{"id":53623,"date":"2022-12-12T15:47:16","date_gmt":"2022-12-12T19:47:16","guid":{"rendered":"https:\/\/homeopathychoice.org\/?p=53623"},"modified":"2022-12-19T14:06:23","modified_gmt":"2022-12-19T18:06:23","slug":"insider21","status":"publish","type":"post","link":"https:\/\/homeopathychoice.org\/insider21\/","title":{"rendered":"FDA Finalizes Guidance\u2026what does this mean?"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"53623\" class=\"elementor elementor-53623\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-3ef26b31 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"3ef26b31\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-1cef2e99\" data-id=\"1cef2e99\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-1a4d6d92 elementor-widget elementor-widget-text-editor\" data-id=\"1a4d6d92\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>Hello from Americans for Homeopathy Choice!\u00a0 Thank you for taking the time to follow along as we inform you about the FDA threat to homeopathy. We trust it\u2019s been an eye-opening look at what we work so diligently to do, each week, at Americans for Homeopathy Choice.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ebd7655 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"ebd7655\" data-element_type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-117aede elementor-widget elementor-widget-button\" data-id=\"117aede\" data-element_type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-md\" href=\"https:\/\/homeopathychoice.org\/homeopathy-action-team\/#\/2\/\" target=\"_blank\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon elementor-align-icon-left\">\n\t\t\t\t<i aria-hidden=\"true\" class=\"fas fa-mobile-alt\"><\/i>\t\t\t<\/span>\n\t\t\t\t\t\t<span class=\"elementor-button-text\">Sign up for the hat team!<\/span>\n\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0811270 elementor-widget elementor-widget-heading\" data-id=\"0811270\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h6 class=\"elementor-heading-title elementor-size-medium\"><a href=\"https:\/\/homeopathychoice.org\/homeopathy-insider-text-group\/\" target=\"_blank\">Sign up for text alerts! <\/a><\/h6>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0ae3845 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"0ae3845\" data-element_type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3f8ffcc elementor-widget elementor-widget-text-editor\" data-id=\"3f8ffcc\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p><em style=\"background-color: transparent; text-align: left;\"><strong>If you&#8217;d like to read the summary of today&#8217;s report, scroll down to the end of this post!<\/strong><\/em><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4239c57 elementor-widget elementor-widget-video\" data-id=\"4239c57\" data-element_type=\"widget\" data-settings=\"{&quot;video_type&quot;:&quot;vimeo&quot;,&quot;show_image_overlay&quot;:&quot;yes&quot;,&quot;image_overlay&quot;:{&quot;url&quot;:&quot;https:\\\/\\\/homeopathychoice.org\\\/wp-content\\\/uploads\\\/2022\\\/12\\\/Screen-Shot-2022-12-12-at-3.28.02-PM.png&quot;,&quot;id&quot;:53631,&quot;size&quot;:&quot;&quot;,&quot;alt&quot;:&quot;&quot;,&quot;source&quot;:&quot;library&quot;}}\" data-widget_type=\"video.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-wrapper elementor-open-inline\">\n\t\t\t<iframe class=\"elementor-video-iframe\" allowfullscreen allow=\"clipboard-write\" title=\"vimeo Video Player\" src=\"https:\/\/player.vimeo.com\/video\/780171505?color&amp;autopause=0&amp;loop=0&amp;muted=0&amp;title=1&amp;portrait=1&amp;byline=1#t=\"><\/iframe>\t\t\t\t<div class=\"elementor-custom-embed-image-overlay\" style=\"background-image: url(https:\/\/homeopathychoice.org\/wp-content\/uploads\/2022\/12\/Screen-Shot-2022-12-12-at-3.28.02-PM.png);\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"elementor-custom-embed-play\" role=\"button\" aria-label=\"Play Video\" tabindex=\"0\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"eicon-play\"><\/i>\t\t\t\t\t\t\t<span class=\"elementor-screen-only\">Play Video<\/span>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c0400fa elementor-widget elementor-widget-text-editor\" data-id=\"c0400fa\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p><strong>Outline:<\/strong><\/p><ul><li style=\"text-align: left;\">The FDA Guidance is now final. It is only a policy document and not the law.<\/li><li style=\"text-align: left;\">Homeopathy remains legal. The Food, Drug &amp; Cosmetics Act recognizes all remedies listed in the Homeopathic Pharmacopeia of the United States. Therefore, homeopathic medicines are recognized by federal law.<\/li><li style=\"text-align: left;\">For the first time, the FDA is saying that homeopathic medicines are &#8220;unapproved new drugs&#8221; and that they are being &#8220;illegally marketed.&#8221;<\/li><li style=\"text-align: left;\">This does not make homeopathic medicines illegal. Nevertheless, this is having a &#8220;chilling&#8221; effect on the market.<\/li><li style=\"text-align: left;\">The FDA asserts that because homeopathic medicines are &#8220;unapproved new drugs,&#8221; they are subject to premarket approval requirements.