Letters
when sitting in any type of seating arrangement. This is particularly important given the high prevalence of back pain in sedentary adults. In conclusion, the SODS is an important tool for helping caregivers improve the quality of life of persons with dementia. We hope that a continuing discussion will reveal possible additional items that may provide strategies for alleviating sources of discomfort in this population. Jiska Cohen-Mansfield, PhD, ABPP Marcia S. Marx, PhD Khin Thein, MD Author Affiliations: Minerva Center for the Interdisciplinary Study of End of Life, Sackler Faculty of Medicine, Tel-Aviv University, Israel (Cohen-Mansfield); Herczeg Institute on Aging, Tel-Aviv University, Israel (Cohen-Mansfield); Innovative Aging Research, Silver Spring, Maryland (Cohen-Mansfield, Marx, Thein). Corresponding Author: Jiska Cohen-Mansfield, PhD, ABPP, Innovative Aging Research, 807 Horton Dr, Silver Spring, MD 20902 ([email protected]). Conflict of Interest Disclosures: None reported. Funding/Support: This study was supported by National Institutes of Health grant 2 R01 AG010172-10A2 and by the Minerva-Stiftung Foundation grant 31583295000. Role of the Sponsor: The sponsors had no role in the preparation, review, or approval of the manuscript or the decision to submit the manuscript for publication. 1. Husebo BS, Ballard C, Cohen-Mansfield J, Seifert R, Aarsland D. The response of agitated behavior to pain management in persons with dementia [published online April 20, 2013]. Am J Geriatr Psychiatry. doi:10.1016/j.jagp.2012.12.006. 2. Cohen-Mansfield J, Thein K, Marx MS, Dakheel-Ali M, Jensen B. Sources of discomfort in persons with dementia. JAMA Intern Med. 2013;173(14):1378-1379.
Gail Charnley, PhD
3. Cohen-Mansfield J, Marx MS, Werner P. Observational data on time use and behavior problems in the nursing home. J Appl Gerontol. 1992;11(1):111-121.
Author Affiliation: HealthRisk Strategies, Washington, DC.
4. Cohen-Mansfield J, Marx MS, Freedman LS, et al. The comprehensive process model of engagement. Am J Geriatr Psychiatry. 2011;19(10):859-870.
Corresponding Author: Gail Charnley, PhD, HealthRisk Strategies, 222 11th St NE, Washington, DC 20002 ([email protected]).
5. National Sleep Foundation Web site. http://www.sleepfoundation.org/article /sleep-related-problems/excessive-sleepiness-and-sleep. Accessed September 19, 2013.
Conflict of Interest Disclosures: Dr Charnley is a consultant to the Juice Products Association.
6. Schofield R, Porter-Armstrong A, Stinson M. Reviewing the literature on the effectiveness of pressure relieving movements. Nurs Res Pract. 2013;2013:124095.
