Understanding Recent FDA Homeopathic Positions in the Current Context
By Cesar Collado
This year when you look at the labels of homeopathic and herbal medicines, you may read a new disclaimer warning indicating that the products “have not been evaluated by the Food and Drug Administration and are not intended to diagnose, treat, cure, or prevent any disease or health condition.”One interpretation suggests that “the medicine is based on outdated theories ‘not accepted by most modern medical experts’and that ‘there is no scientific evidence the product works.’” 1.
So, the next obvious questions are, “Is this supplement safe?” and “Why should I use it, if it may not work?”
It is important to note that the history of the FDA dates back to the passage of the 1906 Pure Food and Drugs Act; while many homeopathic and natural medicines have been used successfully around the world for centuries and date back thousands of years! In fact, a significant percentage of existing pharmaceuticals were originally derived from plants. Hippocrates, the “Founder of Medicine” and Aristotle, his pupil, used medicinal plants for the treatment of diseases. After that, Theophrastus, a Greek scientist, founded the School of Medicinal Plants. Then, Pedanius Dioscorides, a physician and surgeon in the years 75-45 BC, wrote an encyclopedia, called De Materia Medica, to describe 600 therapeutic medicinal plants in the form of a series of scientific studies on medicinal plants.3.
This irrefutable history makes some interpretations of the recent FDA position paper, titled “Drug Products Labeled as Homeopathic and Industry, Guidance for FDA Staff,” December 2018, disconcerting and impractical. There is also a lot of misinformation out there as various stakeholders are trying to oversensitive individuals to not use these products that have proven efficacious empirically over the test of time. In some cases, herbal remedies used thousands of years ago are still used today throughout the world. In other cases, many FDA approved medicines are derived from natural products that provided medical benefit. I believe Big Pharma would like to see homeopathic remedies removed as a patient option. Thus, I’d like to offer some explanation of what I believe is really going on.
(This will be the first of a series of articles explaining more about homeopathic, natural medicines, food as medicine, and pharmaceuticals to provide perspective on many questions readers have asked on these topics.)
Homeopathy is a medical system based on the belief that the body can cure itself. Those who practice it use tiny amounts of natural substances, like plants and minerals. They believe these stimulate the healing process. It was developed in the late 1700s in Germany. True homeopathy is rarely used in the US (estimated at <2% of the adult population). It is much more commonly used in many European countries and India.
Homeopathy is based on two unconventional theories:
- “Like cures like”—The notion that a disease can be cured by a substance that produces similar symptoms in healthy people;
- “Law of minimum dose”—The notion that the lower the dose of the medication, the greater its effectiveness.
Homeopathy is practiced by over 200 M people around the world. While not considered homeopathic medicines, allergy shots and drops follow the same principle and are a mainstay of allergy medicine. Homeopathic medicine also plays an important role in veterinarian medicine for pets.
Confusion Amongst Medicinal Alternatives
One challenge is that homeopathic medicines are often considered interchangeably with other alternative medicines. These include herbal medicines, natural remedies and dietary supplements. This is an important distinction for most people.
- According to the World Health Organization, an estimated 80% of people around the world use herbal medicine. Studies show certain herbs are effective in treating a number of health issues, like allergies, premenstrual syndrome, chronic fatigue, and more.
- Ayurveda is one of the world’s oldest medical systems. It started in India more than 3,000 years ago and is still widely used in that country today.
Past Homeopathic Regulation
Homeopathic medicines are regulated by the FDA under the Food Drug and Cosmetic Act of 1938. The primary regulatory requirement is that the active ingredients must be listed in the FDA Pharmacopeia. The U.S, Pharmacopeia (USP) is published in a combined volume with the National Formulary. . If a drug ingredient or drug product has an applicable USPquality standard (in the form of a USP-NF monograph), it must conform in order to use the designation “USP” or “NF.” Drugs subject to USP standards include both human drugs (prescription, over-the-counter, or otherwise) and animal drugs. Historically,homeopathic products were mostly prepared by homeopathic physicians for individual patients. (For a link in relevance with Microbalance Health Products, it is of note that all products were historically produced in a compounding pharmacy specifically for Dr. Dennis’s patients.)
The Reason for Changes
Over the past couple of decades, there has been an exponential increase in homeopathic offerings, nutritional supplements, and product availability. They are everywhere: grocery stores, shopping centers, and on the internet. The reality of the situation is that because of the historically relaxed regulatory environment, numerous products with suspect efficacy, safety, and scientific evidence have flooded the market. Unfortunately, if you include all of the products that are sold, marketed, and distributed “everywhere,” they have a wide variance in quality ingredients, and scientific evidence. Lack of consistent quality control and standardization of manufacturing homeopathic medicine and herbal remedies across all suppliers has become problematic.
In fact, the homeopathic and herbal market is expected to grow substantially with a compound annual growth rate of 14-18%. This is attributed to many factors:4.
- Aging population;
- Astronomical increases in cost for allopathic or western healthcare and pharmaceutical medicines;
- Increased consumer awareness for preventive healthcare;
- Transition of market from ingredient-based selection to branding;
- Proliferation of retail availability;
- Consumer-directed healthcare due to DTC advertising of pharmaceuticals and healthcare;
This projected increase is one of the primary reasons for increased regulatory pressure. In response to the widened use by individuals who may not be fluent with homeopathy and homeopathic medicines, certain safety recommendations have been incorporated in FDA policy positions on Homeopathic Medicines.
