Dietary Supplement Practicum 2018: Meeting the Stakeholders—A Conversation with the Industry


>>Paul Coates:
–our colleagues in the dietary
supplement industry and in the, sort of,
we use the term, watchdogs, but it’s really intended
to be a people who have a very different, but overlapping,
role in this space. And that’s commenting
on currents in dietary — in the dietary
supplement space. This session has been going on
for the entire time that we’ve held
this practicum. The folks who come
to talk with us do this because they’re good people.
We don’t tell them what to say. We don’t care to tell them
what to say. What we’re asking them to do is to represent
their perspective about dietary supplements, and then to engage
in discussion with you. So, that’s where
you come in. There will be plenty
of opportunity for you to ask questions of
our colleagues in three places. We’ll have a discussion
that will come coincident with presentations
from three industry colleagues. Then we’ll have discussion
following presentations by three watchdog colleagues. And then all six of them
will join me at the front here to engage
in further conversation, which might be
between them. It might be you asking
a different set of questions now that you see people who have
very different points of view. I encourage you to do this. We’ve left a fair bit of time
for you to be able to engage in
conversation with these folks, and you won’t — you might
not get another chance. So, you’re forewarned. So, we’re going to start
with presentations from three of our
industry colleagues. I’ll just list them in order. They’ve flipped from
the order in your agenda. Douglas Duffy MacKay
from the Council for Responsible Nutrition
will start. And he’ll talk
for about 15 minutes. Then, Laura Harkness
from Church & Dwight will talk for 15.
And then Merle Zimmerman from the American Herbal
Products Association will also talk for 15 minutes,
or up to 15 minutes. If they leave you time for
individual questions at the end, I’ll keep them to 15. But then you’ll have a chance
to talk with them for another 15 minutes
or so as a group. So, may I start now
with Duffy MacKay, who represents the Council
for Responsible Nutrition, and he’ll tell you what role
you have in all of this.>>Douglas MacKay: Thank you,
Paul.>>Paul Coates: Thanks a lot. [applause]>>Douglas MacKay: So,
thank you guys, all, for your time and attention. It’s really a great pleasure
to be here. I’m Duffy MacKay.
I’m the Senior Vice President for Scientific
and Regulatory Affairs at the Council
for Responsible Nutrition. My goal here is to give you
a 15-minute overview of who CRN is,
and why we might be important. I’d like to think I have more
than 15 minutes of material on the importance side, but I’m going to cram it
all together. But, I — you know,
I came with somewhat of a cookie-cutter presentation, but as I sat here and listened
for the last day and a half, you know, I could hear
in the questions there’s a lot of disconnect
between parts of what you guys have heard and, sort of,
looking at the big picture. You know, we’ve heard
the extremes of spiked products and illegal ingredients
in products, which is clearly a threat
to public health. And then, on the other side, we have companies making
high quality products with lots of science going into
it, and everything in between. So, I’m going to try to connect
some of those dots and answer
some of the questions. That’s why I brought some notes.
So, essentially, CRN is an industry-based
trade association. So, for those
who aren’t familiar, many industries here
in Washington, D.C., we have a collective voice. So, when NIH or FDA
has questions for the industry, they don’t often prefer
to go to one company. They go to a collection
of companies in a trade association. And, our organization’s
mission is here. And it’s essentially
to enhance an environment so that they can do business. But that — that comes
with a great responsibility, because if we’re in an industry
that has illegal actors that are spiking products
with ingredients that people don’t know
that cause liver failure, we have a great responsibility when you have
the white-hat companies making multivitamins
and fish oil and whey protein, and these basic products that
have been around a long time. We have to
put our resources — join forces
with other stakeholders and make sure that
we maintain consumer trust. So, that’s really what our
mission as an organization is. Just a little bit of nuts
and bolts. We have 20 staff here
in Washington, D.C. We have about 120 members
of our organization. And this includes branded,
finished products that you see
at the store shelves, but also includes
the ingredient suppliers, the global suppliers
of vitamin B, and C, and fish oil. And so, you know,
there’s a lot of issues that we encounter with a lot of
different regulatory agencies. We also have all
of our associate members, the law firms,
the testing labs, the consultants,
the research organizations. And I will mention,
I’m hearing a lot of, sort of, skepticism
about the industry and some cautionary tales
in what we’re hearing. And, frankly,
this is an industry that does a lot of good science
and, frankly, hires a lot of Ph.D scientists,
toxicologists, nutritionists. So, you know, there is
potential future careers, especially if we can maintain
and grow the trusted and responsible side
of this industry. So, here is some of our members. You can recognize brands,
you know, the big ones: Centrum, you know,
Flintstone vitamins, it’s been around a long time. You know, these are tried
and true, trusted brands. We cover every different segment
of the market. We’re in the grocery store.
We’re in the pharmacy. There’s direct to consumer
models, as well as companies that sell directly
to health care providers. So, you probably recognize
some of these names. And I will mention, we have a lot of pharmaceutical
companies in this business applying their quality
control principles. We have the likes of Pfizer. We have the likes
of Proctor & Gamble. So, when you think about
the dietary supplement industry, do not segregate it
because we overlap, and we’re involved with
a lot of different entities that have reputations to protect
and brands to protect. So, a lot of energy goes into
integrity and product quality. So, I’d like to put up
this slide because we have
heard conversations that, sort of, span
this whole spectrum. And, I’d like to look at —
we have, sort of, this one side of our consumer
that uses these products, probably, for good reasons,
you know, fill nutrient gaps, get a little bit of energy,
add some fiber to my diet, maybe some CoQ10
because of my heart, there’s good evidence there. You know, people who
are looking at evidence, looking at integrity. We have products
like multis and fish oils. But, on the other side of that
equation, we have this shadow industry. And we like to call them
the bad actors. We have a problem. We have
to recognize this problem. The regulatory structure is not
a pre-market approval structure. And, so, there’s a lot
of responsibility that’s laid on
the manufacturer marketer. And there are
unscrupulous players taking advantage of this. And we’ve heard about a lot
of them in the space related to the military. This idea that you’ve got
military consumers that want to get bigger,
faster, stronger. And they’re gullible. They’re going to believe you
if you say, Take this product. It’ll make your muscles grow,
when, really, we know that the only thing
that’s going to do that may be a little
extra protein or steroids. And all of those products
that were just previously showed to you are illegal today,
illegal by today’s standards. The regulation says
those products with ostarine, SARMs, they’re illegal. The FDA says they’re illegal.
