Ask Dr. Mike: How Can You Determine the Validity of a Product Label?

Additional Info

• Segment Number: 5
• Audio File: healthy_talk/1510ht1e.mp3
• Organization: Life Extension
• Guest Website: Healthy Talk MD
• Transcription: RadioMD Presents: Healthy Talk | Original Air Date: March 3, 2015
  Host: Michael Smith, MD
  
  RadioMD. It's time to Ask Dr. Mike. Do you have a question about your health? Dr. Mike can answer your questions. Just email: AskDrMikeSmith@RadioMD.com or call now: 877-711-5211. The lines are open.
  
  Okay. So, I had two questions come in. One was about how can you determine if what you're reading on a label is true and then how do you really know what you're taking is safe.
  
  So, let's take the question about product claims first. The actual question is: "How can I, as the consumer, determine the validity of product claims?"
  
  Okay. So, the first thing I want to address with this. We're talking about supplement products, I assume, right? Okay. So, you're questioning or wondering how you can really determine if what you're reading on a label, probably, as you're in the grocery store or the health food store and you're buying a product and it says, "improves cardiovascular health", right? Or, aids in digestion", "improves memory and recall", "improves muscle strength", or whatever. Right? Those are the kind of claims that you would see. How do you know those are valid claims? Okay. Well, there are a couple of ways to answer this.
  
  The first thing to understand is that there are what are known as structure function claims that we can make about certain ingredients and it's dictated by the FDA.
  Now, what is a structure function claim? It's not a claim of treatment or cure. Instead, it's a claim where, based on the research...Let me use pomegranate as an example because I love pomegranate. There are tons of pomegranate studies, especially ones focused on cardiovascular health, okay?
  
  There are some showing pomegranate can...Now, I'm not talking about a pomegranate labeled product. I'm just talking about the ingredient pomegranate for a moment, right? Pomegranate has these antioxidants in it. Those antioxidants, when you concentrate them in a capsule form, have been studied and shown to lower blood pressure. That's a treatment claim. But, I'm not talking about a product. I'm talking about the ingredient of pomegranate. So, there are studies--peer-reviewed publications; clinical studies--showing that pomegranate can lower blood pressure; can lower cholesterol; can improve what is known as arterial elasticity so there's less chance of arterial plaque build-up. I mean, that's all been studied and those are all conclusions from human clinical trials with pomegranate.
  
  But, here's the problem: if I manufacture a pomegranate product, let's say I look at all those great studies and I'm like, "Well, that's awesome. I would like to sell pomegranate to people." Well, I can't make a product, label it "Dr. Mike's Pomegranate" and put on that label "lowers blood pressure". I can't do that. "Lowers cholesterol", "improves arterial elasticity". I can't say that because the pomegranate that I have put in that product that I've labeled "Dr. Mike's Pomegranate" wasn't the pomegranate that was tested, mostly likely. I could try to get that pomegranate, but even if I do, I still can't make those claims because my bottle, "Dr. Mike's Pomegranate"—that bottle, those capsules in that bottle—were not studied so I can't make those treatment claims. But, the FDA will allow me to make a structure function claim which says something along the lines of "Dr. Mike's Pomegranate supports a healthy heart", "supports health cholesterol already in normal range", "supports the health of the endothelial cell lining of the artery".
  
  You see? Those are structure function claims that the FDA allows me to make because pomegranate—not my pomegranate in that bottle, but pomegranate in general—has been show in human clinical trials to lower blood pressure; lower cholesterol. So, I can take that information, make a Dr. Mike's pomegranate product and say it's good for your heart. That's a structure function claim.
  
  So, the very first thing you need to understand is when you read a claim like that on a bottle, it's a structure function claim. It should be and you can go to the FDA.gov/food webpage and they list all of these allowed structure function claims for nutrients. So, Dr. Mike's Pomegranate says it's good for the heart. How do you know it's good for the heart? Because the FDA allows me to say pomegranate is good for the heart based on all these other peer-reviewed publications that showed the benefit.
  
  Maybe my particular pomegranate wasn't the thing that was tested in those studies, but based on the pomegranate research; based on the conclusions drawn from that research, the FDA says, "Dr. Mike, you can make a pomegranate product and you can say it supports a healthy heart." So, if I put that on the label, I'm getting that straight from the FDA which comes from the research on pomegranates. So, in a sense you can trust that because the FDA—the government institution that oversees all of this—has said, "Yes, you can make that claim about pomegranate." So, that's important to understand that as a supplement company, Dr. Mike's Pomegranate—I'm not just making that up.
  
  I'm not just creating a product, popping on this label and saying, "Pomegranate's good for the heart." That has to be backed up to some degree. Even though my product wasn't specifically tested, it's backed up by all that other pomegranate research.
  
  And, there's a law called "DESHEA". It started in 1994. It allows supplement companies to make these types of structure function claims with the nutrients in their product based on all that other research out there. You can see it all at FDA.gov/food. Okay. I want to just talk about that because I think there's some confusion. I think some people think that supplement companies have no regulation whatsoever--that they can just plop whatever they want on a label. That is not true. If you're going to make a structure function claim about pomegranate and a heathy heart, it has to be accepted by the FDA and supported by research so that I can make that structure function claim.
  
  Now, does that mean that there isn't an immoral, unethical supplement company out there at times that pops up? These fly-by-night companies that want to take advantage of the pomegranate market and they do something online, right? And they sell the pomegranate and they make some treatment claims about it? "Oh, our pomegranate actually does lower cholesterol. It's not just about a healthy..." Yes. You're going to find that sometimes and those companies need to be found and prosecuted because they're breaking the law, but there are good, solid supplement companies that have been around for a long time like Life Extension where I'm the senior scientist. In my book, I list about 12 companies that I love to use. These are companies that do it the right way and they make appropriate claims—structure function claims—that we're allowed to make based on research. That's the oversight. So, that's one thing.
  
  Now, when you're looking at a claim on a label, you have to understand that that is supported by research. I wouldn't be allowed to make that claim if it wasn't. Dr. Mike's Pomegranate would just simply say, "Dr. Mike's Pomegranate" if I couldn't make that claim based on the research. That's the first thing. So, I think really what the question might be, and a more important question would be, "How do I know then, that Dr. Mike's pomegranate really has the right amount of pomegranate in it to make that claim?"
  
  I think that's a better question. How do I know that Dr. Mike's Pomegranate has pomegranate in it, number one; and it has the right amount?" Well, Dr. Mike's Pomegranate, because I am serious about quality, I produce what is called a "Certificate of Analysis" and all the big companies do this. It is a document, called Certificate of Analysis". That is proof of what is in that label. Ask the company for it. They will share it with you. That's how you confirm the validity of a product claim. The C of A—Certificate of Analysis.
  
  This is Healthy Talk on RadioMD. I'm Dr. Mike. Stay well.
• Length (mins): 10
• Waiver Received: No
• Internal Notes: NO GUEST
• Host: Mike Smith, MD