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Americans' Views on the Use and Regulation of Dietary Supplements

Americans' Views on the Use and Regulation of Dietary Supplements This article presents the views of Americans on what the government's future role should be in regulating or overseeing the growing sales of dietary supplements for health purposes. Based on results of multiple national opinion surveys, including the views of both users and nonusers of supplements, we found that a substantial percentage of Americans surveyed reported that they regularly take dietary supplements as a part of their routine health regimen. However, they reported that they do not discuss the use of dietary supplements with their physicians because they believe that the physicians know little or nothing about these products and may be biased against them. Many users felt so strongly about the potential health benefits of some of these products that they reported that they would continue to take them even if they were shown to be ineffective in scientifically conducted clinical studies. However, there also was broad public support for increased government regulation of these products. We found that a majority of Americans surveyed supported the following: to require that the Food and Drug Administration review the safety of new dietary supplements prior to their sale; to provide increased authority to remove from sale those products shown to be unsafe; and to increase government regulation to ensure that advertising claims about the health benefits of dietary supplements are true.One of the most striking changes in Americans' health behaviors in the 1990s was the widespread and growing use of dietary supplements for health reasons. Since 1994, dietary supplement sales have grown by nearly 80%, from $8.8 billion to an estimated $15.7 billion for 2000. Sales of specific herbal remedies, such as echinacea, ginseng, Ginkgo biloba, and St John's wort, exceeded $200 million per product per year, and these supplements are taken routinely by millions of Americans.The sharp rise in the use of these supplements has raised concerns in the medical community and the media about the potentially serious health risks of the mostly untested and unregulated products. Various reportsfrom poison control centers and practicing physicians have indicated examples of individuals being harmed by taking these supplements. Othershave raised the concern that the use of these products may be leading some to forgo proven conventional medical treatment when they are seriously ill.Furthermore, the issue has been raised that as these products are increasingly advertised in the media and sold in drug stores and supermarkets the public may be given a false sense of security about their safety. They may believe that supplements are subject to existing government regulations similar to those applicable to over-the-counter medications sold to the public without a prescription. In fact, dietary supplements are subject to a less stringent government standard of safety testing than other over-the-counter medications.After receiving thousands of letters from supplement users in a heated advocacy campaign, Congress passed the Dietary Supplement Health and Education Actof 1994, which freed dietary supplement manufacturers from many existing Food and Drug Administration (FDA) regulations. In the Nutrition Labeling and Education Actof 1990, Congress gave the FDA the authority to require manufacturers of dietary supplements to provide evidence that their products were safe prior to sale and to approve the health claims made about these products before they could be used in marketing. After the 1994 legislation was enacted, the burden of proof concerning the safety of dietary supplements shifted. Instead of the manufacturer having to show that a supplement was safe, the FDA had to prove that it was unsafe. Also, as a result of the legislation, manufacturers have been able to make general health claims about products as long as they do not contain references to preventing or curing specific diseases. These supplements are now sold under the same oversight standard as vitamins and are categorized under a separate FDA category as "foods."Recently, the question of the need for stricter regulation of these products has been raised in editorials, medical journals, and articles in the media, particularly on the issue of safety and the specific health claims that can be made by the manufacturers.What has been missing in this growing debate over what the government's role should be in regulating dietary supplements are the views of the American public, both users and nonusers of these products.In this article, we seek to fill this void by summarizing the available public opinion survey data on the dietary supplement issue. We used national opinion survey data to answer the following questions: (1) What are the characteristics of people who use dietary supplements regularly, and how are users different from nonusers? (2) How are regular users' attitudes about dietary supplements and their usefulness different from those of nonusers? (3) What are Americans' attitudes toward government regulation, and are there differences between the attitudes of regular users and nonusers? (4) What are the policy implications of these differences, and how might they affect the debate on the national level?DATA AND METHODSRelatively few polls investigating Americans' views of dietary supplement use and regulation have been conducted. The data presented herein came primarily from 2 sources.The first source consisted of specific results drawn from 4 national opinion surveys conducted from 1996 to 1999. These surveys did not differentiate between the views of regular users and nonusers of dietary supplements. These data were compiled from the public opinion database at the Roper Center for Public Opinion Research in Storrs, Conn.The second source consisted of 2 surveys that differentiated the views of users and nonusers of dietary supplements. One survey was designed by researchers at National Public Radio, the Henry J. Kaiser Family Foundation, and the John F. Kennedy School of Government. Telephone interviews were conducted with 1200 randomly selected US adults by Princeton Survey Research Associates between February 19 and 25, 1999.The second survey was designed by researchers at the Henry J. Kaiser Family Foundation and the Harvard School of Public Health. International Communications Research conducted interviews via telephone with 