The FDA is poised to start banning homeopathic remedies. In this interview Paola Brown, President of Americans for Homeopathy Choice, talks about their recently released Citizen’s Petition. It’s an aggressive tactic to block the FDA’s Draft Guidance on Homeopathy. Be sure to support it by commenting to the FDA docket and contacting your Congressional Representatives.
Paola Brown is the President of Americans for Homeopathy Choice (HomeopathyChoice.org). She has been a college professor of English for 13 years, is a passionate activist, advocating for homeopathy, and sits on the board of the Texas Society of Homeopathy.
AS: Could you tell us something about yourself and how you got interested in homeopathy?
PB: I am originally from Brazil where homeopathy is generally more accepted. So, when we were preparing to immigrate to the United States (my dad was attending University), my mother knew we would not afford regular health insurance. So, she picked up a homeopathy kit and book, and we relied on homeopathic medicine for most of my childhood. But there’s a sad twist to this story: when my father graduated from school, and got a ‘real job’ which provided health insurance, my mother basically said, “Now we can FINALLY have the real medicine and professional care!” and she threw out the homeopathy kit! My parents worked so hard to achieve the American dream, and for my mom, traditional medical care was a big part of that dream.
I had pretty robust health until about the time that I got married and developed reoccurring UTI’s for which I took many, many rounds of antibiotics. By then, the ways of homeopathy were forgotten in my family. Then I developed a more chronic illness: Interstitial Cystitis (among others). When my doctors offered me horrible options like “A pill that might make all your hair fall out,” or “We can cut the nerve to your bladder and you learn to pee on a schedule,” or “You can take opioid pain killers the rest of your life, but you’d have to join a support group for the forthcoming addition,” I thought that there had to be a better way. I actually searched natural medicine for a long time before I found homeopathy. I remember when I took my first homeopathic remedy as an adult; it was Cantharis to help with a UTI, and I had this incredible sensory flashback to my childhood, remembering those little sugar pellets I took as a child. It launched me back into the world of homeopathy. I researched online and found so much information, and I’ve never looked back. Today, my entire family appreciate homeopathy, especially my mother and father who are learning that there was more to this type of medicine than they had originally given credit for. My family and I are really close, but homeopathy has offered yet another opportunity for us to grow closer together. Watching me get cured with homeopathy and witnessing the amazing health me and my kids and my parents have experienced has been transformative for my family. I have two brothers who appreciate homeopathy as well and take remedies when I tell them to, but they’re a little slower to the punch, as brothers often are. Ha!
AS: How did your interest in homeopathy get directed toward founding Americans for Homeopathy Choice?
P.B.In our organization, Americans for Homeopathy Choice, we keep referring to ourselves as “Mama Bears” (and we’re made up of “other bears” too!). A “Mama Bear” is a nice way of saying that we would be ready to rip someone to shreds if they hurt our bear cubs. And when the FDA came out with a draft guidance on Homeopathy–a form of medicine that we love dearly and rely upon–we were all pretty angry about it. But, thankfully, I’ve also learned how to smooth my ruffled feathers and get to work.
By the time the Draft Guidance on Homeopathy came out December 2017, I had already dabbled in homeopathy awareness. I used to host Homeopath Joette Calabrese’s podcast, interviewing her and other moms who love homeopathy, and I had also led several intro-to-homeopathy classes, averaging about 100 students in each class. I love teaching and I love homeopathy. So when the FDA showed up with their Draft Guidance, I already had a network of amazing mothers (and others) who were concerned. The bear claws really came out. As their teacher who taught them homeopathy, several students turned to me asking, “What should we do, Paola?” One thing really led to another and not 8 weeks later I was on Capitol Hill with our Media Director Kaylee Braz and our VP Mindy McLane. We visited about 100 offices and met with over a dozen offices. It was a good running start.
A.S. That’s some serious pavement poundingfor Capitol Hill. So all this was necessary because of the FDA’s proposed Risk-based Enforcement Approach. Can you tell us how this threatens access to homeopathic remedies?
P.B. Oh boy. Where do I start? I’m a cup half-full kinda gal, so I like to see the positive side of everything. It’s definitely not good that the FDA wrote the 2017 Draft Guidance on Homeopathy. It’s actually really really bad for homeopathy: it makes all homeopathic remedies technically illegal until they go through a ‘new drug’ application, which would cost upwards of 3 million dollars per remedy, and quite likely much much more than that. The FDA says that they won’t actually conduct any enforcement actions on all the categories, but nothing in their proposed Draft Guidance actually limits them from doing this to all of homeopathy. Call me crazy, but I don’t have that kind of blind trust in the FDA.
But on the bright side, the proposed Draft Guidance on homeopathy is so poorly written, so systemically flawed, that it’s been a joy to break apart, exposing all of its weak parts. At this point, we have written over 62 pages of analysis on the Draft Guidance, all which have been submitted to the FDA docket, either in the Draft Guidance docket or under our newly released Citizen’s Petition. On our Facebook page, we also have dozens of hours worth of live video broadcasts that dissect how flawed the FDA’s reasoning is.
