McCAIN TO FDA: REGULATE JOE THE PLUMBER
Attorney Jonathan Emord
February 15, 2010
If you had any doubt about whether John McCain is a limited government conservative, you may put that doubt to rest—he is not. On February 3, 2010, John McCain introduced to the United States Senate the Dietary Supplement Safety Act of 2010. Reflecting upon this poorly written bill, I am struck by the fact that John McCain apparently sees little difference between fissile material and dietary supplements. He is intent on regulating supplements as if they were radioactive enriched uranium rather than bioactive vitamins, minerals, amino acids, and botanicals that more often than not help people.
The Dietary Supplement Safety Act of 2010 enjoys support from the most liberal members of Congress. It is an invitation for the FDA to assume broad new powers and replicate here the system now operating in Europe over dietary supplements where dietary ingredients are presumed adulterated and unlawful to sell unless pre-approved by the government. In short, good bye free enterprise, good bye limited government, and hello more heavy handed, arbitrary and punitive FDA bias against the beleaguered dietary supplement industry. Yes, this is the same John McCain who unsuccessfully tried to rally Reagan Republicans on the notion that he was the true Reagan clone. If you believed that rhetoric, let me assure you, John McCain is no Ronald Reagan. He is very wide of the mark of that great man.
Now lest you think the FDA lacks power to remove dietary supplements from the market when sold in forms or dosage amounts that present a risk of illness or injury, let me also assure you that it has that power. It is codified in statute and embedded in regulation. FDA can halt the sale of any dietary ingredient that presents a risk of illness or injury, can get an injunction blocking the sale, and can prosecute those responsible. The power already exists. But McCain’s bill gives FDA power beyond the necessary. He apparently wants the FDA to function outside the bounds of due process of law and the separation of powers.
Consider the provisions of the Dietary Supplement Safety Act of 2010. Under it, every year every person or entity that manufactures, packages, holds, distributes, labels, or licenses a dietary supplement has to register with FDA and identify who they are and all of the products they sell or become a federal felon. Remember McCain’s rather pedestrian “Joe the Plumber” example during the campaign? Well I would not be surprised if Joe the Plumber keeps his large family above the poverty line during these hard economic times by selling vitamins from his house as a multi-level marketer. Well, Joe, the same McCain who promised you regulatory and tax relief is now offering you the chance to comply with a whole host of new federal regulations and, if you don’t, to learn what it is like to have three square meals given you year after year in a prison cell at the federal penitentiary.
Under Senator McCain’s bill everyone from Joe the Plumber to the local health food store owner to the large multi-national supplement manufacturer and distributor must report to FDA their names, addresses, dietary supplement products they held and sold, and the ingredients of those products, or go to jail. For the first time in American history, every person who distributes supplements will be tracked by the federal Food and Drug Administration, subjecting him or her to inspection and to the panoply of regulatory restraints that the FDA now uses against wholesalers and large retailers. Joe, call your lawyer.
Under Senator McCain’s bill, the FDA Commissioner (in the same manner as the European Food Safety Authority) will create a list of “Accepted Dietary Ingredients.” If a dietary ingredient is not on the Commissioner’s accepted list, it will be unlawful to sell in the United States. In other words, all supplements are presumed unlawful unless and until the FDA Commissioner says otherwise. Forget about requiring the government to prove food elements unsafe before removing them from the market. Under McCain’s bill, at her whim or caprice FDA Commissioner Margaret Hamburg can ban the ingredient as unsafe. She can do it summarily without a hearing, without a rulemaking, and without any due process.
Senator McCain’s bill renders all who sell these products instantaneously second class citizens who must get down on bended knees before the new federal Dietary Ingredient Queen (the FDA Commissioner) and beg and plead for dear mercy to sell the very same substance that yesterday were sold without serious adverse reactions.
Oh, speaking of adverse reactions. Senator McCain’s bill imposes even more reporting requirements, and they are imposed on everyone who manufactures, packs, holds, distributes, labels, or licenses a dietary supplement. I guess John McCain likes red tape after all. The law already requires manufacturers to report any serious adverse event and has a liberal adverse event reporting system that invites through the Medwatch system every doctor in the country to report on any suspected injury arising from a dietary supplement. Not enough says the Senator. Now “non-serious adverse events” have to be reported. What in the world are “non-serious adverse events/” The bill does not say.
Lets think about this for a moment. If the cat swallows your multi-vitamins, is that a non-serious adverse event? If the supplement is designed to promote regularity and you have more frequent bowel movements than you would like, is that a non-serious adverse event? If you fail to drink water with your multi-vitamin and it gets lodged in your throat, is that a non-serious adverse event? If you experience a niacin flush, is that a non-serious adverse event? If you don’t like the taste, color, or consistency of the product, is that a non-serious adverse event? If you think the name of the product stupid, is that a non-serious adverse event?
