The Food and Drug Administration (FDA) has reportedly declared that “virtually all” homeopathic drugs are illegal. Reports that the FDA is cracking down on the use of natural medicines have been circulating for a while. However, in a recently released “guidance document,” the FDA is now quoted as saying that homeopathic drugs are considered “new drugs” that are allegedly being sold illegally.
The FDA released its new guidance document last month, and sources in support of the use of homeopathic drugs are still attempting to translate what the FDA is calling a “draft guidance” that’s been released for “comment purposes only.” Homeopathy is becoming an increasingly popular form of treating various diseases naturally for people worldwide.
According to the Homeopathy Research Institute, more than 200 million people now regularly use homeopathic drugs, with over 6 million people in the U.S. alone using homeopathy “for self-care of specific health conditions.” More and more people are turning to homeopathic drugs versus prescriptions drugs due to alleged lower cost and fewer side effects. Natural medicines are also said to heal, rather than simply mask the symptoms of a disease.
With a growing number of the adult population around the world turning to homeopathy, as well as the recent “war on opioids” in the news, the FDA decided to announce new policies on the use of homeopathic drugs. An article on the Alliance for Natural Health USA from just over two weeks ago states that the FDA has effectively labeled “virtually every single homeopathic drug” as illegal, as outlined in the homeopathic guidance document.
In an attempt to decode the “FDA’s current position” on the use and sale of homeopathic drugs, the previously mentioned article says that since not one homeopathic drug has yet to be approved by the FDA as being “safe and effective,” then “all homeopathic drugs” are effectively illegal, and therefore, currently being sold illegally.
“A new drug cannot be marketed unless it goes through the FDA’s approval process. No homeopathic drugs have gone through FDA approval nor can any producer afford to take them through the approval process.”
Citing the guidance document on the FDA website, homeopathic drugs are “marketed unapproved new drugs” with “potential safety risks” and “lack evidence of effectiveness.” The document goes on to say that homeopathic drugs are considered “health fraud products,” which, in turn, “present challenges” in getting the FDA’s approval as new drugs. The FDA then goes on to outline a “risk-based” approach to regulating homeopathic drugs.
An article on Mercola from Tuesday states that both adults and children currently use homeopathic drugs because natural medicines are still considered “generally safe.” Unlike some prescription medications, homeopathic remedies are also said to not carry the same risk of dependency, and according to Mercola, are “unlikely” to cause “severe” side effects.
However, as noted on Mercola, the FDA still plans to take a new approach of regulating homeopathic drugs that reportedly carry a greater “risk to patients.” After essentially determining that homeopathic drugs are “new drugs” that haven’t been approved for manufacturing, distributing or marketing, the FDA notes that it plans to enforce “regulatory actions” against “certain categories” of homeopathic drugs.
Those categories include homeopathic drugs with already “reported safety concerns,” homeopathic drugs with ingredients that are determined to “raise safety concerns,” including products that contain multiple homeopathic ingredients, homeopathic drugs that are not for use orally or topically, as well as homeopathic products that claim to prevent or treat “serious” or “life-threatening” health conditions.
However, SmithsonianMag reported in November of 2016 that the Federal Trade Commission (FTC) had already announced a policy that requires a disclaimer on homeopathic drugs that state there is no scientific evidence to prove that homeopathy really works to treat illness and disease. The article on SmithsonianMag goes on to clarify that the FDA did not yet “police” homeopathic drugs and remedies.
With the FDA recently joining the FTC in regulating the use of homeopathy, while basically stating that “all homeopathic drugs are illegal” and unapproved new drugs, supporters of natural medicine are speaking out. There are several petitions circulating online in support of legalizing all homeopathy, and other supporters are simply speaking their minds on social media and in forums and message boards.
Gizmodo notes that the FDA is taking comments on the new “guidance document” for 90 days from its release date in December before deciding on regulations and enforcement policies for “illegal” homeopathic drugs. Comments on Gizmodo are mixed, from some supporters of homeopathy saying that people have died from doctor-prescribed medications to critics saying that there are “only a very few” homeopathic drugs that actually work.
Patients who turn to homeopathy to treat health conditions often become fed up with conventional medical treatments, and the Huffington Post reported that a high percentage of homeopathic users in India would “not switch to conventional treatments,” while even physicians around the world are increasingly turning to homeopathic drugs as “alternative” treatments.
When asked if homeopathic drugs are going to be removed from the market, the FDA clarifies on its website that “top concern is patient safety.”
“FDA’s draft guidance states that it is intended to provide notice that any product labeled as homeopathic that is being marketed illegally is subject to FDA enforcement action at any time. However, the agency recognizes that many homeopathic products will likely fall outside the risk-based categories described in the guidance and remain available to consumers.”