CRN responds to vitamin B6 citizen petition
On September 20, 2021, Emery Pharma filed a citizen petition requesting FDA to require warning on vitamin B6 or B-complex product labeling and to reclassify products with more than 10 mg vitamin B6 to be prescription-only.
The petitioner asserts that mega-doses of vitamin B6 (which they define as 50 – 500 mg) cause symptoms of peripheral neuropathy and neurotoxicity, and presents one case study. In addition, the petitioner references “upper limits” for vitamin B6 established by international regulatory bodies, with the lowest value of 10 mg/day set by the UK and the highest value of 100 mg/day set by the U.S. Finally, the petitioner recommends that FDA ask manufacturers to voluntarily recall all vitamin B6 supplements and revise product labeling to include a warning for consumers that vitamin B6 may be “dangerous when used in large amounts or for a long time.”
CRN has prepared a response that members can use with their customers and for media queries. In the response, CRN criticizes the petitioner’s requests for lacking credible scientific evidence and for unnecessarily raising alarm without benefiting consumers.
To date, the issue has been covered in WebMD. CRN will continue to monitor for media coverage of this issue, responding as necessary.
CRN plans to submit full comments to the docket at a later time. CRN members interested in comment development should submit their contact information to this Google sign up form.
Feel free to contact Rashidah Denton with questions.
