Dietary Supplement Practicum (5 of 21): Food vs. Drugs vs. Dietary Supplements

>>Regan Bailey: Okay. So, our next presentation
is going to be comparing food to drugs and
dietary supplements. They all have different
paths to regulation. And we have someone on
our ODS team who came off the injured reserve list
to be here with you today. So, he — we’re really
grateful to Dr. Betz for coming in and
doing this for us. How many of you
have heard of a pharmacognosist? Okay. Well, you know, if I said
that in a normal crowd most people would say
no, but you guys are a different audience. So, I consider him
to be one of the pharmacognosists in the
world and we are so lucky to have him, so please
join me in welcoming Dr. Joseph Betz. [applause]>>Joseph Betz:
Thank you, Regan. Yeah, I’ve recently had
my knees replaced, so if I sit down halfway
through you’ll understand why [laughs]. So anyway, a long time
ago I worked at FDA, so I have a little bit of
experience with some of this stuff and I actually
live through some of the things that I’m going
to talk about today. And some of the slides
and some of the information is fairly
old, back from the ’90s, but I think it’s the best
illustration there is from a time when FDA and
industry and consumers were all trying to figure
out what the rules were following the
passage of DSHEA. So, because I talk too
much, I’ll get right into the talk itself. First thing is, according
to the Food, Drug, and Cosmetic Act, the
products are foods, dietary supplements, or
drugs based on their intended use. Okay? Doesn’t made of what —
doesn’t really matter what it’s made out of. If you make a
disease-curing claim for distilled water, FDA can
if they so choose to regulate that as a drug. And whatever regulations
for that category, food, drug, or dietary
supplement, are the regulations that apply to
that commercial product. Intended use is
ascertained by labeling claims, advertising
materials, oral or written statements that
the manufacturer makes about the product. So, the manufacturer is
in control of what the product is because
they’re the ones that create the labels and the
advertisements and things like that. Just as a note that I
added because I give this — similar talks in other
countries, there is no regulatory category for
functional foods in the United States; there
are in several other countries. FDA considers the
regulations about health claims for conventional
foods sufficient to cover the intent of
functional foods. FDA regulates products —
this is very important — commercial products in
interstate commerce. They don’t regulate the
practice of medicine at all; individual states
regulate the practice of medicine. So, if you’ve got a
bottle of pills with a label on it, that’s what
FDA regulates and they regulate it in
interstate commerce. If you were able to
create a product entirely within a single state,
get all your materials or your — all your
packaging materials, your bottles, your — the
cotton that goes in, all within a single state
and none of that stuff crossed state lines, FDA
has no authority over that product. So, to get right to the
heart of things, drugs are intended — and these
are more or less quotes directly from the Code
of Federal Regulations. “Drugs are articles
intended to diagnose, cure, mitigate, treat,
prevent disease in man or animals, affect the
structure or function of the body.” This part of the law is
older than DSHEA and it caused some consternation
when the DSHEA came out and people started
talking about structure/function claims
— and we’ll talk about that just a
little bit later. And anything listed in an
official compendium can be considered a drug,
something like the United States Pharmacopeia. The most — the key to
drugs and the regulation of drugs is that drugs
must be generally recognized as safe
and effective, GRASE, G-R-A-S-E. We’ll talk about that
difference between that and foods in
a little bit. Because of the safe
and effective part, pre-market approval is
required for drugs — for new drugs via the
investigational new drug process and the new drug
application process. So, there’s pre-market
approval; FDA looks at the data and says, “Yes,
you can market this product,” based on their
evaluation of whether it’s safe or effective. This is a very lot of
bullets for one slide, but I wanted to get —
cover as much of the regulatory environment
for drugs as possible. Drugs are unsafe by
definition until the sponsor who is the
manufacturer proves otherwise to FDA, so
that’s that whole pre-market approval
side of things. Unsafe by definition. Pre-market review and
approval is by FDA. They review for efficacy
as well as safety. There are user fees
associated with this process. So, when a company wants
to try and get a new drug approved, they pay FDA
to look at the approval. There are mandatory
formulation standards that are reviewed in
advance of marketing, so part of the
investigational new drug application process
involves the company giving chemistry
manufacturing and control information to the FDA
and FDA reviews that information — the
formulation standards, how it’s made — before
the company can proceed with the process. There is obviously
product registration because everything
has to go through FDA. FDA approves the claims;