Arsenic in Rice and Other Foods To the Editor As a toxicologist and consultant to the Juice Products Association, I write to correct errors in the Viewpoint titled “Public Health Responses to Arsenic in Rice and Other Foods.”1 The Food and Drug Administration (FDA) has an established, enforceable limit for levels of arsenic in juice, 23 parts per billion (ppb). This “level of concern” was determined from juice consumption data and the reference dose for arsenic determined by the Environmental Protection Agency (EPA). A reference dose is the amount of a substance that can be consumed daily for a lifetime that is unlikely to produce adverse effects, even in sensitive people. The reference dose for arsenic was calculated from epidemiologic studies in southeast Taiwan, where people are exposed throughout their lives—in utero, as infants and children, and as adults—to naturally high levels of arsenic in drinking water.2 The reference dose was based on the level of exposure in those studies that did not produce precancerous lesions and dividing it by an uncertainty factor to ensure that it would protect health. To set its limit on arsenic in juice, the FDA divided the EPA’s reference dose 298
for arsenic by the amount of juice that the 90th percentile of juice consumers drink daily over a lifetime, including childhood. Juice consumption data came from the 2003-2004 National Health and Nutrition Examination Survey by the US Centers for Disease Control and Prevention. The southeast Taiwan data have been criticized because the poor nutrition of residents increases their risks from arsenic exposure. More recent data from northeast Taiwan, an area with more similarities to exposures in the United States, established 5.5 μg (arsenic)/kg (body weight)/d as a total daily lifetime arsenic exposure that did not produce an increase in cancers.3-5 That concentration can be divided by 3, using standard reference dose methodology, to obtain a lifetime arsenic intake unlikely to be associated with cancer risk, even in the most sensitive individuals, of 1.8 μg/kg/d. That arsenic intake can be used to estimate arsenic concentrations in apple juice that similarly would not be associated with increased cancer risk by dividing it by 2007-2010 National Health and Nutrition Examination Survey apple juice intake data. The levels of concern derived from the northeast Taiwan data are almost 3 to 8 times higher than the FDA’s current level of concern of 23 ppb. This suggests that the current limit not only provides adequate safety but also does so in a conservative, health-protective manner. The juice industry complies with FDA’s arsenic limit and conducts voluntary testing at several points in the production process. Consumers can be confident that juice products do not exceed the limit.
1. Navas-Acien A, Nachman KE. Public health responses to arsenic in rice and other foods. JAMA Intern Med. 2013;173(15):1395-1396. 2. Tseng WP. Effects and dose—response relationships of skin cancer and blackfoot disease with arsenic. Environ Health Perspect. August 1977;19:109-119. 3. Chen CL, Chiou HY, Hsu LI, Hsueh YM, Wu MM, Chen CJ. Ingested arsenic, characteristics of well water consumption and risk of different histological types of lung cancer in northeastern Taiwan. Environ Res. 2010;110(5):455-462. 4. Chen CL, Chiou HY, Hsu LI, et al. Arsenic in drinking water and risk of urinary tract cancer: a follow-up study from northeastern Taiwan. Cancer Epidemiol Biomarkers Prev. 2010;19(1):101-110. 5. Benford DJ, Alexander J, Baines J, et al. Arsenic (addendum). In: Joint FAO/WHO Expert Committee on Food Additives (JECFA). Safety Evaluation of Certain Contaminants in Food: WHO Food Additives Series 63: FAO JECFA Monographs 8. Rome, Italy: Food and Agriculture Organization of the United Nations; 2011:153-316.
In Reply In 2008, the Food and Drug Administration (FDA) specified a 23-μg/L (or parts per billion) “level of concern” for arsenic in apple and pear juice, noting that samples exceeding this level would be considered, along with “other factors,” to determine whether regulatory action would be needed. Neither the other factors nor the nature of the regulatory action were specified.1 In July 2013, after our article was published, the FDA proposed an action level of 10 μg/L for inorganic arsenic in apple juice,1 the same level set by the Environmental Protection
JAMA Internal Medicine February 2014 Volume 174, Number 2
Copyright 2014 American Medical Association. All rights reserved.
