Steve Mister is president and CEO of the Council for Responsible Nutrition (CRN), an industry trade association and advocacy group. NBJ spoke to Mr. Mister from his Washington, DC offices about the regulatory outlook for supplement companies and future areas of interest for the council.

NBJ: We recently heard from a source that Dr. Sharfstein of FDA cited 30 failures among the first 90 companies audited under the new GMPs. What are you hearing about compliance?

Steve Mister: The number is concerning, but I don't think we should overreact to it. Dr. Sharfstein also said you should expect, even in more established sets of regulations like they have in pharmaceuticals and food, as much as 20% of your inspections to surface compliance issues. I do think this sends us a signal. We need to redouble our efforts. Companies who may not have given GMPs as much attention as they should have, those companies should get those regulations out again, read through them and make sure they're ready for those inspectors when they come. Trade associations such as CRN, we have certainly done a number of webinars, in-person seminars, written materials, all kinds of things to educate the industry and help our companies comply. We can't make them comply. That's up to them.

NBJ: What's causing these companies to ignore their regulatory responsibilities?

SM: It could be that some of the regulations need further explanation. We still haven't gotten small business guidance from FDA. It would be helpful to tell smaller companies some of the specific things they need to do to comply. FDA has not been very clear in what constitutes adequate vendor qualifications. They've said we have to do it, but they haven't really told us what that means. So I think there are areas where it's a learning process for industry and FDA. We have to figure out what some of these very broad terms mean in practice.

NBJ: Do you have any sense of why those 30 audits failed?

SM: The reasons for the 483s — the forms that record the specific exceptions — are all over the map. There are some trendareas. For instance, failure to do adequate audit of your upstream suppliers. The regulations are pretty clear that you cannot accept a certificate of analysis at face value anymore. You need to do something to qualify that vendor and make sure your supplier is supplying a quality ingredient.

Likewise, you have to do 100% identity testing on every lot that comes through your doors. Several of the 483s talk about failure to do adequate identity testing. And when you start to think about it, that's not a lot to ask of the industry. If you're putting something out there for the consumer and you're telling them that it's vitamin D, you should test every drum that comes into your plant to make sure it's vitamin D. Some of these things are very basic, and what I would say to the industry is this: Do you really want your consumer to have to take this on faith, or do you want to say to your consumer with confidence that your company has taken adequate steps to assure a quality product. That's what the GMPs are all about.

NBJ: Is it accurate to infer that these were larger companies failing these audits, given the timeline of GMP implementation?

SM: Some were large and some were medium, so companies with more than 20 employees. What does concern me is the potentiality that smaller companies might not be as on the ball as the larger companies subjected to these early audits. Smaller companies got three years to get ready for this, but I'm not sure if they've taken the process seriously enough. So we'll have to see what happens when FDA gets to the small companies, which I think will start to happen this winter.

NBJ: What do you see as FDA's top priorities right now?

SM: The number one priority for the agency is product contamination with prescription-drug ingredients. There are a lot of products out there calling themselves supplements that are not. Dr. Sharfstein talked to us about this at our conference, and I've had conversations with him since then. If you asked Dr. Sharfstein what keeps him up at night, this is it. Everybody knows prescription drugs have side effects, interactions, all kinds of precautions. When you put a product into the market, and you put a prescription drug in it without telling the consumer, you are very clearly creating a potential health hazard. It's just waiting to happen. Sports, sexual enhancements and weight loss are the primary areas for this issue.

NBJ: Have you heard anything new about NDIs?

SM: Not a word. That's one of our priorities for FDA, but I don't know if it's FDA's priority for FDA. We think it's very important that we get some guidance early in 2011. I think FDA is concerned, and rightly so, about how to best describe what constitutes a new dietary ingredient. They could end up including ingredients that have been on the market since 1994. If we get this wrong, all those ingredients would suddenly be considered new.

What FDA has said previously is that, in order to prove that you're grandfathered, you have to be able to provide some sort of a catalogue, an invoice, customer marketing materials, something that demonstrates you actually sold that ingredient prior to '94. And that's going to be very difficult for the industry. People don't have those records at hand — they're 16 years old. If you think about it, 1994 was just before companies really converted to computer. So, to the extent that they even have old sales records, catalogues, invoices, bills of lading, we're probably talking about microfiche.

