[The bill requires supplement manufacturers to] provide the FDA with…some basic information about…whether there’s any chemical included in the product that might interact with other drugs or cause some difficulty. It’s just basic information.
In his own words, Sen. Durbin is saying that supplement producers would be legally liable for identifying anything about the supplement that “might” interact with a drug or cause some vague and ill-defined additional difficulty.
This is not “basic information.” Even drug companies are not required to report how a drug might interact with all other drugs, because they could not do so. How would the supplement producers know about what “might” interact with every single drug? Or cocktail of drugs? No supplement producer could possibly comply with this requirement, and could face jail or bankruptcy for failing to comply. Sen. Durbin knows full well that this would shut down the supplement industry.
To make it more confusing, Durbin’s bill doesn’t actually require what the senator says it does. Perhaps he wanted this provision but dropped it for the time being and then forgot. Whatever the explanation, this seems to be yet another instance of a senator not reading or understanding his own bill.
The bill does require the FDA to create a list of ingredients that could cause drug interactions, AERs, or problems for sensitive populations. This is still nonsense, because the FDA also would not be able to be sure whether an ingredient interacted with a drug, given the numbers of ingredients and drugs. And of course to be complete, a list of interactions would decide whether the interaction was minor or potentially serious and cover not just one ingredient and one drug, but cocktails of ingredients and drugs. Good luck to anyone trying to figure this out.
According to the bill as written, the IOM (U.S. Institute of Medicine) would study the FDA’s list of interactions. Those judged to be risky would require warnings on the labels. That’s right, completely arbitrary determinations resulting in label warnings—which, if the IOM is involved, will probably include warnings on dosages of vitamins. This creates a slippery slope to a restrictive system like the one they have in the European Union, because it starts with an arbitrary determination of risk and mandatory labeling, and goes from there.
Remember how the IOM originally identified 10,000 IU as a safe threshold for vitamin D, then suddenly and without explanation decided to set the limit at 4,000 IU? The IOM now recommends 600 IU as a daily dosage for people between the ages of 1 and 70 (as if all ages and body weights from infancy on should be identical). By contrast, Harvard and the Vitamin D Council recommend anywhere from 1,000 to 5,000 IU a day.
So if, in the senator’s bill, the IOM gets to decide on dosages, we might see warning labels for dosages that many respected health researchers believe are minimal therapeutic amounts! This is particularly absurd given the enormity of evidence for higher levels of vitamin D. This could be an eventual backdoor to the extremely low Upper Limits favored by the European Food Safety Authority (EFSA) and Codex, which have already led to extremely low dietary supplement dosages in the EU.
The senator always takes care to sound reasonable, even when he is being anything but reasonable. For example:
I want at least to be sure, as a consumer, of what I’m consuming and what my family would be consuming.
Well, we can certainly agree with the Senator about: the Right to Know [SUP][7][/SUP]! We believe all food and food-like substances (which is the technical definition of a dietary supplement) should be clearly labeled as to what they contain.
As we’ll discuss further below, this is already required by law with one glaring exception: genetically modified organisms. Unfortunately support for GMO labeling would no doubt get the senator in trouble with Big Farma in Illinois.
The senator continues:
I’m not ruling out dietary supplements….but I think the standard we’ve tried to establish is, Are they safe? Are they safe for the general public?…And secondly, are they effective?
Safety and efficacy: these terms, to the average person, probably again sound quite reasonable. However, these are the exact FDA code words [SUP][8][/SUP] for the drug approval process! The senator clearly intends to subject dietary supplements to FDA drug standards.
Here’s the problem.
If either healthy foods or the dietary supplements were regulated by the FDA like drugs, they would be subjected to the drug industry’s “gold standard”—the RCTs that cost billions of dollars. The latest average cost figure we have seen is $2.3 billion per approval.
In most cases, natural products like supplements can’t be patented, so supplement companies could never hope to make back an investment in FDA approval. In addition, many supplements should be taken with co-factors and so should not be studied in isolation like a drug.
If Sen. Durbin gets his way, most dietary supplement companies would be put out of business, clearing the way for Big Pharma to take over with their synthetic versions of the same products—at prescription prices. And as we noted last month [SUP][3][/SUP], 157 million Americans—half the US population—take supplements each year, but less than one-hundredth of one percent of them have adverse effects from them—an average of only 1,575 per year. By comparison, there are on average 526,527 adverse events for prescription drugs [SUP][9][/SUP] each year—275,421 of which have “serious outcomes,” including death.