Downloaded From: http://archinte.jamanetwork.com/ by a Ndsu Library Periodicals User on 05/23/2015
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Letters
Agency for arsenic in drinking water. The proposed action limit is based on quantitative risk assessment using data on lung and bladder cancer cases from southwestern Taiwan. The increasing evidence for arsenic health effects at low-to-moderate arsenic levels, including both cancer and noncancer end points,2-5 should be considered to evaluate the adequacy of 10 μg/L as the action level for apple juice. For rice, the FDA’s risk assessment is ongoing; an action level has yet to be proposed. As we discussed, in addition to establishing standards for juice, rice, and other foods, adequate monitoring systems are needed for arsenic species in food. Finally, on September 30, 2013, the FDA withdrew the approvals of roxarsone, arsanilic acid, and carbarsone, which are arsenic-based animal drugs.6 Thus, people who eat poultry may be less likely to be exposed to dietary arsenic. Nitarsone, however, is still approved. Ana Navas-Acien, MD, PhD Keeve Nachman, PhD, MHS Author Affiliations: Department of Environmental Health Sciences, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland (Navas-Acien, Nachman); Department of Epidemiology, Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland (Navas-Acien); Department of Health Policy and Management, Johns Hopkins Center for Livable Future, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland (Nachman). Corresponding Author: Ana Navas-Acien, MD, PhD, Department of Environmental Health Sciences, Johns Hopkins Bloomberg School of Public Health, 615 N Wolfe St, Office W7513D, Baltimore, MD 21205 ([email protected]). Conflict of Interest Disclosures: None reported. 1. US Food and Drug Administration. Supporting document for action level for arsenic in apple juice. http://www.fda.gov/Food/GuidanceRegulation /GuidanceDocumentsRegulatoryInformation/ChemicalContaminantsMetals -NaturalToxinsPesticides/ucm360023.htm. Accessed November 25, 2013. 2. Sohel N, Persson LA, Rahman M, et al. Arsenic in drinking water and adult mortality: a population-based cohort study in rural Bangladesh. Epidemiology. 2009;20(6):824-830. 3. Chen Y, Graziano JH, Parvez F, et al. Arsenic exposure from drinking water and mortality from cardiovascular disease in Bangladesh: prospective cohort study. BMJ. 2011;342:d2431. 4. García-Esquinas E, Pollán M, Umans JG, et al. Arsenic exposure and cancer mortality in a US-based prospective cohort: the Strong Heart Study. Cancer Epidemiol Biomarkers Prev. 2013;22(11):1944-1953. 5. Moon KA, Guallar E, Umans JG, et al. Association between low to moderate arsenic exposure and incident cardiovascular disease: a prospective cohort study [published online September 24, 2013]. Ann Intern Med. doi:10.7326/0003-4819-159-10-201311190-00719. 6. US Food and Drug Administration. FDA response to citizen petition on arsenic-based animal drugs. http://www.fda.gov/AnimalVeterinary/SafetyHealth /ProductSafetyInformation/ucm370568.htm. Accessed November 25, 2013.
Conflicts of Interest in Approvals of Food Additives To the Editor In concluding that financial conflicts of interest are ubiquitous in the conduct of “generally recognized as safe” (GRAS) determinations, Neltner et al1 fundamentally misunderstand the legal framework that governs the use of substances in food. The authors draw on principles regarding conflicts of interest that were articulated by the Institute of Medicine in the context of medical education, research, and practice. Nowhere do the authors explain why it is approprijamainternalmedicine.com
ate to apply those principles in the context of a GRAS determination by a food manufacturer. It is not appropriate. In conducting a GRAS determination, a food manufacturer is not recommending a course of therapy to a patient or rendering an opinion on whether the Food and Drug Administration (FDA) should approve a drug. Rather, the manufacturer is exercising a responsibility explicitly conferred by the Federal Food, Drug, and Cosmetic Act. That law authorizes a manufacturer to determine whether the proposed use of a substance in food is GRAS (ie, whether the proposed use of the substance is safe and whether there exists general recognition among qualified experts of such safety). There is no question on whose behalf the manufacturer is acting. If the manufacturer errs in its GRAS determination, the manufacturer is subject to substantial civil and criminal liability. In some instances, it may be desirable for a manufacturer to convene a panel of experts to assess whether there exists general recognition of safety. Even in those instances, the ultimate responsibility for a GRAS determination rests with the manufacturer. A manufacturer therefore has strong incentives to seek out the most highly qualified food toxicologists (not food technologists) and other appropriately qualified experts to help the manufacturer determine whether there exists general recognition of safety among such experts. In the end, what the authors appear to object to is the fact that Congress chose to establish the GRAS statutory provision that charges manufacturers with the responsibility of determining when it applies. In the more than 50 years since the law was enacted, that choice has proven wise. Manufacturers have adhered to the law and regulations in order to facilitate innovations that have contributed to the production of safe, nutritious, and affordable food, and the FDA has been left free to focus its limited resources on matters that merit the agency’s attention. Leon Bruner, DVM, PhD Author Affiliation: Science and Regulatory Affairs, The Grocery Manufacturers Association, Washington, DC. Corresponding Author: Leon Bruner, DVM, PhD, Senior Vice President for Scientific and Regulatory Affairs, Grocery Manufacturers Association, 1350 I St NW, Ste 300, Washington, DC 20005 ([email protected]). Conflict of Interest Disclosures: None reported. 1. Neltner TG, Alger HM, O’Reilly JT, Krimsky S, Bero LA, Maffini MV. Conflicts of interest in approvals of additives to food determined to be generally recognized as safe: out of balance. JAMA Intern Med. 2013;173(22):2032-2036.
