This presentation provides an overview of the TGA’s Food-Medicine Interface Guidance Tool (FMIGT) and the regulatory management of food-like products.

1. Regulatory and legal implications of food-like
presentations
Philippa Horner, Principal Legal Adviser, TGA
Trisha Garrett, Assistant Secretary, Complementary Medicines Branch, TGA
ARCS Scientific Congress 2015
7 May 2015

2. Why do we need to know?
• The TGA and food regulators (state and territory) need
to ensure the legality of:
– inspection and seizure of goods
– recall of unsafe goods
– enforcement actions
• Industry needs to know which regulatory regime to comply:
– criminal and civil penalties for importing, manufacturing unapproved therapeutic
goods
– pre-approval requirements for therapeutic goods, for example, good
manufacturing practice (GMP) and inclusion in the Australian Register of
Therapeutic Goods (ARTG)
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3. Why do we need to know?
The TGA needs to:
• identify goods on the ARTG that are ‘food’ and therefore are not regulated by the TGA
• respond to advertising complaints about unfair competition from goods that are not on
the ARTG
• provide accurate information to industry and the public
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4. How can a food be therapeutic goods?
Definition of ‘therapeutic goods’ in the Therapeutic Goods Act
Goods that are:
• represented to be for ‘therapeutic use’, or
• likely to be taken to be for ‘therapeutic use’ because of the way in
which they are presented, or for any other reason.
Concerned with the
apparent intended use
of goods.
Goods that are in a class, the sole or principal use of which is, or ordinarily is,
‘therapeutic use’.
Concerned with the
actual use of that
class of goods
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5. How can a food be therapeutic goods?
Therapeutic use includes:
• preventing, diagnosing, curing or alleviating a
disease, ailment, defect or injury
• influencing, inhibiting or modifying a physiological
process
If such goods are for oral use/human consumption, they also come within the
definition of ‘food’ in the Food Standards Australia New Zealand (FSANZ) Act and
therefore can come within the regulatory jurisdiction of the states and territories.
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6. What does the Therapeutic Goods Act say?
• The Act excludes particular types of ‘food’ from definition of ‘therapeutic goods’
• Goods cannot be ‘therapeutic goods’ if they are:
1. goods for which there is a standard under the FSANZ Act [paragraph (e) of the definition
of ‘therapeutic goods’]
2. goods which in Australia or New Zealand have a ‘tradition of use as foods’ in the form in
which they are presented [paragraph (f) of the definition].
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7. 1. Goods for which there is a Food Standard
Potentially relevant FSANZ Food Standards include:
2.9.4 – Formulated supplementary sports food
2.9.5 – Food for special medical purposes
Careful consideration is needed to determine whether the goods are covered by a Food
Standard.
If goods are covered by a Food Standard, then the fact that:
• therapeutic claims are made about the goods on the label or in advertising, or
• the goods do not comply with requirements in the Standard, or
• undisclosed scheduled substance are found in them
does not make the goods therapeutic goods.
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8. 2. Goods which have a ‘tradition of use as foods’
• ‘Tradition of use’ in Australia or NZ:
– a history of significant human consumption in the broad community
– adequate knowledge in the broad community that there is reasonable certainty no harm
will result from intended use
• In the ‘form in which it is presented’, for example:
– coffee, cocoa (Sumabe), garlic in pill form, tea in teabags/tablets
• If goods have a tradition of use as a food, then the fact that:
– therapeutic claims are made about the goods on the label or in advertising, or
– undisclosed scheduled substances are found in them
does not make the goods therapeutic goods.
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9. Listed complementary medicines
• As sponsors list their medicine on the ARTG via a certification
process, the TGA cannot assess at that time if the goods are not
‘therapeutic goods’ and are in fact ‘food’
• Administrative Appeals Tribunal (AAT)
Sumabe (2012):
The AAT found that ‘Leptin Green Coffee’ and ‘Leptin Green Hot
Chocolate’ were properly cancelled from ARTG on the basis that they
were covered by paragraph (f) of the definition i.e there was a tradition
of use in Australia/New Zealand as food in that form (sachets)
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10. Legislative options
Section 7
• A declaration can be made by the Secretary that goods are therapeutic goods even if they are covered by a
