By Mary Borneman, Sr. Director of Communications & Public Affairs, Hyland’s, Inc.
March 1, 2017
It’s not news that the Internet and access to information has created what one could argue is the most knowledgeable consumer any business has ever had. From using crowdsourcing and reviews to determine the best electronic or household appliance to seeking recommendations and insights into health care options, today’s consumer uses all the resources at her disposal to make the most informed decision possible for herself and especially for her family. Even with the newer technologies, though, labeling remains an important factor in consumer decision-making and the responsibility lies with the manufacturer to ensure its product labels are as informative as possible to the consumer. This is true for the homeopathic medicine manufacturers in the United States as well.
In 1988, the Food and Drug Administration (FDA), working with the homeopathic industry, developed Compliance Policy Guide 400.400, Conditions Under Which Homeopathic Medicines May be Marketed (CPG). While the Federal Food, Drug, and Cosmetic Act of 1938 recognizes homeopathic medicines as “drugs,” the CPG provides additional labeling requirements for compliant marketing of over-the-counter (OTC) homeopathic drugs in the United States, including that all homeopathic drug products must state “homeopathic” prominently on drug labels.
Over the course of the last 25 years, the CPG has stood the test of time, allowing homeopathic medicines to be more accessible to consumers and setting the standards for high-quality medicines. In fact, at a hearing in April 2015 by the FDA to assess its effectiveness, the overwhelming testimony was in favor of the CPG as it stands. Doctors, practitioners, patients, manufacturers and even regulators spoke to how the CPG has ensured consumers access to safe, effective and natural health care options.
Of course, in 25 years and in a more informed consumer age, there are certainly opportunities for improvement as well. Regulatory agencies have expressed concern that consumers do not know that FDA does not approve homeopathic medicines and that consumers assume all claims are backed by the same clinical studies as allopathic medicines. While there is no clear evidence this is the case, in its submission to the Federal Trade Commission (FTC) workshop on homeopathic products in 2015, AAHP presented data that demonstrate the use of appropriate disclaimers in advertising and on labels can alleviate any perceived consumer confusion.
With the first operating principle in AAHP’s mission statement to encourage regulatory compliance among its members, AAHP is committed to providing best-in-class guidance and education to its membership. For that reason, in August 2012, AAHP adopted revisions to its long-standing advertising guideline to provide that:
Advertising to consumers for an OTC homeopathic drug should include the following statement:
“These statements have not been reviewed by the Food and Drug Administration.”
Additional language which explains the homeopathic nature of the claim may also be included in conjunction with the statement above.
FTC has expressed a concern that the consumer is confused by the FDA’s role bringing a homeopathic drug product to market. It is the AAHP’s position that the disclaimer above can help improve consumer comprehension.
In 2015, AAHP funded a study in which the researcher found that most consumers are aware that allopathic and homeopathic drugs are not the same. The study demonstrated that 76 percent of consumers understood that FDA reviewed claims for allopathic OTC drugs, while only 24 percent thought the same about FDA reviewing claims for homeopathic OTC drugs. In another study, the same researcher further tested the use of disclaimers on consumer perception. The key finding of this study was that, when a homeopathic drug bears a label disclaimer, only between one percent and eight percent of consumers believe that homeopathic drug claims are approved by FDA — a marked improvement!
As noted in AAHP’s submission to FTC:
These two studies, taken together, show both that consumers: (1) understand the limited role that FDA plays in reviewing homeopathic drug products, and (2) that disclaimers are an excellent way to inform consumers about the role of FDA in the marketing of homeopathic drugs.
The FTC’s November 2016 guidance on advertising and marketing claims for homeopathic drugs further substantiates the benefits of a disclaimer in improving consumer comprehension of the benefits and limitations of homeopathic drug products, making AAHP’s current voluntary advertising and labeling mandatory. And FTC has made it clear that the AAHP’s current disclaimer is insufficient in their opinion. FTC argues that the disclaimer should inform consumers that FDA has not approved the product, the science upon which claims are made and the science that is not used for making such claims. For example, FTC wants to see a disclaimer that states FDA has not approved the claims, that the claims are based on homeopathic practice or tradition and that the claims are not based on “modern science.” Clearly this last point is one of contention and should be considered carefully as we move forward.
AAHP has taken steps to commission a study to determine the most effective standard to meet the FTC’s needs, remain true to the nature of homeopathic literature and inform the consumer of what they are buying. In the meantime, manufacturers are strongly encouraged to review their labeling and advertising to ensure claims are for self-limiting conditions and bear a disclaimer as recommended by the AAHP’s advertising guidelines. Consumer understanding of homeopathic drug products will only be enhanced if every company consistently discloses “homeopathic” prominently and disclaims as discussed.