1013 randomly selected US adults between December 16 and 21, 1999.In the analysis of data from these latter 2 surveys, regular userswere defined as respondents who reported that they regularly use products, such as echinacea, ginseng, over-the-counter hormones, or amino acids. Respondents who reported using dietary supplements sometimes were classified as sometimes users. Lastly, nonuserswere defined as those respondents who reported that they never use these products. We compared the views of both sometimes users and nonusers with regular users. Differences between these groups were tested using a χ2test, and significance is noted in the individual tables.All surveys were subject to sampling and nonsampling errors. Results may have differed from what would have been obtained if the whole population of adults had been interviewed. The size of this error varied with the number surveyed and the magnitude of difference in the responses to each question. These surveys had sample sizes of approximately 1000 to 1200 persons. With a sample this size, the results, with a 95% degree of confidence, have a statistical precision of ± 3 to 3.5 percentage points compared with what would have been obtained if the entire population had been interviewed. Possible sources of nonsampling error include nonresponse bias and question wording and ordering effects.RESULTSDEMOGRAPHIC CHARACTERISTICSA review of the findings of these surveys showed that approximately half (48%) of all American adults surveyed reported taking some type of nonprescription vitamin, dietary, or mineral supplements regularly.One in six (16%-18%) reported regularly using dietary supplements, like echinacea, ginseng, amino acids, or over-the-counter hormones.Table 1displays the differences between demographic groups in terms of the frequency of dietary supplement use. American respondents with higher levels of education reported greater use than those with less education. Regular users were also more likely to be white (non-Hispanic). Americans older than 45 years were more likely to use supplements regularly than those who were younger (24% vs 14%, respectively).Table 1. Demographics of US Respondents*Total (N = 1196)Frequency of Dietary Supplement UsePRegular (n = 235)Sometimes (n = 381)Never (n = 580)National. . .181566. . .Income, $†<20 0001920305020 000-29 99915202753. . .30 000-50 00018163748>50 00025173449EducationLess than high school graduate17162856High school graduate34152857<.001Some college27223642College or more23223345Race or ethnicityWhite, non-Hispanic80203050Black, non-Hispanic1083360.03Hispanic7143453Other3244531Insurance statusInsured83151074.05Uninsured16211664Age, y18-343316345035-4422143254<.00145-6428243145≥6517222652SexMale48183052. . .Female52193249*Data are expressed as percentages unless indicated otherwise. Percentages may not equal 100% because of rounding. The values sum horizontally. National indicates the percentage of the national population in each group; ellipses, not applicable. Data are from a survey conducted by Princeton Survey Research Associates.†Percentages do not equal 100% because of missing data.Also, uninsured American respondents were significantly more likely than those with insurance to use dietary supplements (21% vs 15%, respectively).Of note, 1 (18%) of 6 parents reported giving dietary supplements to their children.BELIEFS ABOUT DIETARY SUPPLEMENTSThe surveys found that a substantial percentage of the Americans surveyed held positive views of the health benefits derived from taking dietary supplements. A 1997 survey found that one third (36%) of the American adults thought that there was a dietary supplement that could help them live longer.Overall, 85% of regular users reported that dietary supplements are good for people's health and well-being. The figure was lower for those who were not regular users.Regular users differed significantly from nonusers in their belief that dietary supplements could help with the treatment of a wide range of medical conditions (Table 2). About half of the American respondents believed that supplements are helpful for people with colds (61%), arthritis (53%), depression (52%), and influenza (49%). Respondents viewed dietary supplements as helpful in the treatment of cancer (35%) and acquired immunodeficiency syndrome (16%).Not surprisingly, regular users were significantly more likely than nonusers to believe that supplements could help people with all the conditions the survey asked about; however, rates were also high among the nonusers. Another studyfound that 82% of the Americans surveyed said that they would seriously consider trying alternative treatments, such as herbal medicines, if they were terminally ill.Table 2. Dietary Supplements' Effect on Health and Well-being According to US Respondents*Total (N = 1196)Frequency of Dietary Supplement UseRegular (n = 235)Sometimes (n = 381)Never (n = 580)Supplements are good for health and well-beingYes528562†34†No1731027Some are, some are not‡1791820Do not know143919Supplements are helpful for people withInfluenza496456§40†Colds61777348†Cancer355441†24†Acquired immunodeficiency syndrome16212012†Arthritis537161†42†Depression527258†42†How important is access to supplements?Very important357340†19†Somewhat important24183222Not too important1771821Not at all important222937*Data are expressed as percentages. Percentages may not equal 100% because of rounding. Data are from a survey conducted by International Communications Research.†Significantly different from regular users (P<.001).‡Respondents volunteered answer; it was not given as an option in the survey.