EDITOR'S SUMMARY: There’s no one-size-fits all when it comes to health and medical interventions, including food-for-nutrition, nutritional supplements, such as vitamins and minerals, herbal formulas, allopathic treatments, preventative holistic modalities, and homeopathy, a unique system of medicine. To each her/his/their own. Freedom to choose what works for you is one of the highest forms of self-sovereignty. Exercise your rights for others and yourself.
Written by Janey Bibolet Ward
Edited by Nicki Steinberger, Ph.D.
The Codex Alimentarius Commission (CAC), is comprised of all member nations in the World Health Organization (WHO) and the Food and Agriculture Organization (FAO). This body meets yearly and is responsible for implementing the global food standards program for the member countries in the United Nations.
In 2005, the CAC adopted a new framework to regulate dietary products, Guidelines for Vitamin and Mineral Food Supplements (Paragraphs 51-54), that was widely criticized for establishing guidance to procedurally restrict access to high dose vitamins and supplements by regulating them as drugs.
As a result, practitioners and consumers have been increasingly denied access to products previously available to them. The most recent meeting held in 2022 adopted over 500 new texts updating guidance to inform governments, in order to direct legislation across member countries regulating trade and the food supply, including acceptable genetically modified organisms (GMOs), pesticide residue levels, and livestock drug transmission.
In the United States, the U.S. Food and Drug Administration (FDA) uses the CAC guidance to enact legislation to regulate dietary supplements, vitamins, and herbal medicines to ensure they are “safe” according to suggested dosages.
The Office of Dietary Supplements (ODS) under the National Institutes of Health publishes fact sheets on available supplements and their uses to educate consumers.
The Dietary Supplement Health and Education Act (DSHE) of 1994 reported significant findings, revealing over 50% of Americans were consuming dietary supplements of vitamins, minerals, and herbs as a means to improve their health.
This was paired with awareness on nutrition to limit the incidence of chronic diseases, reduce long-term health care expenditures, and avoid excessive costs from allopathic medical services.
Notably, the act encouraged consumers to explore natural medicines, stating that unnecessary regulation was a hindrance to public health policy, and adverse reactions were relatively rare.
Under the guise of consumer protection, stringent regulation of natural medicine was enacted with the Dietary Supplement Labeling Act (DSHE) of 2013.
This enlisted the Department of Health and Human Services (HHS), and the National Academies of Sciences, Engineering, and Medicine (NASEM) to create a list of supplement ingredients that could cause “potentially serious adverse events” without proof of definitive outcomes or specific incidents of harm.
Over the last few decades, U.S. consumers have become more empowered to seek alternative care to prevent disease and maintain healthy lifestyles, and are speaking up with their dollars.
Many people are willing to pay out-of-pocket costs to receive care from functional medical doctors and holistic practitioners that use natural modalities, including nutrition, herbal medicine, high-dose supplements, and homeopathy. In 2022, spending on traditional alternative medicine represented 34% of the market share.
The market is growing rapidly around the world with over 200 million people across multiple countries integrating natural health practices into their lives, and within the greater organization of national health systems.
By 2024, the value of the U.S. dietary supplement market is expected to reach $56.7 billion. The global homeopathic product market was valued at $10.7 billion in 2021, and is expected to reach $32.4 billion by 2031. From 2022–2027 the market is forecasted to grow over 18%.
This bipartisan legislation was intended to mandate dietary supplement manufacturers to register their products with the Food and Drug Administration (FDA) to ensure full transparency and listing of all ingredients.
This act was proposed to meet the need to further strengthen the existing regulations from the DSHE of 1994, which initially granted the FDA authority to regulate dietary supplements.
The FDA draft guidance submitted to the Office of Management and Budget (OMB) and the Office of Information and Regulatory Affairs (OIRA) took only a few days to review the regulations, found no significant issues, and moved swiftly to approve it.
The Natural Products Association (NPA) challenged the vague, misleading language in the bill, as it no longer supported allowing full access to natural products, and instead reversed previous guidance that ensured consumer protection and safety.