We say they’re illegal. In fact, one of our efforts
right now is my organization has introduced legislation to make it easier
for the DEA to schedule SARMs. We successfully did that
with anabolic steroids. We passed the Designer
Anabolic Steroid Control Act. And that gave DEA an easier time scheduling these
designer steroids. So, we’re trying to do
the same thing with SARMs. So, my CEO has, sort of,
coined this, The tale of two industries. We, literally,
have this one side of the industry aware
of the regulations, engaged with the agencies,
doing good science. And then we have a somewhat
of a shadow industry. And we are all working towards,
you know, maintaining the responsible
side of this. And what I’ve observed here is we’ve heard from all of these
different stakeholders that have different
perspectives. We’ve heard from FDA, FTC.
We’ve had questions about. Who are the third-party
certifiers? And what I realize is that
each one of these stakeholders has a slightly different view
of this industry. If you’re a regulator
and your job is to keep
350 million Americans safe, and you’re realizing, I don’t even know
what’s in all these products, that’s a hefty load. You’re going to be very
skeptical as a regulatory agent. But if you’re industry and your
perspective is to sell products, you’re going to feel
a lot more confident in the regulatory structure. But then we have people
like Paul here at the NIH where they’re just objective. They’re just here
to look at the science. They don’t — they’re a —
has been point, they’re agnostic to regulations
and they’re agnostic to sales. So, our perspectives feed into
a lot of the information that you’ve heard. So, our goal is so that
the entire industry, somewhere in the future, is willing
and able to behave responsibly, be compliant
with the regulations, ultimately to protect consumers
and maintain consumer trust. So, we prioritized
some of our efforts, and we have our top priority
being consumer safety. So, that’s one area.
So, the ingredient safety, how it’s made,
how things come to market. The next one
is product integrity. Is what is on the label
actually inside the bottle? And the third
is conveying accurate and meaningful information so that consumers
can make informed choices. So, not overstating claims, but providing good evidence
to consumers, health care providers,
dieticians. Now, what I realized
is these are the one in the same priorities
of most of the people that you’ll hear from today. It’s just that
their different perspectives allow them to see
it slightly different. So, while we prioritize consumer
safety, product integrity, and accurate information
to consumers, we also want to sell products.
FDA, same priorities. They want consumers safe,
product integrity, conveying accurate claims. But, their job
is to catch the bad actors. So, they just look at it
differently. So, you’ll see on the other
column, these are just
some of our activities, which I’m going to go through,
that you’ll see, by design, are tactics to fill one
of these objectives, whether it’s safety,
product integrity, or getting accurate messages
out. The first one is the dietary
supplement registry, we call the Supplement OWL,
or the Online Wellness Library. So, essentially, this was born
out of some legislation that was introduced in 2013 to
re-regulate dietary supplements. Now, remember, we have not
had a change in regulations since 1994. That was the core
change to the Food, Drug and Cosmetic Act
that regulates supplements. However, we have had additional
regulations overlaid on that. So, we have the
Food Safety Modernization Act, which changed
the responsibilities and the supply chain
for supplement manufacturers. We had the Designer
Anabolic Steroid Control Act. We had the Adverse Event
Reporting Law. So, even though DSHEA
was passed in 1994, we’ve had a variety of
incremental legislative changes that have changed the grading
environment for our companies. But, in 2013, there was
some legislation put forth by a strong critic of
the dietary supplement industry. Most of it was terrible,
and it had no chance of passing. However, there was one piece
in that legislation, that as the supplement CEOs
sat around the table, they said, You know, a product
registry kind of makes sense. You know, the fact that we don’t
have to register our products or ingredients with the agency,
FDA being the agency, is inconsistent with what
takes place around the globe. It would be only fair to give
FDA a direct line of sight into our products
and our ingredients, what we’re using,
how much we’re using. So, in the event
an ingredient like SARM or an ostarine pops up, the instant they decide
there’s a safety problem, they can connect the dots
to every single person and every single product
that is selling it. So, it makes sense. So, we wanted to answer
that question, Who are the companies
in the industry? What brands
are being marketed? What ingredients are
in the marketplace? And which products contain
which ingredients? This is what we came up —
this is what it looks like. You can go online right now
and look at the Supplement OWL. And when we started
on this project, we noticed right away,
of course, we have this stellar
Dietary Supplement Label Base put out by the Office
of Dietary Supplements. They had been doing it for a
good 10 years at that point. And we went to the Office
of Dietary Supplements, and we started a discussion
about our needs as an industry and our desires
to have a self-regulatory tool. And we quickly learned that
the dietary supplement label database had very set goals
and objectives. And they are not completely
aligned with our desires to have
a self-regulatory effort. And, so, therefore,
the industry — you know, we wanted
to demonstrate self-regulation, but we also wanted this idea that we’re providing FDA
with information. And that’s where we started
to have asks, potential asks to the Office
of Dietary Supplements that we realized, you know,
this would be a big change for what you guys are doing. And the conclusion was industry
needs to go do this itself, so it can make it
how it wants. But, the key is,
we’ve got a memorandum, not a written formal, just — we realized that we need
both of these databases to be successful in order to
support the different audiences. So, the DSLD from
Office of Dietary Supplements, the research community benefits
tremendously from that tool for a variety of reasons
in how it’s designed. But, the self-regulatory
functions are really what we built
into the OWL, the idea being that if someday we’re looking
at legislation again, that we will already have
a registry in place and say, Congress, we agree to this.
This is how it should work. A variety of other Voluntary
Guidelines and Best Practices, but I think you can see
the most relevant one. This is an old list. We have significant efforts
right now related to SARMs. We are trying
to pass legislation. So, we are paying lobbyists
to go on Capitol Hill to try to pass a law
to protect consumers from SARMs because we see that as a direct
threat to public health, a direct threat to trust
with our consumer. We have a consumer campaign
right now on our website, SARMs Can Harm. It’s directed to the athlete.
