In a world in which the soil—and therefore much of the food that comes from the soil—has been depleted of the nutrients we need to live and thrive, access to quality dietary supplements is more important than ever. Proper supplementation is vital to maintaining optimum health and preventing disease yet, as we explain elsewhere on this site, the FDA has consistently been hostile towards dietary supplements and natural products.
In the Dietary Supplement Health and Education Act of 1994 (DSHEA), according to Sens. Tom Harkin and Orrin Hatch, the legislation’s two principal authors, “Congress made clear that consumers should continue to have access to dietary supplements that meet the law’s definition [and]should also refrain from erecting barriers that will inhibit or needlessly delay consumer access to safe products.” This landmark law defines dietary supplements as food and not drugs—a distinction that is critical to maintaining access to high quality, natural food-supplements.
FDA working for Big Pharma?
As we have noted repeatedly, the FDA’s allegiance to the pharmaceutical industry comes from their huge financial ties—Big Pharma essentially pays FDA’s bills. This is the motivation for the FDA approving and promoting pharmaceutical drugs while actively discriminating against dietary supplements by trying to regulate them as if they were drugs and thus removing them from the market. This ensures big sales for Big Pharma, and continued income for the FDA. Numerous legislative efforts over the years, most of which emanate from the office of Sen. Dick Durbin (D-IL), have sought to give the FDA what it wants—a pre-approval system for supplements that would result in the disappearance of thousands of supplements from the shelves. Fortunately, all of these efforts have (so far) failed thanks to the concerted efforts of ANH-USA members and other stakeholders.
The FDA has, however, been resourceful in the face of defeat. On numerous occasions, the FDA has taken regulatory actions against particular supplements to clear the market for a new pharmaceutical drug. Substances like curcumin, boswellia, aloe vera, and more have already been banned from being compounded. Recently the FDA took action against picamilon and vinpocetine, brain health supplements that could compete with an expected blockbuster Alzheimer’s drug on its way to market.
How vitamins become “drugs”
Another notable example is the case of pyridoxamine, one of three natural and bioavailable forms of vitamin B6. This vitamin has many health benefits; indeed, we could not live without B6. Despite this, in 2009 the FDA banned the supplement form of pyridoxamine in response to a petition from a drug company that wanted to use it in a drug formulation.
The company in question, BioStratum, Inc., argued that supplements containing pyridoxamine were illegal because BioStratum had filed an investigational new drug (IND) application with the FDA in 1999, and there was no evidence that supplements containing pyridoxamine had been marketed before then. The FDA agreed and banned pyridoxamine in supplement form. To add insult to injury, nothing ever came of BioStratum’s drug application—meaning that pyridoxamine is no longer available today in any form, either drug or supplement. The FDA apparently couldn’t care less about this outcome.
The example of pyridoxamine shows what could happen to thousands of other supplements currently on the market. If a drug company files an IND on a nutrient that has not been registered as a New Dietary Ingredient (NDI)—and is not grandfathered in because it was sold before 1994—that nutrient can no longer be sold as a supplement. But, as we explain on our NDI page, the FDA’s rules for filing NDI notifications have not been finalized, meaning companies are in the dark about how to comply with this process. Thousands of products, then, are potentially vulnerable to being removed from the market if a drug company files an IND.
An even more important form of vitamin B6, pyridoxal-5′-phosphate (P5P), faces this threat. The FDA has a petition from Medicure Pharma to ban P5P because the company wants to turn this critical vitamin into a drug. This is especially scary—all forms of B6, natural or synthetic, must be converted to P5P for the body to use them. If the FDA approves the petition, anyone who is not able to convert synthetic B6 to P5P would have to rely solely on Medicure’s product to stay alive.
The FDA has attacked other natural substances on an ad hoc basis, like folate. Under the new proposed FDA rules, the word “folate” (i.e., natural folate) will be banned from the Supplement Fact labels—only the term “folic acid” (i.e., the synthetic form) will be allowed. This is a backdoor ban on folate: if you can’t list it on the label, then you can’t put it in the product. The problem is about 30% of the population is unable to convert synthetic folic acid to bioavailable folate; and if they can’t get enough folate in their diet, they need to get it from a supplement—which the FDA now wants to ban.
The pattern, then, is clear. When it’s not politically (or legally) feasible for the FDA to ban a natural substance outright to protect their Big Pharma clients’ bottom lines, the agency resorts to back-channel methods to eliminate them.
The FDA’s legendary antipathy toward supplements is one of the greatest dangers natural medicine is facing. Given the massive conflict of interest that predisposes the FDA to be hostile towards supplements, we believe the regulation of dietary supplements should be moved to a separate agency devoted to regulating food. As long as the FDA continues to have jurisdiction over supplements, we can expect these kinds of attacks to continue.