Regulatory Overview of Health Supplements

What is a Health Supplement?

A health supplement is a product which is used to supplement a diet and to support or maintain,enhance and improve the healthy functions of the human body. It cannot be an injectable or a preparation that needs to be sterile, such as injections or eyedrops. It cannot be an item of a meal or diet.

A health supplement must also contain one or more, or a combination9 of the following ingredients:

a. Vitamins, minerals,amino acids, fatty acids, enzymes,probiotics and other bioactive substances

b. Substances derived from natural sources, including animal,mineral and botanical materials in the forms of extract,isolates, concentrates and

c. Synthetic sources of ingredients mentioned in (a) and (b)

A health supplement must be administered in small unit doses in dosage forms such as the following:

  1. capsules
  2. softgels
  3. tablets
  4. liquids
  5. syrups

Products used on animals as well as products presented in the form of food and beverages,such as biscuits,coffee and juice are not supplements.

Controls of Health Supplements

Health supplements are not subject to approvals and licensing by Health Singapore Authority (HSA) for their importation, manufacture and sales. HSA prohibits the addition of medicinal ingredients such as steroids in health supplements. HSA also sets strict limits on toxic heavy metals in these products. Dealers have the obligation to ensure that their products are not harmful or unsafe and that they conform with the following guidelines before supplying health supplements into Singapore.

Voluntary Notification of Health Standards

Dealers may voluntarily notify HSA of their health supplements supplied in Singapore.Companies MUST provide HSA with relevant documents to demonstrate that their products meet the necessary safety and quality standards

+ Substances NOT allowed
+ Toxic Heavy Metal limits
+ Microbial limits
+ Vitamin and mineral limits

(Please refer to HSA website under the heading "Regulatory Overview of Health Supplements - Singapore for the details.)

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Our range of 20 test chambers are running 24 / 7 for shelf life accelerated aging tests for international clients in over 3 continents

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Quality Standards - What Tests are Needed ?

Your product must achieve acceptable standards of quality in terms of

  1. Product Stability and Shelf Life
  2. Form Function and Efficacy for entire life of product
  3. Storage Conditions and Distribution Practice Manufacturing, packaging and assembly conditions.

QRA International can assist your company in meeting the Quality Standards to meet the stringent requirements for sale into Singapore and internationally.

Speak with the experts, call QRA International today !

Tel: (65) 6795 1486
Or email:
1. qrasales@qra.com.sg
2. mark@qra.cm.sg

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