FDA Proposes Changes to How They Enforce Homeopathic Drugs

Homeopathic Drugs

As I discussed in a previous blog, the Food and Drug Administration (FDA) is the governmental body in the United States that regulates drug development and marketing. Drugs must be shown, through research, to be safe and effective before they are approved for marketing. The FDA defines a “drug” as a substance that is:

  • recognized by an official pharmacopoeia or formulary
  • intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease
  • intended to affect the structure or any function of the body (but is not a food)

Drugs can be further categorized as prescription, over-the-counter (OTC), or homeopathic. Prescription drugs are drugs that require a person who is licensed, such as a medical doctor (MD) or advanced practice registered nurse (APRN), to write an order for a patient to take them. Drugs assigned to this category are usually ones used for diseases that require a diagnosis by a doctor and drugs where the balance of benefit and risk calls for a healthcare professional to monitor the patient and the effects of the drug. Over-the-counter medicines are used for conditions that a person may identify on their own such as a fever or constipation. These medicines are generally considered to have greater benefits than risks so that a healthcare professional is not needed to monitor the patient for drug effects. Some medicines that start out as prescription drugs are later reclassified as OTC after years of experience with them. Examples of medicines that have been reclassified from prescription to OTC include ibuprofen and ranitidine.

Homeopathic drugs are different and their use and marketing has been controversial. The Merriam Webster Dictionary defines homeopathy as, “a system of medical practice that treats a disease especially by the administration of minute doses of a remedy that would in larger amounts produce in healthy persons symptoms similar to those of the disease.”  Some people are supporters of homeopathy, some don’t believe these medicines work but that they are safe because they are dilute, while still others believe their use is harmful because people use them instead of using traditional medicine. There have been reports of harm in children from some homeopathic medicines . Still, it is clear that homeopathic drugs remain popular. Results from 2012 U.S. government health surveys indicate that 2.2% of adults and 1.8% of children age 4 to 7 years used a homeopathic product during the prior year.

Regardless of your feelings about homeopathic medicines, the fact is that the nature of homeopathy as a discipline makes it difficult to apply traditional research methods to study it. So, while the FDA has regulated the labeling and marketing of homeopathic drugs, to date the FDA has not required manufacturers prove safety and effectiveness of these drugs like they do with prescription and OTC drugs. However, on December 18, 2017, the FDA proposed changes to their policies for enforcement of homeopathic drugs. The FDA will prioritize regulatory actions involving homeopathic products according to the perceived risk of the product. The proposal recognizes the following categories of products as ones with higher risk:

  • Products with reported safety concerns
  • Products that contain ingredients with potential safety concerns
  • Products that are taken by a route other than oral or applied to the skin (examples include injections or products put in the eye)
  • Products used for serious or life threatening diseases
  • Products used by vulnerable groups such as infants, children, or pregnant women
  • Products that do not meet quality, strength, or purity requirements or that do not follow good manufacturing practice requirements

If you use homeopathic medicines for yourself or your family, some of them may become unavailable if they fall under the above categories and the FDA determines they are not safe. The goal of this proposal is to protect the public from unsafe homeopathic products while still offering this class of medicine as an option to those who choose it.

You may comment on these proposed changes for 90 days from their posting. You are also encouraged to report any adverse effects or quality issues you experience for any medicine type – prescription, OTC, homeopathic – by submitting a report to https://www.fda.gov/Safety/MedWatch/default.htm. This is one way that the FDA becomes aware of problems.

Margaret Burke
Dr. Margaret Burke is a board-certified pediatric pharmacotherapy specialist and medical writer. She earned her Bachelor of Science in Pharmacy and Doctor of Pharmacy degrees at The State University of New York at Buffalo School of Pharmacy and Pharmaceutical Sciences and completed a pediatric pharmacy residency and fellowship at The University of Illinois at Chicago. She has worked as a clinical pharmacist caring for neonates and children for more than 20 years. In her spare time she enjoys reading, hiking, and travel adventures with her husband.

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