Memory Supplements: Clarifying FDA and FTC Roles Could Strengthen Oversight and Enhance Consumer Awareness
Published: 2017-05-16T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: 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.
section_title: What GAO Found
paragraphs: 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.
section_title: What GAO Recommends
paragraphs: 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.

section_title: Letter
paragraphs: Approximately 5.4 million Americans were living with Alzheimer’s disease  in 2016, a number that is projected to more than double by 2050 as baby  boomers age into their later years, according to the U.S. Department of  Health and Human Services’ (HHS) National Institutes of Health.  Alzheimer’s disease, considered the most common form of dementia, is a  progressive disease that begins with mild memory loss and has no known  cure. Consumers searching to prevent or treat age-related memory loss,  including Alzheimer’s disease, have increasingly turned to dietary  supplements for help. Scientific evidence shows that some dietary  supplements are beneficial for overall health and for managing some  health conditions; however, in some instances, dietary supplements have  caused serious adverse health effects. Specialty dietary supplements that  claim to address specific health issues, including those that claim to  improve or in other ways positively affect memory (referred to in this  report as memory supplements), have emerged in the market. The  memory supplements market reportedly almost doubled from 2006 to  2015, with total estimated sales increasing from $353 million to $643  million. Older adults are especially vulnerable to claims that promise to  prevent or reverse declines in cognitive function, according to the Federal  Bureau of Investigation.
HHS’s Food and Drug Administration (FDA) and the Federal Trade  Commission (FTC) share responsibility for overseeing the marketing of  dietary supplements, including the claims made on dietary supplement  product labels and in dietary supplement product advertising,  respectively. FDA regulates dietary supplements, including labeling,  under the Federal Food, Drug, and Cosmetic Act, including amendments  made by the Dietary Supplement Health and Education Act of 1994  (DSHEA). As part of its authorities over dietary supplements, FDA  exercises primary jurisdiction over dietary supplement labeling, which  includes marketing information accompanying the product. FTC is  responsible for preventing false advertising—advertising is defined  broadly to include traditional print and broadcast advertisements,  infomercials, Internet marketing, social media, press releases, and other  promotional materials—for dietary supplements and most other products  sold to consumers under the Federal Trade Commission Act. FDA and  FTC authorities are generally limited to after dietary supplements go to  market, and in most cases neither agency has premarket authority that  allows for approvals of labeling or advertising claims before dietary  supplements may be sold to consumers.
There is no federal law specifically regulating the subset of dietary  supplements we refer to in this report as memory supplements, and there  is no definition of a memory supplement in federal law. As a result, the  oversight of memory supplements falls under FDA’s general authority to  regulate dietary supplements and labeling of dietary supplements, and  under FTC’s general authority to enforce the prohibitions against unfair or  deceptive acts and practices, including false advertising.
Given the growth of memory supplements and older adults’ vulnerability  to exploitation, especially those adults experiencing age-related memory  loss, you asked us to review how memory supplement companies market  their products and how FDA and FTC oversee memory supplements and  memory supplement marketing. 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 FDA and FTC  have undertaken in overseeing memory supplements and their marketing;  and (3) what challenges FDA and FTC face in overseeing memory  supplements.
To conduct our work, we reviewed relevant laws and regulations related  to each agency’s oversight of dietary supplements. We worked with  officials from FDA and FTC, as well as representatives from the HHS  National Institutes of Health, to develop and obtain concurrence on a  single definition of memory supplements for the purposes of this review.  To determine how memory supplements are marketed, and the extent to  which the marketing targets older adults and is potentially deceptive or  inconsistent with federal requirements, we conducted a market review in  which we monitored five media channels (the Internet, retail stores,  television, magazines, and newspapers) in 2 months of 2016, targeting  media most likely used by older adults, to identify, catalogue, and review  memory supplement advertisements for marketing claims. We also  conducted a targeted review of the Internet search results from the  market review to identify (1) examples of Internet marketing containing  memory supplement advertisements in the form of text and visuals  targeting older adults, and (2) visuals that may positively affect a  consumer’s view of the product, such as pictures of medical professionals  or testimonials made by older adults. Although our review of the memory  supplement market is not generalizable and cannot be projected to the  entire memory supplement market, we believe that our sampling  methodology provides us with the ability to obtain important insights into  memory supplement marketing practices. In addition, we identified and  reviewed marketing claims for examples that may be potentially deceptive  or in violation of federal requirements–specifically, disease-related claims  that a product can treat, cure, or prevent a memory-related disease. We  shared the examples with staff from FDA and FTC for their review.
To determine what enforcement and outreach actions FDA and FTC have  undertaken in overseeing memory supplements and their marketing, we  collected and analyzed agency oversight policies. We also conducted  semistructured interviews with FDA and FTC officials to review their  activities and guidance related to dietary supplement enforcement and  outreach efforts. We also interviewed agency officials about strategic  plans and program priorities related to dietary supplements as well as  reviewed documents showing how each agency prioritizes dietary  supplement work in their enforcement or outreach efforts. Additionally, we  conducted semistructured interviews with consumer groups and industry  associations regarding FDA and FTC oversight efforts of dietary  supplements, including memory supplements and efforts specific to older  adults. Finally, we obtained and analyzed data from FDA and FTC on  their enforcement actions involving dietary supplements and memory  supplements for fiscal year 2006 through fiscal year 2015—the most  recent years for which such data were available at the time of our review.  As part of this analysis, we interviewed FDA and FTC staff about these  memory supplement actions. Based on our analysis of the data provided  on memory supplement enforcement actions as well as the responses  from FDA and FTC officials to our questions about these data, we  determined these data to be sufficiently reliable for the purposes of  providing the number of enforcement actions taken by each agency that  involved dietary supplements as well as the number of enforcement  actions taken by each agency that involved memory supplements.
To identify what challenges FDA and FTC face in overseeing memory  supplements, we interviewed agency officials, consumer groups, and  industry groups, and reviewed relevant documentation. We analyzed top- marketed memory supplements to identify potential new dietary  ingredients (NDI), and asked FDA officials to confirm whether the  supplements contained an NDI and whether a notification was filed with  FDA for the product, to the extent possible. Where applicable, we also  assessed FDA and FTC oversight issues and challenges against federal  internal control standards for communicating quality information with  external parties to achieve objectives. For more detailed information on  our methodology, see appendix I.
We conducted this performance audit from February 2016 to May 2017 in  accordance with generally accepted government auditing standards.  Those standards require that we plan and perform the audit to obtain  sufficient, appropriate evidence to provide a reasonable basis for our  findings and conclusions based on our audit objectives. We believe that  the evidence obtained provides a reasonable basis for our findings and  conclusions based on our audit objectives.
subsections: section_title: Background
subsections: section_title: Memory Supplements
paragraphs: For the purpose of this review, we define a memory supplement as a  dietary supplement that is intended to improve or in other ways positively  affect memory, as exhibited by the claims on its label or advertising.  Claims may involve proxies for memory loss such as cognitive function,  brain power, and absentmindedness. There is no federal law specifically  regulating or defining the subset of dietary supplements we refer to in this  report as memory supplements.
There is no definitive source of data regarding dietary supplements,  including memory supplements, on the market, since federal law does not  require that dietary supplements be listed with FDA or another federal  agency. However, available data indicate that memory supplements  comprise a small segment of the overall dietary supplement market, but  their number has grown substantially over the recent decade and they are  valued in the hundreds of millions of dollars. Specifically, in 2015 memory  supplement sales were estimated at $643 million, and accounted for  nearly 2 percent of total dietary supplement sales in that year,  approximated at $39 billion. As shown in figure 1, memory supplement  sales nearly doubled in value from 2006 to 2015–a larger increase than  for dietary supplements overall.
