease.

- Regulatory Oversight: Drugs are subject to more stringent regulatory oversight, including clinical trials and post-marketing surveillance. Health foods, while regulated, do not undergo the same level of scrutiny. This difference means that while health foods can be beneficial, they may not have the same level of evidence supporting their efficacy as drugs.


Conclusion
In summary, while both the vitamin C supplement and the multivitamin you mentioned are registered with the MOHW and considered safe for consumption, it is essential to use them appropriately and be aware of individual health needs. Always consult with a healthcare professional if you have concerns about specific dosages or potential interactions with other medications. Understanding the differences between drugs and health foods can help you make informed choices about your dietary supplements and overall health.

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