I think one of the many fundamental issues we take with the Draft Guidance is that it doesn’t actually guide the specific enforcement of homeopathic medicine. It’s a blanket statement on how they’re going to begin choosing which remedies to enforce, but no actual compliance policy guidelines are offered! In one of our meetings with the FDA, I asked them “Why are you rescinding the very comprehensive Compliance Policy Guide (CPG) 400.400 and replacing it with this weaker one? There have been virtually no issues with homeopathy, no deaths…so what’s the problem??”
In response the FDA cited “several” issues relating to homeopathy and sent us to their FDA.gov website to identify these issues. We found 4. One was regarding the teething tablets, which we have very legal concerns over (I told the FDA that varying levels of Belladonna in terms of one-thousandth of a percent is not a toxicity concern. I asked them whether or not they measured all pharmaceutical drugs down to their nano-particle? They, of course, do not. So I asked that the FDA treat homeopathy, as far as toxicity is concerned, in the same way, that they treat all the pharmaceutical drugs they review, instead of using this biased approach to homeopathy). The other 3 issues had more to do with improper labeling of products that are not actually homeopathic than with homeopathy itself. Now here is the kicker–all 4 of the issues cited on the FDA’s website are enforceable under the current CPG 400.400, and the proposed Draft Guidance on Homeopathy does not address those 4 concerns! So it begs the original question: Why is the FDA replacing a comprehensive guidance document with one that is less comprehensive and will actually position homeopathic manufacturers to possibly make mistakes!?
The proposed Draft Guidance is littered with weak ideas and arguments in every single page. Another example is the categories of homeopathic medicines that they are going to approach with a risk-based assessment. It says that “products that contain or purport to contain an infectious agent with the potential to be pathogenic, a controlled substance…multiple ingredients that when used in combination raise safety concerns…or ingredients that pose potential toxic effects, etc.”
Our response to this is very simple. We know of no product properlylabeled Homeopathic which contains an agent that bears any of these risks. Any product that contains any such agents or falls into such categories that are labeled homeopathic is improperly labeled and the FDA has ample authority, set out in CPG 400.400, to regulate such a product. This is a key reason why we urge for the agency to withdraw this proposed Draft Guidance and reaffirm CPG 400.400.
But this entire discussion indicates how the FDA has used the Draft Guidance to put homeopathy on the defense. And (even though our defense has been strong as a whole–spanning across all our awesome major organizations like NASH, AIH, NCH, etc), I knew that I wanted to somehow position ourselves into the offensive position, with the FDA in the defensive position.
And by golly, Alan, we’ve done it. We’re now running an offensive play at the FDA via our newly released Citizen’s Petition.
AS: What kind of response did you get from the people you spoke with at the FDA? Could there be people above them pulling the strings? Not long ago the FDA cooked up a phony story about homeopathic teething remedies killing babies. That was the lead-in to their “Risk Based Approach”
PB:I think almost everyone at the FDA has been incredibly cordial and willing to listen. I get the feeling that organizations like the FDA will often hire ‘nice and generous’ people to be the face of their organization, people who may genuinely care about and want the best for the public. But unfortunately, they’re not also vested with the powers to make a difference. I would imagine that a person has to be working a long time for an agency –to the point that they are fully worn out by the bureaucracy–before they can actually be in any kind of position that creates change and affects influence. It’s absolutely clear that at some level, the FDA’s actions are undermining homeopathy. Comparing Nux vomica to rat poison in one of their press releases about the teething tablets is totally indicative that somewhere in the FDA there is bias against homeopathy. It’s either that or the FDA has put no effort into trying to understand the uniqueness of homeopathic medicine before releasing a draft guidance which ultimately begins to injure this wonderful medicine.
The only way to leverage the FDA is by crafting a very clever plan, one that legally forces the FDA to react to us for once, and not the other way around. That’s what we have done at Americans for Homeopathy Choice. We are beginning to develop an overall legislative strategy around homeopathy, while also maneuvering to protect the problem of the draft guidance that is facing us here and now. The here and now is being addressed by a Citizen’s Petition. Let me explain what that is:
Per the Administrative Procedures Act, we have the right to petition any Federal Agency to consider a request. Of course, agencies have ways of maneuvering and getting out of a request, but with that in mind, if the FDA doesn’t comply with our request, we have asked for a hearing with them where we could really deal with the issue. Outcomes from meetings like the 2015 meeting homeopathy had with the FDA can be ignored. This is not so easily done in a formal hearing. Our petition asserts our long-standing position that the CPG 400.400, a fair compliance policy guide that has been in place for decades, is the best way to create homeopathic remedies that are safe and compliant with the Food Drug and Cosmetic Act. We are asking that the FDA to:
- Form an FDA advisory committee on homeopathy.
- Withdraw the Draft Guidance on Drug Products Labeled as Homeopathic dated December 2017 which threatens to severely restrict the availability of homeopathic remedies.
- Convert Compliance Policy Guidance 400.400 (with minor changes) into a regulation. This is the policy that has guided the agency since 1988 and resulted in high standards of quality assurance in the manufacture of homeopathic remedies even as choice and availability continues to grow.
We really need everyone to support our petition. You can do this by visiting our website at: https://homeopathychoice.org/petition/