MEMORY 

SUPPLEMENTS

Clarifying FDA and 

FTC Roles Could 

Strengthen Oversight 

and Enhance 

Consumer Awareness

Accessible Version

Report to Congressional Requesters

May 2017

GAO-17-416

United States Government Accountability Office
United States Gov ernment Accountability Office

Highlights of GAO-17-416, a report to 

congressional requesters

May 2017

MEMORY SUPPLEMENTS

Clarifying FDA and FTC Roles Could Strengthen 

Oversight and Enhance Consumer Awareness

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.

View GAO-17-416. For more information, 

contact Seto Bagdoyan at (202) 512-6722 or 

bagdoyans@gao.gov or Steve Morris at 

(202) 512-3841 or morriss@gao.gov.

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 agencyoversight.

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 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.
Page i GAO-17-416 Memory Supplements

Contents

Letter 1

Background 5

Most Memory Supplements Were Marketed on the Internet, and, 

While Few Advertisements Targeted Older Adults, Some May 

Have Violated Federal Requirements 20

Similar Types of Enforcement and Outreach for Memory 

Supplements Taken by FDA and FTC Align with Their Agency 

Priorities 27

Limited Market Information Poses Oversight Challenge for FDA, 

While Consumer Groups Reported Uncertainty about FDA and 

FTC Roles Overseeing Internet Marketing 37

Conclusions 44

Recommendations for Executive Action 45

Agency Comments 45

Appendix I: Objectives, Scope, and Methodology 47

Appendix II: Comments from the U.S. Department of Health and Human Services 53

Appendix III: Comments from the U.S. Federal Trade Commission 55

Appendix IV: GAO Contacts and Staff Acknowledgments 58

Appendix V: Accessible Data 59

Data Tables 59

Agency Comment Letters 64

Related GAO Products 69

Tables

Table 1: Examples of Food and Drug Administration (FDA) and 

Federal Trade Commission (FTC) Surveillance Actions 17

Table 2: Review of Memory Supplement Marketing by Media 

Channel 22
Table 3: Food and Drug Administration (FDA) Enforcement 

Actions, Fiscal Years 2006 through 2015 29

Table 4: Federal Trade Commission (FTC) Enforcement Actions, 

Fiscal Years 2006 through 2015 31

Abbreviations

Page ii GAO-17-416 Memory Supplements

CFSAN Center for Food Safety and Applied Nutrition

DSHEA Dietary Supplement Health and Education Act of 1994

FDA Food and Drug Administration

FTC Federal Trade Commission

HHS Department of Health and Human Services

NDI new dietary ingredient

SARS Severe Acute Respiratory Syndrome

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Page 1 GAO-17-416 Memory Supplements

441 G St. N.W.

Washington, DC 20548

Letter

May 16, 2017

The Honorable Claire McCaskill

Ranking Member

Committee on Homeland Security and Governmental Affairs

United States Senate

The Honorable Robert P. Casey, Jr.

Ranking Member

Special Committee on Aging

United States Senate

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 

supplements1for 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.2 Older adults are especially vulnerable to claims that promise to 

 

1The Dietary Supplement Health and Education Act of 1994 (DSHEA) defines a dietary 

supplement in part as a product (other than tobacco) that, among other requirements, is 

intended to supplement the diet; contains one or more dietary ingredients (including 

vitamins, minerals, herbs or other botanicals, amino acids, and other substances) or their 

constituents; is intended to be taken by mouth as a pill, capsule, tablet, or liquid; and is 

labeled on the front panel as being a dietary supplement. DSHEA places dietary 

supplements in a special category under the umbrella of foods.

2Nutrition Business Journal, Mental Acuity Health Condition Specific Supplement,

Pharmaceutical Sales (Boulder, Colo.: Penton Media, Inc., 2016), chart 116.
Letter

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,

Page 2 GAO-17-416 Memory Supplements

3

including amendments 

made by the Dietary Supplement Health and Education Act of 1994 

(DSHEA).4 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.5 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.

 

3

21 U.S.C. §§ 301-399.

4Under DSHEA, Pub. L. No. 103-417, FDA regulates dietary supplements, including 

vitamins, minerals, herbals and other botanicals, amino acids, certain other dietary 

substances, and derivatives of these items. 

5Section 5 of the Federal Trade Commission Act, 15 U.S.C. § 45, prohibits unfair or 

deceptive acts or practices in or affecting commerce, and Section 12, 15 U.S.C. § 52, 

prohibits the false advertisement of food (w hich includes dietary supplements), drugs, 

devices, services, or cosmetics. Although FDA authorities distinguish betw een drugs and 

foods and provide distinct regulatory frameworks for health claims and structure-function 

claims, FTC’s authorities generally make no such distinctions.
Letter

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.

Page 3 GAO-17-416 Memory Supplements

6 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 

 

6We did not find a consistent definition among federal agencies as to w hat age constitutes 

“older,” w ith some federal law s and agencies using 60 or 65 years as the threshold and 

other sources using 50 years. For the purposes of this review, w e define the term older 

adults to include persons age 50 years and older to be consistent with relevant FDA 

educational material aimed at older consumers of dietary supplements, w hich use 50 

years of age as the threshold for defining older. This definition w as also consistent w ith 

AARP representation (an advocacy group for older adults). By using this lower threshold, 

w e are also able to capture consumers of dietary supplements aiming to prevent memory 

loss before it begins. 
Letter

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.

Page 4 GAO-17-416 Memory Supplements

7 Finally, we obtained and analyzed data from FDA and FTC on 

their enforcement actions8involving 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.9

As part of this analysis, we interviewed FDA and FTC staff about these 

memory supplement actions. Based on our analysis of the data provided 

 

7We identified the consumer groups actively w orking on dietary supplement issues as w ell 

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 interview s w ith other consumer groups and 

industry associations. 

8

For the purpose of this report, we use the term “enforcement” to refer to actions an 

agency takes against a dietary supplement firm or product after a violation has been 

identified—this includes advisory communications and regulatory actions (administrative 

and judicial court actions) taken by FDA as w ell as administrative court and judicial court 

actions taken by FTC. 

9At the time w e undertook our review in 2016, FDA and FTC w ere able to provide 

information on actions taken through 2015; complete data for 2016 w ere not available at 

the time w e concluded our audit w ork. According to FTC staff, the agency took no actions 

involving memory supplements in 2016. We subsequently received information about tw o 

memory supplement-related actions taken by FTC in 2017, shortly before the issuance of 

this report; w e included information related to these actions, as appropriate. Also, in 

February 2017, FTC issued a consumer alert about scams involving deceptive “brain 

booster” supplement advertisements that mimic new s w ebsites and rely on fake 

endorsements from public figures to promote their products.
Letter

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 topmarketed 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.

Background

Page 5 GAO-17-416 Memory Supplements

Memory Supplements

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 
Letter

agency.

Page 6 GAO-17-416 Memory Supplements

10 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,11 and accounted for 

nearly 2 percent of total dietary supplement sales in that year, 

approximated at $39 billion.12 As shown in figure 1, memory supplement 

sales nearly doubled in value from 2006 to 2015–a larger increase than 

for dietary supplements overall.

