Can Nutritional Supplements Claim Therapeutic Effects Without Approval? - Nutrition

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Can dietary supplements claim to have therapeutic effects?


Hello, I would like to ask about many protein supplements that claim to "treat" osteoporosis, bone spurs, and arthritis, and also claim to be approved by the FDA in the United States, yet lack the approval number from Taiwan's Ministry of Health and Welfare.
The seller explains that (essentially, food products do not need to display the so-called "Ministry of Health and Welfare food approval number." Products with a "Ministry of Health and Welfare food approval number" are merely recognized by the Ministry as being subject to food management rather than drug management, and it does not imply that they have passed laboratory testing.
The verification and registration as food primarily target imported "tablet and capsule" foods, as these forms resemble pharmaceutical dosage forms.
To avoid confusion at customs regarding whether these products are food or drugs, importers must first apply to the Ministry of Health and Welfare for a determination of the product's classification.
According to the Q&A section of the food information website of the Ministry of Health and Welfare, question Q10 mentions whether products with a "Ministry of Health and Welfare food approval number" are more reliable.
The answer is: Generally, food products are treated equally regardless of whether they have an approval number; the presence of a "Ministry of Health and Welfare food approval number" only indicates that the product is classified as food in terms of management.) However, do these "therapeutic" nutritional supplements not require official approval? Is our food safety compromised? If side effects occur, will this lead to unnecessary waste of medical resources in Taiwan, and is there currently no way to manage this?

Júzi sè de xiǎo bái, 20~29 year old female. Ask Date: 2005/06/25

Dr. Shi Guimei reply Nutrition


Hello! The food registration number from the Department of Health is merely a reference number for correspondence.
The Department of Health adopts a self-management approach for general food products.
Food itself serves only to provide nutrients and cannot claim any therapeutic effects.
Even health foods certified by the Department of Health are not intended for the treatment or correction of human diseases; rather, they are meant to provide specific nutrients or possess particular health benefits.
Although manufacturers may claim to have FDA certification in the United States, if they assert that their products have therapeutic effects during sales (as you mentioned, the manufacturer stated that food does not need to display the food registration number, indicating that what they are selling is food and not medicine), this constitutes a violation of the law.
You may report such illegal manufacturers to your local health bureau.
In addition to relying on the management of health authorities, it is a proactive measure for the public to report illegal manufacturers upon discovery, ensuring the health and safety of the community.
Sincerely, Dietitian Shih Kuei-Mei, Director of the Nutrition Department, Taoyuan Hospital, Department of Health, Executive Yuan.

Reply Date: 2005/06/25

More Info


The question of whether nutritional supplements can claim therapeutic effects without official approval is a significant concern, especially in the context of consumer safety and regulatory practices. In the United States, the Food and Drug Administration (FDA) regulates dietary supplements under a different set of regulations than those covering conventional foods and drug products. This means that while dietary supplements can be marketed without prior approval from the FDA, they cannot legally claim to treat, cure, or prevent any disease unless they have undergone rigorous clinical trials and received FDA approval as a drug.

In your case, the protein supplements claiming to "treat" conditions like osteoporosis, bone spurs, or arthritis without FDA approval raise red flags. Such claims can mislead consumers into believing that these products have been scientifically validated for therapeutic use when, in fact, they may not have undergone the necessary testing to substantiate their efficacy and safety. The seller's explanation regarding the lack of a health authority number in Taiwan reflects a common misunderstanding about the regulatory framework for dietary supplements. While it is true that many food products do not require a specific approval number, this does not exempt them from safety and efficacy standards.

In Taiwan, the Ministry of Health and Welfare oversees the regulation of food products, including dietary supplements. Products that claim health benefits must be substantiated by scientific evidence, and any claims made must comply with local regulations. The absence of a health authority number does not necessarily mean that a product is safe or effective; it simply indicates that it has not been formally recognized by the regulatory body.

The potential for adverse effects from unregulated supplements is a valid concern. Consumers may experience side effects from taking products that have not been thoroughly tested for safety, leading to unnecessary medical complications and increased healthcare costs. This situation can strain healthcare resources, as patients may seek medical attention for issues arising from the use of these unverified supplements.

To ensure safety, consumers should be encouraged to:
1. Consult Healthcare Professionals: Before starting any new supplement, individuals should consult with healthcare providers, especially if they have pre-existing health conditions or are taking other medications.

2. Research Products: Look for supplements that have been tested in clinical trials and have transparent labeling regarding their ingredients and potential side effects.

3. Be Skeptical of Claims: Be cautious of products that make bold claims about treating or curing diseases, especially if they lack scientific backing.

4. Report Adverse Effects: If a supplement causes unexpected side effects, it should be reported to health authorities to help monitor the safety of these products.

In conclusion, while nutritional supplements can be marketed without prior approval, consumers must exercise caution and seek professional advice to ensure their safety and efficacy. Regulatory bodies like the FDA and Taiwan's Ministry of Health and Welfare play crucial roles in overseeing these products, but consumers also have a responsibility to be informed and vigilant.

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