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.]
Filing Comments with the FDA
The FDA held public hearings on April 20 and 21, 2015 on this topic and then opened up for comments, using the federal governments www.regulations.gov website.
On behalf of the United States Justice Foundation, we filed comments opposing the FDA’s power grab. The initial comment period closed August 21, 2015, with the FDA receiving over 8,600 comments. But there were so many demands to extend the comment period, that the FDA relented, and Comments now may be filed until November 9, 2015. See http://www.regulations.gov/#!docketDetail;D =FDA-2015-N-0540.
Although there is no guarantee that the FDA will listen to anyone, we each need to suspend disbelief, and take advantage of this opportunity to let them know exactly what we think of their plan. Comments can be filed by email or on line. Please file your comments!
Homeopathic Remedies Are Not Drugs
However, in seeking comments, the FDA ignores the threshold question: does the FDA have any statutory, or, indeed, constitutional authority to sit in judgment over the choice of Americans to use homeopathic remedies? It is our contention that the FDA has no such authority.
The FDA purports to exercise authority over homeopathy under the Federal Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. §§ 301, et seq. The FDCA defines a “drug” as, inter alia:
articles recognized in the … official Homoeopathic Pharmacopoeia of the United States … and … articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals…. [21 U.S.C. § 321(g)(1)(A)-(B) (emphasis added).]
The basic statutory definition of a drug as including “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals” employs language so broad that the definition could encompass virtually every substance that is consumed or comes in contact with the body.
For example, a bottle of water now sold at the corner 7-Eleven could be said to be “intended for use in the … cure of” thirst — which presumably has not yet been classified as a “disease” by modern medicine. However, if that same bottle of water was “intended for use in the … cure of” the medical conditions of Dehydration or Polydipsia — it would be a drug, by this definition.
Clearly, the “intent” of the person selling the substance cannot determine whether a substance is a drug. The statutory definition is overinclusive, as in the case of water, but it is also underinclusive, as it would exclude a pharmaceutical if it was not advertised to address a medical condition. This cannot be the way Congress intended to define a “drug.”
One of the defining characteristics of a pharmaceutical drug is that it has serious toxicity — a key characteristic shared by all pharmaceutical drugs. Because of that toxicity, the federal government limits public access, to protect the public. That rationale does not apply to homeopathy. Where the reason for the rule does not apply, so also should not the rule.
Indeed, when one school of medicine attempts to use the government to quash another school of medicine, that can be a good indication that those demanding the protection of the public have been losing market share. What cannot be accomplished in the marketplace can be imposed by government. Pharmacy Professor Richard Henry Parrish II explains the historic pattern of certain health care providers turning to government to accomplish by compulsion what they could not do by persuasion:
Government became the arbiter of pharmaceutical fact because the professions of pharmacy and medicine, as well as the pharmaceutical industry, could enforce their standards only through police powers reserved to government … at the expense of others’ rights of association, speech, and property. [Richard Henry Parrish II, Defining Drugs: How Government Became the Arbiter of Pharmaceutical Fact, Transaction Publishers, (2003), p. 132.]
FTC Joins the Attack on Homeopathy
Simultaneously, the FTC has opened up another front in the fight against homeopathy. This was to be expected, as the FTC and FDA have long worked in tandem in seeking to shut down access to alternative healthcare. The FTC issued an announcement that it would accept comments, and deadline for comments is now November 20, 2015.
The FTC also scheduled a “workshop” to be held on September 21, 2015, described as “homing in on homeopathy.” Such language triggers the mental image of a drone locked in on an “enemy of the state.” The agenda for the workshop makes it clear that the FTC is thinking about how deceptive advertising laws might be used “as possible remedies to address” homeopathic product claims. (Evidencing inter-agency cooperation, the FTC agenda also lists two FDA employees as panelists.)
Interestingly, the FTC also submitted comments to the FDA in the FDA’s rulemaking, together with an August 21, 2015 press release. The FTC urged the FDA to amend or repeal its current regulatory framework, so that the FTC would be able to freely regulate homeopathy. The FDA’s framework — the 1988 Compliance Policy Guide — requires homeopathic products to contain an indication for use. Yet the FTC complains that the FDA does not “require sellers to have competent and reliable scientific evidence to support the indication for use.” The FTC’s desire is to force homeopathic remedy manufacturers to comply with its scientific substantiation policy, something entirely unsuited for homeopathy.
Although American pharmaceutical manufacturers might prefer to suppress homeopathy so that they may be better able to market their drugs domestically and internationally, such would be a profoundly corrupt motive for the FDA to sanction. For many decades, the FDA has thus far understood that homeopathic remedies are virtually devoid of side effects, inexpensive, and found by millions to be effective for them. Thus, such remedies are completely different from toxic pharmaceuticals, and for these reasons, the FDA has recognized personal choice diversity in health care choices.
Applying the system for government-mandated pharmaceutical drug regulation to homeopathy would have a major ramification on the rights of citizens in a free society: It would stop citizens from acting in their own best interest, and would shift consequent responsibility to professionals and to government. The federal government has neither jurisdiction nor warrant to change direction now and interfere with the right of citizens to have unfettered access to homeopathic remedies.