NBJ: How would you solve the NDI problem?

SM: I wrote a blog a couple of months ago suggesting that one way to address the problem is this: When FDA comes out with the new dietary ingredient definitions, they should simultaneously move up the grandfather date to 2007. Since we adopted adverse event reporting (AER) three years ago, presumably, if you have an ingredient that's causing safety questions, FDA should have three years of AERs to study. And if you don't have any AERs linked to an ingredient, there's a very good chance that it doesn't have safety issues surrounding it. That's not an official position of CRN — this was just something I wrote and put on CRN's blog to try to generate some conversation around this issue. You want to engage FDA, not appear to be telling them what to do. The idea is to engage FDA on ideas where we think we can be of benefit, nudging the ball forward.

NBJ: How would you grade CRN's performance in 2010?

SM: I am obviously biased, but I think we have done an incredible job for the budget that we have. CRN has been active on multiple fronts, tackling some tough issues. It started with the McCain legislation back in February. We orchestrated some high level meetings with McCain's staff to get them to understand the bill and what they we're really doing to the industry. Certainly the May hearing, where I testified in front of the Senate Aging Committee, was another moment where we really demonstrated to Congress that the majority of the industry is serious about producing quality products and making responsible claims. I think we did a pretty good job distancing that majority of industry from the bad actors in those GAO reports.

I also think the work we've done with the media all year long is having an effect. We can't stop the negative stories, but we're certainly putting more balance into them. The Life…supplemented campaign — that's our proactive consumer outreach platform — is really starting to connect. We've seen the increase in consumer impressions and hits to the website go up geometrically. I'd also mention CRN International, which launched this year and allows us to spread our wings more globally with a stronger presence in Europe and Asia.

NBJ: What else would you like to be doing that current budget levels won't allow?

SM: I would like to redo our website so that we keep up with both the technology and the look and feel that consumers expect. The touch that consumers have with Internet sites is changing. Hopefully we can revisit that in 2011.

The other area where I wish we were more involved is creating dialogue between industry, healthcare professionals, and insurance companies. The insurance companies understand — Obamacare or not — that they have to change consumer behavior to keep people healthy. Everyone sees their healthcare costs going up and up, and if they're ever going to keep these costs in line — and be able to make a profit in the future — insurers have to understand that they need to keep insurees healthy in the first place. So I wish we, as an industry, were doing more to talk to insurance companies, healthcare practitioners, nurse practitioners on the front lines of healthcare, pharmacists, dieticians. We've done the research with Life…supplemented that tells us there ‘s an openness to our products. The more consumers know, the more comfortable they feel with supplements. But that kind of effort takes dollars. Our budget is a little over $4 million, which might sound like a lot of money — it's not. Not for a trade association in an industry as big as ours.

NBJ: How would you grade the supplement industry's performance in 2010?

SM: Well, I am knocking on wood as I say this. I think the industry has done a good job. Every year, I think the industry continues to elevate its stature, its hold on consumer confidence. We have not had the kinds of crises that even the traditional food products had this year: Look at eggs, spinach. Collectively, the industry seems to be policing itself. Now, we can do better, absolutely, but I do think the industry should pat itself on the back. We do consumer confidence surveys every year, and every year it crawls a little higher. You also look at product sales and the fact that, throughout the recession, sales for supplements were still up. That says consumers believe in our products. Again, the industry should pat itself on the back. We are doing something right.

What's in Your Medicine Cabinet?

NBJ: Do you personally take any dietary supplements?

Steve Mister: I take a whole handful every day. Ready? I take a multi, I take a C, I take a D, I take an E, I take omega-3s, I take a joint product with glucosamine and chondroitin, I take a lutein, and I take an EpiCor. You know those daily pill containers? I had to get two for all the supplements that travel with me now.

And I don't want to neglect probiotics. I don't take a probiotic supplement, but I do eat a lot of probiotic yogurt. I feel like I get my active cultures that way.