<\/li><li style=\"text-align: left;\">The FDA knows that the new drug application process, which is designed to evaluate the risks of chemical pharmaceuticals, is not appropriate for homeopathic medicines, and also not financially feasible for manufacturers of homeopathic remedies.<\/li><li style=\"text-align: left;\"><span style=\"text-align: center;\">The Agency stated that it is using the designation of \u201cunapproved new drug\u201d<\/span><br style=\"text-align: center;\" \/><span style=\"text-align: center;\">as an enforcement tool to give it the authority to remove homeopathic medicines<\/span><br style=\"text-align: center;\" \/><span style=\"text-align: center;\">whenever necessary.<\/span><\/li><li style=\"text-align: left;\">However, the FDA would have to pull medicines off the market one-by-one and would likely end up in court as a result. It could not, for instance, pull all versions of Aconitum napellus off the market all at once.<\/li><li style=\"text-align: left;\">But the FDA has other means to force medicines off the market, such as smear campaigns and blocking imports of homeopathic medicines which is already happening.<\/li><li style=\"text-align: left;\">Americans for Homeopathy Choice formed to fight this deeply flawed guidance, and we need your help now more than ever, so please consider joining the Homeopathy Action Team (HAT)!<\/li><li style=\"text-align: left;\">HAT enrollment has been temporarily reopened &#8211; the deadline to sign up is Tuesday December 13th!<\/li><li style=\"text-align: left;\">Please also consider donating to AFHC &#8211; we need financial resources to wage this fight!<\/li><li style=\"text-align: left;\">Lastly, be sure to sign up to our email list and text alerts if you haven&#8217;t already!<\/li><li style=\"text-align: left;\">We&#8217;ll see you after the New Year for the next Insider report and more updates.<\/li><\/ul>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e2e1894 elementor-widget elementor-widget-text-editor\" data-id=\"e2e1894\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<h3 style=\"text-align: center;\"><em>Our job is not to change the world;<\/em><\/h3><h3 style=\"text-align: center;\"><em> our job is to steward the gifts we\u2019ve been given.<\/em><\/h3>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c552d13 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"c552d13\" data-element_type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f371681 elementor-widget elementor-widget-button\" data-id=\"f371681\" data-element_type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-md\" href=\"https:\/\/homeopathychoice.org\/homeopathy-action-team\/#\/2\/\" target=\"_blank\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon elementor-align-icon-left\">\n\t\t\t\t<i aria-hidden=\"true\" class=\"fas fa-mobile-alt\"><\/i>\t\t\t<\/span>\n\t\t\t\t\t\t<span class=\"elementor-button-text\">sign up for the hat team!<\/span>\n\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-488974e elementor-widget elementor-widget-heading\" data-id=\"488974e\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h6 class=\"elementor-heading-title elementor-size-medium\"><a href=\"https:\/\/homeopathychoice.org\/homeopathy-insider-text-group\/\" target=\"_blank\">Sign up for text alerts! <\/a><\/h6>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-62db920 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"62db920\" data-element_type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ed2ff29 elementor-widget elementor-widget-text-editor\" data-id=\"ed2ff29\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p><em><span style=\"background-color: transparent; text-align: left;\"><b>Summary of Today&#8217;s Episode:<\/b><\/span><\/em><\/p>\n<p>This is Paola Brown, president of Americans for Homeopathy Choice, here today with another report for Homeopathy Choice Insider. The most important development has been the finalizing of the FDA Guidance on homeopathy. The Guidance is now final, which means that it represents the current thinking of the FDA regarding homeopathy. This is a policy document. It is not the law and any statements in it are merely the thoughts of current FDA officials. This has led to some misunderstandings. Let me clear those up:<\/p>\n<p><\/p>\n<p>1. Homeopathy remains legal. The FDA has said for the first time that homeopathic medicines are \u201cunapproved new drugs\u201d and that they are being \u201cillegally marketed.\u201d That doesn\u2019t make homeopathic medicines illegal. These medicines are written into the Food, Drug and Cosmetic Act which recognizes the <a href=\"https:\/\/www.hpus.com\/\">Homeopathic Pharmacopoeia of the United States.<\/a> Homeopathic medicines are therefore recognized in federal law.<\/p>\n<p><\/p>\n<p>2. The FDA asserts in its Guidance (which is not a law!) that because homeopathic medicines are \u201cunapproved new drugs,\u201d they are subject to premarket approval requirements. The Agency states that there are no FDA approved homeopathic medicines and that this is why FDA is going to treat homeopathic medicines as if they are being \u201cillegally marketed.\u201d (Again, this is just the FDA\u2019s thinking and we do NOT agree with it.) The FDA therefore claims that it can remove any homeopathic medicine from the market at any time without any reason other than that it is being marketed illegally.