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The Willner Window Product Reference Catalog, Winter 2018
Since 1911
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Willner Chemists: The Nutritional Supplement Professionals
The Willner Chemists web site is a valuable resource for information on nutritional supplements how to choose
them, and how to use them.
. . . and remember to visit Don’s Blog
Dietary Supplements:
Safe, Beneficial and Regulated
Q. Who is the dietary
supplement industry?
A. In the U.S., the dietary supplement
industry is a $41 billion industry. Dietary
supplement products include vitamins,
minerals, botanicals, sports nutrition
supplements, weight management
products and specialty supplements.
These products are intended to be used
as supplements to, not substitutes for, a
well-balanced diet and a healthy lifestyle.
When used properly, they help promote
overall good health and prevent disease.
More than 170 million Americans take
dietary supplements annually.
Q. Is the dietary supplement
industry regulated?
A. Yes. The dietary supplement industry is
regulated by FDA and the Federal Trade
Commission (FTC). The FDA has
regulatory authority under the Federal
Food, Drug and Cosmetic Act as
amended in 1994 by the Dietary
Supplement Health and Education Act
(DSHEA) and in 2006 by the Dietary
Supplement and Nonprescription Drug
Consumer Protection Act.
Q. Why do some people say the
industry is unregulated?
A. When critics say dietary supplements
are "unregulated," what they generally
mean is that dietary supplements are not
regulated like drugs. Dietary supplements
have always been regulated as a category
of food in this country, and DSHEA did
not change that fact. Virtually all facets of
dietary supplement manufacturing,
labeling and marketing are covered by
extensive regulations issued and enforced
by FDA and FTC. If dietary supplements
were regulated like drugs, there would
likely be no dietary supplement industry
and the products that did exist would
cost what drugs cost.
Q. Is it true that before DSHEA
was passed in 1994, FDA had
pre-market approval authority?
A. No. FDA never had pre-market
approval over dietary supplements, and
DSHEA did not change that fact. Under
the law, dietary supplements marketed in
the U.S. before passage of DSHEA are
"grandfathered" and assumed to have a
history of safe use. If a supplement
manufacturer wants to introduce a new
ingredient, it must provide FDA with 75
days notice, along with safety
information. If FDA has any concerns
about the ingredient or submitted safety
profile, the agency can request more
information or deny the product's entry
into the marketplace. Since the passage
of DSHEA, FDA has turned down about
half of the New Dietary Ingredient
notifications filed.
Q. Without pre-market approval,
how do we know these products
are safe?
A. Pre-market approval is not a guarantee
of safety as witnessed by those drug
products that have been approved by
FDA, only to be later recalled due to
safety concerns. Like food products,
dietary supplements do not undergo pre-
market approval, but that does not mean
that companies don't do testing, or that
products are unsafe. There are provisions
under DSHEA that protect consumers
from potentially unsafe products. But the
overwhelming majority of dietary
supplements are safely used by 170
million Americans annually.
Q. What did DSHEA do?
A. DSHEA specifically reaffirmed the
status of dietary supplements as a
category of food and created a specific
definition for dietary supplements.
Further, DSHEA provided FDA with
additional enforcement authority,
including the ability to remove from the
market products the agency deems
unsafe through: 1) an "imminent hazard"
clause which permits FDA to
immediately remove a product it
considers to present an immediate safety
concern and 2) a "significant or
unreasonable risk" clause that allows
removal of a product considered to pose
an unacceptable risk of illness or injury.
Q. Shouldn't companies have to
abide by Good Manufacturing
Practices (GMPs)?
A. Absolutely. It's the law. Responsible
companies do abide by GMPs and many
observe procedures which go above and
beyond what the current regulations
require. In June 2007, GMPs specific to
dietary supplements were released from
FDA. The GMP rule provided a staggered
three-year "phase in" compliance period
for manufacturers. And for large
companies more than 500 employees
the compliance date was June 2008.
Firms with less than 500 employees had
to be compliant by June 2009, and for
small manufacturers that employ less
than 20 employees, the compliance date
was June 2010. Responsible companies
in the industry have fully supported the
need for dietary supplements GMPs in
order to create a level playing field for
companies across the board and help
increase consumer confidence in the
quality and safety of these products.
Q. Should serious adverse events
associated with dietary
supplements be reported to
FDA?
A. Yes. CRN and mainstream industry
supported the Dietary Supplement and
Nonprescription Drug Consumer
Protection Act which passed the 109th
Congress and was signed into law by
President Bush on December 22, 2006.
The law requires manufacturers to notify
the FDA of all serious adverse events
associated with an over-the-counter drug
or a dietary supplement that they
receive. This law strengthens the
regulatory structure for dietary
supplements and builds greater consumer
confidence in this category of
FDAregulated products thus ensuring and
protecting Americans' continued access
to safe, beneficial dietary supplements.
Consumers have a right to expect that if
they report a serious adverse event to a
dietary supplement manufacturer FDA
will know about it.
Q. Is DSHEA a good law?
A. Yes. DSHEA provides an appropriate
framework for regulating the dietary
supplement industry as long as it is
enforced. In the past several years, FDA
has actively engaged in more vigorous
implementation of DSHEA and stronger
enforcement actions these efforts are
encouraged and supported by the
mainstream dietary supplement industry.
Even top officials at FDA have stated they
are not asking Congress to change the
law, noting they have adequate authority
to remove unsafe supplements from the
market. DSHEA provides FDA with
appropriate regulatory authority while
still allowing consumers to have the
desired access to a wide variety of
affordable, high quality, safe and
beneficial dietary supplement products.
Reference: (1) 2016 Nutrition Business
Journal
Council for Responsible Nutrition
W
e still hear ignorant, biased and irresponsible
comments on TV, radio, etc about dietary
supplements. Some of the TV "medical experts"
are the worst offenders. We have responded to this
nonsense many times in the past. I'm tired of it. But, for
those who might still worry, I am including the following
from the Council for Responsible Nutrition.
The pharmacists and
nutritionists at Willner
Chemists will be happy to
assist you in choosing the
most appropriate
product for your needs.
