FTC has issued an enforcement policy statement that could spell trouble for a centuries-old alternative field of medicine that generates billions in sales: homeopathy.
Earlier this month, the agency revealed it would hold efficacy and safety claims for over-the-counter (OTC) homeopathic drugs to the same standard as products making similar assertions. Health-related claims must be backed, or substantiated, by competent and reliable scientific evidence. Generally, the agency requires human clinical tests for claims that a product can treat a disease.
FTC, which is responsible for cracking down on unfair or deceptive practices in advertising and labeling, has long held health and safety claims to the same substantiation standard. However, the agency acknowledged it has “rarely challenged misleading claims for products that were homeopathic or purportedly homeopathic."
Homeopathy, dating back to the late 1700s, is grounded in “the notion that a disease can be cured by a substance that produces similar symptoms in healthy people," according to the National Institutes of Health’s National Center for Complementary and Integrative Health (NCCIH). Homeopathy also subscribes to the idea that “the lower the dose of the medication, the greater its effectiveness," the NCCIH says on its website.
Homeopathic remedies derive from animals, minerals and plants, such as crushed whole bees, poison ivy and stinging nettle. However, most modern medical experts have rejected homeopathic product claims, and many products are so diluted that they fail to contain detectable levels of the initial substance, according to FTC.
“For the vast majority of OTC homeopathic drugs, the case for efficacy is based solely on traditional homeopathic theories and there are no valid studies using current scientific methods showing the product’s efficacy," FTC declared in its enforcement policy statement. “Accordingly, marketing claims that such homeopathic products have a therapeutic effect lack a reasonable basis and are likely misleading in violation of Sections 5 and 12 of the FTC Act."
Nevertheless, the agency said certain disclaimers to consumers could prevent a statement from being misleading even if the promotion of an OTC homeopathic product isn’t substantiated by competent and reliable scientific evidence. Specifically, the promotion of an OTC homeopathic product must effectively convey to consumers that:
(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.
The agency cautioned “perfunctory disclaimers are unlikely" to be adequate to avoid a misleading claim.
“The Commission will carefully scrutinize the net impression of OTC homeopathic advertising or other marketing employing disclosures to ensure that it adequately conveys the extremely limited nature of the health claim being asserted," FTC stated in the enforcement policy statement. “If, despite a marketer’s disclosures, an ad conveys more substantiation than a marketer has, the marketer will be in violation of the FTC Act."
The Center for Inquiry, a nonprofit organization that has been critical of homeopathy, welcomed FTC’s announcement.
“Consumers can’t help but be confused when snake oil is placed on the same pharmacy shelves as real science-based medicine, and they throw away billions of dollars every year on homeopathy based on its false promises," said Michael De Dora, public policy director of the organization, in a statement.
FTC’s divulged enforcement policy was not the only recent development causing turmoil for the industry.
Last month, The New York Times reported FDA was investigating 10 infant deaths possibly related to the use of homeopathic teething gels and tablets. The newspaper said the agency also received reports of seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness and agitation after children had taken homeopathic teething products. In September, FDA warned consumers that such products may pose a risk to infants and children.
Hyland’s, one of the companies which distributed teething gels and tablets, said it was unaware of “any medical or statistical evidence to support a causal link between homeopathic testing tablets and adverse outcomes at this point." However, in a letter to parents on its website, the company said it had decided to discontinue the distribution of teething medicines in the United States.
Responding last month to FDA’s investigation of serious adverse events linked to homeopathic teething products, the National Center for Homeopathy defended the industry.
“Homeopathy has a laudable and extensively documented clinical record and there are hundreds of high quality, peer-reviewed basic science, pre-clinical, and clinical studies showing its efficacy and safety," the organization asserted in a statement. “There are no studies linking homeopathically-prepared medicines and serious adverse events."
Since 1988, homeopathic companies have distributed drug products without FDA approval under conditions set forth in a compliance policy guide. But the agency has reminded homeopathic companies in warning letters that they may only market a homeopathic product as an OTC drug if is amenable to self-diagnosis and treatment.
The American Association of Homeopathic Pharmacists, and several other homeopathic entities, did not immediately respond to requests for comment on FTC’s enforcement policy statement.