
Is the TGA undermining the food industry’s confidence in its own compliance? By Charles Fisher (FoodLegal Principal) © Lawmedia Pty Ltd, December 2020 Following the issuing of its new sports supplement order in September 2020, the Therapeutic Goods Administration (TGA) appears to have demonstrated that it has no regard for the legal compliance of food products and is willing to take action outside its jurisdiction against food products that are completely safe. This article explores how the new order crosses the fragile line between food and therapeutic good and how the TGA appears to be undermining confidence in food regulatory compliance without a properly considered rationale. Is the TGA Order an appropriate regulatory response to the problem? The outcome of the TGA Order is that a certain number of products (that were mostly previously categories as food products) will now automatically be classified as therapeutic goods based on certain compositional and marketing criteria. Our October 2020 article "TGA introduces new laws targeting sports supplements: What this means for food businesses" analysed the impact of the order and provides further detail. The order was one of a number of different regulatory responses to some safety incidents (including a fatal overdose) caused by consumption of sports supplements that were very high in caffeine. This TGA order is separate to the response by Food Standards Australia New Zealand (FSANZ), which immediately made any food containing more than 5% caffeine non-compliant, and the listing of caffeine in the Poisons Schedule. As a result, all the products that were of concern would have been found to be in breach of both food regulation and therapeutic legislation without further need of the TGA Order. Any presence of non-compliant products on the market would represent a failure in enforcement, not in regulation. In fact, given that the majority of non-compliant sports supplements are imported from overseas, making such products a risk food at the Australian border (and therefore making every single shipment subject to mandatory inspection) would have been a far more effective tool to prevent such goods reaching Australian consumers than by changing their regulatory classification. However, notwithstanding receiving a large number of submissions from both the supplements industry and their consumers (as well as being the subject of the “Save Aussie Supplements” campaign), the TGA decided to proceed with an amended version of the order which declared two categories of product that could previously have been seen to be non-compliant food to being therapeutic goods. This is not an inconsequential change. Take for example a sports food that contains slightly too much of a nominated substance. If that non-compliance were no threat to public health and safety (and these breaches rarely are) then a food regulator would likely simply have notified the supplier and brought them back into compliance. Under the new TGA Order, that product now automatically becomes reclassified from non-compliant food to being a non-compliant therapeutic good, which has significant ramifications not just in compliance but in manufacturing licensing, claims approval and more. Essentially, if you get an ingredient wrong, you are thrust into a whole different regulatory regime, as opposed to being brought into compliance in the regime you would like to be in. On its face, this approach is clearly not fit for purpose. There would be much more efficient ways of removing these products from market, not least of which would be funding food regulators to make sports food compliance an enforcement priority. Alarmingly, this TGA Order appears to be a demonstration of the fact that the TGA sees food law as an impediment to its own enforcement, rather than something to be supported: *Why the problems with current legislation impede appropriate regulatory enforcement to address safety concerns* The existence of Food Standard 2.9.4 means that sports supplements, irrespective of the ingredients they contain or their presentation, can be argued to fall out of the remit of the TGA because they can claim to be specifically formulated to assist sports people in achieving specific nutrition or performance goals. The weakness in this argument is that many of the products that are claimed to be ‘formulated supplementary sports foods’ principally or solely contain active ingredients that have no proper or legitimate use in sports nutrition. Further, some of the products principally or solely contain active ingredients the use of which is prohibited in sport. Nevertheless, the issue is open to interpretation and therefore exposes regulatory actions to the risk of delay and obfuscation through vexatious legal argument. What the above extract, taken from the TGA Regulation Impact Statement, designates any argument by a food supplier that their product is food and outside of the TGA’s jurisdiction to be “delay and obfuscation through vexatious legal argument”. What does this say about the TGA’s view of food regulation and its enforcement agencies? The TGA states that Standard 2.9.4 does not prohibit ingredients listed in the Poisons Schedule or the WADC Prohibited List. Standard 2.9.4 does not need to as other prohibitions - such as those against nutritive substances and novel foods – prohibit their addition. But even if this were the key issue, it would be simple to amend Standard 2.9.4 to expressly prohibit these substances rather than declare the products to be