Agency officials say clinical studies needed for health claims
Posted Oct. 28, 2015
Federal Trade Commission officials are considering whether homeopathy product advertisements have evidence to back their claims.
Michelle Rusk, senior staff attorney in the FTC advertising practices division, said in a public hearing Sept. 21 on over-the-counter homeopathic products that advertisements lauding the health benefits of medical products need to be based on competent, reliable, and rigorous scientific support.
“As a general rule, for treatment claims, we expect randomized, double-blind, placebo-controlled human clinical studies—not in vitro studies, not animal studies, not anecdotal evidence, no matter how compelling it is,” she said. “Second, we expect the studies to be internally valid. That means well-designed, reliably conducted, using procedures accepted in the field of research. It also means that results are not just statistically significant but also strong enough to be clinically meaningful.
“Third, the evidence has to match the product and the specific claim.”
The law enforcement agency is responding to decades of growth in the market for over-the-counter homeopathy products. And its examination coincides with the Food and Drug Administration’s reconsideration of a 1988 policy that allows, without FDA approval, the manufacture and sale of products listed in the Homoeopathic Pharmacopoeia of the United States.
The FDA policy applies to prescription and over-the-counter products, together totaling about $3 billion in annual sales, according to agency figures.
The FTC is accepting comments on its evaluation through Nov. 20 .
||Michelle Rusk, senior staff attorney in the Federal Trade Commission's advertising practices division, describes in a public hearing the commission’s expectations for evidence backing products with health claims. This still frame was taken from video provided by the FTC. (Courtesy of the FTC)
Homeopathy is based on the principles that diseases can be treated with substances that would cause similar symptoms in healthy individuals and that those substances can become more powerful when diluted and subjected to “succussion,” or agitation by beating their containers against solid surfaces. The dilutions are based on a centesimal scale in which a 1C mixture is one unit of a treatment in 100 units of solution, and 2C is a 1-in-10,000 dilution, with those greater than 12C considered to be of high potency.
In opening remarks at September’s hearing, FTC Commissioner Maureen K. Ohlhausen said the FTC wants to ensure the public has accurate and reliable information about products they buy, and agency officials have indications people are buying homeopathic products on the basis of incomplete information. Many in the public believe FDA or manufacturers test the products for efficacy, and side-by-side placement with conventional drugs in stores is confusing, as are the terms used on homeopathy products.
The commissioner cited as an example the terms used to describe product dilution that results in near-undetectable traces of the products in alcohol or water.
The FTC also is urging that FDA officials reconsider their homeopathic product policies, which could conflict with FTC policies on advertising substantiation, harming consumers and confusing advertisers. In comments submitted to the FDA, the FTC officials cite evidence of public lack of understanding about homeopathy, regulation of homeopathic products, and the level of scientific evidence supporting homeopathic claims.
Elaine C. Lippmann, regulatory counsel for the Food and Drug Administration, said during September’s hearing that those in the FDA are deciding whether the time is right to adjust enforcement policies to better reflect the variety, volume, and complexity of homeopathic products on the market. Safety, quality, and policy concerns have emerged in recent years, she said.
Kathleen Dunnigan, senior staff attorney for the national advertising division of the Council of Better Business Bureaus, also advocated in the hearing that health performance claims, including those on product labels, be backed by scientific evidence. She described the advertising division as a self-regulatory forum used by competitors in varied industries to challenge one another’s claims, as well as operator of a program that asks for substantiation of claims in industries where competitors tend not to challenge one another, particularly the cosmetic, dietary supplement, and homeopathy industries.
Presence in the homeopathy pharmacopeia alone is insufficient, she said.
“Also, generally speaking, homeopathic provings, in vitro studies, and animal studies are also not considered on their own to be competent and reliable scientific evidence,” she said.
A “proving” in homeopathy involves administering a substance to healthy individuals and recording their reactions.
Health claims can be powerful, touching on fears and vulnerabilities, Dunnigan said. Buyers are reasonable in assuming the products were tested on humans.
Paul Herscu, director of the New England School of Homeopathy, argued during the hearing in favor of the types of trials used by homeopaths.
“While randomized control trials have propelled science forward and propelled medicine forward, it is, in a sense—and this is not a homeopathy comment, it is a scientific comment—it is a blunt, vague instrument,” Herscu said. “It does not correspond to reality very well.
“Simply put, it fits within the model of the 1950s and 1970s, not in medicine of 2015.”
Al Lorman, an attorney speaking on behalf of his client the American Association of Homeopathic Pharmacists, said people surveyed by the AAHP have indicated they knew homeopathic products did not have the same evidence as that supporting FDA-evaluated drugs, and the FDA’s existing policy shows the agency's recognition that “Congress may well have adopted a different standard of effectiveness for homeopathic drugs.” Lorman thinks most homeopathy products carry disclaimers indicating the FDA has not evaluated the product claims, and he said at least one survey had indicated people were less likely to think the products were FDA-approved when they saw such disclaimers.
But he said the AAHP is willing to give consumers more information and comply with the FTC’s legal standard, and the organization would rather cooperate than litigate. If the FTC were to require that advertising be backed by clinical trials equal to those used in gaining FDA approval, he said, makers of homeopathic products likely would cease advertising rather than endure those costs.
But Rusk, of the FTC, said disclaimers about lack of FDA approval fail to fully address consumer misunderstandings.
“A claim that a product is effective to treat a certain condition carries with it the implied claim that the advertiser, in fact, has done the research to know that it’s effective for that condition,” she said.
In the absence of that research, “the claim is misleading.”
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