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# Suspend Vitamin B6 Sales: Emery Pharma Petition
- URL: https://www.fdaweb.com/suspend-vitamin-b6-sales-emery-pharma-petition/
- Published: 2021-09-23T12:00:00.000Z
- Updated: 2026-09-14T17:15:54.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150207

Emery Pharma is asking FDA to issue a regulation, revise industry guidance, and request a recall and suspend sales of vitamin B6 (pyridoxine) from the U.S. market. A 9/20 [petition](https://downloads.regulations.gov/FDA-2021-P-1019-0001/attachment%5F1.pdf?ref=fdaweb.com) says mega doses (50-500 mg) of vitamin B6 are widely available over-the-counter and online. When taken in excess, the petition says, vitamin B6 can cause symptoms of peripheral neuropathy and neurotoxicity.

Emery says FDA should implement safe guidelines for using “this widely abused vitamin,” including: 

- asking manufacturers of vitamin B6 or B-complexes to include labeling about the vitamin’s potential toxicity, including a warning to consumers to discontinue B6 supplementation if they experience signs or symptoms of toxicity; and
- reclassify doses greater than 10 mg as behind-the-counter and available by prescription only, under the supervision of a physician with proper monitoring.

Emery says there is an existing precedent for its recommendation since vitamin D supplementation includes several strengths (400 IU to 10,000 IU) available over-the-counter but there is a requirement that patients prescribed 50,000 IU must have a prescription and lab monitoring under the supervision of a physician. “This principle should be applied in the case of vitamin B6,” the petition says.