TGA flexes its muscles with a proposal to bulk-up regulation of sports supplements

What you need to know

• In October 2019, the Therapeutic Goods Administration (TGA) invited submissions in relation to a proposal to declare that certain sports supplements, when used, advertised or presented for supply in a particular way, are therapeutic goods (medicines). 
• The proposed declaration is intended to clarify regulatory requirements regarding sports supplements and to ensure they are regulated appropriately to safeguard public health and safety.
• Submissions from interested parties closed on 3 December 2019.  The TGA will make a decision about the proposed declaration following consideration of the submissions received.

What you need to do

• Manufacturers and suppliers in the sports supplements industry should await the TGA's decision in relation to the proposed declaration. 
• If the declaration is made, manufacturers and suppliers of sports supplements currently purported to be foods, but which are declared to be therapeutic goods, will need to consider changing the manufacturing, formulation, labelling and/or advertising of these products to ensure they meet applicable compliance requirements.  If the products are medicines and are to continue to be supplied in Australia, they will need to be entered on the Australian Register of Therapeutic Goods (ARTG).

Background

In Australia, food and medicines are governed by separate legislative frameworks.  The application of one or other of the frameworks to a product can depend on the specific combination of ingredients, claims and overall presentation of the product.  Due to the way that the food and medicine regulations operate, a product cannot be both a food and a medicine.

Sports supplements cover a wide range of ingested goods which relate to sport, fitness or other physical activity and which vary broadly in terms of ingredients, use, labelling and form. 

An increasing number of sports supplements are being marketed as foods in Australia and are, therefore, not subject to the safety, efficacy and quality requirements which apply to medicines.  While this is appropriate for some products, the TGA has identified a number of sports supplements currently claiming to be foods which should be classified as medicines by virtue of the therapeutic claims made about their operation, ingredients or dosage forms (in particular, pills, tablets or capsules).  

Further, the TGA is concerned with a number of safety problems and reported adverse events associated with the use of certain sports supplements (including deaths) and relies on these events in support of its position that such products are not sufficiently regulated under the Food Standards Code.  

TGA's proposal to declare that certain supplements are therapeutic goods

In October 2019, the TGA commenced consultation and sought comments from interested parties in relation to a proposal to declare that certain sports supplements when used, advertised or presented for supply in a particular way, are therapeutic goods.

The proposed declaration is contained in the draft Therapeutic Goods (Declared Goods) Order 2020 (Order), proposed to be made under subsection 7(1) of the TG Act.  The Order provides that a sports supplement will be treated as a therapeutic good if the sports supplement: 

1.  is for oral administration and is represented (expressly or by implication) as being for the improvement or maintenance of physical or mental performance in sport, exercise or any other recreational activity; 

2.  is manufactured in the dosage form of a tablet, capsule or pill, or contains (or is represented to contain expressly or by implication) one or more of the following:

i.  a substance included in the current Poisons Standard; 

ii.  a substance identified on the World Anti-Doping Agency (WADA) Prohibited List;

iii.  a "relevant substance" (defined in the Order to mean any of the following substances:

a)   β-methylphenylethylamine (BMPEA) (Acacia rigidula);

b)   dendrobium (Dendrobium nobile);

c)   methylliberine; and

d)   N-phenethyl dimethylamine (Eria jarensis extract);

iv.   a substance with equivalent pharmacological action to one of the above substances;

v.    an ingredient in an amount that exceeds any limit specified in the Permissible Ingredients Determination when used in accordance with the directions for use in relation to the product;

vi.    an amino acid in an amount that exceeds any limit specified in section S29-18 of the Food Standards Schedule 29 when used in accordance with the directions for use in relation to the product;

vii.    a substance in an amount that exceeds any limit for the substance specified in section S29-19 of the Food Standards Schedule 29 when used in accordance with the directions for use in relation to the product; and

3. is used, advertised, or presented for supply for therapeutic use or in a way that is likely to be taken to be for therapeutic use. Examples of therapeutic use include gaining muscle, increasing mental focus, increasing stamina, modifying hormone levels, losing weight or fat, preparing for workout and recovering from workout.

Next Steps

The period for submissions from interested parties to the TGA closed on 3 December 2019.  The TGA will make a decision in relation to the declaration following consideration of the submissions received. 

Consequences of a declaration

There has been significant publicity regarding the potential declaration with some media suggesting that up to 70,000 supplements may be withdrawn from Australia and hundreds of jobs lost if the declaration is made.  While the TGA has stated that these concerns are unwarranted, the cost of compliance with the new regime is likely to be significant.  

If the declaration is made, manufacturers and suppliers of sports supplements currently purported to be foods will need to review each product they provide to determine if they are now classified as therapeutic goods and, if so, consider changing the manufacturing, formulation, labelling and/or advertising of these products to ensure they meet applicable compliance requirements. 

Significantly, if products are therapeutic goods, they will need to be entered on the ARTG and satisfy the stricter quality, safety and efficacy requirements which are necessary for that registration. 

The TGA has indicated that if the proposal goes ahead, there will be a transition period of 2 to 3 years.  However, it is not clear whether suppliers of supplements will be willing to jump over the additional hurdles necessary to satisfy ARTG requirements or if the declaration will simply mean that these products are no longer supplied in Australia.