We’ve developed relationships with a variety
of sports organizations, like the International
Racquet Club and others. But we’re trying to educate
their members that the same thing
that Office of the — the OPS website is doing is to
distinguish legitimate products from illegitimate products. So, you can see, that fulfills
our objective of safety. We heard from Adam yesterday
about protein measurements and how the current
regulatory standard for protein measurements is to just do a dip stick
and look in there and see
how much nitrogen is there. And, obviously,
that’s a very easy test to fool if you add free amino acids
that are rich in nitrogen. So, we put together a protein
measuring and labeling standard for the industry
that, very specifically, says, Only measure native proteins. Any free amino acids
do not count to the protein content
of that product. So, you can see how that effort
goes towards product integrity. And then you can see best
practices for probiotic manufacturing. We have been trying to get FDA
to change their — the label regulations
so that probiotics are not listed in metric units
or milligrams. They’re actually listed
in colony forming units, which is the meaningful
measurement that actually
gives consumers information that they can align
with science to tell them if this product is actually
going to do anything for them. So, you can see how that effort
goes to communicating consumers information they can use to making
purchase pro-choices. And so, we are constantly active
in the environment, identifying problems and working
as a collective to address them. We heard from the Federal Trade
Commission yesterday about their efforts to look
at unsubstantiated scientific advertising claims. We realized that the
Federal Trade Commission has limited resources,
can’t get to everything. Therefore, we set up a program
with the Better Business Bureau, National Advertising Division.
We give them — we’ve given them, like,
six million dollars in grants so that they can go out
and do cases against companies who are uncompliant
with their claims. So, I’m going to just
fast-forward one more, Paul. With claims, we noticed
a pattern where companies will go
to great efforts to make sure
their complains — their claims are compliant
and didn’t make any drug claims. But, what was taking place
is that the retail level, the sales clerks,
the sales representatives were out there extending
and saying, Oh, yeah, you can use this
for heart disease and high blood pressure. So, we went on a big effort
to educate third-party retailers about the limitations about what
you could say about their — our products, so — I hope to get to the rest
of this stuff in my Q&A time, but thank you for listening.
Our contact information is here. And Paul is incorrect. You can
contact me any time you want. [laughter] Today is not the only time
you can talk to us.>>Male Speaker: Okay, good. [applause]>>Female Speaker: Thank you. [applause]>>Paul Coates: So, it’s now
a pleasure to introduce somebody whom I’ve not had the pleasure
of talking to before, except by phone, Laura Harkness, who is from a manufacturing
company called, Church & Dwight. And I hope that
you can educate me, Laura, about what Church & Dwight
does in this space.>>Laura Harkness: So,
good afternoon, everyone. It’s a pleasure to be here.
And, I have to confess, I’ve been a registered
dietician for 30 years. So, my first job was working
in a hospital with patients. So, I — for those fellow
dieticians in the room, keep up the good fight. Let me talk a little bit
about Church & Dwight because everybody’s, you know, people aren’t familiar
with the company always go, Is that a law firm? [laughter] Well, believe it or not,
we are 172 years old. We were founded in 1846 by
Austin Church and John Dwight. And those are the two gentlemen.
They were brother-in-laws. They commercialized
making baking soda. So, we own Arm & Hammer. So, I think now you
probably know who we are. For most of our history,
in fact, that’s what we did. We made baking soda.
And we still make baking soda. In fact, we make 14 different
grades of baking soda, all the way from
industrial cleaners to USP grades that are used
by hospitals for renal dialysis and IV sodium bicarbonate, so —
and everything in between. You might be cleaning your pool
with our baking soda. And a little factoid. When the Statute of Liberty
turned 100 on July 4, 1986, 100 tons of Arm & Hammer baking soda were used
to clean Lady Liberty. [laughter] So, about 20 or 25 years ago, Church & Dwight embarked
on an acquisition spree. And, so we are now
in 15 categories. And I wanted to show you
this slide because I want to impress
upon everybody the fact that we are the makers
of medical devices, over-the-counter drugs. In fact,
we own one prescription drug. And, so we are very,
very involved with FDA-regulated products and quite stringent
about following regulations and quality controls
within our facilities. So, as you can see,
probably everybody in this room, I would gather, might have one
of our products in your pantry. Is there anybody who
doesn’t have Church & Dwight? So, anything Arm & Hammer
comes from us. We own a number of oral care
brands, toothpaste, Orajel,
mouth rinses and so forth; cleaning products like OxiClean
and other fabric cares. And then we also own Trojan. So, I’m the only dietician
in the world who can say that I run the product
development team for condoms. [laughter] We also own a large
animal nutrition business. So, that’s a B to B business. And we sell animal
nutrition products for farms, so, for dairy cattle, for beef
cattle, swine, and poultry. And the goal of that team is,
largely, to reduce the amount
of antibiotics that are given to animals. So, we provide nutritional
products for animals, as well as probiotics
to the farms to try to reduce the use
of antibiotics by farmers. So, I want to talk a little bit
about the fact that we really do follow
all of the FDA guidance around good
manufacturing standards. And what that entails is,
really, from the time a — we source a raw material, we actually will audit
our raw material suppliers, and they have to pass our own
internal audit standards. As well as when we receive the
raw materials into our facility, we test them, and we make sure they are free
from microbial contaminations, from heavy metals,
from all sorts of — anything that may be adulterated
in that raw material, all the way through
the manufacturing process to make sure that the products
that go to consumers are safe. We don’t release anything
out of our facilities that we haven’t put through
very rigorous testing processes in terms of making sure what our consumers get
on the shelf are safe. We also follow all of
the FDA regulations in terms of labeling.