that’s the whole efficacy and safety part. Manufacturer’s prohibited
from selling a new drug without pre-market
approval. If they do sell a drug
that has not yet been approved, then they’re
sell — they’re guilty of selling an
adulterated drug. The manufacturer has to
comply with drug-specific current good
manufacturing practice, CGMP, as well as drug
labeling regulations. The manufacturer for
prescription drugs is responsible for reporting
serious adverse events to FDA. And the manufacturer
bears all of these regulatory burdens. They bear the cost of all
of this stuff, of doing the clinical trials,
of developing the new chemical entity, doing
the pre-clinical animal work. The manufacturer pays for
all of that stuff; that’s why the drug approval
process is expensive. So, because this is a
relatively short talk, we have to jump
fairly quickly. Foods: “Articles used for
food, drug — or drink for man or other animals,
chewing gum, and articles used for components
of any such article.” That’s pretty much a
quote, a direct quote of the Food, Drug, and
Cosmetic Act of the definition of food. It’s essentially,
“Article used for food are food.” That’s essentially the
gist of the definition. They add some more
language about consume for taste, aroma and
nutritive value further on in the regulation but,
you know, essentially, it’s, “Foods are foods.” There is such thing
as medical foods. They’re — they were
authorized by Congress, but FDA has never gotten
around to writing the regulations. So, in any of these
regulatory things, you have the statute which,
you know, it lays out the broad strokes; it’s
essentially the skeleton of the laws. But then FDA or another
regulatory agency writes the regulations that
flesh out these statutes. Well, there are —
there’s a skeleton for medical foods so there is
a medical foods category created by Congress, but
FDA has never gotten to the point of issuing
regulations to flesh out that skeleton for
medical foods. So medical foods are
confusing and I’m not going to talk about them
because they’re confusing and it’s a short lecture. New ingredients in food. A new ingredient added to
a food is considered to be a food additive unless
it’s generally recognized as safe, GRAS. You may recognize
that acronym. Notice that as opposed to
drugs it doesn’t have an “e” at the end of it,
so we’re talking GRAS instead of GRASE. They have to be generally
recognized as safe by qualified experts,
generally recognized as safe for their
intended use. So just because something
is GRAS as a food additive for addition
to a food doesn’t mean you’re allowed to just
dump grams of this stuff into that food. You have to add the
minimum amount to achieve the technical effect. So, if you’re using an
artificial color or an artificial flavor, you
can’t just dump a vat load into your food; you
have to use the minimum amount necessary to
achieve the color or the odor that you’re
trying to achieve. This is a safety thing. The evaluation by
qualified experts has to be performed by
scientific procedures, whether it’s an animal
toxicology study or something like that. This is fairly important:
A substance used in food prior to January 1st,
1958 is considered to have a history of use and
is grandfathered — and we’ll talk about
grandfathering later when we talk about DSHEA. So, for foods and food
additives, it’s 1958 is the key date. So, anything that was on
the market legally prior to 1958 can
continue to be sold. FDA does go and do
periodic reappraisals of the safety of some
ingredients and there’s one notable example,
a substance called nordihydroguaiaretic
acid, NDGA. It’s a substance that’s
found naturally in a plant, chaparral, that
was at one time an approved food additive
for its antioxidant properties. And FDA reevaluated it
and removed it from the market because it caused
some animals’ kidneys to fall out. So, FDA does go back and
look at old ingredients every once in a while. The food label. I’m not focusing it all
on good manufacturing practice or other parts
of the regulations, I’ll — because the consumer
and the nutritionist who’s doing this sort of
work is exposed to this stuff kind of in
a forensic way. You’ll see a food label
or a package label and you have to decide what
it is, whether it’s legal. You know, so the
manufacturer has the advantage of knowing
what’s supposed to be there, but you as a
consumer or as even a regulator, especially for
food, are in a position of looking at a label,
determining whether the label is legal, and
whether it provides enough information to you
to make recommendations about its use for various
— for nutrition or for anything else. So, food labels have
to have a statement of identity or the name of
the food and the net quantity statement or the
amount of the product on the principal
display panel. So, the principal display
panel is — if you’ve got a box it’s usually — is
this a laser pointer? All right. So, if this is a cereal
box, for instance, so the big wide front of the box
is the principal display panel, then other
information is — goes on the side of the box,
which is the information panel. If it’s a bottle or a jar
or something like that, then this is the
arrangement for principal display panel and
