Two weeks ago, Sen. Dick Durbin (D-Ill) introduced the Dietary Supplement Labeling Act, much to the dietary supplement industry's dismay. The bill would require the U.S. Food and Drug Administration (FDA) to establish a definition for "conventional foods," increase warning language on supplement labels and require manufacturers to register dietary supplements with FDA.
As Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), sees it, FDA already has enough power—it just needs to use it. Mister revealed his thoughts about the bill's potential impact and its likelihood of passing in a recent conversation with NewHope360.
NewHope360: What are some of the requirements of the Dietary Supplement Labeling Act that already exist under the current law? Why do you think there are duplications? Is Congress not talking closely enough with FDA?
Steve Mister: That's exactly what we wonder. There's a provision in the bill that requires FDA to come up with a definition of a "conventional food." FDA has always had that ability to come up with definitions. They have been invited to do that on any number of occasions, including [by] the GAO report from about 10 years ago. In fact, FDA has issued guidance documents for beverages along that same line, making the distinction between a conventional food that's a beverage and a dietary supplement that's in liquid form. So we don't need a bill to tell FDA to come up with the definition.
The second thing is the batch number requirement. As a practical matter, companies already have batch numbers on their products because the GMP regulations require what's called a "unique identifier" on the label. So FDA doesn't use the word "batch number" as a requirement, but the only way you're going to satisfy that in a large company is to have batch numbers or lot numbers on those product because of the requirement for a unique identifier.
With respect to the warning label provision, that would give IOM [Institute of Medicine] the ability to develop warning labels, but the statute already gives FDA the authority to require a warning label on a particular product if there's a need for it.
What this bill does is it directs IOM to across the board start developing warning labels for all of our products. Our position is, if there is an issue that arises… FDA has two different methods in the statute that it could require warnings on those products. We don't need to create a process where the Institute of Medicine starts going through the encyclopedia of ingredients and trying to develop warning labels for all of them.
NewHope360: What are the potential implications for industry in the event this bill passes?
SM: If you had to point to one thing in the bill that you think is the most ominous, it's the potential for IOM and FDA to get together and require warning labels on products. Also, I'm concerned that the requirements in the bill on the registration piece are very burdensome.
NewHope360: Is this bill likely to pass?
SM: I want to be cautious because I don't want people to let their guard down. We should not be dismissive. At the same time I don't see a real strong appetite in Congress to do something like this right now. This is bound to impose more cost on the system and to tax FDA's resources even more. Congress is looking to reduce spending to the agency, not to give it more work to do that costs more money.
NewHope360: What can manufacturers and suppliers do now to oppose the bill?
SM: Let members of Congress know you oppose this bill. The one thing I would say is you need to understand what you're going to say to your member of Congress. I would caution that at every turn if we say, "This bill is going to take supplements out of my medicine cabinet," that we could lose our credibility if we cry wolf too often. That's why we at CRN make such an effort to really understand what is in the legislation and what the implications of it are.
Members of Congress are getting ready to come home for a month for August recess. While they're home is a great opportunity to attend a town hall meeting or to visit the district office. If you have a manufacturing facility, invite the member of Congress to come take a quick tour to see what actually goes on in a dietary supplement plant, how these products are made and see what GMP looks like. At the end of the day, it's those kinds of things that convinces them that there are votes at stake, that the economic health of the district is at stake and that supplements really make a difference in their constituents.