regulatory and legal implications of food-like presentations

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

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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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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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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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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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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1. Goods for which there is a Food StandardPotentially 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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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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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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Legislative optionsSection 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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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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http://www.tga.gov.au/community-qa/food-and-medicine-regulation

The Food Medicine Interface (FMI) Guidance ToolThe 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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http://www.tga.gov.au/food-medicine-interface-guidance-tool-fmigt-plain-version

Outcome of application of the Guidance ToolProduct 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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Guidance Tool diagram – is the product a ‘therapeutic good’?

Q1. Is the product for oral use for humans?

NoIssue 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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14Regulatory and legal implications of food-like

presentations

Example 1

Example 1: Herbal wine

No

Yes

NoQ1. 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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Example 2


presentations

Green tea (bag)

Example 2: Green tea (bag)

No

No

Yes

NoQ1. Is the product for oral use for humans?



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


Yes


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?



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Example 3


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Coriander powdered capsule

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


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


No

Q7. Is the product in a class of goods the sole or principal use of which is, or ordinarily is, a therapeutic

use?


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?


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Example 4


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Sports supplements

Example 4: Sports supplements

Q1. Is the product for oral use for humans?No


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


Yes*


*Provided the goods are goods to which the actually

standard applies


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regulatory and legal implications of food-like presentations

Health & Medicine

goods therapeutic goods

therapeutic goods act

orthe goods

therapeutic use

class of goods regulatory

definition of food

legal implications of

therapeutic claims