FDA Citizen Petition on Vitamin B6: Press Coverage

By October 27, 2021

October 27, 2021- Press coverage regarding Emery Pharma’s Citizen Petition with the FDA on high-dose Vitamin B6 supplements available over-the-counter.


WebMD:
Does Vitamin B6 Need a Warning Label?

Vitamin B6, widely promoted and taken as a supplement, should carry a warning label about possible nerve problems, according to the CEO of a large contract research lab in Northern California.

And doses above 10 milligrams should be switched from over-the-counter to prescription status, says Ron Najafi, PhD, CEO of Emery Pharma, who filed a citizen’s petition with the FDA on Friday. He wants the agency to regulate and revise industry guidance on high doses of over-the-counter vitamin B6, due to risks of severe toxic exposure that causes numbness and tingling of the hands and feet.

The full article can be found here


Pharma Insight:
Petition Suggests Rx-Only Vitamin B6 At 10-MG And Up In US, Add Warning To All Doses

A California contract pharmaceutical research laboratory suggests vitamin B6 in doses larger than 10 mg should be available in the US Rx-only and that all doses of the nutrient should be labeled with a warning about potential danger from using large amounts.

Najafi Pharma Inc., dba Emery Pharma, asks the Food and Drug Administration to impose the changes in a citizen petition which discusses potential health risks from use of the nutrient, also known as pyridoxine, saying “there is a significant lack of data to justify supplementation in individuals with adequate B6 levels, entirely.”

The full article can be found here


San Francisco Business Times:
Why this East Bay research group wants to shut down vitamin B6 ‘mega doses’

Emery Pharma of Alameda filed a “citizen petition” Monday with the FDA that asks the regulator to slap a warning label on vitamin B6 supplements to alert consumers of potential side effects and to require a prescription for high-dose products. Overdosing of the vitamin, they said, can cause nerve damage. There is no money to be made by the 15-employee boutique contract research lab in filing the petition. There’s also little expense.

The full article can be found here


UCSF News:
PharmD alum advocates for responsible regulation of vitamins

UCSF School of Pharmacy: PharmD alum advocates for responsible regulation of vitamins:
The patient was a healthy man with no significant medical history. Like many others, though, he was concerned about contracting COVID-19. So in the summer of 2020, he began taking a supplement of vitamin B6 to “strengthen” his immune system.

In May 2021, the man’s health took a turn for the worse. Doctors struggled to explain his mysterious symptoms, such as numbness in his hands.

Months later, a blood test revealed an unusually high level of the active form of vitamin B6. The man stopped taking the supplement and most of his symptoms subsided within a few months.
In the fall of 2021, UCSF School of Pharmacy alum Ana Najafi, PharmD ’21, learned of this patient’s experiences and began to dig into the literature. As a strategic pharmaceutical development associate for Emery Pharma, Najafi was tasked with following up on his case, which he had submitted to the company via an online inquiry form. The full article can be found here.


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About Emery Pharma
Emery Pharma is a contract research and development laboratory, specializing in analytical chemistry, microbiology, and cell biology services, utilizing state-of-the-art equipment such as Nuclear Magnetic Resonance Spectroscopy (NMR), LC-MS/MS, HPLC, UPLC, and much more. The facility is located in Alameda, CA, in the San Francisco Bay Area. Emery Pharma’s mission is to help “Save Lives and Save the Environment.” Emery Pharma is FDA registered and inspected, DEA licensed, and GLP/cGMP compliant. Emery Pharma’s previous citizen petition was about NDMA, a known carcinogen and its presence in Ranitidine, sold under many different brands including Zantac, which resulted in the recall of Ranitidine (Zantac) from the US market.