Are Homeopathic Drugs a Thing of the Past?

by | Nov 4, 2020 | FDA, Homeopathic, Medicine, Pharma, Pharmaceuticals, Quality, Regulatory

Homeopathic medicines have been around since the 1700s, and the premise behind them has not changed much in the past 300 years. The idea behind them is the premise of “like cures like”, meaning that the substance that causes a symptom in a person, can be used in a diluted form to cure that symptom. This logic is very similar to that of vaccines – using an inactive form of a virus to create immunity to that virus in the host body. Despite these similarities, the debate between homeopathic drugs and conventional drugs has been ongoing for as long as both have been around. 1

In modern-day, the big difference between homeopathic and conventional drugs lies with FDA regulations. Currently, there are no FDA approved homeopathic medicines. Up until recently, homeopathic drugs were allowed on the market through an FDA guideline established in 1988, Compliance Policy Guideline 400.400, “Conditions Under Which Homeopathic Drugs May be Marketed”. This pathway was significantly less involved than the FDA pathway for conventional drugs because the FDA was not particularly concerned about the safety of homeopathic drugs. This lack of concern was because homeopathic drugs are typically made of natural ingredients at a very diluted concentration. Recently, however, The FDA has had growing concerns about the safety of homeopathic drugs, as there have been situations where they have contained toxic substances or had stronger concentrations than advertised. These concerns have led the FDA to retract guideline CPG 400.400.1

Without this guideline in place, all the homeopathic drugs that have been able to exist unregulated on the market will now require the submittal of a New Drug Application. This will make legally marketing homeopathic drug very challenging since homeopathic drugs are typically made of common substances (making it difficult to get a patent), and are typically tailored for individuals (making it difficult to conduct clinical trials with significant findings).

While the FDA is in the process of creating new guidelines around homeopathic medicines, the homeopathic medicine community is strongly fighting back in hopes of convincing the FDA to reconsider the changes they are making. Until this gets sorted out, however, there is certainly a gray area around homeopathic medicines. Whether you are currently marketing homeopathic medicines, or if you are just starting to develop homeopathic medicines, our regulatory experts at EMMA International can help ensure your product is compliant with the regulatory requirements. Contact us at 248-987-4497 or info@emmainternational.com for additional information.


1FDA. (2020, February 11). Homeopathic Products. Information by Drug Class, 1-3. Retrieved November 01, 2020, from https://www.fda.gov/drugs/information-drug-class/homeopathic-products

Catherine Milford

Catherine Milford

More Resources

Change Management And Control

Change Management And Control

One of the biggest and most important aspects of quality management is a system to monitor changes and how they impact the product. Change management is an approach for changing processes or products in a way which adheres to regulatory standards by ensuring stability and consistency throughout processes. It applies across all changes within a process and throughout an entire products life cycle.
Aseptic Technique and Gowning

Aseptic Technique and Gowning

One of the most common techniques to prevent contamination of products and reduce quality impacts in the pharmaceutical industry is called aseptic gowning. Humans are the biggest sources of microbial contamination in cleanroom environments and therefore proper gowning procedures are essential to ensuring product quality. Proper training, education, hygiene, qualification, and authorization must be put in place and be required for entry to all clean room environments...
Importance of Pharmaceutical GMP

Importance of Pharmaceutical GMP

Having high quality standards is vital to any organization but is even more essential in the pharmaceutical industry. Practices that are governed by these standards are commonly called Good Manufacturing Practices (GMP) and ensure consistent and controlled production of products. These practices govern all aspects and procedures within production and provide documented proof that procedures are consistently followed during the manufacturing processes every time products are made. They are designed to minimize risks throughout the manufacturing process that are not able to be eliminated in final product testing so that pharmaceuticals are safe for use...

Ready to learn more about working with us?

Pin It on Pinterest

Share This