§Significantly different from regular users (P= .02).The surveys also found that those who were regular users believed strongly in the usefulness of various dietary supplements irrespective of the scientific evidence. When asked what they would do if a government agency said that the supplement they use most often was ineffective, 71% of regular users reported that they would continue to use it (Table 3).In the follow-up survey, respondents were asked what they would do if the FDA specifically said that the supplement they use most often was ineffective to see if using the FDA's name vs an unknown government agency would alter the result. The addition of the FDA did not lead to different responses (Table 3). Once again, two thirds (67%) of regular and sometimes users said that they would continue to take the supplement.Table 3. US Respondents' Use of Dietary Supplements Considered Unsafe by Government Agencies*Total (N = 1196)Frequency of Dietary Supplement UseRegular (n = 235)Sometimes (n = 381)If a government agency said that the dietary supplement is ineffective, what would you do?Stop using the supplement252425Keep using the supplement727172Do not know443If the FDA said that the dietary supplement you use most often is ineffective, what would you do?Stop using the supplement333233Keep using the supplement666765Do not know111*Data are expressed as percentages. Percentages may not equal 100% because of rounding. The first question was from a survey conducted by Princeton Survey Research Associates.The second question was from a survey conducted by International Communications Research.FDA indicates Food and Drug Administration.Given how beneficial most regular users believed dietary supplements to be, it is not surprising that access to them is very important for regular users. Of those who reported that they regularly use dietary supplements, 91% said that access to them is "very" or "somewhat" important. Of note, 72% of sometimes users and 41% of nonusers felt this way (Table 2).CONFIDENCE IN PHYSICIANS' OPENNESS TOWARD AND KNOWLEDGE OF DIETARY SUPPLEMENTSThe respondents who reported regular use of dietary supplements were divided in their assessment of their physician's level of knowledge of and openness toward these products. More than two thirds (70%) of those who reported taking supplements regularly said that they had shared this information with their regular physician. However, the survey did not provide a measure of the extent of information shared between patients and physicians, and many regular users were skeptical of their physician's knowledge of and attitudes toward supplements. Nearly half (49%) of regular users believed that physicians are prejudiced against supplement use and 44% believed that their own physician knows only a little or not much at all about these products.SAFETY OF DIETARY SUPPLEMENTSRegular users of dietary supplements had much more confidence in the safety of these products than nonusers. As shown in Table 4, only 37% of the respondents believed that dietary supplements are adequately tested. However, regular users were more likely (49%) than nonusers (33%) to believe that there is adequate testing of these products. Also, the majority of regular users (53%) believed that people are "rarely or never" harmed by taking dietary supplements. In contrast, 51% of nonusers reported that people are "often or sometimes" harmed by these supplements.Table 4. US Respondents' Opinions on the Safety of Dietary Supplements*Total (N = 1196)Frequency of Dietary Supplement UseRegular (n = 235)Sometimes (n = 381)Never (n = 580)Supplements are adequately testedYes374938†33†No48394753Do not know15121514Advertising for supplements isNot true492943†60†Generally true37574525Do not know15141216How often are people harmed by supplements?Often or sometimes47384651†Rarely or never44534838Do not know109611*Data are expressed as percentages. Percentages may not equal 100% because of rounding. Data are from a survey conducted by Princeton Survey Research Associates.†Significantly different from regular users (P<.001).ROLE OF ADVERTISING INFORMATIONCommercial advertising has been shown to be an important source of information about over-the-counter medications.One recent surveyfound that 39% of the respondents reported that television commercials are the most influential source of information in their decision about which cold medicine to buy. In the area of dietary supplements, data are not available on the frequency of use of commercials as an important information source. However, a majority (57%) of regular users thought that the claims made by supplement manufacturers in the advertisements are generally true (Table 4). Those who were not regular users were less likely to believe the claims made by these advertisements.ATTITUDES TOWARD GOVERNMENT REGULATION OF DIETARY SUPPLEMENTSA substantial percentage of the respondents were confused about the role that the government currently plays in regulating dietary supplements. Slightly more than half (53%) of the respondents were aware that supplements are not regulated by the government (Table 5). One third (35%) of the respondents believed that supplements are currently regulated, and 12% reported that they did not know. The results were similar for regular users.Table 5. US Respondents' Attitudes Toward FDA Regulation of Supplements*Total (N = 1196)Frequency of Dietary Supplement UseRegular (n = 235)Sometimes (n = 381)Never (n = 580)Does the government regulate dietary supplements?Yes353242†33No53584954Do not know1211913Allow new dietary supplements to be sold only if they have been tested by the FDAFavor81708084Oppose14241710Do not know5636Remove dietary supplements from the market if the FDA shows that they are unsafeFavor80787980Oppose16181914Do not know5316*FDA indicates Food and Drug Administration. Data are expressed as percentages. Percentages may not equal 100% because of rounding. Data are from a survey conducted by Princeton Survey Research Associates.†P= .003 compared with regular users.However, even with this level of public confusion, a majority of respondents expressed support for increased government regulatory efforts to ensure that dietary supplements are not harmful and are pure, that doses are consistent, and that advertising claims are true (Table 6).As shown in Table 5, 81% of the respondents supported giving the FDA the authority to allow new supplements to be sold only if the safety of the supplements has been tested by the FDA; 80% supported giving the FDA the authority to remove dietary supplements from the market if they are proved unsafe. Similar levels of support were found among regular users.Table 6. US Respondents' Attitudes Toward Levels of Regulation*Level of RegulationTotal (N = 1196)Frequency of Dietary Supplement UseRegular (n = 235)Sometimes (n = 381)Never (n = 580)To make sure that supplements are not harmfulToo much7975†Not enough59555962Right amount24272622Do not know or refused to answer109811To make sure that supplements are pure and doses are consistentToo much694‡6§Not enough60556162Right amount23252521Do not know or refused to answer11101012To make sure that advertising claims are trueToo much71065&par;Not enough64626564Right amount20192120Do not know or refused to answer109711Supports more regulation for children's supplements77787777*Data are expressed as percentages. Percentages may not equal 100% because of rounding. Data are from a survey conducted by Princeton Survey Research Associates.