And, as you well know, we are in the midst
of changing our labels. We, actually,
are moving forward with changing to the new
supplemental facts panel. So, you’re going to start
seeing those products on the shelf very soon. I think they should start
hitting, actually, this month. FDA is requiring that all
nutrition labels get changed over by January 2020. We decided to go ahead and move
forward with that anyway. And so, for those of you
that deal with patients, I can say that there is going
to be confusion on shelf because you’re going to see
the current labels, as well as some new labels
rolling through. I’ve already seen those,
particularly on foods. So, I think that the healthcare
providers in the room, that’s going to be
really critical for you to help people understand
the fact that they may have products —
the same product, two different supplemental
facts label on the back. We also follow all of
the FDA standards when it comes to making
any kind of label claims. And the FDA does require us
to produce dossiers for every single product
we have on the market. And that’s based on the full
representation of the science. So, we have to do
a complete literature review and make sure that we’ve looked
at every study that would support,
or not support, the claim we would like
to make on that product. It really does take a village
to take an idea from a piece of paper
all the way to a product that a consumer
would purchase in a store and take to their home. And these are just the people
within R&D that are involved
in developing a product. I actually didn’t list
the people in the business side from the pyramid folks, the transportation people
to the operational folks in the factories
and to my marketing colleagues. But, it really does take
a number of critical functions, consumer research,
clinical science, toxicology, and so forth,
to get a product to market. I wanted to highlight that we do
a tremendous amount of testing. So, we do a lot of testing
and toxicology work, and we have a separate,
independent group who’s responsible for that. They report directly
into the head of R&D. They don’t report to me. So, if they find that there is
a safety or toxicology issue relative to the products
that I’m responsible for, I have no — I can’t weigh in
on their decision. They come and tell me
what their decision is, whether that product meets
our safety standards or not. We do a lot of sensory
testing because we, actually, manufacture gummy
dietary supplements. And, so, people are chewing
and adjusting our products. And we want to make sure
they taste the best we can
absolutely make them taste. We do a lot of analytical
testing. We test incoming raw materials.
Once a product is produced, we test it on the factory floor
at multiple points during
the manufacturing process. And then we test it after it’s
bottled and it’s on the shelf. And we do a series of tests,
post-bottling, over several months, to make sure that it still
meets our standards. FDA also looks at
our testing protocols and our stability program,
as well as our retail partners. So, the retail partners,
the big ones, if you think of Walmart, the Costco’s,
the Targets, the CVSs, they require us to submit all of
our analytical testing to them, as well. So, I had a discussion over
lunch with somebody in the room, and they were saying
that this discussion came up among their colleagues:
Where should you buy things? Well, I can tell you that
the big retailers are adamant about making sure we submit
to them both our consumer, as well as
our stability testing. So, how does a —
for those of you who haven’t done
product development, how does it work? Well, believe it or not,
a lot of ideas are generated. We get, I — we get hundreds
and hundreds of ideas to get down
to one single product. And then we ask the consumer, What would you like
this product to be? How should it taste? What are
your expectations of it? What should it look like? And, from that, we then start to
work on developing the product. So, we have an idea of what
the consumer wants. It does —
do they want it to be yellow? Do they want it
to taste like oranges? Do they want it to have
these specific ingredients? And we start to develop
the product based on feedback
from the consumer. And it’s an iterative loop
where we will then go back
to the consumer and say, Is this what you had in mind?
Is this what you would like? And, at the same time,
my business partners are making the business case
to make sure that we can — we can market the product
and make money on it. And then I’m going to
show you a little bit. But then we have to figure out
how to scale something up. So, we make a kitchen-sized
batch of things, but then it has to be scaled up
to a factory level scale, so we can make mass quantities to be able to get it out
to the retailers and then to
the consumer’s home. So, this is a little snapshot
of what that means. So, first, we go ahead and,
in the lab, we make a product. And we make a lot of iterations
of a product. We probably make two or three
thousand iterations of a product before we actually have
something we’re happy with. And then it goes to
what’s called, a pilot, or test plant, which will make
a little larger sized batch because that’s where the process
engineering team will start to say, Okay. So, product development,
you handed me a recipe, but now I have to figure out
how to make this on bigger equipment,
industrial-sized equipment. I have to figure out
the processing parameters. I have to figure out how to get
this product into a bottle. So, the processing team
spends a lot of time in the pilot plant figuring out
how to scale up a recipe. As I said,
we make gummy vitamins. And I wanted to give
a little bit of a snapshot of what the gummy vitamins are because it’s an interesting
matrix to put a vitamin in. It’s quite different
than a capsule or a tablet. A gummy, for those of you
who’ve made them at home, you know, is really
a super-saturated sugar solution that’s stabilized with some
kind of hydrocolloid. And then it’s colored
and flavored, and it’s what’s called,
deposited. And I — I’m going to show you that you can actually
look on YouTube to see a video
of how gummies are deposited. I couldn’t find one
that looked very good, but you can go on your own. A gummy vitamin is really
a gummy that’s fortified
with active compounds. Easier said than done. So, there’s a variety
of hydrocolloids that go into making a gummy. There are —
there are pectin-based gummies. So, the pectin is typically
either from citrus or apple. There are gelatin-based gummies. Gelatin is the tried
and true gummy matrix. That’s how gummies
have been made for 100 years. And then there’s
starch-based gummies, which are typically corn
or potato starch. Swedish fish, if you’ve
ever had those, are starch-based gummies. So, if you want to compare
and contrast the bite and the taste,
those are a starch-based gummy. The solubilization is
quite different depending on the kind of starch,
of hydrocolloid that’s used. And the setting temperature
is quite different. Our gummies are —
tend to be gelatin-based so the cook temperature can be
up to 240 degrees Fahrenheit. So, it would be really hard
for a microbial agent to survive in that kind of cooking
and solubilization temperature. And I was quite startled to hear
that there was a product on the market that had come out
with a pretty nasty bacillus because that —
in a gummy process, we just wouldn’t see
that kind of thing happen. There’s a distinctly
different bite for a consumer in terms of the kind of
hydrocolloid system that’s used. And how we have to set the
hydrocolloid is quite different depending on the matrix we pick. So, how do you actually
deposit a gummy? Believe it or not,
there’s these massive, what they look like,
cookie sheets that are full of starch.
