Attorney Jonathan Emord
December 21, 2009
Over a year ago, the FDA adopted a 1,000 plus page final rule on Good Manufacturing Practices (GMPs), mandating process controls from source to finished product for dietary supplements. It did so presumably to protect the American public from adulterated products but it is imposed on every company, not just those that cause harm. The rules impose substantial new compliance requirements and costs on every company in the industry. Under this new prior restraint, a product is deemed adulterated as a matter of law if a company fails to keep “adequate” records or to follow procedures in a manner that FDA deems “appropriate.” Some would consider it ironic that the major trade association for the dietary supplement industry, the Natural Products Association, first proposed the GMP rule to FDA. Others, including me, find nothing unusual about this because major players in virtually every maturing market favor imposition of “public interest” regulation to increase costs of entry and business for smaller competitors, thus driving them out of business and securing the larger firms’ market shares.
The GMP rules are particularly wicked because they give virtually unbridled discretion to FDA agents in determining the adequacy of compliance measures and any measure deemed inadequate is defined as an act of adulteration as a matter of law. The Final Rule does include a chilling admission that FDA enforcement of it will cull from the industry a quarter or more of all companies now in business, will exact a disproportionate penalty on small companies, will increase unemployment, will limit entry into the dietary supplement market, and will increase the costs of supplements. At the same time, because the dietary supplement market is already characterized by remarkable safety, it will yield no provable improvement in public safety.
Over a year ago my firm issued a notice to clients warning of the imminent implementation of the draconian rule. That notice included a doctored photo from the 1930s of stormtroopers invading Paris marching under the Arc de Triumph. It was entitled, “Here Come the Stormtroopers” and raised several eyebrows, including ones at the FDA. Through the magic of digital imaging, we had the Nazi soldiers images modified to include FDA tags on their shirts and standards bearing not the Nazi emblem but that of the FDA. The picture produced the effect we desired, alerting clients to a threat of abuse of power. We wanted to awaken an industry preoccupied with surviving a recession to the very real peril we saw coming from FDA enforcement of the new rules. Many in the industry presumed that if their products were safe to consume their government would not destroy them so long as they agreed to correct errors that were technical in nature. We advised to the contrary. We were right.
The proof is now in the offing. Within the last three months, the FDA has unleashed its agents across the United States, visiting company after company. Our phones ring daily with stories of new FDA investigations. The agency is conducting more inspections of dietary supplement companies than ever before in the same time span.
In 18th Century England, the right of a person to be safe in his person and effects against unreasonable search and seizure first arose in British law. At that time, radical Whigs who engaged in comments critical of the Crown and majority party (i.e., seditious libel) heard thereafter the unfriendly knock of the constable who would enter a house or place of business and ransack it, combing over the premises for any possible evidence of illegality. Upon finding that evidence, the party responsible would be arrested and tried.
General warrants, as they were called, were issued without probable cause of illegality and without proof of any imminent threat to the public safety. At a time when the rights of men were discussed seriously in the Age of Enlightenment, while the theories of individual rights against the state from John Locke, Cato (the nom de plume of Thomas Gordon and John Trenchard), Algernon Sidney, and Edmund Burke among many others circulated, the environment was ripe for taking down tyranny, and change came. In famous English cases that received applause in the American colonies the General Warrants were condemned, and the law came to respect the rights of citizens to be secure in their papers and effects against unreasonable search and seizure.
That basic right has been lost to the regulatory state. Under contemporary law, regulators enjoy great power to “investigate” without probable cause of illegality. Moreover, regulators can obtain warrants without notice to the regulatee, enabling them to seize and remove all manner of products, confidential papers, and materials on the strength of a mere affidavit alleging that there is, e.g., “adulteration.” Because mere record keeping omissions or mistakes under the GMP Final Rule constitute adulteration by operation of law, it is a simple affair for an investigator to execute an affidavit of a finding of adulteration, triggering a warrant ex parte (without notice to the regulatee) from a federal court.
With such extraordinary power at their disposal, rendering them no different from those who executed General Warrants against our forebears, FDA investigators can easily intimidate and humble regulatees. Uppermost in the mind of the regulatee is that if the investigator chooses to he or she can invariably find something arguably remiss, declare it proof of non-compliance, and endanger the future business of the company. It is often the case that a party investigated will turn over all manner of information, even beyond what is legally required of them, to satisfy FDA investigators.
Those investigator then return to their offices and comb over the materials for any potential basis for a law violation, alerting other government agencies federal and state if they find matters that might also offend those other agencies’ regulations. When violations are found (and invariably if an agent wants to find a violation he or she will), the agency may then refer the matter for civil and criminal prosecution to the United States Attorney. Prosecutions occur even when there is no evidence of any harm to the public. Indeed, the product may be health enhancing, but labeled improperly or made without requisite record proof of compliance with the GMPs, yet those technical infractions may be translated into a civil or criminal law violation carrying with it draconinan penalties and even jail time.
The effective return of General Warrants through the regulatory agencies is a remarkable devolution in the history of liberty, one sadly among many. The scope of liberty available to Americans is shrinking day by day. We are increasingly becoming wards of an ever expanding state. With each new law and new agency mandate comes a greater intrusion into our affairs and a constriction of our free choices. There is a tipping point at which those intrusions will cause such hardship and such interference with the rights of a once free people that those people will demand in overwhelming numbers that the rights violation stop. We have yet to reach that tipping point, and it is anyone’s guess when we will.
� 2009 Jonathan W. Emord - All Rights Reserved