†Significantly different from regular users (P= .005).‡P= .002 compared with regular users.§P= .007 compared with regular users.&par;P= .004 compared with regular users.CONCLUSIONSIt is clear from the rapid growth in sales that dietary supplements have become a big business. Millions of Americans now regularly take these products as part of their routine health regimen. This phenomenon is being driven by a widespread belief that these untested products contain substances that can lead to better health. Many users feel so strongly about the potential health benefits of some of these products that they reported that they would continue to take them even if they were shown to be ineffective in scientifically conducted clinical studies.Although only 16% to 18% of the respondents were regular users, the majority of the respondents thought that access to these products is important. This finding suggests that Americans want to be able to use supplements if needed. It also may be due to a belief that there are therapeutic or beneficial substances that the medical community is not aware of.However, the growing enthusiasm for dietary supplements does not mean that there is not support for stronger regulation that would require FDA review of the safety of new dietary supplements prior to their sale and that would give the FDA ample authority to remove from the market those products shown to be unsafe. Broad support also exists for increased government regulation to ensure that advertising claims about the health benefits are true, that the ingredients in the products are pure, and that dose levels are consistent with the labeling.The caveat is that a substantial number of the respondents were not prepared to be denied access to existing dietary supplements that have not been previously tested for safety. Many respondents held skeptical views about physicians' and most likely scientists' motivations and knowledge about dietary supplement issues and will likely want clear evidence of a safety hazard before supporting the removal of supplements from the market.Thus, efforts to increase FDA oversight may not gain support from a critical segment of the public if there is not a clear understanding that any proposed expanded FDA authority is narrowly focused on the testing of either new products or those in use in which there is evidence of potential hazards or untruthful health claims.These findings also point to the importance for physicians of becoming both more involved with patients in discussing their use of dietary supplements and more knowledgeable about them, particularly in regard to safety issues. The fact that 1 of 6 parents reported giving these supplements to their children should prompt physicians to devote more attention to discussing this practice with parents as they seek health care for their children.Finally, although the question was not asked directly in the surveys, the findings suggested that there is considerable support for increased research efforts by the government and industry to test and evaluate dietary supplements, particularly for safety purposes. Given how quickly these products are moving into mainstream use, more research seems warranted.GGugliottaHealth concerns grow over herbal aids: as industry booms, analysis suggests rising toll in illness and death.Washington Post.March 19, 2000:A01.MAngellJKassirerAlternative medicine: the risks of untested and unregulated medicine.N Engl J Med.1998;339:839-841.WBJonasAlternative medicine: learning from the past, examining the present, advancing to the future.JAMA.1998;280:1616-1617.GGugliottaTaking aim at an energy-booster.Washington Post National Weekly Edition.2000;17(2):7-8.JForemanSt. John's wort: less than meets the eye.Boston Globe.January 10, 2000:C1.Not AvailableDietary Supplement Health and Education Act,21 USC §343-2 (1994).Not AvailableNutrition Labeling and Education Act,21 USC §343-1 (1990).MCimonsHouse OKs bill on vitamin benefit claims: health measure gives consumers continued access to products but affords government right to oversee nutritional and dietary supplement industry.Los Angeles Times.October 8, 1994:A16.JForemanFDA loosens reins.Boston Globe.January 10, 2000:C1.Not AvailableRegulating dietary supplements.The New York Times.January 9, 2000:18.PBFontanarosaGDLundbergAlternative medicine meets science.JAMA.1998;280:1618-1619.Chilton Research News survey firm; ABC News, survey sponsorVitamin supplements.In: Iraq/food/vitamins. Storrs, Conn: Roper Center for Public Opinion Research; November 11-12, 1997. Study USABC1997-6857.ABC News pollNot AvailableStorrs, Conn: Roper Center for Public Opinion Research; January 17, 1997.International Communications Research, survey firm; Harvard School of Public Health and Robert Wood Johnson Foundation, survey sponsorsNot AvailableStorrs, Conn: Roper Center for Public Opinion Research; April 22, 1999.Wirthlin Worldwide, survey firmNot AvailableStorrs, Conn: Roper Center for Public Opinion Research; February 19, 1999.Princeton Survey Research Associates, survey firm; National Public Radio, Henry J. Kaiser Family Foundation, and John F. Kennedy School of Government, survey sponsorsNot AvailableStorrs, Conn: Roper Center for Public Opinion Research; February 19, 1999.International Communications Research, survey firm; Harvard School of Public Health and Henry J. Kaiser Family Foundation, survey sponsorsNot AvailableStorrs, Conn: Roper Center for Public Opinion Research; December 16-21, 1999.MSWilkesRABellRLKravitzDirect-to-consumer prescription drug advertising: trends, impact, and implications.Health Aff (Millwood).2000;19:110-128.Accepted for publication October 2, 2000.Supported jointly by the Henry J. Kaiser Family Foundation, Menlo Park, Calif, and National Public Radio, Washington, DC.The views expressed herein are solely those of the authors, and no official endorsement by any of the sponsors is intended or should be inferred.Corresponding author and reprints: Robert J. Blendon, ScD, Department of Health Policy and Management, Harvard School of Public Health, 677 Huntington Ave, Boston, MA 02115 (e-mail: cdesroch@hsph.harvard.edu). http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA Internal Medicine American Medical Association

Americans' Views on the Use and Regulation of Dietary Supplements

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American Medical Association
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Copyright 2001 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.