information panel. And this is just a
description of what I just showed you
in the picture. The information panel has
to have the name, place of business, and the
manufacturer or the packer or the
distributor, the ingredient list, any
nutrition labeling, required allergy
labeling, label identification of
artificial flavoring, coloring, chemicals,
or preservatives. So that goes on that side
label; it’s not on a principal display panel. There are federal
regulations that tell you what font size and all
that business, where this information has to go. If you’re really into
this stuff, I provide this information. You can just enter this. You know, years ago when
I started at FDA you couldn’t do this, but you
can just enter 21 CFR Part 101 and google and
get right to several websites that give
you the exact text. There are academic
websites, there’s the Food and Drug
Administration’s website, and you don’t have to
have this enormous URL that takes you
directly to FDA. You can do the search
based just on that. So that’s why I tend
to include this stuff. The Nutrition Facts label
was fairly static for a relatively long
amount of time. The requirement for a
Nutrition Facts label goes back to NLEA,
Nutritional Labeling and Education Act of 1990. In May of 2016, just a
couple of days over a year ago, there were new
regulations published about the — what’s
required on the Nutrition Facts label for
nutrition labeling. The main changes are the
list of nutrients that are required or permitted
to be declared is updated. Vitamin D and potassium
are required on the label now; they weren’t before. Calcium and iron continue
to be required as they were before. Vitamins A and C are no
longer required, but being — can be included
on a voluntary basis; this is for
conventional foods. This is because of some
research that was done by FDA and I believe the
Academy of Medicine on nutrients status and it
was found that nutrition status for Vitamins
A and C in the U.S. was pretty much replete,
so it’s not as important a nutrient as it was
thought previously. There are some other
things, some technical things on the
Nutrition Facts label. So, the serving size font
has to be in a bigger, bolder type than
the old label. Serving sizes are updated
because it was estimated that companies were
basically lying when they told you what size the
serving size was, which gave you either an
overestimation or an underestimation of the
number of calories and things like that
of nutrients. The number of calories is
in a larger font and a larger type. Added sugars have to be
included on a Nutrition Facts label, so if — you
know, if there’s any — so there’s their total
— there was the total sugars on the label
before, but now if there’s any added sugars
those have to be labeled and listed, as well. Let’s see. Actual amounts of these
particular nutrients have to be declared and, as
I mentioned earlier, there’s a change in the
nutrients required. There’s also a new
footnote — let’s see if I can read it. Oh. That deals with the
percent daily value. It — it’s kind of an
explanation of what the percent daily value is
in relation to the total number of calories
consumed and things like that. So that’s — those are
the main structural changes in the Nutrition
Facts label and, as I said, those new
regulations are about a year old. What kinds of claims
besides nutrient content claims can you make? Well, you can make
health claims. That goes back
to NLEA in 1990. You can make the nutrient
content claims; those are the claims that were
on the nutrients facts label. Nutrient content claims
can also be the sort of claims that say, “A good
source of,” and then insert nutrient here. There are things called
qualified health claims and there are
structure/function claims. A little bit more detail
on health claims. A health claim describes
a relationship between a substance and a disease
or a health-related condition. So, you can actually use
the word “disease” on a food label with an
approved health claim, something that you
cannot do with a dietary supplement for
the most part. Health claims require
prior authorization by FDA, so there’s sort of
a pre-market approval process for these
health claims. You submit your data and
your evidence to FDA. FDA says, “Yes, you can
make a claim on your Cheerios about, you know,
fiber and cancer or heart disease or whatever
the claim is.” Unqualified — these
actual health claims, when they — when people
use the word “health claim,” they really are
unqualified health claims because FDA has done some
pre-market review and found that the claims
are backed by strong evidence. The standard of evidence
is significant scientific agreement. There are also — and
this was the result of a law suit, a First
Amendment law suit. There are things called
qualified health claims. You can make a
qualified health claim. It still has to be looked
at by FDA, but you have to provide the totality
of the evidence for the claim, so if there
are any caveats and disclaimers. So, if four studies said,
you know, “Oat bran is good for such and such,”
and seven studies said, “There’s no effect,”
that’s not significant scientific agreement. You can make the
statement, but you have to have those — you
know, those caveats. You have to make the
