Vitamin B6 is a vital nutrient that supports a range of functions in the body. Also known as pyridoxine, it plays a crucial role in energy production, nervous system function, immune defence, hormone regulation, and even mood balance. It’s commonly found in multivitamins and B-complex supplements, and is often used to support energy levels, reduce fatigue, relieve premenstrual symptoms, and support heart health. 

Following a detailed review of recent scientific evidence and stakeholder feedback, the Therapeutic Goods Administration (TGA) has now finalised a change to how high-dose vitamin B6 supplements are available in Australia. The aim of this change is to strengthen consumer protection and ensure that products are used safely, particularly at higher doses or when combined with other sources of vitamin B6. 

These new measures are intended to reflect a careful, evidence-based approach to medicine regulation. Vitamin B6 remains a safe and effective nutrient – and consumers can continue to access a wide range of products that meet Australia’s high regulatory standards. 

Here’s what the change means and how to make sure you’re using vitamin B6 safely. 

What’s changing? 

Products that contain 50 mg or less of vitamin B6 per day will remain available for general sale, including in pharmacies, supermarkets and health food stores – provided they comply with the TGA’s strict requirements for safety and quality. 

From 1 June 2027, vitamin B6 products that contain more than 50 mg per day will move to a new classification: Schedule 3 (Pharmacist Only Medicine). This means these higher-dose products will be kept behind the counter at pharmacies and are only available after a consultation with a pharmacist. 

Why the change? 

The decision follows a TGA safety review and consultation with industry, health professionals and consumer groups. While vitamin B6 is widely used and safe when taken as directed, excessive intake (especially over long periods) has, in rare cases, been linked to a condition known as peripheral neuropathy, which can cause tingling, numbness or pain in the hands and feet. 

The new measures are designed to help reduce the risk of accidental overconsumption, particularly for those taking multiple products that each contain vitamin B6 (such as a multivitamin and a protein powder). They also help to ensure that consumers taking higher doses do so under guidance from a pharmacist. 

It’s worth noting that vitamin B6 toxicity is rare and most often associated with peripheral neuropathy from excess intake. The scientific literature reports most cases are associated with doses of 200-500mg, especially for extended periods of time. Sensitive individuals may experience symptoms at lower doses. However, in most cases, symptoms resolve over time after stopping supplementation. Neuropathy is a symptom of other conditions as well, so, it is important to seek advice from a health professional. 

What does this mean for you? 

If you currently use a vitamin B6 supplement with 50 mg or less per day, nothing will change. These products will remain available for over-the-counter purchase as usual. 

If you take a supplement that contains more than 50 mg of vitamin B6 per day, this product will no longer be available for self-selection in shops after 1 June 2027. Existing products with an AUST L on the label that contain more than 50 mg will need to go through an extensive registration process with the TGA, if they are to remain available. 

Where is vitamin B6 found? 

Vitamin B6 is naturally found in a wide variety of foods. Good sources include poultry, fish, eggs, bananas, spinach, potatoes and legumes. It’s also commonly added to fortified foods, such as breakfast cereals, meal replacement shakes, energy drinks and snack bars. 

Why do some vitamin B6 supplements contain more than the RDI? 

The Recommended Dietary Intake (RDI) for vitamin B6 in Australia is typically 1.3 to 2 mg per day for adults. That’s the amount recommended to prevent deficiency-related conditions, such as fatigue or nerve dysfunction caused by low B6 levels. Importantly, peripheral neuropathy can also be associated with vitamin B6 deficiency. 

But there’s an important distinction between the amount of a nutrient required to prevent deficiency, and the amount needed to achieve a therapeutic health benefit or to meet the additional demands our lifestyle choices place on our nutritional needs. 

Many people take vitamin B6 for therapeutic reasons – such as supporting energy levels, , premenstrual symptoms or cardiovascular health. In these cases, the amount used in a product may be higher than the RDI. This is because it reflects the amount shown as effective in scientific research. 

In Australia, vitamins and dietary supplements are regulated as medicines and there is a TGA requirement that the dosage must reflect the evidence. If research supports a certain benefit at, for example, 50 mg of B6 per day, then by law, that’s the amount required in the product to support the product health claim. These therapeutic doses are still held to strict TGA requirements and,  may include additional labelling and warnings. 

How to use supplements safely 

In Australia, vitamin and dietary supplement products are called ‘complementary medicines’ and are regulated as medicines (not foods). That means they’re held to very high standards by the TGA, which sets strict rules and requirements for quality, safety and efficacy. 

When choosing a vitamin or dietary supplement: 

• Look for products with an AUST L, AUST LA or AUST R number on the front of the label. This indicates the product is listed or registered with the TGA and must meet strict regulatory standards. 

• Always follow the dosage instructions on the label. 

• Read any label warnings to help you decide if the product is right for you. 

• If you’re taking more than one complementary medicine or fortified foods, be aware of overlapping ingredients like vitamin B6. 

• If you’re unsure about what’s right for you, check with a healthcare professional – such as a pharmacist, GP, dietitian, nutritionist or naturopath. 

Vitamin B6 remains a trusted and effective nutrient when used properly. These new regulations are designed to help ensure you can continue to use it with confidence. 

Disclaimer 

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