automatically therapeutic goods. Such an amendment to the Food Standards Code was urgently approved in relation to caffeine, after all. The Regulation Impact Statement goes on to talk about the international issues with sports supplements, given that most of the non-compliant products are being imported from overseas. Again, making these products a risk food triggering a 100% inspection rate at the border would do more to prevent these products entering Australia than mandating that they be therapeutic goods, as therapeutic compliance is not assessed at the border. Moreover, neither personal imports of food nor of therapeutic goods are inspected for compliance, thus failing to capture the very goods that caused the safety incidents that triggered everything in the first place. But isn’t the issue limited to sports supplements? The TGA Order declares two different types of products to be therapeutic goods: As of 30 November 2020 (e.g. on the market right now), products represented as being for the improvement or maintenance of physical or mental performance in sport, exercise or recreational activity; that contain a prohibited substance; and are as being for therapeutic use; and As of 30 November 2023, products represented as being for the improvement or maintenance of physical or mental performance in sport, exercise or recreational activity; in tablet, capsule or pill format (other than a product that contains glucose only); and represented as being for therapeutic use. The TGA has long desired to rule that anything in tablet, capsule or pill format is a therapeutic good and cannot be food. The Food-Medicine Interface reinforces the TGA’s weighting of format. However, this Order is still limited to the moment to products represented as sports supplements. Of far more concern to FoodLegal is the TGA’s view of what constitutes “represented as being for therapeutic use”. Does the TGA see all health claims as therapeutic? Whether the TGA likes it or not, Standard 2.9.4 is a standard in the Food Standards Code and thus products that comply with this standard fall outside the TGA’s jurisdiction. What is concerning is that the second category of products under the TGA Order can be fully compliant food products. First of all, they do not need to contain any prohibited substances. Secondly, there is no food prohibition against selling food in tablet, capsule or pill form (otherwise breath mints would be non-compliant medicines). Thirdly, sports food are defined in Standard 2.9.4 are being “a product that is specifically formulated to assist sports people in achieving specific nutritional or performance goals”. And finally, by way of example, food products that are classified as being a protein energy supplement are expressly allowed to claim that they “may assist in the development of muscle bulk” and may be “useful before, during, or after sustained strenuous exercise”. And yet, the Explanatory Statement for the TGA Order states that gaining muscle is a claim for therapeutic use “because those uses may be characterised as uses in or in connection with influencing, inhibiting or modifying a physiological process in persons. Moreover, gaining muscle may also be characterised as a use in or in connection with modifying parts of the human anatomy. ” It is this last factor that is the most concerning, as it indicates that the TGA will implement its own definition of a therapeutic use, which is different from the food definition of a prohibited therapeutic claim. If this view were ever to be expanded beyond health supplements, it would mean that every single health claim permitted by food legislation on behalf of food products would be illegal. The Therapeutic Goods Act prohibits claims about modifying a physiological process that are made in relation to food, yet food legislation expressly permits a claim that a product can have a physiological process or outcome. When can a food company ever be confident in its own compliance? Putting to one side whether the TGA Order is fit for purpose, this is the latest in a long list of attempts by the TGA to state that fully compliant foods products ought to be regulated as medicine. The TGA is within its rights to an extent. Its legislation does prohibit health claims on behalf of food. But food is supposed to be outside the TGA’s jurisdiction. The abovementioned scenario considers a compliant food product, only containing compliant food ingredients, making claims expressly permitted on behalf of food that would be deemed to automatically be a therapeutic good under the TGA Order. To not even be food at all. If this is the ongoing view of the TGA, when can any food manufacturer ever be confident of their own compliance? For as much as the TGA does not like food making health claims, we are a society plagued with chronic health conditions where a large proportion of the treatment and cure is through dietary choice of food. Not medicine. And if food manufacturers cannot communicate that message in compliance with food regulation (and note that Standard 1.2.7 of the Australia New Zealand Food Standards Code already expressly governs the regulation of food health claims and nutrition content claims), the TGA can only be described to be actively over-regulating and working against the Australian food industry, and against public health education, dietary guidelines and consumer food choices. This is general information rather than legal advice and is current as of 14 Dec 2020. 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.

