INTRODUCTION
The use of complementary and alternative medicine (CAM) has
steadily increased in popularity over the past two decades. More
than 70% of the US population has used CAM at least once,
and annual spending on CAM in 2007 has reached $34 billion.
From 1997 to 2007, annual spending on nonvitamin, nonmineral,
natural products (herbal supplements) has more than doubled
to $14.8 billion.1 To put these numbers in context, the amount
spent on herbal supplements is equal to about 31% of what the
public spent out of pocket for pharmaceutical drugs in 2007.1
In a 2007 study, 4 out of 10 adults, and 1 out of 9 children had
used some type of CAM in the past year.2 Of particular relevance
to dermatologists is the fact that 49% of patients who reported
skin problems in the past 12 months also reported using CAM
in the same period.3 Among those using CAM for skin problems
specifically, by far the most common modality was herbal supplements.
3 CAM therapies are particularly sought after by patients
with chronic non-life threatening disease, and chronic disease
such as psoriasis, atopic eczema, and acne are common in
dermatologic practice. Herbal medicine safety has therefore become
a critical issue for practitioners, in caring for patients who
are self-medicating with herbal supplements. Despite the popular
belief in the safety of "natural" ingredients, numerous cases
of adverse reactions to CAM formulations have been reported.
There are many challenges related to the safety monitoring of
herbal medicines, and adverse events arising from the consumption
of herbal medications may be due to any number of factors.
The risks of alternative medications include external quality problems
and intrinsic quality problems. External quality problems
include contamination, adulteration, and misidentification of
botanicals. Adverse events related to the intrinsic properties of
the supplements are typically caused by the pharmacologically
active phytochemicals contained within these medications.4, 5
Before discussing the risks associated with herbal medication it
is important to understand what quality control mechanisms are
currently in place. In 1994, Congress defined the term "dietary
supplement" in the Dietary Supplement Health and Education
Act (DSHEA) as products containing any one of the following: a
vitamin, a mineral, an herb or other botanical, an amino acid, a
dietary substance for use by man to supplement diet by increasing
total intake (eg, enzymes or tissues from organs or gland), or
a concentrate, metabolite, or extract.6 Since 1994, the FDA has
issued regulations to ensure the safety of dietary supplements.
The final dietary supplement Current Good Manufacturing Practice
(CGMP) rules were issued in 2007. These regulations focus
on practices that ensure the identity, purity, quality, strength, and
composition of dietary supplements.6, 7 However, the FDA states
that unlike drug products that must be proven safe and effective
for their intended use before marketing, there are no provisions to
"approve" dietary supplements for safety and effectiveness before
they are marketed.6 Furthermore, once a product is marketed,
the burden of proof rests with the FDA to show that the product is
"unsafe" before it can take action to restrict the product's use or
removal from the marketplace.
If CGMP guidelines are rigorously followed, contamination of herbal
supplements by microbes, toxic heavy metals, and pesticides should
be well under control. However, these problems persistently recur.
In 2008, 20% of Ayuverdic medicines sold in the US were found to
contain detectable levels of lead mercury and arsenic.8 Seventy-five
percent of the metal-containing products claimed Good Manufacturing
Practices, or metal testing, and these claims were not associated
with a lower prevalence of toxic metals. In addition to Ayuverda,
other traditional medicines originating from Asia, have been found
to contain lead and other heavy metals.5 In products where metals
were detected, one or more standards of daily metal intake were
exceeded.8 Contamination of heavy metals can occur due to plant
accumulation of heavy metals from the environment, contamination
during production, or intentional addition.5 Some proponents of
traditional Chinese or Indian Ayuverdic medicines believe that traditional
preparations of these metals render them nontoxic, however,
poisonings related to heavy metal exposure have been reported.8-11
Adulteration of herbal medicines with pharmaceutical drugs and
plant materials is a common and dangerous phenomenon in alternative
medicines. The most prevalent adulterants in herbal
creams are corticosteroids.12 In 2011, FDA analysis of the popular
cream, "Heimlich Natural Clear Cream," found up to .04% Betamethasone
valerate. This is by no means the first time that over
the counter products have been found to contain willfully added
corticosteroids; there are numerous cases in the literature of this
transgression.13, 14 Dr. Heimlich's Natural Cream was marketed by
word of mouth as safe and corticosteroid free. Reviews on Amazon.
com, described this product was as "suspiciously amazing."15
With an average rating of 4.4 out of 5 stars, it was particularly popular
for parents to use for their children's eczema, though it was also
very expensive. The FDA subsequently issued an enforced recall
in 2011, but the product was marketed for years prior to the recall.
One of the greatest dangers when using herbal therapies is the
failure on the patient's behalf to assume that because these
products are "natural," they are therefore "safe."16 In contrast,
when a physician is evaluating the use of a medication to treat
a specific illness, he weighs the known risk of predictable and