The number of dietary supplements on the market has grown  exponentially, from an estimated 4,000 products in 1994 to an estimated  80,000 in 2016, according to FDA officials. Dietary supplement data  from the National Institutes of Health estimate the number of memory  supplement products at almost 500 in 2016, though officials believe this is  likely a low estimate.
Memory supplement firms may market their products in numerous ways,  including through advertisements on television, in print, and on the  Internet, as well as placement of products and displays in stores.  Consistent with general definitions, in this report the term “marketing”  includes all general promotional practices such as those listed above,  whereas “advertising” is a subset of marketing that refers to promotional  materials, such as Internet product reviews, television commercials, print  advertisements, or in-store visual displays.
section_title: Oversight Agencies and Federal Requirements for Dietary Supplement Safety, Labeling, and Claims
paragraphs: FDA and FTC share oversight responsibility for the marketing of dietary  supplements and their claims—with FDA generally taking responsibility  for labeling claims and FTC generally taking responsibility for claims  made in product advertising. FDA and FTC authorities related to dietary  supplements are generally limited to after dietary supplements go to  market (postmarket). In general, neither agency has premarket authority  that allows for approvals of labeling or advertising claims before dietary  supplements may be sold to consumers, although as explained below,  under relevant provisions of FDA regulations, firms may not make health  claims that FDA has not authorized. Under DSHEA, FDA does not have  the authority to require dietary supplements to be approved for safety or  effectiveness before they are sold to consumers, as it does for drugs.  Additional details about FDA oversight of supplements can be found in  figure 2.
Additional details about FTC oversight of supplements can be found in  figure 3.
Dietary supplement firms must meet federal requirements for dietary  supplements related to safety, quality, and labeling elements, including  the following:  Quality Requirements. FDA established current good manufacturing  practice regulations for dietary substances describing the conditions  under which supplements must be manufactured, packed, labeled, and  held. These requirements were implemented in phases, according to  company size, and became fully effective in 2010.
Required Labeling Elements. FDA regulations implementing DSHEA  require that dietary supplement labels include, among other things, a  statement of identity that identifies the product as a supplement, a list of  ingredients present in significant amounts and the quantity of such  ingredients in the product. Since December 2007, the Federal Food,  Drug, and Cosmetic Act, as amended by the 2006 Dietary Supplement  and Non-prescription Drug Consumer Protection Act, has required dietary  supplement manufacturers, distributors, or packers (dietary supplement  firms) to include on the dietary supplement product label several  elements, including the firm’s name and a domestic phone number or  domestic address for individuals to submit an adverse event report to the  manufacturer, packer, or distributor whose name appears on the product  label as a way, according to FDA officials, to enhance FDA’s ability to  identify and act on public health issues associated with the use of dietary  supplements.
FDA Labeling Claim Requirements. Under federal law, firms can make  certain labeling claims about dietary supplements but are generally  prohibited from claiming that a supplement can treat, cure, or prevent a  disease (such claims are referred to as disease claims). Allowable claims  for foods are generally either: structure-function and related types of  claims, health claims, or nutrient content claims. The Federal Food, Drug,  and Cosmetic Act stipulates that the firm submit structure-function and  related types of label claims to FDA for review within 30 days of the  dietary supplement’s first being marketed with the claim. FDA reviews the  claims that firms make about dietary supplements, including the following:
Structure-function and related types of claims: Structure-function  claims describe the role of substances intended to affect the normal  structure or function in humans. An example of a structure-function  claim would be “calcium builds strong bones.” Related types of claims  include those related to a classical nutrient deficiency disease for  which the prevalence of such disease in the United States is disclosed  with the claim, and general well-being claims from the consumption of  a dietary ingredient. DSHEA requires that the manufacturer have  substantiation that structure-function claims in labeling are truthful and  not misleading. This requirement is consistent with FTC’s requirement  that advertising claims be truthful, not misleading, and substantiated.
Health claims: Health claims characterize the relationship between a  substance (food or food component) to a disease or health-related  condition. To make a health claim, the firm must first present FDA  with a petition or notification that contains scientific evidence  supporting the proposed claim, and FDA must authorize the claim  before it can be made. Health claims are limited to express or implied  claims about disease risk reduction and cannot be claims about the  cure, mitigation, treatment, or prevention of disease. For example,  “Low fat diets rich in fruits and vegetables (foods that are low in fat  and may contain dietary fiber, vitamin A, and vitamin C) may reduce  the risk of some types of cancer, a disease associated with many  factors. Broccoli is high in vitamins A and C, and it is a good source of  dietary fiber,” characterizes the reduced risk of the disease and has  been authorized by FDA. In addition, in response to a federal appeals  court ruling, FDA allows “qualified health claims.” Qualified health  claims are health claims not authorized as health claims but for which  the agency has stated its intention to exercise enforcement discretion  (i.e., to refrain from taking enforcement action) under certain  circumstances. Qualified health claims must include qualifying  language that characterizes the level of evidence supporting the  health claim, as well as any other information necessary to prevent  the claim from being misleading. FDA reviews a qualified health claim  petition and responds with a letter of enforcement discretion that  outlines the level of evidence the agency found and the conditions  under which the claim may be used, or a letter of denial if the claim is  not supported by credible evidence. For example, FDA has issued a  letter stating it intends to consider exercising enforcement discretion  for, among other claims, “consumption of phosphatidylserine may  reduce the risk of dementia in the elderly.”
Nutrient content claims: Nutrient content claims describe the level of  a nutrient in a food using terms such as “free,” “high,” or “low,” or they  compare the level of a nutrient in a food to that of another food, using  terms such as “more,” “reduced,” or “light.” For example, a  statement such as “only 200 mg of sodium” characterizes the level of  sodium as being low and would have to conform to the criteria of an  appropriate nutrient content claim or carry a disclosure statement. The  Nutrition Labeling and Education Act of 1990 permits the use of  nutrient content claims if they have been authorized by FDA and are  made in accordance with FDA’s authorizing regulations.
FTC Requirements for Advertising Claims. In regulating advertising,  according to FTC guidance, all parties who participate directly or indirectly  in the marketing of dietary supplements have an obligation to make sure  that claims are presented truthfully and to check the adequacy of the  support behind those claims. To this end, FTC may take actions against  supplement manufacturers as well as advertising agencies, distributors,  retailers, catalog companies, infomercial producers, and others involved  in promotions it deems as deceptive. In addition, while FDA’s laws and  regulations governing structure-function claims, health claims, and  nutrient content claims do not apply to the FTC and its authority over  advertising, structure-function claims must be truthful and not misleading,  and they must be substantiated by competent and reliable scientific  evidence. Further, according to FTC guidance, the agency generally  defers to FDA authorizations of health claims and generally applies FDA’s  definitions for nutrient content claims to advertising.
New Dietary Ingredients. Under DSHEA, dietary supplement firms with  an NDI—an ingredient that was not marketed in the United States before  October 15, 1994—may be required to notify FDA at least 75 days before  marketing the product, depending on whether this ingredient has been  present in the food supply. The NDI notification should include information  showing that the product containing the ingredient is reasonably expected  to be safe. The NDI notification process is not a premarket approval  process, and, as with other dietary supplements, to find that an NDI is  adulterated, FDA must demonstrate that there is inadequate information  to ensure a supplement containing an NDI does not present a significant  or unreasonable risk of illness or injury. There has been a long-standing  effort by FDA to issue guidance to industry on the NDI notification  process. We recommended in previous reports issued in 2009 and 2013  that FDA issue NDI guidance. FDA issued draft guidance in 2011 and  revised draft guidance in August 2016, but this guidance has not yet been  finalized and FDA is in the process of reviewing public comments on it.
