Hello frio80-ga, and thanks for an interesting question. I've done
some work on food safety policy issues over the years, so this is a
topic dear to my heart.
The general answer to your question is, no, there aren't any special
requirements for companies to market food supplements, whether they
sell them on the web or in brick and mortar stores. At least, this is
the case in the U.S.
The story I've always heard is that a U.S. Senator had a relative with
cancer that did not respond to conventional treatments, but who was
cured by an alternative therapy involving nutritional supplements.
The Senator vigorously -- and successfully -- lobbied to exempt such
supplements from FDA approval.
Whether the story is true or not, the exemption itself is undeniably
real. As the FDA's own "Dietary Supplements" website notes:
http://www.cfsan.fda.gov/~dms/supplmnt.html
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 with FDA nor
get FDA approval before producing or selling dietary supplements.
Manufacturers must make sure that product label information is
truthful and not misleading.
FDA's post-marketing responsibilities include monitoring safety, e.g.
voluntary dietary supplement adverse event reporting, and product
information, such as labeling, claims, package inserts, and
accompanying literature. The Federal Trade Commission regulates
dietary supplement advertising.
---------------------
In other words, the governments authority begins *after* a product is
already on the market. It is up to producers to make sure the product
is safe, and their advertising claims are accurate.
If a product is found to be unsafe, only then can the FDA take action.
If an advertising claim is found to false, then the FTC can get
involved.
So...to answer your specific questions (and again, this is the answer
for the U.S.):
--What kind of rules and regulations (if any) do these people have to
follow?
None, to bring a product to market. But they are responsible for the
product's safety and for truthful advertising, and can be found liable
for failing to insure either of these. The only real restriction on
these products is that they cannot claim to cure disease, unless they
have formally been screened by FDA as a drug, rather than as a food
supplement.
--Do they have to be licensed to do such an activity?
Nope.
--Does a Doctor have to be on staff or have viewed/tested the product?
Nope.
--I guess the real question would then be, can any regular individual
sell this stuff online without being properly qualified? I sure hope
not...
Sorry to dash your hopes, but anyone can bring a new product like this
to market.
A fuller discussion on the history and rules regarding food
supplements can be found at another FDA site discussing the background
on the "DIETARY SUPPLEMENT
HEALTH AND EDUCATION ACT OF 1994":
http://vm.cfsan.fda.gov/~dms/dietsupp.html
Hope that answers your questions, but if you need any elaboration on
what I've written here, or if you would like additional information,
just let me know by posting a Request for Clarification, and I'll be
happy to assist you further.
And please....stay healthy!
pafalafa-ga
search strategy: combined existing knowledge of the topic with a
search on FDA's site for "dietary supplements". |
