Some people say "let food be thy medicine and let medicine be thy food". In fact, food and medicine have different but important roles in our health. Generally speaking, food is for nutrition, while medicine treats or prevents disease.
Whether a product is food or medicine also has important implications for how it is regulated, which impacts you as the consumer.
What distinguishes food and medicine?
There are similarities between foods and medicines:
- all foods and many medicines are taken orally
- foods and medicines can support your health
- foods and medicines can contain some of the same ingredients
- you can have an allergic reaction to either food or medicine.
But the differences between foods and medicines are significant:
- taste is important to food, while taste isn't the focus of medicine
- food has a social role, while medicines treat individuals
- food is self-selected, while many medicines should only be used under the supervision of a health practitioner
- nutrition is ongoing and essential for life, while many medicines are situational or for temporary use
- food is usually low risk, while medicines balance risk against benefit
- the manufacture of medicine is usually more complex than preparation of food.
Of course, there are exceptions. Some people with type II diabetes can initially manage their condition through diet, not medicine. Coriander is a food, but tastes like soap to some people. And while chewing gum is usually a food, nicotine gum is regulated as a medicine. But these exceptions are not the rule.
How are foods and medicines regulated?
State and territory food agencies regulate food in accordance with both state/territory and national food legislation, including food standards set by statutory body Food Standards Australia New Zealand (FSANZ). The TGA regulates medicines at the federal level.
Any product that is taken orally (eaten) can be classified as food.
A food cannot be a medicine, and a medicine cannot be a food. When deciding if a product taken orally is a medicine or a food, there are two main reasons why it may not be considered a medicine (but may be a food):
- if it has an applicable food standard, or
- if it has a tradition of use in that form as food in Australia or New Zealand.
In general, if a product for human consumption and taken orally is not a medicine, then it is likely to be considered a food.
A product is classified as a medicine if it is represented to be a therapeutic good, likely to be taken for therapeutic use, or declared to be a therapeutic good.
In Australia, we do not have a separate regulatory category for dietary supplements. All supplements are either foods or medicines, depending on the supplement's individual features.
Why do I need to know if a product is food or medicine?
Whether a product is regulated as food or medicine has important implications:
- state and territory food enforcement agencies make decisions about foods, while the TGA makes decisions about medicines
- the TGA manages medicine complaints, while local food enforcement agencies handle food complaints
- medicines must be manufactured according to Good Manufacturing Practice, while food is produced according to food safety standards
- medicines must meet evidence requirements proportionate to their health claims
- foods and medicines have different labelling requirements (for instance, medicine labels must display the active ingredient, while food labels must include nutrition information)
- medicines have tighter restrictions on where and how they can be sold and who can access them.
Broadly, medicines have more stringent regulatory requirements than foods, which reflects their greater relative risk.
What if there is ambiguity?
Most of the time, it is straightforward to determine whether a product is food or medicine. But sometimes there's ambiguity. Blueberries are food, but blueberry extract sold in a capsule might be medicine. Another product that represents itself as a medicine could have an applicable food standard.
We call the potential regulatory overlap between foods and medicines the Food-Medicine Interface. We pose a series of questions to make a determination:
- Is the product for oral use, for humans?
- Is there a (post 2010) Therapeutic Goods Act 1989 section 7 declaration in relation to the product that it is a therapeutic good? (This lets us declare that a product is a medicine)
- Is the product covered by a Therapeutic Goods Act 1989 section 7AA declaration? (This lets us declare that a product is not a medicine)
- Is the product 'goods for which there is a standard' in the Food Standards Code?
- Is the product goods which, in Australia or NZ, have a tradition of use as foods for humans in the form in which the thing is presented?
- Is the product represented in any way to be for therapeutic use, likely to be taken by someone to be for therapeutic use because of the way in which it is presented, or likely to be taken by someone to be for therapeutic use for any other reason?
- Is the product in a class of goods the sole or principal use of which is, or ordinarily is, a therapeutic use?
You can use our interactive Food-Medicine Interface Guidance Tool to apply these questions to a product.
Final food for thought
If we have not made a declaration about the product, look for a food standard or applicable tradition of use. If the product fits either of these, it is not likely to be a medicine, and may be a food.
If there is no food standard or tradition of use, then the product could be a medicine. It does not have to be represented as a medicine: remember that products that are likely to be taken to be medicines are also regulated as therapeutic goods.
Remember that foods and medicines are fundamentally different, and you wouldn't expect one to do the job of the other. Then you'll be able to enjoy food at every meal and take medicine when you need it.