Exploring International Dietary Supplement Regulations: A Comprehensive Analysis of Dosage Forms and Approved Functional Ingredients in Key Markets

In recent years, the growing emphasis on health and nutrition has made dietary supplements a significant part of people's daily lives. However, the lack of uniform regulatory standards for dietary supplements, coupled with regulatory variations among countries, has introduced uncertainties and risks to these products. Exploring the regulatory confusion and unified trends in dietary supplement regulations across various countries is crucial for import and export research, market analysis, and regulatory development in the dietary supplement industry, especially in the era of globalization.

In this article, we delve into the comparison of dosage forms and raw material supervision for dietary supplements in prominent countries worldwide.

functional ingredients

Dosage Form Management:

Due to the diverse nature of dietary supplements and the influence of cultural and economic factors, each country establishes distinct requirements for the dosage forms of dietary supplements. The following summarizes dosage form requirements in select countries:

1. China:
Capsules, tablets, oral liquids, gel candies, granules, powders, and food forms. Specifications can be found in the Chinese Pharmacopoeia.

2. USA:
Typically tablets, capsules, powders, soft capsules, or oral liquids. Should not resemble traditional food or serve as the sole food component of a meal.

3. Australia:
No clear regulations; only materials in the "List of Allowed Raw Materials and Excipients" can be used for dosage forms.

4. U.K.:
Should be in small-dose forms like capsules, tablets, sachets of powder, liquid ampoules, drops, or similar powder and liquid preparations in small packages.

5. Singapore:
Small dosage forms like capsules, tablets, oral liquids, and syrups. Food form products like biscuits, coffee, and juice are not considered health supplements.

6. Canada:
No clear provisions.

7. Japan:
Various forms under Nutritional Functional Foods (FNFC) and Food with functional labeling (FFC). No clear regulations for Food for Specified Health Use (FOSHU).

The requirements for dosage forms are influenced by factors such as distinguishing supplements from ordinary food or medicine, consumer preferences, and safety considerations.

Allowed Categories of Functional Ingredients:

Functional ingredients are the core components of dietary supplements, and the regulatory definition of these ingredients determines the market scope. Here is a comparison of functional raw material categories in some major countries:

1. China:
Nutrient supplements (e.g., vitamins, minerals) and other functional raw materials.

2. USA:
Vitamins, minerals, plants or their components, amino acids, and dietary substances used by the human body to supplement the diet.

3. Australia:
Amino acids, charcoal, choline salts, essential oils, plant raw materials, homeopathic preparations, microorganisms, minerals, mucopolysaccharides, non-human animal raw materials, etc.

4.U.K.
Nutrients, amino acids, essential fatty acids, fiber, various plant and herbal extracts, and others.

5. Singapore:
Vitamin minerals, amino acids, fatty acids, enzymes, probiotics, and other biologically active substances.

6. Canada:
Plants or plant materials, algae, bacteria, fungi or non-human animal materials, extracts or isolates of these substances, vitamins, amino acids, essential fatty acids, syntheses of substances mentioned, minerals, probiotics.

7. Japan:
Nutritional Functional Food (FNFC): Various essential nutrients. Functionally labeled food (FFC) and Foods for Specific Health Use (FOSHU) have no clear regulations.

In summary, countries generally recognize vitamins and minerals as basic functional raw materials for dietary supplements. Probiotics, plant-based raw materials, proteins, amino acids, and other functional ingredients are acknowledged but may have varying regulations. The acceptance of these ingredients is influenced by safety, efficacy, and market demand. The regulatory landscape for dietary supplements varies globally. As cross-border trade continues to evolve, understanding and navigating these regulatory challenges is crucial.