December 18, 2013
This summer, Sens. Dick Durbin (D-IL) and Richard Blumenthal (D-CT) reintroduced the infamous Dietary Supplement Labeling Act, after being previously defeated in a landslide 2011 vote. The bill aims to confer new powers on FDA, by allowing the agency to approve or reject supplements before their introductionbasically the same procedure currently applied to prescription drugs. Proponents say the legislation will help curb crooked supplement manufacturers that intentionally mislabel products or obscure the inclusion of dangerous additives. The fact is, this is a classic example of absurd over-regulation.
Under existing law, FDA already oversees finished dietary supplements and ingredients. The Dietary Supplement Health and Education Act of 1994 (DSHEA) already requires supplement manufacturers to ensure the safety of their products, and allows FDA to take legal action against violators. The agency can and does take such actions when needed.
Under Durbin's proposal, supplement makers would be required to submit all products to FDA for pre-approval prior to marketing or distributing any product, and the agency would have near-complete discretion to approve or deny (ban) any dietary supplement. FDA has no current authority for such a pre-approval process, and no funding or personnel with which to do it. Does this really seem like the best possible use of limited FDA resources?
Durbin claims that a rise" in adverse events reports (AERs) connected with dietary supplements makes such a change necessary. This claim is absurd for three reasons. First, the alleged rise" he refers to is probably related to reporting changes, not actual events. Second, the adverse events reported by supplement users are miniscule compared to those reported for either the drug industry, or the food industry as a whole. And third, the solution he proposes hasn't worked for prescription drugs, so why would it work for supplements?
A Rise in Adverse Events?
The claim of the alleged rise" in supplement-related adverse events comes from a U.S. General Accounting Office (GAO) report issued in March 2013. In it, GAO observed in 2007, only about 400 supplement-related adverse events were reported to FDA. From 2008 to 2011, the number of such events reported increased to about 2,100 annually. Sens. Durbin and Blumenthal point to this alleged increase to support their case for increased regulation.
What they don't mention is that a new law went into effect in December 2007, requiring mandatory reporting to FDA of all serious adverse events (e.g., hospitalization, death or permanent injury) related to supplements. Comparing the number of reports prior to this law with reports afterward does not show an increase in events, but only that there was an increase in reportswhich is natural and expected after reporting became required. GAO estimated adverse events may still be under-reported, perhaps even by 50 percent, but noted that a prior similar pattern followed the implementation of mandatory reporting for prescription and over-the-counter (OTC) drugs. In short, there is plenty of evidence that mandatory reporting is ramping up as it shouldbut no evidence that the underlying events are dramatically increasing.
In any event, the GAO report specifically points out that according to FDA officials, An AER by itself does not demonstrate a causal relationship between the dietary supplement and the reported health problem." It therefore follows that an increase in AERs, by itself, would clearly not justify the increased regulation proposed by the Durbin/Blumenthal bill.
Supplement AERs are Fewer and Less Serious
As noted previously, serious AERs are estimated by GAO to be in the neighborhood of 2,100 per year. About 2 percent of actual reports were fatal (98 deaths during a four-year period, out of 6,307 AERs). Since about 53 percent of Americans take supplements, that would be about 162 million out of the 2008 U.S. population of 305 million. So, the chances of a reportable adverse event associated with supplements are less than one in 50,000, and the chances of death are about one in 2.6 million.
Food-borne illnesses sicken 48 million Americans every year, hospitalize 128,000 and kill about 3,000. Everyone eats food, so all of that same 2008 population of 305 million is affected. Chances of illness are about one in six, hospitalization about one in 2,300, death about one in 101,000. Currently, supplements are generally regulated as food, even though they have more restrictions. Supplements really are food, and a particularly safe kind of food, if the statistics tell us anything.
Finally, properly prescribed and properly administered prescription drugs kill at least 100,000 Americans in hospitals every year. The deaths from medical errors, prescription drug abuse, and deaths at home and elsewhere causes the death toll for prescription drugs to surely be much higher. Since only about 48 percent of Americans use prescription drugs (a little less than the 53 percent using supplements), this would be about 146 million of that same 2008 population. Do the math for yourselfthe chance of a fatal prescription is well over 100,000 in 146 million, or about one in 1,460. Is this really the regulation model we should copy for supplements?
These statistics speak for themselves. The dietary supplement industry is far safer than either the food industry as a whole, or the highly regulated drug industry of which Sen. Durbin is so keenly enamored. In fact, the odds of being struck by lightning in any given year (one in 700,000) are more than three times higher than the odds of being killed by a supplement. The Dietary Supplement Labeling Act is a ridiculous solution to a nonexistent problem.
Costs of Regulation
If this bill passes, the implication for consumers could be disastrous. As supplement producers cope with the cost of new regulatory requirements, the cost of dietary supplements could rise dramatically. Increased overhead would burden the already slim profit margins of smaller manufacturers, likely putting many out of business, and for consumers, reduced competition nearly always means fewer choices and higher prices. The bill would also allow FDA to arbitrarily reclassify certain supplements as drugs, opening the door for Big Pharma companies to re-brand inexpensive dietary supplements into more expensive OTC or prescription drugs.
While mislabeled supplements are an occasional problem within the industry, history shows increased regulation is rarely the answer. After all, consumers are already protected by the strong wording of DSHEA, and FDA should be encouraged to punish rule breakers within the scope of existing law.
The failure of the first version of this bill was in part a result of a speedy response by the Alliance for Natural Health USA (ANH-USA). This organization, whose member organizations constitute a large part of the natural health community, convinced Congress that supplements are different from drugs and deserve to be examined separately. To ensure your consumer freedom and the continued vitality of the natural health industry, help us speak out against the Dietary Supplement Labeling Act.
Matt Warnock is president of RidgeCrest Herbals.
Originally published in INSIDERs November/December print issue.
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