Complementary Alternative Cardiovascular Medicine

Chapter 2 / Herbs and Supplements 15
nutritionals and forbade the FDA from treating them as food chemicals
or as drugs unless manufacturers made drug claims for their products.
DSHEA allows dietary supplements to bear health-benefit claims called
“statements of nutritional support,” commonly referred to as structure/
function claims, because they may describe the effect of the supplement
on the structure or function of the body. These statements must be truthful
and not misleading and must be supported by scientific evidence.
Labels must carry a disclaimer that the product is not intended for treating,
curing, or preventing disease. With the passage of DSHEA, the
United States changed virtually overnight from one of the most hostile
regulatory environments in the world for herbs to one of the most permissive.
DSHEA allows fairly informative labeling of products without
previous government approval, yet it requires a scientific basis and truth
in labeling, which the FDA is empowered to enforce. However, there
have been some abuses of the new law because of both opportunists
making exaggerated claims and inadequate FDA scrutiny.
DSHEA is clearly a compromise solution to the regulation of herbs for
health care. Better models allowing more frank and informative labeling
of herbal products will surely arise. There is still no regulatory framework
for traditional forms of herbal medicine that are not based on
scientific research, for example TCM and Ayurvedic medicine. The
German regulatory system also lacks an appropriate mechanism for those
remedies, whereas the systems used in France, the United Kingdom, and
Canada may work somewhat better. These systems focus on informing
the public about traditional uses rather than expecting strong scientific
backing of all remedies.
The European regulatory model has provided greater research incentives
for herbs than the FDA model provides, which crippled American
medicinal plant research. European regulations made European drug
companies the leaders in natural product medicine. The changes in US
supplement regulation have finally opened the doors to better research
funding for natural products and more informative labels and labeling
for products.
TYPES OF HERBAL PRODUCTS
Herbal products span a range of different forms, from jars of dried
leaves, flowers, and roots to glossy, full-color boxes of blister-packed,
coated tablets that look much like conventional drugs. The most popular
forms of herbal products in the United States are capsules and tablets.
Most of these products contain standardized herb extract.
Other ancient types of herbal products are also still available. Many
health-food stores continue to carry hundreds of herbs in the original