Health Products for Seniors: 'Anti-Aging' Products Pose Potential for Physical and Economic Harm
Published: 2001-09-07T00:00:00

Fast Facts:

Highlights:
section_title: What GAO Found
paragraphs: Evidence from the medical literature shows that a variety of frequently used dietary supplements marketed as anti-aging therapies can have serious health consequences for senior citizens. Some seniors have underlying diseases or health conditions that make the use of the product medically inadvisable, and some supplements can interact with medications that are being taken concurrently. Furthermore, studies have found that products sometimes contain harmful contaminants or much more of an active ingredient than is indicated on the label. Unproven anti-aging and alternative medicine products also pose an economic risk to seniors. The Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) have identified several products that make advertising or labeling claims with insufficient substantiation, some costing consumers hundreds or thousands of dollars apiece. Federal and state agencies have efforts under way to protect consumers of these products. FDA and FTC sponsor programs and provide educational materials for senior citizens to help them avoid health fraud. At the state level, agencies are working to protect consumers of health products by enforcing state consumer protection and public health laws, although anti-aging and alternative products are receiving limited attention. GAO summarized this report in testimony before Congress (GAO-01-1139T).

section_title: Letter
paragraphs: The risk to consumers from potentially harmful health products is a  perennial concern for consumer protection groups, health authorities,  federal and state regulators, and law enforcement officials.  Many  alternative medicine products, including dietary supplements, have  widespread popular appeal among consumers, and some have yielded  promising results in studies that focus on chronic health conditions that  affect many older adults, such as depression, dementia, and arthritis. For  example, some studies have suggested that St. John’s wort may counteract  feelings of mild to moderate depression and that ginkgo biloba may  improve cognitive performance in dementia. At the same time, regulators  and medical experts are concerned that some products have health risks or  are marketed with misleading and unsubstantiated claims.
Some companies promote their products to senior citizens by using “anti- aging” or “cure-all” claims for which there is little or no supporting  scientific evidence of either safety or efficacy. In addition, there are  concerns that some of these products may cause physical or economic  harm.  Seniors are thought to be at particular risk of physical harm because  they often take multiple prescription pharmaceuticals, increasing their risk  of possibly dangerous supplement-drug interactions. Seniors can also be  harmed indirectly if they decide to follow an unsubstantiated alternative  regimen and forgo needed conventional medical treatment.  There is also  concern that seniors may be wasting money on products that have little or  no therapeutic value.
Since 1994, when the Dietary Supplement Health and Education Act  (DSHEA) was enacted, sales of dietary supplements have soared.  A  significant number of these products are herbal supplements, and others  are nonherbal specialty supplements. DSHEA permits dietary supplements  to feature so-called structure/function label claims, which are statements  that an ingredient in the product will benefit a body’s structure (such as  “builds strong bones”) or function (such as “promotes restful sleep”). As  we reported last year, consumers may incorrectly view such statements as  claims to reduce the risk of or to treat a disease.
In light of these concerns, you asked us to examine (1) whether there is  evidence that anti-aging and alternative medicine products, particularly  dietary supplements aimed at conditions of aging, cause physical harm to  senior citizens; (2) whether there is evidence that questionable anti-aging  and alternative medicine products cause economic harm to senior citizens;  and (3) federal and state oversight efforts to protect consumers from  questionable anti-aging and alternative medicine products.
To address these questions, we obtained documents from and interviewed  officials with the Food and Drug Administration (FDA), the Federal Trade  Commission (FTC), the National Institutes of Health (NIH), state Attorneys  General (AG) offices, and state health departments, as well as  representatives of the dietary supplement industry and other interested  organizations and experts.  We also reviewed the scientific literature on  dietary supplements and other products marketed as anti-aging therapies.  Our work focused primarily on those products that purport to have anti- aging properties or which claim to address chronic diseases and conditions  common among senior citizens, such as cancer, memory loss, and arthritis.   We conducted our review from April through August 2001 in accordance  with generally accepted government auditing standards. (See app. I for  further information on our scope and methodology, including a list of the  organizations we contacted.)
subsections: section_title: Background
paragraphs: Dietary supplements and other alternative medicine products are widely  used by seniors.  For example, as many as 4 out of 10 senior citizens have  reported using herbal dietary supplements. In 2000, total U.S. sales for the  herbal and specialty supplement industry reached $5.8 billion.  Research  suggests that some of these products show promise for mitigating  symptoms associated with certain health conditions.  FDA, FTC, and state  agencies all have oversight responsibility for alternative medicine  products.
subsections: section_title: Use of Alternative Medicine Products by Older Americans
paragraphs: A number of surveys have been conducted to determine the proportion of  the population that uses alternative medicine products.  One national  survey of more than 2,000 adults conducted in 1997 found that 42 percent  of Americans of all ages used at least one type of alternative therapy in the  prior year for conditions such as back problems, fatigue, arthritis, high  blood pressure, insomnia, depression, and anxiety. The survey found that  12 percent used herbal remedies. Other studies have found that 16 to 18  percent of Americans used dietary supplements, including amino acids and  over-the-counter hormones.
