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New TGA Vitamin B6 Restrictions: What Australians Need to Know Before 2027

New TGA Vitamin B6 Restrictions: What Australians Need to Know Before 2027

In November 2025, the Therapeutic Goods Administration (TGA) confirmed major changes to how higher-dose vitamin B6 supplements will be supplied in Australia. From 1 June 2027, only low-dose products (50 mg or less per recommended daily dose) will remain available for general retail sale, while higher-dose preparations will move behind the pharmacy counter or require a prescription. These changes follow years of mounting reports of peripheral neuropathy – sometimes severe and long-lasting – in people taking vitamin B6 from multiple sources, often without realising how much they were consuming. For Eco Traders customers, this is not a reason to panic, but it is a clear signal to pause, check labels, and talk with a health professional about your real B6 needs. This article explains what’s changing, why it’s happening, and how to protect yourself from inadvertent B6 overdose.

Vitamin B6 has long been marketed as a helpful nutrient for energy, mood, hormone balance and nerve health. For many Australians, it has seemed like one of the “safer” vitamins – something you might add into a daily multivitamin, a stress formula or a menopause blend without much thought.

Over the past several years, however, Australian regulators, GPs and patient advocates have been piecing together a different story. A growing number of people have developed peripheral neuropathy – tingling, burning, numbness and weakness in their hands and feet – after long-term intake of vitamin B6, sometimes at doses that were not obviously “mega-dose” on the label. In many cases, these people were unknowingly taking B6 from multiple supplements plus fortified foods and drinks. Some have been left with persistent disability and life-changing symptoms.

In response, the Therapeutic Goods Administration (TGA) has now finalised stronger safety controls for vitamin B6. These rules amend the Poisons Standard and change how many higher-dose B6 products can be sold in Australia, with a transition period leading up to 1 June 2027. For consumers, retailers and health professionals, this is an important moment: it recognises that the risk of B6-related nerve damage is real and sometimes underestimated, and it asks all of us to be more deliberate about how – and why – we use this nutrient.

As a retailer focused on evidence-based natural health, Eco Traders supports measures that reduce preventable harm. At the same time, it is important that people who genuinely need B6 continue to have safe, appropriate access, and that everyone understands how much is “enough” versus “too much”.

What: The TGA has finalised new scheduling rules for vitamin B6 so that only low-dose products (≤ 50 mg per recommended daily dose) remain available for general retail sale, while higher doses will require pharmacist advice or a prescription.

Why it matters: Long-term, excessive intake of vitamin B6 can damage peripheral nerves, causing tingling, burning, numbness and weakness. Some Australians have experienced serious, life-altering neuropathy after unknowingly taking B6 from multiple supplements and fortified foods.

How to act: Review all supplements and fortified products you use, identify any that contain vitamin B6 (including under other names), add up your total daily intake, and discuss with your GP or pharmacist whether ongoing B6 supplementation is actually needed and at what dose.

References & sources for this article

All regulatory decisions, news coverage and clinical commentary referenced in this article – including TGA notices, medical college statements and Australian news reports on vitamin B6 toxicity – are listed in the Sources box below the post. This article is for general education only and is not a substitute for personalised medical advice.

What has the TGA decided about vitamin B6?

On 25 November 2025, the Therapeutic Goods Administration (TGA) published a media release announcing stronger safety controls for products that contain vitamin B6 (also known as pyridoxine, pyridoxal or pyridoxamine). The decision amends the national Poisons Standard and changes how different vitamin B6 doses are scheduled and supplied in Australia.

The core structure of the decision is dose-based:

  • ≤ 50 mg vitamin B6 per recommended daily dose – these products will remain available for general retail sale (unscheduled). This includes many low-dose supplements, some multivitamins and certain combination formulas.
  • > 50 mg to ≤ 200 mg per recommended daily dose – these products will become Schedule 3 (Pharmacist Only). They can still be supplied without a prescription, but only after a pharmacist has assessed the consumer and provided advice.
  • > 200 mg per recommended daily dose – these high-dose products will continue to require a prescription from a medical practitioner.

These thresholds are designed to reduce the risk that people will accumulate very high total intakes of vitamin B6 over time, particularly when they use multiple supplements or fortified products at once. The TGA notes that vitamin B6 deficiency is relatively uncommon in the general Australian population, and that the recommended dietary intake for adults is between roughly 1.3–1.7 mg/day – far below the doses present in many stand-alone B6 supplements.

