McCAIN'S BILL S-3002 IS AN OVERKILL ON DIETARY SUPPLEMENTS
PART 1 of 2
Scott Tips, JD
March 10, 2010
“There is nothing more frightful than ignorance in action.” —Johann Wolfgang von Goethe
Only a few short weeks after introducing his so-called “Dietary Supplement Safety Act,” Republican Senator John McCain was already feeling the heat – so much so that, like Custer at the Little Big Horn, he felt compelled to dismount his high horse and defend his hugely mistaken foray into hostile Native territory. Short of ammunition and evidently just as shy on literacy, Johnny McCain issued a Senate Floor Statement that accused his opponents of the very faults he himself is displaying.
“[O]pponents to this bill and their well paid Washington lobbyists,” his Senate Floor Statement of February 22nd dissembled, “have spread false statements and rumors about the legislation, which is really a disservice to consumers, and instead proudly boast that they remain largely untouchable by the Food and Drug Administration (FDA). This legislation,” it continued, “would simply require dietary supplements to list all ingredients on the packaging, mandate that all dietary manufacturers register with the FDA to ensure the FDA knows what is being sold and provide the FDA mandatory recall authority of any dietary supplement if the FDA finds the supplement to be hazardous to one’s health.”
It is sad enough that Senators in Washington, D.C. rarely read other Senators’ bills before voting on them, but when they do not even read their own, or worse do not even understand what they have read of their own, then it is long past time for that politician to perhaps take that overdue remedial reading course. Or, as John McCain has just done on March 4th, admit that he has made a mistake and withdraw support from his own bill.
How It All Began
There are bad actors in any industry. Just look at the U.S. Senate. Yet, somehow, because the dietary-supplement industry has long been an increasingly competitive thorn in the side of the pharmaceutical industry, its few bad actors can be used to justify the harshest draconian clamp-down by the best politicians and regulators that drug money can buy. Never mind that properly-approved drugs and state-licensed medical doctors and hospitals kill nearly one million persons a year, “dangerous” and “unregulated” dietary supplements that cause fewer deaths and injuries every year than bee stings or even lightning strikes must be regulated. Of course, the long-standing fact that supplements are already regulated and that the FDA already possesses the authority and power to track down and eliminate the bad actors is rarely, if ever, mentioned by the mainstream media.
So it was that the Senate Committee on the Judiciary Subcommittee on Crime and Drugs held a hearing last September 29th to discuss the problem of “enforcement barriers” to body-building products and hidden steroids within them. A dog-and-pony show of witnesses favorable to increased drug-like regulation of the supplement industry was put on for the subcommittee, with witnesses from the FDA, the Drug Enforcement Agency and the World Anti-Doping Agency. (See testimony one and testimony two) No one, to my knowledge, appeared to testify to the contrary. The impression given to the subcommittee was that existing laws and powers were inadequate to rein in designer steroid drugs and that the Dietary Supplement Health and Education Act of 1994 (DSHEA) was to blame.
The Final Solution
Ostensibly because some highly-paid professional as well as some amateur athletes took dietary supplements that were illegally spiked with steroids, Senators John McCain (R-AZ) and Byron Dorgan (D-ND) introduced their Senate Bill 3002 on February 4, 2010, to require: (1) comprehensive registration of all manufacturers, distributors and holders of supplements; (2) prohibition of sale of any dietary supplement not on an FDA-approved positive list; and (3) burdensome reporting of each and every adverse event, whether serious or trivial, affecting dietary supplements. (See the bill text itself here)
Looking at its disparate elements, S.3002 clearly constitutes overkill. As the Washington, D.C. Law firm of Venable LLP has pointed out, the bill would impose significant administrative and compliance requirements on the dietary supplement industry, the costs of which would be passed on to consumers, including the following.
