IFN 02-19 – Formulated supplementary sports food (updated)

25 January 2019

Purpose

The purpose of this notice is to advise importers of formulated supplementary sports foods that some of the products currently being imported are not compliant with the Australia New Zealand Food Standards Code (the Code) and may pose a risk to human health. Under section 8 of the Imported Food Control Act 1992, it is an offence to import food into Australia if the importer knows, or ought reasonably to have known, that it poses a risk to human health. The offence carries a penalty of imprisonment for 10 years.

This notice supersedes the previous notice 13/18 issued on 3 October 2018. The notice has been amended to update the list of substances considered to pose a risk to human health.  Formulated supplementary sports foods or formulated supplementary foods containing any of the substances listed below are considered failing food under the Imported Food Control Act 1992.

Sports supplements – food or therapeutic goods?

These are foods specifically formulated to assist sports people in achieving specific nutritional or performance goals, examples include food supplements which are mixed (usually with water) and consumed pre-workout.

Some ‘sports supplements’, particularly those in tablet or capsule form, may be considered to be therapeutic goods, rather than formulated supplementary sports foods. The requirements of the Imported Food Control Act 1992 and the Code do not apply to therapeutic goods. Therefore it is important to know whether the supplement products you import are food or therapeutic goods.

Determining whether a product is a food or a therapeutic good can be difficult at times because it depends on many factors, such as ingredients, dosage form and in particular the way in which the product is presented for supply, including advertising and labelling. Often, a product that is a powder to be mixed with water or some other food prior to consumption is considered food. On the other hand, where a supplement is either represented as a therapeutic, or may be used by someone for therapeutic use because of the way it is presented, then it is probably a therapeutic good. In addition, if the supplement carries an AUST L number on the label this usually means that the person responsible for the supply or import of a product has determined that it is a therapeutic good, and entered it themselves on the Australian Register of Therapeutic Goods. This determination may be checked post market by the Therapeutic Goods Administration (TGA). If the supplement carries an AUST R number on the label it has already been assessed by the TGA as a therapeutic good.

If in doubt as to whether your product is a food or therapeutic good, contact your state regulatory food authority, a food consultant, or the TGA.

What are the issues with Formulated Supplementary Sports Foods?

Standard 2.9.4 of the Code allows various amino acids, vitamins, minerals and nutritive substances to be added to formulated supplementary sports foods. Other parts of the Code also control what can be added to these foods, for example, food additives in Standard 1.3.1 and prohibited plants and fungi in Standard 1.4.4.

Importers are responsible for ensuring that the food they import complies with the Code and is safe, suitable and properly labelled.

If the food contains as an ingredient any substance listed under the Standard for the Uniform Scheduling of Medicines and Poisons (created under the Therapeutic Goods Act 1989) then the food will be assessed to determine whether it poses a risk to human health. Under the Imported Food Control Act, if a food is determined to pose a risk to human health, it is considered a failing food under Section 3 ((2)(a)(vii)). Examples of such substances (noting others may be added to the list as more evidence becomes available) are:

  • Cardarine.
  • 1, 3-dimethylamylamine (DMAA) also known as methylhexamine; forthane or 4-methyl-2- amino-4-methylhexane.
  • 1, 3-dimethylbutylamine (DMBA) also known as AMP Citrate.
  • 1, 5-dimethylhexylamine (DMHA) also known as Juglans Regia.
  • 2, 4-dinitrophenol (DNP). 
  • Ibutamoren.
  • Melatonin.
  • β-methylphenylethylamine (BMPEA) (sourced from Acacia rigidula).  
  • Phenibut.
  • Stenabolic.
  • Synephrine (Oxedrine) (except in preparations labelled with a recommended daily dose of 30mg or less) Synephrine is generally marketed as Citrus aurantium or ‘bitter orange’.
  • Tadalafil.
  • Yohimbine.

Other therapeutic substances, new botanical extracts or synthetic analogues may have been added to these products. If the substance is ‘new’ with no history of human consumption in Australia, the department will consult with FSANZ, the TGA, and/or the Australian Government Department of Health. If the ingredient is an unassessed substance and poses an unknown risk to human health, then it may be considered a Novel Food, in which case its addition to food is not permitted until a pre-market food safety assessment has been completed. Products containing substances identified as novel food for which there is no permission in the Code will be assessed as failing food under Standard 1.5.1. Examples of such substances are:

  • Methyl liberine, also known as Dynamine.
  • N-Phenethyl Dimethylamine (also known as Eria Jarensis extract) 
  • Dendrobium (Dendrobium nobile)

Some plants or fungi, or their derivatives, are also prohibited or restricted. They either cannot be added to food or can only be added in very limited circumstances. Synthetic versions of these substances are not suitable for use in food.

Also, some substances cannot be added to formulated supplementary sports foods because there is no permission to add them. Citrulline, commonly listed as citrulline malate, falls into this category.

Finally, the Code places a limit on the amount of some substances that can be added to formulated supplementary sports foods. For example, L-alanine is limited to 1.2 g (or 1200 mg) per one-day quantity.

What to do next

If you import any formulated supplementary sports foods take immediate steps to ensure the food complies with the Code.

Products that contain either:

  • Scheduled poison/medicines e.g 1,3-dimethylamylamine (DMAA)
  • Non permitted novel food (e.g dynamine or methyl liberine);
  • Prohibited botanicals; or
  • Nutritive substances that are not permitted; (e.g. citrulline) or
  • Substances at levels that are not permitted (e.g. L-alanine is present in excess of 1.2 g (or 1,200 mg) per one-day quantity)

should not be imported and if already distributed, should be removed from sale.