FDA back-channel allows drug companies to transform common supplements into expensive prescription drugs

The depths of corruption within federal agencies know no bounds: A backchannel at the FDA has given Big Pharma the ability to turn ordinary nutritional supplements into expensive medications and treatments — and also gives drug companies the ability to file requests that ultimately lead to the supplement version being removed from the market. This is government collusion at its finest, as a federal agency literally works to protect a pharmaceutical company’s financial interests while also jeopardizing public health. Now, consumers may find themselves asking how many supplements have been banned by the FDA under false pretenses.

Vitamin B6, or pyridoxamine, has already suffered this tragic fate.

A dangerous precedent

Once widely used as an over-the-counter nutritional supplement with an array of health benefits, the FDA ruled that the pyridoxamine form of B6 could no longer be sold in supplement form. They decided it was illegal, because a pharma company named Biostratum began manufacturing a pyridoxamine-based drug for diabetic kidney disease. The FDA’s reasoning was that pyridoxamine was authorized (by them) for investigation as a drug before it was ever marketed as a supplement.

It’s unlikely that the FDA truly knows when or where B6 was first sold as a dietary supplement, but you can bet dollars to donuts it probably happened before Biostratum began investigating it as a kidney drug. But in 2005, the company petitioned the FDA to ban the sale of the nutrient as a supplement. When the FDA publicized their decision in 2009, the Council for Responsible Nutrition (CDN) stated they were “dissapointed” in the FDA’s decision — and rightly so. As CDN would point out, the ruling on this case has set a dangerous precedent for the future — and that future is now here.

That the FDA has prioritized corporate interests above all else in this matter is self-evident, but it is also growing increasingly obvious federal agencies as a whole have gotten too big for their britches.

The back-channel

All drug-makers have to do is file for an IND — investigative new drug — and they can corner the market by petitioning the FDA to remove supplement forms of whatever nutrient they’re looking to profit off of. As The Alliance For Natural Health (ANH) reports, the FDA just approved a new drug for sickle cell disease, known as Endari. That drug is based off of L-glutamine, an amino acid. Currently, one can purchase L-glutamine for about $10 a bottle — but if Endari’s manufacturer decided to enforce their IND and petition the FDA, the days of affordable L-glutamine are over. Estimates suggest a year’s worth of Endari will cost about $40,000.

As ANH explains, CBD supplements are likely going to be the next target. Now that the FDA is saying CBD is a drug and not a supplement, it will only be a matter of time before Big Pharma is at the helm of the CBD market. Given the federal government’s consistently draconian stance on the medicinal value of cannabis, it is extremely hypocritical to give CBD approval for use as a drug provided it is sold exclusively by pharmaceutical companies — and it reeks of bureaucracy. In fact, it is bureaucracy: A group of unelected officials are making all the big decisions for us, while our elected representatives are twiddling their thumbs in Congress.

As ANH contends further:

Until we close down the IND back channel that allows Big Pharma to turn supplements into drugs, we will continue to see this happen. There’s too much money to be made. That’s why ANH is advocating for a legislative change that will protect natural substances from being turned into drugs by eliminating the market exclusivity that drug companies get when a new drug investigation is on a dietary ingredient currently being sold in the market in a dietary supplement. 

You can view The Alliance of Natural Health’s petition to shut down the FDA’s back-channel here.

See more coverage of the FDA’s latest atrocities at FDA.news.

Sources for this article include:





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