The FDA wants to up-end the homeopathic industry—because it’s become too popular. Help us stop this insanity! Action Alert!
The FDA has tossed out the guidance that previously governed homoeopathy and has proposed a new framework that threatens the entire industry.
Long-time natural health champion Senator Orrin Hatch (R-UT) and Rep. Ryan Costello (R-PA) are spearheading efforts in Congress to correct this overreach. They are preparing sign-on letters which argue that the FDA should not completely withdraw the previous regulatory framework (Compliance Policy Guide 400.400) for homeopathic products.
A few weeks ago, we told you about the FDA’s latest action against homeopathic products. The agency’s new position is technically that every homeopathic product on the market is being sold illegally because 1) no homeopathic drug has been determined to be generally recognized as safe and effective (which is required for a drug to be sold over-the-counter) and 2) no homeopathic drug has gone through the FDA’s new drug approval process.
With the FDA’s new guidance, homeopathic products will be subject to the same rules as other over-the-counter drugs or new drugs—a move that could eliminate many homeopathic products from the market. New drug approval for homeopathic products is burdensome, duplicative, and inappropriate. The Homœopathic Pharmacopœia of the United States (HPUS) establishes standards for homeopathic products to follow.
An ingredient’s inclusion in HPUS means that it has been determined to be safe and effective by the Homœopathic Pharmacopœia Convention of the US. In essence, then, homeopathic products have undergone premarket reviews for safety and effectiveness; requiring further review, or expensive testing to confirm safety and effectiveness, is unnecessary and would impose tremendous regulatory costs on the homeopathic industry. Others have also pointed out that this is in fact a higher regulatory threshold than that applied to allopathic over-the-counter (OTC) drugs, since many OTC drugs can be sold as long as they comply with an FDA OTC monograph.
The FDA excluded homeopathic drugs from the new drug approval process and the over-the-counter review process for decades because they were viewed, appropriately, as a separate category of medicine. The reason for the FDA’s change of heart is the growth of the homeopathic industry—growth which no doubt threatens the bottom line of the drug manufacturers that work closely with the FDA.
Since 1988, Compliance Policy Guide 400.400 has served as the FDA’s blueprint for the regulation of homeopathy. It clearly defines homeopathic drugs as “any drug labeled as being homeopathic which is listed in the Homeopathic Pharmacopeia of the United States,” and it appropriately exempts homeopathic products from certain rules and regulations that apply to pharmaceutical drugs. This policy covers labeling requirements for homeopathic products and states that the FDA will focus enforcement actions against companies who fail to comply with 400.400.
Compliance Policy Guide 400.400 worked. Homeopathic drugs manufactured in conformance with the HPUS and current good manufacturing practice do not pose a public health risk; nothing is safer than homeopathic preparations. A World Health Organization report on homeopathic products concluded that “Adverse events occurring during homeopathic treatment are rarely attributed to the homeopathic medicine itself.”
Considering the myriad public health problems facing this country, including the opioid epidemic and the overuse of antibiotics, it is ludicrous that the agency is focusing on homeopathic drugs. Could it be that, like supplements, homeopathic drugs compete with pharmaceutical drugs? Recall, too, that the FDA has announced that they are targeting alternatives to opioids in the midst of an epidemic of opioid addiction that is killing 115 Americans every day.
We must encourage our senators and representatives to sign on to the Hatch and Costello letters and send a clear message to the FDA: the previous regulatory policy was sufficient to ensure consumer access to safe homeopathic remedies, and we don’t need to fix what isn’t broken.
Action Alert! Write to your elected officials and urge them to support reigning in FDA overreach in regulating homeopathic products. Please send your message immediately.
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The issue at hand is that homeopathics are categorized as drugs. An alternative is to put them in a different category. They could be labeled as dietary supplements, although some of them would not be on the list of approved dietary supplements, many of them would. Additinally, we should perhaps decide if it is even appropriate for the government to tell it’s citizens what they can and can not use as medicine. Even prescription drugs should be called into question. Are we protecting the citizen from hurting themselves or are we protecting the pracptitioners and pharmaceutical companies livelihood/legal responsibilities. If there were no prescription drugs, the responsible person could learn about the drugs/herbs/supplements etc available and make an informed choice. The person who does not want to take responsibility for their own health could still go see a practitioner. (Which brings up yet another point, that the govt is currently deciding which practioners will be reimubursed through insurance and which ones won’t. Why should that be the govt/insurance decision rather than the citizen’s decision who paid for the insurance?) Perhaps we should question who’s decision it should be to decide what type of educational material we want to read or what products we want to consume period. Currently, we are allowing the govt. to decide what educational data will be available to us from supplement companies and which of those products will be allowed to be available. If we change the laws and really have free speech around disceminating data on dietary supplements it means the citizen needs to actually be responsible for educating themselves about their health and supplements. Are we ready for this or do we want to continue being told what we can have available on the market as far as educational material and supplements? If we are not ready to take full responsibility, expect the govt. and interested parties such as pharmaceutical companies to keep taking away our right to purchase and perhaps even grow our own herbs and supplements.
The government, married to the pharmaceutical empire, is already deciding for us, and so-called ‘laws’ are being passed without citizen approval, by corporations. It is much more subversive and corrupt than most people even have a clue about. There needs to be a revolution.
