The FDA can count on mainstream media to mislead the public. Let’s get the truth out and stop this bill. Action Alert!
Sen. Dick Durbin (D-IL)’s bill, S.1425, is meant to “improve the safety of dietary supplements by [requiring]manufacturers of dietary supplements to register dietary supplements with the Food and Drug Administration and to amend labeling requirements with respect to dietary supplements.” Sounds innocuous, doesn’t it? But as we reported in August, this is nothing but a smokescreen—a naked power grab for the FDA and an attempt to regulate safe dietary supplements as if they were dangerous FDA-approved prescription drugs.
A recent article in Newsday quotes “a top agency official” (probably FDA’s Division of Dietary Supplement Programs director Dan Fabricant, who is quoted extensively in the article) as saying that 70% of supplement companies have violated FDA’s manufacturing rules over the last five years—with the clear implication that such manufacturing violations somehow puts the American public at risk. There is no mention of the nature, context, or seriousness of these alleged violations, and no link to any official reports or documentation.
The article declares that the number of adverse events caused by supplements “outstrips” those triggered by prescriptions drugs. This is totally false. The Newsday article’s author, Delthia Ricks, tells us that approximately “6,300 people nationwide complained about adverse reactions to dietary supplements between 2008 and 2012, according to FDA statistics. But the actual number may be more than eight times higher, some experts say, because most people don’t believe health products can make them sick.” This “eight times higher” claim has no basis in fact, and no documented source. Even if it were true, this number is far less than for prescription drugs.
The 6,300 figure averages to 1,575 per year, which is extremely low considering that 157 million Americans—half the US population—take supplements. This is in comparison to 526,527 adverse events for prescription drugs, 275,421 of which had “serious outcomes,” including death.
Why would we want to let the agency regulate supplements as if they were drugs when the drugs they approve cause over 400 times the adverse events than supplements do? When the Government Accountability Office (GAO) looked at the number of adverse events for supplements at the request of Senator Durbin, it was unable to uncover anything alarming, as we reported back in March.
On the contrary, the GAO report showed that FDA-approved drugs caused 80% of Poison Control fatalities. More than 100,000 calls to Poison Control Centers, 56,000 emergency room visits, 2,600 hospitalizations, and nearly 500 deaths each year are attributed to acetaminophen (Tylenol) alone!
The Newsday article goes on to describe, in detail, the FDA’s authority to regulate the vitamin supplement industry, noting the agency’s inspection of supplement company facilities, and its ability to issue product warnings, recalls, and seizures and levy steep fines against companies that run afoul of FDA regulation. Inexplicably, the article then quotes Dan Fabricant as saying, “There is little the FDA can do to exercise more power over supplement safety without an act of Congress,” and concludes that FDA has “limited power” to regulate supplements. In what universe does that statement make sense?
The only way it makes sense is if mainstream media pieces like this Newsday article are viewed as propaganda: a concerted alliance between the media, the FDA, and legislators like Sen. Durbin to weaken the public’s determination to keep dietary supplements freely available. Lest this sound too conspiratorial, we need to remember that drug advertising is what keeps much of print media alive in these days of online competition.
The theme of adverse events is very much echoed in Durbin’s legislation. His bill requires that the FDA, together with the Institute of Medicine (IOM), compile a list of dietary ingredients (supplements) that might lead to adverse events, or are otherwise deemed risky in some way—based on completely arbitrary or nonexistent standards. Given the FDA’s profound bias against supplements, and the skewed, anti-science recommendations of the IOM’s vitamin D report, these are hardly trustworthy sources of guidance!
By the way, speaking of IOM and adverse events, why does the IOM absolutely refuse to study adverse events from vaccinations? In this case it holds that adverse events are meaningless because not studied, but then refuses to study them.
Returning to supplements, the FDA already has complete authority to keep them safe—it’s just a matter of enforcement, as the FDA’s Fabricant himself said when he worked for the Natural Products Association: “The barriers to enforcement are simple: [FDA] money, manpower, and will.” (You’ll note he doesn’t say “more regulation”!) He also made the distinction between the “legal, safe and healthy dietary supplement industry” and “the seedy, fly-by-night, unsafe world of illegal steroids,” and called on FDA, DEA, and other appropriate agencies to work together to enforce the laws that already exist. Most of the violations cited in the Newsday article are examples of bad manufacturing practices, which are already illegal and subject to FDA enforcement action. All the FDA has to do is enforce existing rules.
Another element in Durbin’s legislation is a greater restriction of health claims: he has said his bill is designed to stop “mislabeling products and making health claims that have no scientific basis.” This is more nonsense.
The vast majority of supplement health claims have plenty of scientific basis—just not the random-controlled trials (RCT) that Durbin and the FDA want. And there’s a very good reason for this: most natural products companies cannot afford to spend up to a billion dollars on RCTs, because in most cases that natural product can’t be patented, so the companies could never hope to make back their investment. In addition, many supplements should be taken with co-factors and so should not be studied in isolation like a drug.
Durbin knows all this. The demand for RCTs is just a backdoor way to get rid of most supplements entirely.
In the past, Dan Fabricant did not support greater restrictions of health claims. In response to IOM’s recommendation that dietary supplement health claims should be subject to the same scrutiny as pharmaceuticals, Fabricant said, “Trying to see foods through the same lens as isolated pharmaceuticals is impractical from a policy standpoint.” He also noted that many widely used general claims about how nutrients work, such as “calcium builds strong bones,” can’t be subjected to the same clinical evaluation as pharmaceutical drugs.
In other words, the FDA’s Fabricant said exactly what we’ve been claiming all along—that supplements are safe and the FDA needs no expanded powers—before he changed employers!
Action Alert! Please write to your senators immediately and tell them to stop Sen. Durbin’s frontal attack on your right to use supplements dead in its tracks! We don’t need this new legislation—all we need is for existing laws to be fully enforced. We need our access to nutritional supplements to be protected. Please write your senators today!