When considering only senior citizens, surveys have generally found that as  many as 40 percent of seniors used herbal and specialty supplements at  some time in the previous year, with a smaller percentage reporting regular  use.  For example, a survey conducted in 1999 for Prevention Magazine  found that 43 percent of seniors used herbal supplements and 23 percent  used specialty supplements in the previous year. This study also found that  one-quarter of older Americans often use herbal and specialty supplements  in combination with prescription medications.  A recent unpublished  Harris Poll survey conducted for the Dietary Supplement Education  Alliance (June and July 2001) found that 12 percent of those aged 65 or  older used herbal supplements and 9 percent used specialty supplements  on a regular basis.  Surveys have found that many older Americans use  these supplements to maintain overall health, increase energy, improve  memory, and prevent and treat serious illness, as well as to slow the aging  process, among other purposes.  Products frequently used by seniors to  address aging concerns include herbal supplements such as evening  primrose, ginkgo biloba, ginseng, kava kava, saw palmetto, St. John’s wort,  and valerian, and specialty supplements such as chondroitin, coenzyme  Q10, dehydroepiandrosterone (DHEA), glucosamine, melatonin, omega-3  fatty acids (fish oil), shark cartilage, and soy proteins (see app. II for details  regarding these substances).
section_title: Research on Alternative Medicine Products
paragraphs: NIH’s National Center for Complementary and Alternative Medicine  (NCCAM) has noted that preliminary evidence-based reviews suggest that  some alternative therapies may have beneficial effects.  These include St.  John’s wort for depression, ginkgo biloba for dementia, and glucosamine  and chondroitin sulfate for osteoarthritis.  For example, one source stated  that increased memory performance and learning capacity have been  established experimentally for ginkgo biloba. One controlled study has  shown positive results for ginkgo biloba in tests of cognitive performance  in dementia. Similarly, some reviews have suggested that studies of  glucosamine in the treatment of osteoarthritis found positive results, as  did studies of St. John’s wort for depression.  A systematic review of  studies of St. John’s wort for depression found evidence of effectiveness in  the treatment of mild to moderately severe depression, although it has  also been associated with potentially dangerous interactions with  prescription drugs.
section_title: Government Oversight of Anti-Aging Products and Dietary Supplements
paragraphs: FDA, FTC, and state government agencies all have oversight responsibility  for products marketed as anti-aging therapies.  In general, the law permits  FDA to remove from the market products under its regulatory authority  that are deemed dangerous or illegally marketed.  FDA’s regulation of  dietary supplements is governed by the Federal Food, Drug, and Cosmetic  Act as amended by DSHEA in 1994. DSHEA does not require manufacturers  of dietary supplements to demonstrate either safety or efficacy to FDA  prior to marketing them.  However, if FDA subsequently determines that a  dietary supplement is unsafe, the agency can ask a court to halt its sale. For  dietary supplements, the Health and Human Services Secretary may  declare the existence of an imminent hazard from a dietary supplement,  after which the Secretary must initiate an administrative hearing to  determine the matter, which may then be reviewed in court. DSHEA does  not require dietary supplement manufacturers to register with FDA, or to  identify to FDA the products they manufacture, and dietary supplement  manufacturers are not required to provide the adverse event reports they  receive to FDA. However, FDA does regulate nutritional and health claims  made in conjunction with dietary supplements.
FTC has responsibility for ensuring that advertising for anti-aging health  products and dietary supplements is truthful and can be substantiated.   FTC can ask companies to remove misleading or unsubstantiated claims  from their advertising and it can seek monetary redress for conduct  injurious to consumers in appropriate cases.  FTC published an advertising  guide for the dietary supplements industry in November 1998 that  reminded the industry that advertising must be truthful and that objective  product claims must be substantiated.  State agencies can take action  against firms that fraudulently market anti-aging and other health products.
section_title: Some Dietary Supplements Have Been Associated With Potentially Serious Health Consequences for Senior Citizens
paragraphs: Some dietary supplements can have potentially serious health  consequences for seniors. Although precise estimates of the physical harm  caused to senior citizens by questionable anti-aging and alternative  products are not available, there is evidence in the medical literature that  seniors are at risk for adverse effects, that dietary supplements are  contraindicated for individuals with some underlying health problems, and  that a variety of frequently used dietary supplements can have dangerous  interactions with drugs that are being taken concurrently.  Although  documented adverse effects from most herbal and specialty supplements  are generally mild, potential complications from supplements that might be  contraindicated under certain circumstances and from interactions with  certain prescription medications may be serious.  In addition, there is  evidence that 1 in 10 herbal products may be contaminated with pesticides  and heavy metals, which can have serious health consequences. Adverse  event reports received by FDA and others give an indication of some  possible risks. FDA has issued warnings to consumers and industry about  the health risks of several dietary supplement products. Recognizing these  health risks, the American Medical Association has recommended that  dietary supplements and herbal remedies include specific warnings on  their labels, and several trade associations representing manufacturers,  suppliers, and distributors of dietary supplements have instituted voluntary  programs to reduce the risk of potentially harmful products.
subsections: section_title: Scientific Evidence Shows Potential Adverse Effects, Contraindications, and Drug Interactions for Some Popular Supplements
paragraphs: Our review of the medical literature identified several areas where  individuals, particularly seniors, may be at risk of physical harm due to  adverse effects--especially if dietary supplements are used when they are  contraindicated--or interactions between these dietary supplement  products and prescription or over-the-counter drugs.
The literature suggests that among healthy adults, most supplements when  taken alone have been associated with only rare and minor adverse effects.  These include stomach distress, headache, breast tenderness, restlessness,  skin reactions, and hypersensitivity to sunlight. However, others are  associated with more serious adverse effects.  For example, the literature  suggests that DHEA may increase the risk of breast, prostate, and  endometrial cancer, and shark cartilage has been associated with thyroid  hormone toxicity.
Contraindications have been identified in the literature for several  supplements. Ginseng is not recommended for persons with hypoglycemia.  Kava kava may worsen symptoms of Parkinson’s disease.  Saw palmetto is  contraindicated for patients with breast cancer, and valerian should not be  used by those with liver or kidney disease without first consulting a  physician. A recent study also suggested that echinacea (promoted to help  fight colds and flu), ephedra (promoted as an energy booster and diet aid),  garlic, ginkgo biloba, ginseng, kava kava, St. John’s wort, and valerian may  pose particular risks to people during surgery, with complications including  bleeding, cardiovascular instability, and hypoglycemia.  Other potential  complications cited were an increase in the sedative effect of anesthetics  and increased metabolism of many drugs.
