Given the amount of indigestion Senator Richard Durbin’s letter-writing and investigating has caused the dietary supplement industry over the last two years, his actual introduction of The Dietary Supplement Labeling Act of 2013 (DSLA) was underwhelming. In fact, when Senator Durbin reintroduced his bill on August 1, along with Senator Richard Blumenthal, there was little fanfare in Congress: no new co-sponsors; no companion legislation in the House of Representatives; and little likelihood that it would receive attention by the appropriate Senate committee.
 
In fact, the greatest concern for the dietary supplement industry is not the full bill, but the possibility that Senator Durbin will take one provision, like the product label registration requirement, and offer it as an amendment to a larger legislative vehicle—similar to what he did last May during the reauthorization of the drug user fee legislation. We’re prepared to counter that tactic, should it occur.
 
The DSLA remains virtually identical to the version introduced in the last Congress, with some small additions. As before, it would require dietary supplement manufacturers to register all product labels with the Food and Drug Administration (FDA). It would require FDA to develop a list of dietary ingredients, and would task the Institute of Medicine (IOM) to review that list and recommend warnings if it is determined that an ingredient could cause potential serious adverse events. FDA would be instructed to develop mandatory label warnings for those products. FDA would also be tasked with issuing a guidance to define the differences between conventional food and dietary supplements. Lastly, a new provision to this year’s bill would require manufacturers to provide substantiation for their structure/function claims to FDA. 
 
The fact is the bill’s requirements are unnecessary. The Food Safety Modernization Act (FSMA) already requires manufacturers to register their facilities with FDA. The agency already has the authority to require warning labels on products if there are safety concerns. Remember that DSHEA makes it illegal to market a dietary supplement if it presents significant health risks under the conditions of use suggested in its labeling; that would include the absence of warnings if they are necessary for safe use of the product. And the agency already has the authority to review the supporting data for structure/function claims when inspecting a facility. Further, FDA is already working on a guidance to clarify the differences between beverages and dietary supplements.
 
So what is Senator Durbin trying to accomplish? The bill would not give FDA additional authority to address egregious actors, but instead would place additional burdens on responsible industry. In short, it doesn’t solve the most relevant and real concerns faced by the dietary supplement industry and our consumers—but it makes it more costly for legitimate manufacturers to do business. 
 
It is doubtful that Senator Durbin’s bill will move in this Congress, and I am confident we would defeat another attempt to offer an amendment to some other bill. However, until FDA weeds out those companies that are misbranding illegal drugs as dietary supplements, until it tackles firms that are making outrageous unsupported claims, and until the whole of industry takes the GMP requirements seriously, Senator Durbin will continue to introduce bills. As one of the more than 150 million Americans who take dietary supplements every year, Senator Durbin, despite what some in the industry may think, is seeking the same thing we are: an industry that manufactures and markets products that have a rightful place in healthy living. Now if only we could all agree on how to best achieve that goal.   
 
Mike Greene is the vice president, Government Relations, for the Council for Responsible Nutrition, the leading trade association for the dietary supplement industry.
 
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The ideas and opinions expressed in this article are those of the author and do not necessarily reflect views held by Nutraceuticals World.