Line Between Supplements and Drugs
Wyn Snow, Managing Editor
goodbye to Cholestin -- a dietary supplement that has been proven
to lower cholesterol and is made from red yeast. A US Court of Appeals
recently upheld the FDA's ban on importing red yeast rice powder
-- agreeing with the agency's argument that it is legally a drug
rather than a food or dietary supplement.
is red yeast?
yeast is a nutritional yeast -- used both in Chinese cooking as
a spice and by traditional Chinese medical practitioners "to improve
blood flow." It is grown on rice by fermentation, and is the main
ingredient in Cholestin, a dietary supplement manufactured by Pharmanex.
Pharmanex has conducted scientific research that demonstrates Cholestin's
effectiveness in lowering cholesterol.
claims that Cholestin is actually a drug
yeast is a complex substance. One component (called mevinolin) is
chemically identical to lovastatin, the synthetic compound in Mevacor,
Merck's cholesterol-lowering drug. Red yeast contains a relatively
low amount of mevinolin -- but also contains other similar compounds,
all of which appear to work together in reducing the body's production
of cholesterol. However, the FDA claims that by manufacturing Cholestin,
Pharmanex is actually manufacturing and marketing lovastatin.
not allowed to be "natural equivalents" of drugs
says that substances that have been approved as drugs cannot be
marketed as dietary supplements. Congress wanted to prevent drug
manufacturers from evading the FDA's drug-approval process by finding
naturally occuring equivalents to approved drugs and marketing them
as dietary supplements.
a substance that has already been marketed as a dietary supplement
or a food is exempt. It does not lose its status as a food if the
FDA later approves that substance for use as an active ingredient
in a new drug.
though red yeast has been used as a spice and dietary supplement
for centuries by the Chinese and for decades in the US, neither
mevinolin nor lovastatin had been marketed as a dietary supplement
or as a food prior to lovastatin's approval as a new drug in 1987.
before the court: What is a drug?
issue addressed by the Court of Appeals had to do with whether this
exclusion and exemption in the language of DSHEA applied to lovastatin
as an active ingredient in an approved drug -- or whether the term
"new drug" meant only the finished product as a whole (namely Mevacor).
unless the language in a law makes Congressional intent unambiguously
clear, government agencies have wide latitude to interpret and enforce
the terms of a law pretty much as they see fit -- unless that interpretation
and enforcement is "arbitrary and capricious". In this case, the
Court of Appeals held that the FDA's interpretation was reasonable
-- and that a single active ingredient qualifies for protection
under this exclusion.
the Court allowed the FDA's assertion that Cholestin is a drug because
it contains mevinolin, which is chemically identical to lovastatin.
The Court of Appeals did not address other issues in the original
suit because the lower court had not addressed them either. The
decision remanded the case back to the lower court for consideration
of these other issues.
When is a tomato not a tomato?
suppose that a company creates "Lycodin", a product based on lycopene,
which is an antioxidant found in tomatoes and certain other red-colored
fruits and vegetables. (Research indicates that lycopene may lower
the risk of cancer and heart disease.) Let's suppose further that
Lycodin gains FDA approval as a new drug -- and in the meantime,
no one markets lycopene itself as a dietary supplement. According
to this court decision, the FDA could then claim that tomato powder
is a drug because it contains lycopene, an active ingredient in
this fictional drug Lycodin.
ludicrous, doesn't it? But taking this hypothetical case one step
further, let's suppose another company creates "Tomatesso", a lycopene-enhanced
tomato-based powder, and sells it either as a food or a supplement
-- after Lycodin's approval as a drug. The FDA could remove Tomatesso
from the market, ruling that it was an unapproved drug because it
contains lycopene, the active ingredient in Lycodin.
is exactly what is happening to Cholestin.
it really matter if Cholestin disappears?
reasonable person might wonder whether it matters if we eat red
yeast, take Cholestin, or get a prescription for Mevacor. Isn't
the end result "mostly the same"?
Prescription drugs are expensive and often have unwelcome side effects.
The toll on our economy and on public health is unacceptably high.
We need alternatives -- the kinds of alternatives that researchers
are discovering among dietary supplements.
Cholestin apply for approval as a new drug?
course -- but this process takes years (usually 8-10 years), hundreds
of millions of dollars (typically $300-$500 million), and the production
of enough pieces of paper to fill a railroad car. And the end result
would be another expensive product that we'd need a prescription
it makes more sense to go ahead and use the knowledge that is already
available from centuries of use in Chinese medicine, knowledge that
includes how to use this substance safely and effectively -- and
add to that knowledge with Western scientific inquiry. The American
public is entitled to choose from among a wide array of health products
-- including dietary supplements.
wise, pound foolish
FDA is charged by the Food, Drug, and Cosmetic Act with protecting
public health and preventing consumer fraud. Yet its action against
Cholestin accomplishes neither of these goals. Public health is
improved rather than threatened by Cholestin. Also, research has
demonstrated that Cholestin is effective, so there is no question
of fraud. The main result of the FDA's action here is to protect
Merck from a competing food-based product.
health is best served by an FDA that focuses less on restricting
beneficial dietary supplements and focuses more on identifying and
weeding out the harmful or ineffective ones.
ago, the Greek physician Galen (AD 130-200, the founder of Western
medicine) used foods to treat disease, just as we now use drugs.
In the intervening years, healers in all cultures used both foods
and medicinal plants. Science gradually learned how to identify
and isolate specific compounds to treat disease. Researchers are
now investigating the ways in which complex groupings of chemicals
in foods and other botanical resources act to promote health and
are now gaining scientific knowledge of a continuum of substances
ranging from food (tomatoes, oats, soy, broccoli, red yeast) through
supplements (Cholestin) to drugs (Mevacor). It is time to recognize
that all three have valuable and interdependent rather than separate
roles to play in human health -- and to preserve and expand our
freedom to use these substances.