The FDA is at it AGAIN!

Lisa K
Lisa K Posts: 1,933 ✭✭✭✭✭

I received an email from Ana Maria Vasquez with the below -

I never thought I'd live in such a strange time where the natural & holistic methods I use to keep myself and my animals healthy could be taken away. Concern for the ability to access homeopathic remedies easily and freely continues. We've seen this in other countries and the limitations that have been imposed are staggering, and heavily restrict our abilities to freely choose therapies that are best for us and our animals. The FDA is planning to withdraw homeopathic medicines from the market place (and prevent ordering from abroad) making homeopathy permanently unavailable.  

After the recent call for comments to the FDA, they released a guidance. This guidance allows the FDA to remove access to homeopathic medicines without any form of evidence to support claims of risk. This conduct is specifically allowed by this guidance. With the FDA making its proposed new guidance final this month, we now must face the prospect that some of our cherished medicines could be gone in the new year as the FDA decides to eliminate remedies that it considers “too risky.” We don’t know what the FDA is talking about because properly manufactured and labeled homeopathic medicines have never killed or seriously injured anyone in over 200 years of use!

Therefore, it is now recommended that people turn to Congress and ask them to step in with legislation that protects homeopathic medicines from the FDA's recently finalized guidance. The Americans for Homeopathy Choice have put together a wonderful page to submit your concern. You must have a US address to submit. First you enter your street address and zip and then you'll be taken to the page that automatically pulls up your legislators. The form asks for your full information, as the legislators are not required to count your comments if your information is not complete or valid. The Americans for Homeopathy Choice have crafted a well written letter on our behalf and you can simply click submit. The site is a little slow, so be patient when you click the buttons.

Please share with others!

Tell Congress: FDA's Final (Mis)Guidance is Wrong for Homeopathic Medicines (homeopathychoice.org)

They are asking for this by January 15t

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Comments

  • JennyT Upstate South Carolina
    JennyT Upstate South Carolina Posts: 1,273 ✭✭✭✭✭
    edited December 2022

    I believe it went through for me, @Lisa K. It was easy with the premade letter already there. 👍😁

  • Michelle D
    Michelle D Posts: 1,465 ✭✭✭✭✭

    That was quite simple to send.

  • Lisa K
    Lisa K Posts: 1,933 ✭✭✭✭✭

    @JennyT Upstate South Carolina and @Michelle D I found it very easy as well and actually received a response from one of the Representatives, granted it was an automatic response but at least I know it went through.

  • shllnzl
    shllnzl Posts: 1,820 ✭✭✭✭✭

    I sent mine.

  • Michelle D
    Michelle D Posts: 1,465 ✭✭✭✭✭

    @Lisa K I received a similar reply.

  • SuperC
    SuperC Posts: 952 ✭✭✭✭

    @Lisa K I sent in mine :) It was simple. Thank you for providing us the link.

  • Mary Pat
    Mary Pat Posts: 1 ✭✭✭

    Sad! I sent emails via the link above. I also decided to create a folder with all documents to government. I sent written letters to my representatives. I get the feeling that a letter might mean more than and email. Can't hurt. I also posted on social. I'm glad I read the article. Thanks

  • Torey
    Torey Posts: 5,679 admin

    Welcome to TGN's forum @Mary Pat.

    When you have time, check out the introductions section where you can let us know what part of the world you are from (and maybe link with others in your area).

  • Lisa K
    Lisa K Posts: 1,933 ✭✭✭✭✭

    You are very welcome @SuperC and @Mary Pat.

  • LaurieLovesLearning
    LaurieLovesLearning Posts: 7,573 admin

    @Mary Pat Welcome!

  • vickeym
    vickeym Posts: 2,134 ✭✭✭✭✭

    I also sent in mine. Doubt they will listen, they usually do not, but worth trying to save out medicines and our right to choose.

  • Lisa K
    Lisa K Posts: 1,933 ✭✭✭✭✭

    @vickeym I so agree!

  • Lisa K
    Lisa K Posts: 1,933 ✭✭✭✭✭

    Here is an email I received from California Senator Alex Padilla -

    "Thank you for writing to share your thoughts on homeopathic medicines. I appreciate hearing from you.  

    The Food and Drug Administration (FDA) is the federal agency responsible for protecting public health by regulating food, dietary supplements, cosmetics, prescription or over-the-counter drugs, and other consumer items. The agency plays a vital role in ensuring that Americans can trust that our food is safe, medicines are effective, and the products we use are free from contamination. 

