Deadline has been extended another 60 days.
Request for comment by November 9, 2015: Homeopathic Product Regulation: Evaluating the Food and Drug Administration's Regulatory Framework After a Quarter-Century
In the Federal Register of March 27, 2015, FDA published a notice of public hearing with a 60-day comment period following the public hearing and requested comments on a number of specific questions identified throughout the document. Comments on the notice of public hearing will inform FDA's decision about whether and how to adjust the current enforcement policies for drug products labeled as homeopathic to reflect changes in the homeopathic product marketplace over the last approximately 25 years. In the Federal Register of June 10, 2015, in response to requests for an extension to allow interested persons additional time to submit comments, FDA extended the original comment period for 60 days, until August 21, 2015.
FDA is reopening the comment period for an additional 60 days, until November 9, 2015. The Agency believes that reopening the comment period for an additional 60 days for the notice of public hearing will allow adequate time for interested persons to submit comments without significantly delaying Agency decisionmaking on these important issues. To read the entire Federal Register and to make comments electronically.
MORE INFORMATION ABOUT SENDING COMMENTS TO THE FDA
As you know, FDA’s two-day public hearing to gather information about the current use of products labeled as homeopathic took place in late April.
The hearing focused specifically on FDA regulations of and labeling requirements for OTC homeopathic medicines.
This hearing was not held to discuss the efficacy of homeopathy, the ability of individuals to practice homeopathy or to consider the removal of homeopathic remedies from the retail market.
But, FDA panelists posed several questions about:
• Consumer attitudes about homeopathy;
• Whether or not consumers have enough information to make informed decisions about purchasing homeopathic products over the counter (OTC);
• And whether there is confusion at store shelves with placement of homeopathic medicines next to non-homeopathic medicines.
Now You Can Help
The public hearing was the first phase of information gathering for FDA. The next phase of information gathering is a public comment period – which is now open and will remain open through November 9, 2015.
YOUR assistance at this time will be invaluable!
Help us get the following messages to the FDA:
• Consumers have positive attitudes about access to over-the-counter homeopathic medicines;
• Consumers ARE able to make informed decisions about purchasing homeopathic products vs traditional OTC medications;
• Consumers want to find the right medicine for their symptoms in the appropriate category area of the store.
We encourage everyone who uses homeopathic products to take 5 minutes to submit comments to the FDA about:
• YOUR own personal position and viewpoint regarding homeopathy;
• YOUR understanding and practical knowledge regarding purchasing decisions of OTC homeopathic products.
Guidance for Submitting Comments to the FDA
1. The most effective, meaningful comments will address:
• YOUR attitudes about homeopathy and/or
• YOUR experiences making decisions about purchasing OTC homeopathic products.
Why? Because THOSE TOPICS are what FDA is interested in gathering more information about.
2. Many, many people have amazing stories to tell about how well homeopathy worked for them. For the purposes of this public comment period, those stories are going to be most meaningful when they focus on using homeopathy for common ailments that can be self-diagnosed and treated at home (like colds, allergies, headaches, minor injuries, etc.) rather than chronic or diagnosed-based conditions. Again, FDA is most interested in hearing about consumer attitudes towards and making decisions about purchasing homeopathic products in stores. Please try to limit your comments to these topics.
3. Pay attention to the length of your comments. Try to submit comments that are neither too short nor too long. For example, a comment with only a few words (like “I have no problems deciding which OTC homeopathic products to buy.”) is not really meaningful to those at FDA without some context (like an example of a purchase of an OTC homeopathic purchase that you made) for those at FDA to understand the circumstances of the decision making process. On the other hand, comments that run for pages and pages without really addressing FDA’s questions (or are tedious to read) will not be helpful to FDA’s goal of understanding consumer attitudes and experiences. So how long is just right? Just make sure your comment tells your story so that the FDA reps reading it will understand your experience. (But, if you’d like a little more guidance, we believe that comments between 300-600 words are probably going to be the most valuable.) And be sure to proofread before hitting submit!
4. Finally, remember to keep comments respectful and constructive. (Unfortunately, we have discovered that some individuals in the homeopathic community have sent very negative, disrespectful messages to FDA representatives about the hearing. We request that community members refrain from making any comments that are not respectful and constructive.)
On the page:
a. Make sure to uncheck that you are submitting comment on behalf of a third party.
b. Select ‘individual consumer’ from the Category drop down menu.
Thank you in advance for your support.
Please forward this call for comment on to anyone else who you think might be interested in participating!