And each cookie sheet, then, has some kind of pattern
laid out into it. So, if you’re making
gummy bears, it has a little bear pattern
that’s stamped into it. And then the candy
comes down into a depositor and gets deposited
into those little starch holes. And that’s called a molgum. And the reason for that
is because the starch will slowly draw the moisture
out of the gummy mixture and let the gummy set up
slowly over time. And that’s how you make
a good gummy. And that whole process
of setting the gummy, drying the gummy,
is called curing or stoving. And, depending on
the hydrocolloid system, it can last anywhere
from six hours to 24 hours. Gummies, typically,
we like to finish them — I don’t know if anybody’s ever
bought a bottle of gummy candy and you left it in a hot room
or you left it in your car and it got all sticky
and liquified and you had to pry
the little gummy bears apart. It’s very susceptible to heat. So, we like to finish
the gummies with some kind
of finished coating because that helps the gummy
stay a little more stable, and they’re less sticky
over time. So, we might oil on them or put
some kind of sour sand on them, or enrobe them in some way
so that they, then, are protected from all
the melting that happens. And, last, I want to show you,
this is the packaging line, so our package engineers — and this is our real line,
believe it or not. One of our factories,
our package engineers designed this line —
this is a new factory — to be able to bottle
the gummies. It’s fully automated
with robots. And, you can see, this robot
will orient the bottles so the labels
are all the same way, so when it gets packed
into a case and gets shipped
to one of our vendors, I mean, retailers, excuse me,
it’s all ready to go. They can just put it
on the shelf, and all the labels
are facing out so whoever’s buying
it can see the label. I think that’s —
I think that was my last slide. So, anyway, thank you very much
for your attention. And I’m happy to be here. [applause]>>Paul Coates: Thank you,
Laura. Now, it’s a pleasure
to introduce Merle Zimmerman from the American Herbal
Products Association, to tell you what they do
and what their role is. So, Merle.>>Merle Zimmerman: Thank you. Hey, everybody.
Wonderful to be here today. And we’re getting
my slides set up, so it might be a great time
to take a small stretch. [laughter] My slides, I have many of them. [laughter] I can guarantee that
every evaluation I’ve gotten has said
I’m incredibly boring, but sometimes make a joke, so —
[laughter] –I’m hoping not to let you down
on this one. So, I’m from the American
Herbal Products Association. We’re focused on products
containing plant ingredients. So, I’ll be able to tell you
a little bit about our members, what we do,
the types of support we have for the regulatory structures
for dietary supplements that include
this type of ingredient. So, first, a little bit
about us. The American
Herbal Products Association was founded back in 1982,
so we’re 36-years-old. We have around 400 members looking at both domestic
and international companies that grow, process,
manufacture and market herbs and herbal products. We’ve got affiliates
who are also like-related in providing services
to the folks that do that. But our core audience
that we help are, aside from
the American consumer, which we’re all in service
of in an industry, are those companies which provide
the service to the consumer. So, products include
dietary supplements and a bunch of other things
that are plants or plant-based. We work in several big areas. We provide a representation
point for industry to reach out to regulators
and legislators with information about what’s going on
in industry, current best practices, supporting folks doing
their best for the country. We provide some educational
training opportunities to do with good
manufacturing practices, FDA inspections,
product labelling. We have guidance documents and related to new
dietary ingredients, adverse event reporting,
and things like that. Some of the things we do include some communication
to members of media to help folks understand
potential subtleties in the area
we’re focused in because we all have
different points of view. And one of the exciting things
that we’re involved with is we — sort of, we’re I guess, all,
maybe, type-A personalities. So, we get everyone together
who likes doing things, and then we all work together and look at
self-regulatory practices to help support the wonderful
market that we have today. So, aside from that, we do
a bunch of collaboration work with different
organizations. Thank you, ODS
for inviting us down here. We’ve also — you’ve seen some
of these names elsewhere, so — In turning onwards here, I’m going to give you
a little overview of some of the stuff we do
with self-regulation, with our interactions
with regulators, with respect
to legislative stuff. But, I’d rather give you guys
a more interactive presentation. So, let me get out from
behind the podium and come up into the room because we’re all here
in this together. And, we can continue
through the slides here. So, I’m going to talk
a little bit about –>>Merle Zimmerman: Okay,
great. I’m going to talk a little bit
about some of the stuff that we’re working on,
which is in the market here. We have Herbs of Commerce
that was mentioned yesterday, as a source for a means
to communicate with the general public but be specific
about what products are and what the ingredients are. With respect to guidances, we’ve looked at a bunch
of different areas, including some good
stewardship-related things, as well as good agriculture
and collection practices. Different requirements
for testing that are needed under the GMP regulations for making sure ingredients
are what they are, and making sure the right
amounts are in all the bottles, as well as the — Some of the outreach
that we heard about from FTC where we’re talking
about communicating where the science currently is, as far as what you can say
on a package or in relation in advertising, to help make sure the folks
in the public understand what we,
as a whole, understand. So, I’ll — there’s a bunch of
these. They’re all listed here. If you’re interested
in something specific, if you want to give me a shout
after the session, I’ll be happy to help you get a look at some
extra stuff that’s not here. In association with new dietary
ingredients, you heard a large number
of products mentioned and sold in the United States,
including, I think, variant weights
for the same sort of products. Centrum probably has, like, a dozen
in different bottle sizes. But, we have a new dietary
ingredients database where we do some analysis
on the new dietary ingredients that FDA has made
available to you, provide a place
to do some research. We’ve got our botanical safety
handbook, which, I think,
may be the most relevant — the most relevant project that I have to share
with you guys today. And, as a surprise, I’ve got
everyone access to this, so you can start browsing it
on your phone. If you’d like to pass
that around? I’m not going to say
what that password is, or what the user names are, but I’ve written down the way
that that works, so you can get signed in
if you’re a presenter. I’m not sure that
you were in the list that I had of everybody,
so give me a shout at the break. I’ll make sure you’re in. So, this talks about
