So tell me about
the Center for Dietary Supplements,
what kind of work do you do?
Well I'm responsible for ensuring the safety of
dietary supplements, responsible for monitoring
adverse events related to dietary supplements and
also ensuring that dietary supplements are
manufactured using good manufacturing practice.
Now, the FDA doesn't regulate dietary
supplements from the very beginning right?
That's correct.
There isn't a pre-market review of dietary
supplements.
Although all dietary supplements that are
marketed must be safe, the onus is on the
manufacturer to ensure that dietary supplements
are safe.
Now, if FDA does identify a problem, that is through
the literature or through adverse event reports,
then we can take action against those supplements
and we have done that several times.
So what's a dietary supplement?
Well, a dietary supplement is several things.
It can be a vitamin, mineral, an herb, a
botanical, a protein.
There are many, many forms of dietary supplements.
So since we don't monitor them pre-marketing, do you
ever sort of go into the dietary supplement store
and get some off the shelf and just do spot checks?
Well, not routinely.
Generally, when we go into sampling product, we have
an issue that we're looking for.
For instance, we did do a large sampling of vitamins
that are used by women of child-bearing age, and we
specifically were looking for lead levels, because
we're concerned about lead that would be consumed by
women during pregnancy.
Uh, adulteration and other things that you find in
adverse events, it's gotten a lot of publicity
recently.
Talk a little bit about what you've been doing and
how you're protecting the public, as best you can.
Well there are various forms of adulteration,
contamination of dietary supplements.
One area that we're quite concerned about is where a
drug is specifically added to a dietary supplement,
and then touted for its drug effects, even though
they label it as a dietary supplement.
For instance, they may add a drug to a weight loss
product that may be a diuretic, that might help
you lose weight very quickly, but in fact it's
a drug.
It might be a stimulant that's added, that also
helps you lose weight.
They are also male potency enhancement products that
could have specific drugs that are used for erectile
dysfunction.
All of those are unapproved drugs and
should not be in those dietary supplements.
So we do monitor for those kinds of adulterants.
The other concern we have is the use of steroids in
dietary supplements.
These are used primarily to enhance performance.
Some of these steroids are -- could possibly be
called dietary supplements, but most of
the ones we see we believe are really drugs.
And so, the consumer really has to be very
careful if they see that a product says it has a
steroid.
Our general advice is to avoid it.
So you also take a look at how these products are
marketed?
Yes.
Part of our review is to see what kind of claims
are made on the package.
So if a product is claiming to basically
affect the structure and function of the body,
without making specific treatment, that is disease
treatment claims, that would be considered an
appropriate type of claim.
But if it starts to go into the treatment of a
disease, that is it's saying you can take this
to prevent you from having H1N1, infection or protect
you from the common cold, that's not a structure
function claim.
You've now entered the drug arena.
And I guess what you do is controversial?
I would say so, yes.
We're controversial in that we have a lot of
products that are in the marketplace, and those
products make a broad range of claims.
You know, so it's -- it's always a changing market.
And the other thing that happens is the internet is
constantly advertising and manipulating claims so
that products that may be based purely on the
package seem to be no problem, could end up to
be sold on the Internet with a lot of claims that
are really not acceptable.
So we're having to monitor the whole Internet, the
international Internet for claims, and then we have
to look at the actual container, what does it
say on the container.
It's quite a challenge.
So what's the future look like
for this kind of regulation?
I guess it just becomes harder and harder as the
ways to advertise these drugs grows.
Well, I'm somewhat optimistic that we do have
some new regulations.
About two years ago, we implemented good
manufacturing regulations for dietary supplements
that we believe will assure the public that
what's on the label is actually what's in the
bottle.
And that's an important step forward.
Well, it's in the company's -- it's in the
industry's best interest to have good product and
not to have a problem, because as we've seen in
foods and some of the other things, a couple of
bad actors can spell real ill for an entire
industry.
Yes, and I think the industry realizes that.
And they have embraced the new GMPs and the adverse
event reporting act and I think everyone thinks that
this could improve the safety of the dietary
supplements and give the dietary supplement
industry a better name.
So you're a collaborator as well as a police person.
That's a good way to put it.
I guess you could say that I'm collaborating, then
I'm trying to help industry to improve the
image of dietary supplements.
Because people like them, and but also we have a
public health function and responsibility.
That's right.
You know, quite a few people take dietary
supplements, whether it's just a vitamin or mineral,
or it could be glucosamine; it could be
all kinds of other products that are sold.
A lot of people take them, so my job is to make sure
they're safe and when they pick up that bottle, it is
what it says it is, that simple.
So your job is to make it safe but not necessarily
efficacious.
Well, there's no review of efficacy by FDA.
That is not part of the act and so the efficacy
has to be assured by the company properly labeling
their product.
The company cannot make false statements, so if
they say a product can help you lose weight and
can help you lose 10 pounds over the next two
weeks, we feel that they have to have studies in
their files that can support that.
And if they don't or if the FTC sees advertising
that's not supported, then those claims have to be
removed from the product.
We've seen that most recently with H1N1, with
all the fraud and the stuff on the Internet and
those kinds of things.
Yes, that's a very good example.
Thank you.