Critique of Proposed Regulations of Homeopathic Medicines and Alternative Proposals
- March 06, 2018 • 14,490 views
Story at-a-glance
- At a time in history when governments are reducing regulations, the Food and Drug Administration (FDA) is planning to increase its regulation on homeopathic medicines, despite their longtime history of being the safest medicines presently available
- The FDA is planning to nullify its previously established guidelines on the regulation of homeopathic medicines and replace them with a risk/benefit analysis that will increase the enforcement of homeopathic medicines that it deems to have a “higher risk” of danger
- The FDA claims that certain homeopathic medicines have been “associated with” an increased number of side effects and a small number of deaths, though, to date, no homeopathic medicines have been proven to contain toxic amounts of a drug ingredient
- The FDA is proposing an increase in regulation of homeopathic medicines sold to “vulnerable” populations, such as pregnant women, infants, children and the elderly, even though the 200-plus years’ remarkable history of safety makes the use of homeopathic medicines to be a preferred method of treatment for these groups of people
By Dana Ullman, MPH, CCH
In December 2017, the U.S. Food and Drug Administration (FDA) announced their interest in protecting consumers from “potentially harmful, unproven homeopathic drugs."1 The FDA is proposing to nullify its previous guidelines by which homeopathic medicines can be marketed. Instead, the FDA would deem all homeopathic medicines to be “unapproved new drugs,” which would make them subject to enforcement based on the perceived “risk/benefit” of a specific drug.
Some legal analysts and health writers initially wondered if the FDA's proposed guidelines would mean that homeopathic medicines may become "illegal,"2 but the FDA has assured the American public that the agency doesn’t plan to begin requiring that homeopathic products get “drug” approval. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, told reporters during a teleconference that many homeopathic medicines will not be considered “high risk” and will still be available to consumers.3
However, Woodcock asserted that the FDA would "go after" homeopathic medicines that "cause or might cause" overt harm. The homeopathic community supports the FDA in its efforts to increase the safest possible use of all types of drugs, including homeopathic medicines, but homeopaths and others question the logic of going after homeopathic medicines that "might cause" harm.
The FDA does not have a history of going after any Big Pharma company on the grounds that a drug "might" cause problems (some potential problems of the FDA prohibiting access to certain homeopathic medicines based on theoretical grounds are discussed later in this article). The previous FDA guidelines have been in use since 1988, and these guidelines provide specificity as to how homeopathic medicines can be marketed and sold.
In contrast, the new guidelines seem to allow the FDA to provide enforcement based on a vague and undefined “risk/benefit” that could change from one year or decade to another. Further, homeopathic medicines have an impressive record of safety, with relatively rare exceptions.
In this light, every rational and reasonably educated person should and must wonder what the motivations are behind the FDA's interest in increased regulation of homeopathic medicine especially since these natural medicines are recognized worldwide as some of the safest medicines presently available.
A small number of Americans have reported instances of health problems that “may” have been caused by a homeopathic medicine, but despite some media claims about homeopathic teething tablets, there has not been to date a single instance in which toxic or dangerous amounts of a medicinal agent were found in these tablets. Although the FDA did report that they found “variable amounts” of belladonna alkaloids in the teething tablets,4 the amounts found were well within safe limits, even if an infant swallowed an entire bottle.
Further, as discussed in more detail later in this document, the common potato has more belladonna alkaloids in it than any homeopathic medicine on the market today. At a time when many regulations are being questioned and reduced, it is a bit odd that the FDA is choosing to significantly increase the regulation of homeopathic medicines, despite their 200-plus years’ history of safety. When we consider the serious problems related to drug use, it would seem that there are many other much more serious problems facing the American public:
The FDA will create a major public relations problem if it chooses to drastically change the regulatory status of homeopathic medicines and will lead to a serious credibility problem for the FDA. Although the FDA doesn’t care about popularity contests, if it is more interested in improving access to safe medicinal agents, regulatory actions on the world’s safest (homeopathic) medicines will instead suggest to the world that there are other concerns that play a larger role than safety issues.
The FDA asserts that new regulation is necessary because homeopathic medicine is now such a "large" industry in the U.S., with sales amounting to $2.9 billion yearly. A more precise calculation suggests that the true figure is less than half this amount. In any case, both the real and inflated estimates still represent less than 1 percent of overall drug sales in the U.S., which are estimated to be $446 billion.5
On Page 1, it asserts: “Adverse events occurring during homeopathic treatment are rarely attributed to the homeopathic medicine itself."6 Further, a detailed review of homeopathic medicines conducted by a group of physicians and public health officials in Tuscany, Italy, found a remarkably high level of safety.7 They asserted that “because minimum doses are used (in homeopathic medicines), they could also be suitable for pregnant women, newborns and children."
Therefore, when the FDA recently expressed concern about the safety of homeopathic medicines, especially for certain “vulnerable populations including pregnant women, infants and the elderly,” it is precisely these groups of people for which homeopathic medicines provide decreased risk of safety problems, as compared with conventional medications. Based on 200 years of a high level of safety in the usage of homeopathic medicines, it would seem that the FDA should be promoting and encouraging the use of these medicinal agents for these vulnerable populations.
This comprehensive report from Italy made reference to a review of adverse effects from homeopathic medicines, saying, "A survey containing data from 1970 to 1995 reported a higher incidence of adverse effects with homeopathic medicines as compared to placebo. However, these effects were mild and transient, leading the authors to conclude that highly diluted homeopathic drugs prescribed by medical doctors specialized in homeopathy are safe."8
The fact that some homeopathic medicines contain belladonna, nux vomica, arsenic or other known poisons is meaningless because every toxicologist and scientist today understands that the dose of a substance determines whether it is dangerous or not. Modern sophisticated technologies can measure infinitesimal amounts of various substances in medicines and our environment. Serious scientists know that these substances are worthy of public-health concern only at levels where they are known to cause specific problems.
Homeopathic practitioners, patients and manufacturers support the FDA in its efforts to improve the already stellar reputation that homeopathic medicines have for safety concerns. At the same time, we do not support the FDA's efforts to reduce access to these basically safe natural medicines, since there is inadequate compelling evidence to date that they pose real risks.
This report to the FDA will question the veracity of some of the underlying assumptions behind the FDA's desire to make significant changes in its regulation of homeopathic medicines. However, before getting into this issue, it is important to acknowledge the good working relationship that the FDA has traditionally had with homeopathic medicine.
Just as medical historians acknowledge that homeopathic medicine provided appropriate critique of 19th century medicine, medical historians will thank homeopaths again for providing appropriate critique of 21st century medical care.As Mark Twain noted in Harper’s Bazaarback in 1890, “The introduction of homeopathy forced the old-school doctor to stir around and learn something of a rational nature about his business. You may honestly feel grateful that homeopathy survived the attempts of the allopaths (conventional physicians) to destroy it."
The FDCA gave separate recognition to the Homeopathic Pharmacopoeia of the United States, as distinct from the United States Pharmacopeia National Formulary or the conventional U.S. Pharmacopeia, for a reason: Homeopathic drugs are not just “additional” drugs available to the public, but represent a different system of making and using medicinal agents.If the intent had been to regulate all drugs in the same way, the FDCA would have recognized one united compendium of drugs — but this was not the intent of this important work of legislation.
The U.S. Centers for Disease Control and Prevention (CDC) recently announced that for the first time, U.S. life expectancy has declined for the second year in a row. The primary reason for this, according to the CDC, was increased deaths from drug overdoses from various pain medications.9
Ironically, a large study conducted in France and published in a conventional pharmacology journal specializing in drug safety showed that patients with chronic musculoskeletal disorders used 50 percent less conventional pain medication when under the care of a homeopathic physician.10
Good evidence published in leading medical journals has shown benefit from homeopathic treatment of fibromyalgia, a musculoskeletal syndrome for which opiate drugs provide little benefit. The BMJ published a double-blind, crossover study showing efficacy from a homeopathic medicine called Rhus toxicodendron,11 and these results were so substantially significant that the difference in benefit between subjects given a homeopathic medicine and a placebo were P=0.005.
Further, the journal Rheumatology published an additional study that found that 50 percent of patients given a homeopathic medicine experienced a 25 percent or greater improvement in tender point pain on examination. For comparison, only 15 percent of those who were given a placebo experienced a similar degree of improvement (P=0.008).12 Further scientific evidence for the usage of homeopathic medicine in various pain syndromes was published in the American Association for Pain Management's textbook, "Weiner's Pain Management."13
If the FDA, other regulatory agencies, and health and medical organizations are sincere in their concern about the overuse of opiate drugs in today's health care, then these regulatory agencies and medical organizations should encourage the increase in health care and medical professionals who are trained to use homeopathic medicines.This assertion is not to imply that homeopathic medicines should be the primary or only method of treatment for pain management but, instead, to simply include it as a part of a comprehensive strategy for this common health concern.