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2168-6106
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2168-6114
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10.1001/archinte.161.6.805
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Abstract

This article presents the views of Americans on what the government's future role should be in regulating or overseeing the growing sales of dietary supplements for health purposes. Based on results of multiple national opinion surveys, including the views of both users and nonusers of supplements, we found that a substantial percentage of Americans surveyed reported that they regularly take dietary supplements as a part of their routine health regimen. However, they reported that they do not discuss the use of dietary supplements with their physicians because they believe that the physicians know little or nothing about these products and may be biased against them. Many users felt so strongly about the potential health benefits of some of these products that they reported that they would continue to take them even if they were shown to be ineffective in scientifically conducted clinical studies. However, there also was broad public support for increased government regulation of these products. We found that a majority of Americans surveyed supported the following: to require that the Food and Drug Administration review the safety of new dietary supplements prior to their sale; to provide increased authority to remove from sale those products shown to be unsafe; and to increase government regulation to ensure that advertising claims about the health benefits of dietary supplements are true.One of the most striking changes in Americans' health behaviors in the 1990s was the widespread and growing use of dietary supplements for health reasons. Since 1994, dietary supplement sales have grown by nearly 80%, from $8.8 billion to an estimated $15.7 billion for 2000. Sales of specific herbal remedies, such as echinacea, ginseng, Ginkgo biloba, and St John's wort, exceeded $200 million per product per year, and these supplements are taken routinely by millions of Americans.The sharp rise in the use of these supplements has raised concerns in the medical community and the media about the potentially serious health risks of the mostly untested and unregulated products. Various reportsfrom poison control centers and practicing physicians have indicated examples of individuals being harmed by taking these supplements. Othershave raised the concern that the use of these products may be leading some to forgo proven conventional medical treatment when they are seriously ill.Furthermore, the issue has been raised that as these products are increasingly advertised in the media and sold in drug stores and supermarkets the public may be given a false sense of security about their safety. They may believe that supplements are subject to existing government regulations similar to those applicable to over-the-counter medications sold to the public without a prescription. In fact, dietary supplements are subject to a less stringent government standard of safety testing than other over-the-counter medications.After receiving thousands of letters from supplement users in a heated advocacy campaign, Congress passed the Dietary Supplement Health and Education Actof 1994, which freed dietary supplement manufacturers from many existing Food and Drug Administration (FDA) regulations. In the Nutrition Labeling and Education Actof 1990, Congress gave the FDA the authority to require manufacturers of dietary supplements to provide evidence that their products were safe prior to sale and to approve the health claims made about these products before they could be used in marketing. After the 1994 legislation was enacted, the burden of proof concerning the safety of dietary supplements shifted. Instead of the manufacturer having to show that a supplement was safe, the FDA had to prove that it was unsafe. Also, as a result of the legislation, manufacturers have been able to make general health claims about products as long as they do not contain references to preventing or curing specific diseases. These supplements are now sold under the same oversight standard as vitamins and are categorized under a separate FDA category as "foods."Recently, the question of the need for stricter regulation of these products has been raised in editorials, medical journals, and articles in the media, particularly on the issue of safety and the specific health claims that can be made by the manufacturers.What has been missing in this growing debate over what the government's role should be in regulating dietary supplements are the views of the American public, both users and nonusers of these products.In this article, we seek to fill this void by summarizing the available public opinion survey data on the dietary supplement issue. We used national opinion survey data to answer the following questions: (1) What are the characteristics of people who use dietary supplements regularly, and how are users different from nonusers? (2) How are regular users' attitudes about dietary supplements and their usefulness different from those of nonusers? (3) What are Americans' attitudes toward government regulation, and are there differences between the attitudes of regular users and nonusers? (4) What are the policy implications of these differences, and how might they affect the debate on the national level?DATA AND METHODSRelatively few polls investigating Americans' views of dietary supplement use and regulation have been conducted. The data presented herein came primarily from 2 sources.The first source consisted of specific results drawn from 4 national opinion surveys conducted from 1996 to 1999. These surveys did not differentiate between the views of regular users and nonusers of dietary supplements. These data were compiled from the public opinion database at the Roper Center for Public Opinion Research in Storrs, Conn.The second source consisted of 2 surveys that differentiated the views of users and nonusers of dietary supplements. One survey was designed by researchers at National Public Radio, the Henry J. Kaiser Family Foundation, and the John F. Kennedy School of Government. Telephone interviews were conducted with 1200 randomly selected US adults by Princeton Survey Research Associates between February 19 and 25, 1999.The second survey was designed by researchers at the Henry J. Kaiser Family