Editor’s Note: This article is intended for information purposes only. Because state and municipal laws vary greatly, as do the circumstances of individual cases, readers are advised to contact an attorney for specific legal advice. © Scott C. Tips 2013
It always happens this way. First, like an artillery barrage, comes the media attack. Then, after the enemy has been softened up, comes the main assault: the legislation. Those who would prefer that you and I suffer from ill-health and be forever chained to their miserable, drug-happy, disease-care system employ this strategy repeatedly to attack their competition: alternative medicine and supplements.
Many of you read my last article in WholeFoods Magazine about Dr. Offit and his ignorant prattle about alternative medicine (see “Do You Believe in Offit,” in June 2013 Legal Tips). Dr. Offit’s attack through his book, Do You Believe in Magic? was the most prominent, recent attack on alternative medicine, but it was by no means the only assault. There are oodles of other drug-industry shills out there, eagerly doing their masters’ bidding. Liz Szabo is one such. In her equally biased June 19th USA Today front-page story on hazardous alternative medicine, she added her pen to those of many others in the mass media who are propagandizing consumers everywhere with their message that supplements are dangers to be avoided at all costs.
The Second Act
In a well-orchestrated attack that fooled no one, Senator Dick Durbin (D-IL) re-introduced on August 1st his previously lapsed and ill-fated bill, the “Dietary Supplement Labeling Act” (then S.1310, and now as S.1425), in yet another attempt to shut down the dietary-supplement industry through a series of gradually suffocating laws, rules and regulations that will do not one ounce of good. Instead, it will price supplements out of the reach of poor and lower-income persons, at least those supplements that remain should his bill be enacted.
The text of S.1425 (see www.thenhf.com/files/pdf/S1425.pdf) is nothing but a sad replay of his same-named bill introduced in 2011. That bill, embarrassingly enough for Durbin, died in Committee with only one Senate supporter, Durbin himself. Fortunately, Committee Chairman Tom Harkin (D-IA) was not about to let that bill slip through.
Like its forerunner, this new bill has the potential to be a disaster for dietary supplements and those consumers who buy them. It would amend the Food, Drug, and Cosmetic Act by requiring, among other things: (1) Extensive registration and re-registration of companies’ products with the U.S. Food and Drug Administration (FDA) every time a dietary-supplement product is created, reformulated or discontinued; (2) The Secretary of Health and Human Services to compile a list of dietary-supplement ingredients that he or she determines are “dangerous” and “risky”; and (3) The Institute of Medicine to then evaluate the safety of all dietary ingredients appearing on the Secretary’s list, which in turn will lead to mandatory label warnings that would warn consumers of “potentially serious adverse events, drug interactions, or contraindications, or potential risks to sub-groups such as children and pregnant or breastfeeding women.”
Of course, this is purportedly all in the name of consumer protection; but the real goal is to heap more and more red tape and costly rule adherence on dietary-supplement companies so as to either drive them out of the market or to price their products well beyond the reach of consumers, all without increasing safety to the public in any way. Besides, if this bill passes, dietary-supplement companies are going to need much bigger bottles simply to accommodate all of the mandated warnings and text! That, or else issue magnifying glasses with each bottle sold.
Durbin’s bill would also require the Secretary of Health and Human Services to establish a definition for the term “conventional food.” It seems that Mr. Durbin is very troubled by all of the conventional foods that are masquerading as dietary supplements when, dagnabbit, they should be tightly regulated as foods instead. You know, the same regulated and inspected foods that kill some 5,000 Americans every year. Mr. Durbin must have failed his commercial-arithmetic class in grade school because there is no other explanation for him wanting to push safe supplements into a higher-risk category than that he cannot subtract multiple-digit numbers to arrive at comparisons.