 

10While food facilities, including manufacturers and distributors of dietary supplements, 

are required to register w ith FDA, federal law does not require that dietary supplements be 

listed w ith FDA or another federal agency. 

11Nutrition Business Journal, Mental Acuity Health Condition Specific Supplement,

Pharmaceutical Sales (Boulder, Colo.: Penton Media, Inc., 2016), chart 116. 

12Nutrition Business Journal, Supplement Category Sales by Channel (Boulder, Colo.: 

Penton Media, Inc., 2016), chart 64. 
Letter

Figure 1: Growth in Sales of Memory Supplements and Dietary Supplements, 2006 through 2015

Page 7 GAO-17-416 Memory Supplements

aDietary supplement sales includes all sales, including memory supplements.

The number of dietary supplements on the market has grown 

exponentially, from an estimated 4,000 products in 199413 to an estimated 

 

13According to the Dietary Supplement Health and Education Act of 1994, the estimated 

600 dietary supplement manufacturers in the United States produced approximately 4,000 

products, w ith total annual sales of such products alone reaching at least $4 billion at that 

time.
Letter

80,000 in 2016,

Page 8 GAO-17-416 Memory Supplements

14 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.15

Memory supplement firms16 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.

Oversight Agencies and Federal Requirements for Dietary 

Supplement Safety, Labeling, and Claims

FDA and FTC share oversight17 responsibility for the marketing of dietary 

supplements and their claims—with FDA generally taking responsibility 

for labeling18 claims and FTC generally taking responsibility for claims 

made in product advertising. FDA and FTC authorities related to dietary 

 

14The total number of dietary supplements on the market is estimated to be over 90,000, 

according to the Natural Medicines Comprehensive Database. Natural Medicines 

Comprehensive Database, About Natural Medicines Comprehensive Database, accessed 

March 30, 2017, http://naturaldatabase.therapeuticresearch.com. According to the 

Centers for Disease Control and Prevention, over one-half of U.S. adults consumed 

dietary supplements betw een 2003 and 2006. Centers for Disease Control and 

Prevention, “Dietary Supplement Use Among U.S. Adults Has Increased Since NHANES 

III (1988-1994),” NCHS Data Brief, April 2011, accessed March 30, 2017 at

https://w ww.cdc.gov/nchs/data/databriefs/db61.pdf. 

15Estimate of memory supplements based on search of the Dietary Supplement Label 

Database.

16For the purposes of this report, dietary supplement firms are companies that 

manufacture, distribute, package, or store dietary supplement products. Similarly, memory 

supplement firms are companies that manufacture, distribute, package, or store memory 

supplement products.

17For purposes of this report, w e define oversight to include surveillance (monitoring), 

enforcement, and outreach. 

18The term “labeling” means all labels and other w ritten, printed, or graphic matter (1) on a 

dietary supplement product or any of its containers or w rappers, or (2) accompanying the 

product. 21 U.S.C. § 321(m).
Letter

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.

Page 9 GAO-17-416 Memory Supplements

19 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.

 

19Although FDA authorities distinguish betw een drugs and foods, FTC’s authorities 

generally make no such distinctions. In 1999 a federal appeals court held that the First 

Amendment does not permit FDA to prohibit a potentially misleading health claim on the 

label of a dietary substance unless FDA first considers whether a disclaimer on the 

product’s label could negate the potentially misleading nature of the claim. Pearson v. 

Shalala, 164 F.3d 650 (D.C. Cir. 1999). In response, FDA established procedures for 

exercising its enforcement discretion to not pursue health claim on labels under certain 

conditions. Petitions for these qualified health claims w ould be evaluated using an 

evidence-based ranking system that w ould rate the strength of the publicly available 

scientific evidence in support of the claim. A claim w ould be denied if there w as no 

credible evidence to support it. Otherw ise, based on the competent and reliable scientific 

evidence in support, a claim w ould be assigned by FDA to one of four ranked levels—the 

first level being “significant scientific agreement among qualified experts” and the 

remaining three levels being for claims supported by some low er level of credible 

evidence. Each of these low er three categories w ould require specific qualifying language. 

FDA w ould send a letter to the petitioner describing conditions for the use of the health 

claim and indicating that the agency w ould pursue the claim as a violation of the health 

claims provisions of Federal Food Drug and Cosmetic Act. For more details see GAO, 

Food Labeling: FDA Needs to Reassess Its Approach to Protecting Consumers from 

False or Misleading Claims, GAO-11-102 (Washington, D.C.: Jan. 14, 2011).
Letter

Figure 2: FDA Oversight Roles and Responsibilities

Page 10 GAO-17-416 Memory Supplements

aOther FDA centers include the Center for Drug Evaluation and Research, which is responsible for 

oversight of over-the-counter and prescription drugs. Center for Drug Evaluation and Research 

officials work with other FDA offices to identify products that are marketed as dietary supplements but 

are not because, for example, they do not contain any “dietary ingredients” or contain active 

ingredients in FDA-approved drugs.

b

Structure-function claims describe the role of substances intended to affect the normal structure or 

function in humans, for example, “calcium builds strong bones.”
Letter

Additional details about FTC oversight of supplements can be found in 

figure 3.

Figure 3: FTC Oversight Roles and Responsibilities

Page 11 GAO-17-416 Memory Supplements

a

All companies—including marketers of dietary supplements—must comply with truth-in-advertising 

requirements. One guide, FTC’sDietary Supplements: An Advertising Guide for Industry, explains 

how to make sure such claims have appropriate scientific support.

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 
Letter

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.

Page 12 GAO-17-416 Memory Supplements

20 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.

21

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 

 

20Products may include “proprietary blends,” w hich must list all ingredients but do not 

need to list the amount of each ingredient. 

21The act requires that dietary supplement firms w ith their names appearing on the 

supplement label report information about any serious adverse event report they receive 

to FDA w ithin 15 business days of receipt. As defined in the act, serious adverse events 

include any health-related events that result in, for example, a death, life-threatening 

experience, inpatient hospitalization, or birth defect, or that require, based on reasonable 

medical judgment, a medical or surgical intervention to prevent these serious outcomes. 

The act does not require firms to report moderate or mild adverse events, such as 

gastrointestinal distress or headaches, but firms may do so voluntarily. Under the act, 

firms are also required to maintain records on each report of an adverse event (w hether 

serious or not) for 6 years and allow HHS officials access to these records during an 

inspection or other limited circumstances. The act also requires dietary supplement firms

to provide FDA follow -up medical information received w ithin 1 year after the initial serious 

adverse event report.
Letter

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.

Page 13 GAO-17-416 Memory Supplements

22 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.23 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 

 

2221 C.F.R. § 101.93.

2321 C.F.R. § 101.14(a)(1).
Letter

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.”

Page 14 GAO-17-416 Memory Supplements

24 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 199025 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,26 dietary supplement firms with 

an NDI—an ingredient that was not marketed in the United States before 

 

2421 C.F.R. § 101.13.

25Pub. L. No. 101-535, 104 Stat. 2353. 