Over the years, GAO has issued multiple reports and testimonies related  to dietary supplement safety, labeling, and claims. For example, in 2010,  we found potentially deceptive marketing about dietary supplements,  including potential disease claims. Similarly in 2011, we reported that  consumers find it difficult to understand the differences among claims and  that consumers are just as likely to purchase a product with a structure- function claim (which FDA does not verify) as they are to purchase a  product with a health claim supported by significant scientific agreement  (which FDA does verify). Based on our findings in 2011, we  recommended that FDA provide guidance to industry on the level of scientific evidence to substantiate structure-function claims, and also  recommended that FDA pursue legal authorities to allow the agency to  obtain evidence for claims from food companies (including dietary  supplement firms). Lastly, we also recommended that FDA provide  additional guidance to inspectors for identifying potentially false or  deceptive structure-function claims on labels. FDA did not implement  these recommendations, citing competing priorities.
section_title: Oversight Activities
paragraphs: As described above, FDA and FTC share responsibility for oversight of  dietary supplements and related marketing, with FDA generally  responsible for safety, quality, and labeling, and FTC generally  responsible for advertising. The coordination of FDA and FTC oversight  authorities is delineated in a 1971 memorandum of understanding  designed to afford maximum protection to the consumer. Under the  memorandum of understanding, FDA and FTC each designate a liaison  to serve as the primary contact to coordinate activity as needed, such as  when similar claims are found in both labeling and advertising, or when  marketing material may be construed as either advertising or labeling, or  both. The memorandum of understanding specifies that FDA has primary  responsibility for preventing the misbranding of foods, among other items,  shipped in interstate commerce and will exercise primary jurisdiction over  all matters regulating the labeling of foods (which includes dietary  supplements); and that FTC has primary responsibility with respect to the  regulation of the truth or falsity of all advertising (other than labeling) of  foods (including dietary supplements), among other things, and will  exercise primary jurisdiction over all matters regulating the truth or falsity  of advertising of foods. Dietary supplement labeling under FDA’s primary  jurisdiction includes, among other things, packaging, inserts, and  information at the point of sale.
In overseeing dietary supplements and related marketing, FDA and FTC  conduct a variety of activities—including surveillance, enforcement, and  outreach to industry and the public—related to the safety and quality of  dietary supplements as well as the validity of labeling claims and the  truthfulness of dietary supplement advertising.
Surveillance. To identify potential safety or quality concerns related  to dietary supplements, both agencies conduct surveillance activities  to monitor dietary supplement firms and markets. These surveillance  activities may result in enforcement actions and related outreach. FDA  primarily relies on postmarket surveillance efforts, such as monitoring  reports of health problems or adverse event reports it receives from  industry, health-care practitioners, and individuals; reviewing  consumer and industry complaints; and conducting inspections of  dietary supplement firms. Similarly, FTC relies on postmarket  surveillance efforts, such as its Consumer Sentinel Network that  collects reports from consumers about potentially deceptive or  untruthful advertising, according to agency officials; and conducting  routine Internet monitoring for a range of potential advertising  violations. Examples of FDA and FTC surveillance actions are listed in  table 1.
Enforcement. FDA and FTC both take enforcement actions against  dietary supplement products and firms if they identify violations.
Once FDA identifies a concern, it may take enforcement action  against a firm through advisory and regulatory actions. Advisory  actions—such as sending a warning or untitled letter to a dietary  supplement firm that manufactures, distributes, or packs a dietary  supplement—notify firms that FDA has found the firm uncompliant with dietary supplement manufacturing or labeling regulations.  Regulatory actions are actions that either restrain dietary  supplement firms from manufacturing dietary supplements or  remove specific dietary supplements from the market, or prevent  entry into U.S. commerce of imported products. Among the  regulatory actions available to FDA are administrative  enforcement tools such as issuing a mandatory recall,  suspending a firm’s registration, administratively detaining a  product, or refusing entry to an imported product; judicial court  actions such as seeking an injunction against a firm, initiating  prosecution of a firm, or filing a seizure action against products  that are adulterated, misbranded, or otherwise in violation of  federal law; and conducting rulemaking to restrict or prohibit the  use of a specific ingredient. In any of these cases FDA must  demonstrate that the relevant statutory standard has been met.  For example, FDA can take a variety of the above actions if a  dietary supplement is adulterated, which can be established by,  for example, demonstrating that it, or a dietary ingredient  contained within, presents a significant or unreasonable risk of  illness or injury.
Under its responsibilities, once FTC identifies potentially deceptive  or untruthful advertising, it may take enforcement action against a  firm or individual through administrative court actions or judicial  court actions. Before taking such action, FTC may compel firms to  produce documents and other information, such as marketing and  labeling materials, sales information, and relevant substantiation  materials. Administrative court actions are complaints issued by  FTC that are adjudicated before an administrative law judge.  These complaints may result in settlements through consent  decrees or, in subsequent actions in a federal judicial court to  enforce administrative orders, injunctions, and civil penalties.  Federal judicial court actions are direct challenges in a district  court and can result in injunctions and monetary relief.
Outreach. To help inform the public—including both consumers and  industry—about potential health or safety issues related to dietary  supplements, FDA and FTC conduct various outreach efforts. Such  efforts can be educational outreach or outreach conducted in response to  a specific enforcement action taken by one or both of the agencies.  Examples of key outreach efforts include consumer or public education  (such as alerts about Internet scams or safety problems), guidance for  industry or consumers (such as on how firms can make sure their dietary  supplement claims have appropriate scientific support), and publicly  available press releases (such as those informing the public about the  results of enforcement actions like court injunctions or product recalls that  warn the public and, according to FDA officials, aim to prevent similar  violations in the future).
section_title: Most Memory Supplements Were Marketed on the Internet, and, While Few Advertisements Targeted Older Adults, Some May Have Violated Federal Requirements
paragraphs: Most of the memory supplement marketing we identified was on the  Internet, with few examples that included text or visuals (images and  videos) targeting older adults. FDA determined the potential disease- related claims we identified may have violated federal requirements.
subsections: section_title: Most Examples of Memory Supplement Marketing Were on the Internet, and Few Advertisements Explicitly Targeted Older Adults
paragraphs: We found during our market review that memory supplements were  primarily marketed on the Internet, with few advertisements containing  text or visuals targeting older adults. 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. Internet  advertisements accounted for 454 products identified and 1,530 of the  marketing examples. Our findings from the market review and analyses  conducted cannot be projected to all memory supplements or dietary  supplements on the market.
Memory supplement advertisements we identified generally contained  claims that products would boost, enhance, improve, increase, or  maintain a healthy memory. Advertisements also contained claims related  to general brain health, cognitive function, and well-being. For 91 unique  memory supplement products, we identified labels or advertisements that  contained sufficient information for us to review to identify examples of  claims and marketing practices. We reviewed these results to identify  examples of claims that products are clinically proven or studied and any  references to evidence supporting the claim. Specifically:
Of the 91 product labels and advertisements reviewed, 37 included  claims that the product had been clinically proven or studied.
Further, 24 of the 37 labels and advertisements claiming to be  clinically proven or studied contained statements referencing  supporting evidence.
Also, we identified examples of memory supplement advertisements on  the Internet containing text and visuals (e.g., images and videos) explicitly  targeting older adults. Specifically, of the 1,530 memory supplement  advertisements we identified on the Internet, 138 (or 9 percent) contained  text and visuals targeting older adults. Targeted advertisements claimed  that products can reduce “senior moments,” make aging adults feel young  again, and stay sharp through later years. The 138 targeted  advertisements were associated with 93 memory supplement products,  which is about 20 percent of the unique products we identified. Examples  of targeted text identified in memory supplement advertisements on the  Internet are shown in figure 4.