FDA-approved drugs cause over 400 times the number of adverse events of nutritional supplements, more than 100,000 calls to Poison Control Centers, 56,000 emergency room visits, 2,600 hospitalizations, and 80% of Poison Control fatalities—nearly 500 deaths each year are attributed to acetaminophen (Tylenol) alone! In each case, the problem is being caused by an FDA approved product ( for more on this see our article today on rheumatoid arthritis drugs).
While we are on the subject of safety, Sen. Durbin’s words show that he either doesn’t know or chooses to ignore that nutritional supplements already go through a safety testing process.
Supplement companies, by law, must comply with the Dietary Supplement Current Good Manufacturing Practices [SUP][10][/SUP] (CGMPs) and must conduct testing throughout the production process as well as testing the finished product for quality control.
As with the pharmaceutical industry, the burden is on supplement companies to test their own products, because in the end they are liable should FDA choose to take enforcement action against them.
More from the senator:
I think most Americans would be surprised to know that the dietary supplements which they’ve purchased…are not registered with the US Food and Drug Administration with any basic information. The bill that I’ve suggested [requires] that every manufacturer provide the FDA with a copy of their label as well as a list of ingredients….
The senator surely knows that:
- The government has already implemented a database of dietary supplement labels [SUP][11][/SUP]—a database of ingredients included in dietary supplements [SUP][12][/SUP];
- Current law mandates that all supplements list all of their ingredients on their labels [SUP][13][/SUP];
- Manufacturers are required to register with the FDA [SUP][14][/SUP]before producing or marketing supplements;
- Existing legislation mandates that dietary supplement manufacturers notify FDA [SUP][15][/SUP] before they produce a product that contains a new dietary ingredient (NDI). If a supplement ingredient isn’t an NDI, then it’s been marketed and used safely by consumers for decades.
Also, let’s not forget that FDA has full power to take enforcement action [SUP][6][/SUP], should any supplement—new or old—prove harmful or illegal.
When asked what’s the “hold-up” on increased regulation of dietary supplements, the senator responds:
I’ve been trying for a long, long time to move in this direction, but there are players in the industry that resist any type of disclosure.
Let’s be honest. Supplement manufacturers have very little influence on Capitol Hill. The “big players” on this bill are actually from the drug industry! PhRMA, the Pharmaceutical Research and Manufacturers of America, is considered one of DC’s [SUP][16][/SUP] top lobbying groups, and is zealously trying to keep natural supplements from gaining any more of a foothold in the lucrative healthcare field.
No, the driving force behind the opposition to Sen. Durbin’s anti-supplement legislation is not the supplement manufacturers, but consumers! After all, it was consumer-activists like you that sent over 100,000 messages to Congress [SUP][17][/SUP] to defeat his 2012 anti-supplement amendment (the 2012 amendment is—verbatim—the same Labeling Bill he’s pushing now).
So far, Sen. Durbin lacks even the support of his own colleagues: S.1424 [SUP][18][/SUP] (the Labeling Act) has only one-cosponsor, and his 2012 amendment was defeated by a vote of 77 to 20 [SUP][19][/SUP](that’s particularly harsh, coming from a Democrat-controlled Congress).
More from the senator:
I think there are opportunities out there [for dietary supplements] and I applaud the research that tries to move us in new areas to find cures.
Despite this further attempt to sound reasonable, the senator knows full well that dietary supplements can’t claim to treat or “cure” diseases: this would make them drugs in the FDA’s eyes, and they would—surprise!—have to be taken through the full FDA approval process.
Just as important as what Sen. Durbin does say is what he doesn’t say. He fails to mention overwhelming consumer support for dietary supplements free from additional government requirements that would destroy the market. He ignores the mountain of evidence that dietary supplements are far safer than even over-the-counter drugs (as was clearly demonstrated by the GAO report that the senator himself requested [SUP][20][/SUP]). And he is blind to the importance of the dietary supplement industry for the American economy—it has the capacity to support 450,000 jobs [SUP][21][/SUP] and, in 2006, paid more than $10 billion dollars in taxes.
Despite all this, we appreciate that Senator Durbin finally put his views on the record, where they can be discussed objectively, not just buried in the dense legalese of his bill.