26Under section 413(a)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

350b(a)(2)), as added by DSHEA, the manufacturer or distributor of a new dietary 

ingredient (NDI) that has not been present in the food supply as an article used for food, 

or a dietary supplement containing such an NDI, must submit a premarket safety 

notification to FDA at least 75 days before introducing the product into interstate 

commerce.
Letter

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.

Page 15 GAO-17-416 Memory Supplements

27 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.28 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 structurefunction 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).29 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 

 

27GAO, Dietary Supplements: FDA May Have Opportunities to Expand Its Use of 

Reported Health Problems to Oversee Products, GAO-13-244 (Washington, D.C.: Mar. 

18, 2013). The 2009 report including a recommendation on issuing NDI guidance is GAO, 

Dietary Supplements: FDA Should Take Further Actions to Improve Oversight and 

Consumer Understanding, GAO-09-250 (Washington, D.C.: Jan. 29, 2009).

28GAO, Herbal Dietary Supplements: Examples of Deceptive or Questionable Marketing 

Practices and Potentially Dangerous Advice, GAO-10-662T (Washington, D.C.: May 26, 

2010).

29GAO-11-102.
Letter

deceptive structure-function claims on labels. FDA did not implement 

these recommendations, citing competing priorities.

Page 16 GAO-17-416 Memory Supplements

30

Oversight Activities

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.31 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,32 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 

 

30The 2011 report covered labeling of foods, including dietary supplements, but the scope 

w as not exclusive to dietary supplement labeling issues. FDA has issued guidance, 

published in 2008, on dietary supplements and the level of evidence to substantiate 

claims, including structure-function claims, made under section 403(r)(6) of the Federal 

Food, Drug and Cosmetics Act.

31This memorandum of understanding, w hich covers an indefinite period of time and may 

be modified by mutual consent, has not been updated or modified since it w as signed in 

1971. 

32These other things include drugs (w ith the exception of prescription drugs), devices, and 

cosmetics, according to the memorandum of understanding betw een the agencies. 
Letter

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.

Table 1: Examples of Food and Drug Administration (FDA) and Federal Trade Commission (FTC) Surveillance Actions

Page 17 GAO-17-416 Memory Supplements

Type of action Description

Complaints Consumers or other parties can contact FDA to submit complaints about FDA-regulated products by phone. 

Complaints may address any aspect of a product including, but not limited to, an adverse event. In one 

instance, a complaint indicated that the dropper dispenser in a liquid dietary supplement broke during use. In 

another instance, a complaint indicated that a fish oil dietary supplement had a rotten fish smell.

FTC receives complaints about specific products from consumer health advocates, industry self-regulatory 

groups, industry competitors, law enforcement organizations, federal agencies, and state attorneys general, 

among others. Individual consumers may also contact FTC directly. FTC manages the Consumer Sentinel 

Netw ork, an online database of consumer complaints available only to law enforcement organizations, from 

w hich complaints may also be identified. 

Inspectionsa FDA inspects firms that manufacture, pack, or hold dietary supplements for compliance w ith current good 

manufacturing practice regulations, among other things. There are four general types of inspections: (1) 

routine surveillance, (2) consumer complaint investigations, (3) for-cause compliance inspections, and (4) 

follow -up to a regulatory action. According to FDA officials, an inspection may include product examinations, 

sampling, and testing, as w ell as the inspection of the firm and facility involved with dietary supplements.

FTC does not conduct inspections of firms.

Internet monitoring FDA monitors the Internet for dietary supplement labeling violations, for new dietary ingredient initiatives, 

and to identify products marketed as dietary supplements that are fraudulently promoted as drugs for 

treating disease.

FTC routinely monitors digital and viral marketing, including the Internet, to identify advertising campaigns 

likely to have the most substantial consumer impact. FTC also partners w ith law enforcement agencies and 

FDA to identify specific health problems, such as Zika virus, that may be the subject of particularly 

w idespread fraud by online marketers—based on this, FTC identifies specific targets for coordinated Internet 

review s. 
Letter

Page 18 GAO-17-416 Memory Supplements

Market survey FDA staff conduct proactive market surveys w hen there is concern w ith an ingredient or type of product and 

focus on particular target areas in the market, including the Internet. These surveys are initiated to help the 

agency understand how w idespread an ingredient is and how many products have the ingredient, or based 

on “hot topics” that are generating new or more products in the marketplace, such as Severe Acute 

Respiratory Syndrome (SARS) or Zika virus. These surveys include Internet market scans to provide product 

label information, according to FDA officials.

FTC routinely monitors major television and print media to identify national advertising campaigns that are 

likely to have the most substantial consumer impact. It also w atches for emerging trends in trade press and 

at industry conferences and meetings.

Reports Firms must notify FDA of structure-function and related types of claims w ithin 30 days after marketing, 

submit health claims and nutrient content claims for pre-authorization, submit notifications w ith safety 

information for certain NDIs, and report serious adverse events.

b

Consumers may submit complaints about potentially fraudulent claims and products directly to FTC through 

FTC’s w ebsite.

Source: GAO analysis of FDA and FTC information. I GAO-17-416

a

FDA uses a risk-based approach to inspect firms that manufacture foods, including dietary 

supplements. According to FDA officials, and consistent with the FDA Food Safety Modernization Act, 

Pub. L. No. 111-353,§ 201(a), 124 Stat. 3885, 3922 (2011) (adding 21 U.S.C.§ 350j(a)), the agency 

inspects firms it deems as high risk once every 3 years and other firms once every 5 years.

b

Firms are required, under the Federal Food, Drug and Cosmetic Act, to rep ort serious adverse 

events to FDA within 15 days and to report follow-up medical information received about serious 

adverse events to FDA within 1 year after the initial report.

· Enforcement. FDA and FTC both take enforcement33 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 letter34 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.35

Regulatory actions are actions that either restrain dietary 

supplement firms from manufacturing dietary supplements or 

remove specific dietary supplements from the market, or prevent 

 

33For the purpose of this report, we use the term “enforcement” to refer to actions an 

agency takes against a dietary supplement firm or product after a violation has been 

identified—this includes advisory communications such as w arning letters and regulatory 

actions (administrative and judicial court actions) such as injunctions taken by FDA as w ell 

as administrative court and judicial court actions taken by FTC. FDA officials told us that 

they do not alw ays use the term enforcement in the same manner. 

34Untitled letters are used for less serious violations than w arning letters, and also 

communicate that corrective action is needed. 

35Firms have 15 days after receiving a w arning letter to begin working w ith FDA to resolve 

infractions to avoid further enforcement action. Similarly, FDA officials said they request 

that firms respond to an untitled letter in 30 days.
Letter

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,

Page 19 GAO-17-416 Memory Supplements

36

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.37

· 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. 

 

36FDA may initiate a mandatory recall if the responsible party refuses to conduct a

voluntary recall after FDA has determined that there is a reasonable probability that food 

(including a dietary supplement or dietary ingredient) is adulterated or is misbranded for 

failure to declare a major allergen on the label, and the use of or the exposure of the 

dietary supplement w ill cause serious adverse consequences or death to humans or 

animals.