Antibiotics
Today’s excessive use of antibiotics has created new public health problems, and virtually every regulatory agency, medical organization and public health advocacy group is seeking ways to rely less upon antibiotics. The journal Pediatrics published an important randomized, double-blind, placebo-controlled study on children suffering from diarrhea.14
Although diarrhea is not a serious problem in the U.S., the World Health Organization considers it one of the most serious public health problems, because several million children die each year from the dehydration it causes.15 The study showed that children prescribed a homeopathic medicine were significantly more likely to have their diarrhea resolved than those given a placebo.
Further, two studies in which different homeopathic practitioners treated children with diarrhea in two separate countries each also found that children prescribed homeopathic medicines had their health restored significantly faster than those given a placebo.16 Today, the most common reason that children in the U.S. go to a physician is for the treatment of an ear infection. A randomized double-blind, placebo-controlled study prescribed individualized homeopathic medicines or placebo to 75 children.17
There were 19.9 percent more treatment failures in children given a placebo. Diary scores showed a significant decrease in symptoms at 24 and 64 hours after treatment in favor of those given a homeopathic medicine. What was particularly impressive about these results was that improvement from homeopathic medicines occurred rapidly and within the first day. Hippocrates enjoined physicians to "First, do no harm." Homeopathic and other safe, natural remedies are reasonable choices for methods that fulfill this dictum.
The newest review of homeopathic research published in Systematic Reviews27 confirmed a difference between the effects of homeopathic treatment and of placebo. In reviewing the "highest quality studies," the researchers found that homeopathic patients were almost twice as likely to experience a therapeutic benefit as those given a placebo.
Further, in reviewing a total of 22 clinical trials, the homeopathic patients experienced greater than 50 percent likelihood to have benefited from the homeopathic treatment than those given a placebo. Perhaps one of the strongest statements in this article was the confirmation that four of the five leading previous systematic reviews of homeopathic research also found a benefit from homeopathic treatment over that of placebo:
The report also reported that 20 of the 22 systematic reviews of clinical research testing homeopathic medicines detected at least a trend in favor of homeopathy.
Because certain skeptics of homeopathy frequently assert misinformation about homeopathy by asserting that there is no good evidence that homeopathic medicines are effective, it is important, even vital, that regulatory agencies avoid relying upon partisan and biased evidence of homeopathy (additional analysis on misinformation on homeopathic research is provided below in the section on "Intellectual Dishonesty and Questionable Ethics from Skeptics of Homeopathy").
The FDA recently asserted that homeopathic teething tablets are dangerous due to the "variable" doses of the herb belladonna in this medicine, even though the 12X dose in the tablets would require a newborn infant to imbibe dozens of bottles in rapid succession to achieve a dose that "might" create minor symptoms. Even at the highest level FDA found, this was still 1,000 times lower than the safe amount.29 Health Canada (the Canadian version of the FDA) has found these same homeopathic teething tablets to have no safety concerns.30
It may seem that the FDA chose to err on the side of caution when they recommended the withdrawal from the marketplace of Hyland's Teething Tablets due to the possibility that they may lead to seizures, but as it will be shown below, the FDA seems to have overreacted. According to the FDA, one bottle of Hyland's Teething Tablets that was found to have the highest amount of scopolamine (an alkaloid in belladonna) had approximately 299 nanograms of it, or .00029 milligrams.31
No other bottle was found to have this amount of this chemical, but even this dose is well within safe doses. Today, a commonly prescribed drug for motion sickness includes .075 mg of scopolamine for infants of 3 years of age,32 or the equivalent of over 250 bottles of this same Hyland's Teething Tablets bottle! Further, seizures are not even listed as one of the common side effects of scopolamine. Instead, it is listed as one of the extremely rare side effects.
In fact, seizures are so rare from this chemical that it is much more likely that an infant will simply experience a random seizure from unknown reasons than it is for the infant to experience a seizure from this chemical. If exposure to alkaloids from belladonna were really an issue, the FDA would have to outlaw potatoes.
The nightshade family of plants (Solanaceae) includes both belladonna and potatoes. These plants possess a diverse range of alkaloid glucosides (alkaloids), such as tropanes (atropine) and hyoscine (scopolamine), as well as nicotine and solanine. Belladonna, for the most part, is a combination of atropine, hyoscyamine and hyoscine.
The FDA's press release also expressed safety concerns about a homeopathic medicine called nux vomica. Although nux vomica is a poisonous plant that contains strychnine, every scientist and toxicologist knows that the dose of a poison is critical in determining whether it is dangerous.
Sir William Osler (1849–1919), widely known as the "father of modern medicine," considered "hope and nux vomica" to be the two most important treatments in his clinics33 — and the doses he used were considerably higher than any homeopathic doses available to the public today. It is disturbing that the FDA would consider reducing the availability of this medicine on "theoretical grounds," because, as yet, there has not been a single report of a poisoning from homeopathic doses of nux vomica.
The FDA says it felt compelled to increase regulation of homeopathic medicines due to an increase in reports of problems to the National Poison Control Centers related to "homeopathic agents." However, these reports combine “miscellaneous dietary supplements, herbs, homeopathic and homeopathic agents,” with no differentiation. To make matters worse, many consumers are confused by the term “homeopathic” and often assume that herbal remedies and other types of supplements are “homeopathic” when this is not always true.
The reports from the National Poison Control Centers provide no assurance that any legally defined homeopathic drug was included in the term "homeopathic agents." The term is not used by consumers or clinicians and may have become a generic category for whatever the consumer or the survey giver could not assign elsewhere. Although it seems that the term "homeopathic agents" was meant to include just "homeopathic drugs," only one death and three "major" outcome problems occurred.
And due to the fact that these reports do not provide any further details about which homeopathic medicine was involved in these incidences, it cannot be assured that the medicines involved were truly "homeopathic" or not. In the National Poison Control Centers reports from 2010 to 2013 for "homeopathic agents," two years (2011 and 2013) report no deaths.
A longer period would be more representative. What about 10 years? In the other two years, a "self-claimed homeopath" gave his wife hydrogen peroxide (2010), which is not a homeopathic remedy, and one death was reported without any details (2012).34 The number of "major" outcome problems during the same period averaged 2.5 annually, indicating that any problems "homeopathic agents" caused were rare.
However, from 2010 to 2017, 633 such complaints (or 79 per year, on average) were lodged. Further, some media reported that there were 10 deaths associated with this homeopathic medicine,35 but this assertion has been proven to be false. The FDA's website noted nanodose levels of a belladonna chemical called scopolamine,36 and yet the U.S. government's own database for toxic substances reports that "there are no reported fatal doses for scopolamine."37
The reports include a disclaimer: "Submission of a safety report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer or product caused or contributed to the event. The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events."
Even more problematic is how the media misrepresents this information from the reporting by citizens on their experiences with various drugs. For instance, one report on the death of an infant included a note saying, "Death did not occur, box needed to be checked to proceed."
One mother complained about her baby having "dry skin," though she admitted it "may be due to solid food (oatmeal)." Another baby ingested one-quarter of a bottle of teething tablets and then, two days later, the baby experienced "difficulty breathing," to which a doctor diagnosed as "croup" (a condition for which belladonna isn't known to cause).
In some cases, the infant was taking conventional pharmaceuticals in addition to the teething product or had been recently vaccinated. It appears that if the report includes a teething product, the FDA considers that part of the evidence against it, even if something else is more likely to have caused the problem. Some of the reports against Hyland's Teething Tablets included reference to a parent giving the infant Orajel Baby Teething Gel, which is not homeopathic and includes propylene glycol, a chemical used in brake and radiator fluids. Opinions differ as to its toxicity.
If the FDA's concerns about "risk assessment" are real, then the vast majority of homeopathic medicines will not undergo any new regulation that will make them unavailable to the general public, as the vast majority of homeopathic medicines are substantially safer than conventional drugs.
For example, it is illegal to jaywalk, and it is illegal to drive a car while drunk. If law enforcement chose to enforce jaywalking vigorously, it wouldn’t have the time or resources to enforce drunken driving. Obviously, there is much greater risk to have drunk drivers than jaywalkers.
That said, there can and must always be exceptions. At rare times, there may be jaywalkers who choose to take exceptional risks in traffic and who create potentially dangerous situations for others. It is obvious where the FDA needs to place its enforcement priorities. The FDA asserts that it intends to focus its new enforcement priorities on the following kinds of homeopathic products38 It will be helpful, therefore, to review each of the above categories individually.
