Understand and learn to apply FDA regulations for dietary supplements and to market them successfully in the U.S. while avoiding regulatory problems.

1. Dietary Supplements in the U.S.
Staying Alert as a Consumer

2. The Figures That Count
Dietary supplements are a $23.7 billion industry in the
United States.
Over 70 percent of the U.S. population has tried at least
one dietary supplement.
In the past 6 years, FDA has identified over 400 dietary
supplement products that were illegally manufactured,
misbranded, or falsely labeled.

3. FDA and DSHEA Join
Hands to Help Regulate
the Industry

4. The Dietary Supplements Health
and Education Act - 1994
DSHEA defines the term "dietary
supplement" to mean a product (other
than tobacco) intended to supplement the
diet that bears or contains one or more of
the following dietary ingredients: a vitamin,
a mineral, an herb or other botanical, an
amino acid, a dietary substance for use by
man to supplement the diet by increasing
the total dietary intake, or a concentrate,
metabolite, constituent, extract, or
combination of any of the aforementioned
ingredients.

5. Regulatory Hurdles
Federal law does
not require dietary
supplement
manufacturers to
seek approvals
before production
nor before
marketing the
products.
Product
advertising too
comes under the
jurisdiction of the
Federal Trade
Commission.
The products have
to reach the
marketplace
before they fall
within the FDA’s
perimeter.
DSHEA does not
set limit levels for
vitamins and
minerals that can
be incorporated in
a pill.
FDA too has but a
limited capacity to
monitor adverse
reactions from
these
supplements.

6. FDA 5 elements to be present
in dietary supplement labels
Statement
of identity -
name of
the dietary
supplement
Net quantity
of contents
statement -
amount of the
dietary
supplement
Nutrition
labelling
Ingredient list
Name and place
of business of
the
manufacturer,
packer, or
distributor

7. Stay Informed, Stay safe
www.complianceonline.com/fda-regulatory-compliance-training
FDA Safety Alerts and Recalls Page:
FDA Safety Alerts and Recalls
Forum to Report Adverse Effects:
Adverse Events