37FDA can also establish that a dietary supplement is adulterated in other w ays; for 

example, by show ing that the supplement has been prepared, packed, or held under 

conditions that do not meet the current good manufacturing practice regulations. FDA 

could also demonstrate that a new dietary ingredient is adulterated by show ing that there 

is inadequate information to provide a reasonable assurance that the new dietary

ingredient does not present a significant or unreasonable risk of illness or injury.
Letter

Federal judicial court actions are direct challenges in a district 

court and can result in injunctions and monetary relief.

Page 20 GAO-17-416 Memory Supplements

38

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).

Most Memory Supplements  Were Marketed on

the Internet, and, While Few Advertisements 

Targeted Older Adults, Some May Have 

Violated Federal Requirements

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 diseaserelated claims we identified may have violated federal requirements.

Most Examples of Memory Supplement Marketing Were 

on the Internet, and Few Advertisements Explicitly 

Targeted Older Adults

We found during our market review that memory supplements were 

primarily marketed on the Internet, with few advertisements containing 

 

38Federal judicial court orders can be permanent, w hereas administrative court orders 

typically expire after 20 years, according to FTC officials.
Letter

text or visuals targeting older adults.

Page 21 GAO-17-416 Memory Supplements

39 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.40 Specifically, as table 2 below indicates, about 96 percent 

of marketing we identified appeared on the Internet.41 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.

 

39Marketing consists of activities, such as product labeling, over w hich FDA exercises 

primary jurisdiction, and advertising (other than labeling), over w hich FTC exercises its 

primary jurisdiction, used by companies to promote their products to consumers. For 

example, companies may select stores to sell their product in, in-store shelf placement, 

and pay to include product advertisements in media channels, such as the Internet, 

television, and magazines. For the purpose of our review w e w ill use these terms as 

follow s: (1) marketing refers to general promotional practices such as product labeling, instore product placement, and selecting television netw orks and Internet search engines to 

advertise products, and (2) advertising refers to marketing practices used in media 

channels to visually or verbally promote a product to consumers, such as Internet product 

review s, television commercials, print advertisements, or in-store visual displays. While we 

use the term “advertising” as described here for the purposes of our report, it is important 

to note that from an oversight perspective, there are some cases w here advertisements 

may also meet the definition of labeling, including Internet advertisements.

40We review ed the memory supplement market, specifically (1) the Internet, (2) retail store 

products and displays, (3) television, (4) magazines, and (5) new spapers, to identify 

memory supplement products and to review how these products are marketed. We 

selected the media channels to review using demographic and survey data relevant to 

older adults. Specifically, w e identified retail stores based on proximity to selected senior 

living facilities, Internet search engines identified by older adults as being used to research 

health concerns online, and magazines w ith highest readership by older adults. We also 

identified three television netw orks to review using data on top shows for older adults, and 

Sunday new spapers from selected cities across the United States w ith the highest total 

print circulation. Our review of the memory supplement market cannot be projected to all 

memory supplements on the market (meaning available for purchase).

41We did not assess the marketing to determine the extent of consumer exposure or 

impact on product sales.
Letter

Table 2: Review of Memory Supplement Marketing by Media Channel

Page 22 GAO-17-416 Memory Supplements

Media 

channels 

reviewed

Total instances of 

product marketing 

identifieda

Percentage of 

marketing identified 

on media channel 

(percent)

Unique memory 

supplement products 

identified on media 

channel

Internet 1,530 96.2 454 

Retail stores 56 3.5 43

Television 4 0.2 1 

Magazines 0 0.0 0

New spapers 0 0.0 0

Total 1,590 100.0b490c

Source: GAO analysis of market review. | GAO-17-416

a

For the purposes of our review, we defined marketing as including advertisements, in -store 

placement or displays, and product label content.

b

The percentage of marketing identified does not equal the total percentage due to rounding.

c

The total number of unique products identified (490) excludes duplicate products across media 

channels. For instance, a product could be identified on the Internet and also on television and 

counted as a product identified in both media channels in the table. However, the product would only 

be counted once for the total. For this reason, the total number of unique products is less than the 

sum of unique products by media channel.

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.42 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.

 

42We determined the claims information w as sufficient to review if the associated product 

met the definition of a memory supplement (as defined for the purposes of this review )

and the claims information w as at the product level, specifically the benefits are 

associated w ith taking the product. For example, an advertisement containing a product 

that states, “product X can prevent memory loss” w ould be deemed sufficient for review . 

We did not evaluate product claims for accuracy and truthfulness or product effectiveness. 
Letter

· Further, 24 of the 37 labels and advertisements claiming to be 

clinically proven or studied contained statements referencing 

supporting evidence.

Page 23 GAO-17-416 Memory Supplements

43

Also, we identified examples of memory supplement advertisements on 

the Internet containing text and visuals (e.g., images and videos) explicitly 

targeting older adults.44 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.

 

43FDA officials told us that firms are not required to include statements describing the level 

of scientific evidence supporting claims on the product labels. How ever, both FDA and 

FTC confirmed that firms must have the supporting evidence in possession. FDA 

guidance suggests consumers contact firms about supporting evidence, but FDA and FTC 

staff noted that firms are not legally required to provide supporting evidence to consumers.

44We review ed the 1,530 Internet memory supplement advertisements for instances of 

advertisements explicitly targeting older adults, including broad marketing containing text 

and visuals, directly or indirectly associated w ith a memory supplement, that are likely to 

appeal to older adults. For example, advertisements mentioning common traits associated 

w ith aging, such as memory loss, and show ing older adults in the marketing, but not 

explicitly stating the benefits of product use would still qualify as an advertisement 

targeted tow ards older adults. We also reviewed the Internet advertisements for visuals 

that w ould potentially encourage a consumer to purchase the product, for example a 

medical professional—person in lab coat—and older adult testimonials or endorsements.
Letter

Figure 4: Examples of Text Targeting Older Adults Found in Internet Advertisements

Page 24 GAO-17-416 Memory Supplements

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.45 However, they explained that the FTC would 

not be able to determine whether the images are considered deceptive 

 

45FDA officials did not review the examples w e shared, but they concurred that the use of 

an image can imply a claim, such as the intent to market as a drug, w hich could be 

problematic. FDA staff stated that w hen review ing for potential claim violations they w ould 

review the context of the total claim (use of the image and w ords) to determine w hether 

there is intent to market as a drug, based on the implied claims.
Letter

without conducting a full investigation, which includes a review of each 

advertisement and supporting evidence.

Page 25 GAO-17-416 Memory Supplements

46

FDA Determined Potential Disease Claims We Identified 

May Have Violated Federal Requirements

Through our market review, we found 28 examples of advertisements 

containing memory supplements potentially making disease-related 

claims,47 and these were associated with 34 products.48 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.

 

46In June 2016, FTC published an Internet blog to consumers shopping online for health 

products, including dietary supplements, cautioning about w ebsites using seals or 

certifications, specifically a “doctor trusted” seal w ith the image of a doctor, claiming that 

products on the site have been tested and evaluated. FTC found the w ebsites’ advertising 

to be deceptive due to the paid doctors’ involved not evaluating product safety or 

effectiveness as claimed.

