Complementary Medicines & Functional Foods
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Foods:
Formula reviews (for regulatory compliance and meeting thresholds to make health claims)
Assistance with formula development
Health-related claims assessment
Label reviews
Country of Origin labelling determination
TGA listed Medicines:
Formula reviews (for regulatory compliance and meeting thresholds to make permitted therapeutic claims)
Product Evidence Packages generated (to substantiate the therapeutic claims made for TGA listed products)
Entering products onto the Australian Register of Therapeutic Goods (ARTG).
Product label guides generated for new products. Label reviews
Regulatory Overview
In Australia, substances that are ingested for human consumption are regulated as either ‘medicines’ or ‘foods’.
There is no 3rd ‘Dietary Supplements’ category, as in New Zealand, Europe or the USA.
FSANZ sets the regulations for ‘foods’ and TGA sets the regulations for ‘medicines’.
Regulatory Overview – FOODS
Food regulations are determined by Food Standards Australia New Zealand (FSANZ).
FSANZ is an independent statutory agency established by the Food Standards Australia New Zealand Act 1991 (FSANZ Act) and is part of the Australian Government’s Health portfolio. FSANZ develops and administers the Australia New Zealand Food Standards Code.
The Code regulates the use of food ingredients, processing aids, colourings, additives, vitamins and minerals and it also sets the requirements for labelling.
FSANZ has no enforcement powers.
State or territory government agencies (eg. State Health Dept.) and local councils are responsible for interpreting and enforcing the Code within Australia. The Federal Department of Agriculture, Fisheries & Forestry (DAFF) is responsible for interpreting and enforcing the Code at the Australian border for imported foods.
Note, the Advisory Committee on Novel Foods (ACNF) document ‘Record of Views’ which gives considered opinions about whether a food is novel, are recommendations only and are not legal advice nor are they legally binding.
Country of Origin information
The Competition & Consumer Act 2010 (CCA) via the ‘Country of Origin Food Labelling Information Standard 2016’ requires mandatory country of origin labelling for most foods sold in Australia. The labelling varies according to whether the food is grown, produced, packed or made in Australia or another country. The most basic labelling has a bar chart and a text statement. In a prescribed format.
‘Non-priority’ foods (seasonings; confectionery; biscuits & snack food; bottled water; soft drinks & sports drinks; tea and coffee; and alcoholic beverages) are exempt from the requirement. The ACCC is responsible for investigating breaches and enforcing compliance.
Failure to comply with the Standard will likely contravene Australian Consumer Law (ACL) and expose the product Sponsor to potential enforcement action by the ACCC.
FSANZ mandatory label information
FSANZ requires a set of mandatory information to be declared on the label. Information such as lot identification, name & address of the supplier, date marking (best before or use by), storage instructions, directions for use, statement of ingredients, information about characterizing ingredients or components, nutrition information, advisory & warning statements and declarations etc …
Allergen labelling
location and format
Precautionary allergen labelling (PAL) includes ‘may contain’ or ‘may be present’ statements about allergens, such as ‘may contain peanuts’. They are voluntary statements and the Food Standards Code does not regulate them.
Note, according to FSANZ, the most common reason for Food Recalls is undeclared allergens.
Voluntary (non-mandatory) label information
Most labels make voluntary statements about their product regarding features & benefits and usually make claims.
FSANZ permits some ‘health’ claims, which are identified in the Code.
A health claim is a claim stating or implying a health effect on the body, including an effect on one or more of the following: (a) a biochemical process or outcome; (b) a physiological process or outcome; (c) a functional process or outcome; (d) growth and development; (e) physical performance; (f) mental performance; (g) a disease, disorder or condition.
To make a permitted ‘health’ claim, the food must meet the Nutrition Profiling Scoring Criterion (NPSC). This score is calculated on the amount of energy, saturated fat, total sugars, sodium etc …
Health related statements not explicitly permissible by FSANZ are generally not permitted. Foods making claims that are ‘therapeutic’ in nature are at risk of being classified as ‘medicines’ and so require entry on the Australian Register of Therapeutic Goods (ARTG).
