What FDA Says About Natural Supplements

Subject:	What FDA Says About Natural Supplements
Date:	Sat, 16 Jan 2010 14:07:54 -0800 (PST)

What FDA Says About Natural Supplements

The following write-up includes FDA positional statements on dietary
supplements, their safety, and regulation. You can read these
comments at http://vm.cfsan.fda.gov/~dms/supplmnt.html. If you have
questions, you may contact FDA at 1-888-INFO-FDA.

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Those who claim that the vitamin and herbal supplement market is
without regulatory review and oversight are misinformed. DSHEA (the
Dietary Supplements and Health Education Act of 1994) provides the
legal framework for such oversight, FDA supports and operates within
that framework, and FTC regulates, and enforces, ethical dietary
supplement advertising. Although DSHEA has been extremely effective
for more than a decade, the pharmaceutical lobby has been hard at work
trying to destroy this consumer-supported legislation in an effort to
extend its monopolistic reach following one of the largest illegal
conspiracies in corporate history: the drug industry's failed
artificial vitamin price fixing scheme, uncovered in the late 1990s.
Consumers in the US who object to this anti-trust style of behavior on
the part of industry should contact their representatives immediately
to express their support for DSHEA. For those of us who take our
personal health seriously, I encourage you to become better informed
about the benefits of using natural medicine in your personal lives.

The drug companies are making a lot of noise about the dangers of
nutrients in human health using their anonymously funded guerilla PR
tactics and media-friendly outlets. What are the real facts? The
following should help clarify the safety "concerns" raised by industry
insiders whose real agenda is control of markets, increased mind
share, and profits.

It is lawful under DSHEA for supplement product claims on labeling,
and in advertising, to "describe a link between a nutrient and the
deficiency disease that can result if the nutrient is lacking in the
diet." FDA also agrees that such claims can "refer to the
supplement's effect on the body's structure or function, including its
overall effect on a person's well-being." The law requires that such
health claims have a scientific basis, otherwise FTC can censure the
maker and take legal action against it. FDA further advises that
"individual states can take steps to restrict or stop the sale of
potentially harmful dietary supplements within their jurisdictions."
And that "dietary supplement manufacturers wishing to market a new
ingredient (that is, an ingredient not marketed in the United States
before 1994) have two options. The first involves submitting to FDA,
at least 75 days before the product is expected to go to market,
information that supports their conclusion that a new ingredient can
reasonably be expected to be SAFE [emphasis added.] Safe means that
the new ingredient does not present a significant or unreasonable risk
of illness or inury under conditions of use recommended in product
labeling." Obviously, FDA reviews such applications, evaluates them,
and may choose to reject them. DSHEA provides the guidelines for this
review and approval process, and has been protecting consumers for
over a decade.

Based on FDA advisement, dietary supplements are unlikely to present
unique risks to consumers, however "as with all products on the
market, consumers need to be discriminating. FDA and industry have
important roles to play, but consumers must take responsibility,
too." In other words, this applies equally to the use of
pharmaceutical drugs. Doctors are NOT AWARE of the elevated risks
associated with any drug prior to its recall, nor to unique risks
following post-trial adverse effects that go unreported until after a
drug has gone to market. It is therefore incumbant upon consumers to
weigh the risks using all facts at their disposal before using EITHER
a pharmaceutical drug or dietary supplement.

Thousands of pharmaceutical drugs have been recalled over the past
several decades, with some 300 individual drugs recalled or relabeled
annually. It is expected that 20% of all prescription medications
will be recalled at some point in the future. Out of thousands of
dietary supplements sold on the world markets, only two have been
found to represent an elevated risk to consumers, although many
disagree that such "risk" was based on good scientific review of the
facts. In one such case, the agent responsible for toxicity response
was external contamination. Following are some of the major drugs
that have required updated adverse health warnings or which have been
recalled altogether:

Accutane
Ativan
Avandia
Baycol
Bextra
Celebrex
Cold-Eeze
Ephedra
Fen-Phen
Lariam
Lamictal
Lamisil
Lotronex
Meridia
Naproxen
Neurontin
OxyContin
Paxil
PPA
Propulsid
Protopic
Redux
Rezulin
Risperdal
Serevent
Seroquel
Serzone
Thimerosal
Viga
Vioxx
Zicam
Zoloft
Zyprexa

When purchasing dietary supplements, choose well-established and
reputatable manufacturers who have a history of building loyal
relationships with their customers. See a partial list below. A
number of these manufacturers are publicly traded and report to
shareholders. Many conform voluntarily to GMP standards of quality
production, and a growing number provide ingredient assays (batch
quality documentation) on request to those who ask. For more
information on nutrition and vitamin supplements, visit http://www.supplementinfo.org.
I have personally used the products of many of these companies, though
certainly not all of them. I placed two "**" to the right of those
names I feel offer exceptional products or value. [note: Since this
list was compiled a while back, I apologize if some of these sellers
may no longer be operational.]