47These 28 examples w ere identified through a targeted Internet search for memory 

supplement advertisements making claims related to diseases, and a review of the 1,590 

memory supplement marketing examples identified in our market review (w here claims 

language w as available for review ).

48There w ere instances w hen an advertisement made claims for tw o or more memory 

supplement products. There w ere also instances w hen tw o or more advertisements 

contained the same product, in w hich case the product w as counted once. For example, 

one advertisement contained four memory supplement products and a second 

advertisement contained one product that w as identified in the first advertisement. In this 

instance, there w ere five total products contained in the tw o advertisements, but only four 

w ere unique products.
Letter

Figure 5: Examples of Potential Disease Related Claims Found in Internet Advertisements

Page 26 GAO-17-416 Memory Supplements

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.49

 

49We also shared the examples w ith FTC to get its opinion w hether the claims are 

considered deceptive. FTC staff agreed some of the examples looked potentially 

problematic. How ever, FTC staff also could not comment on w hether they are deceptive,

as that determination requires a full investigation—independent review of examples, 

expert review of claims, and review of supporting evidence held by the firm or marketer.
Letter

Similar Types of Enforcement and Outreach for 

Page 27 GAO-17-416 Memory Supplements

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. 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.

FDA and FTC Have Taken Similar Types of Enforcement 

Actions for Memory Supplements as for Other Dietary 

Supplements

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 
Letter

of 17 advisory actions (6 untitled letters and 11 warning letters) and 2 

regulatory actions (1 injunction and 1 seizure),

Page 28 GAO-17-416 Memory Supplements

50 as shown in table 3.

 

50FDA conducted at least one inspection in 9 of the 19 memory supplement matters. FDA 

w as not able to provide us with the total number of inspections that involved memory 

supplements, in part because FDA does not categorize dietary supplements by type of 

use, such as memory supplements. How ever, w e w ere able to confirm through our 

analysis of FDA inspections data w hether each memory supplement matter involved an 

inspection.
Letter

Table 3: Food and Drug Administration (FDA) Enforcement Actions, Fiscal Years 2006 through 2015

Page 29 GAO-17-416 Memory Supplements

Advisory 

Untitled lettera

Advisory

Warning letter

Regulatory

Injunctionb

Regulatory

Mandatory recall

Regulatory

Seizure

Total

Memory supplements 6 11 1 0 1 19

Other dietary supplements 71 432 20 1 8 532

Total 77 443 21 1 9 551

Source: GAO analysis of FDA data. | GAO-17-416

aUntitled letters notify firms that FDA has found the firm out of compliance with dietary supplement 

manufacturing or labeling regulations and provide an opportunity to take voluntary and prompt action 

to correct a violation. Untitled letters are used for less serious violations than warning letters.

bWhen a violation is not corrected, FDA may initiate an action such as an injunction to enjoin a firm 

from continuing the problematic practice.

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.51 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.52 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 

 

51A dietary supplement firm and its ow ners or principals signed a consent decree for 

permanent injunction by the U.S. District Court for the District of Minnesota on September 

13, 2011, for violating the Federal Food, Drug and Cosmetic Act by marketing products as 

drugs w ithout approval. 

52The court ordered the U.S. Marshals Service to seize dietary supplements and 

unapproved drugs from a New York firm.
Letter

resources, rather than focusing on actions against a specific therapeutic 

category of dietary supplements.

Page 30 GAO-17-416 Memory Supplements

53

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 2015,54 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 4.55 These 2 FTC 

enforcement actions involving memory supplements included 1 

administrative action and 1 judicial action.56

 

53According to Office of Dietary Supplement Program officials, the office has 26 staff and 

an annual budget of $5 million, compared to a dietary supplement industry w ith an 

estimated value of $40 billion and an estimated 80,000 different dietary supplement 

products. 

54In January 2017, FTC, along w ith the State of New York, filed a complaint in district 

court seeking an injunction against the marketers of a memory supplement w idely 

marketed on television and the Internet for making false or unsubstantiated claims that the 

dietary supplement rapidly improves memory, provides cognitive benefit and is “clinically 

show n” to w ork. Specifically, the complaint alleges that the marketers of the dietary 

supplement relied on a study that failed to show the product w orks better than a placebo 

on any measure of cognitive function. This law suit is ongoing. In February 2017, FTC, 

along w ith the State of Maine, filed a complaint in district court seeking an injunction 

against the marketers of a separate dietary supplement for, among other things, allegedly 

using radio advertisements formatted as educational talk show s to advertise dietary 

supplements purporting to, among other things, improve memory. Specifically, the 

complaint alleges the marketers of this dietary supplement made false or misleading 

claims to improve memory by 44 percent, to improve memory in as little as 3 w eeks, and 

is clinically proven to improve memory. The court prohibited the firms from making further 

false or unsubstantiated health claims, among other things. According to FTC officials, 

these actions w ere the only actions FTC took involving memory supplements since the 

end of 2015. 

55Approximately 60 percent of FTC enforcement actions related to dietary supplements 

involved w eight loss supplements. 

56In addition to actions involving memory supplements, FTC officials told us they also 

pursued enforcement action against a broader category of cognitive products that included 

action against the marketers of brain games. 
Letter

Table 4: Federal Trade Commission (FTC) Enforcement Actions, Fiscal Years 2006 

Page 31 GAO-17-416 Memory Supplements

through 2015

AdministrativeaJudicialbTotal

Memory supplements 1 1 2

Other dietary 

supplements

12 64 76

Total 13 65 78

Source: GAO analysis of FTC data. | GAO-17-416

a

Administrative refers to administrative court actions.

b

Judicial refers to judicial court actions.

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 
Letter

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.

Page 32 GAO-17-416 Memory Supplements

57 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 2015.58

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 

 

57FDA and FTC staffs also meet w ith other law enforcement agencies for purposes of 

collaboration, including the U.S. Department of Justice. 

58Officials from both agencies also confirmed such interaction to have occurred in FTC’s 

January 2017 enforcement action involving a memory supplement.
Letter

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;

Page 33 GAO-17-416 Memory Supplements

59 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.

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. 

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 

 

59According to FTC officials, the agency can take actions in instances where safety claims 

are deceptive or unfair.
Letter

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 

Page 34 GAO-17-416 Memory Supplements
Letter

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.

FDA and FTC Enforcement and Outreach Efforts 

Page 35 GAO-17-416 Memory Supplements

Prioritize Egregiousness of Deception or Impact and 

Ensuring Consumer Safety

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 
Letter

vulnerable or at risk,

Page 36 GAO-17-416 Memory Supplements

60 including older adults that would be consumers of 

memory supplements. According to officials from CFSAN’s Office of 

Dietary Supplement Programs,

61 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 

 

60The FDA Food Safety Modernization Act of 2011 directs FDA to take a risk-based 

management approach. To this end, FDA’s Foods and Veterinary Medicine Program 

Strategic Plan (2012-2016) states that, as part of its effort to improve the safety of dietary 

supplements and fully implement DSHEA, FDA w ill develop and implement strategic, risk‐

based, and innovative compliance and regulatory strategies to address dietary 

supplement safety issues. This strategic plan does not specifically identify the protection 

of older adults from dietary supplement risks as a priority. Further, FDA’s Foods and

Veterinary Medicine Program Strategic Plan for Fiscal Years 2016 to 2025 also states the 

agency’s imperative to take a “risk-informed approach.” 

