The list is a short one!
In the US, herbal products and food supplements are largely unregulated.
That is, the products are not screened or subject to FDA approval
prior to their going on the market. Rather, it is the product
manufacturer that has the responsibility to make sure that anything
being sold as a food supplement is safe.
For that reason, you will often see statements on herbal products sold
in the US to the effect of: "This statement has not been evaluated by
the FDA. This product is not intended to diagnose, treat, cure, or
prevent any disease". You can see a bit about this, here:
and you can read about FDA's role in what they call dietary supplements, here:
FDA regulates dietary supplements under a different set of regulations
than those covering "conventional" foods and drug products
(prescription and Over-the-Counter). Under the Dietary Supplement
Health and Education Act of 1994 (DSHEA), the dietary supplement
manufacturer is responsible for ensuring that a dietary supplement is
safe before it is marketed. FDA is responsible for taking action
against any unsafe dietary supplement product after it reaches the
market. Generally, manufacturers do not need to register their
products with FDA nor get FDA approval before producing or selling
Given the FDA's limited role in oversight of herbal products, and
other dietary supplements, very few of them are actually regulated.
In fact, I am only aware of one class of supplements that has been
out-and-out banned as too dangerous -- ephedrine:
FDA Issues Regulation Prohibiting Sale of Dietary Supplements
Containing Ephedrine Alkaloids
A number of other supplements are subject to FDA warnings to
consumers, and these can be seen here:
Warnings and Safety Information
The list includes:
FDA Concerned About Botanical Products, Including Dietary Supplements,
Containing Aristolochic Acid
FDA Advises Dietary Supplement Manufacturers to Remove Comfrey
Products From the Market
Hepatic Toxicity Possibly Associated with Kava-Containing Products
FDA alerts consumers and health care professionals about LipoKinetix,
a dietary supplement weight loss product.
FDA Issues Nationwide Alert for "Liqiang 4" Due to Potential Health Risk
PC SPES and SPES
MedWatch Safety Alert: Consumers Warned to Stop Using the Dietary
Supplement/Herbal Products PC SPES and SPES
St. John's Wort and Indinavir
FDA Public Health Advisory: Risk of Drug Interactions with St. John's
Wort and Indinavir and Other Drugs
FDA Warns Consumers Against Consuming Dietary Supplements Containing Tiractricol
Triax Metabolic Accelerator
FDA Warns Against Consuming Triax Metabolic Accelerator
FDA Warns Public About Chinese Diet Pills Containing Fenfluramine
Information that FDA provided on a few other dietary supplements can be seen here:
Products That Consumers Inquire About
I trust this information fully answers your question.
However, please don't rate this answer if you find there's anything
else you need. Instead, just post a Request for Clarification, and
I'll be happy to assist you further.
search strategy -- searched FDA's website for information related to
herbal products and dietary supplements.
Clarification of Answer by
29 Mar 2006 11:41 PST
Nice to hear back from you.
As to your questions:
>>So I should look for the manufacturer that FDA approved for my
herbal products? Do you have a list of that from FDA?<<
I'm not sure I'm following you here...Can you clarify further what
you're looking for? In fact, if you have a particular product or
manufacturer you want to know more about, it would help to give me the
>>1) Ephedrine is the only that FDA banned. (actually it seems still a
pending case accroding to recent news)<<
Yes, as far as I know, this is the only one. Any FDA rule can be
contested and/or taken to court, so that Yes...the matter can still be
considered pending. But for now, as I understand things, ephedrine
products are banned.
>>To get the update warning from FDA on herbal product, the link will be
Yes, that's the best source I know of for up to date information.
Hope that does the trick, but if there's anything else you need, just let me know.