In recent years, the number of people obtaining B6 blood-level tests from the TGA has grown rapidly. The TGA reports that one laboratory has experienced a greater than 100% increase in the number of B6 tests conducted each month, reflecting the growing awareness of the potential for toxicity.
Many popular products, such as multivitamins, energy drinks, protein shakes, and supplements containing magnesium or zinc, includes B6 as a supplement. Multiple sources of consumption may lead to people ingesting high cumulative doses of B6 without their knowledge.
The lack of effective labelling and regulation prior to the introduction of legislative changes in Australia in 2022 to reduce the amount of B6 that would trigger a mandatory warning label (from >50 mg/day to >10mg/day) to have minimal positive effect. The TGA
Health professionals have indicated that the amount of cases currently reported are likely only the "tip of the iceberg" and that many cases may go unreported, in part because the symptoms of B6 toxicity can mimic other health problems.
What’s Changing: New Regulation & Safer Guidelines
In response to increasing public concern, the Therapeutic Goods Administration was announced new regulations for vitamin B6 supplements.
• Starting in June 2027, anyone taking more than 50mg of vitamin B6 (via supplement) daily will need to obtain them from a pharmacy, with the assistance of a pharmacist to oversee this process, as well as an appointment for a prescription to be filled through a pharmacy to obtain vitamin B6 over 200mg daily.
• Products that contain daily doses of vitamin B6 at +10mg must now have a label warning to inform customers about the potential for developing peripheral neuropathy.
• In addition to providing additional labels or warnings, the TGA is working to raise awareness for consumers on how they can identify B6, as well as on the various forms of B6 that exist, as well as what the risks may be when using more than one form of B6, in multiple supplement forms, or other fortified products.
• Ultimately, these changes to the TGA's Approvals Process are designed to reduce the number of individuals who develop Vitamin B6 toxicosis and to promote educated and informed decisions when using B6.
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How to Protect Yourself- Smart Tips for Vitamin Users
B6 should ideally come from food sources rather than a supplement. A typical diet usually has enough B6 for the needs of most people and therefore, additional B6 supplementation is not typically needed unless recommended by a physician.
When purchasing B6 vitamins, be aware that it may be listed as pyridoxine, pyridoxine HCL, pyridoxal, or pyridoxamine in ingredients lists on product labels. If you consume multiple vitamins and energy drinks or any type of fortified product that also contains B6, proceed with caution since it’s possible to exceed the daily recommended intake from those products.
Do not use high dose/multiple B6 supplements. Avoid using greater than 50mg/day of B6 without first consulting a physician to rule out any potential problems associated with excessive levels of this vitamin.
Understand the key warning signs of vitamin B6 surplus so you can avoid it before irreversible nerve damage occurs. Symptoms of nerve-related issues include pain (burning), numbness, tingling or weakness of the hands or feet.
Consult a qualified health professional, such as your general practitioner or pharmacist, about starting a vitamin/mineral regime prior to combining the use of several products. They will be able to assess your need for the addition of these vitamins/minerals and whether they are safe for you to take concurrently.
Conclusion
Historically thought to be safe because of its high dose and low toxicity, Vitamin B6 is becoming a concern as research reveals that overconsumption of this vitamin leads to neurological impairment. With Australia now facing significant numbers of people who have developed neurological disorders related to excessive use of B6 supplementation, newly imposed regulatory standards coupled with increased public education will help protect individuals from future harm.
Individuals who currently use dietary supplement products should evaluate their current use of Vitamin B6 to determine if it is safe for them to continue use and/or be informed in making future decisions regarding their nutritional habits.