statement that, you know, some — a few studies
have shown that this is true and a bunch of other
studies have shown that it’s not true. So that tends to make for
a very large label, so it takes a lot of space on a
label by the time you end up adding all the
caveats and disclaimers. But they are permitted
and they’re — those are called qualified
health claims. You can make health
claims both qualified and unqualified for both
conventional foods or dietary supplements, but
the thing about health claims is they relate
nutrients in the food or the dietary supplement
to the disease or health-related
conditions. So, a lot of the dietary
supplements, especially botanical dietary
supplements or things like glucosamine and
chondroitin, don’t have much in the way of an
actual nutrient content in them. So, there’s very little,
you know, vitamins, minerals, you know,
macronutrients in something like Saint
John’s wort, which is why for the most part you
won’t see health claims on botanical dietary
supplements and a lot of other dietary
supplements, as well. You can see health claims
on other types of dietary supplements, so something
like a fish oil capsule. The fish oil is oil;
it’s fatty acids. Those are nutrients. You could probably make
a health claim about the health beneficial effects
of the — of a dietary supplement with fish oil. Somewhere on a label you
have to identify the nutrient level to which
the claim refers, so you can’t fairy-dust products
with a nutrient and say, “This is good for heart
disease or cancer.” This is the list of
FDA-approved health claims. You have it in your
handout; I’m not going to read all these things,
but you’ll recognize some of them. Calcium, osteoporosis,
sodium, hypertension, plant stanol and sterols,
and cardiovascular disease, soy protein,
soluble fiber, and cardiovascular disease. That’s your —
essentially your Cheerios health claim. Switch gears. Dietary supplement is
any product other than tobacco that contains a
vitamin, mineral, or a other botanical. You had this from Dr.
Swift this morning a little bit. I just wanted to present
this because it allows me to add this: Not
represented as a conventional food —
and this will become important in one of my
case study examples at the tail end of the talk. So, everybody knows the
definition of a dietary supplement now, everybody
knows what could be in a dietary supplement, what
can’t be in a dietary supplement, but this
is very important. So, you can’t have
Jetson’s pills. You can’t have a pill
that, you know, you would say, “Well, here is
your bacon and eggs for breakfast,” and call
it a dietary supplement because that would be
representing it as a conventional food. So, the label;
back to labels. Again, we’re not talking
about good manufacturing press — practice
or anything else. So again, same as with
the food label, statement of identity, the net
quantity, any nutrition labeling — except
instead of calling it nutrient facts or
Nutrition Facts we call it Supplement Facts —
the ingredient list, the name and place of
business, these are all required elements
on the label. There’s the principal
display panel, statement of identity, net quantity
of contents, any claims and all that kind of
stuff are the — on the information panel. So, your
structure/function claim goes here, directions for
use go here, Supplement Facts. In this case there’s no
nutrient content claimed, so it just tells you
how much of a botanical extract is present; in
this case it’s oriental ginseng powder and
250 micrograms. Any other ingredients —
coloring agents, gelatin for the capsule covers,
you know, water, glycerin, all that kind
of stuff goes in the other ingredients part. Name and place, business,
and the manufacturer. So, it’s very similar to
the food label with a couple of other, you
know, minor things thrown in. The product — the label
somewhere has to have the word “dietary supplement”
on it so that you know that you’re buying a
dietary supplement. Ingredient identity on
the information panel can get kind of complicated
for botanicals. So, you can use a common
or usual name for a botanical. If you use a common name,
that common name has to be in the American Herbal
Products Association’s book, Herbs of Commerce. If you don’t have an
Herbs of Commerce common name, then you have to
use the Latin name of the plant which is a Latin
binomial along with the author, the person who
created the name, and you also have to indicate
what the plant part used was. So, something — a common
name that’s accepted is Saint John’s wort. So, you have to put
something like Saint John’s wort above ground
parts, which is leaves, stems, and flowers
if — for a botanical ingredient. You have to indicate the
quantity of the — of each ingredient. There is one thing that
makes reading these labels complicated. There’s such a thing
as the propriety blend concept. So, if you’ve ever read
a can of Campbell soup, they don’t tell you
exactly how much tomato is in the tomato soup. There’ll be a list of
ingredients; there’ll be tomatoes, spices, water,
you know, et cetera. That’s because they
don’t want to give the competitors the key to
reverse engineering their product, so it’s called a
propriety blend concept. The ingredients have to
