Details Description of Steps in the manufacturing process

1. Steps in the Manufacturing Process
Step in the
Manufacturing
Process
Questions you should be
asking:
Other considerations:
Raw ingredients
are purchased to
go into supplement
Where are raw ingredients
coming from?
Are they the correct
ingredients?
How do you know the
ingredients are not
contaminated with
substances prohibited in
sport, microbes, heavy
metals, or other
substances?
Ingredient suppliers have an economic motivation to
“cut” expensive, high quality ingredients with lower
quality or entirely different (but cheaper) ingredients.
This practice has been dubbed “economic
adulteration” by many in the field.
Beware, some ingredient suppliers simply invent
official-looking “certificates of analysis” that fool even
the most skeptical companies into thinking they are
receiving legitimate, high quality ingredients.
Beware- herbals may have been grown in soil
contaminated with heavy metals- how would you
know?
Ingredients
received and
stored in
manufacturing
plant
How and where are the
ingredients stored?
Are they stored in proximity
to substances prohibited in
sport?
Are they stored under
proper conditions?
Many dietary supplement companies outsource the
manufacturing of their products. Thus the person
ordering ingredients has them shipped to a third
location- the manufacturing plant. The people
running the company may not be aware of issues or
problems in the manufacturing plant.
Supplement is
manufactured
Are the machines clean?
How were they cleaned?
Are the machines used to
produce supplements that
contain substances
prohibited in sport?
Does the manufacturing
company conduct quality
testing to ensure a
consistent batch run?
Does the manufacturing
company conduct label
verification at the end?
Many different companies may use the same
manufacturing plant. Your favorite “clean” product
may be produced on the same machines or stored in
the same place as ingredients such as DHEA or
stimulants. This creates opportunity for
contamination that the supplement company
themselves may not be aware of.
Even though GMP regulations require them to, some
manufacturers don’t conduct proper testing of the
end product because they either don’t know how to
(the tests they run are not the right ones to reveal
problems), or they choose not too because it is time
consuming and expensive.
Supplement is
packaged and
labeled
How sure are you that the
product contains what is on
the label in the amount
specified?
Depending on how the product was manufactured,
there may be more or less of a particular ingredient
in the product than what is stated on the label. Some
third-party organizations conduct “label verification”
to independently validate the ingredient list.

2. How sure are you that there
is nothing else in the
product that is not on the
label?
Some companies deliberately leave ingredients off of
the supplement label, or use made-up names to hide
certain ingredients. The FDA has issued many
warnings about deliberately spiked or adulterated
products.
Supplement is
distributed
Does the supplement
company have a list of the
sellers of their product so
they can recall it if needed?
Has the retail outlet made
any effort to ensure this
product is a properly
manufactured and labeled
product?
Most retailers of dietary supplements are not aware
of the various manufacturing or contamination issues
of dietary supplements. Just because a product is on
a store shelf doesn’t mean it is safe. There are plenty
of products that contain substances prohibited in
sport at your local grocery store.
Retailers are supposed to remove products from
shelves when there is a recall, but not all do, and
some are quicker than others. Some retailers may
not even hear about a recall.
You buy the
supplement.
Do you really know what is
in this product?
Will you hear about recalls
or other enforcement
actions against this
company if they occur?
Regardless of issues such as contamination or
mislabeling, some products list right on the
ingredients substances that are otherwise prohibited
in sport. It is important to be aware of these
ingredients just as if they were pharmaceutical drugs.
Manufacturers are supposed to report "adverse
events" to FDA and these reports are good to review
along with public recalls and warnings that they
make, but it is wise to remember not all adverse
events get reported.