The literature also identifies a number of possible interactions with  prescription medications. Since seniors take more prescription medicines  on average than do younger adults, the risk of interactions among seniors  may be higher. For example, evening primrose oil, garlic, ginkgo biloba,  ginseng, glucosamine, and St. John’s wort magnify the effect of blood- thinning drugs such as warfarin or coumadin. We also identified reports  suggesting that ginkgo biloba may reduce the effects of seizure medications  and glucosamine may have a harmful effect on insulin resistance.
An additional concern is that individuals with potentially serious health  conditions may seek alternative therapies, some of which are unproven, in  lieu of conventional medical therapies, and may do so without consulting  their physician.  For example, the Prevention Magazine survey we  described earlier found that 39 percent of the respondents aged 65 or older  who used a herbal supplement to prevent or treat a disease used the herbal  remedy instead of an over-the-counter medication and 34 percent had tried  a herbal remedy instead of a prescription medication.  Surveys have also  found that individuals who use alternative therapies (either in conjunction  with or instead of traditional therapies) often do not discuss this fact with  their physicians. For example, one survey found that only 39 percent of  adults who used an alternative therapy said they informed their doctor,  and a Harris poll survey found that 49 percent of respondents who used a  dietary supplement informed their doctor.  In addition, many respondents  in that survey were found to have misperceptions about the responsible use  of supplements. For example, one-third said they did not think it was  necessary to follow recommended dosage guidelines. Nearly 40 percent  thought they would benefit from having more information about avoiding  potential adverse reactions.
section_title: Some Dietary Supplements Contain Harmful Contaminants or Too Much Active Ingredient
paragraphs: Commercial and scientific studies of selected dietary supplements have  repeatedly found that contaminants may be present and that the amount of  active ingredient present does not always match that indicated on the  product label.
Contaminants can pose significant health risks to consumers. Some  pesticides and heavy metals, for example, are probable carcinogens and  can be toxic to the liver and kidney or impair oxygen transport in the blood.   One commercial laboratory found contamination in samples from  echinacea, ginseng, and St. John’s wort products.  As much as 20 times the  level of pesticides allowable by the U.S. Pharmacopeia was found in two  samples of ginseng. Overall, 11 percent of the herbal products tested were  contaminated in some way.  Three percent of the specialty supplement  products showed signs of contamination.
Some scientific studies have found that there may be significantly more  active ingredient in some herbal and specialty supplement products than is  indicated on the label.  Amounts of active ingredients that exceed what is  indicated on a product label may increase the risk of overdose for some  patients. For pharmaceuticals, the tolerable range of product content is  between 90 and 110 percent of the amount of active ingredient stated on  the label.  For example, one study of DHEA found that only 44 percent of  the products sampled were within this range and one brand contained 150  percent of the amount indicated on the label. In a study of ephedra, one  product was shown to have  as much as 154 percent of the active ingredient  indicated on the label. A study of feverfew (promoted as a migraine  prophylaxis) found that 22 percent of the products tested contained more  than 110 percent of what the authors considered to be the therapeutic dose  of its active ingredient, in two cases doubling that amount. Studies of  ginseng have found that product concentrations varied nearly fivefold  across different products and that 38 percent of the products tested had  more than 110 percent of the amount of active ingredient on the label, four  of them containing more than twice as much. Studies of SAM-e (promoted  as an antidepressant and in the treatment of the joint pain, stiffness, and  inflammation associated with osteoarthritis) and St. John’s wort also found  that products frequently contained more of the active ingredient than  indicated on the label.  This was true for 42 percent and 20 percent of the  products tested, respectively.
section_title: Reports of Adverse Events Associated With the Use of Dietary Supplements Signal Possible Risks
paragraphs: Although FDA does not determine causality in the adverse event reports it  receives, it does use these reports to signal possible risks to consumers  from dietary supplements.  The agency also consults other sources, such as  reports in the medical literature, to identify dietary supplements that may  be hazardous to consumers.
In 1993, FDA published a list of dietary supplements for which evidence of  harm existed. In 1998, the agency also published a guide to dietary  supplements, which included a list of supplements associated with  illnesses and injuries.  FDA has also issued warnings and alerts for dietary  supplements and posted those to its Web site.  The most recent alert  reiterated the agency’s concern, first noted in 1993, that the herbal product  comfrey represents a serious safety risk to consumers from liver toxicity.   In addition, the agency has issued warnings for products including, among  others,  chapparal, which is promoted as an antioxidant and cancer cure  and is associated with nonviral hepatitis; aristolochic acid, which is sold as  “traditional medicine” and has been associated with permanent kidney  damage and some cancers; and L-tryptophan, which is promoted for  insomnia and depression but has been associated with an autoimmune  disorder and deaths. CDC has also identified reports of adverse events  associated with dietary supplements and reported them in Morbidity and  Mortality Weekly Report. CDC’s report about L-tryptophan also noted that  the substance has led to at least 27 deaths.
section_title: Medical Organizations and Trade Associations Have Taken Steps to Address Health Risks
paragraphs: Medical organizations and trade associations that represent manufacturers,  suppliers, and distributors of dietary supplements recognize that some  health risks are associated with these products and have made  recommendations and adopted voluntary programs to address some of the  concerns. For example, the American Medical Association has issued a  policy statement recommending that dietary supplements and herbal  remedies include the following information on the product label: “This  product may have significant adverse side effects and/or interactions with  medications and other dietary supplements; therefore it is important that  you inform your doctor that you are using this product.”  The policy  statement also recommends that manufacturers be required to label  products with data on adverse effects, contraindications, and possible drug  interactions.