Food Standard or have a tradition of use as a food
Section 7AA
• Legislative instrument can be made by the Minister to exclude goods that are not appropriate to regulate
under the Act, for example: wrist bands, could be used to exclude food in appropriate cases (if not covered
by a Food Standard and don’t have a tradition of use as a food).
Section 9F
• Secretary can remove individual products from the ARTG that are not therapeutic goods, for example: the
product has a tradition of use in Australia as food in the form in which it is presented
– sponsor has an opportunity to make submissions before decision is made
– subject to internal and external (AAT) review
– decisions published on the TGA website when effective
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11. Food Medicine Interface
• Presentation is only one of the factors relevant to whether a product is a therapeutic good
(usually a medicine) or a food
For example:
– minced or crushed garlic in a bottle that makes claims that ‘garlic relieves cold
symptoms’ is likely to be a food, as there is a tradition of use of garlic as food in that
form, even if the claim could be regarded as a therapeutic claim
– however, if the garlic is concentrated and marketed in a capsule with claims that it can
be used to relieve cold and flu symptoms, it might be considered a medicine
• More information can be found on the Food and medicine regulation page on the TGA website
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12. The Food Medicine Interface (FMI) Guidance Tool
The FMI Guidance Tool is:
• developed with and endorsed by state and territory food regulators and FSANZ
• designed to take the user through the relevant definitions in the Act
• used when regulators need to work out whether a particular product is likely to be therapeutic
good and therefore to be regulated by the TGA
• available on the TGA website - Food-Medicine Interface Guidance Tool (FMIGT)
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13. Outcome of application of the Guidance Tool
Product judged to be a therapeutic good and should be on ARTG
• TGA can take action against the importer, exporter, manufacturer or supplier (offence under the
Therapeutic Goods Act)
• If the product represents a potential health risk (for example, it contains substances that are only
available when prescribed by a health professional), the TGA can publish an alert and order a
recall of the product
Product is on the ARTG and is judged to NOT be a therapeutic good
• TGA can remove the product from the ARTG under section 9F of the Act
• If likely to be a food then relevant state/territory food regulators contacted for any appropriate
regulatory action to be taken
Product is not on the ARTG and is judged NOT to be a therapeutic good
• If likely to a food then relevant state/territory food regulators contacted for any appropriate action
to be taken
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14. Guidance Tool diagram – is the product a ‘therapeutic good’?
Q1. Is the product for oral use for humans?
No
Issue of the food medicine interface does not arise (may be a
therapeutic good).
Yes
Q2. Is there a s.7 declaration that the product is a therapeutic good? The product is a therapeutic good.
No
Q3. Is the product covered by a s.7AA declaration?
The product is not la therapeutic good.
It may be food within state/territory food regulation legislation and/or
regulated under other state/territory legislation.
No
Q4. Is the product goods for which there is a standard in the Food Standards Code? The product is not likely to be a therapeutic good.
It is likely to be food within state/territory food regulation legislation
and/or regulated under other state/territory legislation.
No
Q5. Is the product goods which, in Australia or NZ, have a tradition of use as foods for
humans in the form in which the product is presented?
Yes
Yes
No
No
Yes
Yes
Yes
The product is not likely to be a therapeutic good.
It is likely to be food within state/territory food regulation legislation
and/or regulated under other state/territory legislation.
Yes
The product is likely to be a therapeutic good.
No
Q7. Is the product in a class of goods the sole or principal use of which is, or ordinarily
is, a therapeutic use? The product is likely to be a therapeutic good.
If it is not a biological or medical device, the product is not likely to be a therapeutic
good. It may be food within state/territory food regulation legislation
Q6. Is the product any of the following:
(1) represented in any way to be for a therapeutic use?
(2) likely to be taken [by someone] to be for a therapeutic use because of the way in which it is
presented?
(3) likely to be taken [by someone] to be for a therapeutic use for any other reason?
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15. 14Regulatory and legal implications of food-like
presentations
Example 1

