[MOL] From Chirrs [00738] Medicine On Line

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To view this information with pictures and graphs in a web-friendly setting, please see http://www2.cancer.org/cid/6010.00/index.htm.

Copyright (c) 1999 The American Cancer Society, Inc.

The text of "Regulatory And Safety Issues For Drugs,  Nutritional Supplem" without the pictures and formatting follows:


In 1937, more than one hundred people died after taking Elixir Sulfanilamide,
the drinkable form of a sulfa medicine. The liquid base of that medicine was
diethylene glycol, a poisonous substance that can cause kidney failure and
death. The liquid sulfa drug, manufactured in Tennessee and sold throughout the
United States, had never been tested for toxicity. It didn't have to be tested,
because at that time there were no government regulations that required tests
for the safety of any drug sold in the United States.

The Food and Drug Act of 1906 did not require testing for safety. It only
governed misbranding of drugs and the adulteration of food and drug products. In
fact, the 1906 Act did not even require manufacturers to report information
about safety and efficacy (effectiveness).

Largely as a result of the liquid sulfa disaster, Congress passed the Federal
Food, Drug and Cosmetic Act in 1958. This Act required that manufacturers prove
the safety of any product that was to be marketed across state lines. It also
banned false and misleading labels on food, drugs, and medical devices.
Unfortunately, however, Congress exempted any drug already on the market and
covered under the 1906 Act. Manufacturers, therefore, did not have to prove the
safety of existing products, which remained for sale to unknowing consumers.

It took another major disaster to convince Congress that tighter regulation was
required to protect the American public. Thalidomide, a drug manufactured in
Germany, was widely distributed in Europe as a sedative. Of the many pregnant
women who took it, nearly four of each ten delivered disfigured babies. The
babies were born with deformed limbs or stumps where arms and legs should be.
The resulting publicity was worldwide, as were cries for protection.

Tennessee's popular Senator Estes Kefauver led the way. He chaired a committee
that was investigating the American pharmaceutical industry. The committee
produced a bill requiring proof that any drug marketed in the United States was
safe and effective. It passed Congress and became law, known as the
Kefauver-Harris Amendments or the Drug Amendments Act of 1962.

The act applied to every new drug and any drug sold after 1938. The Food and
Drug Administration was given the authority to enforce the regulations and serve
as a watchdog over the drug industry.

However, tens of thousands of over-the-counter drugs were available for sale
throughout the United States, and it was impossible to review and evaluate each
of them within a reasonable time frame. As a stopgap measure, the Food and Drug
Administration attempted to regulate this massive collection of potentially
harmful products by permitting their sale only if product labels did not claim
to prevent or cure disease. This plan did not work as well as had been hoped.
Some manufacturers and marketers of over-the-counter drugs, including dietary
supplements and herbal remedies, continued to make inappropriate and misleading

To this day, there is no regulation against making unproven claims for the food
supplements and herbs on the market. What is equally disturbing is the absence
of a regulatory process requiring manufacturers to provide any guarantee of what
the product contains or fails to contain. And nothing prevents sellers from
making indirect unproven claims by quoting people who say they were "cured" of
various ailments after using food supplements.

As a result, we are in a "let the buyer beware" mode when it comes to
nutritional supplements and herbal medicines. There is no dependable way to know
for sure if a product that claims to contain, for example, 400 milligrams of an
active ingredient actually includes that amount, and no way to know what other
items, including dirt, are also contained in each capsule.

Bee pollen is a good example of a currently unregulated product often sold in
nutritional food stores. Bee pollen sometimes includes insect feces, rodent
hairs and other impurities, ingredients that are not listed on the label. No
regulations control the purity of the product. Nor is there scientific evidence
that it is helpful.

There is a great need for public protection in this area. To this day, there is
no requirement for proof of safety, accurate labeling, or proof of a health
benefit for nutritional supplements or herbs sold in the United States. Congress
has seen the need to protect the public against harmful prescription
medications, but this protection is not extended to products sold
over-the-counter in health food stores and pharmacies.

An attempt was made in Congress to pass such protective legislation. However, a
multimillion dollar effort by the food supplement industry resulted in passage
of a watered-down Dietary Supplement and Health Education Act of 1994. That
legislation "protected" from review 20,000 vitamins, herbs, minerals, and any
other food supplement then on the market. The regulation gives the Food and Drug
Administration permission only to stop production of a product after the fact:
when the FDA proves that the product is dangerous to the health of Americans.
Manufacturers still are not required to show that their products are safe or

There are other government controls that apply to the sale of nutritional
supplements and herbal remedies. The U.S. Postal Service (USPS) controls
products marketed through the mail. From time to time, it has challenged
products accompanied by outlandish claims of cure for cancer and other diseases.

The Federal Trade Commission regulates the advertising of food, cosmetics,
non-prescription products, and some other health-related goods and services that
are sold across state lines.

Individual states also have regulatory powers through licensing laws. State
boards can regulate medical and dental practices. A few states have new laws
regulating alternative and complementary therapies and their use by physicians.

But the public still has limited protection against the marketing of products
that often promise much and produce little if any benefit. Indeed, some products
marketed in health food stores have recently been removed from shelves only
after serious harm and even death from those products were reported.

Until Congress passes useful legislation, the challenge is to determine which
products are safe and which are not. Read labels carefully and talk with a
nutritionist or your doctor before you buy.

 Revised:   01/06/98                                                            

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