Contact FDA

Guidelines for writing a letter to the FDA:

We would love to have provided you with only a copy-and-paste letter to send the FDA, however our attorneys and specialists in the field are telling us that form letters alone are not helpful when it comes to the FDA. Rather, the quality of unique, individualized letters submitted are more important than simply a large quantity of ‘copy-and-paste’ form letters submitted (although numbers are also important). Therefore, if you can write an individualized letter please follow the Letter Writing Guide below. But if writing your own letter is not an option, you may copy and paste the Sample Letter that is at the end of these guidelines.

Letter Writing Guide Guidelines for the letter we hope you will write.
  • Keep the tone respectful.
    There will be an FDA staffer who has to read every single one of these letters. Imagine that she is a sweet little Grandma, mom, or daughter working tirelessly, sifting through thousands of these homeopathy/FDA letters. You want her to have positive feelings and to give a positive report to her boss about what she read in these letters. Keep the tone positive and respectful.
  • Address the letter to the right people.
    Dear Dr. Gottlieb, Dockets Management Staff, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, and other pertinent FDA Staff.
  • Be sure to list the docket numbers.
    • Agency Docket No. FDA-2017-D-6580
    • Document No. 2017- 27157
  • Clearly state your concern.
    You are concerned that the FDA is withdrawing the Compliance Policy Guide (CPG) 400.00, a document which has fairly guided the manufacturing and marketing of homeopathy for 30 years, and is replacing it with a less comprehensive guidance that no longer monitors proper production. You are also concerned that the draft guidance could result in unnecessarily restricting access to homeopathic remedies.
  • Explain what the FDA has done WELL.
    Thanks to the FDA’s CPG 400.400, we as consumers have been able to buy homeopathic remedies with confidence: What is written on the bottle of a homeopathic remedy (i.e. Arnica 30) is actually what is inside that bottle.
  • Acknowledge the problem.
    There may be some concerns regarding the labeling of homeopathic products. Most of these problems are the result from noncompliance with current laws and regulations.
  • Give the call to Action.
    To the minimal extent that problems exist, I recognize that these issues can be handled with relatively small changes, if any, to the current Compliance Policy Guide (CPG) sec. 400.400. I want to empower the FDA to use the authority it already has to address concerns.
  • Encourage the FDA to value YOU as an individual.
    Explain that you have turned to homeopathy because you/your family do not respond favorably to drugs and medications. Ask the FDA to appreciate and recognize your need for this highly individualized form of medicine that benefits your family.
  • Share a personal experience.
    Be careful. You don’t want to share inflammatory stories that freak the FDA out. Consider sharing:
    • A personal letter about yourself, a family or friend, or something you have read or heard about homeopathy, or just about why “freedom of health choice” is crucial in health matters.
    • If you share a story, you can perhaps describe how you self-treated a non-serious and self-limiting condition (i.e. cold/flu).
    • If you suffered from a condition of more serious in nature, then indicate that you worked with a qualified health professional/qualified homeopath.
    • Keep the narrative short, simple, and sweet—150 or so words is appropriate.
  • Conclude the letter.
    Thank them for their time and attention and ask them to please withdraw their proposed draft guidance and instead keep homeopathy effectively regulated, as they have done for the past 80 years, including the past 30 years under CPG sec. 400.400.
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Sample Letter

Here is a sample letter you can cut and paste if you cannot write your own unique letter.

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Agency Document No. FDA-2017-D-6580 Docket No. 2017-27157

Dear Dr. Gottlieb, Dockets Management Staff, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, and other pertinent FDA Staff,

I see homeopathy as an inherently safe health option for millions of people in the US and around the world. I urge FDA to withdraw its proposed Draft Guidance on Homeopathy, modifying regulatory guidelines. They have the potential to limit access to the homeopathy option.

The growing use of homeopathy by Americans demonstrates the benefits this form of health treatment brings to them. The safety of homeopathy is a testament to the effectiveness of FDA enforcement, and this is thanks to the comprehensive CPG sec. 400.400, which has safely guided homeopathy for 30 years. To the minimal extent that concerns exist regarding the guidance of homeopathic products, these issues can be handled within the current language of the CPG 400.400, or perhaps with relatively small changes.

I believe very strongly in health choice and therefore I urge the FDA to withdraw its proposed homeopathy guidelines and instead empower the FDA to retain the system that has effectively regulated homeopathy for the past thirty years.

Sincerely,
{Your Name}

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Official Letter Sent by Americans for Homeopathy Choice

AHC Memo Sent to the FDA