Several of the targeted advertisements, specifically 32 of 138, also  contained visuals, such as images of older adults engaging in active  lifestyles or looking frustrated, older adult testimonials, or images of  medical professionals. We shared examples of advertisements we  identified that contained images of medical professionals with FTC staff,  to obtain their opinion on the images and whether they might be  considered deceptive. FTC staff noted that a picture of a medical  professional may contribute to the impression that the claimed benefits  are scientifically proven. However, they explained that the FTC would  not be able to determine whether the images are considered deceptive  without conducting a full investigation, which includes a review of each  advertisement and supporting evidence.
section_title: FDA Determined Potential Disease Claims We Identified May Have Violated Federal Requirements
paragraphs: Through our market review, we found 28 examples of advertisements  containing memory supplements potentially making disease-related  claims, and these were associated with 34 products. Twenty-two of  these products were in advertisements identified on informational  websites—product reviews or articles discussing the use of specific  dietary supplement ingredients—and one product appeared in a  magazine at a store. These memory supplement advertisements claimed  products protect against, reduce the risk of, and assist with symptoms of  dementia, Parkinson’s disease, or Alzheimer’s disease. Examples of  potential disease-related claims we identified in Internet advertisements  are shown in figure 5.
We shared the 28 examples with FDA staff. 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. As of March 2017, FDA officials reported that they had issued  advisory letters to two firms who voluntarily complied with FDA’s  concerns. FDA officials also reported that they would continue monitoring  all of the examples that were identified. FDA identified the remaining  example as a structure-function claim—a claim that describes the role of  substances intended to affect the normal structure or function in  humans—which, assuming other regulatory requirements are met, are  allowable for dietary supplements.
section_title: Similar Types of Enforcement and Outreach for Memory Supplements Taken by FDA and FTC Align with Their Agency Priorities
paragraphs: 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. Moreover, the agencies coordinate  enforcement actions involving memory supplements in the same manner  they do for all dietary supplements. In conducting outreach, FDA and FTC  have at times conducted outreach efforts aimed at dietary supplement  use by older adults, and the agencies have conducted some specific  outreach about memory supplement enforcement 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.
subsections: section_title: FDA and FTC Have Taken Similar Types of Enforcement Actions for Memory Supplements as for Other Dietary Supplements
paragraphs: Between 2006 and 2015, FDA and FTC conducted similar types of  enforcement actions for memory supplements as they did for other dietary  supplements. Of the 551 dietary supplement actions taken by FDA, 19  involved memory supplements. Similar to its enforcement actions for  other dietary supplements, the majority of the 19 memory supplement  enforcement actions FDA took between 2006 and 2015 were advisory,  namely notification by FDA that the agency has found the firm out of  compliance with dietary supplement manufacturing or labeling regulations  or with the prohibition against marketing an unapproved new drug.  Specifically, these 19 memory supplement enforcement actions consisted  of 17 advisory actions (6 untitled letters and 11 warning letters) and 2  regulatory actions (1 injunction and 1 seizure), as shown in table 3.
FDA’s two regulatory actions involving memory supplements consisted of  one injunction and one seizure. FDA filed for an injunction in 2011 against  a dietary supplement firm and its principals whose products’ advertising  continued to contain prohibited claims to treat or cure Alzheimer’s, among  other diseases, despite prior FDA warnings to stop making claims to treat  the disease. Similarly, FDA brought action in federal court in 2012 to  seize dietary supplements that were marketed for treating a variety of  diseases or conditions, including dementia. In addition, FDA determined  that the products were not manufactured according to the current good  manufacturing practice regulations. FDA officials told us the agency has  subsequently closed these cases. Such disease claims are no longer  present on the memory supplement products’ websites and, according to  FDA officials, the agency has not taken further public action on these  cases.
FDA staff investigate and pursue actions against firms and products as  individual safety concerns or other violations are identified. According to  FDA officials within the Office of Dietary Supplement Programs—the  office that leads and sets priorities for FDA dietary supplement  enforcement efforts—the agency currently plans to prioritize actions  against products presenting immediate safety concerns, given its limited  resources, rather than focusing on actions against a specific therapeutic  category of dietary supplements.
In terms of FTC enforcement actions involving memory supplements, the  agency took some administrative and judicial actions involving memory  supplements between fiscal years 2006 and 2015, similar to its  enforcement actions for other dietary supplements. Approximately 3  percent (2 of 78) of FTC’s dietary supplement enforcement actions  involved memory supplements, as shown in table 4. These 2 FTC  enforcement actions involving memory supplements included 1  administrative action and 1 judicial action.
In 2014, FTC took an administrative action after it determined that  advertising for a dietary supplement, that included claims that the  supplement was “clinically shown to improve adult memory,” was not  backed by adequate scientific evidence. The administrative action applied  to two supplement firms responsible for the claims, and the settlement  bars them from making such claims unless those claims are supported by  reliable scientific evidence and clinical proof, among other things. In 2015,  FTC took judicial action when it filed suit against a firm for deceptive  advertising claims after finding that the claim that its supplement could,  for example, “help users match the memory power of others 15 years  younger in as little as 30 days!” were false, misleading, and  unsubstantiated. According to FTC officials, the agency discovered these  illegal advertisements through a targeted enforcement sweep—an  enforcement effort that focuses on popular products or focuses on  specific high-profile health conditions and is initiated to gather additional  information after advertising is identified as potentially problematic—of  dietary supplements generally. As of February 2017, according to FTC  officials, they have not conducted targeted enforcement sweeps of the  Internet or other media channels focusing specifically on memory  supplements. Further, FTC officials would not confirm whether the agency  plans to conduct enforcement sweeps focused specifically on memory  supplements in the future, due to the sensitive nature of its law  enforcement priorities. FTC officials also acknowledged that one  approach it could take to targeted enforcement against deceptive memory  supplements would be to identify a handful of firms with the most  aggressive advertisements or largest market share, and then look into the  validity of those claims.
In sharing jurisdiction for dietary supplements, FDA and FTC coordinate  enforcement actions based on the 1971 agreement. Based on the 1971  memorandum of understanding, the agencies have articulated where  each has primary responsibilities for oversight of dietary supplements (a  type of food) and their related marketing —with FDA generally  responsible for supplement safety and labeling and FTC generally  responsible for supplement advertising. Staff from each agency confer by  phone on a quarterly basis to discuss and coordinate individual and joint  efforts. Agency officials also meet as needed between quarterly  meetings to exchange information on specific cases. According to FDA  and FTC officials, FDA scientists sometimes serve as resources or  experts for FTC in investigations involving dietary supplements.
FDA and FTC have conducted joint enforcement actions involving some  dietary supplements, but, to date, the agencies have not conducted a joint  enforcement action specifically involving memory supplements. When  asked about future plans to conduct joint enforcement actions on memory  supplements, officials from both agencies noted that, due to the sensitive  nature of their law enforcement role, they would not publicly disclose  specific future enforcement plans or give information about ongoing  investigations. However, FDA and FTC both emphasize the importance of  collaborating with their partners in their strategic planning and budget  documents. FTC officials noted that, while memory supplement cases to  date may not have required joint enforcement action, any FTC case that  involves dietary supplements will involve some level of interaction with  FDA, as with the two memory supplement cases FTC took enforcement  action against between 2006 and 2015.
