Sep 1 2003
In order to understand the problems one must know the different ways in which the law deal with herbals, etc. as opposed to the responsibility for prescription and over the counter drugs. The FDA must pre-screen all prescription and over the counter drugs with peer reviewed science that demonstrates they are safe and effective. A 1994 federal law, pushed by the industry, exempted supplement companies from federal regulation, including the reporting of adverse reactions. The FDA must prove that one of these products is dangerous before it can be removed from the market - the reverse of normal drug approvals that, first, must prove safety before the drug is available.
The following list itemizes some of the specific problems with unregulated products:
1. Tests of many of these products reveal dangerous contaminants such as lead, arsenic, or mercury.
2. Poor quality control - often every container has a different strength and different ingredients.
3. The potency of the pill may not match what the label says.
4. The supplements industry has almost no accountability and can almost do anything it wants.
5. Pharmaceutical companies manufacturing prescription and over the counter drugs can not advertise a medical benefit that research does not support. Supplement companies have a great deal of leeway in their advertising. In our book Worst Pills Best Pills we stated "the promotion of nutritional supplements is now reminiscent of the 'snake oil' sales seen at the beginning of the 20th century."
It is of concern to us that we are receiving more and more mail with people describing negative effects from herbals or dietary supplements they are using. Poison control centers are also reporting increased adverse reactions to a broad range of supplements and a disturbing trend of increasing numbers of children being adversely affected. A guiding rule is that everything reacts to everything else and one must make decisions with their physicians of the risks and benefits of any particular product. Never assume because something is natural or over-the-counter that it is safe. A common misconception is that some people believe if a product weren't safe, the government would not allow it to be sold. Never use these products without your doctor's knowledge- they may react or interact with prescription drugs you are taking.
We believe the public has a right to a marketplace free of untested products that can be sold for unsubstantiated uses. The passage of the Dietary Supplement Health and Education Act (DSHEA) stripped the FDA of any authority to act proactively to ensure the public's safety. The DSHEA has left American consumers almost without protection in the anarchistic dietary and herbal supplement marketplace. With the proliferation of dietary supplements, the public seems to have forgotten the basics - proper diet, exercise, and a lifestyle compatible with good health - supplements can't take their place.
The goals of the Health Research Group are to educate the public about critical health issues, and to monitor the state and federal agencies which regulate the delivery of health care and the safety of drugs, medical devices, food, and environments. Our small staff's time is spent pursuing these goals, and we are unfortunately not able to respond in detail to questions raised in the tremendous amount of mail we receive.
Betty Blount, RN BSN
Public Citizen Volunteer