<\/p>\n<p><\/p>\n<p>This is having a \u201cchilling\u201d effect on the market for homeopathic medicines. We are very concerned about that. This Guidance explains how the FDA will remove homeopathic medicines from the market. But it provides absolutely no path for homeopathic medicines to enter and remain in the market legally.<\/p>\n<p><\/p>\n<p>The FDA has stated that homeopathic medicines can go through the drug approval<br>process. But that process was designed for chemical pharmaceuticals to determine<br>whether their risks (usually toxic risks) are outweighed by their benefits. In addition, the<br>cost of such applications runs in the tens of millions of dollars. Since homeopathic<br>medicines are NOT patentable\u2014they are made from commonly available<br>substances\u2014there is no way for any company making such an application to recoup its<br>investment in the application.<\/p>\n<p><\/p>\n<p>The FDA knows this because we met with Agency personnel and explained it to them.<br>The FDA admitted that the new drug application process doesn\u2019t work for homeopathic<br>medicines. The Agency stated that it is using the designation of \u201cunapproved new drug\u201d<br>as an enforcement tool to give it the authority to remove homeopathic medicines<br>whenever necessary.<\/p>\n<p><\/p>\n<p>The Guidance states that many homeopathic medicines fall outside the enforcement<br>priorities of the Agency. But because the Guidance is not law, the Guidance may be<br>disregarded by the Agency whenever it wishes to. It is true that the FDA would have to pull medicines off the market one-by-one and would likely end up in court as a result. It could not, for instance, pull all versions of Aconitum napellus off the market all at once.<\/p>\n<p><\/p>\n<p>But the FDA has other means to force medicines off the market, namely, conduct a<br>smear campaign using unfounded accusations to frighten consumers away and thus force companies to discontinue manufacture of the targeted medicines. Another way is blocking imports of homeopathic medicines &#8211; which is already happening.<\/p>\n<p><\/p>\n<p>Americans for Homeopathy Choice formed to fight this deeply flawed Guidance and we need your help now more than ever. Please consider signing up for the Homeopathy Action Team. This is a critical group for connecting us to Congress where we think we have a chance to pass legislation that will protect homeopathy.<\/p>\n<p><\/p>\n<p>We are a resource for members of Congress and their staffs. It\u2019s important that WE are seen as the source of reliable information, NOT the FDA, NOT Wikipedia. One of our HAT members actually received a call from a Congressional staff person almost as soon as the Guidance was finalized. The staff person was concerned about this development and asking for updates.<\/p>\n<p><\/p>\n<p>This is why joining the Homeopathy Action Team is so important. The deadline to enroll is Tuesday, December 13. After the initial training, there is only a modest time<br>commitment each month.<\/p>\n<p><\/p>\n<p>There are two other things you can do: 1) Become a free member and sign up to receive our weekly Insider report and occasional alerts and 2) make a <a href=\"https:\/\/homeopathychoice.org\/donate\/\">donation<\/a>. We need financial resources to wage this fight.<\/p>\n<p><\/p>\n<p>Thank you so much. I\u2019ll see you after the New Year with another Homeopathy Choice Insider report.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5e2bb59 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"5e2bb59\" data-element_type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-37cf80f elementor-widget elementor-widget-button\" data-id=\"37cf80f\" data-element_type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/homeopathychoice.org\/homeopathy-action-team\/#\/2\/\" target=\"_blank\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon elementor-align-icon-left\">\n\t\t\t\t<i aria-hidden=\"true\" class=\"fas fa-mobile-alt\"><\/i>\t\t\t<\/span>\n\t\t\t\t\t\t<span class=\"elementor-button-text\">sign up for the hat team!<\/span>\n\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-643f542 elementor-widget elementor-widget-heading\" data-id=\"643f542\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h6 class=\"elementor-heading-title elementor-size-small\"><a href=\"https:\/\/homeopathychoice.org\/homeopathy-insider-text-group\/\" target=\"_blank\">Sign up for text alerts! <\/a><\/h6>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b8fd99b elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"b8fd99b\" data-element_type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1c90b97 elementor-widget elementor-widget-menu-anchor\" data-id=\"1c90b97\" data-element_type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div id=\"Text\" class=\"elementor-menu-anchor\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Hello from Americans for Homeopathy Choice!\u00a0 Thank you for taking the time to follow along as we inform you about the FDA threat to homeopathy. We trust it\u2019s been an eye-opening look at what we work so diligently to do, each week, at Americans for Homeopathy Choice. Sign up for the hat team! 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