61In December 2015, the Office of Dietary Supplement Programs w as elevated—from a 

division under the former FDA Office of Nutrition Labeling and Dietary Supplements (now

called the Office of Nutrition and Food Labeling)—to an independent office-level entity 

w ithin CFSAN. According to FDA officials, this elevation reflected a higher priority placed 

by FDA on dietary supplements.
Letter

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.

Page 37 GAO-17-416 Memory Supplements

62 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.

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 

 

62Federal Trade Commission, Prepared Statement of the Federal Trade Commission on

Deceptive Marketing of Dietary Supplements: FTC Enforcement Activities, Before the 

Senate Special Committee on Aging, 111th Cong., May 26, 2010.
Letter

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.

FDA Has Limited Information on the Memory Supplement 

Page 38 GAO-17-416 Memory Supplements

Market

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.63 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.

Information on the Memory Supplement Market

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 

 

63GAO, Dietary Supplements: FDA Should Take Further Actions to Improve Oversight and 

Consumer Understanding, GAO-09-250 (Washington, D.C.: Jan. 29, 2009); Dietary 

Supplements: FDA May Have Opportunities to Expand Its Use of Reported Health 

Problems to Oversee Products, GAO-13-244 (Washington, D.C.: Mar. 18, 2013).
Letter

number is unknown.

Page 39 GAO-17-416 Memory Supplements

64 This has been an ongoing challenge for dietary 

supplement oversight, as we previously reported on this issue in our prior 

work.65 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.66

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.

Information on New Dietary Ingredients

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 

 

64Estimate sources include FDA, the National Institutes of Health and the Natural 

Medicines Comprehensive Database.

65GAO-09-250.

66GAO-09-250. Some examples of the legislation are S. 3002, 111th Cong., S. 1310, 

112th Cong., S. 1425, 113th Cong.
Letter

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.

Page 40 GAO-17-416 Memory Supplements

67 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 

 

67We used memory supplement market review data, as described previously, 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. 
Letter

recommended that FDA provide additional guidance on the NDI 

notification process.

Page 41 GAO-17-416 Memory Supplements

68

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. 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.69 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 “flyby-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.

 

68GAO-09-250 and GAO-13-244.

69Under these circumstances, a w ebsite could be both labeling and advertising, and both 

agencies could take action based on the claims made on the w ebsite.
Letter

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.

Page 42 GAO-17-416 Memory Supplements

70

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 

 

70The 2007 letter specified that a website w ould generally be considered labeling, and 

subject to the applicable FDA rules, if it promotes a supplement and allow s consumers to 

directly purchase the supplement on the w ebsite. The letter also stated that if a product 

label referred to a w ebsite for additional information about a claim for the product, the 

w ebsite is likely considered labeling. See FDA, Guidance for Industry and FDA: Dear 

Manufacturer Letter Regarding Food Labeling, issued January 2007.

https://w ww.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatory Informatio

n/ucm053425.htm.
Letter

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.

Page 43 GAO-17-416 Memory Supplements

71 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.72 In this 

 

71In addition to the w ebpage’s referenced above, FDA has a consumer information 

w ebpage related to dietary supplement use, and this site includes a link to general 

information on reporting problems and also a link to information on FTC. How ever, the 

w ebpage does not include specific information for consumers on FDA and FTC shared 

oversight of Internet marketing and determining w here to report related issues.

72GAO, Standards for Internal Control in the Federal Government. GAO-14-704G 

(Washington, D.C.: Sept. 2014). Principle 15: Management should externally 

communicate the necessary quality information to achieve the entity’s objectives. 
Letter

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.

Page 44 GAO-17-416 Memory Supplements

73 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.

Conclusions

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 

 

73GAO, Managing for Results: Key Considerations for Implementing Interagency 

Collaborative Mechanisms, GAO-12-1022 (Washington, D.C.: Sept. 27, 2012). 
Letter

Internet marketing, agencies may be able to act to address potential 

problems and violations faster, improving their oversight of Internet 

marketing.

Recommendations  for Executive Action

Page 45 GAO-17-416 Memory Supplements

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.

Agency Comments 

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.
Letter

Seto J. Bagdoyan

Director

Forensic Audits and Investigative Service

Steve D. Morris

Director

Natural Resources and Environment

Page 46 GAO-17-416 Memory Supplements
Appendix I: Objectives, Scope, and 

Methodology

Page 47 GAO-17-416 Memory Supplements

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. For all three 

objectives, we reviewed relevant laws and regulations related to each 

agency’s oversight of dietary supplements.

Review of Memory Supplement  Market

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.1 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.

 

1We did not find a consistent definition in the federal sphere as to what age constitutes 

“older”, w ith some federal law s and agencies using 60 or 65 years as the threshold and 

other sources using 50 years. For the purposes of this review , w e define the term older 

adults to include persons age 50 years and older to be consistent with relevant FDA 

educational material aimed at older users of dietary supplements, w hich use 50 years of 

age as the threshold for defining older. This definition w as also consistent w ith AARP

representation (an advocacy group for older adults). By using this lower threshold, w e are 

also able to capture consumers of dietary supplements aiming to prevent memory loss 

before it begins.
Appendix I: Objectives, Scope, and 

Methodology

· 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 

Page 48 GAO-17-416 Memory Supplements
Appendix I: Objectiv es, Scope, and 

Methodology

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.

Page 49 GAO-17-416 Memory Supplements

2 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.

 

2We determined the claims information w as sufficient to review if the associated product 

met the definition of a memory supplement and the claims information w as at the product 

level, specifically the benefits are associated with taking the product. For example, an

advertisement containing a product that states, “product X can prevent memory loss”

w ould be deemed sufficient for review . 
Appendix I: Objectives, Scope, and 

Methodology

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.

Page 50 GAO-17-416 Memory Supplements

3 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.4

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.

Memory Supplement  Enforcement Actions and 

Outreach

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 

 

3The search terms w e used w ere: “age,” “aging,” “young,” “senior,” and “elderly.” We 

identified advertisements using images depicting older adults and common traits 

associated w ith aging, such as mild memory loss or cognitive decline.

4The search terms included: “Memory supplement Alzheimer’s”; “Alzheimer’s pill dietary 

supplement”; “Alzheimer’s vitamin”; “cure Alzheimer’s supplement”; “cure dementia 

supplement”; “dementia vitamin”; “dementia drops”; “prevent Alzheimer’s”; “treat 

Alzheimer’s”; “dietary supplements to treat dementia”; “supplement products for 

dementia”; “Parkinson’s cure”; “Parkinson’s supplement”; “Parkinson’s disease vitamins”; 

“dietary supplements to prevent Parkinson’s”; and “dietary supplements to treat 

Parkinson’s disease.”
Appendix I: Objectives, Scope, and 

Methodology

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

Page 51 GAO-17-416 Memory Supplements

5 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.

6 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.