In deciding how to pursue cases, and in maximizing agency resources  and the effectiveness of this collaboration, FDA and FTC told us that they  consider what strategies or procedures promise the greatest benefit to the  public. To this end, FDA and FTC may identify the same product or firm  as potentially violating federal requirements, and in such an instance the  two agencies may work together to decide how best to proceed. They  may choose (1) to each pursue the case independently, (2) to pursue the  case jointly, or (3) that one agency is in a better position to pursue the  case because it has a clearer path or stronger enforcement tools to bring  the firms or products into compliance or to otherwise resolve the potential  violation. For example, firms are required to possess evidence that  substantiates the claims being made; that is, scientific evidence that  provides a reasonable basis for the claims being made on product labels  and in product advertisements. Firms are not required to put this  substantiation information on their websites or provide it to consumers;  however, FTC has the authority to compel substantiation evidence for  product claims. In contrast, FDA does not have explicit authority to  compel such substantiation. Consequently, there may be some instances,  according to agency officials, where the two agencies agree that FTC  should pursue the case instead of or in conjunction with FDA given its  authority to compel documentation. Additionally, FTC officials told us that  they generally refer all instances where product safety is at issue, such as  where a product claims to be acting as a drug, to FDA; similarly, FDA  officials told us that they may refer cases to FTC where only fraud is at  issue and that they focus where FTC does not have jurisdiction over such  things as manufacturing, to make sure each agency is conducting  different types of work and given the agency’s limited resources.
section_title: 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
paragraphs: 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.  According to agency officials, general dietary supplement information  provided through its outreach would also apply to memory supplements  as a subset of dietary supplements that are subject to the same laws and  regulations. Both agencies have published information about the risks to  older adults in using dietary supplements on their websites through tip  sheets, consumer alerts, and blog posts, among other things. For  example:
Tip sheets. Both FDA and FTC have published dietary supplement  “tip sheets” on their websites to help older adults become more  discerning consumers. These tip sheets contain key questions for  consumers to ask before purchasing dietary supplements; tips for how  to identify false claims; and information on the potentially dangerous  interactions between dietary supplements and prescription drugs.
Consumer updates and alerts. FDA has published Consumer  Updates and Health Fraud alerts on its website that include  information specifically about dietary supplements and older adults or  Alzheimer’s-related memory loss. FTC has published alerts on its  website about “miracle health claims” and products that specifically  target those with serious conditions without a cure, such as  Alzheimer’s disease.
Blog posts. FTC publishes blog posts on its consumer and business  education blogs in coordination with its press release following an  enforcement action, such as the agency did for the action it took  against dietary supplements claiming to improve memory and provide  other cognitive benefits.
In terms of outreach to consumers and the general public, FDA and FTC  each have social media presence, which they use, for example, to  disseminate their alerts and blog posts. Further, both FDA and FTC use  agency press releases as well as blog posts or updates to educate  industry and the general public about specific enforcement actions taken  involving dietary supplements, including memory supplements. For  example, FDA issued a press release in October 2012 regarding a  seizure of memory supplement products that claimed to treat or cure  specific diseases, including senile dementia. While FDA and FTC have  conducted outreach to consumers on certain general categories of dietary  supplements, such as weight loss or sexual enhancement, the agencies  have not conducted similar efforts aimed at the general category of  memory supplements. Rather, according to agency officials, limiting  outreach on memory supplements to specific enforcement actions  involving memory supplements was the best use of limited resources  given the size of the market and scope of violations to date. FDA and  FTC officials told us they have no specific plans to coordinate outreach on  memory supplements specifically beyond individual cases that may arise  over time. However, FDA officials from the Office of Dietary Supplement  Programs acknowledged that, as the office and its priorities evolve, they  would like to coordinate more with FTC and other federal agencies on  dietary supplement outreach.
In terms of industry outreach, FDA and FTC do so by, for example,  issuing guidance on supplement advertising and labeling, and attending  industry conferences and workshops, according to agency officials. For  example, FDA has issued “A Dietary Supplement Labeling Guide” and  FTC has issued “Dietary Supplements: An Advertising Guide for  Industry.” Such outreach to industry is primarily focused on advertising or  labeling requirements that apply to all dietary supplements, including  memory supplements. According to officials from both agencies, there is  no need for industry guidance specifically on memory supplements since  there is no applicable federal law or policy that makes memory  supplements different from other dietary supplements.
section_title: FDA and FTC Enforcement and Outreach Efforts Prioritize Egregiousness of Deception or Impact and Ensuring Consumer Safety
paragraphs: In prioritizing actions related to enforcement and outreach, FDA and FTC  officials told us that they focus first on ensuring consumer safety. In  addition, FDA and FTC officials told us they also prioritize the  egregiousness of deception or impact of supplement claims being made  because of the potential harm or adverse impact to consumers—either  financial (in the money spent on the supplements) or health-related (for  example, if the deceptive advertising persuades consumers to take the  dietary supplement and forgo prescribed medications). FTC officials told  us they focus on firms and products with the greatest impact on  consumers in part to most efficiently extend the reach of its resources.  Similarly, FDA officials told us they focus on products with broad health  implications given its public health mission. Both agencies also prioritize  safety. FDA officials acknowledged that the agency focuses primarily on  safety concerns in its enforcement and outreach efforts. FDA investigates  a supplement if, for example, the agency suspects the supplement to  contain an active pharmaceutical ingredient or if it receives reports from  doctors, consumers, or the product manufacturer or distributor,  documenting adverse health effects associated with the supplement.  Similarly, FTC officials stated that safety is a top concern for the agency  and that it refers to FDA any instances in which the safety of the  supplement is at issue.
FDA does not prioritize efforts by type or category of dietary supplement,  such as memory; but it does focus on populations that are particularly  vulnerable or at risk, including older adults that would be consumers of  memory supplements. According to officials from CFSAN’s Office of  Dietary Supplement Programs, it is currently in the process of  developing its strategic priorities and confirmed it intends to prioritize  future efforts according to three broad goals:  1.  product safety—its top goal, given the vast size of the market, and  includes postmarket enforcement reviews as well as actions to stop  products from going to market where they can identify safety issues  ahead of time;  2.  product quality, identity, and integrity—to provide assurances that  dietary supplements contain only the ingredients stated on their label  and that products are being manufactured according to current good  manufacturing practice regulations; and  3.  informed decision making—reflecting that consumers and health-care  providers need reliable information to make informed decisions before  purchasing, recommending, or prescribing dietary supplements.
Moreover, officials from the Office of Dietary Supplement Programs  stated that the office also intends to focus internally on four operational  areas interconnected to its oversight goals, including developing relevant  policies for industry and consumers. According to FDA officials,  prioritizing supplement use by older adults is not a subject the office is  currently focused on. However, according to these same officials, as the  office moves towards a more proactive paradigm and once it has more  information about the dietary supplement market—what supplements are  on the market, what these supplements are being used for, and who is  using these supplements—the office will be better positioned to identify  vulnerable populations with respect to dietary supplements, potentially  including older adults, that need specific focus.