In their analysis, re: the language put forth in the bill:
“Its subtle wording would effectively create a situation where supplement manufacturers would require pre-market approval in order to enter the marketplace, otherwise, they’d be deemed misbranded and subject to legal action.”
The bill was not enacted, yet the language provided was used in the recently released FDA guidance and can be used to write future legislation.
The FDA recently launched a review of homeopathic medicines, and issued a report on December 6, 2022, “Homeopathic Drug Products Guidance for FDA Staff and Industry.”
Homeopathic medicines were recognized in 1938 by the Federal Food, Drug, and Cosmetic Act (FD&C Act). The guidance now views homeopathic remedies as “new drugs” that need to be tested, regulated, and labeled.
“At this time no homeopathic drug products have been determined by FDA to be generally regarded as safe (GRAS/E), all homeopathic drug products remain subject to the premarket approval requirements.”
This lays the regulatory groundwork for eliminating these remedies from the marketplace without proof of cause of harm or adverse effects, as they have not been tested or regulated as drugs previously. From the FDA:
“The FDA is prioritizing specific categories of drugs, such as those intended for populations at greater risk for adverse reactions. There are currently no FDA-approved products labeled as homeopathic, and the agency cannot ensure these drugs meet standards for safety, effectiveness, and quality. Previously, the FDA warned the public about homeopathic products, including those containing a toxic substance and ones recalled due to contamination.”
The National Center for Complementary and Integrative Health (NCCIH), under the Department of Health and Human Services (HHS), has reversed course from the previous regulatory acts, and has taken a strong position against homeopathy and states definitively:
“There’s little evidence to support homeopathy as an effective treatment for any specific health condition. Some products labeled as homeopathic may contain substantial amounts of active ingredients and could cause side effects and drug interactions.”
And yet, from the study, “Low-dose Drosera rotundifolia induces gene expression changes in 16HBE human bronchial epithelial cells,” published in January 2021 in Nature, found that a low dose of the homeopathic remedy Drosera was effective for bronchial/respiratory healing.
It noted: “The mechanisms of action recognized so far are linked to the known effects of specific components, such as flavonoids, but are not completely understood.”
A 2021 case study, “Homeopathic Treatment for COVID-19-Related Symptoms: A Case Series,” published in Complementary Medicine Research, reported findings that all five patients treated with homeopathic remedies responded favorably with a shorter duration of illness, and complete recovery from severe symptoms.
Two homeopathic studies noted from the University of Minnesota, “Is There Good Scientific Evidence for Homeopathy?” concluded:
One: “Forty-six patients with rheumatoid arthritis were randomized to homeopathic remedies or placebo. The remedies were selected according to traditional homeopathic principles to match each individual. Both groups were allowed to continue their conventional anti-inflammatory drugs. Objective follow-up measurements were made by an independent assessor, noting the measured articular (joint) index, limbering up time, grip strength, and pain.
Significant improvement occurred in those treated with homeopathic remedies, but not in the placebo group. Within one year, 42% of homeopathically treated patients were able to stop all conventional pharmaceutical treatments (Gibson, 1980).”
Two: “Eighty-one Nicaraguan children, age 6 months to 5 years, with acute diarrhea (a major cause of morbidity and mortality) were treated with standard support of IV fluids, plus either an individualized homeopathic remedy or placebo, and they followed up for five days.
The group that received a homeopathic remedy had a statistically significant decrease in duration of diarrhea and in number of stools per day after 72 hours of treatment. Such intervention has the potential for saving both lives and dollars, especially in developing countries where this issue is so prevalent. This model of study is an excellent format for evaluating the efficacy and effectiveness of the homeopathic method itself (Jacobs et al., 1994).”
The current pharmaceutical being prescribed for COVID-19 severe respiratory distress is PAXLOVID, manufactured by Pfizer by prescription only. A five-day course is $530.00, subsidized by the government with taxpayer money.
In November 2021, the U.S. government agreed to a deal, paying $5.29 billion for 10 million courses of the experimental COVID-19 antiviral drug. In contrast, homeopathic medicines such as Drosera cost far less, around $8.00 for a course of treatment, and can be accessed easily over the counter.
