I received a query regarding the Dietary Supplement Health and
Education Act of 1994 two days before seeing comment-card boxes in
our Madison Whole Foods store. There is citizen action going on
around DSHEA, regarding proposed modifications to that rule that
will in some cases reclassify wellness as disease prevention and
natural states (like pregnancy and menopause) as diseases.
The reason I post it to you is that the issue has elements in common
1) organic labeling
2) labeling of rBGH-containing products
in terms of the federal government regulating communication around
particular products, and who gets to define what particular terms
mean, in order to control commerce.
I also see this as a sustag-related issue given that growing herbs
is a sideline for quite a few of the smaller-scale farms I know of
(organic or not), and that there is a long tradition of folk or
experiential knowledge behind their use in supporting overall
health. It also fits with the phytonutrients issue here on SANET in
You can decide...or delete. In any event, wanted to share the results
of my very quick Web search for information on this issue.
The FDA's squib (12/1/95) on DSHEA:
A table of regulatory actions related to supplements since DSHEA was
Each action is referenced to the pertinent issue of the /Federal
Citizens for Health
"FDA could reclassify many natural health products as drugs. FDA
has proposed new rules which will deny your access to essential
information about your health choices. Your access to many vitamins,
mineral and herbs could be greatly restricted based on how you
"intend" to use those products.
"For instance, if you use a supplement to lower cholesterol_even if
the supplement label makes no such explicit claim_FDA could
reclassify that product as a drug, simply because high cholesterol
is linked to heart disease! The result? You'll have limited access
at higher cost."
Here is an individual's page on the issue, with links to FDA info
sources, including the text of the proposed rules:
He appears to be some kind of consultant to folks in the natural
foods industry. His home page has lots of links to sustag stuff.
"The FDA has released new proposed rules regarding the regulation of
structure, function, and health claims on dietary supplements. These
proposed rules were printed in the Federal Register on April 29,
1998. We have until September 25th to comment on the rules. Linked
below are Citizens For Health's web site to give you complete
information on the need to comment to the FDA, the FDA's press
release about the proposed rules, the Federal Register pages
containing the proposed rules, and comments from the FDA on the
report of the Commission on Dietary Supplement Labels."
FDA's 4/24 press release
Text of press release follows:
FDA PROPOSES RULES TO MAKE CLAIMS FOR DIETARY SUPPLEMENTS MORE
INFORMATIVE, RELIABLE AND UNIFORM
In response to recommendations made by the Commission on Dietary
Supplement Labels, the Food and Drug Administration today proposed
rules to give consumers better information about dietary supplements
by making the labeling of these products more reliable and uniform.
The proposal, which defines certain permitted and prohibited types of
labeling claims for dietary supplements, will not affect the
availability of these products or consumers' access to them.
In addition to the new proposal, the FDA today is also responding to
the report of the Commission on Dietary Supplement Labels. (See the
separate fact sheets on the new proposal and the response to the
Commission report.) The Commission was an independent panel of experts
mandated by the Dietary Supplement Health and Education Act of 1994
(DSHEA) and appointed by President Clinton to study and make
recommendations on the regulation of label claims and statements for
dietary supplements, including procedures for evaluation of such
Under DSHEA, dietary supplements may carry "structure/function" claims
-- claims that a product may affect the structure or functioning of
the body -- but not claims that they can treat, diagnose, cure or
prevent a disease.
Today's proposal defines the criteria for the structure/function
claims that DSHEA permits and the disease claims that it prohibits,
and provides examples for both categories.
The law allows, without FDA's authorization, claims that are truthful
and not misleading about the effect of a dietary supplement on the
structure or function of the body for maintenance of good health and
nutrition. Under the proposal, such permissible structure/function
claims can state, for example, that the product "promotes regularity,"
"helps maintain cardiovascular health," or "supports the immune
The proposal also identifies many types of so-called "disease claims"
that are prohibited under DSHEA. In general, these claims state or
imply benefits for a disease, which the proposal in part defines as
any deviation from, impairment of, or interruption of the normal
structure or function of any part, organ, or system of the body that
is manifested by a characteristic set of signs or symptoms. Under the
proposal, dietary supplements that expressly or implicitly claim to
diagnose, treat, prevent or cure a disease continue to be regarded as
drugs, and have to meet the safety and effectiveness standards for
drugs under the Food Drug and Cosmetic Act (FDCA). Examples of such
prohibited disease claims for a dietary supplement include "protects
against cancer," "treats hot flashes," and "reduces nausea associated
The proposal also describes various means -- such as product names,
vignettes, graphics and citations -- by which a dietary supplement
could make or imply a disease claim prohibited under DSHEA.
"Consumers want access to dietary supplements, but also need reliable
information about the products they are consuming," said William
Schultz, FDA's Deputy Commissioner for Policy. "By clarifying for
manufactures what types of claims can and cannot be made on a dietary
supplement label, this new proposal helps consumers make more informed
and wiser choices."
Today's proposal and FDA's response to the Commission's report will be
published next week in the Federal Register. The agency welcomes
written comments and recommendations on the proposed criteria and
other aspects of the proposal, and will accept such communication for
the next 120 days. The agency will also accept written comments on its
response to the Commission on Dietary Supplement Labels. All comments
should be addressed to:
Dockets Management Branch (HFS-456)
Food and Drug Administration
12420 Parklawn Dr., Room 1-23
Rockville, MD 20857
An anti-holistic health site; note that it focuses on herbs:
"Health Care Reality Check"
"As a result of the 1994 Dietary Supplement and Health Education Act
(DSHEA), the herbal marketplace is entirely unregulated. Herbal
products don't have to be proven safe or effective to be sold, and
there is no guarantee that the herbal product is what it says it is on
"While prescription and over-the-counter drugs and food additives
must meet the Food and Drug Administration's (FDA) safety and
effectiveness requirements, herbs that are marketed with medical
claims bypass these regulations. Herbal products can go to market
with no testing for efficacy, thus skipping the years-long process
that drugs must undergo. The FDA is also prohibited from taking an
herb off the market unless the agency can prove that using the herb
will create a medical problem. Unfortunately, this law places the
burden of proof of an herb's safety on the over-taxed FDA rather
than on the companies profiting from the sale of the herb.
"FDA approval is not required for package or marketing claims, so
herbal manufacturers can put unsupported health claims on their
labels. While the label does have to say that claims have not been
reviewed or approved by the FDA, this caution is usually in small
print. Lastly, supplements do not have to be manufactured according
to any standards. Since herbs are not regulated as drugs, no legal
standard exists for their processing, harvesting, or packaging. In
many cases contents and potency are not accurately listed on the
Michele Gale-Sinex, communications manager
Center for Integrated Ag Systems
UW-Madison College of Ag and Life Sciences
Voice: (608) 262-8018 FAX: (608) 265-3020
Community--that's what Jah say. --Alpha Blondy
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