Products with reported safety concerns.
If a homeopathic medicine is reported to have safety concerns, it is reasonable for the FDA to investigate them. However, because some safety concerns are false, imaginary or the result of antagonists to homeopathy, the FDA should explore: 1) what the modern literature from toxicology suggests are and aren’t safe doses; and 2) whether similar safety concerns occur in other countries. For example, Hyland's Homeopathic Teething Tablets were reported in the U.S. to potentially cause seizures in children. These same teething tablets were sold in Canada with no such reports.39
Products that contain or claim to contain ingredients associated with potentially significant safety concerns.
The vast majority of homeopathic medicines are oral and topical, though homeopathic eye drops (for acute eye conditions of an OTC nature) and nasal sprays (for acute nasal ailments, including the common cold or respiratory allergies) are occasionally employed. Historical usage supports both means of dispensing homeopathic medicines. In fact, Dr. Samuel Hahnemann, the founder of homeopathic medicine, sometimes encouraged patients to simply sniff an alcoholic solution of a homeopathic medicine.
In recent times, Zicam (a homeopathic medicine for symptoms of a common cold) uses a cotton swab-like device inserted into the nose. This application of a homeopathic medicine is new and does not have a record of historic usage. Because this means of application is not a time-tested method of administrating homeopathic medicines, it may be reasonable for the FDA to deem this type of dispensing a “new drug."
Products intended to be used for the prevention or treatment of serious and/or life-threatening diseases and conditions.
Homeopathic medicines sold to consumers are, by definition, over-the-counter drugs and, as such, should be marketed only for "over-the-counter ailments," — that is, ailments that do not require a medical diagnosis, are not life-threatening and are basically self-limiting.
To date, none of the leading established homeopathic manufacturers make or market OTC homeopathic medicines for “serious diseases” and, in fact, homeopathic manufacturers support the FDA in its efforts to crack down on individuals or companies that make or market homeopathic medicines for heart disease, cancer, diabetes or any other life-threatening disease.
Products for vulnerable populations.
There is certain logic in reducing the availability of potentially dangerous drugs to vulnerable populations. However, due to homeopathy's longtime impressive safety record, these medicines can be used by vulnerable populations. Pregnant and lactating women, infants and children are ideal populations for such usage. In fact, historically and internationally, these vulnerable populations have benefited from having access to homeopathic medicines due to the products' high level of safety.
It is common for parents to use homeopathic medicines for their infants and children for minor health problems, and it is essential that parents maintain access to homeopathic medicines for such nonserious and non-life-threatening ailments. Parents experience much higher risks with virtually any conventional medication than with homeopathic ones.
Products that do not meet standards of quality, strength or purity as required under the law.
Present FDA regulations allow for enforcement of standards of quality, strength and purity. However, modern technologies can measure exceedingly small variations in these factors. In a recent action on homeopathic teething tablets, the FDA found "variable amounts" of a listed ingredient, belladonna.
However, what the FDA did not report was that the variable amount was still in the safe range, with a vast margin of error. Therefore, it is prudent for the FDA to only consider enforcement of these standards when the public's safety is seriously threatened.
The American Medical Association (AMA) was founded in 1848, two years after the formation of the American Institute of Homeopathy. Starr notes that the AMA was founded, in part, to slow the growth of homeopathy. From 1860 to 1900, the AMA's code of ethics prohibited AMA members from consulting or even socializing with medical doctors who practiced homeopathy.
This ethical code was one of the few that were ever enforced. An extreme example of this prejudice occurred on the night of Lincoln’s assassination. William Seward was one of Lincoln’s closest political advisers and an advocate for homeopathic medicine. On the night Lincoln was assassinated, Seward was stabbed in the multi-person assassination plot against the Union.
Thanks to the medical care provided by Dr. Joseph K. Barnes, U.S. Surgeon General, Seward survived. However, Seward's personal physician was a homeopathic doctor, and due to the fact that the AMA had a policy that it was an ethical violation for conventional physicians to consult with a homeopathic doctor or even provide care for a homeopathic patient, Barnes was denounced by the AMA for providing medical care.45
Medical history shows that homeopathy gained its greatest popularity in Europe and America due to its impressive results during infectious-disease epidemics, including typhoid, cholera, yellow fever, scarlet fever, pneumonia and influenza.46 A book titled "The Logic of Figures" compared the death rate from various infectious diseases in the 19th century in conventional versus homeopathic hospitals. The death rate in the conventional hospitals was between two and eight times greater.47
In 1855, a governmental report on the London cholera epidemic of 1854 "just happened" to omit the mortality figures of the London Homeopathic Hospital. This epidemic was made famous because Dr. John Snow took the matter into his own hands by removing the handle of the pump from which Londoners were getting their tainted water. Because the homeopathic hospital was the closest hospital to this pump, many people who developed cholera went there for treatment.
The mortality rate at this hospital was only 19 percent as compared with 33 percent to 53 percent at all other London hospitals. When the authors of this report were challenged in the House of Lords, a representative of the Board of Health disingenuously proclaimed that inclusion of these statistics would give "an unjustifiable sanction to the empirical practice alike opposed to the maintenance of truth and to the progress of science."48
Of the three votes in favor, two members were so newly appointed that they did not attend any of the hearings. The remaining "yes" vote was from Evan Harris, a medical doctor and devout antagonist to homeopathy. Ironically, shortly after this vote, Harris was voted out of office from a general election by a twenty-something-year-old candidate who had no previous political experience.
More recently, the Australian National Health and Medical Research Council (NHMRC) published a report on homeopathy that concluded there is "no reliable evidence that homeopathy is effective for any condition." However, the definition of "reliable evidence" was so high that only between 2 to 5 percent of conventional medical practices would be deemed to have reliable evidence, despite the billions of dollars on medical research conducted yearly.49
Even more problematic about the Australian report was the fact that this governmental agency hid evidence of the existence of this first report. This previous review found homeopathic medicines effective. In other words, not only has there been "intellectual dishonesty" in the attacks on homeopathy but also serious breaches of ethics in evaluating it.50
Of special importance, the dosages remaining in water were similar in size as doses to which our bodies' hormones and cell-signaling agents are known to operate.53 Josephson went on to describe how many scientists today suffer from "pathological disbelief;" that is, they maintain an unscientific attitude that is embodied by the statement "even if it were true I wouldn't believe it."
Ultimately, homeopathic medicine is the "original nanopharmacology,"54 and any new regulations that stifle this important system of medicine just as new and strong evidence is emerging to verify its mechanism of action and its efficacy could have detrimental effects on the future of health and medical care. Because some of the testimony given to the FDA repeats a historic bias against homeopathy, it is important to understand the origins of this misinformation and not let it be accepted without verifiable evidence.
The founding of the U.S. placed a special value on personal freedoms and cultural diversity. America was temporarily thought to be a "melting pot" country, but today, it is much more clear that we are a cultural mosaic or, if you will, a "salad bowl" with diverse ingredients, each with its own value.
Likewise, there has never been just one school of thought and practice in medicine and in healing, both historically and internationally. The appreciation for diversity in medicine and healing was canonized in the federal Food Drug and Cosmetic Act of 1938. This important legislation gave recognition to the Homeopathic Pharmacopeia of the United States as an equal, but different, body of medicinal agents to the U.S. Pharmacopeia.
The fact that U.S. law recognizes both of these compendiums of drugs means that there are two different standards for drugs in America. We are not a homogenized culture where there is just one school of thought and practice in medicine. We are a pluralist society and therefore need pluralist laws that respect this diversity.
In 1988, the FDA issued the Compliance Policy Act 400-400 titled Conditions Under Which Homeopathic Drugs May Be Marketed, and this document has established clear, measurable and enforceable standards for the manufacture and sale of homeopathic drugs in the U.S.
These guidelines contribute significantly to improving cost, quality and access to safe homeopathic drug products. There may be certain challenges to respecting different schools of thought and practice in medicine, but Thomas Jefferson, our third president, reminded us of the importance of American liberty and of the necessity to work to educate the population how to make the best of our freedoms. He said:
In December 2017, the U.S. Food and Drug Administration (FDA) announced their interest in protecting consumers from “potentially harmful, unproven homeopathic drugs."1 The FDA is proposing to nullify its previous guidelines by which homeopathic medicines can be marketed. Instead, the FDA would deem all homeopathic medicines to be “unapproved new drugs,” which would make them subject to enforcement based on the perceived “risk/benefit” of a specific drug.
