First, if you’re not aware of any of this, perhaps that’s just the best place you could be. Just keep seeking natural health for you and your family via homeopathy! However, if you are aware, I’ll try to give some background in the most concise and least-verbose way I can.
To begin, we must go to the source. In 1938 Congress passed the United States Food, Drug, and Cosmetics Act (FD&C), which established the Food and Drug Administration (FDA). Among other responsibilities, FDA is and always has been responsible for the manufacturing and labeling of drug products, including homeopathic medicine. The FD&C was led by U.S. Senator Royal Copeland, MD, who was also an ardent supporter and practitioner of homeopathy.
This Act of Congress effectively made homeopathic medicines legal drugs. Homeopathy was widely used in the marketplace prior to 1938, but were officially defined as legal. The FD&C also required any new drugs to have an approved application before marketing. This law has remained relatively unchanged since 1938. What has been added over time is information used to demonstrate safety and efficacy of any drug products, homeopathic or otherwise.
Part of the uproar over recent media coverage on this topic pertained to the recent FDA assertion that all homeopathic drugs are unapproved new drugs. This is not new information. They have always been unapproved new drugs as outlined by FD&C since 1938. Instead, and on three separate occasions in the past 40 years, FDA has stated that the best way to regulate homeopathic products is through enforcement discretion and regulatory guidance due in part to the knowledge that homeopathic products are safe. Effectively, no other FDA regulation is necessary.
In 1988, FDA adopted Compliance Policy Guidance (CPG) 400.400 (Conditions Under Which Homeopathic Drugs May Be Marketed). CPG 400.400 established clear standards for the manufacturing and sale of homeopathic drugs, and helps facilitate access to only safe homeopathic medicines to consumers. This is good for everyone – consumers (foremost), as well as manufacturers, and practitioners of homeopathy.
Beginning in 2015, FDA began public hearings on the regulatory framework for homeopathic medicines given that the current guidance (CPG 400.400) had been in place for over 25 years. Over 9000 comments were submitted. The vast majority (approx. 78%) were positive and in favor of homeopathy. The vast minority were not in favor of homeopathy.
FDA published their draft guidance on December 18, 2017. FDA guidance is nothing more than opinion. It is meant to inform FDA staff and the industry about what their priorities are. FDA guidance does not have the force of law, and cannot change the legal status of products. As such, homeopathic remedies have not been banned or are now suddenly unapproved for use, as some media sources and/or reports may state or imply. However, even though the opinion of an FDA guidance document is informal, it is still used to regulate homeopathic products.
Thus, the FDA guidance published in December 2017 highlighted six areas of priority, all of which primarily revolve around safety. Despite the legal status of homeopathic products remaining unchanged since 1938, there are several concerns about the FDA draft guidance, since it excluded important details and left too much room for ambiguous interpretation.
- First, it excluded CPG 400.400. This makes it challenging for FDA regulators to authenticate what is and what isn’t a homeopathic medicine during their investigations.
- Second, there is no reference to homeopathic literature for substantiation of homeopathic products (i.e. research showing efficacy). This could result in anything being put on the shelves and calling itself ‘homeopathic’, regardless of whether or not it has any connection to homeopathic medical literature.
- Third, the guidance is silent pertaining to the combination of homeopathic active ingredients with dietary substances or pharmaceutical drugs. We homeopaths know that homeopathic remedies shouldn’t be combined with other ingredients which may have their own safety issues. This could cause undue risks to the consumer, and thereby connect homeopathy with products that are unsafe, also resulting in a tarnished image for homeopathy. However, the current FDA draft guidance doesn’t consider that.
The American Academy of Homeopathic Pharmacists (AAHP) has been actively involved in this entire process. AAHP is asking for help in drafting comments to FDA to convince them to reinstate critical specific language into the draft guidance so that dangerous products can’t enter into the market, and only safe homeopathic products can. Having the public add draft comments will help amplify the industry message to FDA that this is an important issue for public health and to help facilitate continued access to homeopathic medicines. You can add your draft comments here. From that linked page, you’ll need to click the blue-colored button “Comment Now.” Please keep your comments congenial, thoughtful, and respectful. The comment period will close on March 18, 2018.
As part of the strategy to respond to the FDA draft guidance, a letter writing campaign has begun. This was a targeted approach and involved making contact with U.S. Members of Congress who are on committees which have jurisdiction over FDA. Constituents in those districts were asked to contact their Representatives and ask them to co-sign letters being sent to FDA. This amounted to people from six states including Tennessee, Washington State, Utah, Colorado, New Mexico, and Pennsylvania. As of writing, there has been an overwhelming response. If you are reading this and live in one of those six states, click here to find out how to take action.
The next phase of the strategic response is more of a grassroots effort. The letter writing campaign is set to go nationwide, beyond just those six states. Stay tuned for more details on how to take action on that approach.
Finally, Mark Land, President of AAHP has been instrumental in leading this effort to update the homeopathic community on the regulatory environment for homeopathic drug products. He presented a comprehensive free webinar on this topic, and you can review the recording of it here.
This was a lofty and information-intensive blog. Nevertheless, it contained critical paths for what is happening in homeopathy, and what we can do about it.
My hope is that this cleared some of the smoke on the topic of FDA-regulation of homeopathy, helped you see where the fire is, and how we can all help to put that fire out.
Contact me if you have any questions.
Thank you for reading, and for your support of homeopathy!