be listed in descending order of the percentage
that they occur in the product. So, for tomato soup,
probably the first ingredient might be water
and the second ingredient might be tomato and then
spices and, you know, the smaller the amount that
it’s in the product, the lower down it
goes on that list. Well, that concept is
true of botanicals, as well. So, the example that
I showed you said 250 micrograms of powdered
oriental ginseng, but if that was a proprietary
blend you would just have a list of botanicals with
no quantities next to the botanicals. They have to give the
total amount of the blend, but they don’t
have to give the percentage or the amount
of the individual ingredients. You have to try and
figure out which is the prominent ingredient by
where it is on that list. And then 21 CFR Part 111
— or 101 compliant, which is the labeling
rules, there is a Supplement Facts rather
than a nutrient facts panel. As with foods, there —
you are allowed to make authorized health claims. They can be either
qualified or unqualified. Very people — very few
people have bothered with this with dietary
supplements because they’re allowed to make
structure/function claims. And structure/function
claims don’t have to be pre-approved by the FDA. The structure/function
claims do have to be substantiated, so the
company is responsible for showing that those
claims are true and not misleading, although FDA
does not get to review the evidence for
that substantiation. They’re not allowed to
ask for the evidence. So as — you know, so FDA
does pre-market approval for the health claim, so
you have to show them the evidence, but for
structure/function claims, these statements
of nutritional support, FDA does not get
to review those. So, I — that’s in the
next bullet point here. However, if somebody
like the Federal Trade Commission, which does
have authority over this sort of thing, goes in
and decides that there aren’t any clinical
trials to support this, then unsubstantiated
claims are considered to be misbranding. Just a little technical
— instead of adulteration, they’re
misbranding the product. There are mandatory
disclaimers that have to go on a label if you make
a structure/function claim. One of the mandatory
disclaimers is, “This product is not intended
to diagnose, cure, or prevent any disease.” That’s to — that’s so
that you can’t confuse this product with a
drug product and that’s mandatory on a label. If the label makes a
claim, it has to have this disclaimer on it. There was kind of an
obscure rule that was important at the
time it was passed. You used to be able to go
into a health food store and — that’s where
you got most dietary supplements back in the
80s and 90s, was health food stores not CBS or
Target or something like that, and you’d see racks
and racks and racks and racks of publications. And at one time, FDA
considered those publications about how
wonderful Saint John’s wort was as part of
labeling for the Saint John’s wort products. So, Congress, when they
wrote the Act, decided that those publications
are a First Amendment exercise in free speech
and as long as they don’t make a direct correlation
to any of the brands, as long as you don’t mention
the brands that that store’s selling, then
those are not considered to be labeling. This is fairly important
for regulatory purposes. It’s kind of obscure but,
you know, I’m that kind of guy. The first encounter with
structure/function claims and DSHEA, they’re
actually called statements of
nutritional support, not structure/functions
claims — and then later on they refer to them
as structure/function claims. Remember the earlier
definition of drugs, it said something that
affects the structure or the function of
the body is a drug? Well, this kind of
confused a lot of people. So, Congress, when they
created the original language, talked about
statements of nutritional support and then created
a shorthand that just called them
structure/function claims; it’s still
kind of confusing. A structure/function
claim describes the role of an ingredient or its
mechanism intended to affect the structure
or function in humans. So, you can make a claim
about maintaining healthy joints from something
like glucosamine, so the ingredient is glucosamine
and it supports healthy joints. You can’t say anything
about osteoarthritis or rheumatoid arthritis
because then it becomes a drug, but you can say
“supports a healthy joint function.” Can’t claim to diagnose,
et cetera, et cetera, diseases. The manufacturer, as I
said, has — required to have substantiation that
the statement is truthful and not misleading. FDA’s not allowed to ask
for it, so therefore it does not — these claims
don’t require prior FDA approval and companies
have — are required to add a second
disclaimer to a label. “These claims have not
been evaluated by the Food and Drug
Administration,” so if you make a claim you
have to add a second disclaimer in addition
to the first one that I already mentioned. So, this is kind of
a comparison between structure/function claims
and disease claims. So, a structure/function
claim on a dietary supplement might be
“helps maintain normal cholesterol levels.” A disease claim would be
“lowers cholesterol.” Why would you want to
