Why is our Evening Cleanse product is listed?

When we first started we really didn’t know anything about the regulations. We were contacted by the Therapeutic Goods Administration (TGA) who informed us there were some compliance issues with our product and we quickly resolved to fix them. There are a number of issues but the main one was the fact that the tea contains the traditional and very popular herbal laxative Senna (Cassia alexandrina). The Therapeutic Goods Administration (TGA) told us that in their opinion, this ingredient is a therapeutic herb, therefore only permissible in a medicine and not permissible in a food due. This is due to its therapeutic effect in the body (Many teas including herbal “teas or infusions”, eg peppermint, are legally classified as a food in Australia). Therefore, we are required to comply with their request and the regulations surrounding therapeutic ingredients, by producing and marketing it as a medicine, not as a food.

This seemed quite straightforward until we discovered a few stumbling blocks:

Even the lowest-risk medicines must be entered on the Australian Register of Therapeutic Goods. An AUST L number is then issued which must be printed on the product label. (Most pharmaceutical medicines have an AUST R number).

All medicines must be made in by a manufacturer that complies with Good Manufacturing Practice (GMP) and hold a license which is issued by the TGA.

Ingredients permitted in foods are not always permitted in medicines, and vice versa. In addition, some Chinese herbal ingredients are not permissible in any foods or medicines in Australia. This situation forced us to change the ingredients in the tea. Therefore, we took this as an opportunity to improve the formulation and we engaged the help of an expert to help with this.

The regulations require us to have a high-level evidence to back up every statement we make. To comply with this legal requirement, we have built a solid dossier of evidence to back up each one of the claims we make for our products.

Claims and indications for medicines are strictly regulated and must be worded in a certain way. So we amended our claims to be a better fit with the regulations, worked on a new formulation, and of course, researched the traditional and scientific literature to come up with our supporting evidence.

You can verify the medicinal status of our Evening Cleanse by the AUST L number on the label. This demonstrates the product has been self-assessed for compliance with the regulatory requirements for herbal medicines including permissible and substantiated claims and indications, compliance with labeling requirements and that it has been made in a manufacturing facility required to comply with GMP for Medicinal Products. You can search the Australian Register of Therapeutic Goods (the ARTG) for our AUST L number and find the product and its details on the register at https://www.ebs.tga.gov.au/

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