Food or Therapeutic Good?
Food or therapeutic good? This is a question I get asked often. Sometimes the answer is straightforward, other times it can be difficult to determine. Especially for some complimentary medicines and foods that wish to make health claims. The line between food and therapeutic good has become blurrier in recent years. Sometimes it comes down to how the product is marketed.
Therapeutic goods are regulated by the Therapeutic Goods Administration (TGA) at the Federal level. Food Standards, however, are set by Food Standards Australia New Zealand (FSANZ) and are regulated at the State level.
The issue of whether products are food or therapeutic goods has become more complex over recent years as health claims are now allowed in relation to a wider range of food products, including products that have traditionally been regarded as food. In 2013, a Food Standard (Standard 1.2.7) that sets out rules for the use of nutrition content and health claims on food labels and advertisements became law.
Another question I sometimes get asked is ‘can I classify my food as a therapeutic good (listed medicine) to make a stronger health claim?’ Often, claims made about a product or the appearance of the product may suggest that it is a therapeutic good. However, the fact that health claims are made about a product does not automatically make it a therapeutic good. If a product falls under the Foods Standards Code, then it is most likely a food.
Regardless of whether a product is a classified as a therapeutic good or food, if a health claim (or any other claim) is made this needs to be properly substantiated. In addition the sponsor must be able to provide the evidence upon request.
With experience in both the food and medicines regulatory environments, we can help you navigate the food – therapeutic goods interface. Contact us for further information.
Therapeutic goods are regulated by the Therapeutic Goods Administration (TGA) at the Federal level. Food Standards, however, are set by Food Standards Australia New Zealand (FSANZ) and are regulated at the State level.
The issue of whether products are food or therapeutic goods has become more complex over recent years as health claims are now allowed in relation to a wider range of food products, including products that have traditionally been regarded as food. In 2013, a Food Standard (Standard 1.2.7) that sets out rules for the use of nutrition content and health claims on food labels and advertisements became law.
Another question I sometimes get asked is ‘can I classify my food as a therapeutic good (listed medicine) to make a stronger health claim?’ Often, claims made about a product or the appearance of the product may suggest that it is a therapeutic good. However, the fact that health claims are made about a product does not automatically make it a therapeutic good. If a product falls under the Foods Standards Code, then it is most likely a food.
Regardless of whether a product is a classified as a therapeutic good or food, if a health claim (or any other claim) is made this needs to be properly substantiated. In addition the sponsor must be able to provide the evidence upon request.
With experience in both the food and medicines regulatory environments, we can help you navigate the food – therapeutic goods interface. Contact us for further information.