Some therapeutics and complementary medicines face de-listing for therapeutic claims in Australia
By Joe Lederman
FoodLegal Lawyers and Consultants
© Lawmedia Pty Ltd, November 2014
The new guidance tool released by Australia’s Therapeutic Goods Administration appears likely to threaten many products with de-listing as therapeutic goods. Many products will need to revise their marketing and branding, or may be re-categorised as ‘food’ and limited to making ‘health claims’ instead of ‘therapeutic claims’. This article examines the issue.
On 7 August 2014, Australia’s Therapeutic Goods Administration (TGA) released a new “Food-Medicine Interface Guidance Tool” (the Guidance Tool). The TGA stated that the purpose of the Guidance Tool is “to assist manufacturers and importers in determining whether their products will be regulated as therapeutic goods or as foods, and to allow consumers to check if the products they are using are classified and regulated suitably”.
What is the impact of a product being classified as a food or a therapeutic good?
Depending on the category under which a product is considered to fall, very different regulatory requirements apply.
Manufacturers may have their own reasons for wanting their product to be regulated as one over the other. For a food, the manufacturing requirements would usually be less stringent, cheaper and less regulated than therapeutic goods. However, stricter limitations over marketing claims apply for some foods.
What is the traditional approach to determining whether a product is a food or therapeutic good?
Four key factors have been traditionally considered to assist in determining what category a product will be considered to fall under and thus determine the regulatory regime.
First, the composition of the product: Does the product have something in it that might disqualify it from being a food?
Secondly, form or presentation of the product: For example, a product in capsule form might create the presumption of being a therapeutic good. Conversely, some functional powders and pills can be foods in new forms.
Thirdly, the claimed function of the product: It is necessary to consider when a claim becomes unacceptable under the Australia New Zealand Food Standards Code (the Food Standards Code) and can cross the line to be a therapeutic goods claim. Foods and therapeutic products can have functional benefits but the legal acceptability of a marketing claim can vary under the different regulatory regimes. Care needs to be taken to ensure that a health claim for a food does not ‘cross the line’ and become an illegal therapeutic claim even when the product is efficacious in helping consumers overcome a difficult health condition.
Fourthly, the usage of dosages: One of the traditional criteria for defining a therapeutic good it that it is consumed in dosages. Nevertheless, it has become more common for food labels to specify recommended serving quantities or restrictions on daily serves or intakes. Moreover, there are even particular food standards in the Food Standards Code requiring declarations of consumption levels or medical type warnings that apply in many circumstances apart from any mandatory allergen declaration.
What will be the impact of the Guidance Tool?
The Guidance Tool aims to assist in distinguishing foods from therapeutic goods. Certain products may previously have been considered to fall under either category, thus allowing the manufacturer a choice.
However, there is a danger in the approach of the Guidance Tool in attempting to delineate a hard line definition between the two categories.
Taking one simple illustration of using the new Guidance Tool on an amino acid powder, the testing tool of the TGA comes up as ‘likely a food, not a therapeutic good’, despite the fact that it is commonly used as a product that falls under the Australian Registry of Therapeutic Goods (ARTG).
Will food products be removed from the Australian Registry of Therapeutic Goods?
It is quite possible that the new tool will be utilized by the TGA to make it easier for the TGA to force removal of products from the ARTG.
According to the same TGA guideline, lozenges can be viewed as confectionary and therefore could fail to be considered as a therapeutic good.
The main consequence of de-listing from the ARTG is that various key marketing claims used for such products could be disallowed as illegal if the claim is a ‘therapeutic’ claim.
It is unclear what the impact may be for a mixed product. For example, if a herb that is not permitted as a food but listed as a therapeutic good was mixed with amino acid powder, where might this product now fall? FoodLegal considers that this will depend on a number of other factors.
Does presentation no longer impact whether a product is a food or therapeutic good?
As noted above, the presentation of a product has commonly been considered a deciding factor in whether it is a food or therapeutic good. A “performance multivitamin effervescent drink” under the ARTG could be an “energy drink” guided by the Food Standards Code, and a herbal infusion could be presented as a tea product. The nature, form, claim, purpose and ingredients of the product have historically had an impact on which category the product falls under.
There have been indications from TGA representatives that the TGA Guidance Tool may allow for an easy methodology to remove some products from the ARTG for being a food. Arguably, the TGA might say that the only thing that had made them a listed therapeutic good had been the making of a therapeutic claim previously.
What are the potential impacts for companies?
For products currently under the ARTG, for which an annual fee is paid, there is a risk that some functional claims could be prevented by law from continuing.
If a product that is currently listed under the ARTG has an express standard under the Food Standards Code – for example, a formulated caffeinated beverage or a sports food – it may be more likely that it will eventually become delisted from the ARTG.
For different products, one preferable option might now be to market and sell the product as a compliant food product. FoodLegal can provide an appropriate risk assessment of the product for its compositional compliance and proposed health or functional claims when categorised as food.
This is general information rather than legal advice and is current as of 12 Dec 2015. We therefore recommend you seek legal advice for your particular circumstances if you want to rely on advice or information to be a basis for any commercial decision-making by you or your business.