Tuesday, February 16, 2010
BY
Dr. Arianna Staruch, ACHS Academic Dean
In
Jan 2009, the Government Accountability Office (GAO) released a report
suggesting that the FDA should take further actions to improve
oversight and consumer understanding of dietary supplements. This
report was triggered by the three-fold increase in adverse event
reports received by the FDA since mandatory reporting went into effect
on December 22, 2007.
The GAO wanted to know if the FDA was able
to “identify and act on concerns about the safety of dietary
supplements, and foods with added dietary ingredients, and to ensure
that consumers have useful information about the safety and efficacy of
supplements.”[1] What it found was that the FDA “has limited
information on the number and location of dietary supplement firms, the
types of products currently available in the marketplace, and
information about moderate and mild adverse events reported to
industry.” In addition the FDA “is hindered by a lack of mandatory
recall authority and the difficult process of demonstrating significant
or unreasonable risk for specific ingredients.”[2]
There is also
concern that some food products could be marketed as dietary
supplements to circumvent the safety standard required for food
additives.
In response to this GAO report, Senator McCain proposed the Dietary Supplement Safety Act of 2010.[3]
To
address the lack of information about dietary supplement firms, the
bill proposes the registration of “dietary supplement facilities” which
would be required to file annually a list of all dietary supplements
“manufactured, packaged, held, distributed, labeled, or licensed by the
facility,” including the names and address of each facility and all
trade names. This will most likely create record maintenance
obligations for downstream manufactures and retailers, who will be
obliged to obtain written confirmation, from ingredient suppliers or
from supplement brand marketers. According to Michael McGuffin,
president of the American Herbal Products Association (AHPA), this
“places new burdens on dietary supplements that are not required for
any other class of food.”
In addition, the Dietary Supplement
Safety Act of 2010 bill would change the “grandfather” status of
dietary supplement products marketed in the U.S. prior to the Dietary
Supplement Health and Education Act (DSHEA), before October 15, 1994.
It instead establishes a list of “‘Accepted Dietary Ingredients’, to be
prepared, published, and maintained by the Secretary,” and defines a
new dietary ingredient as any ingredient not included on such list. Any
substance not on the list would have to be submitted to the FDA 75 days
before being used in a supplement with data supporting its history of
use and safety.
The Government Accountability Office wants to
extend the mandatory reporting of adverse event from the current
serious adverse events to mild and moderate adverse events, with the
manufacturer keeping records on all of them for a minimum of three
years. The AHPA notes, “Marketers of conventional foods have no adverse
event reporting requirements, even for serious adverse events.”
In
addition, the GAO wants the FDA to have recall authority over
supplement products, to order the cessation of distribution,
notification of distributers, importers, retailers and consumers, of
any product that is determined to cause serious, adverse health
consequences or death, or is adulterated or misbranded. The problem
here is that products could be considered adulterated if it has an
ingredient not on the established list, or if the formula was changed
or reformulated and the change was not registered or updated, even if
this change does not present any hazard to the public. Herbs can vary
in availability and quality and sometimes formulas are changed to
maintain the overall effectiveness of the product. McCain’s bill
includes monetary penalties for non-compliance with these regulations
What
is of particular interest is the loss of supporters reported by Senator
McCain’s office: Major League Baseball, the National Basketball
Association, the National Football League, the National Hockey League,
the United States Olympic Committee, the American College of Sports
Medicine, National College Athletic Association, and the PGA Tour.
This
gives the impression that what McCain is really trying to do is to curb
the use of herbs and supplements that might have anabolic or
performance enhancing effects and are currently “getting around”
regulations.
References: