We all are aware of how food and medicine are different in terms of how they individually nourish the body, but both eventually tend to mainly assist in maintaining our health. While we are trying to enhance our immunity, improve our stamina or deal with current chronic health concerns, we sometimes tend to buy unknown food and food supplements, with poor labeling, which can cause more harm than good. To help consumers get high-quality food and medicines throughout the year, Regulatory partners like Freyr, ensure global food and drug manufacturers comply with dynamic Regulations laid out by the health authorities across-the-globe. Read on to find out how food or medicines manufacturers can discover if their products are regulated as a food or a medicine in Australia.
Similarities and Differences between Food and Medicine
- All foods and many medicines are taken orally
- Foods and medicines assist in maintaining and improving health
- Foods and medicines can contain some of the same ingredients
- Allergic reactions are common with food or medicine
- Taste is important to food, while it isn't the focus of medicine
- Food has a social role, while medicines treat individuals with varied health concerns
- 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 considered to have low risk, while medicines balance risk against benefit
- The manufacturing of medicine is usually more complex than the preparation of food
Ways Foods and Medicines Are Regulated In Australia
State and territory food agencies regulate food in accordance with both state/territory, and national food legislation, including food standards set by the statutory body Food Standards of Australia and New Zealand (FSANZ). The TGA regulates medicines at the federal level.
Any product that is taken orally (eaten) is classified as food.
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 maybe categorized as 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 is made for human consumption and taken orally then it is not a medicine, it is more likely to be considered a food.
A product is classified as a medicine if it is represented to be a therapeutic and more likely to be taken for a therapeutic use or is declared to be a therapeutic good.
In Australia, we do not have a separate Regulatory category for dietary supplements. All supplements are either considered as foods or medicines, depending on the supplement's individualistic features.
Know whether your product is regulated as food or medicine in Australia
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 in Australia
- Medicines must meet scientific evidence requirements proportionate to their health claims
- Foods and medicines have different labeling requirements (for instance, medicine labels must display the active ingredient, while food labels should include nutritional 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.
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 maybe regulated as 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 cannot expect one to do the job of the other.
Our team of Regulatory experts at Freyr can assist you in complying with all your dynamic Regulatory requirements listed by FSANZ and the TGA. Freyr is a niche Regulatory solutions provider for the Food and Dietary supplement industry to ensure global partners and manufacturers comply and adhere to country-specific regulations/guidelines. Freyr provides the best Regulatory methodologies, strategies and submission assistance to ensure food and drug manufacturers achieve an expedited market entry. To find whether your product is regulated as a food or medicine in Australia, get in touch with our Regulatory experts today!