an academic, sort of, review. And the first edition,
we had 550 herbs and talked
about safety concerns. But the more recently-released
second edition was partially funded by ODS —
many things — provided information
on 700 herbs. And it, basically, provides
little reference articles reviewing the current research
on each one. And we’ve been updating that and started posting
new revisions on the website. So, you can browse the latest
of what we’ve got available. Events-wise, we hold an industry
event to get folks together in the same room,
look at current events, current supply chain
[unintelligible] place, things like that. We provide a bunch of technical
trainings to do identification and help — one of the things
closest to the heart in AHPA has been the American
small business. So, we were founded by — a bunch of the starting members
were small businesses. We try to keep folks in mind, help people pursue
the American dream, go from getting informed
to doing great. So, we have a bunch of trainings
that we continue to provide, and reference materials
to help people excel. Among these, if you want to
check this out on your phone. It might not be that exciting unless you like
looking at plants. [laughter] But, we’ve got a —
this Botanicalauthentication.org is this reference site
that’s aimed towards experts who are doing identification
work with plants. And we bring together
a bunch of publicly available, or resources
we’ve got permission to make publicly available, together with citations
and everything so that people can look
at voucher specimens, analeptic characteristics, some macroscopy, microscopy
properties all in one place, just, like, as a thing to do
for the general public. So, AHPA’s been committed
for a long time to work with regulators on dietary
supplement-related issues, organics, adverse event
reporting, NDI guidances. Most recently, we’ve been
on this big project to look at trying to find
deficiencies in the regulation so we can have a — the funds that are available
go as far as possible, helping the marketplace
be excellent. So, we’re also been committed
since, I guess, 2010, we set up a site,
like Patricia was mentioning, to sort of track
these products that are pretending
to be dietary supplements, but are drug-spiked, to try
to help raise awareness of that. And, recently,
with FISMA passing, there are some really
cool new controls and places for folks
to keep an eye on in a more structured way, so the regulators
can also follow it. So, we’re working on —
we’ve published a set of good agricultural
collection practices that we’ve developed
in conjunction with the industry to help support that and have
been doing some trainings on that this last month. So, I guess we were involved
in writing DSHEA back in the day. But, we’re kind of —
the folks that remain engaged, but maybe who don’t talk
about ourselves too much, so you don’t hear too much. But feel free to give me a shout
anytime if you have questions. We also have an educational
foundation that’s been doing [unintelligible]
research projects. Most recently, they just
finished up, or are finishing, this Harvest Sustainability
Project on Osha, which is wild crop that’s
in the Midwest, I believe. Dr. Kelly Kindscher
from the University of Kansas has been able to run it with the aid of our industry
folks and supporters. So, that’s been a multiyear
field experiment. It looked at different
harvest pressures on the crop
in the wild. Finally, I think we have
a few resources for consumers, while we provide a directory
of our members who are all great,
responsible manufacturers. We also have some
other resources like the Field Guide
to Supplements, this yearly event
that gets people outdoors looking at plants,
not just cubicles. And then, that —
a tracking site that looks
at those tainted products that aren’t dietary supplements. So, thank you very much. [applause]>> Paul Coates: So,
as promised, we will now ask
the three speakers, Duffy and the others,
to come and sit at the front. I’ll moderate for 15,
or so, minutes. We’ll go until three, so there’s
a little more than 15 minutes. Thank you, folks,
for being so very cooperative with time management. And, so you’ve heard
from our industry colleagues. And I want to know if you have
any questions from them. Yes?
To the right.>>Female Speaker: Hi. My name is Marianne from Wake
Forest School of Medicine. And my question is
for the Council for Responsible Nutrition and American Herbal
Products Association. The companies
that you partner with, or work with, how do
they become a member, so to speak,
of your association, and is there any sort of,
like, requirements or background check
?>>Merle Zimmerman: Yes. So, with the American Herbal
Products Association, we have a long set
of requirements that are member
responsibilities, including — I think I didn’t mention
while I was getting that note, running around, about
the Botanical Safety Handbook. There’s a requirement
for all AHPA members to include certain
warning label language about drug interactions,
possible safety concerns, on labels that have
those herbs where — of academic research
and peer-reviewed journals has showed a potential hazard.>>Female Speaker: Great.>>Douglas MacKay: So,
we, at CRN, we do have a vetting process where they get a legal review
from our outside counsel. It takes a look
at their advertising claims and previous
enforcement actions. And then we have a discussion
at the Board level. So, there’s a variety of vetting
processes that take place. In addition, we do have
a Code of Ethics in our voluntary guidelines. So, before membership —
so, you — the voluntary guidelines
are above and beyond what
the regulation requires. We’re asking them, you know,
Will you — caffeine’s a good example. Several times, it was said that
the way the regulations are, if there’s naturally-occurring
caffeine in a botanical,
you can add the botanical, but not disclose that
the absolute amount of caffeine that’s found.
And so, we felt, like, Well, that’s not letting
the consumer know how much caffeine’s
in a product. And so, we have
a voluntary guideline that says, No matter what the source, you will disclose
the total amount and put a warning label,
blah, blah, blah. So that if a company
doesn’t want to do that, then we can say,
you know, No thanks. This is our membership.
So –>>Female Speaker: Okay, great.
Thank you.>>Douglas MacKay: I will say,
there are antitrust laws that put a limit. You can’t just, you know, say,
Hey, we’re the insider club and we’re not going
to let you be part of it. So, we have — there has
to be objective reasons not to include them.>> Paul Coates: Somebody had
a question towards the back? You, in the –>>Female Speaker: Yeah,
I have a question. So, back, I think it was
the January or February, the Clean Label Project dot Org,
they published some — about 137 top brands
off of Amazon. They tested protein powders,
some of them vegan, some of them, obviously,
from animal sources. So, they had some reviews that weren’t great
for products that — I think,
I was a little surprised. I think you had Garden of Life as one of your companies
that you represent. So, there was, you know,
some heavy metal contamination found in some
of their powders. As a representative for
some of those companies, if the Clean Label Project or Consumerlabpublishes
information that says, Your label’s misleading.