A dietary-supplement facility (meaning “any business or operation engaged in manufacturing, packaging, holding, distributing, labeling or licensing a dietary supplement for consumption the United States”) would be required to register with the FDA and disclose all of its trade names. It would also have to file a list of all supplements manufactured, packaged, held, distributed, labeled or licensed by the facility with all of their ingredients and a copy of the labeling for each product (Section 2(b)(2)(B)(i), p. 3–4). Note that under this definition, even an individual multi-level marketer would have to register as a “dietary-supplement facility.”
The dietary-supplement facility would then have to update its registration annually, and update its registration of any new dietary supplements or reformulations of existing supplements on or before the date it is marketed (Section 2(b)(2)(B)(ii), p. 4).
Importantly, the proposed legislation changes the definition of the term, “new dietary ingredient.” A new dietary ingredient would henceforth mean any dietary ingredient that “is not included on the list of ‘Accepted Dietary Ingredients,’ to be prepared, published, and maintained” by the FDA (Section 2(c)(2), p. 5–6). The bill does not provide any guidelines or guarantees as to which ingredients would be placed on this list. This provision could have significant consequences if enacted since a large majority of ingredients that are now considered “grandfathered” could be considered “new” and subject to the notification provisions. To my mind, the “Accepted Dietary Ingredients” list sounds suspiciously like the overly restrictive European Union’s Positive list for accepted vitamin and mineral food supplements. And I can almost guarantee you that if it does not start out as an all-encompassing positive list, then it will end up that way.
For any supplements containing new dietary ingredients, the bill further requires that any person submitting information to the FDA must maintain a scientifically-reasonable substantiation file relating to the dietary ingredient’s safety. The dietary-supplement facility or retailer must obtain adequate written evidence from the preceding responsible entity that the product is registered and the information-submission requirement for new dietary ingredients has been met, and maintain such compliance records for inspection by the FDA (Section 2(c)(3), p. 6).
Amazingly enough, McCain also wants every single manufacturer, packer, holder, distributor, labeler, and licensee of a dietary supplement whose name appears on the product's label to submit each year to the FDA a compilation report of all serious and non-serious adverse events associated with the use of the product in the United States! The Bill fails to define what a non-serious adverse event even is, making it possible that reporting would be required for everything from a cut finger while opening the bottle to a consumer’s objection to the smell emanating from an opened bottle. Evidently, the FDA was not receiving enough adverse event reports on supplements before, so this is its way to increase the numbers – report everything! Unfortunately, taxpayer-funded bureaucrats would then have to sort through non-serious adverse event reports when they could be doing far more-important tasks. Reporting of serious events is already required under the law; and, as previously predicted, the law that mandated that camel’s nose in the tent is the precedent allowing this follow-up nonsense.
Of course, with these increased regulatory demands go increased regulatory penalties. In addition to other penalties, non-compliance could bring a civil penalty of twice the gross profits or other proceeds derived from the sale of the dietary supplements (see Section 2(d), p.7).
And with that considerable financial club, the FDA would be given a second hefty club: the power to make its own, arbitrary determination that there is a “reasonable probability” that a dietary supplement would cause serious, adverse health consequences or death, or is adulterated or even just misbranded. In those cases, the FDA could immediately order the company to cease distribution and to notify others of the FDA order with instructions to stop their own sale and use of the product (see Section 2(f), p.9). The FDA already has the power to halt the sale of any dietary ingredient that risks illness or injury, can get an injunction blocking the sale, and can prosecute those responsible. But McCain’s bill encourages abusive and arbitrary use of this extended regulatory power by the FDA since it lacks normal, due-process requirements. Any FDA stop-order could remain in effect for years before there is a trial on the merits, making it very costly for any company to contest it.
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This hodge-podge bill supports Milton Friedman’s contention that the government solution to any problem is usually at least as bad as the problem itself. McCain’s solution is no solution at all, just a gimmick for his re-election campaign into which DSHEA-restrained bureaucrats could join in their own bid for more power. For part two click below.
Click here for part -----> 2,
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