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Feds Coming for Your B-Vitamins

Feds Coming for Your B-Vitamins

B vitamins are essential to life, but Congress could be following in Europe’s footsteps in placing outrageous restrictions on these and other vitamins. Action Alert! 

A few weeks ago, we told you about the threat to high-dose supplements represented by mandatory product registration for supplements. This regulation is the beginning of the end for Americans’ ability to stay healthy using supplements, in part because it moves us closer to the draconian dose restrictions happening right now in the European Union (EU). The threat to vitamin B6 illustrates the harmful effect of these developments.

B6 is an incredibly important nutrient with an array of health benefits. It is crucial to immune function and the inflammatory response. It plays a role in heart health and preventing coronary artery disease. Inadequate intake has been linked with cognitive decline and Alzheimer’s disease. It also appears to help prevent certain cancers: a study of 500,000 older adults found that the risk of esophageal and stomach cancers was lower in participants in the highest quintile of total vitamin B6 intake. There have been profound effects reported from taking 100-300mg B6 per day, along with other supplements, for perimenopause and menopausal mood swings, anxiety, depression and fatigue. These are just a few of the many clinical uses that have been noted in the literature.

There are six common forms of vitamin B6: pyridoxal, pyridoxine (pyridoxol), pyridoxamine, and their phosphorylated forms. You might have also heard of pyridoxal 5′-phosphate (P5P), which is a derivative of B6 and is the bioactive coenzyme form. These are all forms of B6, but they are not all created equally. The different forms have different bioavailability (how well they are absorbed) and different effects on the body.

These nuances are lost on European regulators, who have moved to limit the B6 allowed in vitamins to just 3.5 milligrams (mg) (Germany), 6mg (Belgium), and 10mg (Italy). These levels are derived from “tolerable upper limits” (TULs) devised by European Union authorities; the TUL set for B6 is 25mg, meaning the highest level, in their estimation, that is safe.

These concerns are supposedly based on the fear that excessive B6 intake can lead to peripheral neuropathy, a tingling, numbness or pain sensation in the extremities. But regulators have wildly overreacted to this danger. Some reports have found that extremely high doses (1,000mg/day) of the pyridoxine form of B6 can yield a degree of peripheral neuropathy after a few months of use; 500mg/day can cause neuropathy in a small number of people but only with long-term use (a number of years). Importantly, at 200mg/day, no one is reported as suffering any peripheral neuropathy.

This not only shows that a TUL of 25mg is overly cautious, to put it mildly; it shows that EU authorities have completely ignored the science. First, no studies in which an objective neurological examination was performed reported evidence of nerve damage at intakes below 200 mg of pyridoxine per day. So a “safe” level of 25mg is ludicrous. More importantly, because of the risks associated with higher doses of pyridoxine, many consumers choose the coenzyme P5P form of B6. And here’s the kicker: There is not a single published report on P5P causing peripheral neuropathy.

So, EU limits on B6 are based on risks posed by extremely high doses of one form of B6, but the draconian restrictions apply to all forms, including P5P, for which no risk of peripheral neuropathy has been reported. This means that consumers will not be able to reap many of the benefits of higher doses of P5P.

But why should we be surprised? Big Pharma, which wields considerable influence in the federal government, doesn’t want you using high-dose supplements to stay healthy. They want you using their expensive, dangerous drugs. This is ultimately why some in Congress are trying to move us closer to European-level restrictions on supplements by instituting a supplement registration system so the FDA can axe these products more easily. We can’t let it happen.

Action Alert! Write to Congress and tell them to oppose mandatory product listing for dietary supplements. Please send your message immediately.

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7 thoughts on “Feds Coming for Your B-Vitamins

  • M. Magnan

    I would be lost without my vitamin Bs. Thank you for letting me know so I could send the action alert. Question for AHN, is there a way for me to know which action alerts I have already filled out?

    Thank you,

  • Dariel Blackburn

    I am writing to ask you to oppose efforts to establish a “mandatory filing” for supplements. I am living proof that supplements are life saving. I had an aggressive form of cancer in 2014 that might have killed me, but due to the many wonderful, healthful supplements I had at my disposal I am still alive and healthy today. I am totally opposed to the FDA and pharmaceutical companies threatening access to the supplements I and millions of Americans and those around the world depend on. It is totally untrue that they are “unsafe”! What is true is that many of the drugs allowed on the market by the FDA and prescribed by the hospitals and AMA are unsafe and have been the cause of death for many, many people. I ask that you do everything in your power to stop this push to ban supplements. Thank you for hearing me.

  • Ryan Joslyn

    This is such a dangerous time, to be living in this country, as an Adult or as a Child, as a Woman or Man or Transgender.

    From the Mass Shootings, and the Capital Attack, to the potential outlawing of abortion, to this threat targeting our access to Supplements.

    It seems no stone is going un-turned. But we can do something directly concerning this issue. I have contacted the Offices of the President, the State Senators and Member in the House of Representatives.

    I encourage you to do the same.

    Thank You, ANH!

  • Bruce

    I have been taking high doses of B vitamins and many other supplements for 60 years and I am in very good condition. What are they trying to protect me from?

  • Jo

    Supplements and other natural means to help the body [ as God has given us] are all connected to food sources, even herbs and certain roots. These things are not medical as a means in which the medical field look at, as medicines. These are food sources produced in a natural way to help others with what un-natural problems may occur by means of other sources that do not connect with the natural ways that can produce a healthy body.

  • Ken B

    I oppose mandatory product listing and have submitted emails stating so to government elected officials and bureaucrats. The real issue, to me, is the Prescription Drug User Fee Act (PDUFA). How in the world is a federal agency such as the FDA supposed to serve the public health and welfare in terms of food and drug safety when a significant portion of its budget is paid by pharmaceutical companies? Why can’t taxpayer dollars be used to fully fund the FDA? The FDA budget for 2022 is $6.5 billion, out of a total federal government budget for 2022 in excess of $4 trillion. Seems like a little re-allocation of priorities could get the FDA fully funded without drug companies contributing to the cost of running the agency. Because of the fees paid by drug companies to the FDA, these drug companies naturally behave as if they are paying the FDA for a service, namely FDA’s expeditious approval of new drugs. Likewise, FDA employees may feel that their salaries are paid in part by drug companies, and therefore, they have an obligation to serve the drug companies rather than serve the general public. What horrible conflicts of interest this arrangement produces. PDUFA is the reason dietary supplements are under attack at the FDA.

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