Like FDA, FTC also does not prioritize efforts by category of dietary  supplement, but the agency does focus on addressing vulnerable  populations in its efforts. In terms of enforcement and outreach efforts by  FTC, agency officials told us they consider it a priority to protect older  adults from economic and health risks associated with using dietary  supplements—echoing FTC’s written statement for the record to the  Senate Special Committee on Aging in 2010. While FTC’s strategic  goals do not specifically address dietary supplements, FTC’s Strategic  Plan for Fiscal Years 2014 to 2018 acknowledges “the agency strives to  understand the issues affecting consumers, including any newly emerging  methods of fraud or deceit, so that it can target its enforcement,  education, and advocacy on those areas where consumers suffer the  most harm or where there will be the greatest impact.” To this end, FTC  officials told us that, as the U.S. population ages, health fraud related to  memory is becoming an area of increasing concern and focus for the  agency. This is illustrated by FTC’s 2017 complaint filed in federal court  against a major memory supplement manufacturer for making false or  unsubstantiated claims that the product could, among other things,  improve memory within 90 days and reduce memory problems associated  with aging.
section_title: Limited Market Information Poses Oversight Challenge for FDA, While Consumer Groups Reported Uncertainty about FDA and FTC Roles Overseeing Internet Marketing
paragraphs: 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.
subsections: section_title: FDA Has Limited Information on the Memory Supplement Market
paragraphs: FDA faces oversight challenges related to limited information about the  dietary supplement market, including memory supplements, such as a  lack of current and accurate data on ingredients and products on the  market, including NDIs, that could inform oversight. These challenges  have been ongoing issues, and we reported on them in our previous work  on dietary supplements. However, FDA officials told us that the agency  is exploring ways to obtain better market information and issued new draft  guidance on NDIs, and these efforts may improve information available to  inform oversight efforts.
subsections: section_title: Information on the Memory Supplement Market
paragraphs: While FDA currently has limited information about dietary supplements on  the market, including memory supplements, officials are considering how  it might be able to obtain better and more current information to help  improve oversight capabilities, according to officials. FDA and FTC  generally are not alerted to memory supplement products going to market  because the agencies do not have premarket approval authorities for  dietary supplements, resulting in limited information on the memory  supplement market. As we stated previously, there is no definitive source  for memory supplements on the market, as is the case with all dietary  supplements. The number of dietary supplement products is estimated  between 50,000 and 90,000 based on different estimates, but the exact  number is unknown. This has been an ongoing challenge for dietary  supplement oversight, as we previously reported on this issue in our prior  work. Specifically, in 2009 we found that FDA oversight efforts were  hindered by limited information on dietary supplement firms and the types  of products currently available on the market. We therefore recommended  that FDA pursue additional authority to require that firms report all  supplement products to FDA. Multiple bills were introduced on the issue,  but none became law.
FDA officials stated that their ability to access reliable and current  information on the dietary supplement market is a challenge, and they are  reviewing options for acquiring data sources that could provide more  insights into the supplement market, such as market studies. They also  said that, in addition to considering data sources that could provide  information within their current legal authorities, they are evaluating  whether any structural or other changes might increase their ability to  have accurate and current meaningful information about dietary  supplement products on the market.
The information constraints described above largely focus on FDA given  the agency’s broad regulatory authority over memory supplements and  other dietary supplements. FTC officials told us that the limited market  information does not affect their work since, as a law enforcement  agency, they focus on supplement issues on a case by case basis. 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.
section_title: Information on New Dietary Ingredients
paragraphs: FDA faces a challenge determining whether a dietary supplement firm  should submit an NDI notification for a dietary supplement product,  including memory supplements. The NDI notification is important to help  FDA review whether new ingredients used in memory supplements and  other dietary supplements are safe for consumption. To review the NDI  notification process, we analyzed three highly advertised memory  supplement products for any ingredients that may be NDIs subject to  notification, and we then provided FDA with a list of these memory  supplement products and their ingredients, asking FDA officials to confirm  whether the products included an NDI and whether a notification was  filed, to the extent possible. The selected products contained a total of  39 ingredients, and we identified 9 unique ingredients as possible NDIs  based on data on previous NDI notifications. FDA officials provided  information indicating whether ingredients in the products potentially  matched a previous NDI notification, but told us that they would have to  conduct a full investigation of a supplement and its ingredients to  determine whether it is subject to NDI notification requirements.  According to FDA officials, supplement firms have initial responsibility for  determining if a supplement product contains an NDI subject to the  notification requirement before marketing the product, and the agency  has the burden of showing that a firm has not met this requirement. FDA  has limited information to readily make such a determination given that  there is no authoritative list of ingredients on the market prior to DSHEA  (“grandfathered” ingredients) that could help rule out ingredients subject  to the NDI notification requirement.
FDA issued revised draft NDI guidance in August 2016, and is in the  process of reviewing public comments on the guidance. The draft  guidance states that FDA is willing to develop an authoritative list of  grandfathered dietary ingredients based on documentation from industry.  The creation of an authoritative list of pre-DSHEA ingredients not subject  to NDI notification could improve FDA oversight of NDIs, allowing FDA to  more easily rule out supplement products that are not subject to  notification and better target supplement firms that should be submitting  notifications and requisite safety information for products containing NDIs.  In addition, three of the four supplement industry groups we spoke with  during the course of this review also stated that additional guidance on  NDI notification is needed to help supplement firms better understand the  notification process. As stated earlier, we previously found issues related  to FDA’s oversight of dietary supplements containing NDIs, and  recommended that FDA provide additional guidance on the NDI  notification process.
section_title: FDA and FTC Have Provided Limited Guidance Delineating Their Shared Oversight of Memory Supplement Marketing on the Internet
paragraphs: 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. As  stated earlier, while FTC exercises primary jurisdiction over advertising,  FDA exercises primary jurisdiction over dietary supplement labeling,  which includes marketing information used in the sale of the product. This  would apply to dietary supplements that are marketed and sold on the  Internet. For example, if a dietary supplement product is promoted on a  website and consumers are able to purchase the product directly from the  website, FDA would likely consider the website labeling over which it  would have jurisdiction. FDA and FTC officials, as well as industry and  consumer groups, expressed concern to us about supplement marketing  on the Internet, particularly the risks posed to consumers by smaller “fly- by-night” supplement companies that operate primarily on the Internet  and may not follow dietary supplement requirements. Officials from both  agencies told us that the low barrier to entry—the ease with which firms  can start websites to sell products—and the vastness of the Internet  presents a challenge to oversight. Also, as described earlier in this report,  our market review found the Internet to be the primary vehicle for memory  supplement advertising, and we also identified instances of Internet  marketing that may have violated federal requirements. While it is not  reasonable to expect that FDA and FTC can catch all deceptive claims on  the Internet given its vast nature, these findings illustrate the risks to  consumers related to the marketing of memory supplements on the  Internet, and indicate the importance of oversight in this media channel.
Consumer groups we spoke to were either unaware of FDA’s role with  regard to Internet sales and marketing of dietary supplements, or said  that the shared oversight roles between the two agencies was unclear.  Specifically, two of the five consumer groups we spoke with were unclear  about FDA’s particular role in overseeing aspects of Internet marketing.  For example, one of these consumer groups was not aware that FDA had  a role in overseeing aspects of Internet marketing, and told us that they  believed all Internet marketing fell under FTC authorities. Two other  consumer groups told us that they thought there was an overall lack of  clarity in the delineation of the two agencies’ roles. For example, one of  these consumer groups told us that there is no satisfactory guidance on  how the agencies coordinate and their different areas of authority over  Internet marketing. The fifth consumer group we spoke to did not respond  to our requests for comment on this subject, and our previous meeting  with them did not cover the issue.
When we asked industry groups about this issue, the two groups that  responded to our inquiry said that they understood that FDA has authority  over Internet marketing that falls under the definition of labeling. One of  the industry groups stated that there is some overlap between FDA’s and  FTC’s oversight of the Internet, while another told us that the nature of  labeling regulations does not always align easily with the advertising  nature of most Internet sites.