16. Example 1: Herbal wine
No
Yes
No
Q1. Is the product for oral use for humans? Issue of the food medicine interface does not arise (may be
a therapeutic good).
Q2. Is there a s.7 declaration that the product is a
therapeutic good?
The product is a therapeutic good, not food.
Yes
Q3. Is the product covered by a s.7AA declaration?
The product is not a therapeutic good.
It may be food within state/territory food regulation
legislation and/or regulated under other state/territory
legislation.Yes
The product is not a therapeutic good.
It is likely to be food within state/territory food regulation
legislation and/or regulated under other state/territory
legislation.
Yes*
Q4. Is the product goods for which there is a
standard in the Food Standards Code?
* Provided the goods are goods to which the actually standard applies
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17. Example 2
16Regulatory and legal implications of food-like
presentations
Green tea (bag)

18. Example 2: Green tea (bag)
No
No
Yes
No
Q1. Is the product for oral use for humans?
Issue of the food medicine interface does not arise
(may be a therapeutic good).
Q2. Is there a s.7 declaration that the product is a
therapeutic good?
The product is a therapeutic good.
Yes
Q3. Is the product covered by a s.7AA declaration?
The product is not a therapeutic good.
It may be food within state/territory food regulation
legislation and/or regulated under other state/territory
legislation.Yes
The product is not likely to be a therapeutic good. It is
likely to be food within state/territory food regulation
legislation and/or regulated under other state/territory
legislation.
Yes
The product is not likely to be a therapeutic good. It is
likely to be food within state/territory food regulation
legislation and/or regulated under other state/territory
legislation.
Yes
No
Q5. Is the product goods which, in Australia or NZ, have
a tradition of use as foods for humans in the form in
which the product is presented?
Q4. Is the product goods for which there is a standard in
the Food Standards Code?
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19. Example 3
18Regulatory and legal implications of food-like
presentations
Coriander
powdered capsule

20. Example 3: Coriander powdered capsules
Q1. Is the product for oral use for humans?
No
Issue of the food medicine interface does not arise (may be a
therapeutic good).
Yes
Q2. Is there a s.7 declaration that the product is a therapeutic good?
No
No
Yes
Yes
No
No
The product is a therapeutic good.
Yes
Q3. Is the product covered by a s.7AA declaration?
The product is not a therapeutic good.
It may be food within state/territory food regulation legislation and/or
regulated under other state/territory legislation.Yes
The product is not likely to be a therapeutic good.
It is likely to be food within state/territory food regulation legislation
and/or regulated under other state/territory legislation.
Yes
The product is not likely to be a therapeutic good.
It is likely to be food within state/territory food regulation legislation
and/or regulated under other state/territory legislation.
Yes
The product is likely to be a therapeutic good.
No
Q7. Is the product in a class of goods the sole or principal use of which is, or ordinarily is, a therapeutic
use?
The product is likely to be a therapeutic good.
If it is not a biological or medical device, the product is not a therapeutic good. It may be food within
state/territory food regulation legislation.
Q6. Is the product any of the following:
(1) represented in any way to be for a therapeutic use?
(2) likely to be taken [by someone] to be for a therapeutic use because of the way in which it is
presented?
(3) likely to be taken [by someone] to be for a therapeutic use for any other reason?
No
Q5. Is the product goods which, in Australia or NZ, have a tradition of use as foods for humans in the
form in which the product is presented?
Q4. Is the product goods for which there is a standard in the Food Standards Code?
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21. Example 4
20Regulatory and legal implications of food-like
presentations
Sports
supplements

22. Example 4: Sports supplements
Q1. Is the product for oral use for humans?
No
Issue of the food medicine interface does not arise
(may be a therapeutic good).
Yes
Q2. Is there a s.7 declaration that the product is a
therapeutic good? Yes
The product is a therapeutic good.
No
Q3. Is the product covered by a s.7AA declaration?
Yes
The product is not likely to be a therapeutic good. It
may be food within state/territory food regulation
legislation and/or regulated under other state/territory
legislation.
No
Q4. Is the product goods for which there is a standard in the
Food Standards Code?
Yes*
The product is not likely to be a therapeutic good. It is
likely to be food within state/territory food regulation
legislation and/or regulated under other state/territory
legislation.
*Provided the goods are goods to which the actually
standard applies
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