To the Editor The article by Neltner et al1 raises concerns about the integrity of the “Generally Recognized as Safe” (GRAS) process. The United States has the most robust assessment of food ingredient safety in the world. The current GRAS process relies on scientific expert consensus, publicly available information, and clinical data. GRAS ingredients have been consumed for decades, and none has compromised public health. Under the current self-affirmation GRAS process, expert reviewers are selected for their academic credentials and experience as specified in the statutes,2 promulgated in 1997 and JAMA Internal Medicine February 2014 Volume 174, Number 2
Copyright 2014 American Medical Association. All rights reserved.
Downloaded From: http://archinte.jamanetwork.com/ by a Ndsu Library Periodicals User on 05/23/2015
299
when sitting in any type of seating arrangement. This is particularly important given the high prevalence of back pain in sedentary adults. In conclusion, the SODS is an important tool for helping caregivers improve the quality of life of persons with dementia. We hope that a continuing discussion will reveal possible additional items that may provide strategies for alleviating sources of discomfort in this population. Jiska Cohen-Mansfield, PhD, ABPP Marcia S. Marx, PhD Khin Thein, MD Author Affiliations: Minerva Center for the Interdisciplinary Study of End of Life, Sackler Faculty of Medicine, Tel-Aviv University, Israel (Cohen-Mansfield); Herczeg Institute on Aging, Tel-Aviv University, Israel (Cohen-Mansfield); Innovative Aging Research, Silver Spring, Maryland (Cohen-Mansfield, Marx, Thein). Corresponding Author: Jiska Cohen-Mansfield, PhD, ABPP, Innovative Aging Research, 807 Horton Dr, Silver Spring, MD 20902 ([email protected]). Conflict of Interest Disclosures: None reported. Funding/Support: This study was supported by National Institutes of Health grant 2 R01 AG010172-10A2 and by the Minerva-Stiftung Foundation grant 31583295000. Role of the Sponsor: The sponsors had no role in the preparation, review, or approval of the manuscript or the decision to submit the manuscript for publication. 1. Husebo BS, Ballard C, Cohen-Mansfield J, Seifert R, Aarsland D. The response of agitated behavior to pain management in persons with dementia [published online April 20, 2013]. Am J Geriatr Psychiatry. doi:10.1016/j.jagp.2012.12.006. 2. Cohen-Mansfield J, Thein K, Marx MS, Dakheel-Ali M, Jensen B. Sources of discomfort in persons with dementia. JAMA Intern Med. 2013;173(14):1378-1379.
Gail Charnley, PhD
3. Cohen-Mansfield J, Marx MS, Werner P. Observational data on time use and behavior problems in the nursing home. J Appl Gerontol. 1992;11(1):111-121.
Author Affiliation: HealthRisk Strategies, Washington, DC.
4. Cohen-Mansfield J, Marx MS, Freedman LS, et al. The comprehensive process model of engagement. Am J Geriatr Psychiatry. 2011;19(10):859-870.