Is the TGA undermining the food industry’s confidence in its own compliance?

By Charles Fisher (FoodLegal Principal)

Following the issuing of its new sports supplement order in September 2020, the Therapeutic Goods Administration (TGA) appears to have demonstrated that it has no regard for the legal compliance of food products and is willing to take action outside its jurisdiction against food products that are completely safe. This article explores how the new order crosses the fragile line between food and therapeutic good and how the TGA appears to be undermining confidence in food regulatory compliance without a properly considered rationale.

Is the TGA Order an appropriate regulatory response to the problem?

The outcome of the TGA Order is that a certain number of products (that were mostly previously categories as food products) will now automatically be classified as therapeutic goods based on certain compositional and marketing criteria. Our October 2020 article "TGA introduces new laws targeting sports supplements: What this means for food businesses" analysed the impact of the order and provides further detail.

The order was one of a number of different regulatory responses to some safety incidents (including a fatal overdose) caused by consumption of sports supplements that were very high in caffeine. This TGA order is separate to the response by Food Standards Australia New Zealand (FSANZ), which immediately made any food containing more than 5% caffeine non-compliant, and the listing of caffeine in the Poisons Schedule.

As a result, all the products that were of concern would have been found to be in breach of both food regulation and therapeutic legislation without further need of the TGA Order. Any presence of non-compliant products on the market would represent a failure in enforcement, not in regulation. In fact, given that the majority of non-compliant sports supplements are imported from overseas, making such products a risk food at the Australian border (and therefore making every single shipment subject to mandatory inspection) would have been a far more effective tool to prevent such goods reaching Australian consumers than by changing their regulatory classification.

However, notwithstanding receiving a large number of submissions from both the supplements industry and their consumers (as well as being the subject of the “Save Aussie Supplements” campaign), the TGA decided to proceed with an amended version of the order which declared two categories of product that could previously have been seen to be non-compliant food to being therapeutic goods.

This is not an inconsequential change. Take for example a sports food that contains slightly too much of a nominated substance. If that non-compliance were no threat to public health and safety (and these breaches rarely are) then a food regulator would likely simply have notified the supplier and brought them back into compliance. Under the new TGA Order, that product now automatically becomes reclassified from non-compliant food to being a non-compliant therapeutic good, which has significant ramifications not just in compliance but in manufacturing licensing, claims approval and more.

Essentially, if you get an ingredient wrong, you are thrust into a whole different regulatory regime, as opposed to being brought into compliance in the regime you would like to be in.

On its face, this approach is clearly not fit for purpose. There would be much more efficient ways of removing these products from market, not least of which would be funding food regulators to make sports food compliance an enforcement priority. Alarmingly, this TGA Order appears to be a demonstration of the fact that the TGA sees food law as an impediment to its own enforcement, rather than something to be supported:

Why the problems with current legislation impede appropriate regulatory enforcement to address safety concerns

The existence of Food Standard 2.9.4 means that sports supplements, irrespective of the ingredients they contain or their presentation, can be argued to fall out of the remit of the TGA because they can claim to be specifically formulated to assist sports people in achieving specific nutrition or performance goals. The weakness in this argument is that many of the products that are claimed to be ‘formulated supplementary sports foods’ principally or solely contain active ingredients that have no proper or legitimate use in sports nutrition. Further, some of the products principally or solely contain active ingredients the use of which is prohibited in sport. Nevertheless, the issue is open to interpretation and therefore exposes regulatory actions to the risk of delay and obfuscation through vexatious legal argument.

What the above extract, taken from the TGA Regulation Impact Statement, designates any argument by a food supplier that their product is food and outside of the TGA’s jurisdiction to be “delay and obfuscation through vexatious legal argument”. What does this say about the TGA’s view of food regulation and its enforcement agencies?

The TGA states that Standard 2.9.4 does not prohibit ingredients listed in the Poisons Schedule or the WADC Prohibited List. Standard 2.9.4 does not need to as other prohibitions - such as those against nutritive substances and novel foods – prohibit their addition. But even if this were the key issue, it would be simple to amend Standard 2.9.4 to expressly prohibit these substances rather than declare the products to be automatically therapeutic goods. Such an amendment to the Food Standards Code was urgently approved in relation to caffeine, after all.

