Legal Question: To what extent can evidence of historical or Traditional Use
information regarding herbs and other nutrients be used to substantiate Dietary
Supplement Claims? Here are some source materials from the FTC and FDA that
impinge on this issue, and the Vitamin Lawyer's comments.
Claims Based on Traditional Uses
FTC - Dietary Supplements: An
Advertising Guide for Industry
"Claims based on historical or traditional use should be substantiated by
confirming scientific evidence, or should be presented in such a way that
consumers understand that the sole basis for the claim is a history of use of
the product for a particular purpose. A number of supplements, particularly
botanical products, have a long history of use as traditional medicines in the
United States or in other countries to treat certain conditions or symptoms.
Several European countries have a separate regulatory approach to these
traditional medicines, allowing manufacturers to make certain limited claims
about their traditional use for treating certain health conditions. Some
countries also require accompanying disclosures about the fact that the product
has not been scientifically established to be effective, as well as disclosures
about potential adverse effects. At this time there is no separate regulatory
process for approval of claims for these traditional medicine products under
DSHEA and FDA labeling rules."
FTC continues - "In assessing claims based on traditional use, the FTC will look closely
at consumer perceptions and specifically at whether consumers expect such claims
to be backed by supporting scientific evidence. Advertising claims based solely
on traditional use should be presented carefully to avoid the implication that
the product has been scientifically evaluated for efficacy. The degree of
qualification necessary to communicate the absence of scientific substantiation
for a traditional use claim will depend in large part on consumer understanding
of this category of products. As consumer awareness of and experience with
"traditional use" supplements evolve, the extent and type of qualification
necessary is also likely to change.
"There are some situations, however, where traditional use evidence alone
will be inadequate to substantiate a claim, even if that claim is carefully
qualified to convey the limited nature of the support. In determining the level
of substantiation necessary to substantiate a claim, the FTC assesses, among
other things, the consequences of a false claim. Claims that, if unfounded,
could present a substantial risk of injury to consumer health or safety will be
held to a higher level of scientific proof. For that reason, an advertiser
should not suggest, either directly or indirectly, that a supplement product
will provide a disease benefit unless there is competent and reliable scientific
evidence to substantiate that benefit. The FTC will closely scrutinize the
scientific support for such claims, particularly where the claim could lead
consumers to forego other treatments that have been validated by scientific
evidence, or to self-medicate for potentially serious conditions without medical
"The advertiser should also make sure that it can document the extent and
manner of historical use and be careful not to overstate such use. As part of
this inquiry, the advertiser should make sure that the product it is marketing
is consistent with the product as traditionally administered. If there are
significant differences between the traditional use product and the marketed
product, in the form of administration, the formulation of ingredients, or the
dose, a "traditional use" claim may not be appropriate.
"Example 29: The
advertiser of an herbal supplement makes the claim, "Ancient folklore remedy
used for centuries by Native Americans to aid digestion." The statement about
traditional use is accurate and the supplement product is consistent with the
formulation of the product as traditionally used. However, if, in the context of
the ad, this statement suggests that there is scientific evidence demonstrating
that the product is effective for aiding digestion, the advertiser would need to
include a clear and prominent disclaimer about the absence of such evidence.
A supplement manufacturer wants to market an herbal product that has been used
in the same formulation in China as a tonic for improving mental functions. The
manufacturer prepares the product in a manner consistent with Chinese
preparation methods. The ad claims, "Traditional Chinese Medicine — Used for
Thousands of Years to Bring Mental Clarity and Improve Memory." The ad also
contains language that clearly conveys that the efficacy of the product has not
been confirmed by research, and that traditional use does not establish that the
product will achieve the claimed results. The ad is likely to adequately convey
the limited nature of support for the claim.
A supplement manufacturer markets a capsule containing a concentrated extract of
a botanical product that has been used in its raw form in China to brew teas for
increasing energy. The advertisement clearly conveys that the energy benefit is
based on traditional use and has not been confirmed by scientific research. The
ad may still be deceptive, however, because the concentrated extract is not
consistent with the traditional use of the botanical in raw form to brew teas
and may produce a significantly different effect.
A supplement ad claims that a supplement liquid mineral solution has been a
popular American folk remedy since early pioneer days for shrinking tumors. The
ad is likely to convey to consumers that the product is an effective treatment
for cancer. There is no scientific support for this disease benefit. Because of
the potential risks to consumers of taking a product that may or may not be
effective to treat such a serious health condition, possibly without medical
supervision, the advertiser should not make the claim."
We can see from the above FTC analysis that RISK and BENEFIT
will be weighed on a spectrum of risk – at one end are products that support
natural structure and function and at the other end are products that claim to
treat life-threatening diseases.
The FDA has some points to add to the mix,
An FDA Guide to Dietary Supplements
“One thing dietary supplements are not is drugs. A drug, which sometimes can
be derived from plants used as traditional medicines, is an article that, among
other things, is intended to diagnose, cure, mitigate, treat, or prevent
diseases. Before marketing, drugs must undergo clinical studies to determine
their effectiveness, safety, possible interactions with other substances, and
appropriate dosages, and FDA must review these data and authorize the drugs' use
before they are marketed. FDA does not authorize or test dietary supplements.
“A product sold as a dietary supplement and touted in its labeling as a new
treatment or cure for a specific disease or condition would be considered an
unauthorized--and thus illegal--drug. Labeling changes consistent with the
provisions in DSHEA would be required to maintain the product's status as a
If a claim is not an allowed Wellness or Structure Function
Claim, or a forbidden Medical Claim, it may be a Health Claim (a claim that
characterizes the relationship between a nutrient and a disease). Some of these
have been allowed, often only after a court fight.
FDA - Qualified Health Claims in the Labeling of
Conventional Foods and Dietary Supplements (information on Health Claims).
The essence of the current American rule on Traditional Uses
is, as stated by FTC, “Claims based on historical or traditional use should be
substantiated by confirming scientific evidence, or should be presented in such
a way that consumers understand that the sole basis for the claim is a history
of use of the product for a particular purpose.” Remember, FDA regulates
labels while FTC regulates advertising (however, FDA can consider literature
about a product to be an extension of the label).
Further, the agencies will look much more closely at products
that claim to cure serious disease than products that claim to support normal
structure and function.
Disclaimers and Disclosures need to be carefully
crafted. These are the regulatory requirements that must be met to base
advertising claims on the Traditional Use of a product.
Here is a sample of a Traditional Use Disclaimer, "This
information is based on Traditional [Chinese Medicine] which often uses natural
herbs and nutrients to support health. The information about these ingredients
has not been evaluated or approved by the FDA and is not based on scientific
evidence from US sources. This product is intended to support general well being
and not intended to treat disease. If conditions persist, please seek advise
from your medical doctor."
The Right of
the Public to the Truth
Nutrient Marketing and Commercial Free Speech
The Standard of Substantiation
FDA and FTC
Regulations of Dietary Supplement Sales
© 2003, 2007