|
_alternative medicine _
By: bmj
The US Food and Drug Administration (FDA) has relaxed guidelines for the sale
of herbal supplements. Its decision has opened the way for manufacturers of
vitamins, herbs, and dietary supplements to market their products for
conditions such as morning sickness, hot flushes, and memory loss in ageing
without first proving that they are safe or effective. The decision marks the
latest in a series of legal and regulatory victories for the dietary
supplement business, which has been growing since Congress passed a law in
1994 that severely restricted the FDA's authority to regulate it. Under the
new law, manufacturers of dietary supplements can make claims about how their
products affect the structure or function of the body, but they may not claim
to prevent, treat, cure, mitigate, or diagnose a disease without prior FDA
approval. The move angered and surprised consumer advocates. This is a
snake-oil exemption, said Dr Sidney Wolfe, director of the Public Citizen's
Health Research Group in Washington, it's a complete cave-in to the
industry. Agency officials insist that the rule, which will take effect from
7 February, is an important part of their 10 year strategy to increase
consumer confidence in the safety, composition, and labelling of vitamins,
herbs, and other nutritional aids. The new law is part of the Dietary
Supplement Health and Education Act, which distinguishes between products that
claim to affect the structure or function of the body and those that claim
to prevent, treat, or cure disease. The law allows the manufacturers of
supplements to sell products without the FDA's rigorous safety and efficacy
review that is required of drugs, as long as they make claims related only to
structure or function and not to disease.
Word Count: 284
|