And if you’re at all curious about the “side effects” (FYI - you can just call them “effects”) of PAXLOVID, here’s a non-exhaustive list taken from the “horse’s mouth” itself, Pfizer. In addition, they clearly state, “These are not all the possible side effects of PAXLOVID.”
- Hives, skin rash
- Trouble swallowing or breathing
- Swelling of the mouth, lips, or face
- Throat tightness
- Hoarseness of voice
- Loss of appetite
- Yellowing of your skin and the whites of your eyes (jaundice)
- Dark-colored urine
- Pale-colored stools and itchy skin
- Stomach area (abdominal) pain
Other possible side effects:
- Change in sense of taste
- High blood pressure
- Muscle aches
- Stomach area (abdominal) pain
- Generally feeling unwell (malaise)”
In September 2022, the District of Columbia Court of Appeals recognized the Center for Inquiry, Inc. as a consumer protection agency, and allowed their lawsuit against CVS and Walmart to proceed.
The Center for Inquiry tells us to uphold standards for “science,” and break down the walls of “pseudoscience.” While it’s true that “real” science doesn’t have a preconceived agenda for outcomes on experiments, a.k.a. “researcher bias,” it’s often not obvious what is science vs. pseudoscience, and it’s up to you to decide.
You must know and trust your sources, and not take advertising at face value.
“Science and pseudoscience stand in direct opposition to one another. Science is the intellectual and practical activity encompassing the systematic study of the structure and behavior of the physical and natural world through observation and experiment. Scientists approach any situation with an open mind. They observe the situation, formulate hypotheses about it, and test those hypotheses with experiments. Where the results of the experiment do not conform to the expected results predicted by the hypothesis, then the hypothesis must be reexamined. This is the central nature of science – it is determined by results, not preconceived ideas.
Pseudoscience, on the other hand places the cart before the horse. It predetermines the desired result, and then seeks evidence for it. When the evidence does not support the desired outcome, that evidence is manipulated and altered. Pseudoscience portrays itself as following the scientific method, but in fact represents the antithesis of science. It dresses itself in the garb of science, and draws on the credibility science has earned. However, it is agenda driven, seeking only to provide justifications for predetermined outcomes.”
In their filing against the retail pharmacies, they argued:
“This sort of product placement is misleading and presents homeopathic products as equivalent alternatives to science-based medicines.”
This decision also allowed their case against the homeopathic product manufacturer, Boiron, to proceed. They alleged:
“Through a carefully crafted scheme of misrepresentation, obfuscation, ambiguity, innuendo and falseties, Boiron off loads otherwise worthless products upon the unwitting, the ill-informed and the vulnerable.”
Why the fervent attack of late to rewrite old laws, in order to expand regulations and discredit reputable brands?
Clearly consumers have spoken up and want to make their own informed decisions about homeopathy and other natural medicines.
Could it be that these natural medicines are being suppressed because they actually work, and are a threat to the sales of conventional medical drugs?
After all, vitamins, herbs, and supplements are generally less expensive to purchase, and do not require a doctor’s visit or prescription.
Promoting well-being and making healthy lifestyle choices contributes to the overall health of society, and utilizing preventative healthcare modalities such as herbs, supplements, and homeopathy can help prevent and treat chronic illness.
Consumers have shown they are willing to pay a premium for the types of healthcare they choose regardless of insurance coverage. Pharmaceutical companies and their shareholders want to increase market shares, and it’s important to note that generally, unwell people contribute (i.e.,incentive to keep sick people… sick).
If access to natural medicine is limited or removed, the likelihood of chronic illness and the subsequent so-called need for prescription drugs is more likely to expand. To learn more about the FDA’s new homeopathy policy, read our curated post from the Alliance for Natural Health USA (ANH-USA).
To help stop the attack on homeopathy, and resist “bad guidance,” let your voice be heard. To say “no” to homeopathy being labeled as “unapproved new drugs,” send a message to your members of Congress in the U.S. House and Senate.
Disclaimer: This article is not intended for medical advice; it is for educational purposes only. Please consult your primary care provider and/or holistic practitioner to address your medical needs.
Published on March 23, 2023
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