The amounts aren’t in there. You have contamination
of some kind. What’s the process
that you guys go through? How are you representing
the industry to, basically, get the trust back
from the consumers?>>Douglas MacKay: So, a lot of
times with an issue like that, the majority of the activity
has to take place between the company
and the tester. Because,
what you may not realize — and protein powders
may not be a good example — but, it’s difficult. And we’ll hear
from Dr. Cooperman later, but it’s difficult. If you don’t know how a product
is put together, to reverse-engineer and test
it is also very difficult. So, if you don’t know what kind
of binding agents and colorants and things are used
to put it together, sometimes you don’t know
how to prep the sample to assess what level. So, the first step is,
get the labs talking because the manufacturer
is going to have a re-team. They’re going to have
their testing data and how — what method they used. And then the lab
that’s claiming that it’s not compliant has theirs. So, that’s one issue
that has to be worked out. Another issue is
with heavy metals. So, as you know, that a lot
of the heavy metals in naturally-occurring materials are just
environmentally present. And so, often you want to read
between the lines because, in California,
we have something called, Proposition 65,
which sets very strict limits. And it’s just a disclosure law;
it’s not related to safety. And, often, these numbers
are irrelevant to what FDA is requiring
with regard to product. So, if the company says,
We tested this product and they don’t pass Prop 65,
well, that’s somewhat meaningless
in a safety standpoint. So, there’s a lot of nuances
to this. But if there’s just
egregious violations and they don’t have
what’s in the product, we will have a discussion. And we’re not going to keep
a member like that. That has not happened, to date. In fact, there was a Canadian
Dateline story that did a bunch
of the got-you testing, and it was a very
sophisticated company that had all their analyses. And they got in a head-to-head
with the lawyers. And I will say that
that did not air, and someone at that broadcasting
place lost their job because they did not do
their due diligence on making sure their
lab results were accurate.>>Paul Coates: Other
questions? Mary, did you have a question?>> Mary Hardy: It’s more of
a comment. I just — I don’t think you — Merle, I don’t think
you tooted your horn well enough about
the Botanical Safety Handbook, which I will be happy to do that
for you since I’ve been involved actively in both the second
and, now, the third edition. This is a really definitive
overview of these data sources for adverse event reports,
pre-clinical data, other kinds of toxicologic data
will be in. And, as far as I’m concerned, as a clinician
and as a researcher, this is the most —
the best kind of source and material
that’s all put together. And then the group that reviews
it has, again, a wide variety of experts,
clinical people, toxicologists,
traditional herbalists, as well as people
with experience, sort of regulatory, et cetera. So, you not only get
a definitive set of data, you get a multidisciplinary
look at it. And then a safety level
is named, and then the reasons
why for different things. So, I think with this password
passing around, everybody should take that
and use it because it’s a really
terrific resource. And, even though I’m
participating, I really would — I would kill to get that, that password if I didn’t
have it already, so — [laughter]>>Merle Zimmerman: Thank you
very much. And if anyone has difficulty
using that, please catch me after
the session or during the break. I’ll take a look.>>Paul Coates: Other questions
for our panel? Yes, ma’am.>>Female Speaker: I have
a question for AHPA and the Council
for Responsible Nutrition. So, if I am a manufacturer and
if I don’t participate with you or I don’t take
the membership, and I directly go
for the FDA approval, or acknowledgment,
as they say. So, how does —
how does it make a difference?>>Merle Zimmerman: So,
I can speak for AHPA. What we — one of the things
that we provide is a lot of opportunity
for mentorship, and a lot of opportunity
for seeing guidances written in industry that are specific
to questions and challenges that you might face
in your facility, on the floor. From FDA, we have
wonderful regulators working in the government side to make sure that
our marketplace is safe. But, sometimes, the learning
process from FDA inspectors isn’t as comfortable as talking
to industry colleagues and getting a heads-up
and help making sure everything’s just as perfect
as possible.>>Douglas MacKay: I’ll add
to that. I think it’s fair. You need to recognize
that all industries do this. So, whether you’re making
trailer hitches, whether you’re
the Dairy Farmers of America, or the Cheesemakers
of America, there’s these trade associations
in Washington, D.C. And what happens is
the sophisticated companies that have a vision
for the future, they realize, Well, God, you know, this issue
with bioengineered material and labeling of
bioengineered material, that could be really costly if that regulation
doesn’t work out well. And, so, they say,
As a single company, are we going to be able to shape
the national regulation on bioengineering?
Probably not. But if we get 25 of
the biggest companies together, and we put our heads together,
we go and say, this is what
this entire industry needs, then you have a voice
in Washington, D.C. And so, really,
it’s the companies that see the value in that. It’s not inexpensive
to join our association. And what they’re doing is
they’re paying for a membership that gets them, you know,
guidance documents; it gets them a voice in D.C.;
it gets them education. I mean, we will explain
upcoming regulations to them, and then they’ll go turn around
to their business units and say, Hey, guys,
we got a deal with this. The law is changing, and we’ve just learned
from our trade association in the next two years labels
are changing. What are we going to do? And then what happens is
they go look at the nuances and they’ll come back to us
and they’ll say, Did you notice that they’re
doing this with the regulation? And that’s not going to work,
you know? It takes this much
to change a label. And that’s — and so,
it’s our job, then, to go communicate back
to the regulator, This is going to be incredibly
costly to the industry without improving
public health. And that’s how we work together. And so, it’s really — it’s — unfortunately, if you don’t join
a trade association, you still get the benefit. And that’s the tricky part
for us, as businesses.>>Female Speaker: Thank you.>>Paul Coates: Other
questions? Bill?>> Bill Gurley: Can you guys
hear me okay? Let me get level
with this thing real quick. All right.
So, Duffy , Merle, Laura, how many companies,
particularly — I kind of — this question’s kind of more
towards Duffy and Merle because they represent more
companies than Laura’s company. But, how many companies
actually do clinical or pre-clinical
research inhouse?>>Merle Zimmerman: So, I guess
when it comes to the herbal products industry, that might be
a complicated question because anyone can go outside
and –>> Bill Gurley: [laughs]
That’s why I asked.>>Merle Zimmerman:
–pick some coffee or look for some chamomile, or get some mint
and use it in their life. So, as far as — I’ve heard,
many companies have to balance the cost of running
different types of studies and trials against
the entire industry using the results to talk
about themselves instead of, maybe,
that particular company when it comes
to the commercial space. But, I think that’s why AHPA,
as well as other organizations, work hard
and have associated projects that support academic research so that these studies
can better be done so that we have
more information, so that benefits
the community as a whole.>>Douglas MacKay: Bill, you raised a really
interesting question because what a lot
of researchers and outside stakeholders don’t realize is that
the financial model within supplements
drives research a lot. We have no intellectual
property protection. These are commodity —
you can’t patent vitamin C. You can’t patent echinacea. So, we don’t have
the same incentives as the drug companies.