lower cholesterol? Well, to prevent
cardiovascular disease; that’s an implied
disease claim. Again, I won’t read all
of these — supports the immune system, supports
the body’s antiviral capabilities. This confuses a lot of
people because there’s a lot of clinical trials
out there that actually use the “d” word. So, “echinacea for
the prevention of experimental rhinovirus
colds,” those people used a dietary supplement
product that they — you know, that they bought
somewhere, you know, like at a supermarket and
did a drug study. This clinical trial is a
drug study because it’s a prevention of colds. You’re not allowed to
prevent, cure, mtigate a disease without
being a drug. So, this is actually
a drug study that was performed using a dietary
supplement product. Same with Saint John’s
wort, Saint John’s wort, and major depressive
disorder. All right, that’s not a
“helps maintain a healthy mood” claim, but it
was a clinical trial. Now, some of these
clinical trials had Investigational New Drug
applications filed, some of them didn’t. Saw palmetto on lower
urinary tract symptoms. Now, this is — this I
throw in just to fool people because benign
prostate hypertrophy, which is what we’re
talking about here, is not considered a disease
by FDA; it’s a normal condition of aging
if you’re a guy. The only reason this
study had a IND is because this was a
dose-escalation study and the third level of the
product was three times the concentration of any
product on the market as a dietary supplement. So, for safety purposes,
they filed an IND with FDA. I was a co-author in that
study, so I know a lot about [laughs] — So, as I said, drug
studies done with supplement products
may require an Investigational New
Drug application. You don’t
always see that. And it’s ODS policy and I
believe NCCIH policy that if you propose to do
a clinical trial, an intervention trial with
a dietary supplement product, you have to send
a letter to FDA saying, “Do we need an IND?” And FDA makes the call;
NIH doesn’t make the call on that. There was — and I think
Dr. Swift covered this a little bit; there was a
law passed in 2006 and essentially what it
required was extra information on the
label because it’s now mandatory for companies
to maintain records about serious adverse events
that occur from dietary supplements as
well as OTC drugs. Before 2006, you had to
report serious adverse events for prescription
drugs, but not for OTC drugs or for dietary
supplements, so this was just a quickie, just
extra thing for dietary supplements. So, the conclusion of
product classification: The rule has changed
depending on which box the manufacturer decides
to put their product into, food, drug,
dietary supplements. There’s a continuum of
effects or outcomes from basic nutrition through
health promotion to cure, treat, mitigate. Some of these areas here
can be a little slippery and a little
bit confusing. The rules change,
depending on the box. The manufacturer decides
on which box, based on their intended use, their
label, and et cetera. If the company messes up,
FDA is left to try and figure out which box was
intended by the company and then will use the
appropriate regulatory framework to enforce it. FDA tends not to be
generous in this effect, so if there’s kind of
confusion about whether it’s a food or a dietary
supplement, FDA will use the dietary supplement
rules — I mean, will use the food — the drug
rules if there’s confusion so it’ll go
to the higher standard, which is expensive
for companies. This is probably my
favorite case study. It — there’s a company
called Hain Celestial Seasonings. Hain back in 1999, five
years after passage of DSHEA, sort of was a —
would be a great idea to market a line of dietary
supplements in cans. So, they created
the Hain’s Kitchen Prescription line. It was chicken broth and
noodles with echinacea, tomato — or tomato basil
with Saint John’s wort. The company submitted
notice of claims with labels to FDA asserting
that the products were dietary supplements. The labels had pictures
of soup, use of the word “soup,” use of the
phrase “heat and serve,” references to tomato,
split pea, chicken broth — those are all food
ingredients or foods — and included echinacea
and Saint John’s wort as part of the
ingredients list. And they made
structure/function claims about the products. As I said, the companies
were called herbal supplements by
the company. However, FDA took a look
at these products; it didn’t take very long for
FDA to take a look at those products, and
concluded that those label statements — like,
calling themselves soups and calling themselves
delicious and all this kind of stuff meant that
the intended use for these products was to
be conventional food. Therefore, they can’t
be dietary supplements. Under the Food, Drug, and
Cosmetic Act, ingredients intentionally added to
conventional food have to be used in accordance
with food additive regulations unless
they’re GRAS. And the agency wrote in
their warning letters to this company that they
were not aware of the basis for concluding the
Saint John’s wort and echinacea are GRAS
for general use in conventional foods. So, FDA said these can’t
be conventional foods because they’re
adulterated with unapproved food
