Questions to ask an overseas supplier of nicotine vaping products

1. Has the U.S. Food and Drug Administration (FDA) issued a 'Premarket Tobacco Product' (or 'PMTA') marketing order for the product?

You can also check if the product is on the list of PMTA marketing orders - external site on the FDA's website.

If the product complies with all of the requirements in a PMTA marketing order, its ingredients, packaging, labelling and manufacturing standards have been assessed by the FDA. If the FDA has not issued a PMTA marketing order for the product, continue with Questions 2 - 9 below.

2. Is nicotine the only active ingredient in the product?

Nicotine is the only active ingredient allowed in nicotine vaping products imported into or supplied in Australia. The nicotine can be in base or salt form. You should not prescribe or purchase a product that contains another active ingredient.

3. Does the product have a prohibited ingredient added to it (see list in Table One below)?

You could also check this yourself if the supplier provides you with a full ingredient list for the product (including the ingredients used in any flavours).

There are known health risks associated with inhaling the prohibited ingredients. You should not prescribe or purchase a product that has a prohibited ingredient added to it.

4. What is the nicotine concentration of the product?

Australian consumers can only purchase products with the nicotine concentration they have been prescribed. The maximum concentration allowed in nicotine vaping products imported into or supplied in Australia is 100 mg/mL (for nicotine salt products, this is the equivalent base form concentration).

5. Are there manufacturing controls to make sure the nicotine content/concentration matches (within +/- 10%) what is stated on the label or in the product information?

If there are inadequate manufacturing controls the product may not be the right strength for you or your patient.

6. Have tests been done on the product and its aerosol/mist/emission to detect the level of the contaminants listed in Table One below?

The potential contaminants lited in Table One have been identified as having inhalation risks. These is currently insufficient information to specify a 'safe' level of these contaminants. We suggest looking for products in which the concentration of these contaminants is below 10 parts per million (ppm) (in both the product and its aerosol/mist/emission).

7. Is the product packaged and provided with information or labelled (in English) as required for supply within the United Kingdom (UK), European Union (EU), Canada or the new regulations currently being phased in in New Zealand (NZ)?

If yes, the product should be packaged and provided with information or labelled as set out in Table Two below. The packaging and information/labelling should be similar or equivalent to the products purchased in Australia which are required to have packaging and labelling compliant with our standard for unapproved and export only nicotine vaping products (TGO 110).

If the product does not have such packaging, information or labelling, continue with Questions 8 - 9.

8. Is the product in child-resistant packaging?

Accidental ingestion of, or exposure to, nicotine vaping products can have toxic - and sometimes severe - effects. Child fatalities have occurred following ingestion of nicotine vaping products. We strongly recommend only prescribing and purchasing products with child-resistant packaging.

9. Does the product come with information about the ingredients, its nicotine concentration and with warnings about keeping the product away from children and avoiding contact with eyes/skin?

This information is useful for ensuring that you know what is in the product and precautions that should be taken to avoid accidental poisonings.

Further information about the requirements of TGO 110 and its application to the Personal Importation Scheme can be found in our Guidance for Therapeutic Goods (Standard for Nicotine Vaping Products) (TGO 110) Order 2021 and related matters. See in particular the 'Personal Importation Scheme' section of that guidance.

Table Two: Packaging and labelling of consumer products supplied within the UK, EU, Canada and NZ

This table summarises the key packaging and labelling requirements for nicotine vaping products supplied as consumer goods within the UK, EU, Canada and, under the new regulations currently being phased in, NZ. Information marked with an asterisk (*) may be provided on an information sheet, rather than the product label itself.

These requirements do not necessarily apply to products exported from those jurisdictions, so check with the overseas supplier that the product is packaged and labelled (in English) in a way that it would allow it to be sold within the relevant country/area.