When we discussed this issue with FDA and FTC, we found that the  agencies had published limited guidance on their roles overseeing dietary  supplement marketing on the Internet. FDA officials told us that the  agency had provided some guidance on its authority over Internet  marketing that is considered labeling in a 2007 letter to industry.  However, the FDA letter may not be easily accessible to the public as a  link to this letter is not included on FDA’s guidance webpage for dietary  supplements. Furthermore, while the letter can be found on a webpage  with other FDA labeling guidance, the title of the letter–“Dear  Manufacturer Letter Regarding Food Labeling”–does not indicate that it  covers definitions of labeling on the Internet that fall under FDA authority,  making it unlikely that consumers would know to look at the letter for  guidance on this issue. FTC officials told us that it has no written  guidance delineating the differing agency roles. The agencies told us that  they see their authorities related to Internet supplement marketing as  overlapping, and stated that they generally determine which agency  should take the lead on a particular issue on a case-by-case basis. FDA  officials also stated that they see a benefit to taking an overlapping  approach to Internet oversight with FTC given the medium’s fast pace of  change in marketing practices.
While the agencies may find it beneficial to decide on a case-by-case  basis which agency will pursue dietary supplement issues involving  Internet marketing, providing some clarifying information could help  consumers better understand how the two agencies share oversight  roles, and which agency to report concerns to regarding Internet  marketing of memory supplements and other dietary supplements.  Consumer complaints on supplement issues are an important tool for  both agencies to identify issues with memory supplement products,  according to officials. If consumers do not understand the different  agency authorities over Internet marketing, there is a risk that consumers  will not report issues to the proper agency, and there is a risk that it may  take longer for the appropriate agency to learn about a potential problem  and take action. Along these lines, one of the consumer groups we spoke  to told us that it was not always clear which agency they should report  potential issues to involving Internet marketing, and in these cases, they  chose to report all issues to FTC because the agency had been more  responsive to their past referrals. Developing and publishing additional  guidance delineating agency roles could help consumers better  understand where to report concerns about supplement issues that  involve 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. In this  case, clearer communication of agency roles and authorities could  contribute to the effectiveness of oversight activities. 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. Moreover,  FDA and FTC have articulated in either their strategic planning or budget  documents, their emphasis on consumer education as part of outreach  efforts. While both FDA and FTC have stated that they believe the  agencies coordinate well through their current processes, it would be  beneficial for consumers to have more clarity about how the two agencies  share oversight roles related to dietary supplement marketing on the  Internet. The ability for consumers to correctly identify which agency they  should reach out to directly with Internet marketing concerns may also  benefit the agencies as it could potentially allow them to learn about  dietary supplement concerns sooner in some cases, by eliminating the  time it takes to receive a referral from the other agency.
section_title: Conclusions
paragraphs: Memory supplements are a growing industry that may target a particularly  vulnerable population—older adults experiencing memory loss and  decline, including conditions such as dementia for which there is no  known cure. The prevalence we identified of memory supplement  marketing on the Internet, as well as the presence of certain Internet  advertisements making inappropriate claims tying memory supplements  to treatment of memory-related diseases, underscores the importance of  agency oversight over supplement marketing on the Internet. FDA and FTC have provided limited guidance explaining their roles overseeing  such marketing. Given the lack of understanding of some of these roles  expressed by some consumer groups we contacted, the agencies have  an opportunity to better explain and clarify to consumers their shared  oversight of Internet marketing of memory supplements and other dietary  supplements. Such clarification would allow consumers to better  understand which agency they should directly report potential dietary  supplement problems to, and may also allow agencies to receive  information about concerns more quickly by eliminating the time it takes  for the other agency to refer the complaint. By more quickly and efficiently  identifying potential dietary and memory supplement problems involving  Internet marketing, agencies may be able to act to address potential  problems and violations faster, improving their oversight of Internet  marketing.
section_title: Recommendations for Executive Action
paragraphs: 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.
section_title: Agency Comments
paragraphs: We provided a draft of this product to HHS and FTC for review and  comment. In their written comments, both agencies generally concurred  with our recommendation (comments from HHS are reproduced in  appendix II and comments from FTC are reproduced in appendix III).  Both agencies stated that they have been in communication about  working together and FDA noted that the two agencies have already  begun to develop materials to address the recommendation. The  agencies also provided technical comments, which we incorporated as  appropriate.
As agreed with your offices, unless you publicly announce the contents of  this report earlier, we plan no further distribution until 30 days from the  report date. At that time, we will send copies of this report to the  Commissioner of Food and Drugs, the Commissioner of Federal Trade,  and other relevant parties. This report will also be available at no charge  on the GAO website at http://www.gao.gov .
If you or your staff have any questions about this report, please contact  Seto Bagdoyan at (202) 512-6722 or bagdoyans@gao.gov, or Steve  Morris at (202) 512-3841 or morriss@gao.gov. Contact points for our  Offices of Congressional Relations and Public Affairs may be found on  the last page of this report. GAO staff who made key contributions to this  report are listed in appendix IV.
section_title: Appendix I: Objectives, Scope, and Methodology
paragraphs: 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. For all three  objectives, we reviewed relevant laws and regulations related to each  agency’s oversight of dietary supplements.
subsections: section_title: Review of Memory Supplement Market
paragraphs: To determine how memory supplements are marketed, and the extent to  which the marketing practices target older adults and is potentially  deceptive or inconsistent with federal requirements, we monitored five  media channels (the Internet, retail stores, television, magazines, and  newspapers) in April and May of 2016. We reviewed media channels  most likely used by older adults, to identify, catalogue, and review  memory supplement advertisements for marketing techniques and  product claims information. We identified five media channels for review  based on demographic and survey data as described below, focusing on  media popular with older adults. Although our review of the memory  supplement market is not generalizable and cannot be projected to the  entire memory supplement market, we believe that our sampling  methodology provides us with the ability to obtain important insights into  memory supplement marketing practices.
Internet: We identified pertinent sources for memory supplement  marketing on the Internet using relevant demographic survey data.  Specifically, we identified search engines used by older adults based  on a 2012 Health Tracking Survey conducted by the PEW Research  Center, in which at least 70 percent of survey respondents ages 50  and older stated that the last time they went online to look for health  information they started with a search engine such as Google, Bing,  or Yahoo. We conducted structured searches for memory supplement marketing on Google, Bing, and Yahoo search engines, using the  same key search terms (“memory supplements” and “memory  support”), and reviewed all webpage links results appearing in the first  three pages of search results.
Retail stores: We visited three retail stores to review memory  supplement marketing in stores, including two grocery stores and one  dietary supplement retailer. We identified appropriate retail stores  based on retail store data and also considered proximity to an older  adult living facility given the review’s focus on older adults.  Specifically, we identified senior living facilities in the Washington,  D.C., metropolitan area and used an annual market survey conducted  by Food World, a trade news publication, to identify the top 10 grocery  retailers in the Washington, D.C., area. We then identified a senior  living facility with a grocery retailer in close proximity and the next  closest grocery store in the same chain, as well as the closest  supplement retailer. For all three stores, we reviewed and catalogued  all memory supplements for sale, as well as any marketing displays  for memory supplements.
Television: We selected three television networks to review for  memory supplement marketing using data on top shows for older  adults. Due to technical constraints, we could only record two  broadcast and one cable channel simultaneously, which limited our  review to three channels. Specifically, we used data on the top 10  prime-time broadcast shows viewed by older adults to select two  broadcast networks. We also identified the number one program  among older adults and conducted a TV listing search using TV  Guide, a magazine that provides television program listings, to identify  the equivalent cable network that airs the program. We recorded and  reviewed 4 days of television programming for the three selected  stations, cataloguing any memory supplement advertisements.
Magazines: We identified appropriate magazines using Mediamark’s  “Fall 2015 Magazine Audience Estimates,” a market research report  on magazine readership and demographics. Specifically, we identified  all magazines in the report where the median age of the audience was  50 or greater and then identified the three magazines with the largest  readership. The three magazines did not include a health-related  magazine, which we thought would be pertinent to the topic of the  review, so we used the data to identify the health-related magazine  with the largest readership within the 50 and older age group. We  reviewed an issue of each magazine consistent with the market  review period—April and May 2016—cataloguing any memory  supplement advertisements.