The new scheduling will come into effect on 1 June 2027. Between now and then, manufacturers and sponsors will need to decide whether to:

  • reformulate products so the recommended daily dose of B6 is ≤ 50 mg,
  • submit products containing > 50–200 mg for evaluation as pharmacist-only or registered medicines, or
  • phase high-dose products out of the Australian market entirely.

The TGA’s own analysis indicates that more than 100 currently listed preparations providing > 50 mg vitamin B6 per recommended daily dose are likely to be affected. Many more lower-dose products, as well as fortified foods and drinks, remain available and will continue to contribute to total intake.

Why is vitamin B6 being restricted? Understanding neuropathy and toxicity

Vitamin B6 is an essential water-soluble vitamin involved in hundreds of enzymatic reactions, including neurotransmitter synthesis, haemoglobin production and amino acid metabolism. We need small, regular amounts from food for optimal health – but more is not always better.

The key safety concern driving these regulatory changes is peripheral neuropathy. This is a form of nerve damage affecting the peripheral nervous system – the network of nerves that carry signals to and from the brain and spinal cord to the rest of the body. In the context of vitamin B6, peripheral neuropathy can manifest as:

  • tingling (“pins and needles”) in the hands and feet,
  • burning sensations,
  • numbness or reduced sensation,
  • weakness, clumsiness or difficulty with fine motor tasks, and
  • unsteady gait, imbalance or falls.

In mild cases, these symptoms may improve once B6 intake is reduced or the offending products are stopped. In more severe cases, people can be left with long-term or permanent impairment, significantly affecting quality of life, mobility and independence.

Importantly, the risk of peripheral neuropathy is not limited to “mega-dose” therapy. A TGA review in 2022 highlighted that neuropathy has occurred at total daily intakes below 50 mg, especially when individuals were unknowingly taking vitamin B6 from multiple supplements at once. Subsequent reporting has shown a steady accumulation of Australian cases, with many described publicly by GPs, medical organisations and affected consumers.

The regulator has also emphasised that B6 is widely present in the food supply. It can appear in some energy drinks, breakfast cereals, weight-loss shakes and other fortified products – meaning that a person’s total intake may be much higher than what they see on the label of a single supplement.

From a clinical perspective, the picture that emerges is not of a rare, exotic side-effect, but of a preventable toxicity that arises when:

  • high-dose B6 supplements are used for long periods,
  • multiple B6-containing products are layered together, and/or
  • people with certain vulnerabilities (for example, older age, chronic illness, polypharmacy) accumulate more B6 than their body can handle.

This is why the TGA’s decision is framed as a safety and health-literacy measure: to make it harder for inadvertent high-dose B6 exposure to occur, while still allowing appropriate clinical use when justified.

How much vitamin B6 do we actually need each day?

When we talk about safety thresholds for supplements, it is helpful to ground the discussion in physiological needs. In other words: how much B6 does the average healthy person actually require – and how does that compare to supplement doses?

Australian dietary guidelines and international references place typical adult requirements for vitamin B6 in the low single-milligram range. For many adults, the recommended dietary intake (RDI) is around:

  • approximately 1.3 mg/day for younger adults, increasing slightly with age, and
  • up to around 1.7 mg/day for older males.

Most people can achieve this through a varied diet containing foods such as poultry, fish, potatoes, bananas, chickpeas and wholegrains. Deficiency is more likely in certain populations, including the elderly, people with alcohol dependence, and individuals with particular kidney, liver or autoimmune conditions – but it remains relatively uncommon in the general population.

Against that backdrop, it becomes clear why long-term daily doses of 50–200 mg sit under regulatory scrutiny. Even the lower end of that range can be more than 30 times the daily intake required by many adults, and when used for extended periods, this margin can create conditions for cumulative toxicity.

It is also important to distinguish between using B6 as a short-term, closely monitored intervention under medical supervision (for example, in certain rare metabolic conditions) and using high doses casually for “energy” or “hormone balance” without clear clinical indication. The TGA’s scheduling changes are aimed at curbing the latter scenario.

Where is vitamin B6 hiding? Common supplement and food sources

To understand your personal risk, you first need a clear picture of where vitamin B6 is coming from in your daily routine. Many people are surprised to learn just how many products can contribute to their total intake.