Trade associations that represent various manufacturers, suppliers, and  distributors of dietary supplements have adopted voluntary programs to  reduce the risks of potentially harmful products.  Thus, the Consumer  Healthcare Products Association has established eight voluntary programs  focusing on either product manufacturing or labeling of specific products.   For example, the association urges manufacturers to put quality control  procedures in place to ensure that ginseng is free of quintozene (a  potentially carcinogenic pesticide) and related compounds.  For kava kava  products, member companies are asked to include specific dosage limits  and cautionary statements, and for comfrey and St. John’s wort products,  members are asked to include general label warnings about the advisability  of consulting a physician. The American Herbal Products Association has  incorporated labeling and warning recommendations in its code of ethics  for members.  These include, among others, labeling recommendations for  ephedra (with both warnings and serving limits), warnings for chaparral  and pyrrolizidine alkaloids (which are found in comfrey and can cause fatal  liver failure), and dosage limits and warnings for kava kava.  The  association has also suggested warning labels for both saw palmetto and  St. John’s wort.
The National Nutritional Foods Association requires all members who  manufacture dietary supplements and herbs under their own label to  participate in a quality assurance program. The program was established, in  part, to increase confidence that products are accurately labeled. Products  are registered, with random testing for content every 2 to 3 years.  Association officials reported that approximately 25,000 product labels are  currently registered under this program, estimating that this accounts for  more than half of the dietary supplements on the market.  The association  also sponsors its own good manufacturing practices program, and 23  manufacturers are currently certified.
section_title: Senior Citizens May Spend Millions of Dollars on Unproven or Poorly Manufactured Products
paragraphs: Senior citizens who buy anti-aging and alternative medicine products may  spend millions of dollars on products that either make unsubstantiated  claims or contain less of the active ingredient than is indicated on the label.   There are no overall estimates of economic harm attributable to  questionable anti-aging products; however, federal officials have identified  a number of expensive products making unsubstantiated claims. In an  analysis of 20 of its cases for products targeted to senior citizens, FTC  estimated that consumers as a whole spent an average of nearly $1.8  million annually per company.  In addition, because some dietary  supplement products contain little or none of the active ingredient listed on  the product label, consumers may be spending millions of dollars per year  on products that are virtually worthless.
subsections: section_title: Expensive Products With Unsubstantiated Claims Cost Consumers Millions of Dollars
paragraphs: FTC and FDA have identified a number of anti-aging and alternative  medicine companies  making unsubstantiated advertising or labeling  claims for their products.  FTC does not have an estimate of economic  harm attributable to these products, but some of these unproven products  can cost hundreds or thousands of dollars apiece.  For example, rife  machines, which are frequently advertised on the Internet, can cost up to  $5,000, and some herbal product packages for cancer cures can cost nearly  $1,000.  PC-SPES, an herbal supplement being studied for prostate cancer,  costs more than $400 per month.
FTC provided us with a partial estimate of economic harm based on 20  cases involving  companies that fraudulently marketed unproven health  care products commonly used by seniors and for which national sales data  were available.  FTC estimated the average annual sales at $1,759,000 per  company.
section_title: Consumers May Waste Money on Products Containing Less Active Ingredient Than Indicated on Product Labels
paragraphs: Consumers may purchase anti-aging and alternative medicine products that  contain much less active ingredient than is indicated on the product label,  thereby wasting their money on worthless products.  Results of  commercial laboratory tests and scientific studies that analyzed product  contents for active ingredient levels have shown that some dietary  supplement products contain far less of that active ingredient than labeled.  For some products, analyses have found no active ingredient.
A series of commercial laboratory analyses of herbal products showed that  22 percent of herbal supplements, and 19 percent of specialty supplements,  contained substantially less active ingredient than the amount indicated on  the label. Tests on echinacea products found that two had no detectable  levels, and for valerian, four products were found to have none of the active  ingredient.  Six SAM-e products tested had less than half of the labeled  amount of active ingredient.
Studies published in the medical literature have shown similar results.  In  an analysis of DHEA products, nearly one-fifth contained only trace  amounts or no active ingredient.  In analyses of garlic products, most  were found to release less than 20 percent of their active ingredient. One  study of ginseng found that 35 percent of the products tested contained no  detectable levels of an active ingredient, and another found no detectable  levels in 12 percent of the tested products. Studies of SAM-e and St. John’s  wort products also found that tested samples often contained less active  ingredient than indicated on the label.
section_title: Federal and State Education, Research, and Enforcement Activities Aim to Protect Senior Citizens
paragraphs: The potential for harm to senior citizens from health products making  questionable claims has long been a concern for public health and law  enforcement officials, and federal and state agencies have activities under  way to protect consumers from these products. FDA and FTC sponsor  programs and provide educational materials for senior citizens to help  them avoid health fraud on the Internet and in other media. NIH is funding  research and research centers to evaluate popular anti-aging and  alternative therapies. FDA has taken various enforcement actions against  firms that have violated legal requirements regarding the marketing and  sales of anti-aging and alternative products, including dietary supplements,  but it has not prohibited the marketing of any specific substances using its  administrative rulemaking authority. FDA’s voluntary adverse event  reporting system for dietary supplements has shortcomings, and proposed  regulations to establish good manufacturing practices for dietary  supplements are still under review by the Office of Management and  Budget. Through “Operation Cure.All,” FTC is trying to stop companies  from making unqualified health claims that are not supported by credible  scientific evidence, and it has been joined in these efforts by FDA and other  agencies. At the state level, agencies are working to protect consumers of  health products by enforcing state consumer protection and public health  laws, although anti-aging and alternative products have received limited  attention.
subsections: section_title: Some Federal Consumer Education Activities Target Health Fraud Against Senior Citizens
paragraphs: Both FDA and FTC sponsor education activities that focus on health fraud  and seniors. For example, public affairs specialists in several FDA district  offices had exhibits at senior health fairs and health conferences where  they distributed educational materials on how to avoid health fraud, as well  as cautionary guidance on purchasing medicines and medical products  online. In addition, officials in some districts made drug safety  presentations that highlighted ongoing FDA programs, including the  MedWatch adverse event reporting system that consumers are encouraged  to use and which encompasses drugs, biological products such as vaccines,  medical devices, dietary supplements, and food products.
