Australia’s Therapeutic Goods Administration (TGA) has announced significant changes to the regulation of vitamin B6 products, aiming to address health concerns regarding high-dose consumption. Following an extensive review prompted by reports of toxicity and lasting nerve damage associated with elevated doses, the TGA will implement tighter controls on the packaging and sale of these supplements.
Effective from June 1, 2027, the new regulations will restrict over-the-counter sales for higher doses of vitamin B6. The TGA’s decision reflects a commitment to balancing the vitamin’s health benefits against potential risks, particularly the harmful effects of excessive intake. This has raised questions among consumers about the safety of vitamin B6 and the implications for supplement purchases.
Understanding Vitamin B6 and Its Importance
Vitamin B6, also known as pyridoxine, pyridoxamine, and pyridoxal, is an essential nutrient that supports over 140 bodily functions. Since the body cannot produce vitamin B6, individuals must obtain it from dietary sources. Good sources include animal products such as meat, poultry, fish, eggs, and dairy, as well as plant-based foods like legumes (chickpeas, lentils, beans), vegetables (potatoes, spinach, carrots, kale), fruits (avocado, bananas, oranges), and grains (corn, brown rice, oats, fortified cereals).
The recommended daily intake of vitamin B6 varies by age and specific health needs. For healthy adults, the upper limit is set at 50 mg per day, while lower amounts are advised for infants and pregnant or breastfeeding individuals. Information about dietary recommendations can be found on the government’s Eat for Health website.
The Risks of Excessive Intake
While a deficiency in vitamin B6 is linked to serious health issues, including certain cancers, mental health disorders, and cardiovascular diseases, such deficiencies are uncommon in Australia. Nevertheless, the use of vitamin B6 supplements has increased, raising concerns about potential toxicity. Prolonged high doses of vitamin B6 can lead to peripheral neuropathy, a condition that damages the nervous system and manifests as pain, weakness, and numbness, particularly in the limbs.
Toxicity from food sources is extremely rare, with the majority of reported cases arising from excessive supplement consumption. Studies indicate that nerve damage can occur at doses below 500 mg/day, though effects are generally not observed at levels under 200 mg/day. The TGA’s new limits reflect these findings.
The updated regulations will require pharmacist supervision for the purchase of products containing more than 50 mg but less than 200 mg of vitamin B6, while prescriptions will be necessary for doses exceeding 200 mg. Products with 50 mg or less will remain available over-the-counter.
Consumers should be aware that many vitamin products, including multivitamins and dietary supplements marketed for skin and hair health, often contain vitamin B6. As such, individuals may unknowingly exceed the recommended intake by combining multiple supplements.
Changes in Labelling and Consumer Awareness
The TGA’s report emphasizes the need for clearer labelling on vitamin B6 products. Mandatory front-of-pack statements will indicate when a product contains vitamin B6, especially in combination products. Most of the 125 medicines that fall under the new regulations will need to be registered with the Australian Register of Therapeutic Goods and relabelled accordingly.
Vasso Apostolopoulos, a researcher with prior funding from the National Health and Medical Research Council (NHMRC), has been involved in discussions regarding these changes. Jack Feehan, an academic with no conflicting interests, highlights the importance of consumer education in interpreting these new guidelines.
For individuals taking vitamin supplements, it is crucial to check labels to ensure total daily intake does not exceed the recommended limit of 50 mg. Those concerned about their vitamin B6 intake or experiencing symptoms of toxicity should consult a healthcare professional.
