Our actions with the FDA seek to protect homeopathy in a proactive manner.
Americans for Homeopathy Choice (AFHC) is on the front lines of the FDA’s Draft Guidance. It’s a place were we are very comfortable and willing to stand. We will remain here until we have seen this advocacy work all the way through. But, as we navigate these waters, and especially for those who are not living and breathing this work as we are, I can imagine that the issue is perhaps confusing. What is really going on? Why does a very small portion of the homeopathy community seem to be saying something different? I intend this article to help clarify these areas, so please read it through until the end.
Voltaire once said, “To learn who rules over you, simply find out who you are not allowed to criticize.” We have to remember that the FDA can (and DOES) discipline manufacturers. That is basically a major part of the job description of the FDA. The natural consequence is that many manufacturers are unable to speak out openly due to their (legitimate and understandable) fear of FDA retaliation. Even so, some manufactures still do speak up, and being a good homeopathic patient and advocate, I would never dream of suppressing anyone’s voice or perspective. I’m sure you would agree.
Because AFHC is a consumer organization made up of mostly mothers and women, the natural effect is that we do not fear the FDA. We are the only group that FDA cannot discipline. Quite the opposite, we are the one group which the FDA has expressed and continues to express interest in. I have been told by high ranking FDA officials that the FDA works for the consumer. I am impressed by this degree of candid engagement, and I agree! Naturally, this gives AFHC a vantage point to speak openly and honestly, without being suppressed by the FDA or any other group. Freedom from fear is a powerful kind of freedom.
There is positive light to shed on our work:
- Because AFHC is so laser focused on unifying the homeopathy community at large, we have been able to listen to the concerns of not only our consumers, but also of practitioners and producers. We even formed the Homeopathy Consumer Council: Consumers, Producers, and Practitioners to formalize this collaboration. (By the way, leaders of any homeopathy organization are invited to contact us if you’d like to join). Our inclusivity and interest in the perspective of all parts of the homeopathy community has resulted in a historic level of collaboration and, dare I say, unity. The homeopathy community seems to realize the opportunity the consumer voice provides. Recently, AFHC released a statement that was endorsed by 16 leading homeopathy organizations, including the National Center for Homeopathy, the American Institute of Homeopathy, and the North American Society of Homeopaths. I am told that something like this has never before happened in anyone’s living memory, because apparently, bringing together a group of very individualistic homeopathic organizations is something like “herding cats.”My experience has been quite the opposite, and I treasure the collaboration from each of these organizations.
- Americans for Homeopathy Choice has a very positive relationship with the FDA, and we have met with them multiple times. The last 2 meetings were with high level officials, including the Director of the Center for Drug Evaluation. Nobody in the homeopathy community has ever met with FDA officials at that level. Further meetings are planned. Additionally, I’m told that after the FDA released the Draft Guidance on Homeopathy, and until AFHC burst into the scene, FDA had very limited communication with the homeopathy community, particularly the manufacturers. Thankfully, the communication between FDA and AFHC has been very positive, and as a result, due to the consumers interest in homeopathy, FDA has for the first time, opened communication with practitioners, and increased communications with HPCUS[1] and manufacturers.
- In large part, due to the Citizen’s Petition we submitted to the FDA, we have slowed the FDA’s actions on the Draft Guidance. Here’s a little insight on administrative history at the FDA: Typically, once the FDA releases a draft guidance, the next action they take is finalizing it (perhaps with some edits). Instead, we were able to get the FDA to completely withdraw their first draft, and FDA issued a new draft. This is not common. Furthermore, we have collected just under 40,000 comments onto this docket so far, which is over twice the number of comments submitted on our Citizen’s Petition and over ten times the number of comments that were collected on the first version of the Draft Guidance in 2017, when AFHC was in its infancy. Together with your support, we also worked with the FDA to extend the comment period to March 23, 2020, and we hope that the 40K comments will surge to 100K by then. (Also note that we will be seeking a further extension of 120 days.)