To help consumers discriminate between legitimate and fraudulent claims,  FTC publishes consumer education materials on certain frequently  promoted products and services, including hearing aids and varicose vein  treatments.  The agency also publishes guidelines on how to spot false  claims and how to differentiate television shows from “infomercials.”
section_title: NIH Supports Research on Alternative Therapies
paragraphs: Federal support of research on alternative therapies is provided by NIH’s  NCCAM, which has developed research programs to fund clinical trials to  evaluate the safety and efficacy of some popular products and therapies.  The trials are studying alternative products and therapies for conditions  such as arthritis, cardiovascular disease, and neurological disorders. There  are also studies, either ongoing or planned, to examine the effects of  glucosamine/chondroitin, St. John’s wort, ginkgo biloba, and others. (A list  of NCCAM studies on alternative therapies relevant to seniors is provided  in app. III.)  In addition, the agency funds specialized, multidisciplinary  research centers on alternative medicine in such areas as cardiovascular  disease, neurological disorders, aging, and arthritis.
section_title: FDA Has Taken Enforcement Actions
paragraphs: FDA has taken enforcement actions against firms selling anti-aging  products alleged to be dangerous or illegally marketed. It has taken actions  to remove from the market anti-aging products that the agency found were  actually unapproved new drugs or medical devices and actions against  firms that promoted their dietary supplements for the treatment or cure of  a disease.  Although DSHEA allows FDA to remove from the market dietary  supplements that the agency can prove are dangerous, the agency has not  prohibited the marketing of any specific substances using its administrative  rulemaking authority.  However, the agency has taken steps to identify for  consumers and industry ingredients it deems to be unsafe and unlawful.   The agency has then pursued cases against specific manufacturers and  products when the ingredients continued to be marketed in dietary  supplements despite the agency’s warnings. FDA’s efforts in this regard  have been unsuccessful, and many of these products remain on the market  and are still available to consumers.  A description of some of FDA’s recent  enforcement activities is provided in appendix IV.
FDA enforcement actions taken against products that it judged to be  unapproved drugs or medical devices include court cases filed to halt  distribution of laetrile products that claimed to cure cancer and to halt the  sale of “Cholestin,” a red yeast rice product with lovastatin that was  marketed with cholesterol-lowering claims.  FDA also took action to halt  the marketing of the “Stimulator,” a device that the manufacturer claimed  would relieve pain from sciatica, swollen joints, carpal tunnel syndrome,  and other chronic conditions. The devices have been purchased by many  senior citizens, according to FDA officials. An estimated 800,000 of these  devices were sold between 1994 and 1997.
FDA has notified some dietary supplement manufacturers that their  promotional materials have illegally claimed that their products cure  disease, but some of these products are still available.  For example, some  manufacturers of colloidal silver products have claimed efficacy in treating  HIV and other diseases and conditions.  Even though FDA banned colloidal  silver products as a U.S. over-the-counter drug in September 1999, after  concluding that it was not aware of any substantial scientific evidence that  supported the disease claims used in marketing the products, colloidal  silver products may still be marketed as dietary supplements as long as  they are not promoted with claims that they treat or cure disease. FDA sent  several dozen “cyber-letters” by electronic mail to Internet-based  companies making such claims stating that their therapeutic claims may be  illegal.  Despite these oversight activities, colloidal silver products claiming  “natural antibiotic” properties to address numerous health conditions  remain available.
FDA has not initiated any administrative rulemaking activities to remove  from the market certain substances that its analysis suggests pose health  risks, but has sought voluntary restrictions and attempted to warn  consumers.  For example, aristolochic acid, a known potent carcinogen  and nephrotoxin, is believed to be present, in certain traditional herbal  remedies as well as a number of dietary supplement products.  Following  reports of aristolochic-acid-associated renal failure cases in Europe, FDA  has recently taken several steps. In May 2000, FDA issued a “letter to  industry” urging leading dietary supplement trade associations to alert  member companies that aristolochic acid had been reported to cause  “severe nephropathy in consumers consuming dietary supplements  containing aristolochic acid.”  This letter also advised the industry that  FDA had concluded that any dietary supplement that contained  aristolochic acids was adulterated under the law and that it was unlawful to  market such a product.  At the same time, the agency issued an import  bulletin (later converted to an import alert) that prohibited the importation  of bulk and finished products that may contain aristolochic acids until the  importer could provide direct analytical evidence that the product was free  of these substances.  In April 2001, the agency issued a new industry letter  and consumer warning after its analysis of marketed products found that  many contained aristolochic acids.  This letter reiterated the agency’s  conclusion that the marketing of such products was unlawful and that  manufacturers needed to take steps to ensure that aristolochic-acid- containing products do not find their way into the marketplace.
FDA pointed to another safety risk for consumers using herbal medicines  in July 2001,  when the agency announced that herbal comfrey products  containing pyrrolizidine alkaloids may cause liver damage.  The agency’s  letter to eight leading dietary supplement trade associations urged them to  advise their members to stop distributing comfrey products containing  pyrrolizidine alkaloids.  However, even though FDA has told firms that  market dietary supplements that products that contain comfrey are  adulterated and unlawful, some firms continue to market them, and the  agency is left to identify and take action to remove them on a case-by-case  basis as it becomes aware of them.
section_title: FDA’s Voluntary Adverse Event Reporting System Has Shortcomings
paragraphs: As we reported in 1999, FDA’s adverse event reporting system for dietary  supplements receives reports for only a small proportion of all adverse  events, and the reports it receives are often incomplete.  FDA’s adverse  event reporting system for dietary supplements is a voluntary  postmarketing surveillance system.  There is no statutory requirement that  dietary supplement manufacturers provide adverse event reports they  receive to FDA. For example, we found that documents disclosed in a  recent court case showed that a manufacturer of a product containing  ephedra had received more than 1,200 complaints of adverse events related  to its product; FDA told us that it was aware of few, if any, of these reports  before the lawsuit was filed.  Similarly, a 2001 report by the HHS Office of  Inspector General noted that FDA’s reporting system fails to capture  sufficient data on medical information, product information, and  manufacturer information. For example, FDA told us that 12 percent of  the dietary supplement adverse event reports that included consumer age  that it has received since 1994 were for senior citizens, but that many of the  reports did not contain information about the age of the consumer.
