Supplement Industry and Regulations

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Supplement Industry and Regulations

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Androstenedione? Human Growth Hormone? Calcium? Vitamin C? Jellybeans? Supplements are NOT... Drugs alter physiological and biological processes. ... – PowerPoint PPT presentation

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Title: Supplement Industry and Regulations


1
Supplement Industry and Regulations
2
What are dietary supplements?
Powdered Protein? Testosterone? Nutra-sweet? EPO?
Androstenedione? Human Growth Hormone? Calcium? Vi
tamin C? Jellybeans?
3
Supplements are NOT
Drugs
Food Additives
Foods
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.
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 result-directly 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.
"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 chewing gum. Foods must
be handled and labeled in accordance with laws of
the FDA.
4
  • 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.

5
  • 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.

6
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.

7
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?

8
In 2004, 18.9 percent of Americans reported that
they had taken one or more dietary supplements in
the past year.
9
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10
  • 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

11
  • 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???

12
  • 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)

13
  • 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.

14
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15
  • Manufacturers can make 3 claims about their
    products

16
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

17
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
18
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
    supplements benefits.
  • - In the eyes of the consumer, it weakened the
    enforcement ability of the FDA.

19
  • 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).

20
  • 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 doesnt mean legal in
    competition...
  • Athletic governing bodies vary in their list of
    banned substances.
  • Many banned substances are legal over-the-counter
    drugs and dietary supplements.

21
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22
  • Consumer Savvy
  • Because the DSHEA requires less pre-market 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...

23
  • 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 dont have
    to eat properly when taking the supplement.
  • Natural doesnt equal safe
  • Be critical of the studies that the manufacturer
    cites as proof of safety/efficacy (mistrust the
    information if you cant find the reference!)
  • Use common sense, if the claim appears too good
    to be true, it probably is.

24
The RD Conundrum
The RD Conundrum
Fast
Good
Cheap
Good Cheap Not fast Good Fast Not
cheap Fast Cheap Not good
Is it better to be FIRST? Is it better to be BEST?
25
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 gtgtgt 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.

26
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

27
Cant 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!