The FDA’s policy explains that they will generally focus enforcement against certain subsets of products, such as those with safety concerns, products with routes of administration other than oral or topical, products to treat “serious or life-threatening conditions,” products for vulnerable populations, and products with “significant” quality issues.
This FDA policy guidance is a serious threat to homeopathic medicines because it sets the stage for the agency to remove homeopathic medicines easily and with very little evidence or support. Why? Because the agency argues in the guidance that by the letter of the law, homeopathic medicines are currently being sold illegally because they have not been “generally recognized as safe and effective” (GRAS/E), nor have they gone through FDA approval as new drugs. So, if it wants to, the FDA now has the legal authority to remove any homeopathic medicine from the market.
The appropriations language we are supporting would prevent the FDA from removing homeopathic medicines simply because they haven’t been recognized as GRAS/E or approved as new drugs—an impossible standard for homeopathic medicines since many of them are hundreds of years old and not patentable like new-to-nature drugs are. The huge investment it takes to get a product through FDA approval cannot generally be recouped in the case of homeopathy. The language would allow the FDA to pursue enforcement actions only against products that actually violate existing manufacturing and labeling standards for drugs while protecting access to homeopathic medicines that are in compliance.
This FDA guidance is a very serious threat, and we are doing everything in our power to stop it. But at the same time, FDA agents are not sweeping the nation’s drug stores and removing all homeopathic medicines from the shelves. We do believe that, slowly but surely, the agency will target and eliminate the homeopathic medicines that compete with FDA approved drugs because the fees companies pay for drug approval fund a substantial portion of the FDA’s operations. Homeopathic medicines are popular for allergies, for example, and this cuts into the market for drugs: the market for antihistamine nasal sprays is just under $2 billion; the market for Zyrtec, one of the most popular antihistamine drugs, was valued at $1.675 billion in 2021. Clearing the market in one fell swoop would create headlines; picking off medicines one by one, over time, allows the agency to accomplish the same goal without drawing as much attention or generating as much outrage.
The FDA has already started this process, targeting injectable homeopathic medicines first.
We need to communicate to Congress that voters care about access to homeopathy and other natural medicines. A national survey found that 70% of Americans are more likely to support Congressional candidates who will protect access to supplements and homeopathic and other natural remedies.
Action Alert! Write to Congress in support of appropriations language that prevents the FDA from attacking safe homeopathic products that comply with existing standards. Please send your message immediately.
https://www.votervoice.net/ANHUSA/Campaigns/103290/Respond