How can the FDA oversee what we can put in our bodies, when the 4th leading cause of death in the U.S. is Prescrition medications that the FDA has approved???
Clicking the “Take Action” button above just leads to a page “anhusa Comment Policy”.
Where should we go to “take action” on this issue?
Clicking the button should have taken you here:
http://www.anh-usa.org/action-alert-help-save-homeopathy/
need to get rid of corrupt fda they are getting bribes from asshole pharma who should be shut down
Also Giant Agrocultural, Monsanto/Bayer amd nine others and their GMO and Roundup that has been proven to cause every cancer known to man and every Plague of the 21st Century.. Look at the commercials for Shriner’s Hospital and St Jude Hospital. One in Five Children die every week from Cancer or Plague !!!
The FDA is protecting Drug, Food and medical device companies. They will never protect the public. All we have is Congress, and they are taking money from Drug, Food and medical device companies. There are only a few in Congress that will stand up to the FDA. What I did many, many years ago was make up a letter to ALL SENATORS in Washington to complain that the FDA was not doing their job. Some weeks later, there was a hearing and there was change in the FDA. We the people must do the same, if you can afford the cost of paper, envelopes, and stamps. The FDA has a black book that they came up with to run the FDA, Congress must get that book. Are you willing to spend the time and money to end the corruption at the FDA ????
Absolutelly correct. These Pharmaceutical Companies are everywhere, taking away people’s choice of medicine all in the name of their own greed.
They are more than corrupt,more like straight criminals with no conscious.Helping big pharma get richer with no effort to cure, but string along until death.Save your money if you donate to the American Cancer Society,Its to big of an Industry to cure cancer and shut it down. Doctors are interested for the most part in selling drugs for big pharma.Thats where the money is.No regard for human life any more,only the money,its truth, If you research it .I’ve seen first hand, and was literally shocked.Sounds crazy, and it truly is.
I don’t donate to any organisation who thinks they are doing good in curing any disease. I get pissed off and cry at these women in pink, they really don’t know what is going on. They seem to think that Big Pharma is in the business to cure people, far from the truth. Big Pharma is only in the business to sell useless drugs and other products for the SICK!
Anything to get rid of Natural for Poison Chemicals that cause more bad than good !!! Stop Corrupt Washington and the Money Hungry FDA, USDA, CDC, and any other Government agency that has in two years taken over $106 Billion Dollar$ in Corrupt Cash !!! Where does that corrupt money go ??? Television Commercials every five minutes Advertising Medication’s that are worse than a disease by natural means. Over 100 New Med’s Every Week advertised and none of them should be on PAY TELEVISION… I Don’t pay to see Commercials every five minutes !!!..
create a deep-web network that caters to an internal standard by the participants managed via dues/fees and a BoD, thereby doing an end run around the “corruption”. Hopefully u guys can avoid their fatal flaw of human nature, lest you become what you loath, but because you ARE humans that seems near impossible until u develop a new construct that self manages these flaws of human nature…capitalism seems to do this very well; serve society well, and u are rewarded accordingly by free will by the one(s) u serve.
I make homeopathic remedies. I live in the mtns. I can also pick the plants you need this summer. Might want to keep me in mind. Sherry
The agencies that are supposed to protect public health are actually ‘captured’, meaning they are under the control of Big Medicine, Big Pharma, Big Ag – both with money, and the revolving doors through which CEO’s and other higher management move from industry into the agencies. It’s pure evil.
What happened to live and let live. Why is greed entering into freedom of choice? It’s my body and I demand the right to decide its fate not be backed into corners by conglomerate corporate thinking. How shameful that legislators seem to go along with this!
you have never lost the freedom of choice, what you have lost is the number and types of choices, it’s always about money in the end.
The best way to disarm Pharma – cut off its blood supply, its money! Pull out any investments you have in any of Pharma stocks! DO IT NOW!!!!
Try to get the Bill Gates (of Hell ) to let go of their profits from investments in Big Agra and funding vaccines .
Homeopathic supplements are popular, affordable, and very effective for things like swelling (arnica) or bee stings. I have friends who have used them for decades. Please tell the FDA to slow down and do more research before eliminating these!
So reading the definition of ‘homeopathic’, I have to agree that SOMEONE is very upset about being regulated, lol. Homeopathy sounds like a HUGE rip-off to those who believe this joke of a product…
The FDA action is long overdue.
For a change in FDA priorities, you need to cut of the head, that is Former Big Agra employees who head the FDA.
Socialism and Communism have been creeping into our country and eroding our liberties everywhere for some time, and the fruits of it are very apparent. From how our children are schooled, to mandated vaccines that do not have any safety testing, propaganda peddling of severely dangerous drugs, No responsibility taken for the harm done to the public and the fact that their policies are acts of treason. Knowingly that these Drugs, Pesticides, various neuro toxins in the environment collectively cause cancer, and neurological disorders, cognitive decline, autoimmune problems,,,etc. Yet they confiscate harmless, effective modalities…. the worst of crimes. BUT WE CAN PREVAIL, In God WE TRUST. Fight the GOOD FIGHT!!!! AMEN