McCAIN TO FDA: REGULATE JOE THE PLUMBER

By Attorney Jonathan Emord
February 15, 2010
NewsWithViews.com

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.