Guidelines for the food-medicine interface

The Therapeutic Goods Administration (TGA) recently released the set of guidelines they use to clarify whether products fall under food or therapeutic goods regulation.

With the rising number of foods and drinks on the market that claim to have medicinal qualities, such as nutraceuticals, the line between food and therapeutic regulation is becoming increasingly blurred for companies and consumers alike.

An increasing number of goods are falling in the grey area in-between, called the 'food-medicine interface'.

To confuse matters even further, the food regulations are overseen by Food Standards Australia New Zealand (FSANZ), while the therapeutic regulations are overseen by TGA. When trying to get a straight answer on the products in the food-medicine interface, FSANZ would send you to TGA (claiming that they don't deal with therapeutic goods), but TGA would send you straight back (claiming they have nothing to do with food products).

In an effort to clear up the confusion, TGA has posted online its guidelines for classifying products that reside in the grey area. The guidelines consist of only four questions, whose answers indicate how to classify the product.

"We've been using these four simple questions since the 90s," said TGA's Dr Fiona Cumming. "They've been reworded and refined over the years, but we've found that they've very rarely let us down when deciding what system a product falls under."

Most of the confusion arises from New Zealand products entering Australia. In Australia, products have to be considered as either food or as therapeutics. In New Zealand, products fall into three categories: food, therapeutics and dietary supplements.

Some foods that fall within the dietary supplement category can be manufactured in New Zealand and, under the Trans Tasman Mutual Recognition Arrangement, can be imported into Australia.

TGA is collaborating with the New Zealand Medicines and Medical Devices Safety Authority to form a trans-Tasman therapeutic regulatory body, much like their counterpart FSANZ.

Dr Cumming is the principal scientific advisor of the joint agency establishment group which is developing the Australia New Zealand Therapeutic Products Authority (ANZTPA).

"When the new body is established, it will oversee regulations in both Australia and New Zealand. At the moment, they're not similar," she said.

TGA's guidelines can be found at http://www.anztpa.org/meds/gt-food-medicine.htm.