section_title: FDA Currently Inspects Relatively Few Dietary Supplement Manufacturers and Related Facilities
paragraphs: FDA inspects relatively few dietary supplement manufacturers and related  facilities. FDA told us that the agency inspected 61 manufacturers and  repackers of dietary supplements in 1999, and 53 in 2000.  In 2001, 80  inspections are planned. The agency does not know precisely how many  facilities are operating, because there is no registration requirement.   However, FDA estimates that there are more than 1,500 facilities,  suggesting that FDA inspects less than 5 percent of facilities annually.  FDA  officials told us that its inspectors look at sanitation, buildings and  facilities, equipment, production, and process controls.
section_title: Regulations to Establish Good Manufacturing Practices for Dietary Supplements Have Not Yet Been Issued
paragraphs: In 1997, FDA published an advance notice of proposed rulemaking  regarding good manufacturing practice (GMP) in manufacturing, packing,  and holding of dietary supplements. In publishing the draft for comment,  FDA noted that much of the dietary supplement industry believes GMP  regulations are important in establishing standards to ensure that dietary  supplements are “safe and properly labeled.” FDA officials have stated that  a proposed GMP rule has now been developed and is still under review by  the Office of Management and Budget.  Publication of final GMP  regulations will improve FDA’s enforcement capabilities, since DSHEA  provides that dietary supplements not manufactured under conditions that  meet GMPs would be considered adulterated and unlawful.
section_title: Recent FTC and Joint- Agency Enforcement Efforts Focus on the Internet
paragraphs: As part of its consumer protection activities, FTC enforces federal statutes  that prohibit misleading and unsubstantiated advertising.  In recent years,  FTC has joined with other organizations to focus attention on the  fraudulent marketing of some anti-aging and other alternative medicine  products.
In 1997, FTC launched an effort to find companies making questionable  claims for health products on the Internet, as well as in other media. This  initiative, which later became known as “Operation Cure.All,” primarily  involved conducting Internet-based searches to identify Internet sites  making unsubstantiated claims that use of their products would prevent,  treat, or cure serious diseases and conditions.  The searches were  conducted with the participation of FDA, CDC, and some state attorneys  general and other organizations.
Evaluations of “Operation Cure.All” have found that some companies have  made changes in their Internet advertising as a result of receiving e-mail  alerts from FTC about potentially unsupported advertising claims. In 1997,  an estimated 13 percent of notified companies withdrew their claims or  Web site, while 10 percent made some changes. In 1998, an estimated 28 percent of notified companies withdrew their claims or Web site, while  10 percent made some changes. By comparison, the percentage of  companies that made no changes in both years exceeded 60 percent.  In  addition, FTC identified for us 15 “Operation Cure.All” cases brought by the  FTC against companies and individuals making claims for products or  services that were not backed by “competent and reliable” scientific  evidence. In total, FTC has brought over 30 dietary supplement cases since  the agency released guidelines on its approach to substantiation of  advertised claims in 1998. A list of relevant cases from FTC enforcement  efforts is provided in appendix V.
A majority of “Operation Cure.All” cases have been settled administratively,  with the companies agreeing to stop making unsupported disease  treatment claims in advertising materials, with some calling for consumer  redress. For example, FTC sued Lane Labs-USA for representing that its  shark cartilage products could cure cancer. The company agreed in June  2000 to stop making these claims and to pay a $550,000 fine to FTC and  $450,000 to be used for purchasing shark cartilage and placebo products to  be tested in a clinical trial sponsored by NIH.  In an ongoing “Operation  Cure.All” case involving a company that markets various herbal packages  as well as a device known as the “Zapper Electrical Unit,” FTC’s complaint  seeks consumer redress and a permanent injunction against false and  misleading claims.
section_title: State Agencies Have Limited Focus on Anti-Aging and Alternative Medicine Products
paragraphs: The fourteen states we contacted varied in their efforts to protect  consumers from fraudulent or harmful health products, but in general  focused little attention on anti-aging and alternative medicine products.  State agencies reported that they receive relatively few complaints  regarding these products.  However, many officials said that consumers are  being harmed in ways that are unlikely to be reported to state agencies and  that misleading advertising and questionable health products are serious  problems. States have identified a number of questionable health care  products, services, and advertising claims that may affect older consumers,  and these are listed in appendix VI.
States protect consumers from fraudulent or harmful health products  through two approaches.  The first is enforcement of state consumer  protection laws against false or misleading advertising.  The second is  through their public health authority to ensure food, drug, and medical  device safety.  With some exceptions, the states we contacted take action  only if there is a pattern of complaints or an acute health problem  associated with a particular substance or device. Seven of the fourteen  states we contacted were involved to some degree in monitoring or  enforcement activity, and three have ongoing efforts to review advertising,  labels, or products to enforce their health and consumer protection laws.
subsections: section_title: Enforcement of Consumer Protection Laws
paragraphs: In the states we contacted, oversight of anti-aging product advertising has  not been a priority for state consumer protection agencies. Although many  representatives of state consumer protection agencies we contacted said  that misleading advertising of health products targeted to seniors is a  serious issue, their agencies have devoted greater resources to larger scale  types of fraud such as identity theft and sweepstakes fraud.
State laws protecting consumers from false or misleading advertising may  be applied to anti-aging and alternative remedies for which complaints  have been filed.  There is often a multi-tiered approach to resolving  consumer complaints.  Individual complaints may be filed with an office,  usually within the Attorney General’s or Governor’s Office, that facilitates  informal resolution between the consumer and the company. Consumers  wishing to pursue legal remedies beyond this point are generally referred to  a private attorney. In cases in which there are patterns or egregious cases  of deceptive advertising, the Attorney General’s consumer complaint  division may pursue administrative or legal remedies against the company.