The Regulation Impact Statement goes on to talk about the international issues with sports supplements, given that most of the non-compliant products are being imported from overseas. Again, making these products a risk food triggering a 100% inspection rate at the border would do more to prevent these products entering Australia than mandating that they be therapeutic goods, as therapeutic compliance is not assessed at the border. Moreover, neither personal imports of food nor of therapeutic goods are inspected for compliance, thus failing to capture the very goods that caused the safety incidents that triggered everything in the first place.

But isn’t the issue limited to sports supplements?

The TGA Order declares two different types of products to be therapeutic goods:

As of 30 November 2020 (e.g. on the market right now), products represented as being for the improvement or maintenance of physical or mental performance in sport, exercise or recreational activity; that contain a prohibited substance; and are as being for therapeutic use; and
As of 30 November 2023, products represented as being for the improvement or maintenance of physical or mental performance in sport, exercise or recreational activity; in tablet, capsule or pill format (other than a product that contains glucose only); and represented as being for therapeutic use.

The TGA has long desired to rule that anything in tablet, capsule or pill format is a therapeutic good and cannot be food. The Food-Medicine Interface reinforces the TGA’s weighting of format. However, this Order is still limited to the moment to products represented as sports supplements.

Of far more concern to FoodLegal is the TGA’s view of what constitutes “represented as being for therapeutic use”.

Does the TGA see all health claims as therapeutic?

Whether the TGA likes it or not, Standard 2.9.4 is a standard in the Food Standards Code and thus products that comply with this standard fall outside the TGA’s jurisdiction.

What is concerning is that the second category of products under the TGA Order can be fully compliant food products.

First of all, they do not need to contain any prohibited substances.

Secondly, there is no food prohibition against selling food in tablet, capsule or pill form (otherwise breath mints would be non-compliant medicines).

Thirdly, sports food are defined in Standard 2.9.4 are being “a product that is specifically formulated to assist sports people in achieving specific nutritional or performance goals”.

And finally, by way of example, food products that are classified as being a protein energy supplement are expressly allowed to claim that they “may assist in the development of muscle bulk” and may be “useful before, during, or after sustained strenuous exercise”.

And yet, the Explanatory Statement for the TGA Order states that gaining muscle is a claim for therapeutic use “because those uses may be characterised as uses in or in connection with influencing, inhibiting or modifying a physiological process in persons. Moreover, gaining muscle may also be characterised as a use in or in connection with modifying parts of the human anatomy. ”

It is this last factor that is the most concerning, as it indicates that the TGA will implement its own definition of a therapeutic use, which is different from the food definition of a prohibited therapeutic claim.

If this view were ever to be expanded beyond health supplements, it would mean that every single health claim permitted by food legislation on behalf of food products would be illegal. The Therapeutic Goods Act prohibits claims about modifying a physiological process that are made in relation to food, yet food legislation expressly permits a claim that a product can have a physiological process or outcome.

When can a food company ever be confident in its own compliance?

Putting to one side whether the TGA Order is fit for purpose, this is the latest in a long list of attempts by the TGA to state that fully compliant foods products ought to be regulated as medicine.

The TGA is within its rights to an extent. Its legislation does prohibit health claims on behalf of food. But food is supposed to be outside the TGA’s jurisdiction.

The abovementioned scenario considers a compliant food product, only containing compliant food ingredients, making claims expressly permitted on behalf of food that would be deemed to automatically be a therapeutic good under the TGA Order. To not even be food at all.

If this is the ongoing view of the TGA, when can any food manufacturer ever be confident of their own compliance? For as much as the TGA does not like food making health claims, we are a society plagued with chronic health conditions where a large proportion of the treatment and cure is through dietary choice of food. Not medicine. And if food manufacturers cannot communicate that message in compliance with food regulation (and note that Standard 1.2.7 of the Australia New Zealand Food Standards Code already expressly governs the regulation of food health claims and nutrition content claims), the TGA can only be described to be actively over-regulating and working against the Australian food industry, and against public health education, dietary guidelines and consumer food choices.

This is general information rather than legal advice and is current as of 14 Dec 2020. 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.