additives, echinacea and Saint John’s wort. You know, the company
itself and its packaging and labeling said
these are — you know, implicated or implied
that these were foods. Because they were not
dietary supplements — structure/function claims
are permitted for foods, by the way; I forgot
to mention that. But those
structure/function claims for conventional foods
have to be based on nutrient content, so the
structure/function claims for these products were
based on the content of Saint John’s wort and
echinacea, not nutrients. Therefore, those
are inappropriate structure/function
claims. Also, FDA said the name
of the product line, Kitchen Prescription,
suggests that the product may be intended to
diagnose, cure, mitigate, or treat a disease. Therefore, it could also
be considered to be a unapproved new drug. So, what we had here was
something claiming to be a dietary supplement that
was a adulterated food because it contained
unapproved food additives, and also an
adulterated drug because it had the word
“prescription” in the name, implying that it
was a drug used to cure or treat a — so this
line of soups disappeared from the marketplace
shortly after FDA issued their warning letters. There are other companies
that took FDA’s warnings to heart and changed
their labeling, changed their advertisements, in
some cases changed the category, and ended up
with a product that’s still on the
market today. Benecol is the one
product; they started out as a dietary supplement,
FDA slapped them around a bit, and then Benecol had
plenty of clinical trials so they submitted the
clinical trial data from Sweden, elsewhere, to
FDA and they changed themselves into
a food additive. So Benecol is now still
on the market as a salad dressing and as a —
you know, a margarine substitute because the
company decided it was worth it to go
ahead and do that. So, this — these were
all the things that FDA told the company that
they had to do and the company just decided it
was too expensive to do it. You know, the, you
know, substantiation of structure/function
effects and all that kind of stuff. This is a segue into the
next part, which is what you see today. It goes back to 2000. So, this is a warning
letter about a product called Arizona Rx Stress
Relief Elixir, you know, the beverages that are
the Arizona Iced Tea company. So, the company existed
and they created a line back in the 2000s called
Arizona Rx Stress Relief Elixir. Had a lot of the same
problems as the previous case. Enhanced with Panax
ginseng, kava-kava, chamomile, valerian,
fortified with minerals. So, kava, valerian
were unapproved food additives. Certain — you can use
ginseng, believe it or not, as an approved food
additive because it was being eaten by people
in the 1890s, 1910s. But — so again, the same
problems as the Kitchen Prescription with
unapproved food additives, Kava
and valerian. So, this line took
the Rx out of it. Some of the companies
started calling themselves dietary
supplements instead of beverages. So, this was an article
from The Washington Post in 2001, “Food Claim
Crackdown.” If you could — if this was a better
picture, you’d see that Odwalla, you know,
there’s some fairly — that’s a Celestial
Seasonings beverage. There’s some fairly big
companies involved in that and it was basically
for the same thing that I just told you about. All of this confusion
about beverages especially — the food
side kind of settled out fairly quickly in the
late 90s, early 2000s, but the beverages was
kind of confusing. So, you saw things that
were sold in giant cans and calling themselves
dietary supplements, these energy drinks
calling themselves dietary supplements, so
FDA was told by Congress to write some guidance
for industry on how to distinguish liquid
dietary supplements from beverages. So, a company Rockstar,
you may have heard of, changed their labeling so
now their energy punches — energy drink, but they
changed their labeling and their ingredients
so that they became conventional beverages
rather than dietary supplements and you can
tell because that’s got a Nutrition Facts
label on it. And if you could read any
of that stuff, you’d see that the list of things
that are in there are not unapproved food
additives; they’re not weird botanicals like
some of the other stuff. What it boiled down to
was FDA said that if a beverage provides enough
hydration to be a hydrating material,
then it’s a food. So, a 12-inch — ounce
can of something, a 16-ounce can of something
is probably a food because there’s enough
water there to actually do hydration. Something in smaller
sizes — so this bottle is 1.93 fluid ounces,
does not contain enough water to actually do
any good as far as a hydrating agent, so
this one still has a Supplement Facts label. So essentially, the —
you know, there’s other things in the guidance
that FDA provided about permitted ingredients and
not-permitted ingredients and stuff like that. But the biggest thing
came down to the volume of water that was in a
product as to whether it was a supplement or
whether it was a diet — or was a
conventional food. And that’s it. So, I think that I went a
couple minutes over, but not as much as
I usually do. [applause]

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