Clearly, Homeopathic remedies have been and continue to be sufficiently regulated, by the FDA and by the Homeopathic industry itself. There has not been a single, verified case of harm or death from a Homeopathic remedy – in 200 years. There has not been a single case of addiction to Homeopathic remedies. Those are the facts, while chemical drug deaths contribute to the third leading cause of death in the nation – “accidental injury” – with drug overdose and the opioid crisis largely to blame. U.S. lifespan is falling, not despite pharmaceutical, chemical drugs, but because of them. Homeopathic remedies need to be accessible to those who opt to use them instead; it is not the role of the FDA to force one kind of medicine on American citizens to the exclusion of all others.
Categories Named by the FDA for New Regulation
In the FDA’s proposed Guidelines on Drug Products Labeled as Homeopathic, the FDA has proposed to withdraw the 1988 Compliance Policy Guide (lst revised in 1995) which governs the manufacturing and marketing of Homeopathic drugs.
The following categories, in bold type, are those targeted by the FDA for new regulation, with my comments below each category:
- Products with reported safety concerns.
There are no such products. A true and pure Homeopathic remedy as found in the HPUS cannot be anything but safe. The few products marketed as Homeopathic that have crept onto the marketplace with non-Homeopathic, synthetic ingredients including artificial colors, but which contain a low-potency “Homeopathic” ingredient, are a perversion of homeopathy (g. Zicam). The word “Homeopathic” could be removed from the labels of such products. Any pure Homeopathic product should be proven unsafe before the FDA can regulate it further, since according to the FDCA, Homeopathic drugs are generally recognized as safe, subject to the provisions of the HPUS. Homeopathy is an exact science, and one medicine cannot be used in place of another. If, for example, one has a Belladonna fever, no medicine other than Belladonna will help. Restricting any pure Homeopathic drugs found in the HPUS will cause needless suffering and hardship, and greater use and reliance on toxic pharmaceuticals.
- Products that contain or purport to contain ingredients associated with potentially significant safety concerns. For example, potentially significant safety concerns are raised with products that contain or purport to contain: 1. an infectious agent with the potential to be pathogenic.
No true Homeopathic product could possibly be pathogenic. The words “associated with” pertain to the material substance, since no Homeopathic ingredient has any potential to be pathogenic. Critics say there is nothing in Homeopathic remedies, as, in fact, there is no measurable medicinal substance in them. Remedies made from disease products, called nosodes, or disease-causing matter (like Pyrogenium, made from decomposed beef) only soundrisky due to the matter from which they’re derived; super-diluting beyond Avogadro’s scale renders them harmless. The dynamic effects of an energetic remedy are distinct, and opposite, from the physiological or poisonous effects of the material substance. Homeopathic nosodes and other such remedies have proven to be invaluable medicinal tools to practitioners and patients for centuries, their safety and benefit understood at the passage of the FDCA.
- A controlled substance.
Although a few Homeopathic remedies are made from substances that are controlled in their material state (g.,opium), the Homeopathic remedy made from opium is energy only. Homeopathically prepared opium cannot ‘drug’ the consumer, be lethal, nor addictive. It will leave the person with no effect at all, or, if needed, can direct the body’s energy to correct stupor or other symptoms associated with effects of the material drug.
- Multiple Ingredients.
Homeopathic ingredients used in combination cannot harmfully interact with each other. Such combination remedies may be effective, if one of the ingredients matches symptoms of the individual’s illness. These can be beneficial to the consumer who does not have access to a professional homeopath to guide him/her to the best, single remedy.
- Ingredients that pose potential toxic effects.
Homeopathic drugs are controlled in the manufacturing process, according to existing law. So long as that is accomplished, there is no potential for toxicity; pure Homeopathic drugs are merely energetic. Many valuable Homeopathic remedies happen to made from plants and other natural substances that can be toxic in material dose, which is of no consequence in assessing pure, Homeopathic/energetic drugs.
