Supplement Industry and
Regulations
What are dietary supplements?
Powdered Protein?
Testosterone?
Nutra-sweet?
EPO?
Androstenedione?
Human Growth Hormone?
Calcium?
Vitamin C?
Jellybeans?
Supplements are NOT…
Foods
Food Additives
Drugs
"Food" means a raw,
cooked, or processed
edible substance, ice,
beverage, or ingredient
used or intended for use
or for sale in whole or in
part for human
consumption, or
A food additive is any
substance added to
food. Legally, they are
"any substance of which
the intended use results
or may reasonably be
expected to resultdirectly or indirectly-in
its becoming a
component or otherwise
affecting the
characteristics of any
food." This includes any
substance used in
production, processing,
treatment, packaging,
transportation or storage
of food. Food additives
must be approved by the
FDA.
Drugs alter physiological
and biological processes.
According to the 1985
Federal Food, Drug, and
Cosmetic Act, a drug is
“intended for diagnosis,
cure, mitigation, treatment
or prevention of disease”
and “articles (other than
food) intended to affect
the structure or function
of the body”. Before a
drug can be sold in the US
it must undergo clinical
studies to determine its
efficacy, safety, possible
interactions with other
drugs, and appropriate
dosage. Drugs must be
approved by the FDA.
chewing gum. Foods
must be handled and
labeled in accordance
with laws of the FDA.
How are Supplements defined?
Supplement = product that supplies a component
missing in diet.
Since 1994 (DSHEA), definition is:
1. A product (not tobacco) intended to supplement
the diet that contains: a vitamin, a mineral, a dietary
substance to increase total daily intake, a
concentrate, a metabolite, a constituent, an extract,
a combination of the above.
2. Intended for ingestion in pill, capsule, tablet or
liquid form.
3. Not for use as a conventional food or as the
sole item of a meal or diet.
4. Labeled as a dietary supplement.
5. Includes products such as approved drugs or
antibiotics that were a dietary supplement prior to
approval.
DSHEA: Dietary Supplement Health
and Education Act
Love it or hate it… KNOW IT!
• Passed originally in Congress in 1994
• Revised in 1999
• Places the “burden of proof” on the FDA to
ensure product safety.
• Created limits on what claims could be made
about dietary supplements.
WHY DSHEA EXISTS
• If you were Congress, would you regulate
dietary supplements like:
– Food?
– Drugs?
– Some sort of in between “natural”
consumable substance?
• How much money are we talking about?
In 2004, 18.9 percent of Americans reported that they had
taken one or more dietary supplements in the past year.
Marketing a new drug requires a complex series
of testing in both animals and humans to
determine:
1. safety
2. effectiveness
3. possible interactions with other substance
4. appropriate dosages
Takes millions of dollars and years of research to
bring a new drug (or food additive) to market.
Prozac, Viagra, Olestra, NutraSweet
Who is responsible for supplement safety and
efficacy?
The FDA (Food and Drug Administration) oversees
safety, manufacturing and product information
(such as claims) in package inserts, on the label, or
in accompanying literature.
FTC (Federal Trade Commission) oversees
advertising (TV, newspaper, magazine, internet?)
The Dietary Supplement Health and Education Act
(DSHEA) of 1994 specifies powers that the FDA
has to regulate the sale of dietary supplements.
The consumer???
Recently revised (1999), DSHEA now
requires that supplement labels must
prominently display the following information:
1. That they are a dietary supplement
2. Statement of identity (e.g. ginseng)
3. Quantity (e.g. 60 capsules)
4. Serving size, amount of active ingredients, list of
ingredients in descending order of quantity.
Cannot make any claim to prevent, treat, cure or
mitigate a disease OR have treatment implied in
the name (e.g. “cardiocure”)
OPTIONAL: structure/function claims
CAN make general claims about a nutrient or other
compound in terms of a non-specific effect on
health and well-being:
“maintains bone health”;
“supports the immune system”
Requires label to say: “This statement has not
been evaluated by the FDA. This product is not
intended to prevent, treat, cure or mitigate disease”
Manufacturers (CRN) have lobbied hard to soften
the FDA position on health claims with some success.
Manufacturers can make 3 “claims” about their products:
Nutrient
content claims
Describes the level of a nutrient in a food or dietary
supplement. For example, a supplement containing
at least 200 milligrams of calcium per serving could
carry the claim "high in calcium."
Show a link between a food or substance and a
Disease claims
disease or health-related condition. FDA authorizes
(needs FDA
these claims based on a review of the evidence.
approval)
Example, “calcium lowers the risk of osteoporosis”.
