The FDA and FTC’s Continuing War against Homeopathy
This summer, while the attention of Americans has been focused on enjoying their family and friends, two dangerous, increasingly lawless, federal government agencies — the Food and Drug Administration and the Federal Trade Commission — have been preparing to substantially restrict the public’s access to homeopathic remedies. We all need to take this threat seriously.
The Arrogance of Power
It is predictable that people in each profession believe that they have special insight. Lawyers believe they are the experts on the Constitution — a document written by and for the People. Physicians believe that they are the experts on the human body, but each of us knows ourselves better than anyone else can. Physicians want deference because they are “scientists.” But most are no more scientists than I am — just clinicians who fall into repetitive patterns, refusing to believe that something that a patient came up with could ever work better than whatever they prescribed. And when the medical establishment cannot persuade others that their opinion of today is a moral certainty, they turn to Government to use all of its coercive power to give them a victory they never earned in the marketplace.
Before describing the current threat to homeopathy, and what can be done about it, however, it is important to return to First Things: From whence does the federal government derive the power to override the judgment of individual Americans as to their own personal healthcare decisions?
When America was the Land of the Free
There once was a time that the People who ratified the United States Constitution in 1789 were treated with a degree of respect by those chosen to serve in national leadership positions. For over a century and a quarter after the founding of this nation, the People were largely free to make intensely personal decisions about their own healthcare, with only a few boundaries, primarily emanating out of the common law — such as the prevention of outright fraud. After all, the federal government was given no enumerated power in Article I, Section 8 over healthcare — and to the extent that any government has any authority over private healthcare decisions, it was to be exercised by the individual states under their limited “police power.”
Even those national political leaders who were fully persuaded that they knew best how to run other people’s lives felt constrained to resist the temptation. Before they “did good,” they asked a threshold question — “Do we have in government the constitutional authority to impose our will on the People?” Of course, it would be wrong to think that politicians, as a class, were ever mostly noble and courageous, for after all, in a wonderfully curious verse, Daniel warns about rulers having one common denominator: they are “the basest of men.” Daniel 4:17. However, during this early period in the nation’s history, even the worst elected officials seemed to understand that the U.S. Constitution ruled over them: that the Constitution is the People’s law that governs the government.
Prior to the Progressive Era, the federal government largely treated Americans as grown-ups, able to make their own decisions, and either benefit from those decisions, or accept the consequences of those decisions. University of Chicago Law Professor David Currie’s wonderful three volume series on The Constitution in Congress demonstrates that the debates in Congress over the constitutionality of proposed laws were often sophisticated clashes, vastly more thoughtful as to what often passes for argument before the current U.S. Supreme Court. Those in Congress repeatedly expressed concern as to whether proposed laws were constitutional. Famously, Congressman Davy Crockett once opposed a popular bill to appropriate money to aid a widow of a naval officer for one simple reason: “We have not the semblance of authority to appropriate it as a charity.” While there are still a few, such men of conviction generally no longer serve in Congress.
The Rise of the Administrative State
These days, limits on government power do not receive much consideration anywhere. In Congress, the highest priority of any member is to be re-elected. Therefore, with an eye to the next election, members of Congress need and want deniability whenever they want something done which will offend the People. Frequently, complicit members of Congress wanting to serve a large, powerful and wealthy constituency (e.g. Wall Street, Big Pharma) rely on administrative agencies to do their dirty work. They stand back and pretend to be powerless, as if they had no authority to intervene.
In the modern era, Congress delegates broad rule making power to administrative agencies ignoring the Constitutional command that “All legislative Powers herein granted shall be vested in a Congress of the United States.” Article I, Section 1. Congress then adds the executive power to enforce those rules. It then completes the package by entrusting these agencies with adjudicatory (judicial) power. The Courts complete the circle by generally refusing to give serious review to administrative actions, citing the need for judges to give deference to bureaucrats, as articulated by the U.S. Supreme Court in Chevron U.S.A. v. National Resources Defense Council, 467 U.S. 837 (1984). Deference to the bureaucrats helps create a short work day for the judges.
The Administrative State has grown so powerful that another brilliant University of Chicago Law Professor, Philip Hamburger, published last year a book addressing the question Is Administrative Law Unlawful? His conclusion: the modern administrative law is best understood as a reversion to the English King’s thoroughly lawless prerogative courts, typified by the Court of Star Chamber which was abolished in 1640.