- Products for routes of administration other than oral and topical.
Homeopathic drugs are properly used orally and topically. They are not intended for injection, and the FDA could properly regulate that unusual circumstance. However, it is not clear whether the FDA objects to eye drops. Certain Homeopathic ophthalmic products have a long history of safety and efficacy, and should be allowed as long as the remedies continue to be manufactured according to the HPUS standards for purity and safety. One such product, made by Similasan Corp. of Switzerland, is an eye drop product made according to the FDA’s Good Manufacturing Practices (GMP). There is no reason the product should be prohibited or be required to be treated as a pharmaceutical.
- Products intended to be used for the prevention or treatment of serious and/or life-threatening diseases or conditions.
No true Homeopathic remedy or product is intended to prevent or treat a specific, named disease. Homeopathy treats an individual’s symptoms, not any disease. Remedy choice is based on characteristic (individual) symptoms. Labels can reflect this fact, and all Homeopathic medicines continue to be regulated according to the HPUS.
- Products for vulnerable populations . . . such as immunocompromised individuals, infants and children, the elderly, and pregnant women . . . due to their varying ability to absorb, metabolize, distribute, or excrete the products or its metabolites.
Homeopathic remedies are completely safe, and do not need to be absorbed, metabolized, distributed, or excreted by the body and result in no metabolites. This is an especially disconcerting category named for greater regulation, since it is these very population groups that can gain the most from the use of non-toxic, energetic Homeopathic remedies that produce no side-effects, pose no toxicity, and cannot be addictive.
- Products deemed adulterated under section 501 of the FD&C Act.
If a Homeopathic product purports to be or is represented as a product recognized in an official compendium but its strength, quality, or purity differs from the standard set forth in that official compendium (defined by 21 U.S.C. 321 as the official HPUS, National Formulary, or any supplement to any of them), or if there are significant violations of current good manufacturing practice requirements, then it should be judged accordingly, ideally by the Homeopathic governing body, the HPCUS. Medicines called “homeopathic” that contain synthetic ingredients like artificial color and flavor can be considered adulterated, in my opinion (even if the active ingredient is Homeopathic); they are not truly Homeopathic in purity. But this is an area covered by existing law; no new regulation is needed.
The rules and regulations concerning Homeopathic remedies already in effect are more than adequate to protect the public. The laws on the books do not need to be amended and supplemented by unelected bureaucrats at the FDA. The original intent of Congress in passing the FDCA was not to promote a single, dominant system of healing in America, but instead, to allow for both chemical and Homeopathic medicines to be available to the public so long as labels disclose all of the ingredients and the remedies are pure, unadulterated, and made according to the pharmacopeia standards applicable to each. This new attack on homeopathy by Big Pharma and its friends must be defeated.
HOW TO FILE COMMENTS
Just as those who came before us have long defended Homeopathy from attack by politicians and competing schools of medicine, the job now falls to us. Frankly, it does not matter if you use Homeopathic remedies or products, or ever plan to. All should be concerned about arbitrary restrictions on the choice. But especially if you have used Homeopathy, make your voice heard today – the deadline is before Midnight on Tuesday, March 20, 2018.
Comments can be filed electronically through the Federal eRulemaking Portal by following the instructions at .
SAMPLE COMMENTS (You can “cut and paste” if you would like)
I strongly oppose any effort to impose new bureaucratic rules and regulations on Homeopathic remedies and products. The FDA has no authority to treat completely safe Homeopathic products as though they were toxic pharmaceutical chemicals. Millions of people in the United States and around the world have used Homeopathic products for more than two centuries without problem. Americans would not use these products if they were not helpful. Even though BIG PHARMA provides much of the FDA’s budget, it should not dictate its policies. The FDA must follow the law, and since 1938 Homeopathic remedies have been given a special status by Congress because they are not toxic and dangerous drugs. The American people insist on continued, unrestricted access to Homeopathic products.