    Under the Federal Food, Drug, and Cosmetic Act (Public Law 75-717), homeopathic products are subject to the same requirements related to approval, adulteration, and misbranding as other drug products. However, there are currently no homeopathic products approved by the FDA. It is recommended that consumers talk to their doctor or health care professional about safe and effective treatments for a condition or illness.

    Please know that I will keep your concerns in mind should legislation regarding the FDA’s regulation of homeopathic medicines come before the Senate for consideration.

    Once again, thank you for writing. Should you have any other questions or comments, please call my Washington, D.C. office at (202) 224-3553 or visit my website at padilla.senate.gov. You can also follow me on Facebook and Twitter, and you can sign up for my email newsletter at padilla.senate.gov/newsletter.

     

    Sincerely,


    Alex Padilla

    United States Senator"

  • gardneto76
    gardneto76 Posts: 528 ✭✭✭✭

    They are still sending the letters out, which makes me happy as I thought I was to late. I sent them to my representatives, whom I have emailed before, and typically get a very generic response or no response at all until after the issues I was writing about had already been voted on.

  • Lisa K
    Lisa K Posts: 1,933 ✭✭✭✭✭

    @gardneto76 I have to admit I was surprised to one of them actually responded, granted it was more to pacify then actually take action.

  • Cornelius
    Cornelius Posts: 872 ✭✭✭✭

    This is terrifying. At least having some seeds/ plants that are medicinal can help prepare for this.

  • Lisa K
    Lisa K Posts: 1,933 ✭✭✭✭✭

    I agree @Cornelius and I am planning on saving my seeds in case seed companies can no longer sell any.

  • vickeym
    vickeym Posts: 2,134 ✭✭✭✭✭

    I am also trying to buy as many homeopathic remedies as I can afford to (so not many) and stocking up on the ones I find I use the most. Since they don't go bad I hope to have as much on hand as possible and growing lots of herbal meds as well.

  • Karon
    Karon Posts: 17 ✭✭✭

    Did anyone else get this in your reply?

    “The 117th Congress adjourned on January 3, 2023, and at that time all pending legislation expired.”

    with the rest of the canned response being a pat on the back of Congress.

    I’m in VA and I didn’t read anything in this response saying this is being kept on file for when it is resubmitted. Any advice for those in the know of how this is handled? Should I resubmit immediately or wait till a new bill is introduced and new number assigned?

  • Lisa K
    Lisa K Posts: 1,933 ✭✭✭✭✭

    @Karon I have asked Ana Marie Vasquez who start this campaign and I will post her response once it get it.

    Thanks for the heads up!

  • Cornelius
    Cornelius Posts: 872 ✭✭✭✭

    @Lisa K Also having some seeds put away can also help. One possible way to do that is to put some in a glass container with a desiccant at the bottom (like rice) and store it in the freezer. This can dramatically increase seed viability over time. You could put some in a little envelope and label them.

  • gardneto76
    gardneto76 Posts: 528 ✭✭✭✭

    @Karon I received responses back from all of my Representatives I had contacted and no one mentioned that it had expired. Some of them sent me a very generic thanks for your feedback response then a few days later sent a more personalized response. I was very please that one responded in detail as to what they had already done to support natural medicines and how they would continue to fight for continued use and support of more natural options in place of pharmaceuticals.

    I had not thought of ensuring to save more seeds for these medicinal plants. I certainly will be doing that now.

  • Lisa K
    Lisa K Posts: 1,933 ✭✭✭✭✭

    @Karon Here is Ana's response.

    "Thank you for reaching out and sharing that. It has been so fascinating hearing the myriad of responses, including none, coming from these representatives. My understanding is there is no one agreed upon strategy for moving forward. My suggestion would be to resubmit and include the wording around keeping your comment/response on file for future, as well as watching for new legislation. Hopefully we will hear some updates soon. However, the wheels of justice move very slowly! Thank you for reaching out and sharing that. It has been so fascinating hearing the myriad of responses, including none, coming from these representatives. My understanding is there is no one agreed upon strategy for moving forward. My suggestion would be to resubmit and include the wording around keeping your comment/response on file for future, as well as watching for new legislation. Hopefully we will hear some updates soon. However, the wheels of justice move very slowly!"