Structure –
function claims
Can make general claims about a nutrient or other
compound in terms of a non-specific effect on
health and well-being. Example, “calcium builds
strong bones”. Manufacturers may base claims on
their review of the literature. These claims do not
need FDA authorization but must include “This
statement has not been evaluated by the Food and
Drug Administration. This product is not intended
to diagnose, treat, cure, or prevent any disease”.
Section 6 of DSHEA
NO DISEASE CLAIMS but statements of nutritional
support and “Structure/Function” Claims are allowed
4 general categories of S-F claims:
1. Nutrient deficiency disease - but must also
disclose its prevalence
2. Role of a nutrient / ingredient in affecting a
structure or function
3. Describes the documented mechanism by which a
nutrient or dietary ingredient acts to maintain a
bodily structure/function
4. General well-being
UNACCEPTABLE: DISEASE (DRUG)
ACCEPTABLE: STRUCTURE FUNCTION
Protects against heart disease
Helps maintain cardiovascular function
Lowers cholesterol level
Promotes healthy cholesterol level
Reduces pain of arthritis
Promotes healthy joints
Prevents urinary tract infections
Promotes urinary tract health
Summary
Difference between a supplement and a drug...
- Why do we care?
Testing and marketing by the FDA is different for
supplements compared to drugs (and food& food
additives).
DSHEA (act signed by Clinton in 1994): basically
allows supplement manufacturers to market more
products as supplements and to provide more
information to the consumer about the
supplement’s benefits.
- In the eye’s of the consumer, it weakened the
enforcement ability of the FDA.
Because of the DSHEA...
- supplement labels are more “consumer friendly”
- But are supplements still “safe”?
Supplements used to regulated as food additives but
getting FDA approval for new food additives takes
years of research...$$$
“Food additive” does not apply to supplements... They
are not subject to the same pre-market safety
assessment.
With the DSHEA, FDA regulation went from evaluating
pre-market safety to policing the industry
This means that the FDA evaluates adverse event
reports and then makes decisions about whether or not
to categorize supplements as adulterated (impure or
questionable).
Supplement Regulation:
Legal in the USA...
- Each state reserves the right to ban the sale of a
substance (ex: ephedra)
- Other countries have different supplement
regulations.
Legal for sale doesn’t mean legal in competition...
- Athletic governing bodies vary in their list of
banned substances.
- Many banned substances are legal over-thecounter drugs and dietary supplements.
“Consumer Savvy”
• Because the DSHEA requires less premarket review for dietary supplements
making an informed decision as a
consumer is important.
– Look for unbiased information and
evaluate studies as we have practiced in
class.
– Also look to see if the findings of a study
have been re-produced...
Tips for developing sport “supplement savvy”
– Be suspicious of a single substance that
claims to do multiple things “build muscle,
increase strength, burn fat and increase
stamina...etc”
– Be wary if companies tell you that you don’t
have to eat properly when taking the
supplement.
– Natural doesn’t equal safe
– Be critical of the studies that the manufacturer
cites as proof of safety/efficacy (mistrust the
information if you can’t find the reference!)
– Use common sense, if the claim appears too
good to be true, it probably is.
The R&D Conundrum
The R&D Conundrum
Fast
Cheap
Good
Good + Cheap = Not fast
Good + Fast
= Not cheap
Fast + Cheap = Not good
Is it better to be FIRST?
Is it better to be BEST?
In the supplement industry, enough research is...
Enough to convince enough consumers to buy the
product that $$ from sales greatly exceeds the
costs of manufacture, distribution and advertising.
$$$$ in >>> $ out
To do more violates the interests of employees,
shareholders and, in terms of price, consumers.
Doing more than the minimum research needed
to maximize sales is not only unnecessary but
even incompatible with the interests of the
company.
For academic scientists, enough research is …..
First: efficacy (does it work?)
safety (does it harm?)
but also:
We are charged with understanding context mechanism of action, impact on endogenous
production,effects on other metabolic pathways etc.
Doing less than the minimum research required to
understand the physiological context is
incompatible with our responsibilities as scientists
Can’t we all just get along?
YES, in the sense that we share the same basic
goals of optimizing safety, health, and performance
NO, in the sense that we have fundamental
disagreements about who (target population), what
(top priorities), why (knowledge/sales), when (how
soon), and how (single study vs. line of research )
Consumer bottom line = DO YOUR HOMEWORK BEFORE
BUYING A SUPPLEMENT!