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If you are a supplier or manufacturer of a product that is intended for consumption, it is important for you to be certain of whether your product is a medicine or a food. This is because different regulatory requirements will apply to each. Therefore, this article will explain the difference between medicines and foods.

Differences Between Medicines and Foods

The interface between food and medicine can be particularly difficult to navigate because medicines and foods can share a lot of similarities. These include that both: 

  • are often taken orally; 
  • can play a role in supporting health; 
  • can contain similar ingredients; and
  • must be safe for consumption. 

However, the two categories are mutually exclusive – meaning a product cannot be both a medicine and a food. 

In general, the following are the common differences between medicines and foods: 

 

Medicine 

Food 

Regulated By

Therapeutic Goods Administration (TGA).

Food Standards Australia New Zealand (FSANZ).

Taste

Taste is not the focus of medicine.

Taste plays an important role in food. 

Role

To treat individuals or prevent disease, generally for circumstantial or temporary use.

For nutrition, which is ongoing and essential, and can also often play a social role. 

Use and Selection 

They are generally used under the supervision of a health practitioner. 

It is self-selected.

Risk Profile

The risk to benefit balance must be considered before use.

Generally, there is a low risk.

Manufacture and Preparation

Generally, it involves a complex manufacturing process.

Generally, it involves a simpler preparation process.

Food Requirements

If your product is food, then you will need to ensure that you comply with the requirements under the Food Standards Code (the Code). The Code sets out the labelling requirements and specific food standards that relate to your specific category of food. 

Medicine Requirements

If your product is a medicine, then you will need to comply with the requirements under the Therapeutic Goods Act. You will also need to register or list your product on the Australian Register of Therapeutic Goods (ARTG) before you supply the medicine in Australia. This means that the product will also be subject to strict advertising requirements about the types of therapeutic and health claims that you can make about the product.   

The Food-Medicine Interface

There may be some products where there is ambiguity about what category they fall under, and therefore what regulations apply. The ambiguity between food and medicine is well known and the TGA refers to it as the ‘Food-Medicine Interface’. As you must include therapeutic goods on the ARTG, the TGA as the regulator for medicines plays an active role in regulating the Food-Medicine Interface. 

The key questions asked by the TGA to determine whether a product is a food or medicine, includes asking is the product: 

  • for oral use, for humans?
  • in a class of goods the sole or principal use of which is, or ordinarily is, a therapeutic use?
  • 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?

As well as asking: 

  • is there a declaration in relation to the product that it is a therapeutic good? 
  • is there a declaration in relation to the product that it is not a therapeutic good? 
  • does the product have a tradition of use as food for humans?
  • is there a relevant standard for the product in the Food Standards Code?

The Ambiguity With Supplements 

Dietary and sports supplements fall into a grey area in the Food-Medicine Interface. Supplements include vitamins, minerals, protein powders or other products that improve nutrition and performance. There is no separate regulatory category for dietary supplements. Consequently, they are regulated either as foods or medicines, with a fine line delineating the two. The regulation of supplements depends on the: 

  • ingredients; 
  • types of claims made on the product; and 
  • the form that the product comes in (powder, bar or tablet).

The TGA has declared certain sports supplements that use higher risk ingredients to be regulated as medicines. Therefore, you must register them on the ARTG. Higher risk ingredients include those that are contained in a schedule to the Poison Standard or an ingredient included in the World Anti-Doping Code Prohibited List. This means that these products must comply with the strict safety, quality and efficacy requirements for medicines. This includes products that make claims relating to performance in sport, exercise or recreation activity and contain ingredients that are higher risk or that are in a medicinal dosage form of a tablet, capsule or pill. 

Common sports supplements, for example protein powders and sports drinks that do not contain high-risk substances, are unlikely to be considered medicines. However, if you are supplying or manufacturing sports supplements, you should be mindful about whether you are making any therapeutic or health claims in your advertising.  

Supplements that fall outside this category will be considered sports foods and will be regulated as Formulated Supplementary Sports Foods under the Code. 

What Happens if You Get it Wrong? 

If a product is registered on the ARTG and is, in turn, determined not to be a medicine, then the sponsor or the Secretary of the Australian Government Department of Health can remove it from the ARTG.

The TGA may become aware that your product is a medicine, but you did not register it on the ARTG. In these circumstances, the TGA will generally contact you to notify you of your need to register your product. In addition, if the TGA determines that your product poses a risk to public health, then the TGA may make a public alert. The TGA can also impose infringement notices and other regulatory or civil actions. 

Key Takeaways 

If you have a product, particularly a product that is intended as a supplement, you should carefully consider if it is a medicine or food. If you think your product is a medicine, you must seek approval from the TGA before supplying, selling or marketing the product in Australia. However, if you think that your product is food, then you must ensure that you are complying with the relevant standards under the Code. For advice about TGA requirements for medicines and requirements for foods under the Food Standards Code, contact LegalVision’s business lawyers on 1300 544 755 or fill out the form on this page.

Frequently Asked Questions

What are the requirements if my product is food?

You will need to comply with the requirements under the Food Standards Code (the Code). The Code sets out the labelling requirements and specific food standards that relate to your specific category of food. 

What are the requirements if my product is a medicine?

You will need to comply with the requirements under the Therapeutic Goods Act and register or list your product on the Australian Register of Therapeutic Goods (ARTG) before you supply the medicine in Australia.

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