01.01.06
Each month Nutraceuticals World will provide coverage of significant interviews we conducted for a particular issue that will take you beyond our articles and into the minds of industry leaders. You will find these insights in a new section we call INTERVIEWS.
For the January/February issue, Nutraceuticals World conducted an in-depth interview with Dan Murray, associate director of nutrition, Lonza, Allendale, NJ, about qualified health claims. See what he had to say about the issues, potential solutions and opportunities.
For the January/February issue, Nutraceuticals World conducted an in-depth interview with Dan Murray, associate director of nutrition, Lonza, Allendale, NJ, about qualified health claims. See what he had to say about the issues, potential solutions and opportunities.
What is your opinion of the qualified health claims system?
I think we need this plan. However, I also think FDA was forced into accepting and creating a qualified health claims system it was not prepared to handle. FDA does not have the time to nurture this system and it does not have the resources to deal with the various areas.
Are companies taking the most appropriate steps in filing qualified claims?
So far, I have been disappointed with some of the claims that people have been seeking and the evidence they have offered in support of those claims. I believe a lot of companies are asking for far more than they can substantiate. This industry has to recognize that FDA is not going to accept animal data for human risk reduction or human data on treatment to substantiate a human risk reduction claim. Most companies have a model of risk reduction and prevention in animals and treatment in humans, if they’re lucky. And we are able to go to market with this, but apart from third party literature the only thing we can do currently is make structure/function claims. The fundamental flaw in many of the applications going before FDA: companies are presenting prevention, treatment and risk reduction data in animals and then treatment data in humans. The problem is, what these petitions are ultimately asking for is prevention and risk reduction claims for a healthy human population. The government has a case in point when it takes issue with the fact that a lot of the petitions demonstrate risk reduction in animals and treatment in humans, but they often do not demonstrate risk reduction in healthy populations for the conditions they are going after.
Proving risk reduction in a healthy population can be a very tall order for a nutraceutical company. So what is the solution?
Companies will need to conduct very large, very expensive long-term studies, which is not realistic from a monetary standpoint for dietary supplement companies. So the question becomes who would be responsible for these studies? I think the burden has to fall on the shoulders of ingredient suppliers because they serve both the supplement and food industries. I think under certain circumstances there can be a coordination of efforts for ingredients segments like niacin, for example. This worked pretty well for the omega 3 segment.
Are there any challenges to creating a unified front for a particular ingredient?
The problem is that if you have two or three companies get together to pay for the research on an ingredient that has reached commodity status, will it be that everyone reaps the benefits? Are you positioned well enough to take advantage of that claim if you get it? These are some things to think about. That said, I could certainly foresee various companies banding together to support research studies for the good of one ingredient. I think that needs to happen in order to produce better data.
What else is FDA looking for?
One of the big things FDA wants to see is a biomarker. If you can demonstrate that a particular ingredient has an effect on a biomarker associated with a specific disease condition, you don’t necessarily have to affect a disease in someone in order to show risk reduction. Unfortunately, while some companies are able to hone in on a biomarker, others may not be as lucky.
How can the industry and FDA overcome some the hurdles presented by qualified health claims?
Companies seeking qualified claims have felt the only course of action they can take is in the area of risk reduction because they are trying to avoid prevention, treatment, cure and mitigation of diseases. In reality, it seems that risk reduction is becoming harder to prove than treatment or prevention. A possible resolution is for FDA to start accepting animal data. It could also lighten up on the treatment side. Suffice it to say that if FDA will not allow anything that remotely suggests treatment or cure, then we are not going to be very successful with these types of claims. In its present structure, the system is not necessarily designed to efficiently deliver truthful and non-misleading label information to the public.
