Looking to support our message to legislators? Click here to send your message.

Want to support the cause? Join the Bear Pack or make a one-time or recurring donation!

Want to support the cause? Join the Bear Pack or make a donation!

The FDA is moving forward! Join the HAT Team Tomorrow (Dec 6th)!

The Homeopathy Choice Insider

Hello! Welcome to the 20th edition of the Homeopathy Choice Insider.  We’re so glad you’ve joined us!  Every Monday, we bring you a closer look at what goes on behind the scenes at Americans for Homeopathy Choice as we diligently work to protect your access to homeopathic medicines. 

If you’d like to read the summary of today’s report, scroll down to the end of this post!

Play Video

Outline:

  • The White House cancelled our meeting! They have essentially given a green light for the FDA to move forward with finalizing its draft guidance document, and we can expect that to happen very soon.
  • This guidance document is a major threat to homeopathy because it ignores law made by Congress and treats homeopathic medicines as new drugs which are being marketed illegally. This means the FDA can remove any and all homeopathic medicines from the market, and there is no pathway in their policy for homeopathic medicines to be “legally” introduced into the market.
  •  AFHC’s goal is to introduce a bill to Congress that would protect homeopathic medicines for generations to come, but we really need your help! Join the HAT team now and help us influence Congress!
  • HAT team enrollment will be open again from December 6th-13th!
  • Have you sent a comment to the FDA yet? Now’s your final chance! Every public comment against the FDA’s draft guidance makes a difference in the eyes of Congress.
  •  Lastly, please consider donating to AFHC this holiday season – every little bit counts and goes a long way towards reaching our goal of protecting your access to homeopathic medicines for good.

Our job is not to change the world;

our job is to steward the gifts we’ve been given.

Summary of Today’s Episode:

Welcome back to Homeopathy Choice Insider, where we give you up-to-date information about the state of homeopathy in America and tips on how you can help promote and protect homeopathy for ourselves and future generations.  I’m Paola Brown, president of Americans for Homeopathy Choice.  Today I will be providing more urgent updates about the FDA’s draft guidance on homeopathic medicines, why we are so concerned about it, what our ultimate goal is, and how you can help.

 

Right before Thanksgiving, we found out that the FDA is trying to move forward with finalizing its draft guidance on the regulation of homeopathic medicines by sending it to a special office at the White House called the Office of Information and Regulatory Affairs (OIRA) for review. This new guidance document has been stalled in draft form for the last five years, in large part due to the hard work of our Homeopathy Action Team (HAT) volunteers.

 

Why is this draft guidance document so concerning? In 2017, the FDA released a policy document–currently in draft form–that categorizes all homeopathic medicines as “unapproved new drugs” and therefore illegally marketed. This has allowed the FDA to remove homeopathic medicines, one at a time, for any reason or no reason at all. Which homeopathic medicine are you willing to lose? We have already lost access to some medicines and the FDA has specifically mentioned Belladonna, Nux vomica, and others as concerns. To read a more detailed explanation of the FDA draft guidance and why it’s a threat, click here: 

THE THREAT TO HOMEOPATHY

 

AFHC’s Strategy & Goal

When we found out that the FDA sent their draft guidance document to the White House for review, we immediately scheduled a meeting with the OIRA office. Our plan was to ask them to pose questions to the FDA about their guidance policy, particularly about the legality of it.

 

However, on the morning that our meeting was to take place, OIRA cancelled the meeting and said they had already reviewed the guidance (in only seven business days which is pretty unprecedented) and had already sent it back to the FDA with no comments or feedback, saying it was good to go. At this stage, we need to assume that the draft guidance is now quickly on its way to being finalized.

 

It’s important to keep in mind that the FDA has already been acting on this guidance document even before it was finalized. We have a lot of evidence and examples where the FDA has blocked medicines from entering the United States and taken various disciplinary actions, and they’ve cited the guidance document as their reasoning for doing so.

 

Obviously, this has us pretty concerned, and we are especially concerned about the legality of this guidance document. Congress put into the law that homeopathic medicines are legally a drug and they are listed in the Food, Drug and Cosmetic Act. However, the FDA’s new guidance document seems to ignore this fact and is treating homeopathic medicines as new drugs which are all being illegally marketed.

 

On top of that, we’re also concerned that the guidance document only outlines a pathway for removing homeopathic medicines from the market – it provides no pathway for how they can enter the market and be in compliance with the new guidance.

 

So, what can we do about this threat? The good news is, a LOT!  But we can only do it with YOUR help. Our ultimate goal here at AFHC is to introduce a bill to Congress that would protect homeopathic medicines for generations to come. But we need to build a powerful foundation as we work towards this goal.

 

Three Things You Can Do To Help Us Reach Our Goal:

 1) Send messages to the FDA through our website

Thanks so much to all of you who have already sent messages to the White House and FDA – they received thousands of messages from our community over Thanksgiving week. Sending these messages is a critical part of our strategy because Congress really loves numbers – they love to see that there’s a lot of people sending in comments to the FDA against the guidance. This really helps influence Congress to take action. So if you still haven’t sent in a comment, please do so ASAP by clicking the link below – it only takes a few seconds!

LAST CHANCE TO TELL FDA!

 

2) Become a member of our Homeopathy Action Team (HAT)

HAT volunteers build personal relationships with their state representatives and staffers, and they are the most powerful and influential tool we have in the fight to save homeopathy. They are a really amazing group of dedicated individuals who are spending their time, energy, and effort getting their training and building relationships with members of Congress. We need more people like this who are willing to step up and protect our access to homeopathic medicines. Did you know that in AFHC’s email list right now, we have at least one person in every congressional district in the United States, but we only have enough HAT team members to represent about half of these districts? We really need to grow this number! Which is why, for the first time in AFHC history, we are going to reopen HAT team enrollment!  We usually only open enrollment to the HAT team once a year, and we recently closed enrollment back in September. In fact, we had a whole campaign to get people enrolled, and we actually had a lot of people sign up, but we are hoping for a lot more! To learn more about what HAT team members do, please take a few minutes to watch our HAT Webinar here:

WATCH THE HAT WEBINAR

 

HAT team enrollment will be open again from December 6th-13th!

Be sure to stay tuned for more updates!

 

3) Donate to AFHC

Last but certainly not least, we need your generous donations in order to continue doing the critical work we are doing. We have many amazing volunteers who donate their time and energy on a daily and weekly basis, and we hope you’ll consider volunteering! But we also need funding for our day to day operations, so please consider donating to our cause this holiday season by clicking the link below:

HomeopathyChoice.org/Donate

 

Hugs and Homeopathy,

Paola Brown

Sharing is caring!

Get the latest advocacy updates with the AFHC text group!

Join the wait list for the

Homeopathy
Action Team