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The American Herbal Products Association (AHPA),
the leading trade organization in the United States dedicated to herbs and
botanical products, launched KeepSupplementsClean.org in 2011 as a service to
consumers and the industry. The site monitors recall and warning notices issued
by the US Food and Drug Administration (FDA) and attempts to disseminate the
information to members of the herb and dietary supplement industries and to the
general public. The website focuses on three particular product categories:
weight loss, bodybuilding, and sexual enhancement.1
“Our focus is on these three categories because FDA has identified these as the
products that are mostly likely to be subject to illegal spiking with
undeclared drugs,” said Merle Zimmermann, PhD, information analyst for AHPA and
maintainer of KeepSupplementsClean.org (email, May 29, 2014).
“All three of these product categories share a common denominator: consumers
that are desperately searching for a silver bullet,” said James Neal-Kababick,
director of Flora Research Laboratories (email, May 28, 2014). “With sexual
enhancement products, you have many men that are too embarrassed to discuss
their medical condition with a urologist/MD…. Sports doping has been around for
decades and in the drive to increase mass and get cut/ripped faster, many
consumers will turn to questionable [products] or outright knowingly purchase
illegal products to meet that end.”
These adulterated products — e.g., those containing an undeclared prescription
medication, controlled substance, or other ingredient that the FDA has
withdrawn from the market due to adverse effects — falsely claim to be dietary supplements
when in fact they are illegal drugs masquerading as supplements. They also
“place consumers at risk and harm the reputation of the legitimate supplement
industry,” said Dr. Zimmermann. “It’s also important to recognize that this is
an international problem.”
Any product labeled as a dietary supplement may not contain prescription drugs;
in the United States, sale of such products is illegal, and the FDA encourages
consumers and health professionals to report suspected tainted supplements at TaintedProducts@fda.hhs.gov.
The KeepSupplementsClean.org site is simple and easy to navigate, linking
viewers to a list of banned supplements, consumer information and tips,
industry information, and an international advisory list with official warning
and recall notices from the health departments of 15 countries. Most of the material
has been quoted from the FDA in support of the Administration’s mission to keep
illegal and dangerous products out of the hands of consumers.
The advisory notices are divided into separate pages by categories, and each
page has a table that includes the product name, distributing company — or
where the product may have been marketed if the company name is unavailable — the
date of notice, and a description of the FDA’s action taken along with a link
to the official notification.
Some of the actions are more than a decade old, dating back to 2003, and some
are as recent as May of this year: Asset Bee Pollen, which was marketed online
as a weight-loss supplement, was found to contain sibutramine, a controlled
substance sold under the brand name Meridia® that the FDA removed
from the market in 2010.2 The FDA issued a warning to consumers on
May 15, 2014.
Following the results of the Sibutramine Cardiovascular Outcomes Trial (SCOUT),
wherein patients who took the drug for obesity showed an increased risk for
major adverse cardiac events, the FDA started requiring contraindications on the
label.3 Eventually, sibutramine was pulled from the market
altogether. However, unscrupulous manufacturers still add this appetite
suppressant to weight-loss aids and sell them as “all-natural” dietary
supplements in spite of the presence of an illegally sold drug, leaving
consumers at an increased risk for heart attack, stroke, or cardiac arrest.
While sibutramine is the most commonly found form of this compound, there are
at least seven known chemical analogs of sibutramine that have been identified
in illegal products masquerading as dietary supplements. Asset Bee Pollen is
one of the latest faux supplements with this compound to be caught by the FDA.
Illegal bodybuilding “supplements” often contain undisclosed steroids or
steroid analogs, and sexual-enhancement drugs frequently use phosphodiesterase-5
inhibitors (PDE-5i) such as sildenafil (the active ingredient in approved
prescription drugs such as Viagra®) or one of the more than 100
analogs of these prescription drugs. Unknowingly consuming any of these drugs
or their analogs can prove detrimental or fatal to patients with certain health
conditions.1
“The issue is massive and beyond the understanding of the industry as a whole,”
said Neal-Kababick. “It is like whack-a-mole. As soon as you discover and
expose one drug analog, another takes its place and the cycle starts again.”
In addition to weight-loss, bodybuilding, and sexual-enhancement products, an
additional category that has been increasingly susceptible to fraud includes
“supplements” for arthritis pain management, which often contain nonsteroidal
anti-inflammatory drugs (NSAIDs) and corticosteroids.
It is unclear how often FDA notices or product recalls result in any
prosecution, as many suppliers work overseas and fall outside of the Administration’s
jurisdiction. If a warning letter has been perceived as ineffective and the
drug poses a direct health hazard, the FDA can go forward with enforcement
actions including seizure of stock, injunctions, or criminal charges.4
According to Neal-Kababick, “While FDA enforcement action helps, it is not
enough. We need criminal prosecution and jail for serious offenders.”
As with any market, opportunists motivated by greed will find ways around the
law: Just this year, the FDA has issued more than 50 new warnings about adulterated
products falsely marketed as supplements. “Over the last six months, FDA has
reported somewhat fewer recalls and consumer advisories of tainted products in
all three of the main product areas. It may be premature though to view this as
a trend,” Dr. Zimmermann warned, “and AHPA will continue to urge FDA to be
vigilant and assertive in enforcing the laws against selling these products to
ensure that those who violate the law are held accountable.”
Recently, Richard Deng of InterTradeCorp and InterTradeMart pleaded guilty in
the Federal District Court in the Northern District of Virginia to unlawfully
selling various male sexual-enhancement dietary supplements that contained the
active ingredients in the prescription drugs Viagra and Cialis®,
dispensing the products without a prescription, and in packaging that failed to
disclose the existence of these substances. Deng faces a maximum penalty of
three years in prison when he is sentenced on August 1, 2014.5
Consumers are advised to purchase their supplements from brands and companies that
have been independently verified by a reputable third party (e.g., NSF
International, United States Pharmacopeia, etc.), are in good standing with the Better Business Bureau, and/or
belong to an established dietary supplement trade association such as AHPA.
Consumers also should be extremely critical in regards to products marketed
exclusively online or through email.
—Hannah Bauman
References
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Main page. KeepSupplementsClean.org. Available here.
Accessed May 19, 2014.
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Public Notification: Asset Bee Pollen Contains Hidden Drug Ingredient. US Food
and Drug Administration. May 12, 2014. Available here.
Accessed May 19, 2014.
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FDA Drug Safety Communication: FDA Recommends Against the Continued Use of
Meridia (sibutramine). US Food and Drug Administration. October 8, 2010.
Available here.
Accessed May 19, 2014.
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Tainted Products Marketed as Dietary Supplements. US Food and Drug
Administration. December 15, 2010. Available here.
Accessed May 28, 2014.
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May 7, 2014: Importer Convicted of Selling Sexual Enhancement Products
Containing Prescription Drugs. US Food and Drug Administration. May 7, 2014.
Available here.
Accessed May 30, 2014.
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