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.