Some legal analysts and health writers initially wondered if the FDA's proposed guidelines would mean that homeopathic medicines may become "illegal,"2 but the FDA has assured the American public that the agency doesn’t plan to begin requiring that homeopathic products get “drug” approval. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, told reporters during a teleconference that many homeopathic medicines will not be considered “high risk” and will still be available to consumers.3
However, Woodcock asserted that the FDA would "go after" homeopathic medicines that "cause or might cause" overt harm. The homeopathic community supports the FDA in its efforts to increase the safest possible use of all types of drugs, including homeopathic medicines, but homeopaths and others question the logic of going after homeopathic medicines that "might cause" harm.
The FDA does not have a history of going after any Big Pharma company on the grounds that a drug "might" cause problems (some potential problems of the FDA prohibiting access to certain homeopathic medicines based on theoretical grounds are discussed later in this article). The previous FDA guidelines have been in use since 1988, and these guidelines provide specificity as to how homeopathic medicines can be marketed and sold.
In contrast, the new guidelines seem to allow the FDA to provide enforcement based on a vague and undefined “risk/benefit” that could change from one year or decade to another. Further, homeopathic medicines have an impressive record of safety, with relatively rare exceptions.
In this light, every rational and reasonably educated person should and must wonder what the motivations are behind the FDA's interest in increased regulation of homeopathic medicine especially since these natural medicines are recognized worldwide as some of the safest medicines presently available.
Regulating Homeopathic Medicines Should Be at the Bottom of FDA's Priorities
Risk-based regulations make sense as a means to use limited governmental resources to help regulate access to medicines. However, homeopathy's long-established reputation of safety far surpasses that of conventional drugs, and there is strong historical and worldwide evidence of this fact, let alone solid scientific evidence from modern toxicology. Therefore, in light of "risk-based" assessment, the regulation of and the enforcement of regulations for homeopathic medicines should be at the very bottom of the FDA's priorities, except in the rare instances where:- Homeopathic medicines are being marketed for serious diseases
- They are not diluted to safe levels of an ingredient as determined by the most up-to-date evidence from toxicology
- Evidence exists of real fraud in their manufacture or marketing
A small number of Americans have reported instances of health problems that “may” have been caused by a homeopathic medicine, but despite some media claims about homeopathic teething tablets, there has not been to date a single instance in which toxic or dangerous amounts of a medicinal agent were found in these tablets. Although the FDA did report that they found “variable amounts” of belladonna alkaloids in the teething tablets,4 the amounts found were well within safe limits, even if an infant swallowed an entire bottle.
Further, as discussed in more detail later in this document, the common potato has more belladonna alkaloids in it than any homeopathic medicine on the market today. At a time when many regulations are being questioned and reduced, it is a bit odd that the FDA is choosing to significantly increase the regulation of homeopathic medicines, despite their 200-plus years’ history of safety. When we consider the serious problems related to drug use, it would seem that there are many other much more serious problems facing the American public:
- The opioid crisis
- The overuse of antibiotics
- The epidemic of polypharmacy (the use of many drugs concurrently)
- The ineffectiveness and real dangers of many prescription drugs
- The high costs of select drugs
The FDA will create a major public relations problem if it chooses to drastically change the regulatory status of homeopathic medicines and will lead to a serious credibility problem for the FDA. Although the FDA doesn’t care about popularity contests, if it is more interested in improving access to safe medicinal agents, regulatory actions on the world’s safest (homeopathic) medicines will instead suggest to the world that there are other concerns that play a larger role than safety issues.
The FDA asserts that new regulation is necessary because homeopathic medicine is now such a "large" industry in the U.S., with sales amounting to $2.9 billion yearly. A more precise calculation suggests that the true figure is less than half this amount. In any case, both the real and inflated estimates still represent less than 1 percent of overall drug sales in the U.S., which are estimated to be $446 billion.5
The Strong Safety Evidence for Homeopathic Medicines
Even homeopathy's strongest critics acknowledge that these medicines provide too low a dose to have a significant physiological effect, let alone a toxic one. Therefore, it simply cannot be true that homeopathic medicines have no physiological effect and yet are somehow toxic. Clearly, whoever is making these determinations is doing so based on factors other than good science or good public policy. The World Health Organization (WHO) published a special report, Safety Issues in the Preparation of Homeopathic Medicines, in 2009.On Page 1, it asserts: “Adverse events occurring during homeopathic treatment are rarely attributed to the homeopathic medicine itself."6 Further, a detailed review of homeopathic medicines conducted by a group of physicians and public health officials in Tuscany, Italy, found a remarkably high level of safety.7 They asserted that “because minimum doses are used (in homeopathic medicines), they could also be suitable for pregnant women, newborns and children."
Therefore, when the FDA recently expressed concern about the safety of homeopathic medicines, especially for certain “vulnerable populations including pregnant women, infants and the elderly,” it is precisely these groups of people for which homeopathic medicines provide decreased risk of safety problems, as compared with conventional medications. Based on 200 years of a high level of safety in the usage of homeopathic medicines, it would seem that the FDA should be promoting and encouraging the use of these medicinal agents for these vulnerable populations.
This comprehensive report from Italy made reference to a review of adverse effects from homeopathic medicines, saying, "A survey containing data from 1970 to 1995 reported a higher incidence of adverse effects with homeopathic medicines as compared to placebo. However, these effects were mild and transient, leading the authors to conclude that highly diluted homeopathic drugs prescribed by medical doctors specialized in homeopathy are safe."8
The fact that some homeopathic medicines contain belladonna, nux vomica, arsenic or other known poisons is meaningless because every toxicologist and scientist today understands that the dose of a substance determines whether it is dangerous or not. Modern sophisticated technologies can measure infinitesimal amounts of various substances in medicines and our environment. Serious scientists know that these substances are worthy of public-health concern only at levels where they are known to cause specific problems.
Homeopathic practitioners, patients and manufacturers support the FDA in its efforts to improve the already stellar reputation that homeopathic medicines have for safety concerns. At the same time, we do not support the FDA's efforts to reduce access to these basically safe natural medicines, since there is inadequate compelling evidence to date that they pose real risks.
This report to the FDA will question the veracity of some of the underlying assumptions behind the FDA's desire to make significant changes in its regulation of homeopathic medicines. However, before getting into this issue, it is important to acknowledge the good working relationship that the FDA has traditionally had with homeopathic medicine.
The History of the FDA's Good and Healthy Relationship With Homeopathic Medicines
Homeopathic medicines have been an integral part of the FDA’s purview since 1938, when Sen. Royal Copeland of New York sponsored the famous consumer rights legislation, called the Federal Food, Drug and Cosmetic Act (FDCA), which empowered the FDA to regulate drugs. Royal Copeland was not simply a senator, he was also a medical doctor and a homeopathic physician. His efforts to empower the FDA have led to safer drugs and improved public health.Just as medical historians acknowledge that homeopathic medicine provided appropriate critique of 19th century medicine, medical historians will thank homeopaths again for providing appropriate critique of 21st century medical care.As Mark Twain noted in Harper’s Bazaarback in 1890, “The introduction of homeopathy forced the old-school doctor to stir around and learn something of a rational nature about his business. You may honestly feel grateful that homeopathy survived the attempts of the allopaths (conventional physicians) to destroy it."
The FDCA gave separate recognition to the Homeopathic Pharmacopoeia of the United States, as distinct from the United States Pharmacopeia National Formulary or the conventional U.S. Pharmacopeia, for a reason: Homeopathic drugs are not just “additional” drugs available to the public, but represent a different system of making and using medicinal agents.If the intent had been to regulate all drugs in the same way, the FDCA would have recognized one united compendium of drugs — but this was not the intent of this important work of legislation.
The Need for Homeopathic Medicines Today and Scientific Evidence That Verifies the Benefits
Opiate DrugsThe U.S. Centers for Disease Control and Prevention (CDC) recently announced that for the first time, U.S. life expectancy has declined for the second year in a row. The primary reason for this, according to the CDC, was increased deaths from drug overdoses from various pain medications.9
Ironically, a large study conducted in France and published in a conventional pharmacology journal specializing in drug safety showed that patients with chronic musculoskeletal disorders used 50 percent less conventional pain medication when under the care of a homeopathic physician.10
Good evidence published in leading medical journals has shown benefit from homeopathic treatment of fibromyalgia, a musculoskeletal syndrome for which opiate drugs provide little benefit. The BMJ published a double-blind, crossover study showing efficacy from a homeopathic medicine called Rhus toxicodendron,11 and these results were so substantially significant that the difference in benefit between subjects given a homeopathic medicine and a placebo were P=0.005.
