Douglas Andersen, DC, DACBSP, CCN
11, number 23, 11/5/93, page 14
I am the first to admit that sometimes the word crisis
is overused. It seems every new year brings another crisis aimed at our
profession. With so much emphasis on chiropractic's role in the Clinton
Health Reform Plan, some of us have overlooked the fact that the FDA would
like to eliminate herbs, amino acids, and accessory nutrients from the
marketplace. They would also like to limit vitamin and mineral supplements
to RDA levels. This is based on their interpretation of the Nutrition
Labeling and Education Act (NLEA). I do not know why the FDA seems so
bent on trying to deny Americans their right to choose dietary supplements.
I have no problem with them attacking frauds whose labels do not reflect
content. I also have no problem with the FDA preventing companies from
making false claims or removing dangerous substances from the market.
I do have a problem with an out-of-control agency that seems to have a
vendetta against an industry whose goals are improving health and preventing
disease. Luckily, we have a solution: S784 and HR1709.
A Bit of History
In 1962 the FDA tried to set limits for amounts nutritional supplements
could contain. They backed down when the people strongly protested.
In the late 1960s to early 1970s, the FDA attempted to: (1) classify any
vitamin as an over-the-counter drug if it exceeded 150% of the RDA; (2)
remove vitamins A and D from the market, making them prescription only;
(3) prohibit most combinations of vitamins and minerals. In 1976 a congressional
amendment to the Food, Drug, and Cosmetic Act prevented the FDA from implementing
numbers 1, 2, and 3.
In the mid to late 1970s the FDA went to court when Congress again rejected
their attempt to regulate vitamins and minerals as drugs. The courts also
denied the FDA.
In the 1980s the FDA prevented manufacturers of bran cereals from making
mention of the benefits of fiber for cancer and other intestinal disorders.
They also prevented health claims about fruits and vegetables for heart
disease and cancer. Companies could also not mention the sodium and hypertension
connection, nor that high-fat diets may be carcinogenic and/or accelerate
In the 1990s, the FDA caved in with overwhelming pressure from science,
Congress, other government agencies, and the citizens, and now food manufacturers
are able to make a few health claims.
From 1983 to 1990 statistics from the poison control centers showed one
death from vitamin overdose. In the few instances where illnesses resulted
from supplements, clear abuse over a long period of time was demonstrated.
In contrast, there are hundreds of deaths on record where patients died
from drugs--not just overdoses, but when taken in prescribed quantities
Last year the Dietary Supplement Act of 1992 was passed. It imposed a
one year moratorium on the FDA's interpretation of NLEA so rational legislation
could be drafted to protect consumers' freedom of choice.
Today, the FDA continues to ban manufacturers from making claims for nutrients.
A few examples are folic acid and its ability to protect against neural
tube defects, vitamin E and the reduction of heart disease, antioxidants
and the risk reduction of some cancers, and the cardiac-protective benefits
of omega-3 fatty acids. Anyone who reads the newspaper knows there are
volumes of scientific evidence for the above examples, yet the FDA maintains
it can prosecute any supplement manufacturer or retailer who provides
consumers with copies of scientific studies, medical articles, or reports
that mention the positive effects of dietary supplements.
As mentioned previously, the FDA interprets the NLEA to give them the
right to make amino acids available by prescription only. They point to
L-tryptophan as to how dangerous amino acids can be. It is this author's
opinion that the ban on L-tryptophan is ludicrous. How can Americans take
an amino acid safely for over 30 years and then suddenly get sick. Clearly,
those people who contracted eosinophilia myalgia were not taking real
tryptophan, but a contaminated copy. Yet the FDA continues to keep it
off the market. At the same time, manufacturers can add it to infant and
pet foods. Have you seen any babies or animals get eosinophilia myalgia
lately? I haven't. Uncontaminated tryptophan is an exceedingly safe substance.
I am baffled as to what motivates these folks.
If S784 and HR1709 are not passed, herbal medicine will be in deep trouble.
We are starting to see excellent studies on the benefits of a wide variety
of herbs. The last thing Americans need in the coming years is for the
FDA to shut down an entire industry that could potentially save us billions
of dollars in healthcare costs. The FDA's pattern of suppressing large
bodies of knowledge and preventing citizens from getting this information
to make their own decisions on how to improve their health is unforgivable.
The following is a quote from the congressional record in the Senate from
April 7, 1993: "In sum, over the past 30 years, FDA has tried to
prevent consumer education regarding the disease prevention properties
of vitamin A, vitamin C, vitamin E and other dietary supplements, and
at times has attempted to assert that many of these products were unsafe.
At the same time the agency has readily allowed people to eat conventional
food products that are high in saturated fat, cholesterol, caffeine, and
calories, or that have few important vitamins and minerals." With
friends like this, who needs enemies? A quote from Senator Hatch's literature
on S784 sums it up nicely: "The agency's position is not only absurd,
it is dangerous."
S784 defines supplements as (1) vitamins; (2) minerals; (3) amino acids;
(4) herbs; and (5) other ingredients for use by man to supplement diet
by increasing dietary intake. This includes concentrates or extracts of
any ingredient described above.
S784 maintains the FDA's authority to take action against toxic substances
or supplements that have a high risk for illness or injury. The FDA can
also intervene if a company uses unsafe material. The determination of
what is safe can be from (1) well-designed scientific studies; (2) A HISTORY
OF SAFE USE; or (3) THE ABSENCE OF ADVERSE SAFETY INFORMATION (my emphasis
on 2 and 3, and a major point of contention of the opposition).
S784 allows agencies to investigate major manufacturing changes to insure
public safety (hopefully, a problem like the manufacturing flaws of L-tryptophan
will never happen again).
S784 orders the FDA in consultation with other agencies to establish new
daily nutrient values based on HEALTH PROMOTION AND DISEASE PREVENTION
instead of the minimum amount of nutrients required to prevent frank deficiency
(my emphasis above--it's about time).
S784 allows health claims for nutrients if (1) the FDA has already approved
the claim for a food that contains the nutrient; (2) the claim reflects
the total body of scientific evidence; (3) TRUTHFUL, NONDISEASE CLAIMS
RELATING TO THE SUBSTANCE'S EFFECT ON THE BODY MAY ALSO BE MADE (another
key point in this bill).
S784 provides administrative hearing and judicial review for manufacturers,
processors, distributors, packers, and retailers if the FDA feels a violation
has occurred. They can only shut down a company if they have proof the
substance or supplement poses an imminent health hazard (the Gestapo tactics
will finally come to a halt).
S784 establishes an Office of Dietary Supplements which will keep up with
current nutritional information from research and studies and advise the
Department of Health and Human Services, the Centers for Disease Control,
and the FDA on issues of importance.
The discussion of this bill is due to come up before the end of the year.
Now is the time to write, fax, or call your representatives and senators
to support S784 and HR1709. Let's make the FDA work for the people instead
of against them.
1. Senator Orrin G.
Hatch, a summary of S784, The Dietary Supplement Health and Education
Act of 1993.
2. Health and Healing. S3(9). Potomac: Phillips Publishing, Inc. September
3. Health and Healing. S3(6). Potomac: Phillips Publishing, Inc. June
4. The Congressional Record of the Senate from April 7, 1993.
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2004, G. Douglas Andersen, DC, DACBSP, CCN, 916 E. Imperial Hwy, Brea,
CA 92821, (714) 990-0824