About 5 million U.S. adults and 1 million U.S. children use homeopathy every year, and the remedies are known to be “generally safe and unlikely to cause severe adverse reactions,” according to the U.S. National Institutes of Health’s National Center for Complementary and Integrative Health.1 Yet, if the U.S. Food and Drug Administration (FDA) continues on its latest crusade, this natural health modality may soon be much harder to come by.
In a draft guidance document released in December 2017, the FDA takes aim at homeopathic remedies, or as they put it, “drug products labeled as homeopathic.”2,3 In a reversal of a long-standing decision to treat homeopathic remedies differently from other drugs, the FDA has now labeled virtually all of these products as “new drugs” that are “subject to FDA enforcement action at any time.”
FDA Declares Homeopathic Drugs Illegal, Plans to Ramp Up Enforcement Actions
While deaths from drugs like opioids are now a public health crisis, homeopathy has maintained a much lower, and presumably safer, profile. Yet, the FDA is using its limited resources to target the latter, citing a need to “protect consumers who choose to use homeopathic products.” Why now? The FDA also cited a “large uptick in products labeled as homeopathic that are being marketed for a wide array of diseases and conditions,” to the extent that homeopathic products are now a close to $3 billion industry.4
Perhaps that’s $3 billion too much for Big Pharma, FDA’s cozy partner in crime. “[I]n one fell swoop, the FDA has declared that virtually every single homeopathic drug on the market is being sold illegally,” the Alliance for Natural Health USA (ANH USA) wrote5 — and it’s not an exaggeration. In essence, the FDA’s guidance reads:6
1. Any homeopathic drug that has not been considered “generally recognized as safe and effective” (GRAS/E) is considered a new drug
2. FDA has not determined that any homeopathic drugs are GRAS/E
3. A new drug cannot be marketed unless it goes through the FDA’s approval process
4. No homeopathic drugs have gone through FDA approval nor can any producer afford to take them through the approval process
The FDA then states that it’s proposing a “new, risk-based enforcement approach” and first plans to target the “unapproved drug products labeled as homeopathic that have the greatest potential to cause risk to patients.” This includes:7
Products with reported safety concerns
Products that contain or claim to contain ingredients associated with potentially significant safety concerns
Products for routes of administration other than oral and topical
Products intended to be used for the prevention or treatment of serious and/or life-threatening diseases and conditions
Products for vulnerable populations
Products that do not meet standards of quality, strength or purity as required under the law
FDA Does About-Face, ‘Penalizes an Entire Industry’
The draft guidance is a complete turnaround from the FDA’s prior stance on homeopathic remedies, which stated, under the 1988 Compliance Policy Guide (CPG) 400.400, Conditions Under Which Homeopathic Drugs May be Marketed, they did not need to get FDA approval prior to coming on the market. Instead, the ingredients in homeopathic remedies were to be verified by the Homeopathic Pharmacopoeia of the United States (HPUS). As noted by law firm Venable:8
“Essentially, the HPUS creates a monograph for homeopathic drugs to follow, not dissimilar to the OTC drug monographs that FDA has developed for allopathic drugs. Accordingly, by virtue of an ingredient’s inclusion in the HPUS, the ingredient has already been closely examined and determined to be safe and effective by the HPCUS [Homeopathic Pharmacopoeia Convention of the United States].
Compliance with the HPUS functions as a premarket review of safety and effectiveness in the homeopathic context. By classifying homeopathic drugs as unapproved new drugs, the FDA is requiring a second showing of safety and effectiveness, a step that is unnecessary, not to mention impractical, given that the Agency intends to hold homeopathic products to an allopathic standard that is inappropriate, given the nature of homeopathic products.”
Further, it was by the FDA’s own deliberate decision that homeopathic drugs were excluded from former drug approval processes and intended to be a separate category. Venable continued:9
“The FDA deliberately excluded homeopathic drugs from both the Drug Efficacy Study Implementation (DESI) review (the process by which all drugs approved between 1938 and 1962 were retrospectively evaluated by the FDA for effectiveness) and the OTC Drug Review in 1972 (the process used to develop OTC drug monographs for allopathic drugs), deciding instead in the latter case to regulate homeopathic products separately because of their uniqueness.
By withdrawing the CPG and classifying all homeopathic drugs as unapproved drugs subject to FDA drug approval, the FDA is now requiring higher regulatory thresholds for OTC homeopathic drugs than are applicable to allopathic OTC drugs, many of which are permitted to be sold pursuant to the FDA monograph system. This move in effect penalizes an entire industry for the Agency’s 1972 decision.”