Wellness Under Fire: FDA Homeopathy Regulation

Is Freedom of Choice important to you?  YES. Do you want access to homeopathic remedies to be limited compared to current availability (such as due to new obstructive enactments or changes in FDA policies)? NO. Then please share your concerns with FDA.  On April 20 and 21 they are having a public hearing - and inviting public comments until June 22 - on the following topic: FDA Homeopathic Product Regulation: Evaluating the Food and Drug Administration’s Regulatory Framework After a Quarter-Century; Public Hearing We believe that the best way to show the FDA how much homeopathy means to us is for people to speak, write to the FDA and share this with your people universe and social media friends. Numbers are needed to tell the FDA that our rights must be preserved and that there is no need or reason to close market access to homeopathic remedies (could there be vested interests pushing for such control?).  The public health issue is clear: homeopathic remedies have very few side effects, and they cannot be grouped with drugs and medications that consistently cause side-effects such as liver damage, heart issues, dry mouth, etc. The proposed restrictions on FDA homeopathy regulation is out of context and dangerous to our freedom of choice. [For example, here are side-effects listed for one common prescription drug  - you will absolutely NOT find this with homeopathic remedies - Bleeding gums, blood in the urine, bloody stools, blurred vision, burning, crawling, itching, numbness, chest pain, confusion, coughing up blood, difficulty with breathing or swallowing, dizziness, faintness, or lightheadedness when getting up suddenly, excessive bruising, headache, increased menstrual flow or vaginal bleeding, nosebleeds, paralysis…] It is possible that a consumer using a homeopathic product may have experienced a side-effect, but the worst would usually be something like an upset stomach, minor allergy or irritation. Very rarely anything like that listed above for a common prescription medication! Homeopathic products have a record of being among the safest in the entire marketplace - and are the perfect choice for young children,6 too! Background: Since 1988, prescription and non-prescription drug products labeled as homeopathic have been manufactured and distributed without FDA approval under the enforcement policies set forth in FDA's Compliance Policy Guide (CPG) 400.400 entitled “Conditions Under Which Homeopathic Drugs May be Marketed” (see 53 FR 21728, June 9, 1988). The CPG defines a homeopathic drug as any drug labeled as being homeopathic which is listed in the HPUS, an addendum to it, or its supplements. The CPG includes conditions specific to ingredients, labeling, prescription status, and current good manufacturing practice. The CPG can be found here. Is a change to this needed? We do not believe that any changes are required to the CPG that will further ‘protect the public health’ other than the FDA adopting Mutual Recognition Agreements with countries who have successfully managed homeopathic remedies for over a century. (This includes countries in industrialized Europe, such as Germany, Switzerland etc.).  But the word is that the FDA wants more control over homeopathic remedies, how they are classified, regulated and sold. So please get the message out to protect your right of access to homeopathic products. Tell them that FDA homeopathy regulation in this context is not just! Go here for more background information on the subject or click here to submit a comment to FDA. (BEFORE JUNE 21)