  • dipat2005
    dipat2005 Posts: 1,289 ✭✭✭✭✭

    I also sent 3 letters. I got 2 replies back-1 said he was to busy to answer and the other was a canned response. I am stocked up on seeds and I am trying to get some of the supplements that I use. The health food store close to me has Senior discount day in the middle of the week now. Since I car share that is a problem. Oh well, I managed to get there last Wednesday and it helped.

  • Lisa K
    Lisa K Posts: 1,933 ✭✭✭✭✭

    @dipat2005 I have been doing the same thing, I am a little worried how my local Sprouts is going to change if this goes through.

  • Torey
    Torey Posts: 5,679 admin

    I don't think this is going to affect herbs or supplements or anything else that a health food store/natural pharmacy would sell.

    At this point they are only going after homeopathic remedies, as they say there is no empirical evidence that they work. Herbal medicines quite often have lots of studies to prove their efficacy and there are many that have been through the approval process. Same for supplements like digestive enzymes, amino acids, antioxidants, EFAs, etc.

    Not to say that they won't go down that road at some point in the future and try to claw things back even further. I believe we should be using as much as we are capable of growing ourselves or sourcing locally as I think it makes better medicine anyway. Seeds are always good to keep on hand.

  • Lisa K
    Lisa K Posts: 1,933 ✭✭✭✭✭

    @torey I hope they have the same logic as you noted above!

  • dipat2005
    dipat2005 Posts: 1,289 ✭✭✭✭✭

    @torey I really hope you are right!. It is a health food store. They have branched out a bit with fresh fruits and vegetables. At times they have had booths and served food like salads! A salad bar!

    I have bought apples and they were yummy!

  • Lisa K
    Lisa K Posts: 1,933 ✭✭✭✭✭

    Here is the response I just received from Mike Levin, CA Congressman, very close to what Senator Alex Padilla said.

    "Thank you for contacting me regarding homeopathic drugs. I appreciate the benefit of your views and welcome the opportunity to respond.

               In 1988, the U.S. Food and Drug Administration (FDA) issued Compliance Policy Guide (CPG) 400.400, entitled “Conditions Under Which Homeopathic Drugs May be Marketed,” which described the agency’s enforcement policy.1 Previously, homeopathic drugs did not require FDA approval prior to going to market.

               In December 2022, the FDA released final guidance regulating homeopathic drugs, subjecting them to the same approval as conventional medicines. This decision was made after discovering contamination and toxic substances in certain homeopathic drugs, and the FDA had allowed for a period of public comment after releasing its draft guidance.2

           I am committed to ensuring that Americans have access to safe and affordable medicines by ensuring proper and thorough oversight. Please know that I will keep your thoughts in mind as Congress considers future homeopathy legislation.

           Again, thank you for contacting me. Please do not hesitate to reach out to me on this or any other issue of importance to you in the future. You can reach my Washington, D.C., office at (202) 225-3906 and you can sign up for my newsletter on my website at http://mikelevin.house.gov."

  • Lisa K
    Lisa K Posts: 1,933 ✭✭✭✭✭

    Here is the response from Senator Dianne Feinstein -

    "Dear Lisa:

      Thank you for contacting me regarding homeopathic drug products. I appreciate the time you took to write and welcome the opportunity to respond.

      I understand you have concerns about the Food and Drug Administration’s (FDA) final guidance on homeopathic drug products. As you may know, until now products labeled as homeopathic that are marketed in the United States have not been reviewed by the FDA for safety and effectiveness to diagnose, treat, cure, prevent, or mitigate any diseases or conditions. In October 2019, the FDA released draft guidance that outlined how the agency would regulate homeopathic products to protect American consumers.

      In December 2022, the agency issued final guidance that describes how it will prioritize regulatory and enforcement actions for homeopathic products that pose a significant risk to public health. The agency has warned that products that have not been evaluated for safety and effectiveness may harm consumers who use them to treat serious diseases or conditions. The FDA recommends that consumers talk to their health care professionals about safe and effective treatments. For more information, you may visit the FDA website here: https://sen.gov/ZZWL.

      Please know I have taken careful note of your thoughts and will be sure to keep them in mind should related legislation come before the full Senate for a vote.

      Once again, thank you for writing.  Should you have any other questions or comments, please call my Washington, D.C., office at (202) 224-3841 or visit my website at feinstein.senate.gov. You can also follow me online at YouTube, Facebook, and Twitter. Best regards.

    Sincerely yours,

     Dianne Feinstein

      United States Senator"