January 2017

DIETITIAN’S VIEW
The
alidity
of Dietary
Supplements
by Nancy M. Ouhib, MBA, RDN, LDN
A
dietary supplement is intended to
supplement the diet; has one or
more dietary ingredients (vitamins,
minerals, herbs or other botanicals,
amino acids, and other substances);
is taken by mouth in the form of a pill,
capsule, tablet, or liquid; and states
on the front label that it is a dietary
supplement. Dietary supplements are a
$37 billion industry in the United States
and 60 percent of women take them
regularly. Ongoing research suggests
that supplements, even mainstays like
calcium, can be harmful at high doses.
Unlike drug products, there are no
provisions in the law for the Food and
Drug Administration to approve dietary
supplements for safety or effectiveness
before they reach the counter. Once a
dietary supplement is marketed, the FDA
has to prove that the product is not safe
to take it off the market. In stark contrast,
before being allowed to market a drug
product, manufacturers must get FDA
approval by providing evidence that the
drug is both safe and effective.
It is impossible to know the quality
of a dietary supplement product
from its label. The degree of quality
control depends on the
manufacturer, the
supplier, and
others in the
production
process.
Dietary
94
supplements are not required by
federal law to be tested for safety and
effectiveness before marketing. The
supplements used in governmentfunded
clinical studies are supposed to
be analyzed for purity and standardized
for dose. Manufacturers are required to
do such analyses and supply the results
to the FDA. Yet, in a report which aired
in January 2016 on PBS’s Frontline
investigative series, few of the thousands
of supplement manufacturers comply
with this process. The FDA lacks the staff
and resources to analyze supplements
or to compel manufacturers to even
comply.
Standardization is a process that
manufacturers may use to make sure
of batch to batch consistency of their
products. Dietary supplements are not
required to be standardized in the United
States. The word ‘standardize’ on a
supplement label does not show product
quality.
As a result, the contents of a supplement
may not be what is described on the
label. In 2013, Canadian researchers
analyzed a random sample of 44
supplement products by 12 different
manufacturers. The results revealed
that more than half of the products
contained substances not listed on the
labels, some of which were potentially
harmful contaminants. In 2015, an
investigation by the New York attorney
JANUARY 2017
general revealed that only 21 percent
of the random samples of popular
brand supplements purchased from
GNC, Target, Walgreens, and Walmart
contained the ingredients in the amounts
listed on the labels. Some contained
no trace at all and some were primarily
fillers such as wheat and soy, which can
trigger allergic reactions in some people.
Studies have also revealed supplements
that are adulterated with steroid
hormones. When it comes to dietary
supplements, the familiar slogan “buyer
beware” is more relevant than ever.
The value of most herbs and
supplements remains unproven. Few are
worth the money spent on them. Even
more important, there is no guarantee
that the supplements contain any of the
ingredients listed on the label – no matter
how convincing it sounds or appears.
With all of this mounting evidence,
taking supplements can be risky. The
October 2013 publication of the New
England Journal of Medicine has a study
that highlights the adverse effects of
supplements. It states the supplements
were responsible for an average of
23,000 emergency room visits per year.
Work on powering up your health with
a well-balanced, nutrient-dense diet
complete with all the food groups as
your everyday value and source of
vitamins, minerals, and nutrients. Steer
clear of the supplement aisle. P