Further, the journal Rheumatology published an additional study that found that 50 percent of patients given a homeopathic medicine experienced a 25 percent or greater improvement in tender point pain on examination. For comparison, only 15 percent of those who were given a placebo experienced a similar degree of improvement (P=0.008).12 Further scientific evidence for the usage of homeopathic medicine in various pain syndromes was published in the American Association for Pain Management's textbook, "Weiner's Pain Management."13
If the FDA, other regulatory agencies, and health and medical organizations are sincere in their concern about the overuse of opiate drugs in today's health care, then these regulatory agencies and medical organizations should encourage the increase in health care and medical professionals who are trained to use homeopathic medicines.This assertion is not to imply that homeopathic medicines should be the primary or only method of treatment for pain management but, instead, to simply include it as a part of a comprehensive strategy for this common health concern.
Antibiotics
Today’s excessive use of antibiotics has created new public health problems, and virtually every regulatory agency, medical organization and public health advocacy group is seeking ways to rely less upon antibiotics. The journal Pediatrics published an important randomized, double-blind, placebo-controlled study on children suffering from diarrhea.14
Although diarrhea is not a serious problem in the U.S., the World Health Organization considers it one of the most serious public health problems, because several million children die each year from the dehydration it causes.15 The study showed that children prescribed a homeopathic medicine were significantly more likely to have their diarrhea resolved than those given a placebo.
Further, two studies in which different homeopathic practitioners treated children with diarrhea in two separate countries each also found that children prescribed homeopathic medicines had their health restored significantly faster than those given a placebo.16 Today, the most common reason that children in the U.S. go to a physician is for the treatment of an ear infection. A randomized double-blind, placebo-controlled study prescribed individualized homeopathic medicines or placebo to 75 children.17
There were 19.9 percent more treatment failures in children given a placebo. Diary scores showed a significant decrease in symptoms at 24 and 64 hours after treatment in favor of those given a homeopathic medicine. What was particularly impressive about these results was that improvement from homeopathic medicines occurred rapidly and within the first day. Hippocrates enjoined physicians to "First, do no harm." Homeopathic and other safe, natural remedies are reasonable choices for methods that fulfill this dictum.
Respected Research Shows the Efficacy of Homeopathic Medicines
Research showing the efficacy of homeopathic medicines has been published in the most respected medical journals in the world, including The Lancet,18 BMJ19,20 (British Medical Journal), Chest (the publication of the American College of Chest Physicians),21 Pediatrics (publication of the American Academy of Pediatrics),22 Cancer (journal of the American Cancer Society),23 Journal of Clinical Oncology,24 Pediatrics Infectious Disease Journal (publication of the European Society of Pediatric Infectious Diseases),25 European Journal of Pediatrics (publication of the Swiss Society of Pediatrics and the Belgium Society of Pediatrics)26 and numerous others.The newest review of homeopathic research published in Systematic Reviews27 confirmed a difference between the effects of homeopathic treatment and of placebo. In reviewing the "highest quality studies," the researchers found that homeopathic patients were almost twice as likely to experience a therapeutic benefit as those given a placebo.
Further, in reviewing a total of 22 clinical trials, the homeopathic patients experienced greater than 50 percent likelihood to have benefited from the homeopathic treatment than those given a placebo. Perhaps one of the strongest statements in this article was the confirmation that four of the five leading previous systematic reviews of homeopathic research also found a benefit from homeopathic treatment over that of placebo:
"Five systematic reviews have examined the RCT research literature on homeopathy as a whole, including the broad spectrum of medical conditions that have been researched and by all forms of homeopathy: four of these 'global' systematic reviews reached the conclusion that, with important caveats, the homeopathic intervention probably differs from placebo."In addition to the above individual studies and the meta-analyses, the largest and most comprehensive review of basic sciences research (fundamental physico-chemical research, botanical studies, animal studies and in vitro studies with human cells) and clinical research ever sponsored by a governmental agency was in Switzerland.28 The Swiss report affirmed that homeopathic high-potencies seem to induce regulatory effects (e.g., balancing or normalizing effects) and specific changes in cells or living organisms.
The report also reported that 20 of the 22 systematic reviews of clinical research testing homeopathic medicines detected at least a trend in favor of homeopathy.
Because certain skeptics of homeopathy frequently assert misinformation about homeopathy by asserting that there is no good evidence that homeopathic medicines are effective, it is important, even vital, that regulatory agencies avoid relying upon partisan and biased evidence of homeopathy (additional analysis on misinformation on homeopathic research is provided below in the section on "Intellectual Dishonesty and Questionable Ethics from Skeptics of Homeopathy").
Is There Really Evidence That Homeopathic Medicines Are Not Safe?
Admittedly, every system of healing has certain risks, though even homeopathy's most severe skeptics assert that these medicines contain such small doses that they cannot be adequately therapeutic. Therefore, it is surprising to hear the claim that these extremely low-dose medicines can be toxic.The FDA recently asserted that homeopathic teething tablets are dangerous due to the "variable" doses of the herb belladonna in this medicine, even though the 12X dose in the tablets would require a newborn infant to imbibe dozens of bottles in rapid succession to achieve a dose that "might" create minor symptoms. Even at the highest level FDA found, this was still 1,000 times lower than the safe amount.29 Health Canada (the Canadian version of the FDA) has found these same homeopathic teething tablets to have no safety concerns.30
It may seem that the FDA chose to err on the side of caution when they recommended the withdrawal from the marketplace of Hyland's Teething Tablets due to the possibility that they may lead to seizures, but as it will be shown below, the FDA seems to have overreacted. According to the FDA, one bottle of Hyland's Teething Tablets that was found to have the highest amount of scopolamine (an alkaloid in belladonna) had approximately 299 nanograms of it, or .00029 milligrams.31
No other bottle was found to have this amount of this chemical, but even this dose is well within safe doses. Today, a commonly prescribed drug for motion sickness includes .075 mg of scopolamine for infants of 3 years of age,32 or the equivalent of over 250 bottles of this same Hyland's Teething Tablets bottle! Further, seizures are not even listed as one of the common side effects of scopolamine. Instead, it is listed as one of the extremely rare side effects.
In fact, seizures are so rare from this chemical that it is much more likely that an infant will simply experience a random seizure from unknown reasons than it is for the infant to experience a seizure from this chemical. If exposure to alkaloids from belladonna were really an issue, the FDA would have to outlaw potatoes.
The nightshade family of plants (Solanaceae) includes both belladonna and potatoes. These plants possess a diverse range of alkaloid glucosides (alkaloids), such as tropanes (atropine) and hyoscine (scopolamine), as well as nicotine and solanine. Belladonna, for the most part, is a combination of atropine, hyoscyamine and hyoscine.
Targeted Homeopathic Medicine Safer Than Potatoes
An average russet potato of 300 grams (0.7 pounds) contains 7 parts per million of belladonna. The amount of belladonna and its alkaloids found in homeopathic teething tablets were in the parts per billion or trillion, making this homeopathic medicine considerably safer than potatoes!The FDA's press release also expressed safety concerns about a homeopathic medicine called nux vomica. Although nux vomica is a poisonous plant that contains strychnine, every scientist and toxicologist knows that the dose of a poison is critical in determining whether it is dangerous.
Sir William Osler (1849–1919), widely known as the "father of modern medicine," considered "hope and nux vomica" to be the two most important treatments in his clinics33 — and the doses he used were considerably higher than any homeopathic doses available to the public today. It is disturbing that the FDA would consider reducing the availability of this medicine on "theoretical grounds," because, as yet, there has not been a single report of a poisoning from homeopathic doses of nux vomica.
The FDA says it felt compelled to increase regulation of homeopathic medicines due to an increase in reports of problems to the National Poison Control Centers related to "homeopathic agents." However, these reports combine “miscellaneous dietary supplements, herbs, homeopathic and homeopathic agents,” with no differentiation. To make matters worse, many consumers are confused by the term “homeopathic” and often assume that herbal remedies and other types of supplements are “homeopathic” when this is not always true.
The reports from the National Poison Control Centers provide no assurance that any legally defined homeopathic drug was included in the term "homeopathic agents." The term is not used by consumers or clinicians and may have become a generic category for whatever the consumer or the survey giver could not assign elsewhere. Although it seems that the term "homeopathic agents" was meant to include just "homeopathic drugs," only one death and three "major" outcome problems occurred.
And due to the fact that these reports do not provide any further details about which homeopathic medicine was involved in these incidences, it cannot be assured that the medicines involved were truly "homeopathic" or not. In the National Poison Control Centers reports from 2010 to 2013 for "homeopathic agents," two years (2011 and 2013) report no deaths.
A longer period would be more representative. What about 10 years? In the other two years, a "self-claimed homeopath" gave his wife hydrogen peroxide (2010), which is not a homeopathic remedy, and one death was reported without any details (2012).34 The number of "major" outcome problems during the same period averaged 2.5 annually, indicating that any problems "homeopathic agents" caused were rare.