The Framers never envisioned the modern administrative state. In Federalist No. 47, James Madison echoed Montesquieu when he explained that the Constitution could never permit it: “The accumulation of all powers, legislative, executive and judicia [l] in the same hands, whether of one, a few, or many, and whether hereditary, self-appointed, or elective, may justly be pronounced the very definition of tyranny.” Indeed, Madison virtually invited us to resist monstrosities such as the FDA and the FTC: “Were the federal Constitution, therefore, really chargeable with the accumulation of power, or with a mixture of powers, having a dangerous tendency to such an accumulation, no further arguments would be necessary to inspire a universal reprobation of the system.” Indeed, it is past time to inspire a universal reprobation of the FDA and the FTC.
When Homeopathy was Respected, and Honored
There once was a time that those who swam against the prevailing currents by resisting a corrupt establishment received accolades. On January 31, 1900, the U.S. Congress passed an Act of Congress (31 Stat. 709) providing for the creation of a monument in Washington, D.C., dedicated to a foreign physician who was one of the great reformers of his era: Christian Friederich Samuel Hahnemann. On June 21, 1900, the monument was dedicated by President William McKinnley, a believer in homeopathy.
The U.S. Department of the Interior’s National Register of Historic Places describes Hahnemann as “the first foreigner not associated with America’s independence to be represented in sculptural form in Washington, D.C.” and only “the second doctor to gain sculptural recognition.” Described by the U.S. Department of the Interior as “precocious and brilliant,” Hahnemann’s abilities as “a consummate linguist, the master of German, Latin, Greek, French, Italian, English, Arabic, Syriac, Hebrew, and Chaldaic” alone should have deserved some honor. But it was his institution of “mild and humane treatment methods” while serving as “the Superintendent of the Insane Asylum at Goergenthal” and as a member of the “Faculty of Medicine at the University of Leipzig,” and as “Hofrath, or Councilor of State” that he grew to fame. Id.
And it is utterly fascinating that the official Department of the Interior records explain clearly that Hahnemann “attempted to legitimize the medical profession and free it from its barbaric practices.” Hahnemann stood against “medical orthodoxy” of the day that “relied on over drugging and bleeding.” Id. Today, at least the medical establishment has abandoned one of those two treatment modalities.
What the FDA is Planning
The FDA has announced that it is conducting an evaluation of:
its current enforcement policies for drug products labeled as homeopathic from scientific, risk, and process perspectives [and] whether and how to adjust the current enforcement policies to reflect changes in the homeopathic product marketplace. [80 Fed. Reg. 16327 (emphasis added). ]
The FDA states that it has permitted what it terms “homeopathic drugs” to be marketed without prior FDA approval under FDA Compliance Policy Guide 400.400 (June 9, 1988) (“CPG”). The CPG also sets forth the labeling requirements for “homeopathic drugs.” The FDA notice asserts authority to control homeopathic remedies when it asserts that the “FDA has not reviewed this class of products for safety and efficacy.” 80 Fed. Reg. 16328. The FDA’s assertion that homeopathic remedies constitute “drugs” is essential for it to assert control over homeopathic remedies, but, as discussed below, that claim is specious.
If you don’t believe the FDA is now seeking to exercise new, broader control over homeopathic remedies, consider the following questions on which the FDA has asked for comment:
- What are consumer and health care provider attitudes towards human drug and biological products labeled as homeopathic?
- What data sources can be identified or shared with FDA so that the Agency can better assess the risks and benefits of drug and biological products labeled as homeopathic?
- Are the current enforcement policies under the CPG appropriate to protect and promote public health in light of the tremendous growth in the homeopathic drug market? Are there alternatives to the current enforcement policies of the CPG that would inform FDA’s regulatory oversight of drugs labeled as homeopathic? If so, please explain.
- Are there areas of the current CPG that could benefit from additional clarity? If so, please explain.
- Is there information regarding the regulation of homeopathic products in other countries that could inform FDA’s thinking in this area?
- A large majority of human drug products labeled as homeopathic are marketed as OTC drugs. These products are available for a wide variety of indications, and many of these indications have never been considered for OTC use under a formal regulatory process. What would be an appropriate regulatory process for evaluating such indications for OTC use?
- Given the wide range of indications on drug products labeled as homeopathic and available OTC, what processes do companies currently use to evaluate whether such products, including their indications for use, are appropriate for marketing as an OTC drug?
- Do consumers and health care providers have adequate information to make informed decisions about drug products labeled as homeopathic? If not, what information, including, for example, information in labeling, would allow consumers and health care providers to be better informed about products labeled as homeopathic? [Emphasis added.]