Common sources include:

  • Multivitamin and mineral formulas – most “multi” products contain some vitamin B6, often alongside the rest of the B-complex family.
  • Stress, mood and energy blends – B vitamins are a cornerstone of many stress and adrenal formulas, sometimes at higher doses than in a basic multivitamin.
  • Hormone and women’s health products – some PMS, menopause and hormone-support blends contain extra B6 for its historical use in premenstrual symptoms.
  • Standalone vitamin B6 or B-complex supplements – these may deliver 25, 50, 100 mg or more per capsule or tablet, especially older formulations.
  • Sports, weight-loss and performance products – certain protein shakes, pre-workout blends and weight-loss shakes are fortified with B6.
  • Fortified foods and drinks – some breakfast cereals, energy drinks and other packaged products include vitamin B6 as part of a fortification mix.

When you add these together, a person might easily consume tens of milligrams of B6 daily without realising it – especially if they are using multiple overlapping products (for example, a multivitamin plus an energy drink plus a separate B-complex or hormone formula).

This is precisely the situation the TGA decision is trying to address: moving higher-dose products behind the pharmacy counter encourages a more deliberate, informed conversation about total exposure, rather than leaving complex decisions solely to consumers reading fine print on labels.

What actually changes on 1 June 2027?

The implementation date of 1 June 2027 gives manufacturers, pharmacies, retailers and consumers time to adjust. Here is what the practical changes are likely to look like:

1. Fewer high-dose B6 products on general retail shelves

Products that provide more than 50 mg of vitamin B6 per recommended daily dose will no longer be sold as unscheduled, general retail items. Many current “mega-B6” products are therefore likely to:

  • be reformulated to 50 mg or less per daily dose, and/or
  • be discontinued if reformulation is not commercially or clinically justified.

2. Pharmacist-only access for moderate-to-high doses

Oral preparations providing more than 50 mg but not more than 200 mg of B6 per recommended daily dose will become Schedule 3 (Pharmacist Only). That means:

  • they can be supplied without a prescription, but
  • a pharmacist must be directly involved in the decision, asking questions and providing advice.

This consultation is an opportunity to review a person’s full medication and supplement list, screen for neuropathy symptoms, and ensure there is a clear indication for using such doses.

3. Prescription-only for the highest doses

Oral products delivering more than 200 mg B6 per recommended daily dose will remain prescription medicines. These formulations are typically used in specific medical contexts and should already be under close clinical supervision.

4. Label updates and stronger warnings

The TGA has also signalled a broader push for clearer labelling of vitamin B6, including consistent naming of ingredients and warning statements on products delivering higher daily intakes. Some of these labelling changes have already begun, and more may appear as sponsors update packaging to comply with the new scheduling.

For consumers, the key point is that by 2027, it should be easier to recognise when a product contains significant amounts of vitamin B6 – and harder to access very high doses without having a meaningful conversation with a health professional first.

If you currently take a vitamin B6 supplement: practical steps

If you are already using a supplement that contains vitamin B6, there is no need for panic – but there is every reason to pause and review your intake thoughtfully. Here are practical steps you can take now.

1. Collect all your vitamins, supplements and fortified products

Gather everything you use regularly: multivitamins, B-complex formulas, stress/adrenal blends, hormone support products, protein or weight-loss shakes, energy drinks and any standalone vitamin B6 products. Include “occasional” products you still take several times a week.

2. Check each label for vitamin B6

On the ingredient list, look for:

  • Vitamin B6
  • Pyridoxine (often as pyridoxine hydrochloride)
  • Pyridoxal (including pyridoxal-5-phosphate, sometimes abbreviated P5P)
  • Pyridoxamine

Note the amount of vitamin B6 provided per tablet, capsule or scoop and the recommended number of units per day. Be mindful that some labels list the amount per unit, while the dosage instructions may suggest multiple units daily.

3. Add up your total daily intake

For each product, multiply the B6 amount per unit by the number of units you typically use per day, then add all of these together. Even if each individual product seems modest, the total may be higher than you expect when several are combined.

4. Watch for symptoms of neuropathy

While this article cannot diagnose or treat medical conditions, it is important to be alert to warning signs that should trigger prompt medical review. These include:

  • tingling, burning or “pins and needles” in your hands or feet,
  • numbness or loss of sensation in extremities,
  • weakness, clumsiness or dropping objects, and
  • unsteadiness, balance problems or unexplained falls.

If you notice such symptoms while taking B6-containing products, stop the supplement and seek medical assessment as soon as possible. Do not wait to see if it “settles on its own”.

5. Discuss your B6 intake with your GP or pharmacist

Once you have a list of all your B6-containing products and an estimate of your daily intake, share this information with your GP or pharmacist. They can help you decide:

  • whether you need ongoing vitamin B6 supplementation at all,
  • what dose, if any, is appropriate in your circumstances, and
  • how to safely simplify your supplement regime to minimise cumulative risk.

