DMAA sports supplements have been
linked to at least two deaths and the U.S. Food and Drug Administration sent
warning letters to 10 manufacturers last spring about a lack of data on their
safety, but a new study finds these supplements can still be purchased online.
DMAA (dimethylamylamine) is a
pre-workout supplement used by athletes to build muscle. Some research suggests
that it may narrow blood vessels, which can elevate blood pressure, and may set
the stage for a heart attack. Canada and the U.K have banned DMAA from all
supplements.
Now, a small study published
online Dec. 3 in the Archives of Internal
Medicine reports that all 16 of the products mentioned in the
FDA's warning letters are still available through online retailers.
"The FDA has its wings
clipped when it comes to dietary supplements because
they have to prove harm in order to remove a product from the market,"
explained study author Philip Gregory, an associate professor of pharmacy
practice at Creighton University in Omaha, Neb. "I would imagine that the
FDA is collecting data on adverse events and slowly building a case for
potentially removing the product."
Efforts by HealthDay to
reach the FDA for comment were unsuccessful.
The original FDA warning letters
stated that the companies had not provided sufficient data showing the safety
of their supplements, and gave the companies 15 business days to respond.
Gregory searched for products
singled out by the FDA on Google,
and found that all 16 were still available via online retailers and on sale
directly from the manufacturers' websites. In addition, 12 of the 16 were available
through General Nutrition Centers (GNC), and eight could be purchased via
drugstore.com, the study showed.
People are drawn to DMAA
supplements because they provide a quick fix, Gregory said. "The product
promises them better results and quickly, [and] this is a pretty tempting
proposition for someone who is dead set on adding bulk and getting
ripped," he said.
"DMAA is a stimulant so the
risks revolve around stimulant-related side effects," he added. "We
don't have much specific data on case reports describing adverse events, but generally
speaking, adverse outcomes have included psychiatric disturbances,
cardiovascular risks such as increased blood pressure, palpitations,
arrhythmia, heart attack or stroke."
Duffy MacKay, vice president of
scientific and regulatory affairs at the Council for Responsible Nutrition in
Washington D.C., said that the FDA is likely still in discussions with these
companies. CRN is a trade group representing dietary supplement manufacturers
and ingredient suppliers.
"The FDA can pull these
supplements if they think they pose a risk, so at this point the assumption is
that the FDA has not come to that conclusion yet," MacKay said. "The
CRN would like to see the FDA take the appropriate regulatory action if
warranted."
Unless and until they do, consumers
will remain confused, he added. "Consumers should at a minimum know what
they are taking and follow the dosing instructions on the product's label, and
talk to their health care provider about whether this product is right for
them," he said.
GNC issued the following
statement regarding DMAA supplements sold in their store:
"All DMAA products sold by
GNC are manufactured by third-party vendors. GNC is simply the retailer and,
like all retailers, relies upon the contractual representations and warranties
made by its vendors that the products are safe and compliant with all
applicable laws and regulations," the statement said. "GNC believes
the products are compliant with all applicable laws and regulations, and are
safe when consumed as directed."
Dr. Pieter Cohen, an internist at
Cambridge Health Alliance and an assistant professor of medicine at Harvard
Medical School, called for a DMAA ban soon after the FDA sent out the warning
letters, and he still thinks the products should be banned.
"Sports supplements produce
hundreds of millions of dollars in revenue a year," Cohen said. "This
entire class of pre-workout supplements,
including DMAA, is very suspect and not a single one is proven to boost
athletic performance, and some ingredients have the potential to cause harm.
The FDA needs to act and proactively remove the hundreds of products that don't
have adequate safety data to support their use."
More information: See the full list of companies that received U.S. Food and Drug
Administration warning letters on DMAA.
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