Although many state consumer protection agencies are monitoring cases to  see if patterns of deceptive advertising are developing that could warrant  full investigation in the future, such patterns may be difficult to determine  for a number of reasons. None of the consumer protection officials we  contacted receives a high volume of complaints about health-related  products. State consumer protection Web sites often refer consumers to a  variety of resources, including the FTC, FDA, and Better Business Bureaus,  and thus the agencies are not likely to have a comprehensive picture of all  consumer complaints. Most of the consumer protection agencies we  contacted could not search their complaint databases to obtain counts of  complaints about health-related products, and none of the agencies we  contacted was able to provide us with counts of complaints.
Some states consider the content of advertisements for health products to  be a matter for federal authorities, whereas other states specifically  regulate such advertising.  For example, Ohio’s consumer sales practices  act covers an advertisement’s claims about the sales transaction—such as  price or quantity—not the content of statements about a product’s  effectiveness. In contrast, Iowa has a special provision in its consumer  protection law for additional penalties when false advertising is targeted at  seniors.
section_title: Public Health Authority
paragraphs: In all but one of the states we contacted, public health officials were either  unable to obtain data on adverse health events resulting from anti-aging or  alternative health products or have received few, if any, reports of relevant  cases in the recent past.  Some noted that the health department may learn  of an acute event linked to a dietary supplement but that the more subtle  forms of harm typically go unreported. With regard to seniors, officials are  particularly concerned about supplements that make unsubstantiated  claims to cure disease. Officials believe that when a product such as a  dietary supplement does not achieve the promised effect, many people  simply stop using it or return it to the retailer rather than notify state  authorities.
Public health laws allow state and local authorities to take action against  adulterated, misbranded, or dangerous products.  Some states have  provisions in their food and drug safety laws that incorporate federal  standards.
Health authorities in the states we contacted are active to varying degrees  in regulating questionable health products. In three of the states we  contacted, consumer protection, law enforcement, or public health  officials routinely review labels and advertising in a variety of media to  determine if they are false or misleading.  In several other states,  authorities have ongoing investigations stemming from consumer  complaints.  Investigators may contact the company, review  documentation that it submits in support of its claims, conduct inspections,  and obtain expert analysis of products.  Remedies can include restitution  for consumers, fines, court orders to change or remove false claims or to  prohibit the sale of misbranded products in the state, and seizure of  harmful products.
section_title: Conclusions
paragraphs: The risk of harm to seniors from anti-aging and alternative health products  has not been specifically identified as a top public health priority or a  leading enforcement target for federal and state regulators. However,  evidence demonstrates that many senior citizens use anti-aging products  and that consumers who suffer from aging-related health conditions may  be at risk of physical and economic harm from some anti-aging and  alternative health products, including dietary supplements, that make  misleading advertising and labeling claims.  The medical literature has  identified products that are safe under most conditions but contraindicated  for consumers with certain health conditions. Other products, such as St.  John’s wort, hold promise as potential treatments for some conditions but  are also associated with adverse interactions with some prescription  medications. Senior citizens may have a higher risk of physical harm from  the use of anti-aging alternative medicine products because they have a  high prevalence of chronic health conditions and consume a  disproportionate share of prescription medications compared to younger  adults.
section_title: Agency Comments
paragraphs: FDA, FTC, and NIH gave us technical comments on the portions of a draft  of this report that addressed their respective activities.  We have  incorporated their suggestions where appropriate.
As agreed with your office, unless you publicly announce its contents  earlier, we plan no further distribution of this report until 30 days from the  date of this letter.  At that time,  we will send copies to the Secretary of  Health and Human Services and others who are interested.  We will also  provide copies to others upon request.  If you or your staff have any  questions, please contact me at (202) 512-7119.  Another contact and major  contributors to this report are listed in appendix VII.
section_title: Scope and Methodology
paragraphs: We began our work by attempting to identify alternative medicine products  marketed as anti-aging therapies that present health and economic risks to  seniors. We asked experts in this area which products pose the greatest  risk to seniors. Most of the responses we received concerned potential  problems with dietary supplements (both herbal and specialty  supplements), and occasionally some potentially harmful devices. We did  not hear widespread concerns regarding alternative medical services.  Therefore, our work focused principally on those herbal and specialty  supplements and devices that address health conditions related to aging,  such as heart disease, memory loss, fatigue, joint health, and cancer. We  reviewed scientific literature and talked with medical and scientific  experts, trade association representatives, consumer group  representatives, individual practitioners, and researchers.  Our  investigation of adverse effects, contraindications, and interactions  focused primarily on those supplements that were most commonly used by  seniors to address issues of aging as identified in a recent survey by  Prevention Magazine. We conducted analyses of the data from this survey  to focus on the use of dietary supplements by people aged 65 years or older.
We also interviewed officials and reviewed documents from the Food and  Drug Administration (FDA), Federal Trade Commission (FTC), and  National Institutes of Health (NIH). From FDA, we obtained all adverse  event reports from 1994 through 2001 reported by people over 65 years old,  as well as all reports for most of the dietary supplements mentioned in our  report. We examined other FDA and FTC documents to identify warnings  that the agencies have issued against certain products because of concerns  about safety, labeling, or advertising. We obtained case information from  FTC and FDA to determine estimates of economic harm, as well as to  review the agencies’ enforcement efforts. We also interviewed state  attorneys general and public health officials in 14 states to examine  enforcement efforts at the state level.  These states were selected because  they were identified by experts as being the most active in their efforts to  curb the marketing and sale of health products making questionable  claims.  (Table 1 lists the organizations we consulted.)
