February 6, 2012

Are Supplements Safe?

(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  Industry supporters aggressively argue that the FDA's new guidance is overly stringent and needs to be withdrawn.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