Speaking of Safety
Remember, dietary supplements are already among the safest consumer products in the world. In recent years, the Centers for Disease Control and Prevention have reported zero deaths from the consumption of dietary supplements and during the last 25 years, more deaths have been reported from bee stings, lightning strikes or horse-riding accidents than from supplements. This compares extremely favorably to FDA-approved drugs, government-licensed hospitals and government-licensed medical doctors that account for hundreds of thousands of deaths a year! Clearly, this legislation is nothing but job-killing, regulatory over-reach that has no connection with reality.
Mr. Durbin must know all of these facts. He must know that drugs, doctors and hospitals are far more dangerous than dietary supplements. Yet, he still chooses to follow his marching orders and heap suffocating laws, rules and regulations upon the dietary-supplement industry until its products are as expensive and as useless as the drugs that they compete against.
Adverse Event Reports
Congress passed the “Dietary Supplement and Nonprescription Drug Consumer Protection Act” (S.3546), requiring reporting of serious adverse events connected with supplements, in early December 2006, during the wee hours of the morning and with many congressional representatives absent. Back in 2007, I advised the industry that this was only the first step towards the treatment of supplements as drugs (see www.thenhf.com/article.php?id=2336).
Now, and very predictably, Mr. Durbin trots out as support for his bill the “sudden” increase in adverse event reports (AERs) for dietary supplements. In fact, supplement AERs did increase from 400 in 2007 to 1,080 in 2008, with their grand total for the period from 2008 to 2011 being 6,307 AERs. But that increase is entirely attributable to the then-new legal reporting requirements as well as a larger number of supplements coming to market since 2007.
If Mr. Durbin were truly interested in consumer health, then he would refocus his myopic eyes upon the greater danger of pharmaceutical drugs and foods. Just in 2008 alone, 526,527 prescription-drug AERs were reported along with 26,517 vaccine AERs! Even math-challenged Durbin cannot ignore the fact that there were almost 500 times more adverse event reports for prescription drugs than there were for dietary supplements.
Durbin’s Anti-Supplement Track Record
Lee Bechtel, the National Health Federation’s lobbyist, has helpfully written a report detailing the history of Dick Durbin’s attacks against the Dietary Supplement Health and Education Act of 1994 (see www.thenhf.com/article.php?id=3447). In that article, Bechtel lists each and every recent legislative effort that Mr. Durbin has made to squelch supplements. Most—including his Dietary Supplement Labeling Act of 2011—have been failures. We can perhaps expect the same with this renewed effort of his in 2013. Still, there is always the possibility that, this time, he will succeed.
S.1425 will do nothing but give broad and arbitrary discretionary powers to FDA bureaucrats to eliminate effective and safe supplements that have been on the market and that are already more than amply regulated by the FDA under the Dietary Supplement Health and Education Act of 1994, as subsequently amended with strict GMP rules and adverse-event reporting requirements. While its likelihood of passage is no greater than that of his previous bill two years ago, Tricky Dick Durbin will almost certainly try at some point to sneak this bill as an amendment into another, unrelated bill.
As with his previous attempt two years ago, this bill must be opposed and defeated, with a stake through its heart. Another crushing and humiliating defeat for Dick Durbin here might just cause him and his sponsors to take a longer pause before they make their next legislative effort.
In addition, Mr. Durbin is up for re-election in 2014; and while not deemed vulnerable by political “experts,” there have been electoral upsets before. It is long past time for Illinoisans to throw out this bum.
In the meantime, write your Senators now and demand that they oppose S.1425. This Durbin bill is yet more validation for the old saying that “you may not take an interest in politics, but politics will take an interest in you.” Your supplements are once again at risk. WF
A graduate of the University of California at Berkeley Law School, Scott C. Tips currently practices internationally, emphasizing Food-and-Drug law, business law and business litigation, trade practice, and international corporate formation and management. He has been involved in the nutrition field for more than three decades and may be reached at (415) 244-1813 or by e-mail at firstname.lastname@example.org.
Published in WholeFoods Magazine, October 2013