Newspapers: We reviewed three Sunday newspapers published on  April 3, 2016. We selected the Sunday newspapers based on highest  total print circulation for newspapers published in the Washington,  D.C.; Seattle; and Dallas areas, locations that coincided with GAO  staff offices and covered different regions across the country.  Specifically, we determined the highest total print circulation numbers  for the Sunday newspapers for the Washington, D.C.; Seattle; and  Dallas areas using the “Average Circulation at the Top 25 U.S.  Sunday Newspapers” published by the Alliance for Audited Media, an  organization that provides independently verified media data. We  reviewed the selected newspapers for the same Sunday to identify  any memory supplement advertisements.
We conducted a number of analyses on the market review data to identify  memory supplement marketing practices as described below:  For all the examples of memory supplement marketing that we identified  on the Internet, in-store, and TV media channels—1,590 in total—we  assessed whether there was sufficient information for review; specifically,  that the associated product met the definition of a memory supplement  and the advertisement provided claims information was at the product  level. For 91 unique memory supplement products identified on the three  media channels, we identified labels or advertisements that contained  sufficient information. We reviewed these results for instances where  advertisements claimed products are clinically proven or studied and  provided supporting evidence for the claim. We did not evaluate product  claims for accuracy and truthfulness or product effectiveness.
We also conducted a targeted review of the marketing examples from the  Internet to identify examples of memory supplement marketing targeting  older adults. Specifically, we conducted a targeted word search of the  Internet search results using the Adobe search function to identify  examples of targeted text, and manually reviewed advertisement  screenshots and the Internet search results to identify visuals depicting  older adults. We also reviewed the Internet search results to identify additional visuals that may encourage a consumer to purchase the  product, such as pictures of medical professionals or older adult  testimonials and endorsements.
To identify marketing claims that may be considered deceptive or in  violation of federal requirements, we reviewed memory supplement  marketing for disease-related claims that a product can treat, cure, or  prevent a memory-related disease. Such claims are generally prohibited.  Specifically, we conducted targeted online searches using a variety of  search terms, and we reviewed all memory supplement marketing  identified on the five media channels for potentially inappropriate claims.  Marketing examples we identified as potentially deceptive or in violation  of federal requirements were shared with staff from FDA and FTC for their  review as to whether the claims may be considered deceptive or in  violation of requirements.
section_title: Memory Supplement Enforcement Actions and Outreach
paragraphs: To determine what enforcement and outreach actions FDA and FTC have  undertaken in overseeing memory supplements and their marketing, we  interviewed FDA and FTC officials on the definition of memory  supplements and collected and analyzed agency oversight policies. We  worked with officials from FDA and FTC, as well as representatives from  the U.S. Department of Health and Human Services’ (HHS) National  Institutes of Health, to develop and obtain concurrence on a single  definition of memory supplements for the purposes of this review. In  addition, we conducted semistructured interviews with FDA and FTC  officials to review their activities and guidance related to dietary  supplement enforcement and outreach efforts. We also interviewed  agency officials about strategic plans and program priorities as well as  reviewed documents showing how each agency prioritizes dietary  supplement work, including whether memory supplements or older adults  are an area of focus in their enforcement or outreach efforts. Additionally,  we conducted semistructured interviews with consumer groups and  industry associations regarding FDA and FTC oversight efforts of dietary  supplements, including memory supplements and efforts specific to older  adults. Finally, we obtained and analyzed enforcement data involving  dietary supplements and memory supplements from FDA and FTC for  fiscal year 2006 through fiscal year 2015—the most recent years for  which such data were available at the time of our review. As part of this  analysis, we interviewed FDA and FTC officials about these memory  supplements actions. Based on our analysis of the data provided on  memory supplements enforcement actions as well as the responses by  FDA and FTC officials to our questions about these data, we determined  these data to be sufficiently reliable for the purposes of providing the  number of enforcement actions taken by each agency that involved  dietary supplements as well as the number of enforcement actions taken  by each agency that involved memory supplements.
section_title: Challenges to Memory Supplement Oversight
paragraphs: To identify what challenges FDA and FTC face in overseeing memory  supplements, we interviewed agency officials and reviewed relevant  documentation. In addition, we conducted a series of semistructured  interviews with five consumer groups and four industry groups. The  consumer groups we spoke to include AARP, Center for Science and the  Public Interest, Consumer Union Consumer Reports, Public Citizen, and  Truth in Advertising. The industry groups we spoke to include the Better  Business Bureau’s Advertising Self-Regulatory Council National  Advertising Division, the Consumer Healthcare Products Association, the  Council for Responsible Nutrition, and the Natural Products Association.  We identified the consumer groups actively working on dietary  supplement issues as well as the dietary supplement industry groups  through a review of past GAO reports on dietary supplements, Internet  searches for groups actively engaged in dietary supplement issues,  referrals from agency officials, and interviews with other consumer groups  and industry associations. To review challenges around oversight of new  dietary ingredients (NDI), we analyzed the ingredients for highly  advertised memory supplement products to identify potential NDIs. We  used data from our review of the memory supplement market, as  described above, to identify highly advertised memory supplements by  determining the total number of advertisements for memory supplement  products, and then identifying those products with the most  advertisements. We provided FDA officials with three highly advertised  supplements that we identified as containing potential NDIs, based on a  comparison of the ingredients to a list of past NDI notifications. We asked  FDA officials to confirm whether the supplements contained an NDI and  whether a notification was filed for the product, to the extent possible.  Where applicable, we also assessed FDA and FTC oversight issues and  challenges against federal internal control standards for communicating  quality information with external parties to achieve objectives.
We conducted this performance audit from February 2016 to May 2017 in  accordance with generally accepted government auditing standards.  Those standards require that we plan and perform the audit to obtain  sufficient, appropriate evidence to provide a reasonable basis for our  findings and conclusions based on our audit objectives. We believe that  the evidence obtained provides a reasonable basis for our findings and  conclusions based on our audit objectives.
section_title: Appendix II: Comments from the U.S. Department of Health and Human Services
section_title: Appendix III: Comments from the U.S. Federal Trade Commission
section_title: Appendix IV: GAO Contacts and Staff Acknowledgments
subsections: section_title: GAO Contacts
section_title: Staff Acknowledgments
paragraphs: In addition to those mentioned above, the following staff members made  significant contributions to this report: Gabrielle Fagan and Thomas Cook,  Assistant Directors; Celina Davidson and Tama Weinberg, Analysts-in- Charge; Jennifer Felder; and Joshua Parr. Additionally, Colin Fallon, Ellen  Fried and Maria McMullen provided technical support; Andrew Stavisky  provided methodological guidance; and Kevin Bray provided legal  counsel.
section_title: Related GAO Products
paragraphs: Dietary Supplements: FDA May Have Opportunities to Expand Its Use of  Reported Health Problems to Oversee Products, GAO-13-244.  Washington, D.C.: March 18, 2013.
Food Labeling: FDA Needs to Reassess Its Approach to Protecting  Consumers from False or Misleading Claims, GAO-11-102. Washington,  D.C.: January 14, 2011.
Herbal Dietary Supplements: Examples of Deceptive or Questionable  Marketing Practices and Potentially Dangerous Advice, GAO-10-662T.  Washington, D.C.: May 26, 2010.
Dietary Supplements: FDA Should Take Further Actions to Improve  Oversight and Consumer Understanding, GAO-09-250. Washington,  D.C.: January 29, 2009.