In April 2015, the FDA held public hearings to collect information on over 9,000 comments from consumers and began re-evaluating its position on these drugs and supplements. As a result, the FDA has changed its position on homeopathic medications.5. However, when reading the documents closely, the language is broader than homeopathic medicines specifically. It includes homeopathic, dietary supplements, OTC, and other products (decided by the FDA.)
Adding fuel to the fire, a few very high-profile homeopathic medicines came under the public eye for very legitimate safety reasons:
- In July, 2017, the FDA took a very strong position on homeopathic
medicine distributed by CVS and Hyland’s (a reputable firm). These products contained belladonna, a toxic substance that has had some historic medicinal use that goes back centuries.6 This known toxic substance was being used carelessly in tablets for child teething. The FDA appropriately acted immediately and Hyland voluntarily recalled the product and issued a warning.
- In 2009, the FDA ordered Zicam to stop marketing three products that contained zinc gluconate after more than 100 users reported losing their sense of smell.
2018 FDA Position
In December, 2018, the FDA took an unusual approach to homeopathic medicines by issuing a non-binding guidance document. This document leaves ambiguous direction to what will happen to homeopathic medicines moving forward. In general, it states the following:
- A drug, including a homeopathic drug, is considered a “new drug” if it is not generally recognized as safe and effective (GRAS/E) by qualified experts for use under the conditions prescribed, recommended,or suggested in the labeling (section 201(p) of the FD&C Act) (21 U.S.C. 321(p)). This includes virtually all homeopathic and natural remedies;
- Any “new drug” must submit a New Drug Application and clinical evidence of efficacy to be approved by the FDA.7
While the ‘FDA Guidance ‘position can be interpreted as making all homeopathic drugs illegal, which would be ridiculous because of the broad consumer use of these products, the agency took a practical approach by publicly describing its position and intent.8.
“Our approach to regulating homeopathic drugs must evolve to reflect the current complexity of the market by taking a more risk-based approach to enforcement. We respect that some individuals want to use alternative treatments, but the FDA has a responsibility to protect the public from products that may not deliver any benefit and have the potential to cause harm.” Scott Gottleib, FDA Commissioner.
It should be clarified that the FDA has not taken any proactive, broad action against the homeopathic or herbal medicine industry. That would be impossible from a resource standpoint, impractical from a consumer standpoint, and unaffordable from an industry standpoint. The FDA recognized the historical importance of the history of medicine. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research stated that they will use their limited resources to “go after” products that cause or might cause “overt harm.”
The vast majority of Homeopathic products do not fall the under following prioritization of FDA enforcement of the guidance!
The FDA’s draft guidance lays out the agency’s proposed plan to prioritize enforcement and regulatory actions for unapproved drug products labeled as homeopathic that have the greatest potential risk for consumers.
Thus, the FDA will focus its enforcement authorities on products
- with reported safety concerns;
- that contain or claim to contain ingredients associated with potentially significant safety concerns;
- that are administered via routes other than oral or topical;
- that are intended to be used to prevent or treat serious and/or life-threatening diseases and conditions;
- that target vulnerable populations;
- that don’t meet standards of quality, strength or purity as required under the law.
- Homeopathic Remedies will remain available and an important option for patients, physicians, and integrative medicine professionals. Thousands of years of worldwide empirical evidence cannot be erased by the modern-day FDA, in my opinion.
- The Government and the FDA have bigger issues to address like pharmaceutical pricing, the impractical and unattainable health care standards, the approval of new drugs for unmet medical needs, medical (and legal) marijuana, and the opioid crisis.
- We can expect a culling of inappropriate or unsafe homeopathic medicines that compromise the entire industry.This limited effort will be the priority of FDA enforcement. The FDA, like the rest of government, is budget constrained during budget deficit times.
- Do not expect explanation or clarity if a product is not technically a “homeopathic medicine.” All products reviewed by the FDA will be evaluated and acted upon at the sole discretion of the FDA.
- You can still find most homeopathic medicines available online or at your local pharmacy or grocery store.
Microbalance Health Products:
Sinus Defense and CellTropin are both homeopathic medicines developed by Dr. Dennis over decades of treating chronic sinusitis patients. Countless years of research and development went into sourcing ingredients, formulating, compounding, testing the medicines for safety, efficacy, and long-term results. You can learn much more about these products on these landing pages which will explain exactly how they work.
- Stoye, Emma, “Homeopathic Medicine Labels Now Must State Products Do Not Work”, Scientific American, November 27, 2016.
- Weeks, John Harvard Study Has Good News for Homeopathic Medicine, Integrative Practitioner, Mar 4, 2016
- Fatemeh Jamshidi-Kia, et. al., Medicinal plants: Past history and future perspective, J Herbmed Pharmacol. 2018; 7(1): 1-7
- Teichner, Warren, “Cashing in on the booming market for dietary supplements”, McKinsey and Company. 2013
- McGinley, Laura, FDA takes more aggressive stance toward homeopathic drugs, Dec 18, 2017
- Fletcher, Jenna “Uses and risks of belladonna” Medical News Today. July 1, 2017.
- “Drug Products Labeled as Homeopathic, Guidance for for FDA Staff and Industry, Dec 17, 2017, https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM589373.pdf
- News Staff, “FDA Proposes New Approach to Regulating Homeopathic Drugs” AAFP, January 08, 2018