 

5For the purpose of this report, we use the term “enforcement” to refer to actions an 

agency takes against a dietary supplement firm or product after a violation has been 

identified—this includes advisory communications and regulatory actions (administrative 

and judicial court actions) taken by FDA as w ell as administrative court and judicial court 

actions taken by FTC. FDA officials told us that they do not alw ays use the term 

enforcement in the same manner. 

6At the time w e undertook our review in 2016, FDA and FTC w ere able to provide 

information on actions taken through 2015; complete data for 2016 w ere not available at 

the time w e concluded our audit w ork. According to FTC staff, the agency took no actions 

involving memory supplements in 2016. We subsequently received information about tw o

memory supplement-related actions taken by FTC in 2017, shortly before the issuance of 

this report; w e included information related to these actions, as appropriate.
Appendix I: Objectives, Scope, and 

Methodology

Challenges  to Memory Supplement  Oversight

Page 52 GAO-17-416 Memory Supplements

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.
Appendix II: Comments from the U.S. 

Department of Health and Human Serv ices

Page 53 GAO-17-416 Memory Supplements

Appendix II: Comments from the 

U.S. Department of Health and 

Human Services
Appendix II: Comments from the U.S. 

Department of Health and Human Serv ices

Page 54 GAO-17-416 Memory Supplements
Appendix III: Comments from the U.S. Federal 

Trade Commission

Page 55 GAO-17-416 Memory Supplements

Appendix III: Comments from the 

U.S. Federal Trade Commission
Appendix III: Comments from the U.S. Federal 

Trade Commission

Page 56 GAO-17-416 Memory Supplements
Appendix III: Comments from the U.S. Federal 

Trade Commission

Page 57 GAO-17-416 Memory Supplements
Appendix IV: GAO Contacts and Staff 

Acknowledgments

Page 58 GAO-17-416 Memory Supplements

Appendix IV: GAO Contacts 

and Staff Acknowledgments

GAO Contacts

Seto J. Bagdoyan, (202) 512-6722 or bagdoyans@gao.gov

Steve D. Morris, (202) 512-3841 or morriss@gao.gov

Staff Acknowledgments

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-inCharge; 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.
Appendix V: Accessible Data

Page 59 GAO-17-416 Memory Supplements

Appendix V: Accessible Data

Data Tables

Data table for Figure 1: Growth in Sales of Memory Supplements and Dietary Supplements, 2006 through 2015

Year Percentage growth: Dietary supplement growth 

from base year (2006) 

Percentage growth: Memory supplement 

growth from base year (2006)

2006 0 0

2007 6 13.6

2008 12.8 30.6

2009 19.6 44.2

2010 25 54.1

2011 33.8 65.7

2012 43.8 78.8

2013 54.7 79.6

2014 62.6 79.6

2015 72.1 82.2

Accessible Text for Figure 2: FDA Oversight Roles and Responsibilities

1. Food and Drug Administration (FDA)

a. Office of Foods and Veterinary Medicine

i. Center for Food Safety and Applied Nutrition 

(CFSAN) (primarily responsible for dietary 

supplement oversight)

1. manages dietary supplement oversight 

through its Office of Dietary Supplement 

Programs

a. Office of Dietary Supplement 

Programs
Appendix V: Accessible Data

i. is responsible for developing 

dietary supplement policy, 

regulations, and guidance; 

providing scientific and 

technical expertise, reviewing 

new dietary ingredient (NDI) 

notifications and structurefunction claims,b and 

directing dietary supplement 

priorities across the agency, 

among other things

b. Office of Compliance

i. has primary responsibility for 

compliance and enforcement 

of FDA regulations and 

federal laws within FDA’s 

jurisdiction with respect to 

foods—including dietary 

supplements

ii. reviews incoming 

investigational findings and 

recommendations to 

determine whether a 

proposed action or remedy is 

supported by the 

documented observations 

and other evidence

iii. assesses the integrity and 

relevance of the evidence

iv. obtains necessary scientific 

verification and policy 

guidance from appropriate 

subject-matter experts

b. Office of Regulatory Affairs

i. Office of Regulatory Affairs (primarily responsible 

for dietary supplement oversight)

Page 60 GAO-17-416 Memory Supplements
Appendix V: Accessible Data

1. is responsible for managing the agency’s 

field operations in 25 regional and district 

offices

2. supports FDA centersaon dietary 

supplement oversight by performing 

inspections and import operations, and by 

taking advisory and regulatory enforcement 

actions, generally in coordination with 

CFSAN’s Office of Compliance

c. Office of Enforcement and Import Operations

i. Health Fraud Team

1. primarily looks for labeling claims that 

indicate a violation of federal law and for 

undeclared ingredients (such as 

pharmaceuticals) in dietary supplements

Accessible Text for Figure 3: FTC Oversight Roles and Responsibilities

Page 61 GAO-17-416 Memory Supplements

1. Federal Trade Commission (FTC)

a. Bureau of Consumer Protection

i. is responsible for protecting consumers against 

unfair, deceptive, or fraudulent practices

1. Division of Advertising Practices

a. manages FTC's health fraud work, 

of which dietary supplement 

oversight is a part. The division 

works to protect consumers from 

unfair or deceptive advertising and 

marketing practices that raise health 

and safety concerns, as well as 

those that cause economic injury-as 

part of FTC's law enforcement 

efforts to prevent unfair competition 

and protect consumers, including 

older adults, from unfair or deceptive 
Appendix V: Accessible Data

practices in the marketplace. The 

Division

i. collects complaints and 

conducts investigations and 

sues companies and people 

to stop deceptive advertising 

practices

ii. develops guidance to 

maintain a fair marketplace, 

and educates consumers 

and businesses about their 

rights and responsibilities, 

among other things

iii. develops rules, reviews and 

enforces a variety of 

consumer-protection laws, 

and develops guidanceincluding its Dietary 

Supplement Advertising 

Guide,a which provides 

business with guidance for 

claims they make for dietary 

supplements

iv. coordinates and addresses 

consumer-protection issues 

with law enforcement 

agencies and industry selfregulation groups by, for 

example, issuing joint 

warning letters with the Food 

and Drug Administration to 

combat fraudulent products 

on the Internet

Page 62 GAO-17-416 Memory Supplements
Appendix V: Accessible Data

Data table for Figure 4: Examples of Text Targeting Older Adults Found in Internet 

Page 63 GAO-17-416 Memory Supplements

Advertisements

· “Are you 55 years of age or older?”

· “Losing your memory or developing brain fog in your 40s, 50s, 60s, 

70s, or even 80s is NOT normal.” 

· “Avoid those embarrassing senior moments.”

· “... designed to help to stay sharp through your later years.”

· “This can help combat age-related memory loss, brain fog, and mental 

fuzziness.”

· “Vital nutrients to preserve your memory as you age.”

· “Improve your memory, so you stay sharp and alert into your 70s, 80s, 

and 90s ...”

· “... memory support supplements are perfect for occasional mild 

memory problems associated with aging.”

· “There are many memory supplements, memory improvement 

medications, or memory enhancers, that fundamentally enhance 

memory, reduce the risk of age-connected memory misfortune, and 

also help concentration.”

· “Now you’ll be able to increase your memory abilities, slow down the 

process of aging, and sharpen your mental focus.”

