Overview, Use of Dietary Supplements & Regulation – DNI/DSI Webcast Part 1

Transcript - Part 1

Overview, Use of Dietary Supplements, and Regulation

Dr. Bonakdar: I really appreciate all the attendees here joining us for this very important talk, and it's a pleasure for me to be presenting on this topic, which is one very near and dear to me.

As you look over the faculty disclosures, I just want to add my thanks also to Nature Made for their financial support. We as family physicians are dealing at an increasing rate nearly every day with questions and scenarios, which involve vitamins, minerals, supplements, nutrients. So this webinar could not be more pertinent and again would not be possible without their support.

So, let's go ahead and get started with the learning objectives for this presentation. At the end of this presentation, I hope that you will be able to better counsel patients about possible shortfalls when combing nutrients and certain drugs. We'll be able to counsel patients about the risk of combining certain drugs and supplements, and recall and use the AAFP applet tool which identifies interactions between nutrients and supplements, which we'll be talking about during our presentation.

I also want to give you an overview of what we will be discussing. As far as backgrounds and trends, I would like to discuss dietary supplement use, as well as medication and dietary supplement concomitant use, the potential for nutrient depletion interaction, as well as the level of discussion we have with our patients about this topic.

Secondly, I'd like to discuss the importance of preparing to counsel patients on this topic and looking at specific areas including the environment of counseling, having a framework, and having resources for doing that counseling.

As far as our introduction, I think it's important to talk about what is a dietary supplement because this can be a confusing topic. I've referenced the official definition here from the FDA website, but to give you a quick summary, "A dietary supplement is any ingested dietary ingredient intended to further nutrition value or to supplement the diet," thus the name. Examples of this could be a vitamin, a mineral, an herbal or botanical, or an amino acid, as examples.

We also know that the definition can mean supplementing the diet by increasing the total dietary intake with things like protein. It can be a concentrate or an extract that’s used, such as fish oil concentrate. And there's many formulations: capsules, tablets, liquids, and powder so it's important to really ask broadly when we do ask about this as we'll come back to.

Dietary supplements, the definition also says, "Can help insure adequate dietary intake of essential nutrients and may also help reduce the risk of disease in certain scenarios."

I think it's important to also know a little bit about use and expenditure in this area. Research, as far as overall use, ranges very widely based on how the question is asked, anywhere from 20 to 80%. However, when that is summarized, we can roughly say that at least half of our patients are using supplements, and as they age, probably 70% or more are utilizing it. In certain ethnic groups, this amount actually is much higher.

We know also that over $30 billion is spent per year on dietary supplements, which is quite significant as far as an out-of-pocket expenditure, and at least 50,000 dietary supplement formulations are available on the market with some estimates going all the way up to over 80,000.

As far as sales trends, I think it's important to keep this in mind, most of the top 10 or 20 dietary supplements tend to do the same year to year. However, there are some that go much higher, much lower. Two examples here, over the last decade or so, include fish oil and probiotics, which have increased quite a bit. That's probably equivalent to us in the clinic hearing more about these.

As far as demographics of the dietary supplement utilizer, I think a few important points to keep in mind. One, they're typically more highly educated. That is typically in the literature equated to folks who do more self-choosing, self-management of health care issues. Supplements fall underneath that.

As far as the health state, there's quite a continuum. On the one side, you have folks that are typically more physically active, more fit, lower BMI, who are doing this as a preventive or a wellness strategy. There's folks in the other continuum that the literature shows that may have end-stage diseases, chronic issues like cancer or end stage conditions where they're looking for an additive supplement to potentially help with part of symptom management.

As far as conditions that are most commonly utilized in the scenario of supplements, pain is one of the most common by far, and we'll go through some of the other examples later on. Women are much more likely to use supplements and folks in certain ethnic groups tend to utilize based on that background.

Regulation is also something to review briefly because there's a lot of confusion here. These are not regulated the same as prescription medication. The FDA does not regulate them if they are pre-approved dietary supplements already on the market. Your glucosamines, your fish oil, something that's already pre-existing does need to get pre-approval before it lands on the shelf. However, dietary supplements are under the umbrella of foods, and do need to follow regulations that are based on food safety and food quality.

Before a supplement can be marketed, the manufacturing firm is responsible for ensuring that the products are safe, compliant in their claims, so it cannot say anything about preventing, treating, or curing a disease. If they do, that's against the DSHEA, the Dietary Supplement Health and Education Act, and they need to be compliant with other currently standing federal acts in the area of food and supplement.

It is also true that the FDA can act both on ingredients that are being brought into the United States, as well as finished products that you might see on the shelf. So the FDA can confirm that the dietary supplement does meet GMP [good manufacturing practice] in number of ways, in their claims, as we've talked about, in the cleanliness, and appropriateness of their facility. They can also make sure that the final product or the in-process, pre-final product are also meeting specifications. And if those are not in order, they can enact recalls as we have seen in the past.