If a product has been prescribed by a doctor, do not stop it abruptly without discussing it first. However, you should still raise the question of total B6 exposure and neuropathy risk at your next review.

What about other B vitamins – and is B3 (niacin) affected?

The TGA’s decision specifically targets vitamin B6 (pyridoxine, pyridoxal, pyridoxamine). It does not directly change the scheduling of other B vitamins such as B1 (thiamine), B2 (riboflavin), B3 (niacin or nicotinamide), B9 (folate) or B12.

However, many products on the market combine several B vitamins at once, and some of the higher-dose formulations that contain B6 alongside other Bs will need to be reformulated or rescheduled. This could mean that certain B-complex products change their composition over the next couple of years, or that manufacturers choose to offer more targeted, lower-dose options instead.

For consumers looking for general B-complex support rather than high-dose isolated B6, it can be more appropriate to focus on balanced formulas and to use them at doses closer to physiological needs, under professional guidance.

Looking at your broader B-vitamin plan?

If you’re reviewing your supplement regime with a health professional and considering how to support general B-vitamin status without high-dose B6, you may discuss balanced options such as Herbs of Gold Activated B Complex 30 Capsules or nicotinamide-focused products like Blackmores Insolar Vitamin B3 60 Tablets. These examples do not remove the need for personalised advice – always review labels and discuss changes with your GP or pharmacist.

How Eco Traders is responding to the new vitamin B6 rules

As a specialist retailer in natural and complementary health products, Eco Traders takes safety and regulatory compliance seriously. The TGA’s decision on vitamin B6 aligns with a broader shift in Australia towards closer scrutiny of high-dose supplements and a clearer distinction between food-like products and therapeutic medicines.

In practical terms, this means:

  • working with suppliers to understand which B6-containing products will be reformulated, rescheduled or discontinued before the 1 June 2027 deadline,
  • prioritising products with responsible, evidence-aligned dosing and transparent labelling, and
  • providing clear educational content – like this article – so customers can make informed decisions with their healthcare team.

Eco Traders staff cannot offer medical diagnoses or prescribe treatments, but we can encourage you to:

  • take neuropathy symptoms seriously,
  • review all sources of B6 in your day, and
  • bring detailed supplement lists to appointments with your GP or pharmacist.

Our long-term goal is to support a retail environment in which supplements are used thoughtfully – not as a substitute for medical care, but as one tool among many in a balanced, evidence-informed health plan.

Key takeaways: Staying safe with vitamin B6

To summarise the most important points:

  • Vitamin B6 is essential in small amounts, but long-term high-dose intake can damage peripheral nerves.
  • The TGA has finalised new scheduling rules so that from 1 June 2027, only low-dose products (≤ 50 mg per recommended daily dose) will remain available for general retail sale.
  • Products containing > 50–200 mg of B6 per daily dose will require a consultation with a pharmacist, and doses above 200 mg will remain prescription-only.
  • Many Australians may be exposed to more B6 than they realise through multiple supplements and fortified foods or drinks.
  • Symptoms such as tingling, burning, numbness, weakness or unsteadiness in the limbs while using B6-containing products warrant prompt medical review.
  • Now is a good time to gather your supplements, check labels for vitamin B6 and related names, calculate your total intake and discuss it with your GP or pharmacist.
  • Other B vitamins, such as vitamin B3 (niacin/nicotinamide), are not directly affected by this decision, but combination products may still change as manufacturers reformulate.

Above all, remember that “more” is not automatically better in nutrition. With vitamin B6, the emerging evidence and regulatory response show that balance, context and medical oversight matter greatly.

Vitamin B6 safety & TGA changes: FAQ

What is vitamin B6 and why do we need it?

Vitamin B6 is a water-soluble vitamin involved in hundreds of reactions in the body, including the production of neurotransmitters (such as serotonin and GABA), haemoglobin in red blood cells, and the processing of amino acids. We need small, regular amounts from food for normal nerve function, brain health and metabolism. Most people can meet their daily requirement – usually in the low single-milligram range – through a varied diet that includes foods like poultry, fish, potatoes, bananas, chickpeas and wholegrains.

Why is the TGA changing the rules for vitamin B6 now?

The TGA’s decision follows an accumulation of Australian reports of vitamin B6-related peripheral neuropathy, as well as a detailed review of the scientific and clinical evidence. It became clear that some people were developing nerve damage after long-term exposure to higher-dose B6, often from multiple supplements and fortified foods. Medical organisations and patient advocates have also highlighted these harms. The new rules are intended to reduce preventable toxicity while preserving access to B6 where it is genuinely needed.