Foundation and the Harvard School of Public Health. International Communications Research conducted interviews via telephone with 1013 randomly selected US adults between December 16 and 21, 1999.In the analysis of data from these latter 2 surveys, regular userswere defined as respondents who reported that they regularly use products, such as echinacea, ginseng, over-the-counter hormones, or amino acids. Respondents who reported using dietary supplements sometimes were classified as sometimes users. Lastly, nonuserswere defined as those respondents who reported that they never use these products. We compared the views of both sometimes users and nonusers with regular users. Differences between these groups were tested using a χ2test, and significance is noted in the individual tables.All surveys were subject to sampling and nonsampling errors. Results may have differed from what would have been obtained if the whole population of adults had been interviewed. The size of this error varied with the number surveyed and the magnitude of difference in the responses to each question. These surveys had sample sizes of approximately 1000 to 1200 persons. With a sample this size, the results, with a 95% degree of confidence, have a statistical precision of ± 3 to 3.5 percentage points compared with what would have been obtained if the entire population had been interviewed. Possible sources of nonsampling error include nonresponse bias and question wording and ordering effects.RESULTSDEMOGRAPHIC CHARACTERISTICSA review of the findings of these surveys showed that approximately half (48%) of all American adults surveyed reported taking some type of nonprescription vitamin, dietary, or mineral supplements regularly.One in six (16%-18%) reported regularly using dietary supplements, like echinacea, ginseng, amino acids, or over-the-counter hormones.Table 1displays the differences between demographic groups in terms of the frequency of dietary supplement use. American respondents with higher levels of education reported greater use than those with less education. Regular users were also more likely to be white (non-Hispanic). Americans older than 45 years were more likely to use supplements regularly than those who were younger (24% vs 14%, respectively).Table 1. Demographics of US Respondents*Total (N = 1196)Frequency of Dietary Supplement UsePRegular (n = 235)Sometimes (n = 381)Never (n = 580)National. . .181566. . .Income, $†<20 0001920305020 000-29 99915202753. . .30 000-50 00018163748>50 00025173449EducationLess than high school graduate17162856High school graduate34152857<.001Some college27223642College or more23223345Race or ethnicityWhite, non-Hispanic80203050Black, non-Hispanic1083360.03Hispanic7143453Other3244531Insurance statusInsured83151074.05Uninsured16211664Age, y18-343316345035-4422143254<.00145-6428243145≥6517222652SexMale48183052. . .Female52193249*Data are expressed as percentages unless indicated otherwise. Percentages may not equal 100% because of rounding. The values sum horizontally. National indicates the percentage of the national population in each group; ellipses, not applicable. Data are from a survey conducted by Princeton Survey Research Associates.†Percentages do not equal 100% because of missing data.Also, uninsured American respondents were significantly more likely than those with insurance to use dietary supplements (21% vs 15%, respectively).Of note, 1 (18%) of 6 parents reported giving dietary supplements to their children.BELIEFS ABOUT DIETARY SUPPLEMENTSThe surveys found that a substantial percentage of the Americans surveyed held positive views of the health benefits derived from taking dietary supplements. A 1997 survey found that one third (36%) of the American adults thought that there was a dietary supplement that could help them live longer.Overall, 85% of regular users reported that dietary supplements are good for people's health and well-being. The figure was lower for those who were not regular users.Regular users differed significantly from nonusers in their belief that dietary supplements could help with the treatment of a wide range of medical conditions (Table 2). About half of the American respondents believed that supplements are helpful for people with colds (61%), arthritis (53%), depression (52%), and influenza (49%). Respondents viewed dietary supplements as helpful in the treatment of cancer (35%) and acquired immunodeficiency syndrome (16%).Not surprisingly, regular users were significantly more likely than nonusers to believe that supplements could help people with all the conditions the survey asked about; however, rates were also high among the nonusers. Another studyfound that 82% of the Americans surveyed said that they would seriously consider trying alternative treatments, such as herbal medicines, if they were terminally ill.Table 2. Dietary Supplements' Effect on Health and Well-being According to US Respondents*Total (N = 1196)Frequency of Dietary Supplement UseRegular (n = 235)Sometimes (n = 381)Never (n = 580)Supplements are good for health and well-beingYes528562†34†No1731027Some are, some are not‡1791820Do not know143919Supplements are helpful for people withInfluenza496456§40†Colds61777348†Cancer355441†24†Acquired immunodeficiency syndrome16212012†Arthritis537161†42†Depression527258†42†How important is access to supplements?Very important357340†19†Somewhat important24183222Not too important1771821Not at all important222937*Data are expressed as percentages. Percentages may not equal 100% because of rounding. Data are from a survey conducted by International Communications Research.†Significantly different from regular users (P<.001).‡Respondents volunteered answer; it was not given as an option in the survey.