Background

Following extensive consultation with the National Food Authority and industry organisations and review by the Traditional Medicines Evaluation Committee (TMEC), the TGA is now implementing an agreed arrangement to resolve the confusion that exists in the marketplace in relation to products containing propolis. Some products have been "grandfathered" as therapeutic goods, others are clearly therapeutic, but have not been included in the Australian Register of Therapeutic Goods (ARTG), while others have been incorrectly labelled and marketed as "foods".

Is propolis a "therapeutic good"?

All products containing propolis are "therapeutic goods" other than propolis flavoured confectionery without therapeutic claims, which will remain classified as food and must comply with all relevant food standards. Products described as "lozenges" (a therapeutic dose form) are "therapeutic goods" rather than "confectionery".

How are products containing propolis regulated?

In accordance with TMEC recommendations, changes will be made to the Therapeutic Goods Regulations to permit products containing propolis for dermal use to be listed in the ARTG. All other therapeutic products (eg. products for oral use) will continue to require registration in the ARTG.

The following conditions will also apply to all existing and future propolis products accepted in the ARTG:

• products for dermal use must carry the following label warning statement -
  "WARNING: Propolis may cause skin irritation. Test before use";
• all other products must carry the following label warning statement -
  "WARNING: Propolis may cause allergic reactions"; and
• finished products for oral use must contain not more than ten parts per million of lead. The TGA will write to all identified sponsors informing them of the need to comply with these conditions by 14 November 1995.

What about existing products?

Existing therapeutic products may continue to be supplied until 29 February 1996 provided an application for registration or listing is submitted by 31 January 1996.

Applications for listing of preparations for dermal use can be submitted as soon as the necessary changes are made to the legislation (these changes are expected in early November 1995). An information sheet showing how to complete an ELF listing application for propolis product for dermal use is available.

Applications for registration can be submitted at any time.

TMEC will meet during February to consider all registration applications based on traditional data (which should include details of documented outcomes) that have been received by 31 January. Applications which are based on non-traditional data will be considered by the Medicines Evaluation Committee (MEC) at its twice-monthly meetings.

Action required by sponsors of therapeutic products containing propolis