For Immediate Release: April 13, 2020
Contact: Center for Inquiry
firstname.lastname@example.org - (716) 636-4869
Makers of homeopathic drugs must be held accountable for the safety and efficacy of their products, the Center for Inquiry told the Food and Drug Administration, urging the agency to take long-overdue action to protect American consumers from risking their health on useless snake oil.
In public comments filed with the agency, the Center for Inquiry (CFI) writes that the FDA’s latest draft guidelines on homeopathic drugs give enormous leeway to manufacturers, largely excusing them from laws that apply to other evidence-based pharmaceuticals except in the most high-risk cases. This is in spite of the fact that the FDA has itself recognized that homeopathy is not effective and has issued numerous warnings to both consumers and manufacturers.
Pointing out the folly of an enforcement approach that gives the benefit of the doubt to the “inherently predatory” manufacturers of homeopathic drugs, CFI writes, “The theory of homeopathy is so scientifically implausible that manufacturers of these products cannot be assumed to act in good faith in accordance with drug safety and efficacy and consumer protection laws.”
Homeopathy is an eighteenth-century pseudoscience premised on the absurd, unscientific notion that ailments can be treated by ingesting dangerous substances thought to cause a particular symptom. Those substances are diluted to the point that no trace of the active ingredient remains. Homeopathic treatments have no effect whatsoever beyond that of a placebo.
“The FDA knows that homeopathic drugs have not been scientifically proven to safely or effectively treat any ailment, said Jason Lemieux, CFI’s Director of Government Affairs. “Now that we’re in the middle of a pandemic with patients being inundated by misinformation about false cures and miracle drugs, it’s more important than ever for the FDA to take a firm stand for Americans’ health and against pseudoscience profiteers.”
CFI calls upon the FDA to retain its detailed instructions for compliance with the Federal Food, Drug, and Cosmetic Act that were included in its previous enforcement guidance for homeopathic drugs. Makers of homeopathic drugs have long flouted the FD&C Act, refusing, for example, to print drug labeling with homeopathic ingredients in plain English, as opposed to the more “scientific” sounding Latin, which serves to deceive and confuse consumers. The FDA’s previous guidance, first issued in 1988, required manufacturers to translate ingredient names “as current labeling stocks are depleted, or by June 11, 1990, whichever occurs first.”
“The requirement to translate ingredient names from Latin to English is more relevant than ever,” writes CFI. “To remove this requirement effectively condones this deceptive practice and tacitly encourages homeopathic manufacturers to violate other FDA regulations. FDA should retain this requirement and renew its commitment to enforcement of it.”
The Center for Inquiry is currently engaged in consumer protection lawsuits against Walmart and CVS for their deceptive sale and marketing of homeopathic medicine, holding the mega-retailers to account for betraying the trust of tens of millions of customers. Last year, CFI conducted a survey of Americans to measure the public’s knowledge and trust of homeopathy. In the study, a large percentage of consumers reported feeling “ripped off” and “deceived” by homeopathic retailers once they learned about the pseudoscience of homeopathy The survey’s respondents also showed increased support for stricter regulation by the FDA.
In 2015, CFI was invited by both the FDA and the Federal Trade Commission (FTC) to provide expert testimony on the sale and marketing of homeopathy, which led the FTC to announce that the marketing of homeopathic drugs for specific diseases and symptoms is only acceptable if consumers are told: “(1) there is no scientific evidence that the product works and (2) the product’s claims are based only on theories of homeopathy from the 1700s that are not accepted by most modern medical experts.”