Consumers assume homeopathic products are ‘natural’ and cannot be harmful, but this is not always the case

Most consumers assume homeopathic products are “natural” and cannot be harmful, but this is not always true.

Homeopathy comes from the Greek word homoios, which means "similar." Homeopathic physicians believe diseases can be cured by giving a substance that causes similar symptoms in healthy people, just in tiny amounts.

In the late 1700s, the German physician and chemist Samuel Hahnemann developed homeopathy as an alternative to conventional medical remedies. Dr. Hahnemann was appalled by the treatments commonly prescribed in his day, such as repeated bloodletting, attaching leeches, and swallowing large doses of compounds containing lead, mercury, and arsenic.

Instead of using these toxic compounds, Dr. Hahnemann gave his patients minimal doses of one medicine at a time and watched how they reacted before giving them more. His patients often felt better and recovered faster than those treated with blood loss or poisonous metals. Homeopathy was born.

Traditional homeopathic remedies are small dissolvable tablets labeled with their active ingredient and the dilution, which is a number followed by an “x." A “1x” dilution is made by diluting one part of the original solution by adding 9 parts of water. The resulting liquid is dripped onto small sugar tablets.

A “2x” dilution is made by diluting the original solution 2 times, using one part active ingredient solution to 9 parts water each time. This is repeated many times. Most traditional homeopathic remedies are dilutions of “100x”, “1000x”, or “10,000x”, meaning that there are little to no molecules of active ingredient left in the product.

In the world of traditional homeopathy, the more diluted an agent is, the more effective it is considered to be. I find it hard to believe that medication can be helpful after diluting it 1000 times or more. You are left with only a few molecules in each sugar pill.

The belief that anything so diluted could not be harmful has led to minimal oversight or regulation of homeopathic products by the Food and Drug Administration (FDA).

In fact, according to the National Center for Complementary and Alternative Medicine (NCCAM), which is part of the National Institutes of Health (NIH), there is little scientific evidence to support using homeopathic remedies.

The FDA does not require homeopathic products to prove safety or efficacy. This allows the manufacturers of any homeopathic remedy containing active ingredients listed in the Homeopathic Pharmacopeia of the United States (HPUS) to skip the expense and oversight otherwise required by the FDA.

One example of this contradiction is Arnica. The FDA classifies Arnica as an unsafe herb when taken by mouth. Under FDA regulations, Arnica is available as an over-the-counter (OTC) homeopathic remedy for various indications in melt-under-the-tongue tablets.

The FDA has not addressed the lack of regulation of homeopathic remedies because it assumed they were too dilute to cause harm. Although that was probably true of homeopathic agents of 1,000x and 10,000x dilutions, some manufacturers market products as homeopathic with dilutions of 3x or 10x.

That was the case with Zicam®, a nose spray containing zinc. It was initially marketed as a homeopathic cold remedy. However, unlike traditional homeopathic formulas, there was a significant amount of zinc in Zicam®. Soon after its introduction, The FDA started receiving reports of loss of smell after using Zicam®. 

In 2009, the FDA issued a warning about Zicam®. It reported evidence of permanent loss of smell in some people with as little as one dose of Zicam®. The FDA eventually forced Zicam’s® manufacturer to reduce its zinc concentration.

The FDA investigated when they received reports linking the use of Hyland’s Teething Tablets® in infants with seizures, shortness of breath, tremors, and even death. They found highly inconsistent levels of the toxic compound belladonna, suggesting poor manufacturing practices.

Although the FDA has since issued several safety warnings on the dangers of homeopathic teething products, the manufacturer of Hyland’s Teething Tablets has continued to sell the product as is. Unfortunately, the FDA has no authority to issue a mandatory recall, despite accumulating over 400 adverse event reports in children associated with Hyland's Teething Tablets®.

To address this, Congresswoman Rosa DeLauro from Connecticut introduced the Recall Unsafe Drugs Act on February 16, 2017. This bill would give the FDA mandatory recall authority over homeopathic products. DeLauro resubmitted it earlier this year as the Recall Unsafe Drugs Act of 2022, and it’s now in the House’s subcommittee on Health.

Homeopathic remedies can be sold in the United States without proving they are safe or effective. I suggest you avoid homeopathic products entirely or use them cautiously.

Dr. Louise Achey, Doctor of Pharmacy, is a 43-year veteran of pharmacology and the author of Why Dogs Can’t Eat Chocolate: How Medicines Work and How YOU Can Take Them Safely. Get clear answers to your medication questions at her website and blog, TheMedicationInsider.com. ©2022 Louise Achey