- AFHC and the consumer voice has also partnered with brand new voices in Congress, Representatives who are impressed by our numbers on the docket and who are supportive and willing to champion our cause. Case in point: An amendment to the Appropriations Bill, which defended our views, was debated on the house floor. I’ve been told that this is another “first” in American homeopathy history. We are thankful for our “mama bears,” “papa bears” and “other bears” (consumers) who actively communicate with their legislators’ offices and relay the important message about homeopathy. (To join our grassroots team, contact us here.)
There is so much more progress, like the meeting between Members of Congress and the FDA as well as a second meeting between Congressional attorneys and FDA attorneys, but I’ll stop reviewing our progress because I want to get to the concerns:
The FDA’s revised Draft Guidance says two different things that seem to conflict with each other. While every bit of me would like to take comfort from the part where the FDA says that “many” homeopathic medicines will “fall outside” their “enforcement priorities,”[2] I simply cannot ignore the fact that the rest of the guidance goes on to explain that the FDA still intends to declare homeopathic medicines to be “unapproved new drugs,” thus treating them as “illegal.”[3] Each of these points requires close examination.
First, because FDA states that “many” remedies fall outside of its risk-based categories[4], a few in the homeopathy community view this as a sign that we should not worry. I have two things to say about this:
- Which remedies are you willing to lose? Belladonna, Aconite, Gelsemium, and Nux vomica (which was compared to rodent poison), have already been mentioned by name in FDA press releases. [5][6]Consumers are not willing to lose even one single homeopathic medicine.
- In addition, the categories listed in the FDA’s draft guidance are so overly broad and vague that FDA has “narrowed down” the categories to include literally all homeopathic medicines. There is very handy language at play that gives the illusion that all will be ok. I want to believe that most homeopathic medicines will remain available (although I want access to them to all), but the very face of the guidance shows they are all at risk.
Second, some say that it is incorrect to assert that FDA is declaring homeopathy as illegal. To begin with, understand the FDA is not saying that homeopathic medicines are illegal. Rather it is saying that the FDA will treat homeopathic medicines as illegal. Here are their exact words:
However, this guidance is intended to provide notice that any homeopathic drug product that is being marketed illegally is subject to FDA enforcement action at any time.[7]
In that document, FDA also says:
This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public.[8]
In other words, while the legal status of homeopathic medicines has indeed not changed, the FDA’s treatment of it has completely changed. The FDA is saying that even though the law may not require it, they will treat homeopathic medicines as “unapproved new drugs,” which means “illegal.”
How does the FDA claim that it can treat homeopathy medicines as suddenly illegal? To the FDA, an illegal homeopathic drug is one that has not gone through a New Drug Application (NDA)[9]. That’s all of them. This means that homeopathic medicine will be at the sole discretion of the FDA for removal from the marketplace, at any time, for any reason, or for no reason at all. The ability to block the buying or selling of homeopathic medicines will be at the sole discretion of the FDA. This is true even though there is no place where the law requires such treatment of homoeopathic medicines.
That’s right. In the Draft Guidance, the FDA has reinterpreted the law, and they are claiming that they can treat any homeopathic drug that is marketed without having gone through an NDA (and that is ALL of them!) as being marketed illegally and is subject to FDA enforcement action at any time.[10]
This may be happening because the FDA is simply using the only model they know and are familiar with, which is the NDA process. But we are gratified that the FDA is engaging with the consumer, and we hope that the fruits of our labors will expand their perspective and help them achieve what they (and we) want, to protect the public while also preserving what we (and what FDA claims they) want, access to homeopathic medicine. In other words, we agree that homeopathy needs proper regulation by the FDA, and the proper manufacturing and labeling of homeopathic medicine is imperative. But putting homeopathic medicine through a system that is designed for homeopathic medicine to fail is a mistake.