When do the new vitamin B6 rules start in Australia?

The new scheduling arrangements for vitamin B6 come into full effect on 1 June 2027. Between now and then, manufacturers will be reformulating or rescheduling affected products, pharmacies will be updating their procedures and retailers will be adjusting their ranges. Some changes – such as updated warning labels – may appear earlier as sponsors respond to the TGA’s decisions.

Will my usual vitamin B6 or B-complex supplement disappear?

Not necessarily. Products that provide 50 mg or less of B6 per recommended daily dose can remain available for general retail sale, and many B-complex or multivitamin products are already in that range. However, high-dose B6 products delivering more than 50 mg per daily dose may be reformulated, moved behind the pharmacy counter as Schedule 3 medicines, or discontinued if there is no strong justification for their continued use. If you rely on a specific product, it is worth checking the label and discussing alternative options with your GP or pharmacist ahead of the 2027 implementation date.

What dose of vitamin B6 is considered “high” or risky?

There is no single universal threshold that is safe for everyone, because risk depends on total daily intake, duration of use, individual susceptibility and co-existing health conditions. However, the TGA decision uses 50 mg per recommended daily dose as a key boundary: doses at or below this level can remain unscheduled, while higher doses require pharmacist or prescription oversight. Importantly, cases of neuropathy have been reported at total intakes below 50 mg when people were taking multiple B6-containing products. This is why reviewing all sources of B6 and working with a health professional is so important.

Can peripheral neuropathy from vitamin B6 be reversed?

Some people experience improvement in symptoms once excessive B6 intake is stopped and total exposure is reduced, especially if the problem is recognised early. However, others report long-lasting or permanent nerve damage even after discontinuing supplements. The outcome depends on many factors, including how long the toxicity was present, the severity of nerve injury and individual differences in nerve recovery. Because of this uncertainty, prevention and early recognition are crucial. If you have symptoms such as tingling, burning, numbness or weakness while taking B6-containing products, seek medical assessment promptly.

How do I calculate my total daily vitamin B6 intake?

Start by listing every product you use that could contain B6: multivitamins, B-complex formulas, stress or hormone blends, protein or weight-loss shakes, energy drinks and any standalone B6 supplements. For each one, note the amount of B6 per tablet, capsule or scoop and the number of units you usually take each day. Multiply the two to get a daily contribution from each product, then add them together. If you are unsure how to interpret a label, bring the products (or clear photos of them) to your GP or pharmacist – they can help you calculate your total.

Are low-dose multivitamins with B6 still safe to use?

For most people, a low-dose multivitamin that contains B6 in roughly physiological amounts (for example, a few milligrams per day) is unlikely to pose a significant risk when used as directed, especially if overall diet and health status are good. However, safety always depends on the bigger picture: your total B6 exposure from all sources, your medical history, other medications and how long you plan to use the product. If you have any neuropathy symptoms, or if you are taking multiple B-vitamin or fortified products, it is wise to have a health professional review your regime.

Do these changes affect vitamin B3 (niacin or nicotinamide) or other B vitamins?

The TGA decision described in this article is specifically about vitamin B6 – not vitamin B3 (niacin/nicotinamide) or other B vitamins. However, some combination products that include B6 alongside other B vitamins may change over time as manufacturers reformulate them to comply with the new scheduling rules. If you use a B-complex or multivitamin regularly, keep an eye on label updates and ask your pharmacist or GP to help you interpret any changes. It is always sensible to avoid unnecessary duplication of B-vitamin products.

What should I do if I think I’ve had too much vitamin B6?

If you suspect your total vitamin B6 intake is high – especially if you have been taking multiple B6-containing products for many months – start by stopping any non-essential supplements and contacting your GP or another qualified healthcare professional for personalised advice. If you are experiencing concerning symptoms such as tingling, burning, numbness, weakness or balance problems, seek medical assessment as soon as possible. Bring a full list (or the actual bottles) of all your supplements, medicines and fortified foods or drinks so your clinician can understand your complete exposure and plan appropriate investigations and support.

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About this article

Dr. Matt McDougall
Dr. Matt McDougall PhD, RN
Founder, Eco Traders Australia

A clinician with a PhD from the School of Maths, Science & Technology and training as a Registered Nurse, he’s dedicated to translating research into practical steps for better health. His work focuses on men’s health, mental wellbeing, and the gut–brain connection — exploring how nutrition, movement, and mindset influence resilience and recovery. He writes about evidence-based, natural approaches to managing stress, improving mood, and supporting long-term vitality.