Reputable Dietary Supplement companies:

A.C. Grace Company **
Abkit
Action Labs
Alacer
Allergy Research Group, Nutricology **
Allimax International Ltd
Almased USA
Alvita Teas
American Bioscience
American Biotech Labs
Aroma Vera
At Last Naturals
Atlas World
Avalon Natural Products
Bach Original Flower Essences
Barlean's
Benfotiamine.Net, Inc.
BIJA Teas by Flora
BioCalth International
Biochem **
Biomed Comm
BIOS Biochemicals
BioTech Corp
Birkmayer Health Enada
BNG Enterprises
Body Rewards by Enzymatic Therapy
Bodyonics (Pinnacle)
Boericke & Tafel (B&T) **
Boiron
California Health
California Life
Camo Care (Abkit)
Carlson **
Club Natural
Country Life, BioChem **
CreAgri
Cytodyne
Desert Essence
Doctor's Best **
Dolisos
Dr. Atkins Diet
Dr. Linus Pauling by Omni Nutraceuticals
Earth Essence
Earthrise
Earth's Bounty
EAS, Inc.
East Park Research **
Eclectic Institute**
Effective Nutrition Inc.
Emerita
Enzymatic Therapy**
Enzymedica**
EPI
ERBL (Coromega)
Essential Formulas Inc (Dr. Ohhira's)
Ethical Nutrients**
Flora**
FoodScience Of Vermont
Fountain of Youth Technologies
Futurebiotics
Gaia Herbs Inc. **
Garden of Life **
Green Foods (Magma) Corporation
Grifron Maitake
Health from the Sun
Health Logics
Health Plus Inc.
Herbal Powers
Herbal-Vedic
Himalaya USA **
Hyland's **
Immune Tree
IQ Air
Iron Tek
Irwin Naturals
ISS Research
Jarrow Formulas **
Kare n Herbs
Ketogenics
Kokoro
Kombucha 2000
Lane Labs **
Lichtwer Pharma
Liddell
Life Enhancement **
Life Extension Organization **
Living Harvest
Long Life
Mega Food **
Mt. Capra Mineral Goat Whey
Muscletech
Mushroom Wisdom
Natren
Natrol **
Natural Balance
Natural Care
Natural Factors
Naturally Vitamins
Nature Works (Abkit)
Nature's Answer
Nature's Apothecary (Now Foods)
Nature's Benefit
Nature's Herbs
Nature's Secret
Nature's Way **
Nutrient Carriers Inc. (NCI) **
New Chapter **
Novogen
Now Foods **
NuAge (Hyland's)
NuNaturals
Nutiva
NutraLife
NutriBiotic **
Nutrilabs
Nutritech (All One)
Olympian Labs Inc.
Organic by Nature (Formerly G.K.C. Int'l)
Pacific Biologic
Paradise Herbs
PEELU
Phi Sciences (Mega-H)
Physician Formulas
Planetary Formulas
Port Trading Co
Prevail (Enzymatic Therapy)
Proper Nutrition Inc.
Pure Essence Labs
Purity Products
Quality of Life Labs
Rainbow Light
Raintree Nutrition
RoseCreek
S. L. Sanders & Co.
Sambuca **
Scandinavian Formulas
Silver Lake Research
Similasan **
Sky Bio Health
Solgar **
Source Naturals **
Sun Chlorella Corp.
Super Nutrition
Sweet Leaf
Swiss Bioceutical
Symbiotics
The Republic of Tea
Thompson
Tiger Balm
Tom's of Maine
TPCS
Trimedica **
TrimSpa
Vitality Works
Viviscal
Wakunaga (Kyolic Garlic) **
Wellwisdom (ImmunoPro)
World Nutrition Inc. (Vitalzyme) **
World Organic **
Yalacta
Yerba Prima
Zand **