Under the guise of keeping Americans safe by restricting their choices, the U.S. Food and Drug Administration (FDA) is plotting a massive power-grab that could crush the popular natural-health industry under an avalanche of regulatory red tape and policy uncertainty. Consumers could also lose access to an array of natural remedies. The controversial federal plot, which critics say has no basis in law or the Constitution, comes as Americans become increasingly disillusioned with “Big Pharma” and establishment medicine generally. The FDA schemes would protect the profits of well-connected pharmaceutical companies while further aligning U.S. policy with the United Nations “Codex Alimentarius” regime. Criticism of the FDA’s proposed scheme is growing louder, though. The public has a week left to comment on the looming regulations.
The controversial federal agency first released the draft of the proposed new “guidelines” in December of 2017. However, like the overwhelming majority of federal regulations — tens of thousands of pages were being added each year under Obama and previous presidents — the scheme to put natural remedies under a federal boot flew largely under the radar until recently. Essentially, the FDA wants to treat natural homeopathic remedies as “drugs,” and regulate them as such. Claiming that the FDA’s regulations play “an essential role” in ensuring that substances are “safe and effective,” the agency argued that the growing popularity of non-FDA approved homeopathic remedies was a “public health concern” that required its urgent attention.
“Recent years have seen an increase in the sale of products labeled as homeopathic,” the FDA said in an eight-page document outlining its desired schemes and the purported rationale behind them. “In the past, these products were mostly prepared by homeopathic physicians for individual patients. Today they are frequently mass manufactured and widely marketed as over-the-counter (OTC) products.” And that growth in consumer interest, according to the militarized food and drug bureaucracy, is cause for concern — so much so that new “enforcement actions” are needed to crush natural-health companies and protect Big Pharma and its lobbyists from free-market competition.
Currently, homeopathic remedies are governed under a “Compliance Policy Guide” regime disgorged by the FDA in 1988 titled “Conditions Under Which Homeopathic Drugs May be Marketed.” But supposedly, due to the growth of the industry and the passage of time, the agency decided it needed to re-examine the “regulatory framework” it had previously created for such products. “As a result of the Agency’s evaluation, … FDA has determined that it is in the best interest of public health to issue a new guidance that applies a risk-based enforcement approach to drug products labeled as homeopathic and marketed without the required FDA approval,” states the agency’s new proposal.
Under the proposed plan, the FDA would claim for itself the power to determine that some products labeled homeopathic are “being marketed illegally.” Then, without being required or expected to even give notice to its targets, the agency would swoop in with vaguely defined “enforcement action.” Whether heavily armed and militarized FDA goon squads would be used, as they have been to terrorize farmers and grocers selling raw milk, was not immediately clear from the proposal. In fact, the agency seems to be trying to be as vague as possible, thereby allowing subjectivity and individual whim to govern its “enforcement actions.”
“In recent years, we’ve seen a large uptick in products labeled as homeopathic that are being marketed for a wide array of diseases and conditions, from the common cold to cancer,” said FDA Commissioner Scott Gottlieb, who made big bucks with Big Pharma before taking his new post. “In many cases, people may be placing their trust and money in therapies that may bring little to no benefit in combating serious ailments, or worse — that may cause significant and even irreparable harm because the products are poorly manufactured, or contain active ingredients that aren’t adequately tested or disclosed to patients.”
The FDA’s approach to regulation of homeopathic products must “evolve to reflect the current complexity of the market,” Gottlieb continued. “We respect that some individuals want to use alternative treatments, but the FDA has a responsibility to protect the public from products that may not deliver any benefit and have the potential to cause harm.” What section of the U.S. Constitution the FDA believes gives it a “responsibility” to restrict the choices of consumers to use alternative treatments was not specified. Instead, the FDA often cites itself or unconstitutional federal statutes as its authority for doing what it wants.
The self-styled overseers of America’s foods and medicines promised to prioritize a number of areas in their “enforcement actions.” Among those being targeted: Products with alleged “safety concerns,” products that contain or purport to contain ingredients with “safety concerns,” products that are not taken by mouth or applied on skin, products that are intended to prevent or treat serious diseases, products for vulnerable populations such as children or the elderly, and products that have been adulterated. Especially concerning, the FDA said, is that homeopathic remedies might cause people to forgo “medical treatments” that the FDA believes to be “safe and effective.” If the FDA decides it does not like a product, the agency would make it unavailable to willing consumers.
Critics, though, are crying foul. Professional homeopath Patricia Feijo, in a brief for the Center for Medical Freedom about the proposed FDA power-grab, blasted the agency for “disregarding federal law and usurping the right of American people to use historically available health-enhancing products of their choosing.” While the scheme would be a major boon for Big Pharma, it would harm Americans “who should continue to have unregulated access to these healing products,” she added, saying the regulations would injure “countless individuals and the nation’s health.”
“Federal law does not give the FDA the authority to apply the rules designed only for toxic pharmaceuticals to nontoxic Homeopathic remedies,” she explained at the CMF, a project of the Conservative Legal Defense and Education Fund. “The FDA’s only job is to ensure that products are manufactured according to legal standards and are properly labeled. The rules and regulations governing Homeopathic remedies that have been in place for most of the last century are more than adequate to protect the public.”
Feijo also blasted the FDA for assuming that the increased use of homeopathic remedies was due to ignorance. Instead, she said, citing data, it is a result of consumers being more informed. “For 200 years, Homeopathic remedies have survived attempts by proponents of pharmaceutical drugs to suppress Homeopathy time and again, but the threat here is real and must be taken seriously,” she continued. “It is not the job of FDA employees to place their value judgment on this system of medicine, but only to ensure that such drugs are manufactured according to legal standards and are properly labeled…. This new attack on homeopathy by Big Pharma and its friends must be defeated.”
The FDA notes on its website the influence of UN “guidelines” on these issues developed by the Codex Alimentarius Commission, a UN body that seeks to develop an Orwellian global regulatory regime over food, vitamins, drugs, and more. “Pursuant to its obligations under the World Trade Organization (WTO), the FDA works with foreign governments and international standard-setting bodies to harmonize food safety laws, regulations and standards based on science,” the FDA boasts on its website. “The FDA also establishes arrangements with regulatory partners to harmonize food safety standards and eliminate duplication or overlap in food safety controls.” The FDA also notes that “WTO obligations are codified in U.S. law.”
Whether homeopathic remedies work better than conventional medical treatments — or not at all — is not the issue here. The issue, rather, is who will make healthcare decisions for Americans, individuals and families in consultation with their healthcare providers, or unaccountable federal bureaucrats beholden to Big Pharma and its lobbyists. Ironically, though, a great deal of evidence suggests that the FDA and the Pharmaceutical-Industrial Complex that dominates it through the infamous “revolving door” have a terrible track record when it comes to accurately assessing drug safety and efficacy. When little-known data such as the Number Needed to Treat (NNT) and Number Needed to Harm (NNH) are considered, it appears that the FDA is often worse than clueless.
Instead of fighting back each time a rogue federal bureaucracy proposes more infringements on the rights of Americans, a better strategy would be to ensure adherence to the U.S. Constitution by all three branches of government. Because the document that created the U.S. government does not authorize federal intervention in “health,” “human services,” food, or drugs, the FDA and the broader U.S. “Department of Health and Human Services” (HHS) should be abolished. The Tenth Amendment to the Constitution guarantees that all powers not delegated to the feds under the Constitution are reserved for the states or the people. The free market remains the most powerful and reliable regulator of all. But any health regulations the public believes are needed ought to be established at the state and local level — not by unelected bureaucrats in Washington beholden to special interests.