Corresponding Author: Gail Charnley, PhD, HealthRisk Strategies, 222 11th St NE, Washington, DC 20002 ([email protected]).
5. National Sleep Foundation Web site. http://www.sleepfoundation.org/article /sleep-related-problems/excessive-sleepiness-and-sleep. Accessed September 19, 2013.
Conflict of Interest Disclosures: Dr Charnley is a consultant to the Juice Products Association.
6. Schofield R, Porter-Armstrong A, Stinson M. Reviewing the literature on the effectiveness of pressure relieving movements. Nurs Res Pract. 2013;2013:124095.
Arsenic in Rice and Other Foods To the Editor As a toxicologist and consultant to the Juice Products Association, I write to correct errors in the Viewpoint titled “Public Health Responses to Arsenic in Rice and Other Foods.”1 The Food and Drug Administration (FDA) has an established, enforceable limit for levels of arsenic in juice, 23 parts per billion (ppb). This “level of concern” was determined from juice consumption data and the reference dose for arsenic determined by the Environmental Protection Agency (EPA). A reference dose is the amount of a substance that can be consumed daily for a lifetime that is unlikely to produce adverse effects, even in sensitive people. The reference dose for arsenic was calculated from epidemiologic studies in southeast Taiwan, where people are exposed throughout their lives—in utero, as infants and children, and as adults—to naturally high levels of arsenic in drinking water.2 The reference dose was based on the level of exposure in those studies that did not produce precancerous lesions and dividing it by an uncertainty factor to ensure that it would protect health. To set its limit on arsenic in juice, the FDA divided the EPA’s reference dose 298
for arsenic by the amount of juice that the 90th percentile of juice consumers drink daily over a lifetime, including childhood. Juice consumption data came from the 2003-2004 National Health and Nutrition Examination Survey by the US Centers for Disease Control and Prevention. The southeast Taiwan data have been criticized because the poor nutrition of residents increases their risks from arsenic exposure. More recent data from northeast Taiwan, an area with more similarities to exposures in the United States, established 5.5 μg (arsenic)/kg (body weight)/d as a total daily lifetime arsenic exposure that did not produce an increase in cancers.3-5 That concentration can be divided by 3, using standard reference dose methodology, to obtain a lifetime arsenic intake unlikely to be associated with cancer risk, even in the most sensitive individuals, of 1.8 μg/kg/d. That arsenic intake can be used to estimate arsenic concentrations in apple juice that similarly would not be associated with increased cancer risk by dividing it by 2007-2010 National Health and Nutrition Examination Survey apple juice intake data. The levels of concern derived from the northeast Taiwan data are almost 3 to 8 times higher than the FDA’s current level of concern of 23 ppb. This suggests that the current limit not only provides adequate safety but also does so in a conservative, health-protective manner. The juice industry complies with FDA’s arsenic limit and conducts voluntary testing at several points in the production process. Consumers can be confident that juice products do not exceed the limit.
1. Navas-Acien A, Nachman KE. Public health responses to arsenic in rice and other foods. JAMA Intern Med. 2013;173(15):1395-1396. 2. Tseng WP. Effects and dose—response relationships of skin cancer and blackfoot disease with arsenic. Environ Health Perspect. August 1977;19:109-119. 3. Chen CL, Chiou HY, Hsu LI, Hsueh YM, Wu MM, Chen CJ. Ingested arsenic, characteristics of well water consumption and risk of different histological types of lung cancer in northeastern Taiwan. Environ Res. 2010;110(5):455-462. 4. Chen CL, Chiou HY, Hsu LI, et al. Arsenic in drinking water and risk of urinary tract cancer: a follow-up study from northeastern Taiwan. Cancer Epidemiol Biomarkers Prev. 2010;19(1):101-110. 5. Benford DJ, Alexander J, Baines J, et al. Arsenic (addendum). In: Joint FAO/WHO Expert Committee on Food Additives (JECFA). Safety Evaluation of Certain Contaminants in Food: WHO Food Additives Series 63: FAO JECFA Monographs 8. Rome, Italy: Food and Agriculture Organization of the United Nations; 2011:153-316.