Third, some say that the FDA’s treatment of homeopathy as illegal has no legally binding effect, because the FDA first needs to seek permission from the Department of Justice (DOJ) before they take any official action on homeopathic medicines. This is a complicated situation but here is the short version as I understand it:
- If the FDA claims there is an eminent health crisis—like babies are getting sick from a product labeled as homeopathic—FDA can act on its own and remove products from the marketplace whenever they believe it necessary.
- Only after they have seized the products (meaning they are no longer available for use by consumers) do they need to contact DOJ to start the process to keep the product off the shelf permanently. But at this point, the product is already gone.
- Keep in mind that our lawyer’s experience is that the DOJ lawyers tend to defer to the FDA lawyers for their interpretation of the law. Routinely, the DOJ resorts to following FDA’s lead. So, if the FDA seeks permission from their friends at the DOJ, it’s quite possible they will get it.
- Once the FDA and DOJ start a court process, they will likely win unless it is determined that they removed the product unlawfully. At that point, we have to hope that the targeted homeopathic pharmacy has both the courage and the resources to defend itself against the government.
- But I need to highlight a third option, one that we have already witnessed. FDA doesn’t need to forcibly remove products from the market. Instead, FDA has enough resources and public relations muscle to avoid these legal loopholes all together. If FDA feels that there is an issue with a product labeled as homeopathic—even without conducting any formal investigation on an issue—all it needs to do is issue one or a series of press releases, destroying public confidence in the product labeled as homeopathic (and, let’s be honest, on homeopathy in general). The result is that—under public pressure—the pharmacy in question will be compelled to do a voluntary recall. No DOJ permission is needed to do this.The result is that the FDA is able to get a product off the marketplace, opportunistic law suits against the homeopathic pharmacies will increase, and the overall image of homeopathy is damaged in the public eye. Homeopathy in America suffers. If this scenario sounds familiar to you, that’s because this is precisely what happened in 2015 with teething tablets. So, it is a mistake to take comfort in the fact that the FDA needs permission from the DOJ before taking official action. It has shown us other ways of getting the job done. Continuing along this line of thinking will only get us more of the same problems we have already witnessed in 2015. That is why most manufacturers contacting us—speaking privately and off the record—see the proposed guidance as a danger to the homeopathic community.
So yes, the FDA technically needs permission from their friends at the DOJ to make their actions permanent, but they could have already removed products from the marketplace before they contact DOJ. And remember, FDA does not need any official authority to seek other types of ‘third options’ which will still result in injuring our access to homeopathy in America. Also, the FDA may not have the authority to officially declare a single ingredient used in many products as illegal, but they absolutely can use their administrative resources and powers to treat homeopathy as a “new drug” and get the same outcomes. That is what their “guidance” to FDA staff and industry makes abundantly clear on its face.
Consumers and Americans for Homeopathy Choice prefer a more proactive approach.
As President of Americans for Homeopathy Choice, I know how imperative it is to seek out legal counsel. Our principle attorney, Jim Turner, says that homeopathy is inherently safe and predates the new drug amendments, which did not include homeopathic medicines in the NDA process. Yes, that is right, when the NDA process was added to the law in 1962, it did not include homeopathy. Please keep in mind that while the AFHC attorney has decades of experience with FDA and Food & Drug law, in an abundance of caution, I have sought out the advice of over half a dozen other attorneys in addition to Turner. These were all Food & Drug attorneys in DC/New York area. They—like others[11]—unanimously agree that it is a mistake to rely on only one sentence in the FDA’s Draft Guidance and ignore the rest. Our strategy is legally sound.
FDA is massively over reaching, and this Draft Guidance is going to hurt American homeopathy in the long term if we do not respond swiftly and decisively. Obviously, the language itself is concerning, but the practical effect that this guidance will have on the manufacturers is that the number of frivolous lawsuits will increase, creating a toxic environment where manufacturers will have an even more difficult time sustaining their businesses.[11] It won’t make sense to keep producing homeopathic medicines in America. Manufacturers will limit their investment, and we can expect many to pull out, like others have done (Heel[12]).
