Additional Insight on our Citizen Petition

Additional Insight on our Citizen Petition

Our FDA petition seeks to protect homeopathy including non-HPUS remedies while we work toward a legislative solution.

The petition is a first line of defense that forces FDA to slow down and respond.

BY PAOLA BROWN, PRESIDENT, AMERICANS FOR HOMEOPATHY CHOICE 

August 30, 2018

We at Americans for Homeopathy Choice are a consumer group made up mostly of mothers who use homeopathy as the first line of health promotion for our families. This July we filed a Citizen Petition with the FDA as a first step in protecting consumer access to homeopathy including non-HPUS remedies.  In our ongoing effort to be transparent with the homeopathy community, we’d like to provide additional insight into our petition.

First, we support and are working towards developing broader legislation to advance homeopathy.  This is a vital part of an overall strategy to protect homeopathy, and we invite all to collaborate with us in this effort. We also believe that filing a petition with the FDA strengthens this legislative strategy. In our view, developing a legislative strategy alone without a petition in place leaves homeopathy vulnerable.

In offering an alternative to the FDA’s Draft Guidance on Drug Products Labeled as Homeopathic (issued December 2017), our petition seeks to maintain the status quo in which homeopathy is governed by the HPUS and quality and purity in the manufacture of homeopathic remedies is appropriately safeguarded through the FDA’s Compliance Policy Guide (CPG) 400.400.

The petition directly addresses the FDA’s Draft Guidance which proposes to eliminate CPG 400.400. The new guidance would establish a precedent that all remedies in the HPUS would technically be illegal unless they undergo the same approval process as pharmaceuticals.  One estimate for this approval process puts the cost for a single remedy at more than $3 million. This is an immediate danger to the availability of current homeopathic remedies within the HPUS.

Given the stakes, to wait for a legislative solution could be fatal to the future of homeopathy in America. In any battle, you must first protect the home front, and that’s exactly what our Citizen Petition accomplishes. It forces the FDA to respond to all issues we list before it can legally begin to enforce any portion of the agency’s Draft Guidance.

The FDA assured us in one of our meetings that it would be prudent in selecting which remedies it chooses to target, promising that the vast majority of homeopathic remedies will remain available. We have a hard time taking the FDA at its word when the agency is at the same time proposing to violate the law by shifting already approved homeopathic remedies listed in the HPUS into the unapproved category. Leaving this FDA threat unaddressed without a counter-proposal would place homeopathy in a defenseless position.

In addition, the FDA currently has three anti-homeopathy petitions on its docket.  Without our petition, all FDA’s regulatory energy would be directed towards petitions that are clearly trying to limit homeopathy. Our petition has shifted the playing field, requiring the FDA to put energy towards policies that support homeopathy.

Our petition is the product of collaboration with practitioners, homeopathy-related organizations, manufacturers, consumers and others. We also used valuable insights gleaned from in-person meetings with the FDA.

Here’s what the petition asks for:

We request the CPG 400.400 be converted into a regulation. This would accomplish two priorities:  First, we would remove the FDA’s discretionary relationship with the CPG 400.400 so that it would be unable to  modify or replace it, as currently proposed by the FDA’s Draft Guidance. Second, forcing the FDA to adhere to guidelines in the CPG 400.400 as a regulation sends a bold message: We are limiting the FDA’s authority and requiring compliance with the Food, Drug and Cosmetic Act.

This is intentional. Bold requests like this get the attention of Congress. In order to advance our larger legislative agenda, we must have congressional attention. We object to an intrusive FDA that places overburdensome regulations on industry and commerce. However, we recognize that the CPG 400.400 has created a healthy and fair framework for FDA enforcement of the existing manufacturing and marketing guidelines for homeopathy over the past 30 years; in many ways it also places important restrictions on what the FDA can do.

We share the concern that there are thousands of important homeopathic remedies that are currently being used, but which are not actually listed in the HPUS.  First, know that the CPG 400.400 makes provision for these non-HPUS remedies saying that non-HPUS homeopathic medicines can be manufactured if documentation is provided.

Second, while this provision is useful, we are fully aware of the critical need to include all these homeopathic medicines within the HPUS and will direct our broader legislative strategy to accomplish this objective.  Again, the FDA’s proposed Draft Guidance will define all homeopathic medicines as technically illegal.

Failing to file the petition would have left the homeopathy community open to actions that could devastate the homeopathy industry long before a legislative solution is achieved. We plan to continue working to create strong legislation to protect homeopathy while also pursuing our petition with the FDA.

If you have not read our petition yet, please read it.  We welcome all comments from individuals or groups that are constructive.  The FDA has opened a comment docket for our petition and we encourage you to file your comments.  Like the FDA, we read each comment and use that feedback to inform our overall strategy.

As mothers, we aren’t afraid to act boldly when necessary, putting words and promises into action. And, we aren’t afraid of taking on the FDA.  Since we formed in January of this year, we have:

  • -personally visited over 100 congressional offices.
  • -had in-person appointments with over a dozen congressional representatives.
  • -been the only homeopathy organization in the United States to hold in-person meetings with the FDA regarding the Draft Guidance on homeopathy, including continued dialogue.
  • -submitted over 62 pages of legal arguments and documents to the FDA.
  • -produced dozens of videos, keeping our members and followers informed with frequent updates.
  • -continuously managed over 100 volunteer moms who are taking action to protect homeopathy.

We seek at all times to keep the homeopathy community united. We believe that we will only succeed as a community if we stick together. The key to our unity is consultation and collaboration that leads to consensus and then action. But, successful collaboration can only be based on accurate and complete information which is why we are circulating this piece to the homeopathy community.

We invite you to collaborate with us and to communicate your ideas and concerns. We look forward to working with all of you in the homeopathy community to reach a solution that will protect homeopathy for the long term.

  1. Compliance Policy Guide, sec. 400.400 under “LABELING” reads: “Documentation must be provided to support that those products or ingredients which are not recognized officially in the HPUS, an addendum to it, or its supplements are generally recognized as homeopathic products or ingredients.” https://www.fda.gov/iceci/compliancemanuals/compliancepolicyguidancemanual/ucm074360.htm
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