section_title: Known Claims, Adverse Effects, Contraindications, and Interactions of Herbal and Specialty Supplements
paragraphs: We focused our review on those herbal and specialty supplements that a  recent survey by Prevention Magazine found were most frequently used by  senior citizens for conditions associated with aging. For each of those  supplements, we have listed in table 2 the health claims frequently  associated with the products, although we have not attempted to validate  the merits of any of the claims. We also list adverse effects that have been  associated with the supplements, conditions for which the supplements  might be contraindicated, and prescription medications with which the  supplements might have dangerous interactions.
section_title: NCCAM Studies on Alternative Therapies Relevant to Senior Citizens
paragraphs: The National Center for Complementary and Alternative Medicine  (NCCAM) supports research to test the safety and efficacy of a variety of  complementary and alternative medicine modalities. Some of this research  focuses on health issues that are relevant to senior citizens, such as  arthritis and cancer (see table 3). In fiscal year 2000, appropriations for  NCCAM totaled $68.3 million. Additional expenditures by other NIH  Institutes and Centers brought the agency’s commitment to complementary  and alternative medicine to $161 million for fiscal year 2000. In fiscal year  2001, NCCAM’s appropriations increased 29 percent to approximately  $89 million.
In addition, NCCAM funds a variety of specialized research centers that  serve as focal points for initiating and maintaining state-of-the-art  multidisciplinary research on complementary and alternative medicine.   Some of these focus on issues specifically relevant to older Americans:    The center for cardiovascular diseases at the University of Michigan is  examining the effect of hawthorn (an herbal supplement) in the  treatment of heart failure; the effect of Reiki (a natural energy therapy)  on diabetes and cardiovascular autonomic function; and the effect of Qi  gong (a Chinese practice that combines movement, meditation, and  regulation to enhance the flow of energy) and spirituality and  psychosocial factors on wound closure, pain, medication usage, and  hospital stay in postoperative cardiac patients.
The center for neurological disorders at Oregon Health Sciences  University is examining the effectiveness of three antioxidant regimens  in decreasing multiple sclerosis disease activity, ginkgo biloba in the  prevention or delay of cognitive decline in elderly patients, hatha yoga  on cognitive and behavioral changes associated with aging and  neurological disorders in multiple sclerosis, and vitamin E and ginkgo  biloba in reducing oxidative end-products.
The center on arthritis at the University of Maryland is investigating the  effectiveness of acupuncture for the treatment of osteoarthritis of the  knee, the effectiveness of mind-body therapies for fibromyalgia, the  effects of electroacupuncture on persistent pain and inflammation, and  the mechanism of an herbal combination with immunomodulatory  properties.
The center on aging at Columbia University is investigating the influence  of a macrobiotic diet on endocrine, biochemical, and cardiovascular  parameters; whether phytoestrogens influence bone metabolism in  postmenopausal women; whether black cohosh (an herbal supplement)  reduces the frequency and intensity of menopausal hot flashes and other  menopausal symptoms; and the biological activities and mechanisms of  a Chinese herbal formula on breast cancer cells.
The center for the study of minority aging and cardiovascular disease at  the Maharishi University of Management focuses on a form of Ayurvedic  Indian medicine that incorporates herbal formulations and medication  in older blacks.  Specific studies focus on the basic mechanisms of  meditation and cardiovascular disease in older blacks, the effect of  transcendental meditation on reducing hypertension, and the effects of  herbal antioxidants on cardiovascular disease in older blacks.
section_title: Recent FDA Actions
paragraphs: FDA identified actions it has taken in response to products making illegal  claims that were targeted at least in part toward senior citizens.  These are  listed in table 4.
section_title: Recent FTC Actions
paragraphs: FTC identified examples of actions it has taken in response to products  with illegal advertisements and that were targeted at least in part to senior  citizens.  These are listed in table 5.
section_title: Examples of Questionable Health Care Products Used by Senior Citizens, as Reported by State Officials
paragraphs: State officials we talked with described a number of products used by  seniors that were questionable or had questionable advertising and where  state action was taken, including the following:   Companies marketing therapeutic magnets with unsubstantiated claims  that they can cure a variety of diseases, including diabetes and  osteoporosis.  One state health department official noted that some  magnet companies are aware that they can only be sold for general well- being, but in other states they continue to be marketed with health  claims.
A national mail-order company selling a variety of health products with  unsubstantiated promises to cure prostate disease, bladder problems,  hair loss, skin discoloration, sexual impotence, and cancer.  Authorities  in one state have obtained restitution for consumers, civil fines, and  court orders to keep this and similar companies from selling  fraudulently advertised products, including anti-aging formulas, to its  residents.  However, the authorities have no means to prevent the  company from publishing misleading material and selling questionable  products in the rest of the country.
A Web-based company advertising a breast-enhancement product to  women who have had mastectomies with the claim that it can  regenerate lost breast tissue.   The company removed its claim after  being contacted by a state attorney general’s office.
Herbal remedies contaminated with toxic substances such as heavy  metals.  Authorities in one state have analyzed products and found cases  of adulteration in imported ingredients used in traditional Chinese  medicine.
Herbal supplements “spiked” with prescription drugs or synthetic  ingredients.  In one case a diabetic had to seek medical treatment after  taking an herbal product that contained a prescription diabetes drug.   Another product marketed as an “all-herbal” weight-loss formula using  ephedra was found to contain ephedrine, a synthetic substance not  listed on the label.  Concerns about the potential health hazards  associated with ephedra have prompted several states to issue  regulations restricting its dosage or sale.
Testing blood and hair samples to diagnose nutritional deficiencies or  illnesses to induce people to buy a particular dietary supplement as  treatment. In one state, there is an ownership link between the out-of- state laboratories doing the analyses and the manufacturer of the  dietary supplements.
section_title: GAO Contact and Staff Acknowledgments
subsections: section_title: GAO Contact
section_title: Staff Acknowledgments
paragraphs: Carolyn Feis Korman, Anne Montgomery, Mark Patterson, Roseanne Price,  and Suzanne Rubins also made major contributions to this report.
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subsections: section_title: Order by Mail or Phone
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section_title: Public Affairs