Now that Henry Waxman is retiring from Congress, it is clearly Senator Dick Durbin (D-IL). State Action Alert!
Sen. Durbin has long demonstrated a bias against dietary supplements. Here’s a taste of his career-long attempt to give FDA the power to sweep thousands of supplements off the shelves:
- In 2004, Sen. Durbin proposed an amendment to a defense funding bill. This has been a frequent tactic of his, using must-pass legislation to push his agenda in the form of unrelated amendments so that anti-supplement proposals can slip into law unnoticed and without debate. This amendment restricted access to nutritional supplements on military bases and created reporting requirements that were stricter than for over-the-counter drugs. Eventually Durbin agreed with supplement defender Sen. Hatch (R-UT) to drop his amendment. In return he agreed to legislation creating an Adverse Event Reporting (AER) System for supplements. The bill passed in 2006.
- As a follow up to the 2006 bill, in 2009 Sen. Durbin along with Reps. Bart Stupak (D-MI), John Dingell (D-CO), and Henry Waxman (D-CA) asked the Government Accountability Office to investigate supplement adverse event reports (AERs). This resulted in a report published that same year: “GAO Report to Congressional Requesters: Dietary Supplements FDA Should Take Further Actions to Improve Oversight and Consumer Understanding.” The most notable finding was that the FDA had seen a threefold increase in dietary supplement AERs compared to the previous year. There’s a good reason for that: the legislation requiring AERs of dietary supplements did not go into effect until 2008. Of course the number of reports will be higher after reports become mandatory!
- Never one to let a good crisis go to waste, in 2011 Sen. Durbin used a troubling but isolated incident—the sale of melatonin-filled brownies called “Lazy Cakes”—to ask the FDA to clarify its authority to regulate foods that contain additives, such as the hormone melatonin, and to clarify the difference between conventional food and dietary supplements. This request simply ignored the fact that clear regulations already existed on both these issues. Since Lazy Cakes were not dietary supplements, the FDA would regulate them as food. Ingredients that are intentionally added to food—in this case, melatonin—are food additives. Food additives require pre-market approval from the FDA based on data demonstrating safety in a food additive petition. Lazy Cakes did not submit a petition to the FDA as they should have, so were already subject to FDA enforcement under existing law. Sen. Durbin at the time seemed to us to be trying his best to confuse this issue in order to paint supplements as being unregulated, which is simply untrue. This was always nothing more than a matter of enforcement, not authority.
- Following the Lazy Cakes incident, Sen. Durbin introduced S.1310, the Dietary Supplement Labeling Act of 2011. He tried to create a new, difficult registration system for supplements, which we were convinced was just a first step toward pre-approval by the FDA of any supplement sold. He also wanted more extensive labeling requirements—good in theory, but not in the hands of FDA staffers hostile to supplements and also influenced by the government’s supplement-phobic Institute of Medicine for dosage guidelines.This bill also sought clarification on the difference between conventional foods and dietary supplements, even though the FDA had already promised a guidance document on that subject. All of these provisions seemed to us, based on Durbin’s own remarks, to represent an effort by Durbin to lay the groundwork for a larger move to regulate supplements as if they were drugs. Of the bill’s eight pages, only two sentences addressed food companies such as Lazy Cakes. Almost all of the bill was aimed at nutritional supplements. It is probably no coincidence that Sen. Durbin’s legislation came out on the very same day—the Friday before a big holiday weekend—as the FDA’s draconian NDI (new supplement) draft guidance.
- Realizing that his legislation was hitting roadblocks, Durbin then sneaked an amendment into a must-pass appropriations bill asking the GAO to examine supplement AER data, and to report back on whether FDA has implemented the recommendations of the aforementioned 2009 GAO report. Fortunately, ANH supporters were able to get the amendment struck from the final bill.
- A few weeks later, in November of 2011, Sen. Durbin joined with the other leading anti-supplement nemesis, Rep. Waxman, and wrote a letter directly to the GAO requesting that AER data be reviewed—but only for supplements. As we asked then, if consumer safety were really Sen. Durbin’s motivation, why didn’t he and Rep. Waxman also ask the GAO to review AER data for vaccines and drugs, which are far more dangerous and have far, far more reported adverse events?
- Durbin is tenacious. In May 2012, he (together with Sen. Richard Blumenthal, D-CT) once again sneaked an amendment into must-pass legislation—this time it was the FDA Safety and Innovation Act. His amendment would have required supplement companies, among other provisions, to register all their products and all of the ingredients they contain with the FDA. Fortunately, grassroots activists like you sent 90,000 messages in less than twenty-four hours, and the amendment was quickly defeated. We took the opportunity to rebut some of the misinformation Durbin was spreading on the Senate floor.
- In March 2013, the GAO report requested in 2011 by Sen. Durbin and Rep. Waxman finally came out—and it totally backfired on them both: the report showed that dietary supplements are remarkably safe, and AERs are low.
- August 2013 saw Sen. Durbin reintroducing his Dietary Supplement Labeling Act (which is identical to the previous version). We don’t think the bill will pass, but will follow it closely and keep you posted on what is happening to it.
- Sen. Durbin has consistently espoused an anti-supplement agenda to the media, which we have consistently rebutted, point by point. It is easy to argue that supplements should have to prove safety and efficacy and otherwise be treated just like drugs. Shouldn’t there be a level playing field?But as we have repeatedly pointed out, it is extremely rare for a company to take a drug through the FDA approval process unless it is patented. The process costs billions on average and is just too expensive for a non-patentable substance. Since natural supplements are not supposed to be patentable, saying that drugs and supplements should get the same treatment is just a sneaky way of eliminating supplements from sale. Sen. Durbin knows this, but continues to make the misleading “level playing field” argument.
Why does Senator Durbin do this? We don’t know what is inside his mind. But we do know that he enjoys the support of Big Pharma.
Here’s another question. If Durbin is really interested in consumer safety, why doesn’t he concern himself more with Big Food companies? Food fraud is a growing problem—common grocery store items substitute inferior, inexpensive ingredients for high-quality ones. Olive oil, milk, tea, tuna, fruit juices—all are top “fraudster” foods, and some of the ingredients are not even food (grass clippings in tea bags) or are dangerous (olive oil that is mostly hazelnut oil—a hazard for people with nut allergies). None of these substitutions are listed on the label. Sen. Durbin could be focusing his energies on real consumer issues like this one.
Action Alert! If you are an Illinois resident, send a message to Senator Durbin challenging him on pushing misguided and unjustified anti-supplement agenda to the detriment of Americans’ health. Show him that his zeal would be better served in fighting a huge consumer problem: food fraud!