Note, Australian Consumer Law (ACL) prohibits making false or misleading representations about goods. This includes claims, statements, images or graphics made on product labels.
Health Star Ratings
The Health Star Rating (HSR) system rates the nutritional profile of packaged food and gives each product a rating from ½ a star to 5 stars. The rating is based on total energy, saturated fat, sodium, fibre, protein and fruit/vege/nut … content. Currently voluntary but FSANZ has proposed they be mandated as compulsory (Proposal 1067).
Intellectual Property (IP)
As a general rule, the recipe information you supply a Contract Manufacturer is your IP and what they supply is their IP.
For example, if you supply the core formula (active ingredients) and they develop the flavouring and sweetening, the Contract Manufacturer will ordinarily own the IP of that flavouring & sweetening part of the recipe.
If you have formulated the product, created samples and provided the formula, method and those samples to the manufacturer to be recreated, you will have full Intellectual Property ownership.
Talk to your Contract Manufacturer to understand IP arrangements before engaging them.
New Product Development – tips
1. develop the formula as ‘mg/g per serve’.
Permitted health and nutrition content claims are based on ‘per serve’ amounts. For example, a food containing at least 4 g of dietary fibre per serve would be eligible for the claim ‘good source of fibre; a food containing at least 10g protein would be eligible for the claim’ good source of protein’.
2. Be mindful of any claims about your product that you want to make.
FSANZ permits some health and nutrition content claims when certain thresholds are met, so by being aware of those thresholds, the formula can be adjusted to meet them.
3. Be mindful of how many times a day the directions for use will be.
For some ingredients, FSANZ has set maximum amounts per day. For example, the maximum daily amount of creatine permitted is 3g. If each serve supplies 2g creatine and the directions are to take 1-2 times a day, 2 serves supplies 4g creatine, which exceeds the permitted limit.
Regulatory Overview – Medicines
Medicines are regulated by the Therapeutic Goods Administration (TGA) which is part of the Australian Government Department of Health, Disability and Ageing.
The Therapeutic Goods Act, Regulations and Orders plus Therapeutic Goods Advertising Code (TGAC) set out the requirements for therapeutic goods.
The TGA only regulates therapeutic goods. Not foods.
Complementary medicines, such as herbal, vitamin, mineral and nutritional supplements are classified as ‘therapeutic goods’ and as non-prescription medicines. They are required to be entered on the Australian Register of Therapeutic Goods (ARTG), usually as listed medicines.
A therapeutic good is a product used in connection with preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury OR influencing, inhibiting or modifying a physiological process.
The only therapeutic claims that can be advertised about a product (eg. on the label; product flyer etc …) are those claims that have been recorded in the products ARTG entry.
General process for developing a TGA listed medicine.
- Develop a draft formula of the active ingredients and the amounts per dose.
- Make sure the ingredients and the amounts are TGA permissible
- Be mindful of the claims you want to make. A claim will require a particular amount of an ingredient per day, so this may affect the ingredient amounts in developing the formula
- Approach a TGA licenced manufacturer for a quote.
- A TGA listed medicine must be made in a TGA licenced facility
- Sign the manufacturers’ Product Specification document.
- This document is generated after the quote is agreed to.
- There may be formula changes and negotiations in this process
- This is the source document used to enter the product onto the ARTG
- Pay the 50% deposit (usually 50%)
- The product will be booked in for production once the deposit is paid
- The payment will contribute to the purchase of ingredients
- The lead time for production usually commences form payment date (eg. 12 weeks)
- Organize the products’ Evidence Package
- Each TGA permitted indication that is entered onto the products’ ARTG must be supported by evidence.
- Enter the product onto the ARTG
- TGA cost is $1014
- Processing usually takes 5 -10 working days
- The TGA certificate that is issued has the AUST L number. This is needed for the labels to be finalized.
- Organize labels
- Make sure the label is compliant.
- The rules are very prescriptive and specific about what is permitted and what is not permitted on the label
Usually the labels must be with the manufacturer several week before scheduled production.
10. Pay balance and receive product
11. Organize stability trials.
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