Fri, Jun 05, 2026 page2

• FDA to tighten rules on health food claims

  • By Lin Chih-yi and Fion Khan / Staff reporter, with staff writer
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  The Food and Drug Administration (FDA) is planning stricter regulation of health food marketing claims by limiting the functional terms that can be used for 17 designated ingredients or compounds and requiring manufacturers to register related products.

  The Ministry of Health and Welfare currently recognizes 14 approved health food functions and grants qualifying products the “little green man” certification mark, allowing them to advertise specific health benefits.

  Approved functions include bone health, blood lipid regulation, gastrointestinal improvement, immune regulation, dental care, liver protection, blood glucose regulation, anti-aging, anti-fatigue, iron regulation, blood pressure regulation, body fat reduction, allergy relief and knee joint care.

  

  The "little green man" health food label is pictured in an undated photograph.

  Photo: Taipei Times

  Products classified as “health foods” undergo rigorous safety and efficacy reviews and must provide substantial scientific evidence before receiving approval and the “little green man” label, Cheng Wei-chih (鄭維智), head of the FDA’s planning and technology management division, said yesterday.

  All other products are categorized as general foods, he said.

  However, in recent years, many manufacturers have used marketing language that skirts regulatory boundaries, creating a gray area in the marketplace, he said.

  Drawing on regulations in Japan, South Korea and the EU, the FDA plans to establish standardized functional descriptions for 17 ingredients or compounds, Cheng said.

  Manufacturers wishing to make functional claims would need to register their products on a designated platform, obtain a registration number and upload scientific evidence proving that the ingredient content meets the standard required for the claim, he said.

  The 17 ingredients or compounds include lutein, indigestible dextrin, inulin, probiotics and lactic acid bacteria, gamma-aminobutyric acid (GABA), eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), glucosamine, collagen, creatine, green tea extracts containing catechin, beta-glucan, ginseng, red ginseng, fructooligosaccharides (FOS), alpha-cyclodextrin, chitosan and phytosterols, Cheng said.

  Under the proposed rules, manufacturers would also have to clearly disclose functional ingredients or raw materials, ingredient content, approved functional claims, target consumers and recommended intake levels, Cheng said.

  Product labeling and advertising would be required to strictly adhere to a "positive list" of approved phrases provided by the FDA, with no room for exaggeration or derived claims, he said.

  The measures are intended to improve product information transparency and strengthen post-market oversight, he added.

  Food products must not contain false, exaggerated or misleading claims and that a clear distinction should be maintained between food and pharmaceuticals, the FDA said.

  The agency said it would continue to gather public feedback and make rolling adjustments to the regulations.

  The policy is being drafted under the existing framework of the Act Governing Food Safety and Sanitation (食品安全衛生管理法) through administrative regulations, meaning amendments to the primary law or the creation of a separate act would not be necessary, it said.

  While there is no definitive timeline for the policy to take effect, the FDA is working on the transition, the agency said.
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