On November 15, 2016, the Federal Trade Commission (FTC) released a new Policy Statement on marketing claims for over the counter (OTC) homeopathic drugs. The Policy Statement is here and the press release and accompanying report are available here and here. The Policy Statement signals the end of the FTC’s decades-long approach of rarely challenging misleading claims for products that were or claimed to be homeopathic. Going forward, homeopathic OTC drugs, like all other OTC drugs, will have to support their claims with competent and reliable scientific evidence or risk an FTC enforcement action.
Background on homeopathic drugs with FDA and FTC
The FTC’s Policy Statement is the culmination of several years of work by the FDA and the FTC to reexamine homeopathic products and their claims of efficacy. Since 1988, FDA has permitted the marketing of homeopathic OTC drugs pursuant to Compliance Policy Guide (CPG) 400.400 Conditions Under Which Homeopathic Drugs May be Marketed (revised Mar. 1995). The CPG permitted marketers to distribute OTC homeopathic products without demonstrating their efficacy; marketers were able to rely upon over 100 years of traditional homeopathic principles, without possessing any modern, scientific data.
In 2015, FDA held a public meeting and called for comments for the purpose of reexamining the CPG. FDA noted a significant increase in both the sales of homeopathic drugs and adverse events, particularly adverse events involving children. FDA has had to issue health warning regarding the use of homeopathic drugs for infant teething and asthma products.
The FTC conducted its own workshop on homeopathic drug promotion in September 2015. The purpose was to examine homeopathic products and claims, how the products were marketed, and what substantiation existed for homeopathic product efficacy claims.
The FTC finished its work first and the release of the Policy Statement signals a much more difficult environment for continued marketing of OTC homeopathics.
The Policy Statement
In the Policy Statement, the FTC explains that “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.” This places OTC homeopathic drugs at odds with other health products, OTC drugs, and dietary supplements. “For health, safety, or efficacy claims, the FTC has generally required that advertisers possess competent and reliable scientific evidence, defined as tests, analyses, research, or studies that have been conducted and evaluated in an objective manner by qualified persons and that are generally accepted in the profession to yield accurate and reliable results.” Policy Statement at 1-2 (footnotes and internal quotations omitted). The FTC announces that, going forward, homeopathic OTC drugs that rely upon traditional homeopathic principles for substantiation and do not possess competent and reliable scientific evidence to substantiate therapeutic claims, “lack a reasonable basis and are likely misleading in violation of Sections 5 and 12 of the FTC Act.”
Trying to qualify any unsubstantiated product claim probably won’t work
The FTC recognizes that a marketer might be able to qualify its lack of competent and reliable scientific substantiating evidence by prominently disclosing to consumers that:
- There is no scientific evidence that the product works; and
- The product’s claims are based only on theories of homeopathy from the 1700s that are not accepted by most modern medical experts.
Policy Statement at 4.
The FTC concedes it may difficult to craft an adequate disclaimer as “Marketers should not undercut such qualifications with additional positive statements or consumer endorsements reinforcing a product’s efficacy.” In other words, even with the prominent disclaimer, a marketer will not be able to claim its homeopathic OTC drug works unless it has competent and reliable scientific evidence substantiating that claim.
The FTC and FDA have long been skeptical of homeopathic claims but have typically taken a “do no harm approach.” So long as the products were safe and labeled for mild, self-limiting conditions that would, eventually, go away on their own, the only harm to patients was the loss of paying for a product that didn’t work. The increasing size of the market and the fact that some products were shown to actively harm consumers spurred the agencies to action. The FTC got there first and its enforcement is not limited to the typical FDA-type warning letter. The FTC can, and does obtain monetary settlements and disgorgement or profits, extracts commitments that extend for many years, and can impose marketing conditions upon large swathes of a company’s portfolio. The Policy Statement signals a reversal of the FTC traditional hands-off stance to homeopathics; homeopathic marketers will need to closely (and quickly!) examine their products and claims to assess risk and immediately align with the Policy Statement to avoid enforcement.