How could you include such an inherently ambiguous invitation to over-regulation as requiring the reporting of “non-serious adverse event reports” and not even define the term in the statute? What is FDA going to do with all of these reports of “non-serious adverse event reports.” Who cares about non-serious adverse event reports? Why should taxpayers fund government employees to mull over, file, and write regulatory letters about non-serious adverse event reports? What next, mandatory inspections for those who file non-serious adverse event reports? Why should we take non-serious adverse event reports seriously?
Every person who, or entity that, manufactures, packs, holds, distributes, labels, or licenses a dietary supplement has to report once a year every “non-serious adverse event” that comes to his or her attention. So Joe the Plumber who supplements his income with the sale of supplements hears from Sally the Teacher that the berry flavored protein shake mix he sold her last week tasted awful, like wall paper paste she says. Dutiful Joe, get your Non-Serious Adverse Event Report form 723 out and fill it in carefully under penalty of perjury and file that in strict accordance with federal regulations or you, yes even you Joe will go directly to jail.
Knock. Knock. Who’s there? FDA. FDA who? FDA come to see if you, Joe the Plumber, are keeping for three years in a manner consistent with federal regulations all of your “non-serious adverse event reports.” Get out, says Joe, I voted for John McCain. We’ve got news for you, Joe, says FDA, John McCain sent us.
Yes, under Senator McCain’s bill every person who or entity that manufactures, packages, holds, distributes, labels, or licenses a dietary supplement has to keep records of “non-serious adverse events” for a period of three years to enable the government to inspect them. No, I am not making this stuff up.
For those more than a few Americans who still value their rights more seriously than John McCain, consider this provision of Senator McCain’s bill. Under the “Recall Authority” section, if in her sole discretion the FDA Commissioner thinks there is “a reasonable probability” (in other words, she needs no proof, just a hunch) that a supplement would cause an injury, she can order without going to a court of law that the product not be distributed, marketed or sold. That’s it.
Margaret Hamburg to Joe the Plumber: John McCain sent me. Joe to Margaret, “he did?” Margaret to Joe: Yes, and I, like Sally the Teacher, do not like your berry flavored protein powder. I hate the taste and, moreover, if the whole can spills on the floor and an infant laps it up that infant could die. So, because of that serious health risk I am ordering you Joe the Plumber to cease and desist selling the powder. But other people also sell supplement powders, says Joe. I don’t care, says Margaret, and to quote one of your fellow Republicans, “I’m the decider.”
There no safeguards in this bill to prevent an abusive use of the new regulatory powers—not a one. Apparently Senator McCain trusts the government. Indeed, he trusts the FDA completely in this bill and trusts those the FDA regulates not at all.
Senator McCain has a solution for those who object. After the FDA Commissioner has forced you out of business on nothing more than “a reasonable probability,” you can ask the Commissioner for a hearing. Now during the hearing, you still cannot market or sell your product and it will cost you hundreds of thousands of dollars and require a lot of scientists to testify and lawyers to defend you but in the end you will have a hearing. It may take months all the while you will not be able to sell your product, but that’s okay because if the hearing lasts long enough you will be eligible for social security and, if you do not eat, you can put that toward your legal bills.
So, without any proof whatsoever, but on a simple hunch, the FDA can ban the sale of any dietary supplement under Senator McCain’s very trusting bill (trusting of the regulator, not the regulatee). The ban can continue without any precise time limit. Government hearings can take years. After the hearing (before the very same party accusing you, the FDA) you will not be surprised to learn that the FDA thinks it was right and you wrong. You will then at the FDA’s election be required at your own expense to recall the product from the market.
Under Senator McCain’s bill, the FDA Commissioner has unbridled discretion to remove any dietary ingredient from the market on a mere suspicion that it causes harm. There is no separation of powers, so the party charging you with a violation (the FDA) prosecutes you and judges your violation. In other words, John McCain fully endorses the modern regulatory state and is opposed to the system of checks and balances and separation of powers prescribed as necessary to avoid tyranny by none other than the Founding Fathers of the United States.
Based on this pedigree I think John McCain would do well resigning from the U.S. Senate and becoming a member of the European Parliament. That legislative body has adopted a system of prior restraint very much like the one he advocates here, and Europeans are suffering from it right now. I hope the silent majority out there who think more like Ronald Reagan than John McCain will send McCain and all elected representatives an unmistakable message: Kill the Dietary Supplement Safety Act of 2010 in committee. It’s unsafe for freedom.
� 2010 Jonathan W. Emord - All Rights Reserved