Regulatory and legal implications of food-like presentations - PowerPoint PPT Presentation

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) Regulatory and legal implications of food-like 1 presentations

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 Regulatory and legal implications of food-like 2 presentations

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 Concerned with the apparent intended use • likely to be taken to be for ‘therapeutic use’ because of the way in of goods. which they are presented , or for any other reason. Goods that are in a class, the sole or principal use of which is, or ordinarily is, Concerned with the ‘therapeutic use’. actual use of that class of goods Regulatory and legal implications of food-like 3 presentations

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. Regulatory and legal implications of food-like 4 presentations

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]. Regulatory and legal implications of food-like 5 presentations

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. Regulatory and legal implications of food-like 6 presentations

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. Regulatory and legal implications of food-like 7 presentations

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) Regulatory and legal implications of food-like 8 presentations

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 Regulatory and legal implications of food-like 9 presentations

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 Regulatory and legal implications of food-like 10 presentations

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) Regulatory and legal implications of food-like 11 presentations

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 Regulatory and legal implications of food-like 12 presentations