· “This herb increases blood circulation in the brain and has been 

shown, in multiple clinical trials, to be useful for improving memory 

and cognition especially in the elderly.”

· “It has been shown to be helpful with many of the complaints of the 

elderly such as short-term memory loss, slow thinking and reasoning, 

occasional headaches, and dizziness.”

Figure 5: Examples of Potential Disease Related Claims Found in Internet 

Advertisements

• "Invest in yourself, protect & secure your future. Order anti-Alzheimer's 

herbs."

• "Improves Cognition and Behavioural Symptoms in Alzheimer's 

patients."

• "Consider it a preventive program for cancer, Alzheimer's Disease and 

more."
Appendix V: Accessible Data

• "Studies indicate this supplement may help protect against age-related 

memory decline, including Parkinson's disease."

• "This herbal combination could reduce risk."

• "It is also beneficial for those in initial and mid-stages of Alzheimer's."

• "Numerous studies have demonstrated curcumin's ability to prevent the 

underlying processes involved in the disease."

• "It is very helpful in the treatment of Alzheimer's disease."

• "Provides homeopathic aid in support of assistance with the symptoms 

of dementia."

• "[W]e have compiled a list of the vitamins which have the most evidence 

for reducing the risk of developing Alzheimer's or dementia as well as 

slowing their progress."

• .. used in high doses ... to treat senile dementia. It may also be used for 

patients with Alzheimer's disease."

Source: GAO Internet search market review (examples); GAO Stock 

Photography (image). GA0-17-416

Agency Comment  Letters

Page 64 GAO-17-416 Memory Supplements

Accessible Text for Appendix II: Comments from the U.S. 

Department of Health and Human Services

Page 1

DEPARTMENT OF HEALTH & HUMAN  SERVICES

OFFICE OF THE SECRETARY

Assistant Secretary for Legislation Washington, DC 20201

APR 27 2017

Seto Bagdoyan
Appendix V: Accessible Data

Director, Forensic Audits & Investigative Service U.S. Government 

Accountability Office

441 G Street NW Washington, DC 20548

Dear Mr. Bagdoyan:

Attached are comments on the U.S. Government Accountability Office's 

(GAO) report entitled, "Memory Supplements: Clarifying FDA and FTC 

Roles Could Strengthen Oversight and Enhance Consumer Awareness" 

(GA0-17-416).

The Department appreciates the opportunity to review this report prior to 

publication.

Sincerely,

Barbara Pisaro Clark

Acting Assistant Secretary for Legislation

Attachment

Page 2

Page 65 GAO-17-416 Memory Supplements

GENERAL COMMENTS OF THE DEPARTMENT OF HEALTH AND 

HUMAN SERVICES (HHS) ON THE GOVERNMENT ACCOUNTABILITY 

OFFICE'S DRAFT REPORT ENTITLED: MEMORY SUPPLEMENTS: 

CLARIFYING FDA AND FTC ROLES COULD STRENGTHEN 

OVERSIGHT AND ENHANCE CONSUMER AWARENESS (GA0-17-416)

The U.S. Department of Health and Human Services (HHS) appreciates 

the opportunity from the Government Accountability Office (GAO) to 

review and comment on this draft report.

Recommendation

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 Federal Trade Commission (FTC) develop and provide 

additional guidance to consumers delineating the agencies' differing roles 
Appendix V: Accessible Data

in their shared oversight of memory supplement and other dietary 

supplement marketing on the Internet.

HHS Response

HHS concurs with GAO's recommendation.

HHS agrees that collaborating with FTC to provide further clarification to 

the public about the Food and Drug Administration and FTC's respective 

oversight roles regarding dietary supplement marketing would be 

beneficial. Our two agencies have already been in communication about 

working together to develop materials toward this end.

Accessible Text for Appendix III:  Comments from the U.S. 

Page 66 GAO-17-416 Memory Supplements

Federal Trade Commission

Page 1

Office of the Secretary

UNITED STATES OF AMERICA

Federal Trade Commission

WASHINGTON, D.C. 20580

April 26, 2017

Seto J. Bagdoyan

Director, Forensic Audits and Investigative Service United States 

Government Accountability Office 441 G Street NW

Washington, DC 20548

Steve D. Morris

Director, Natural Resources and the Environment United States 

Government Accountability Office 441 G Street NW

Washington, DC 20548
Appendix V: Accessible Data

Dear Messrs. Bagdoyan and Morris:

The Government Accountability Office (“GAO”) recently forwarded for the 

Federal Trade Commission’s (“FTC” or “Commission”) review and 

comment a draft of a GAO report entitled MEMORY SUPPLEMENTS: 

Clarifying FDA and FTC Roles Could Strengthen Oversight and Enhance 

Consumer Awareness (GAO-17-416). FTC staff provided GAO with 

information about the FTC’s enforcement and education efforts in 

connection with the preparation of the draft report, and the Commission 

appreciates the opportunity to have assisted GAO in its work. The 

Commission also appreciates having the chance to respond to the 

specific recommendation set forth in the draft report: that the Food and 

Drug Administration (“FDA”) and FTC provide additional guidance to 

consumers clarifying the agencies’ roles in their shared oversight of 

memory supplement and other dietary supplement marketing on the 

Internet. The draft report notes that this could assist consumers in filing 

complaints and the agencies in following up on such complaints.

As the draft report notes, the FTC has established outreach programs 

directed at both consumers and businesses. In addition to guidance such 

as tip sheets and alerts for older adults, the FTC regularly posts blogs 

aimed at consumers and businesses in connection with its dietary 

supplement enforcement actions, including actions targeting memory 

supplements. See GAO draft report at 27-28. Most recently, the FTC 

issued a consumer alert warning that some companies are deceptively 

promoting “brain booster” supplements via websites that look like news 

websites and feature fake endorsements purportedly from public figures 

such as Stephen

Seto J. Bagdoyan and Steve D. Morris -Page 2

Hawking. 1 We have collaborated on consumer education pieces with 

the FDA in the past,2 but we agree that additional guidance may be 

useful and have discussed GAO's recommendation with FDA personnel. 

We will continue to work with the FDA to educate consumers and 

businesses about the agencies' roles and efforts in the area.

By direction of the Commission.

Donald S. Clark Secretary

Page 67 GAO-17-416 Memory Supplements
Appendix V: Accessible Data

Page 2 

Page 68 GAO-17-416 Memory Supplements

1 FTC, Consumer Information: "Scammers are spoofing news sites to 

promote health products" (Feb. 23, 2017), available at 

https://www.consumer.ftc.gov/blog/scarnmers-are-spoofing-news- sitespromote-health -products.

2 See, e.g., FTC, Consumer Information: Dietary Supplements (Feb. 

2011), available at https://www.consumer.ftc.gov/articles/0261-dietary -

supplements; FTC, Consumer Information: Dietary Supplement Ads 

Infographic (Nov. 2015), available at 

https://www.consumer.ftc.gov/articles/0538-dietary-supplement-adsinfographic.

Accessible Text for
Related GAO Products

Page 69 GAO-17-416 Memory Supplements

Related GAO Products

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.

(100489)
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