How Government Decisions Impact the Homeopathy Industry

Homeopathy, like all sectors of the healthcare industry, is subject to oversight and influence from various parts of the U.S. government. From Congress to regulatory agencies, different entities play a role in shaping policies, standards, and market conditions for homeopathic drug products. Understanding how these government actors impact homeopathy is essential for manufacturers, retailers, and consumers alike. This article will explore how different parts of government shape how homeopathic drug products are produced, marketed, and available to consumers. 

United States Congress
Advancing Legislation that Impacts Homeopathy 

As the legislative branch of government, Congress passes laws that may either directly or indirectly impact homeopathic products. While homeopathy has been, formally or informally, a part of the U.S. healthcare system for almost two centuries, new healthcare and pharmaceutical legislative initiatives can introduce changes that affect homeopathic drug products. 

For example, Congress has the authority to: 

• Introduce and pass bills that redefine how homeopathic drug products are regulated. 

• Allocate funding to agencies like the Food and Drug Administration (FDA) to increase oversight of homeopathic drug products. 

• Hold hearings and inquiries into homeopathic drug product safety, efficacy, and consumer protections. 

Advocacy efforts within Congress are critical for regulations to strike a balanced between homeopathic drug products remaining accessible for the benefit of consumers and protecting consumers. AAHP is committed to making sure the needs of our members are considered by policymakers. 

U.S. Food and Drug Administration (FDA)
Regulating Homeopathic Products 

FDA plays the most direct role in regulating homeopathic drug products. Per the Federal Food, Drug, and Cosmetic Act (FDCA), homeopathic medicines are categorized as drugs and are expected to be manufactured and marketed as such 

Key FDA activities include: 

• Guidance Updates: FDA’s most recent guidance, issued in 2022, shifted regulations from a compliance approach to a risk-based enforcement approach. FDA listed six enforcement priorities, some of which are applicable to allopathic OTC (e.g., products with serious adverse events, significant quality issues, or OTC with Rx claims).. 

• Manufacturing Oversight: FDA inspects homeopathic manufacturers’ facilities to ensure compliance with Current Good Manufacturing Practices (cGMP), as all pharmaceutical companies have a duty to guarantee public safety through product safety, purity, and consistency.  

• Warning Letters & Enforcement Actions: FDA also monitors OTC label claims and has taken action against companies for specific homeopathic drug products it deems unsafe or improperly marketed, thus influencing the overall industry’s compliance landscape. All companies should read these public warning letters — which often include specific points that should be addressed — to learn steps they can take towards compliance. 

Understanding and engaging with FDA regulatory processes is crucial for homeopathic companies to navigate compliance while maintaining product availability. FDA is the government agency that has the most oversight of homeopathy. AAHP maintains regular oversight of FDA’s actions to demystify regulations, helping our members comply with the ongoing changes in regulatory requirements. 

U.S. Federal Trade Commission (FTC)
Setting Marketing Standards 

FTC regulates the marketing and advertising of homeopathic drug products to ensure claims are not misleading. In 2016, FTC published its Enforcement Policy Statement on Marketing Claims for Over-the-Counter Homeopathic Drugs.  

In response to concerns raised by FTC, AAHP developed the following disclaimer for use on product labels and in advertising: “Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.”  

The AAHP disclaimer is an example of the power and savings provided by the association that continues to deliver value. AAHP hired a third-party consultant throughout 2017 to create proper disclaimer language and to keep the FTC informed of its efforts — a monumental task that would prove too costly for any one company. 

State Governments
Licensing and Consumer Access 

While not often involved in larger regulatory matters, state governments also play a role in shaping the homeopathic industry through licensing and healthcare policies. 

• States regulate the practice of homeopathy by sometimes (but not always) licensing homeopathic practitioners. 

• State attorneys general may enforce consumer protection laws that affect the marketing and sale of homeopathic drug products. 

• Legislation at the state level can impact insurance coverage and consumer access to homeopathic treatments. 

It is important for producers of homeopathic drug products to ensure compliance with the regulatory environment in each state where their products are sold. Consumer access in each market is impacted by both state and federal regulations. 

In general, states may not enact laws that conflict with federal law. This is true for laws related to the labeling of homeopathic products. 

The White House
Executive Orders 

The President can shape the regulatory landscape of homeopathy directly through executive orders and policy objectives or indirectly through personnel appointments. For example: 

• Appointing FDA and FTC leadership, which can influence how these agencies approach homeopathic oversight. 

• Issuing executive orders that impact regulatory reform. 

• Signing or vetoing legislation passed by Congress that could impact homeopathy. 

Each Presidential term offers new opportunities and challenges for the homeopathic industry.  

Staying Involved in the Regulatory Process 

For the homeopathic industry, staying informed and involved in the regulatory process is critical. Industry groups such as AAHP actively engage with legislators and regulatory bodies to advocate for fair policies that support safe and accessible homeopathic products. 

By understanding how the different branches of the government influence homeopathy, industry stakeholders can navigate regulatory challenges, advocate for appropriate supportive policies, and ensure consumers continue to have access to homeopathic drug products.