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Foot patch

Introduction

Foot patch is a product in the form of an adhesive pad which can be applied directly onto the sole of the foot.

Classification of foot patch :

Category Explanation
Medical Device
  • Foot patch is classified as medical device when the intended purpose/ indication of the product is to absorb unwanted toxins from the body. Based on the intended purpose/ indication of the product, the foot patch can be classified as Class 1 Medical Device and registered with the Therapeutic Good Administration, Australia to be entered into the Australian Register of Therapeutic Goods (ARTG)9. The health claim that is allowed must be in line with the intended purpose/ indication of the product.
  • This includes foot patch product that functions as physical barrier or protective barrier for the user.
Traditional
  • Foot patch is classified as traditional product when the product contains herbal ingredients such as plant extracts, Chitosan Loquat leaves and others.Below are the indications that can be allowed:
  • Used traditionally for
    • general health
    • promoting blood circulation
    • relieving tiredness
  • Any health claims/ indications other than those stated above must be supported by clinical trial papers.
Non Prescription
  • Foot patch is classified as non prescription product when the product contains pharmaceutical ingredients; for example, Vitamin C that has exceeded the allowable limit as side ingredient/ excipient in traditional product.

Example of claims which are NOT allowed:

  • To detox
  • To reduce body weight
  • To cure diabetes
  • To reduce high blood pressure
  • To assist in strengthening of body immune system, etc.

These claims are not allowed because they can cause confusion among the general public.

Registration Requirement

  • Medical Device
    • The registration of medical device by the Medical Device Authority (MDA) is conducted in accordance to the enforcement of the Medical Device Act.
    • Please refer to www.mdb.gov.my for further information.
  • Traditional & Non Prescription
    • These categories of foot patch products must be registered with the Drug Control Authority (DCA) through the National Pharmaceutical Control Bureau (NPCB) which acts as the secretariat for the DCA.
    • The registration of such products is subjected to the regulatory requirements for product registration as stated in the Drug Registration Guidance Document (DRGD). The DRGD can be downloaded from the website www.bpfk.gov.my

The ingredients used in the formula for foot patch include :

Example of active ingredients which claim to have effect on the health of the user :

  • Bamboo/ wood vinegar; pyroligneous acid :
    • Has sterile effect, odor eliminating and the capability for better absorption.
  • Tourmaline ; crystal:
    • mits electromagnetic wave and releases anion. If tourmaline is placed under pressure or experienced a change in temperature, it will generate electrical charge. This mineral is the only known mineral to emit infrared heat and negative ions.
  • Chitosan:
    • cts as antioxidant and has the characteristics of anti-mutagen.
  • Ascorbic acid/ Vitamin C:
    • Promotes healing of burn wounds and skin inflammation.

Safety issues

There are many foot patch products which put the indication/ function of the products as products which can be used to detox the body, to reduce high blood pressure, to reduce body weight and etc.

However, there are no scientific studies2,8 that validate the truth for such indications claimed for foot patch products.

Specialist states that the change in colour of the foot patch is actually due to the presence of dead skin cells and dirt on the sole of the feet1. There is also opinion regarding the interaction between sweats from the user’s body and ingredients in the foot patch, which eventually causing the change of colour in the product.

Hence, consumers are advised to be cautious with advertisements for such products by doing a thorough reading about the products before purchasing them.

Last Reviewed : 20 January 2014
Writer : Nurhidayah bt. Baharuddin

 

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