The Significant Limitations on FDA Adverse Events Data
In 2017, the FDA forced Hyland’s to take their teething tablets off the market. Despite the fact that these tablets have been in the marketplace for almost a century, with a stellar record of safety, in the past decade the FDA has recorded an increase in “adverse events” associated with this medicine. From 2006 to 2009, the FDA received just four records of complaints associated with Hyland’s Teething Tablets.However, from 2010 to 2017, 633 such complaints (or 79 per year, on average) were lodged. Further, some media reported that there were 10 deaths associated with this homeopathic medicine,35 but this assertion has been proven to be false. The FDA's website noted nanodose levels of a belladonna chemical called scopolamine,36 and yet the U.S. government's own database for toxic substances reports that "there are no reported fatal doses for scopolamine."37
The reports include a disclaimer: "Submission of a safety report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer or product caused or contributed to the event. The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events."
Even more problematic is how the media misrepresents this information from the reporting by citizens on their experiences with various drugs. For instance, one report on the death of an infant included a note saying, "Death did not occur, box needed to be checked to proceed."
One mother complained about her baby having "dry skin," though she admitted it "may be due to solid food (oatmeal)." Another baby ingested one-quarter of a bottle of teething tablets and then, two days later, the baby experienced "difficulty breathing," to which a doctor diagnosed as "croup" (a condition for which belladonna isn't known to cause).
In some cases, the infant was taking conventional pharmaceuticals in addition to the teething product or had been recently vaccinated. It appears that if the report includes a teething product, the FDA considers that part of the evidence against it, even if something else is more likely to have caused the problem. Some of the reports against Hyland's Teething Tablets included reference to a parent giving the infant Orajel Baby Teething Gel, which is not homeopathic and includes propylene glycol, a chemical used in brake and radiator fluids. Opinions differ as to its toxicity.
Priorities for FDA Enforcement
The FDA says it has no intention of outlawing homeopathic medicines but claims that it wants to reduce potential problems arising from them. The agency claims that it plans to develop "a new, risk-based enforcement approach to homeopathic drug products that have the greatest potential to cause risk to patients." The FDA asserts that they wish to align "risk-based" assessments of all types of drugs, to protect the public.If the FDA's concerns about "risk assessment" are real, then the vast majority of homeopathic medicines will not undergo any new regulation that will make them unavailable to the general public, as the vast majority of homeopathic medicines are substantially safer than conventional drugs.
For example, it is illegal to jaywalk, and it is illegal to drive a car while drunk. If law enforcement chose to enforce jaywalking vigorously, it wouldn’t have the time or resources to enforce drunken driving. Obviously, there is much greater risk to have drunk drivers than jaywalkers.
That said, there can and must always be exceptions. At rare times, there may be jaywalkers who choose to take exceptional risks in traffic and who create potentially dangerous situations for others. It is obvious where the FDA needs to place its enforcement priorities. The FDA asserts that it intends to focus its new enforcement priorities on the following kinds of homeopathic products38 It will be helpful, therefore, to review each of the above categories individually.
| 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 |
If a homeopathic medicine is reported to have safety concerns, it is reasonable for the FDA to investigate them. However, because some safety concerns are false, imaginary or the result of antagonists to homeopathy, the FDA should explore: 1) what the modern literature from toxicology suggests are and aren’t safe doses; and 2) whether similar safety concerns occur in other countries. For example, Hyland's Homeopathic Teething Tablets were reported in the U.S. to potentially cause seizures in children. These same teething tablets were sold in Canada with no such reports.39
Products that contain or claim to contain ingredients associated with potentially significant safety concerns.
- An infectious agent with the potential to be pathogenic;
- A controlled substance, as defined in the Controlled Substances Act, 21 U.S.C. 812;
- Multiple ingredients that, when used in combination, raise safety concerns due to possible interactions, synergistic effects or additive effects of the various ingredients; and,
- Ingredients that pose potential toxic effects, particularly when those ingredients are concentrated or in low dilution presentations (e.g., 1X, 2X or 1C) or are not adequately controlled in the manufacturing process.
• The FDA is claiming homeopathic
medicines that contain ingredients of an infectious agent pose a safety
risk. The FDA here is referring to what are called "homeopathic
nosodes," that is, homeopathic medicines made from bodily tissue or
fluids that contain bacteria or viruses. Nosodes are generally available
in high dilutions, where the dose is so small that it is not known to
have toxicological or infectious effects.
Most nosodes in the U.S. are available only to homeopathic health and medical professionals, because most of the nosodes are intended for more complex health and medical conditions, for which an OTC (over the counter) drug is not indicated.
A small number of nosodes, however, are known to treat OTC conditions and to help reduce the severity and duration of common and relatively minor ailments. Therefore, it makes sense to maintain the present status of homeopathic nosodes as those remedies that are available only to certain licensed health and medical professionals as well as those who are certified or licensed to practice homeopathy.
In 2016, Hahnemann Laboratories provided testimony at an FTC hearing on homeopathic medicines. This testimony affirmed the safety of homeopathic medicines, asserting that "the FDA has never received an Adverse Event Report for a classical single remedy oral use homeopathic product with a 'safe' dilution level of 6C (one part per trillion) or more."40 This statistic includes nosodes presently sold as OTC drugs.
• The FDA already does not allow homeopathic medicines to be made from substances defined in the Controlled Substances Act. This includes those that have a high potential for abuse, have no currently accepted medical use for treatment in the U.S. or for which accepted safety protocols for use under medical supervision do not exist.
Some of the substances to which this act refers include heroin, morphine, psilocybin, cannabis and peyote.41 There is no real logic to making homeopathic doses of these substances illegal to professional homeopaths whose patients would sometimes benefit therapeutically when a patient had overdosed or simply became ill after abusing crude doses of these drugs. In this instance, the FDA should consider changing its position that disallows homeopathic doses of Schedule I drugs.
• There is no evidence that multiple ingredients of the nanodoses used in homeopathic medicines have safety concerns. And because there is greater use and sale of multiple-ingredient homeopathic medicines than single-ingredient, one would expect more evidence of problems from such medicines, and this evidence simply doesn't exist.
Unless the FDA can provide adequate evidence that a combination of ingredients in homeopathic doses pose actual danger, it should not prohibit the marketing or sale of homeopathic formula products, except in the marketing for conditions of serious ailments (which OTC drugs are not allowed to do anyway).
• The homeopathic community has collaborated with the FDA and with scientists who specialize in toxicology to determine at what dose a plant, mineral, animal or biological medicine is no longer safe. The homeopathic community has no problem reducing access to doses that pose safety risks, but such restrictions must not be just theoretical. Toxicological science must verify such risks, not politics or economics. Present FDA regulations already incorporate this determination.
Products for routes of administration other than oral and topical.Most nosodes in the U.S. are available only to homeopathic health and medical professionals, because most of the nosodes are intended for more complex health and medical conditions, for which an OTC (over the counter) drug is not indicated.
A small number of nosodes, however, are known to treat OTC conditions and to help reduce the severity and duration of common and relatively minor ailments. Therefore, it makes sense to maintain the present status of homeopathic nosodes as those remedies that are available only to certain licensed health and medical professionals as well as those who are certified or licensed to practice homeopathy.
In 2016, Hahnemann Laboratories provided testimony at an FTC hearing on homeopathic medicines. This testimony affirmed the safety of homeopathic medicines, asserting that "the FDA has never received an Adverse Event Report for a classical single remedy oral use homeopathic product with a 'safe' dilution level of 6C (one part per trillion) or more."40 This statistic includes nosodes presently sold as OTC drugs.
• The FDA already does not allow homeopathic medicines to be made from substances defined in the Controlled Substances Act. This includes those that have a high potential for abuse, have no currently accepted medical use for treatment in the U.S. or for which accepted safety protocols for use under medical supervision do not exist.
Some of the substances to which this act refers include heroin, morphine, psilocybin, cannabis and peyote.41 There is no real logic to making homeopathic doses of these substances illegal to professional homeopaths whose patients would sometimes benefit therapeutically when a patient had overdosed or simply became ill after abusing crude doses of these drugs. In this instance, the FDA should consider changing its position that disallows homeopathic doses of Schedule I drugs.
• There is no evidence that multiple ingredients of the nanodoses used in homeopathic medicines have safety concerns. And because there is greater use and sale of multiple-ingredient homeopathic medicines than single-ingredient, one would expect more evidence of problems from such medicines, and this evidence simply doesn't exist.
Unless the FDA can provide adequate evidence that a combination of ingredients in homeopathic doses pose actual danger, it should not prohibit the marketing or sale of homeopathic formula products, except in the marketing for conditions of serious ailments (which OTC drugs are not allowed to do anyway).
