The Food and Drug Administration (FDA) must take a much firmer stance on the manufacturing and marketing of homeopathic health products, said the Center for Inquiry (CFI) in comments submitted to the FDA March 26, urging the agency to take seriously its duty to inform and protect American consumers from wasteful and dangerous fake medicine. CFI called for the agency to expand the scope of its Draft Guidance for Drug Products Labeled as Homeopathic1 to fulfill its responsibility to the American people and ensure that these pseudoscientific products are properly tested and labeled.
“Homeopathy is a sham. About this, there is no doubt whatsoever. Every piece of credible scientific research has demonstrated that it has no effect of any kind other than as a placebo,” said Nick Little, CFI’s vice president and general counsel. “Nonetheless, this modern-day snake oil exists in a shadow legal status, where it can be sold without being subject to the same testing and labeling requirements that real, science-based medicine must follow. It is a recipe for waste, fraud, and tragedy.”
The FDA’s draft guidelines suggested a risk-based approach, focusing on the regulation of homeopathic products when the ingredients or method of administration pose particular dangers, the condition it claims to treat is particularly serious, the target population is particularly vulnerable (such as children or the elderly), or when the product is revealed to be tainted. However, the draft also recommended the withdrawal of the existing Compliance Policy Guide regarding homeopathy.
In its comments, CFI drew the FDA’s attention to the absence of evidence for the efficacy of homeopathic products and the absurdity of the claims made as to the nature of homeopathy. For example, homeopaths maintain their products become stronger the more diluted they are. The homeopathic product Oscillococcinum, marketed to reduce the duration and severity of flu symptoms, contains the heart and liver of the Muscovy duck, diluted to a level of 200C, leaving one part of alleged active ingredient to every 10400parts of water. For reference, current estimates suggest that the known universe contains up to 1082 atoms.
“We enthusiastically support the FDA coming down hard on homeopathy where the products are tainted or sold as miracle cures for fatal diseases,” said Little. “But that’s not nearly enough. Americans waste billions of dollars every year on homeopathic sugar pills. The FDA has a duty not just to those poisoned by homeopathy, but also to those fleeced of their hard earned dollars.”
CFI requested that the FDA use its existing power to ensure homeopathic products are required to pass the same safety and efficacy tests applied to non-homeopathic drugs. Alternatively, CFI asked that at the very least the FDA mandate that homeopathic products carry labels indicating they have not been evaluated for safety or effectiveness by the FDA and list in plain English the claimed active ingredient in the product and its quantity.
“Consumers have a right to the truth about the medical products they purchase,” said Little. “Homeopathic manufacturers should not be allowed to hide behind archaic ingredient names and mystifying measurement systems on their labeling. That’s why CFI has already filed a complaint with the District of Columbia Attorney General’s office regarding the marketing of homeopathic products.”
- 1. https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM589373.pdf.