§Significantly different from regular users (P= .02).The surveys also found that those who were regular users believed strongly in the usefulness of various dietary supplements irrespective of the scientific evidence. When asked what they would do if a government agency said that the supplement they use most often was ineffective, 71% of regular users reported that they would continue to use it (Table 3).In the follow-up survey, respondents were asked what they would do if the FDA specifically said that the supplement they use most often was ineffective to see if using the FDA's name vs an unknown government agency would alter the result. The addition of the FDA did not lead to different responses (Table 3). Once again, two thirds (67%) of regular and sometimes users said that they would continue to take the supplement.Table 3. US Respondents' Use of Dietary Supplements Considered Unsafe by Government Agencies*Total (N = 1196)Frequency of Dietary Supplement UseRegular (n = 235)Sometimes (n = 381)If a government agency said that the dietary supplement is ineffective, what would you do?Stop using the supplement252425Keep using the supplement727172Do not know443If the FDA said that the dietary supplement you use most often is ineffective, what would you do?Stop using the supplement333233Keep using the supplement666765Do not know111*Data are expressed as percentages. Percentages may not equal 100% because of rounding. The first question was from a survey conducted by Princeton Survey Research Associates.The second question was from a survey conducted by International Communications Research.FDA indicates Food and Drug Administration.Given how beneficial most regular users believed dietary supplements to be, it is not surprising that access to them is very important for regular users. Of those who reported that they regularly use dietary supplements, 91% said that access to them is "very" or "somewhat" important. Of note, 72% of sometimes users and 41% of nonusers felt this way (Table 2).CONFIDENCE IN PHYSICIANS' OPENNESS TOWARD AND KNOWLEDGE OF DIETARY SUPPLEMENTSThe respondents who reported regular use of dietary supplements were divided in their assessment of their physician's level of knowledge of and openness toward these products. More than two thirds (70%) of those who reported taking supplements regularly said that they had shared this information with their regular physician. However, the survey did not provide a measure of the extent of information shared between patients and physicians, and many regular users were skeptical of their physician's knowledge of and attitudes toward supplements. Nearly half (49%) of regular users believed that physicians are prejudiced against supplement use and 44% believed that their own physician knows only a little or not much at all about these products.SAFETY OF DIETARY SUPPLEMENTSRegular users of dietary supplements had much more confidence in the safety of these products than nonusers. As shown in Table 4, only 37% of the respondents believed that dietary supplements are adequately tested. However, regular users were more likely (49%) than nonusers (33%) to believe that there is adequate testing of these products. Also, the majority of regular users (53%) believed that people are "rarely or never" harmed by taking dietary supplements. In contrast, 51% of nonusers reported that people are "often or sometimes" harmed by these supplements.Table 4. US Respondents' Opinions on the Safety of Dietary Supplements*Total (N = 1196)Frequency of Dietary Supplement UseRegular (n = 235)Sometimes (n = 381)Never (n = 580)Supplements are adequately testedYes374938†33†No48394753Do not know15121514Advertising for supplements isNot true492943†60†Generally true37574525Do not know15141216How often are people harmed by supplements?Often or sometimes47384651†Rarely or never44534838Do not know109611*Data are expressed as percentages. Percentages may not equal 100% because of rounding. Data are from a survey conducted by Princeton Survey Research Associates.†Significantly different from regular users (P<.001).ROLE OF ADVERTISING INFORMATIONCommercial advertising has been shown to be an important source of information about over-the-counter medications.One recent surveyfound that 39% of the respondents reported that television commercials are the most influential source of information in their decision about which cold medicine to buy. In the area of dietary supplements, data are not available on the frequency of use of commercials as an important information source. However, a majority (57%) of regular users thought that the claims made by supplement manufacturers in the advertisements are generally true (Table 4). Those who were not regular users were less likely to believe the claims made by these advertisements.ATTITUDES TOWARD GOVERNMENT REGULATION OF DIETARY SUPPLEMENTSA substantial percentage of the respondents were confused about the role that the government currently plays in regulating dietary supplements. Slightly more than half (53%) of the respondents were aware that supplements are not regulated by the government (Table 5). One third (35%) of the respondents believed that supplements are currently regulated, and 12% reported that they did not know. The results were similar for regular users.Table 5. US Respondents' Attitudes Toward FDA Regulation of Supplements*Total (N = 1196)Frequency of Dietary Supplement UseRegular (n = 235)Sometimes (n = 381)Never (n = 580)Does the government regulate dietary supplements?Yes353242†33No53584954Do not know1211913Allow new dietary supplements to be sold only if they have been tested by the FDAFavor81708084Oppose14241710Do not know5636Remove dietary supplements from the market if the FDA shows that they are unsafeFavor80787980Oppose16181914Do not know5316*FDA indicates Food and Drug Administration. Data are expressed as percentages. Percentages may not equal 100% because of rounding. Data are from a survey conducted by Princeton Survey Research Associates.†P= .003 compared with regular users.However, even with this level of public confusion, a majority of respondents expressed support for increased government regulatory efforts to ensure that dietary supplements are not harmful and are pure, that doses are consistent, and that advertising claims are true (Table 6).As shown in Table 5, 81% of the respondents supported giving the FDA the authority to allow new supplements to be sold only if the safety of the supplements has been tested by the FDA; 80% supported giving the FDA the authority to remove dietary supplements from the market if they are proved unsafe. Similar levels of support were found among regular users.Table 6. US Respondents' Attitudes Toward Levels of Regulation*Level of RegulationTotal (N = 1196)Frequency of Dietary Supplement UseRegular (n = 235)Sometimes (n = 381)Never (n = 580)To make sure that supplements are not harmfulToo much7975†Not enough59555962Right amount24272622Do not know or refused to answer109811To make sure that supplements are pure and doses are consistentToo much694‡6§Not enough60556162Right amount23252521Do not know or refused to answer11101012To make sure that advertising claims are trueToo much71065&par;Not enough64626564Right amount20192120Do not know or refused to answer109711Supports more regulation for children's supplements77787777*Data are expressed as percentages. Percentages may not equal 100% because of rounding. Data are from a survey conducted by Princeton Survey Research Associates.