• The homeopathic community has collaborated with the FDA and with scientists who specialize in toxicology to determine at what dose a plant, mineral, animal or biological medicine is no longer safe. The homeopathic community has no problem reducing access to doses that pose safety risks, but such restrictions must not be just theoretical. Toxicological science must verify such risks, not politics or economics. Present FDA regulations already incorporate this determination.
The vast majority of homeopathic medicines are oral and topical, though homeopathic eye drops (for acute eye conditions of an OTC nature) and nasal sprays (for acute nasal ailments, including the common cold or respiratory allergies) are occasionally employed. Historical usage supports both means of dispensing homeopathic medicines. In fact, Dr. Samuel Hahnemann, the founder of homeopathic medicine, sometimes encouraged patients to simply sniff an alcoholic solution of a homeopathic medicine.
In recent times, Zicam (a homeopathic medicine for symptoms of a common cold) uses a cotton swab-like device inserted into the nose. This application of a homeopathic medicine is new and does not have a record of historic usage. Because this means of application is not a time-tested method of administrating homeopathic medicines, it may be reasonable for the FDA to deem this type of dispensing a “new drug."
Products intended to be used for the prevention or treatment of serious and/or life-threatening diseases and conditions.
Homeopathic medicines sold to consumers are, by definition, over-the-counter drugs and, as such, should be marketed only for "over-the-counter ailments," — that is, ailments that do not require a medical diagnosis, are not life-threatening and are basically self-limiting.
To date, none of the leading established homeopathic manufacturers make or market OTC homeopathic medicines for “serious diseases” and, in fact, homeopathic manufacturers support the FDA in its efforts to crack down on individuals or companies that make or market homeopathic medicines for heart disease, cancer, diabetes or any other life-threatening disease.
Products for vulnerable populations.
There is certain logic in reducing the availability of potentially dangerous drugs to vulnerable populations. However, due to homeopathy's longtime impressive safety record, these medicines can be used by vulnerable populations. Pregnant and lactating women, infants and children are ideal populations for such usage. In fact, historically and internationally, these vulnerable populations have benefited from having access to homeopathic medicines due to the products' high level of safety.
It is common for parents to use homeopathic medicines for their infants and children for minor health problems, and it is essential that parents maintain access to homeopathic medicines for such nonserious and non-life-threatening ailments. Parents experience much higher risks with virtually any conventional medication than with homeopathic ones.
Products that do not meet standards of quality, strength or purity as required under the law.
Present FDA regulations allow for enforcement of standards of quality, strength and purity. However, modern technologies can measure exceedingly small variations in these factors. In a recent action on homeopathic teething tablets, the FDA found "variable amounts" of a listed ingredient, belladonna.
However, what the FDA did not report was that the variable amount was still in the safe range, with a vast margin of error. Therefore, it is prudent for the FDA to only consider enforcement of these standards when the public's safety is seriously threatened.
Suggestions for Regulating Homeopathic Medicines
| In 1988, the FDA adopted CPG 400.400 to eliminate the confusion over what could and could not be sold as a homeopathic drug. The recent FDA guidelines seek to eliminate this guidance and replace it with vague guidelines that will create confusion for the homeopathic industry and for consumers. It makes more sense to maintain the CPG 400.400 guidelines and to simply add more specificity to them rather than abolish them. |
| In some European countries, a medicinal agent can only be considered homeopathic if it is in at least a 3X dilution. A change in this definition would help differentiate herbal doses from homeopathic ones. Further, this change in regulation would make it more difficult for new medicinal agents to be marketed under the "homeopathic" banner that tend to work by conventional pharmacological means. |
| The FDA could make it clear to manufacturers and consumers that a homeopathic ingredient cannot be mixed with a nutritional supplement (which the FDA deems to be a "food"). Such "formulas" would constitute mixing a "drug" and a "food." As I understand it, present FDA regulation already doesn't allow mixing drugs and foods. |
| The new FDA guidelines are exploring whether to
prohibit the marketing of mixed-ingredient homeopathic medicines. These
"homeopathic formula products" have a long history of usage and safety
throughout the world, and studies have found them effective for many
conditions, especially respiratory allergies. For example, a randomized, double-blind and placebo-controlled trial has been published in the Lancet42 in the treatment of people with hay fever and a high-quality study published in the British Medical Journal43 confirmed homeopathic doses of various allergens were found effective for respiratory allergies to that allergen. |
| The small group of homeopathic medicines made from
diseased tissue, bacteria or viruses are called “nosodes” and, at
present, the vast majority of them are available only by prescription by
certain health and medical professionals. No new regulation of
homeopathic nosodes is necessary unless the FDA has some new
toxicological or epidemiological evidence. Most single-ingredient homeopathic medicines are regulated as over-the-counter drugs and, as such, the FDA requires that manufacturers list a specific ailment for which each drug is indicated. Because single-ingredient recommendations are based on a pattern of symptoms, not a specific disease diagnosis, it behooves the FDA to consider withdrawing the requirement for an “indication for treatment” for single-ingredient homeopathic drugs, except when adequate research confirms the efficacy of that homeopathic medicine. |
| FDA guidelines do not allow the sale and marketing of homeopathic medicines made from controlled substances, such as opium, heroin or (still) cannabis sativa (or indica). These guidelines have been enforced for several decades, even though it is a somewhat ludicrous regulation due to the obvious fact that no one can or does use homeopathic doses of these drugs in recreational ways. Therefore, the FDA should rescind this regulation. |
| Even if an extremely small number of people may be
hypersensitive to exceedingly small doses of a medicinal agent in a
homeopathic medicine, our society doesn’t outlaw common foods that are
known allergens (milk, peanuts, wheat, strawberries),
nor does it make them available only upon prescription by a physician,
even though some can cause significant distress, anaphylactic shock or
death. Therefore, the remote possibility that this might occur does not justify restricting the availability of homeopathic medicines that benefit many others. |
Intellectual Dishonesty and Questionable Ethics From Skeptics of Homeopathy
Pulitzer Prize–winning author Paul Starr, in his book “The Social Transformation of American Medicine: The Rise of a Sovereign Profession and the Making of a Vast Industry,” acknowledged that homeopathic medicine in the 19th century was a medical, scientific and economic threat to conventional medicine. Starr even asserted, “Because homeopathy was simultaneously philosophical and experimental, it seemed to many people to be more rather than less scientific than orthodox medicine."44The American Medical Association (AMA) was founded in 1848, two years after the formation of the American Institute of Homeopathy. Starr notes that the AMA was founded, in part, to slow the growth of homeopathy. From 1860 to 1900, the AMA's code of ethics prohibited AMA members from consulting or even socializing with medical doctors who practiced homeopathy.
This ethical code was one of the few that were ever enforced. An extreme example of this prejudice occurred on the night of Lincoln’s assassination. William Seward was one of Lincoln’s closest political advisers and an advocate for homeopathic medicine. On the night Lincoln was assassinated, Seward was stabbed in the multi-person assassination plot against the Union.
Thanks to the medical care provided by Dr. Joseph K. Barnes, U.S. Surgeon General, Seward survived. However, Seward's personal physician was a homeopathic doctor, and due to the fact that the AMA had a policy that it was an ethical violation for conventional physicians to consult with a homeopathic doctor or even provide care for a homeopathic patient, Barnes was denounced by the AMA for providing medical care.45
Medical history shows that homeopathy gained its greatest popularity in Europe and America due to its impressive results during infectious-disease epidemics, including typhoid, cholera, yellow fever, scarlet fever, pneumonia and influenza.46 A book titled "The Logic of Figures" compared the death rate from various infectious diseases in the 19th century in conventional versus homeopathic hospitals. The death rate in the conventional hospitals was between two and eight times greater.47
In 1855, a governmental report on the London cholera epidemic of 1854 "just happened" to omit the mortality figures of the London Homeopathic Hospital. This epidemic was made famous because Dr. John Snow took the matter into his own hands by removing the handle of the pump from which Londoners were getting their tainted water. Because the homeopathic hospital was the closest hospital to this pump, many people who developed cholera went there for treatment.
The mortality rate at this hospital was only 19 percent as compared with 33 percent to 53 percent at all other London hospitals. When the authors of this report were challenged in the House of Lords, a representative of the Board of Health disingenuously proclaimed that inclusion of these statistics would give "an unjustifiable sanction to the empirical practice alike opposed to the maintenance of truth and to the progress of science."48
Intellectual Dishonesty Has Continued Into the 21st Century
In 2010, the U.K. House of Commons’ science and technology committee report on homeopathy was highly critical of this subject. However, any rational person should be suspicious of this “report.” The Science and Technology Committee normally consists of 14 members of Parliament, yet this report was approved and signed by only three members, with one vote against the report (most members of the committee did not take this investigation seriously).Of the three votes in favor, two members were so newly appointed that they did not attend any of the hearings. The remaining "yes" vote was from Evan Harris, a medical doctor and devout antagonist to homeopathy. Ironically, shortly after this vote, Harris was voted out of office from a general election by a twenty-something-year-old candidate who had no previous political experience.
