Indeed, the FDA and FTC have both been mulling over how to best regulate this class of products, and just last year, the National Health and Medicine Research Council (NHMRC), Australia’s expert medical body, issued a report detailing their findings regarding the efficacy of homeopathic medicines.
Consumer fraud cases have been on the rise over the last decade, including cosmetics, dietary supplements, over-the-counter (OTC) drugs, among others, and have all been under scrutiny of the courts based on the lack of data supporting marketing claims.
Recently, the evidence supporting the efficacy of homeopathic therapies has come under increased scrutiny, making them a perfect target for consumer fraud.
Indeed, the FDA and FTC have both been mulling over how to best regulate this class of products, and just last year, the National Health and Medicine Research Council (NHMRC), Australia’s expert medical body, issued a report detailing their findings regarding the efficacy of homeopathic medicines. The NHMRC report concluded “…that there are no health conditions for which there is reliable evidence that homeopathy is effective.”
Briefly, for those who are not familiar with what homeopathy is, it is a practice of medicine based on three core principles: (1) Like cures like, (2) Dilution enhances potency, and (3) Give one remedy at a time. The remedies are prepared through a processof potentization in which the active ingredient is repeatedly diluted and vigorously agitated. While a full discussion of homeopathy is beyond the scope of this article, we direct our readers to other resources such as the American Institute of Homeopathy.
Of course, by using highly diluted medicines, questions have been raised as to how homeopathic medicines can be efficacious. Indeed, clinical studies have produced inconsistent results when it comes to testing the efficacy of homeopathic medicines under rigorous study designs. Proponents of homeopathy argue that randomized controlled trials (RCTs) do not provide the best assessment of the efficacy of these treatments since treatments are individually tailored to each patient.
The NHMRC Report
For the 2015 report, the NHMRC conducted a review of the scientific literature evaluating the effectiveness of homeopathic medicine.
The NHMRC identified and reviewed 57 systematic reviews, which included 176 controlled studies. According to the NHMRC, they concluded:
“…there are no health conditions for which there is reliable evidence that homeopathy is effective. Homeopathy should not be used to treat health conditions that are chronic, serious, or could become serious. People who choose homeopathy may put their health at risk if they reject or delay treatments for which there is good evidence for safety and effectiveness. People who are considering whether to use homeopathy should first get advice from a registered health practitioner. Those who use homeopathy should tell their health practitioner and should keep taking any prescribed treatments.” (NHMRC Report)
Further, in a media release by the NHMRC, they also noted that while some of the underlying studies did report that homeopathy was effective, these studies tended to be small and/or of poor quality, and thus, do not permit reliable conclusions to be drawn on the effectiveness of homeopathy.
Earlier this year, Dr. Paul Glasziou, Chair of the Homeopathy Working Committee tasked with producing the NHMRC report, stated in a post on the British Medical Journal’s blog that he “[began] the journey with an ‘I don’t know’ attitude, curious about whether this unlikely treatment could ever work.” He then went on to indicate that while he started with an open mind, he “lost interest after looking at the 57 systematic reviews (on 68 conditions) which contained 176 individual studies and finding no discernible convincing effects beyond placebo.”
He further elaborated that during the course of the review some RCTs actually reported positive results from the use of a homeopathic medicine. However, he noted that a certain number of studies would be expected to produce statistically significant results (p-values under 5%), just by chance:
“Of course, with 176 trials we would expect a few p-values under 5% just by chance: 1/20 of 176 is about 9 which luck would class as ‘statistically significant.’ So we relied on replication and systematic reviews to avoid such false positives … Though that body was mixed in size and quality, no clear signal of effectiveness emerged from the higher quality studies.”
Overall, while Dr. Glasziou acknowledges his report has generated considerable pushback from the homeopathic community, he stands by his conclusions.
So what does this mean for U.S. homeopathic companies making marketing claims for their products?
State of U.S. Regulations for Homeopathic Medicines
In the United States, homeopathic medicines are regulated by the FDA under the Federal Food, Drug, and Cosmetic Act. The current policy, summarized in section 400.400 of the Compliance Policy Guide, indicates that 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).”
The Homeopathic Pharmacopeia of the United States contains standards for source, composition, and preparation, as well as monographs for homeopathic treatments. Importantly, a homeopathic medicine’s compliance with the Homeopathic Pharmacopeia of the United States, does not establish that homeopathic medication as safe, effective, or not misbranded for its intended use.
This standard is very different from the FDA’s regulations for OTC and prescription medications, which require clinical data supporting the safety and efficacy of the drug prior to being marketed.
Further, the FTC, which oversees the advertising of all of these substances, requires competent and reliable scientific evidence to support marketing claims made for each product. This standard of evidence has raised questions regarding the claims of homeopathic medicines due to their inconsistent efficacy data.
On this note, the FDA recently held a public hearing and the FTC recently held a workshop, both regarding homeopathic medicines. The goal of FDA’s April 2015 public hearing was to obtain information and comments from stakeholders regarding the current use of human drug and biological products labeled as homeopathic, as well as the FDA’s regulatory framework for homeopathic medicines. The FTC’s workshop, in September 2015, evaluated the advertising of homeopathic products. To date, neither agency has published additional guidelines or news regarding the regulation of homeopathic medicines.
Given the wide interest in these products, and potential changes in how they are regulated, we expect consumer fraud litigation to follow alleging lack of efficacy from this class of products.
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