Complementary Alternative Cardiovascular Medicine

20 Alternative Cardiovascular Medicine
In some cases, the laboratories used different testing methods than those
used by the product manufacturers. Nonetheless, each publication reported
a significant number of products that failed to meet label claim. This
highlighted problems of consistency and probably ethics in the industry
and considerably damaged public confidence in herbal products. To
date, the herb industry has been unable to implement effective selfregulation,
and the FDA has simply failed to act against products that fail
to meet label claim, although it is its responsibility to do so. FDA spokesmen
claim that the problem is the industry is “unregulated,” but in a
hearing before a congressional subcommittee, FDA Commissioner Jane
Henney, MD, affirmed that the FDA has adequate authority and bears
responsibility for regulating supplements, including herbal products.
INTERPRETING SUPPLEMENT LABELS
Claims
In the United States, supplement marketers can make “statements of
nutritional support,” often called “structure/function claims,” because
they describe the way an herb affects the structure or function of the
body. Wellness claims about maintaining healthy body functions are
acceptable, if there is evidence to support such claims, and drug claims
that the product is intended to treat or mitigate disease are not allowed.
For example, consider possible label claims for garlic. A garlic product
might claim “helps maintain healthy cholesterol levels” or “helps maintain
heart health,” but, if the label claimed that the herb “helps prevent
heart disease,” the product would be considered a mislabled drug. Here
are some more examples:
• Saw palmetto is effective against prostate enlargement. Illegal drug
claim: “Relieves symptoms of prostate enlargement.” Legal statement
of nutritional support: “Helps maintain prostate health.”
• Echinacea stimulates the immune system and reduces the frequency
and duration of colds. Illegal drug claim: “For colds and flu.” Legal
statement: “Boosts natural resistance.”
Other countries employ similar compromises. In England, products
may be labeled “a traditional herbal remedy for (insert condition: sleep,
menstrual disorders, etc.).” In France, herbs may be labeled “traditionally
used for (condition).”
People are capable of understanding the difference between “take two
aspirins for headache” and “a traditional herbal remedy for headache.”
The American situation is more complex, but people can understand that
herbal dietary supplements are not the same as conventional medicines,
although they may have similar uses in health care.