†Significantly different from regular users (P= .005).‡P= .002 compared with regular users.§P= .007 compared with regular users.&par;P= .004 compared with regular users.CONCLUSIONSIt is clear from the rapid growth in sales that dietary supplements have become a big business. Millions of Americans now regularly take these products as part of their routine health regimen. This phenomenon is being driven by a widespread belief that these untested products contain substances that can lead to better health. Many users feel so strongly about the potential health benefits of some of these products that they reported that they would continue to take them even if they were shown to be ineffective in scientifically conducted clinical studies.Although only 16% to 18% of the respondents were regular users, the majority of the respondents thought that access to these products is important. This finding suggests that Americans want to be able to use supplements if needed. It also may be due to a belief that there are therapeutic or beneficial substances that the medical community is not aware of.However, the growing enthusiasm for dietary supplements does not mean that there is not support for stronger regulation that would require FDA review of the safety of new dietary supplements prior to their sale and that would give the FDA ample authority to remove from the market those products shown to be unsafe. Broad support also exists for increased government regulation to ensure that advertising claims about the health benefits are true, that the ingredients in the products are pure, and that dose levels are consistent with the labeling.The caveat is that a substantial number of the respondents were not prepared to be denied access to existing dietary supplements that have not been previously tested for safety. Many respondents held skeptical views about physicians' and most likely scientists' motivations and knowledge about dietary supplement issues and will likely want clear evidence of a safety hazard before supporting the removal of supplements from the market.Thus, efforts to increase FDA oversight may not gain support from a critical segment of the public if there is not a clear understanding that any proposed expanded FDA authority is narrowly focused on the testing of either new products or those in use in which there is evidence of potential hazards or untruthful health claims.These findings also point to the importance for physicians of becoming both more involved with patients in discussing their use of dietary supplements and more knowledgeable about them, particularly in regard to safety issues. The fact that 1 of 6 parents reported giving these supplements to their children should prompt physicians to devote more attention to discussing this practice with parents as they seek health care for their children.Finally, although the question was not asked directly in the surveys, the findings suggested that there is considerable support for increased research efforts by the government and industry to test and evaluate dietary supplements, particularly for safety purposes. Given how quickly these products are moving into mainstream use, more research seems warranted.GGugliottaHealth concerns grow over herbal aids: as industry booms, analysis suggests rising toll in illness and death.Washington Post.March 19, 2000:A01.MAngellJKassirerAlternative medicine: the risks of untested and unregulated medicine.N Engl J Med.1998;339:839-841.WBJonasAlternative medicine: learning from the past, examining the present, advancing to the future.JAMA.1998;280:1616-1617.GGugliottaTaking aim at an energy-booster.Washington Post National Weekly Edition.2000;17(2):7-8.JForemanSt. John's wort: less than meets the eye.Boston Globe.January 10, 2000:C1.Not AvailableDietary Supplement Health and Education Act,21 USC §343-2 (1994).Not AvailableNutrition Labeling and Education Act,21 USC §343-1 (1990).MCimonsHouse OKs bill on vitamin benefit claims: health measure gives consumers continued access to products but affords government right to oversee nutritional and dietary supplement industry.Los Angeles Times.October 8, 1994:A16.JForemanFDA loosens reins.Boston Globe.January 10, 2000:C1.Not AvailableRegulating dietary supplements.The New York Times.January 9, 2000:18.PBFontanarosaGDLundbergAlternative medicine meets science.JAMA.1998;280:1618-1619.Chilton Research News survey firm; ABC News, survey sponsorVitamin supplements.In: Iraq/food/vitamins. Storrs, Conn: Roper Center for Public Opinion Research; November 11-12, 1997. Study USABC1997-6857.ABC News pollNot AvailableStorrs, Conn: Roper Center for Public Opinion Research; January 17, 1997.International Communications Research, survey firm; Harvard School of Public Health and Robert Wood Johnson Foundation, survey sponsorsNot AvailableStorrs, Conn: Roper Center for Public Opinion Research; April 22, 1999.Wirthlin Worldwide, survey firmNot AvailableStorrs, Conn: Roper Center for Public Opinion Research; February 19, 1999.Princeton Survey Research Associates, survey firm; National Public Radio, Henry J. Kaiser Family Foundation, and John F. Kennedy School of Government, survey sponsorsNot AvailableStorrs, Conn: Roper Center for Public Opinion Research; February 19, 1999.International Communications Research, survey firm; Harvard School of Public Health and Henry J. Kaiser Family Foundation, survey sponsorsNot AvailableStorrs, Conn: Roper Center for Public Opinion Research; December 16-21, 1999.MSWilkesRABellRLKravitzDirect-to-consumer prescription drug advertising: trends, impact, and implications.Health Aff (Millwood).2000;19:110-128.Accepted for publication October 2, 2000.Supported jointly by the Henry J. Kaiser Family Foundation, Menlo Park, Calif, and National Public Radio, Washington, DC.The views expressed herein are solely those of the authors, and no official endorsement by any of the sponsors is intended or should be inferred.Corresponding author and reprints: Robert J. Blendon, ScD, Department of Health Policy and Management, Harvard School of Public Health, 677 Huntington Ave, Boston, MA 02115 (e-mail: cdesroch@hsph.harvard.edu).

Journal

JAMA Internal MedicineAmerican Medical Association

Published: Mar 26, 2001

References