Is your product a medicine, device, cosmetic or food? Know how to tell.
Many products make claims about their health effects. This does not necessarily mean that they are therapeutic goods. However, the desire to extract more health benefits from our cosmetics and foods has made it hard to tell and raises the question: what is my product?
Depending on its use, it’s important to decide the intended purpose early. If you are not building the correct supporting evidence during development, you might find you need to modify your claims or re-do work to meet regulatory requirements. Here’s some general guidance on navigating through the regulations.
A therapeutic good is broadly defined as a product for use in humans in connection with;
• preventing, diagnosing, curing or alleviating a disease or injury
• influencing, inhibiting or modifying a physiological process
• testing a person for a disease
• preventing conception or testing for pregnancy
If your product has one or more of these intentions it is likely a medicine or device and will be regulated as a therapeutic good.
Sometimes it can be unclear as to whether a product is a complementary medicine or a food. To start, product presentation may help determine whether it is a food. For example, orange juice is a food. However, if vitamin C is extracted, concentrated and marketed in a tablet with claims that it may ‘relieve cold and flu symptoms’ it’s considered a therapeutic good.
Foods may not make claims that are therapeutic in nature. They may not refer to the prevention, diagnosis, cure or alleviation of a condition. However, they can make nutrition content claims (e.g. good source of dietary fibre or source of vitamin C) and some health claims (e.g. enhances bone mineral density, reduces blood cholesterol, necessary for normal bone structure, contributes to regular laxation, contributes to heart health) if they meet specific conditions.
In addition to foods, cosmetics may not make claims that are therapeutic in nature. They also are not to refer to the prevention, diagnosis, cure or alleviation of a condition. Even if a product is intended to be a cosmetic, it may be classified as a medicine depending on its ingredients, the route of administration and if therapeutic claims are made on its label, or in advertising.
At the end of the day it can be hard to make the call as to which regulations apply to your product. Regulations also vary from country to country if you intend launching your product globally. It’s wise to consult a regulatory expert for advice to ensure you’re aware of the requirements.
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