Required Labeling Elements. Dietary supplement labeling under FDA’s primary  jurisdiction includes, among other things, packaging, inserts, and  information at the point of sale. Enforcement. We identified 490 memory  supplement products associated with 1,590 total examples of memory  supplement marketing through a review of five media channels over a 2- month period. Specifically, as table 2 below indicates, about 96 percent  of marketing we identified appeared on the Internet. After reviewing these  potential disease-related claim examples, FDA preliminarily determined  that 27 of the 28 examples appeared to be disease claims—claims to  treat, cure, or prevent a disease—which are generally prohibited in the  labeling of dietary supplements and cause the product to be regulated as  a drug. FDA officials also reported that they would continue monitoring  all of the examples that were identified. Similar Types of Enforcement and Outreach for Memory Supplements Taken by FDA and FTC Align with Their Agency Priorities

FDA and FTC have taken similar types of enforcement actions for  memory supplements as for other dietary supplements between 2006 and  2015—with FDA taking mostly advisory actions and a few regulatory  actions (administrative and judicial court actions), and FTC taking a mix of  administrative and judicial actions. In prioritizing  what enforcement actions to take and how to conduct outreach related to  memory supplements, the agencies focus on safety and the  egregiousness of deception or impact of the supplement’s marketing, as  they do with all dietary supplements. FDA and FTC Have Conducted Some Outreach on Dietary Supplement Use by Older Adults, as Well as Some Specific Outreach about Memory Supplement Enforcement Actions

FDA and FTC have conducted some outreach aimed at industry and  consumers on dietary supplements generally, including dietary  supplement use by older adults, as well as some outreach accompanying  enforcement actions specifically involving memory supplements. Limited Market Information Poses Oversight Challenge for FDA, While Consumer Groups Reported Uncertainty about FDA and FTC Roles Overseeing Internet Marketing

FDA faces oversight challenges related to limited information about the  dietary supplement market, including memory supplements, and limited  information on NDIs to inform oversight efforts. FDA officials said the  agency is exploring ways to improve information available for oversight by  obtaining additional market information. Also, while dietary supplement  marketing on the Internet was said to be a concern for agencies and  consumer and industry groups, we found that consumer groups were  unclear about how FDA and FTC share oversight of Internet marketing. Few documents explicitly delineate their differing roles and coordination in  oversight, or communicate the differing roles to industry and consumers. As a result, consumers may be unclear on which agency to report  concerns to involving Internet marketing of dietary supplements. Consumer complaints are an important tool for both agencies to learn  about potential dietary supplement problems, according to agency  officials. FTC  officials feel their existing tools and information to identify supplement  issues—such as consumer tips, and proactive media monitoring—are  sufficient to identify issues. FDA and FTC Have Provided Limited Guidance Delineating Their Shared Oversight of Memory Supplement Marketing on the Internet

FDA and FTC share oversight of dietary supplement Internet marketing,  including memory supplements, but consumer groups told us the  delineation of their differing roles was unclear—particularly with regard to  FDA’s role—and we found that few documents explain the agencies’  differing roles and coordination in overseeing Internet marketing. Such actions would be in line with federal  internal control standards that state that agencies should communicate  quality information with external parties to achieve objectives. We have also  previously reported that delineating roles and responsibilities, as well as  developing ways to continually update and monitor written agreements,  are issues agencies should consider when collaborating. Recommendations for Executive Action

To enhance consumer understanding of agency oversight roles and to  strengthen agency oversight of Internet marketing, we recommend that  the Secretary of the Department of Health and Human Services and the  Chair of the FTC develop and provide additional guidance to consumers  delineating the agencies’ differing roles in their shared oversight of  memory supplement and other dietary supplement marketing on the  Internet. Appendix I: Objectives, Scope, and Methodology

