Are Supplements Safe?
- Reported, January 16, 2012
 (Ivanhoe
Newswire) -- Whether it is for sexual enhancement, dietary purposes, or overall
well being, Americans have reportedly spent more than $28 billion on various
supplements. They consume vitamins, amino acids, herbal ingredients, minerals,
and other natural products all the while assuming they are effective and safe.
As a result approximately 51,000 new supplements have been introduced to the
public since the Dietary Supplement Health and Education Act of 1994 (DSHEA).
DSHEA was supposed to ensure that new ingredients that were introduced after
1994 provide the Food and Drug Administration (FDA) with evidence that suggests
an expectation of safety. However, this aspect of the law has not been enforced.
Only 170 of new supplement ingredients were submitted to the FDA for approval, a
small fraction of the ingredients for which should have been submitted do to the
exponential amount of new products available. In fact industry supporters and
the FDA have admitted that new products were introduced without an assessment of
safety. For example, Zotrex (a sexual enhancement supplement) was recently
recalled by a highly respected dietary-supplement company in Utah because it
contained an analogue of sildenafil that was never tested on humans.
What have recently been under debate by industry supporters is the FDA's new
guidelines designed to help assess new ingredients. The proposed guidance
clarifies what the FDA will use to assess the evidence of safety. Supplements
would be evaluated according to three factors: formulation and proposed daily
dose (more or less than formerly consumed), documented history of use
(supplements or herbal medicine sold outside of the U.S.), and the recommended
duration of use (long-term or intermittent). The guidelines would improve safety
of new supplements by requiring animal, in vitro, and tolerability testing for
products marketed for consumption higher than past recommended dosage. Also more
clarity will be given to what exactly is an old ingredient and what is a new
ingredient. Industry supporters aggressively argue that the FDA's new guidance
is overly stringent and needs to be withdrawn. According to advocates, the
requirement for in vitro and animal testing undermines the DSHEA law because the
FDA is requiring the same safety standards for supplements as they are for food
additives; such as, a chemical preservative sprayed inside a can of tomato soup.
Congress did not require the standards to be the same when drafting DSHEA
because food additives needed more evidence for safety. However, the new law is
for new supplement ingredients. Generally the FDA's legal authority over new
products, including new supplement ingredients, is greater than established
products. It would be impossible to assess the reasonable expectation of safety
of new ingredients without experimental data.
Supporters of the new FDA guidelines fear that if the FDA gives into industry
pressure then the public health consequences will be significant due to the
rising number of Americans turning to new supplement products to treat ailments
or sustain their health. They believe that if the FDA will still insist on
scientific evidence to demonstrate safety, then a database could be created to
provide evidence to consumers, physicians, scientists, and regulators for them
to make an informed decision about whether they should actually use a supplement
or not and while also improving the safety of supplements in the future.
SOURCE: New England Journal of Medicine, February 2012
-
WF Team
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