The FDA has extended the comment period on its completely unacceptable guidance that shifts how the agency will regulate homeopathic medicines. While the agency says that it will exercise enforcement discretion and focus on certain categories of homeopathic drugs, the wording of the guidance, in fact, says that all homeopathic drugs are currently being marketed illegally, leaving the door open for the agency to take action against any and all products. Concerned consumers must make their voices heard to stop this draconian guidance from moving forward.
Recently, the FDA announced the withdrawal of Compliance Policy Guide 400.400, a document that had been in place since 1988 and which established the agency’s enforcement policies regarding homeopathic medicines. In its place, the FDA has issued a revised draft guidance declaring all homeopathic drugs are being marketed illegally. We must fight back against this attack on homeopathic medicine.
The FDA wants to up-end the homeopathic industry—because it’s become too popular. Help us stop this insanity! Action Alert! 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.
What do parents do if their child has an adverse reaction to a vaccine? See their doctor of course. But does the doctor offer help and support, just dismiss the parents, or worse, give totally useless and harmful advice? Here are a few stories from my practice that will make you shake your head in disbelief.
In the United States today, the federal government controls which substances can be used to treat diseases, and which ones cannot. In general, only pharmaceutical drugs which can be patented are allowed. In many cases, either the FDA decides certain health claims about natural substances are invalid and bans it, or the DEA claims certain plants, such as cannabis, are illegal, jeopardizing both use and research. The FDA’s best and most high paying customers are in the pharmaceutical business, which pays the FDA over $2 million per licensing fee to accept its own testing proving efficacy and safety. The FDA only reviews the pharmaceutical industry’s testing. But several independent researchers have determined most pharmaceutical tests are at best not quite right and sometimes totally fraudulent. In other words, the FDA protects the pharmaceutical industry, not its customers.
The Federal Trade Commission (FTC) recently issued a policy statement explaining that the agency will hold efficacy and safety claims for over-the-counter (OTC) homeopathic drugs to the same standard as claims for other OTC drugs. This means homeopathic OTC products will need to back up claims with “competent and reliable scientific evidence” for health-related claims, or else use certain FDA-approved disclaimers. Here are some examples of acceptable disclaimers, as noted in the FTC’s policy statement: “There is no scientific evidence that the product works,” or “The product’s claims are based only on theories of homeopathy from the 1700s that are not accepted by most modern medical experts.” The FDA is no doubt pulling the strings on this. The most likely motivation of the FTC is that the homeopathic industry is rapidly expanding, which presents a clear threat to pharmaceutical drug company profits, which is enough for the FDA to put homeopathy in its scopes.
I am 16 years old. For me, everything started a few days after I received the HPV vaccine, Gardasil. I woke up one day choking and unable to breathe. I felt like I was going to pass out so my parents took me to a hospital. I was stabilized, kept overnight and sent home, just like that. No tests, no medications, no explanations as to what could have caused the problem. This was only the beginning. Then it progressed to choking, hyperventilating, panic attacks and soon enough I was getting panic attacks every day, sometimes as many as four times a day. Then the depression came. Every doctor we went to dismissed us and tried to get rid of us. I genuinely had to force myself to want to live. I wanted to disappear. I wanted all of the symptoms to stop.
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. 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 June 22, 2015. YOUR assistance at this time will be invaluable!
The FDA wrapped up a two-day hearing recently on whether or not homeopathic remedies should be regulated like drugs. Listening to critics of homeopathy try to justify why they don't think the American public should have free access to homeopathic remedies leaves one wondering just what the real motivation is behind these criticisms. The two dominant criticisms made against homeopathic remedies are antithetical to each other. Critics complain that due to a lack of regulation homeopathic remedies are dangerous, but then they turn around and say that homeopathic remedies are simply useless sugar pills with no therapeutic effect whatsoever, and no better than a placebo. Both cannot be true. Is this the new standard of scientific scrutiny that federal agencies are using to supposedly protect the public? The FDA is clearly not concerned about homeopathic remedies because they are a danger to the public. There are no deaths associated with homeopathic remedies, and very few side effects. By contrast, FDA-approved drugs have millions of adverse side effects, including over 100,000 deaths each year. Homeopathic remedies are a danger to the FDA's monopoly on drugs, and so they clearly want to either eliminate the competition, or get in on the action and take over the market.
Homeopathy was one of the most common medical practices in the United States in the 1800s. In 1892, homeopaths in the United Stated controlled about 110 hospitals, 145 dispensaries, 62 orphan asylums and old peoples homes, over 30 nursing homes and sanitaria and 16 insane asylums. However, the pharmaceutical industry did everything it could to stomp out homeopathy, and it is not as widespread in the U.S. today as it once was. (See: American Medical Revolutions: How the AMA Took Over America.) Worldwide, homeopathy is the second largest system of health care used behind conventional pharmaceutical-based medicine. The number of homeopaths worldwide doubled between 1999 and 2009, and the number of homeopathic hospitals grew from under 2,000 to over 7,000. Currently, there are no homeopathic hospitals in the United States. There are still homeopaths practicing in the U.S., however, and we have highlighted some of their work here at Health Impact News. Their ability to help heal vaccine injuries, for example, is quite impressive. Soon, however, the FDA may take steps to further reduce or even eliminate homeopathy in the U.S., as the Alliance for Natural Health reports here.