The time to stop this is now, before it gains momentum! Action Alert!
The FDA is holding a public hearing later this month to evaluate its enforcement policies for homeopathic drug products. It says the agency is seeking input on whether and how to adjust the policy to adjust for changes that may have occurred over the past twenty-five years.
Why is the FDA doing this? It appears that it has decided that it missed out on millions of dollars it could have charged Homeopathic manufacturers to go through the FDA approval process before granting these dilute natural medicines OTC drug status.
The Federal Food, Drug, and Cosmetic Act (the Act) recognizes as official the drugs and standards in the Homeopathic Pharmacopeia of the United States and its supplements (Sections 201 (g)(1) and 501 (b), respectively). Until recently, homeopathic drugs have been marketed on a limited scale by a few manufacturers who have been in business for many years and have predominantly served the needs of a limited number of licensed practitioners. In conjunction with this, homeopathic drug products historically have borne little or no labeling for the consumer. Today the homeopathic drug market has grown to become a multimillion dollar industry in the United States, with a significant increase shown in the importation and domestic marketing of homeopathic drug products.
Here is a little background: in 1938, in early FDA formation legislation, Sen. Royal Copeland (D-NY) succeeded in getting homeopathic drugs exempted from the usual drug approval process. In those days, FDA only had authority to require safety evaluation, but when an evaluation of efficacy was added homeopathic medicines remained exempt, because they had been around for hundreds of years were generally regarded as safe. Today, FDA required human trials cost more than $250 million dollars for each new drug approved. It appears that the FDA wants this money back and Big-Drug Companies want to get rid of the competition so that consumers don’t have access to any alternatives other than prescription drugs that have gone through the FDA multi-million dollar process
For anyone who knows anything about homeopathy, nothing could be safer than homeopathic remedies. And millions of Americans use them because they work safely and often more quickly than drugs, without the side effects. What has rankled the FDA is the fact that they cannot require new homeopathic medicines to pay their fees and submit to their approval or disapproval process. In the eyes of the FDA, it seems that the besetting sin of homeopathic preparations, as with supplements, is that they can under certain circumstances compete with FDA-approved Big Pharma drugs—the very drugs that pay the FDA’s salaries.
Aren’t homeopathic remedies already regulated by the FDA?
The short answer is, absolutely! Although they do not need to go through the New Drug approval process, they must undergo pre-market approval with a monograph from the Homeopathic Pharmacopoeia of the United States (HPUS), which involves some clinical verification of the efficacy of the substance. And the FDA has strict guidelines that must be followed for any new homeopathic medicine to be approved as homeopathic.
Since 1988, prescription and non-prescription drug products labeled as homeopathic have been manufactured and distributed without FDA approval under the enforcement policies set forth in FDA’s Compliance Policy Guide (CPG) 400.400 entitled “Conditions Under Which Homeopathic Drugs May be Marketed” (see 53 FR 21728, June 9, 1988). The CPG defines a homeopathic drug as any drug labeled as being homeopathic which is listed in the HPUS, an addendum to it, or its supplements. The CPG includes conditions specific to ingredients, labeling, prescription status, and current good manufacturing practice. The CPG can be found at: http://www.fda.gov/iceci/compliancemanuals/compliancepolicyguidancemanual/ucm074360.htm.
What does the FDA really want?
The FDA’s recent moves are probably intended to gain tighter control of homeopathy and make it harder for manufacturers to make so many products that compete with other prescription drugs made by Bid Drug Companies that have to go through the FDA multi-million dollar approval process. The efforts follows several court cases in California against Boiron, the world’s leading homeopathic manufacturer. In one case, the plaintiffs alleged that Boiron claimed that its Children’s Coldcalm product would provide relief from cold symptoms.
You can read our more detailed coverage of these cases here. But the takeaway is this: in none of the cases did the plaintiffs say they were physically harmed. They merely claim that the products did not relieve their symptoms as was claimed they would, and that they suffered minor economic loss by purchasing the product. (So apparently if your cough medicine doesn’t work well enough for you, you should sue the company!) Care to guess who initiated these cases? Upset consumers—or lawyers calculatedly trying to earn settlement fees?
For readers new to homeopathy, treatment is based on the idea that “like treats like.” When you chop a red onion, for example, it causes watery eyes and a runny nose in most people. Allium cepa is a remedy created from red onion; in very small doses, Allium cepa is intended to activate the body’s own mechanism for stopping watery eyes and a runny nose.
Practitioners of conventional medicine are often hostile toward homeopathy: one commentator called homeopathy “a fraud perpetrated on the public with the government’s blessing.” This kind of response is understandable considering that homeopathic medicine is often so diluted that the original ingredient is virtually undetectable. The mechanism of action is therefore uncertain. But there is scientific support for efficacy, in addition to anecdotal evidence from centuries of use.
Scientific Evidence Supporting Homeopathy
Here are some scientific studies from the past ten years showing that homeopathy can indeed be effective. These studies—which range from random controlled trials (RCTs, the supposed “gold standard”) to observational studies to meta-analyses—often look at homeopathy as an adjunct to conventional medicine. Here is just a sampling:
- Acute otitis media (when the middle ear gets blocked with fluid and infected with bacteria): a 2012 RCT showed that symptomatic improvement was quicker in the homeopathy group than the conventional therapy group, with a much lower antibiotic requirement.
- Allergies: a 2012 observational study revealed that homeopathy substantially improved allergy symptoms and the dosage of conventional medicine could be substantially reduced; a 2013 study listed the effectiveness of different homeopathic treatments for allergies based on the type of allergy.
- Asthma: in a study of individualized homeopathic treatment, there was evidence that it decreased the severity of asthma in children.
- Other studies show effectiveness of homeopathy for conditions ranging from chicken pox, diarrhea, and in a multi-center observational study, chronic sinusitis. Homeopathy could be an effective treatment for low-grade chronic inflammation, which is the root of many diseases, and could be a complement to conventional anti-tubercular treatment (a finding that is especially important as patients are becoming resistant to TB drugs).
- Further, as our friends at ANH-Europe have reported, the Swiss government reviewed a large body of evidence in 2011–2012 and found homeopathy to be both effective and cost-efficient.
Much more research is needed despite the abysmal lack of funding for it. At the very least there is promising evidence supporting homeopathy. What we don’t need now is for the FDA to move to shut it down when the industry is already under unfair attack in California.
The timing of this is critical—it will be much easier for the FDA to hear us now, before the issue gains momentum. Write to the FDA immediately and tell them that current regulation of homeopathic remedies is more than sufficient to ensure public safety. Please send your message today!