So, you guys talked about how there’s not safety included
in these studies. Well, when I run a study
at a university on echinacea, I’m not trying to get
approval in three years. So, no one’s — if I was trying
to get drug approval, everyone’s saying, Well, if you’re going to spend
the money on the study, make sure you collect
this, this, and this, because you’re working towards
a certain goal. In addition, when you’re
working for one goal, you’re using the same material.
So, if I’m studying a botanical, I’m going to use a very
well-characterized botanical, and I’m going to use
the same one in every study. And what we see
in botanical research is: University A does
a study in echinacea; then University B does it;
and then University C. And, lo and behold, they all source
their echinacea different. It was all processed different. So, you can’t use that data
and combine it, and figure out what’s
going on with echinacea. So, that financial reality and lack of intellectual
property protection — when people complain
that the data doesn’t have
good safety markers, that it’s, you know,
that we’re not using the same material every time, it’s the nature
of the environment. However, when a big company
like Church & Dwight is going to go out there
and make a strong claim like, Help you get
to sleep at night, they have an obligation to be
able to support that claim. The majority
of the solid data actually comes from
the ingredient suppliers. So, the ingredient supplier
is selling a unique ingredient with unique characteristics, it’s in their best interest
to get some data so that when I go
to a manufacturer to sell it, I say, If you use
this ingredient, in this amount, these are the types of things
you can say about the product. >>Merle Zimmerman: If I could
also jump in. When it comes to
herbal products, specifically, there’s often a really
massive traditional set of use and exposure to
the human populations, which you might want to have
a historian and librarian do that research, rather than the types
of studies we do, are running today.>>Bill Gurley: Yeah, well,
that’s all well and good, except that’s traditional use and these are not
traditional use products, to be quite honest with you.>>Merle Zimmerman: Oh, the question specifically about a new –>>Merle Zimmerman: –
-ingredient.>>Male Speaker: –question
is primarily towards finished formula — finished form herbal products,
not a traditional use like a cava preparation
from Fiji, but actually –>>Merle Zimmerman: Okay.>> Bill Gurley: –a cava
dietary supplement that may be marketed — might be manufactured
by one of your –>>Merle Zimmerman: Okay.>> Bill Gurley: –affiliates.>>Merle Zimmerman: Well,
as far as the folks I’ve met that are in industry,
most of the people, at least, that I’ve seen
in the office space, have been looking very closely
at traditional uses during the designs of their
products for the consumer, so –>>Male Speaker: Yeah. So —
and I’m not trying to be — I’m kind of a little bit
trying to be a little bit of Devil’s advocate –>>Merle Zimmerman: Yes. Bill Gurley: –because I think
that if there was a way for FDA, or USDA, or someone to — if there were some incentives
for companies that actually had, let’s say,
a multi-ingredient product that was sourced properly
or whatever, these proprietary
blends that everybody –>>Merle Zimmerman:
[affirmative].>> Bill Gurley: –talks about,
if there was a way to show that your proprietary blend — even if you had just gone
through the due diligence to do some proper,
pre-clinical safety assessments and maybe even
some clinical studies. I know it ‘s expensive –>>Merle Zimmerman: Yes.>> Bill Gurley: But if
you had — if you meet some of those — if you meet some of those —
what’s the word I’m looking for?>>Merle Zimmerman: Well,
we have seen –>> Bill Gurley: If you meet
some of the –>> Bill Gurley: If you meet
some of those benchmarks –>>Merle Zimmerman: Yes.>> Bill Gurley: –then you —
that — you get some protection.>>Merle Zimmerman: Yes.>> Bill Gurley : If there was
a way to convince –>>Merle Zimmerman: Well –>> Bill Gurley: –the
regulatory industry –>>Merle Zimmerman: When –>> Bill Gurley: That would be
something that would be extremely helpful
for the consumer.>>Merle Zimmerman: If I could
offer a –>>Laura Harkness: So,
my company doesn’t make herbal supplements, but it —
so, I’ll speak about — if we have a proprietary claim,
we do the clinical research.>> Bill Gurley: [affirmative].>>Laura Harkness: And, to put
in a little plug for those of you going to ASN, we have two posters
on Monday [laughs], so — and I can’t speak
for all the other companies, but I think the member companies
that are very responsible, and players probably
do the same thing, that they do their own
in-house clinical research. We work with a number of
academics and contract research organizations
to do the research.>> Bill Gurley: And, so,
that’s another — this is a question
from my own edification. Are there any specific contract
research organizations that only deal with botanical
dietary supplements?>>Merle Zimmerman: There are
contract research organizations that specify — they work only in our space,
but none that I know of that just specifically
do botanical supplements. I think the experts
are truly at NCCIH. You know, they’re doing
the most rigorous — and you’re familiar
with their work — you know, from start
to finish, preclinical. But I want to challenge
you back. And another thing that’s really
difficult for our industry is that we can’t make
disease claims.>>Merle Zimmerman:
[affirmative]. I understand.>> Bill Gurley: Right? So,
think about designing a study that shows your product
keeps you normal.>>Merle Zimmerman:
[affirmative].>> Bill Gurley : And I’ll —
so I’ll come back at you, Duffy , and I’ll say, I’m not
really concerned about that. I’m concerned about
whether or not someone that takes your product
is harmed by it. I’m old — I have no problems with products
that if you can’t make a — but, to me —
and I’m kind of gearing more towards these
multi-ingredient products. And I noticed a couple of the
companies that you listed and will make a lot
of pre-workout supplements. And if you look
at some of the ingredients in some of those
pre-workout supplements, I question the research behind why
those combinations were made. So, that’s just —
that’s what I’m looking at. It’s more from a safety issue
as opposed to an ethicacy issue.>> Paul Coates: Let’s take
a pause. It’s okay because I’m just —
>> Bill Gurley: I’m sorry. I didn’t mean
to be argumentative.>> Paul Coates: –trying —
no, no, I — this is what you want to do.
But let’s take a little pause. We’ve got a break
for about 15 minutes. Our second panel will come up.
We’ll talk with them and then we’ll talk again
with everybody together. So, there may be some follow-up
on questions from the discussion
that was started here. Thanks to the panel members. [applause]

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