More recently, the Australian National Health and Medical Research Council (NHMRC) published a report on homeopathy that concluded there is "no reliable evidence that homeopathy is effective for any condition." However, the definition of "reliable evidence" was so high that only between 2 to 5 percent of conventional medical practices would be deemed to have reliable evidence, despite the billions of dollars on medical research conducted yearly.49
Even more problematic about the Australian report was the fact that this governmental agency hid evidence of the existence of this first report. This previous review found homeopathic medicines effective. In other words, not only has there been "intellectual dishonesty" in the attacks on homeopathy but also serious breaches of ethics in evaluating it.50
Stifling Homeopathic Medicines Could Have Detrimental Effects
Brian Josephson, Ph.D., is a British physicist who won a Nobel Prize in Physics in 1973 for work he completed when he was only 22 years old. He is currently a professor at the University of Cambridge. Responding to an article in New Scientist, Josephson wrote:"Regarding your comments on claims made for homeopathy: criticisms centered around the vanishingly small number of solute molecules present in a solution after it has been repeatedly diluted are beside the point, since advocates of homeopathic remedies attribute their effects not to molecules present in the water, but to modifications of the water's structure.
Simple-minded analysis may suggest that water, being a fluid, cannot have a structure of the kind that such a picture would demand. But cases such as that of liquid crystals, which while flowing like an ordinary fluid can maintain an ordered structure over macroscopic distances, show the limitations of such ways of thinking. There have not, to the best of my knowledge, been any refutations of homeopathy that remain valid after this particular point is taken into account.
A related topic is the phenomenon, claimed by Jacques Benveniste's colleague Yolène Thomas and by others to be well established experimentally, known as 'memory of water.' If valid, this would be of greater significance than homeopathy itself, and it attests to the limited vision of the modern scientific community that, far from hastening to test such claims, the only response has been to dismiss them out of hand."51Josephson's remarks on the structure of water have been confirmed by more recent research.52 The American Chemistry Society’s journal, Langmuir, published a series of studies that confirmed using three different types of spectroscopy that nanodoses of six different homeopathic medicines persist in water solutions even after dilutions of 1-to-100, six times, 30 times and 200 times.
Of special importance, the dosages remaining in water were similar in size as doses to which our bodies' hormones and cell-signaling agents are known to operate.53 Josephson went on to describe how many scientists today suffer from "pathological disbelief;" that is, they maintain an unscientific attitude that is embodied by the statement "even if it were true I wouldn't believe it."
Ultimately, homeopathic medicine is the "original nanopharmacology,"54 and any new regulations that stifle this important system of medicine just as new and strong evidence is emerging to verify its mechanism of action and its efficacy could have detrimental effects on the future of health and medical care. Because some of the testimony given to the FDA repeats a historic bias against homeopathy, it is important to understand the origins of this misinformation and not let it be accepted without verifiable evidence.
Closing Thoughts
Is America a pluralist society or a homogenous one — and should regulation reflect our society? This is not just an academic question but a practical one, and the way it is answered will play an important role in how the FDA should regulate homeopathic medicine (as well as other systems of healing).The founding of the U.S. placed a special value on personal freedoms and cultural diversity. America was temporarily thought to be a "melting pot" country, but today, it is much more clear that we are a cultural mosaic or, if you will, a "salad bowl" with diverse ingredients, each with its own value.
Likewise, there has never been just one school of thought and practice in medicine and in healing, both historically and internationally. The appreciation for diversity in medicine and healing was canonized in the federal Food Drug and Cosmetic Act of 1938. This important legislation gave recognition to the Homeopathic Pharmacopeia of the United States as an equal, but different, body of medicinal agents to the U.S. Pharmacopeia.
The fact that U.S. law recognizes both of these compendiums of drugs means that there are two different standards for drugs in America. We are not a homogenized culture where there is just one school of thought and practice in medicine. We are a pluralist society and therefore need pluralist laws that respect this diversity.
In 1988, the FDA issued the Compliance Policy Act 400-400 titled Conditions Under Which Homeopathic Drugs May Be Marketed, and this document has established clear, measurable and enforceable standards for the manufacture and sale of homeopathic drugs in the U.S.
These guidelines contribute significantly to improving cost, quality and access to safe homeopathic drug products. There may be certain challenges to respecting different schools of thought and practice in medicine, but Thomas Jefferson, our third president, reminded us of the importance of American liberty and of the necessity to work to educate the population how to make the best of our freedoms. He said:
"I know no safe depository of the ultimate powers of the society but the people themselves; and if we think them not enlightened enough to exercise their control with a wholesome discretion, the remedy is not to take it from them, but to inform their discretion by education."
Consumer Actions
1. The American Association of
Homeopathic Pharmacists is encouraging those who live in certain states
(Colorado, New Mexico, Pennsylvania, Tennessee, Washington, Utah) to
urge their legislators to tell FDA not to scrap the current guidelines
regarding the regulation of homeopathic products. These representatives
work on committees that have oversight on the FDA. You are simply asked
to sign your name to the letter.
You may wish to do one additional, simple thing and that is to add some type of personal statement about your experiences with the safety and efficacy of homeopathic medicines. Click HERE or HERE to access more information and to access your political representatives (please note that there are certain senators and other congresspersons to contact). If you happen to have a personal relationship with any of the congresspersons who work on FDA issues, please consider contacting the American Association of Homeopathic Pharmacists (office@aahp.info).
2. The homeopathic community is NOT encouraging everyone to write to the FDA. Now is not the time to express fear about the FDA's potential actions or to condemn them. Consider submitting short positive comments to the FDA in support of homeopathy.
You might tell the FDA that its current regulatory guidelines (Compliance Policy Guide 400.400) for homeopathic products provide much consumer protection and that any further changes place your right to choose in jeopardy. The period for public comment before FDA makes its final decisions about this important policy closes March 20, 2018. Click HERE to make your comment to the FDA.
3. Consider supporting homeopathic organizations, pharmacies and resource centers that work to provide useful, practical information about homeopathy so that you can optimize your usage of these natural medicines. Becoming a member of the National Center for Homeopathy is particularly important because they will keep you informed about developments with the FDA and about future suggested actions to consider. For details, go to www.HomeopathyCenter.org. Put your wallet where your heart is and where your health is!
You may wish to do one additional, simple thing and that is to add some type of personal statement about your experiences with the safety and efficacy of homeopathic medicines. Click HERE or HERE to access more information and to access your political representatives (please note that there are certain senators and other congresspersons to contact). If you happen to have a personal relationship with any of the congresspersons who work on FDA issues, please consider contacting the American Association of Homeopathic Pharmacists (office@aahp.info).
2. The homeopathic community is NOT encouraging everyone to write to the FDA. Now is not the time to express fear about the FDA's potential actions or to condemn them. Consider submitting short positive comments to the FDA in support of homeopathy.
You might tell the FDA that its current regulatory guidelines (Compliance Policy Guide 400.400) for homeopathic products provide much consumer protection and that any further changes place your right to choose in jeopardy. The period for public comment before FDA makes its final decisions about this important policy closes March 20, 2018. Click HERE to make your comment to the FDA.
3. Consider supporting homeopathic organizations, pharmacies and resource centers that work to provide useful, practical information about homeopathy so that you can optimize your usage of these natural medicines. Becoming a member of the National Center for Homeopathy is particularly important because they will keep you informed about developments with the FDA and about future suggested actions to consider. For details, go to www.HomeopathyCenter.org. Put your wallet where your heart is and where your health is!
Dana Ullman, MPH, CCH, is one of America's leading
advocates for homeopathy. He has written 10 books, including, "The
Homeopathic Revolution: Why Famous People and Cultural Heroes Choose
Homeopathy" and the best-selling, "Everybody's Guide to Homeopathic
Medicines," with Dr. Steven Cummings.
He is the founder of Homeopathic Educational Services (https://homeopathic.com/), a leading resource center for homeopathic books, tapes, medicines, software and correspondence courses. Ullman recently created an e-course on Learning to Use a Homeopathic Medicine Kit.
He is the founder of Homeopathic Educational Services (https://homeopathic.com/), a leading resource center for homeopathic books, tapes, medicines, software and correspondence courses. Ullman recently created an e-course on Learning to Use a Homeopathic Medicine Kit.
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