This report examines: (1) how memory supplements are marketed, and  the extent to which the marketing targets older adults and is potentially  deceptive or inconsistent with federal requirements; (2) what enforcement  and outreach actions the Food and Drug Administration (FDA) and  Federal Trade Commission (FTC) have undertaken in overseeing  memory supplements and their marketing; and (3) what challenges FDA  and FTC face in overseeing memory supplements. Internet: We identified pertinent sources for memory supplement  marketing on the Internet using relevant demographic survey data.
Why GAO Did This Study

Memory supplements—dietary supplements claiming to improve memory—are a growing market, with sales estimated at $643 million in 2015, almost double 2006 sales. FDA and FTC share oversight of memory supplement marketing—labeling and advertising claims—but generally do not approve claims before products are marketed.
GAO was asked to review memory supplement marketing and oversight. This report examines (1) how memory supplements are marketed and the extent marketing targets older adults and may violate federal requirements; (2) related enforcement and outreach actions taken by FDA and FTC; and (3) challenges to agency oversight.
GAO reviewed five types of media (Internet, television, among others) to identify examples of memory supplement marketing practices and potential violations of federal requirements. GAO selected these channels using demographic and survey data relevant to older adults. GAO analyzed FDA and FTC data on enforcement actions for fiscal years 2006 through 2015—the most recent data available. GAO also reviewed relevant agency oversight policies, interviewed agency officials, and interviewed selected consumer and industry groups.

What GAO Found

GAO's market review during a 2-month period found most examples of memory supplement marketing on the Internet. About 96 percent of marketing identified appeared on the Internet, and a total of 490 memory supplement products were identified by the market review. GAO found 28 examples of advertisements that linked supplement use to treatment or prevention of memory-related diseases, which is generally prohibited by federal law. Food and Drug Administration (FDA) officials subsequently determined that 27 of these examples appeared to violate federal requirements. Officials reported that they had issued two advisory letters to two firms and would continue monitoring all of the examples that were identified.
Oversight of memory supplements falls under FDA's general authority to regulate dietary supplements and their labeling, and the Federal Trade Commission's (FTC) general authority to enforce the prohibitions against deceptive advertising. Between 2006 and 2015, FDA and FTC have taken similar types of enforcement actions for memory supplements as for other dietary supplements—with most FDA actions being warning letters and FTC actions being a mix of administrative and federal court actions. Nineteen of 551enforcement actions involved memory supplements. The agencies coordinate enforcement actions in the same way for all dietary supplements. FDA and FTC have done some outreach to industry and consumers on dietary supplement use by older adults as well as some specific outreach related to memory supplement enforcement actions. In prioritizing enforcement and outreach efforts, the agencies focus on safety, egregiousness of deception, and impact of marketing.
FDA faces challenges related to limited information about the dietary supplement market, including memory supplements, to inform its oversight efforts. FDA officials said the agency is exploring ways to obtain additional market information to improve its oversight. FTC officials believe their existing tools and information are sufficient to inform its oversight efforts. While Internet marketing of dietary supplements was a concern for agencies, consumers, and industry groups, GAO found that consumer groups were unclear about FDA's and FTC's roles for overseeing supplement marketing found on the Internet. FDA and FTC share oversight of marketing on the Internet, with FTC exercising primary jurisdiction over advertising on the Internet and FDA exercising primary jurisdiction over aspects considered to fall under labeling, including information provided at the point of sale. However, few documents explicitly delineate their differing roles and coordination in oversight, or communicate the roles to industry and consumers. Federal internal control standards state that agencies should communicate quality information with external parties to achieve objectives, and GAO has also previously reported that delineating roles and responsibilities are issues agencies should consider when collaborating. Absent clarification of FDA and FTC roles, consumers may not understand which agency to report concerns to involving Internet marketing, and there is a risk that agencies may not receive consumer complaints directly, which may delay agencies taking action to address a problem. Consumer complaints are an important tool for both agencies to learn about potential dietary supplement issues, according to agency officials.

What GAO Recommends

GAO recommends that FDA and FTC provide additional guidance to consumers clarifying the agencies' differing roles in their shared oversight of memory supplement and other dietary supplement marketing on the Internet. The two agencies concurred with GAO's recommendation.