The AFHC position is that we need to support our manufacturers, even if a very small number of them are unable to voice the same strategy. We totally understand that some manufacturers may be more interested in calming the waters and aligning with FDA’s views, all in an effort to minimize controversy. We get that. We also totally appreciate that the main priority of most any business, particularly a retail business, is to secure the sales of homeopathic remedies in the retail market and assure retailers that “all is well,” that there is no controversy with homeopathy.
But like any mother who cares for her children today while also preparing for their future, consumers are seizing this opportunity to prepare for the long-term future of homeopathy in America. We do encourage all manufacturers to expand their thinking so that the consumer perspective, which has been outlined here, is included. Finally, I once again want to remind you that the FDA’s job is to discipline these producers and make sure their manufacturing is up to standard.[13] It’s important for consumers to understand that although our perspective is different from some manufacturers, all manufacturers are still part of the homeopathy family and we appreciate and respect their work. We embrace them fully and without reservation.
Similarly, we are asking FDA to also expand their thinking to include the consumer. FDA’s Draft Guidance statement is titled, “Drug Products Labeled as Homeopathic; Guidance for FDA Staff and Industry” which also says, “Contains Nonbinding Recommendations.” They address this statement to “Staff and Industry,” not to consumers. FDA says:
You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the title page.[14]
They invite industry to step forward with “an alternative approach,” a better plan for homeopathic remedies. Again, we believe leaving the consumer out of the discussion is a mistake. We as consumers are stepping forward and discussing an alternative approach with the FDA just as the guidance suggests to industry. We appreciate the FDA’s willingness to continue working with us.
Americans for Homeopathy Choice seeks to unify the homeopathy community at all times. I hope this information helps! Thank you so much for raising awareness on this issue. Right now, the goal is to reach 100K comments by March 23rd. We are approaching the half way mark. Please help us raise these numbers:
https://homeopathychoice.org/fdacomment/
Signed,
Paola Brown, President
Americans for Homeopathy Choice
[1] The Homeopathic Pharmacopoeia Convention of the United States
[2] See Pg. 1, Lines 21-23 of the Draft Guidance on Homeopathy
[3] See Pg. 4, Lines 146-148 of the Draft Guidance on Homeopathy
[4] See pg. 1, lines 21-22 of the Draft Guidance on Homeopathy
[7] See pg 4, lines 146-148
[8] See pg. 1, lines 5-10 of the Draft Guidance on Homeopathy
[9] See pg. 2, lines 78-81 of the Draft Guidance on Homeopathy
[10] See pg. 4, lines 146-148 of the Draft Guidance on Homeopathy
[11] Todd Harrison, Claudia A. Lewis, Todd Halpern, and Jose Rey Antonio Lesaca of Venable LLP. “By explicitly reaffirming that homeopathic drug products do not have any special status under federal law, the agency is essentially saying that all homeopathic drug products that are not marketed under an approved new drug application (i.e., all homeopathic drug products) are unlawful. This could embolden the plaintiff bar to initiate lawsuits against all companies selling homeopathic products – even those that survive the increased scrutiny of this new FDA enforcement policy.” https://www.venable.com/insights/publications/2019/10/fda-and-homeopathy-the-end-of-diluted-enforcement
[12] Heel Inc. “In the USA and Canada, manufacturers of OTC homeopathic medicinal products have been confronted with accusations through class action lawsuits. Heel Inc., the Heel Group’s U.S.-based subsidiary, was also faced with two such attempts recently. Both cases have been settled without conceding the allegations. The financial burden on Heel Inc., however, was substantial. In a subsequent risk-benefit analysis of its global activities, the Heel Group decided to focus on strengthening its excellent position in South America, Central Europe and Eastern Europe and to withdraw from business activities in the USA and Canada for the time being.” https://web.archive.org/web/20150413100059/http:/www.heel.com.co/heel-com-news-May2014.html
[13] http://www.txoptions.com/announcement-lab-pharmacy-pellets-luyties-2019
[14] See pg. 1, lines 5-10 of the Draft Guidance on Homeopathy