Download HW205 Unit 2

How are supplements
regulated?
Melissa Dengler, ND, HFS, CLC
 Understand
how the FDA is involved in
supplement regulation.
 Understand what DSHEA is and why it is
important.
 Learn what the difference is between
RDAs, DRIs and UL vs. concept of
“supplement dosage”.
 Understand Good Manufacturing
Practices.
 Learn what to look for in choosing a
quality supplement.
What
is a dietary supplement?
A
dietary supplement is a product that
contains vitamins, minerals, herbs or other
botanicals, amino acids, enzymes, and/or
other ingredients intended to supplement the
diet. The U.S. Food and Drug Administration
has special labeling requirements for dietary
supplements and treats them as foods, not
drugs.
What
four (4) conditions
must be met for the product
to qualify as a supplement?

Product intended to supplement the
diet and that contains one or more
of the following: vitamins, minerals,
herbs or other botanicals, or amino
acids

Intended to be taken in tablet,
capsule, powder, softgel, gelcap, or
liquid form

Not represented for use as a
conventional food or as a sole item
of a meal or the diet

Labeled as being a dietary
supplement.
FDA
DSHEA
GMP
FDA
DSHEA
GMP
 The
first set of nutrients standards in the US
originally called Recommended Dietary
Allowances (see William’s pg.15)
 Developed to address the poor nutrition
status of WWII recruits
 Information
gathered from expert
scientists who studied nutrient needs.
 Needs
are set high above the
recommended range to meet the
needs of most healthy people.
 Recommendations
scientific research.
are made based on
1. Estimated Average
Requirements (EAR)
2. Recommended Dietary
Allowances (RDA)
3. Adequate Intakes (AI)
4. Tolerable Upper Level
Intake Levels (UL)
Copyright 2005 Wadsworth Group, a division of Thomson Learning
Copyright 2005 Wadsworth Group, a division of Thomson Learning
1.
Meet nutritional needs.
2.
Avoid nutrient deficiencies.
3.
Prevent nutrient toxicity.
Given
the definition of RDAs, do
you think that most people in
America are “healthy”?
How do we define this?
How many people fall in to the
“healthy” category?
 Estimated
Energy Requirement
 Acceptable Macronutrient
Distribution Ranges
 Carbohydrate:
45% - 65%
 Fat: 20% - 35%
 Protein: 10% - 35%
Copyright 2005 Wadsworth Group, a division of Thomson Learning
Copyright 2005 Wadsworth Group, a division of Thomson Learning
 Specific
claims about food and
health are allowed.
 An approved list of health claims.
 Foods bearing health claims must
contain 20% or less the daily
value of:





Fat (13g),
Cholesterol (60mg),
Saturated fat (4g) and
Sodium (480mg)
OR 20% or more of the daily value Calcium
(160 mg)
 Claims
made without FDA approval
 Cannot make statements about disease.
E.g. “Improves memory”, “slows aging”
 Where do you see the role of structure and
function claims to help support health?
Red Flags of Nutrition Quackery
Satisfaction
guaranteed
Marketers may make
generous promises, but
consumers won’t be
able to collect on them.
Quick and
easy fixes
Even proven
treatments
take time to
be effective.
Natural
Natural is not
necessarily better
or safer; any
product that is
strong enough
to be effective is
strong enough
to cause
side effects.
One product does it all
No one product can possibly
treat such a diverse array of
conditions.
Time tested
Such findings would be
widely
publicized and accepted by
health professionals.
Paranoid
accusations
And this product’s
company doesn’t
want money?
At least the drug
company has
scientific research
proving the safety
and effectiveness
of its products.
Personal
testimonials
Hearsay is the
weakest form of
evidence.
Meaningless
medical jargon
Phony terms hide
the lack of scientific
proof.
 They
are regulated as foods, not drugs, so
there could be quality issues in the
manufacturing process.
 Supplements can interact with prescribed
or over-the-counter medicines, and other
supplements.
 "Natural" does not necessarily mean "safe"
or "effective."
 Consult your health care provider before
starting a supplement, especially if you
are pregnant or nursing, or considering
giving a supplement to a child.

Reading: Read Chapters 1 and 2 in William’s Essentials
of Nutrition and Diet Therapy and read two articles by
the U.S. Food and Drug Administration.

Further Notes: Review the Further Notes

Discussion: Discuss whether supplements should be
regulated by the FDA and the consequences of
regulation. Also answer the question about structurefunction claims.

Project: You will keep a food journal for one week and
analyze the nutrients. You will then write a report
indicating where you were deficient
 Does
anyone have any questions about the
material covered today?