The senator’s bill has been repeatedly defeated. Why capitulate now?
A trade journal reports that some in the supplement industry are apparently considering supporting a Durbin-style proposal for a supplement pre-market notification system. It was reportedly discussed at a recent trade meeting.
What is the explanation? One that we have heard is that some supplement companies are seeking to placate industry critics such as New York Attorney General Eric Schneiderman. We previously reported on his seriously flawed (and failed) investigation into some herbal supplement manufacturers. Another possible and even more sinister explanation is that some larger producers are trying to shut out smaller producers who have fewer resources.
Whether the motivation is fear or crony capitalist greed, the supplement industry had better be careful. Once the pre-notification genie is out of the bottle, supplement opponents like Sen. Dick Durbin (D-IL) will likely keep pushing and pushing until supplements are treated identically to drugs, even though drug companies have patents to help pay the billions of dollars often necessary for FDA approval and can charge as much as $100,000 for a single drug treatment. Few supplement companies have billions to spend on one approval, let alone one for each of their supplements. And the market will never support the sort of supplement prices that prescription drugs command.
In passing the landmark Dietary Supplement Health and Education Act of 1994 (DSHEA), which regulates supplements, Congress said that supplements should be regulated like food, not drugs. As we’ve reported numerous times, this regulatory framework works just fine and supplements have an exemplary track record of safety.
All of this is even more important in the light of what is happening on Capitol Hill. Last week, we reported that natural health activists successfully defeated Durbin’s most recent supplement attack, a sneak provision in the Defense bill. But we also warned that Durbin reportedly plans to reintroduce his Dietary Supplement Labeling Act as a standalone bill.
In all of its previous introductions, Durbin’s bill has had two sections. The first sets up a pre-market registration system that would require supplement manufacturers to submit a description of each supplement they produce, a list of all ingredients, and a copy of the label. The second section calls for the creation of a list, with the help of the Institute of Medicine, of supplement ingredients that could cause “potentially serious adverse events.” This section also calls for warning labels on products containing what the government determines to be dangerous ingredients.
You will note that current regulation already ensures that unsafe products either don’t make it to market or are removed from the shelves—provided the FDA does its job and enforces the rules properly. From a consumer safety standpoint, the second section does nothing that isn’t already accomplished under current law—except make it more difficult and costly to produce supplements.
On the other hand, the Durbin bill goes far beyond what current law provides, because it wouldn’t simply remove unsafe products. It would forever brand all products containing any ingredients that they believe—with no proof whatsoever—COULD POTENTIALLY cause adverse events.” Not deaths. Not actual harm. Not even a serious adverse event. The ingredient could potentially cause an adverse event, which is defined as “any undesirable experience associated with its use.” That is a very low threshold indeed.
Let’s hope some supplement companies don’t inadvertently throw away the many successes we have had in holding Sen. Durbin’s legislation at bay.