ALERT! 'Calming' Ashwagandha now a prohibited novel food

‍

‍

Food Standards Australia New Zealand (FSANZ) has just classified Ashwagandha as a novel food. Novel foods are judged to be unsafe for human consumption and cannot be sold as or in food in Australia – penalties and other liabilities may be incurred if your business does not comply.

There are a slew of food products already in market containing Ashwagandha, from big-brand ‘relaxing’ teas to a wide range of lesser known products sold through Chemist Warehouse and other retailers as aids to sleep and stress reduction. While permission for use still exists for complementary medicines, products positioned as foods containing Ashwagandha can no longer be lawfully sold in Australia.

So, what is Ashwagandha and what practical steps does your business need to take to stay on the right side of the law?

What is Ashwagandha?

Withania somnifera, known commonly as Ashwagandha or winter cherry, is an evergreen shrub in the Solanaceae or nightshade family that grows in India, the Middle East, and parts of Africa. It has a history of medicinal use (traditional [Ayurvedic] medicine; homeopathic) in teas and tisanes, primarily as a remedy for the effects of emotional stress on the human body. This plant may also be viewed as an ‘adaptogen’ on that basis: a term for plants and fungi that are believed to have a ‘stabilising’ effect on the human body and biological processes by neutralising or treating the effects of stress. As such, the history of traditional medicinal indicates that most products containing Ashwagandha are intended to be consumed for a therapeutic purpose. These products should be viewed as complementary medicines requiring listing with the Therapeutic Goods Administration (TGA).

Why is Ashwagandha considered a novel food?

FSANZ defines novel foods as non-traditional foods that require a safety assessment by FSANZ prior to the food being sold as a food in Australia and New Zealand. Generally, if a substance has a history of consumption as food in Australia or New Zealand it will be considered a traditional food and will not be classed as a novel food on that basis. Although Ashwagandha has been consumed in accordance with Ayurvedic traditions in other countries, FSANZ was not satisfied that there was a history of consumption as food in Australia or New Zealand.

While Ashwagandha is not currently listed on the Poisons Standard, it is a TGA regulated substance. Ashwagandha is listed permissible ingredient in complementary medicines per the TGA Determination. This does not automatically indicate that Ashwagandha is unsafe for general consumption (the permissible ingredient Determination lists common colours and flavours too) but the restrictions on use set out in the Determination do indicate that safety concerns persist.  

The permissible ingredient Determination stipulates that use of Ashwagandha in complementary medicines requires that the following warning statement be included on the label:

(WITHANIA) 'If you are pregnant, or considering becoming pregnant, do not take without consulting a health professional' (or words to that effect)

unless:

1. the plant part is root;
2. the plant preparation is an extract;
3. the extraction solvents are only water, ethanol or methanol; and
4. the maximum recommended daily dose of the medicine contains no more than the equivalent quantity of 12 g dry root.

Consequently, because Ashwagandha is in the TGA permissible ingredients list subject to these limits for use in medicine, it is clearly a substance that is not completely safe for use in food. Some reports suggest that consumption of Ashwagandha (particularly in high concentrations) can lead to digestive discomfort, diarrhoea, vomiting, and, in rare cases, interference with liver function. Further, there is an indication that consumption may increase the risk of miscarriage in pregnant women.  These reports are assumed to have been considered persuasive by FSANZ in categorising Ashwagandha as a novel food.

How does this impact your business?

Foods containing Ashwagandha cannot be lawfully sold in Australia and should now be withdrawn from market or listed as medicines under the TGA. Businesses wishing to market foods containing Ashwagandha in Australia must first obtain a satisfactory safety assessment from FSANZ, which requires that at least one applicant provide convincing evidence in support of the safe use of Ashwagandha before it can be included in food. Even then, permission for the sale of novel foods may be granted subject to conditions including volume limits and form restrictions as well as potential mandatory warnings or advisory statements.

If you currently have a product that contains Ashwagandha or are thinking of putting a new product on the market containing herbal or medicinal substances, contact UC F&B today to discuss how we can ensure your business is compliant with all applicable regulations.

NEXT STEPS

At Universal Counsel, our F&B experts can provide a comprehensive evaluation for clients covering not only whether ingredients are currently permitted under the Food Standards Code, and whether there are potential concerns about safety, but also your options for bringing a product with those ingredients to market on a low-risk/compliant basis (whether as a food or medicine).

If you are considering including a nutritive substance or substance used in traditional/herbal medicine in one of your products, please download our Permissions Pathways Flowchart, which outlines how we get from idea to execution in being able to add a substance and also being able to talk about what that substance does. 

Universal Counsel commonly assists F&B business with:

-       Product labelling and collateral compliance reviews

-       Ingredient safety and compliance analysis including procuring scientific toxicology studies

-   Strategic path to market advice for businesses operating in the food-medicine interface, specialising in functional foods and complementary medicines.

-       Claims strategy and compliance tools and solutions

Stay tuned also for our explainer on the food-medicine interface and path to market for functional foods. Our Chief Counsel, Amelia Edwards, will be speaking on the New Frontier: Navigating the Food-Medicine-Cosmetics Interface at the Naturally Good expo in Sydney on 6 June, a presentation that will be free to attend.

Contact the UC F&B team today: food@universalcounsel.com.au

‍

‍