In Reply In 2008, the Food and Drug Administration (FDA) specified a 23-μg/L (or parts per billion) “level of concern” for arsenic in apple and pear juice, noting that samples exceeding this level would be considered, along with “other factors,” to determine whether regulatory action would be needed. Neither the other factors nor the nature of the regulatory action were specified.1 In July 2013, after our article was published, the FDA proposed an action level of 10 μg/L for inorganic arsenic in apple juice,1 the same level set by the Environmental Protection
JAMA Internal Medicine February 2014 Volume 174, Number 2
Copyright 2014 American Medical Association. All rights reserved.
Downloaded From: http://archinte.jamanetwork.com/ by a Ndsu Library Periodicals User on 05/23/2015
jamainternalmedicine.com
Letters
Agency for arsenic in drinking water. The proposed action limit is based on quantitative risk assessment using data on lung and bladder cancer cases from southwestern Taiwan. The increasing evidence for arsenic health effects at low-to-moderate arsenic levels, including both cancer and noncancer end points,2-5 should be considered to evaluate the adequacy of 10 μg/L as the action level for apple juice. For rice, the FDA’s risk assessment is ongoing; an action level has yet to be proposed. As we discussed, in addition to establishing standards for juice, rice, and other foods, adequate monitoring systems are needed for arsenic species in food. Finally, on September 30, 2013, the FDA withdrew the approvals of roxarsone, arsanilic acid, and carbarsone, which are arsenic-based animal drugs.6 Thus, people who eat poultry may be less likely to be exposed to dietary arsenic. Nitarsone, however, is still approved. Ana Navas-Acien, MD, PhD Keeve Nachman, PhD, MHS Author Affiliations: Department of Environmental Health Sciences, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland (Navas-Acien, Nachman); Department of Epidemiology, Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland (Navas-Acien); Department of Health Policy and Management, Johns Hopkins Center for Livable Future, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland (Nachman). Corresponding Author: Ana Navas-Acien, MD, PhD, Department of Environmental Health Sciences, Johns Hopkins Bloomberg School of Public Health, 615 N Wolfe St, Office W7513D, Baltimore, MD 21205 ([email protected]). Conflict of Interest Disclosures: None reported. 1. US Food and Drug Administration. Supporting document for action level for arsenic in apple juice. http://www.fda.gov/Food/GuidanceRegulation /GuidanceDocumentsRegulatoryInformation/ChemicalContaminantsMetals -NaturalToxinsPesticides/ucm360023.htm. Accessed November 25, 2013. 2. Sohel N, Persson LA, Rahman M, et al. Arsenic in drinking water and adult mortality: a population-based cohort study in rural Bangladesh. Epidemiology. 2009;20(6):824-830. 3. Chen Y, Graziano JH, Parvez F, et al. Arsenic exposure from drinking water and mortality from cardiovascular disease in Bangladesh: prospective cohort study. BMJ. 2011;342:d2431. 4. García-Esquinas E, Pollán M, Umans JG, et al. Arsenic exposure and cancer mortality in a US-based prospective cohort: the Strong Heart Study. Cancer Epidemiol Biomarkers Prev. 2013;22(11):1944-1953. 5. Moon KA, Guallar E, Umans JG, et al. Association between low to moderate arsenic exposure and incident cardiovascular disease: a prospective cohort study [published online September 24, 2013]. Ann Intern Med. doi:10.7326/0003-4819-159-10-201311190-00719. 6. US Food and Drug Administration. FDA response to citizen petition on arsenic-based animal drugs. http://www.fda.gov/AnimalVeterinary/SafetyHealth /ProductSafetyInformation/ucm370568.htm. Accessed November 25, 2013.
Conflicts of Interest in Approvals of Food Additives To the Editor In concluding that financial conflicts of interest are ubiquitous in the conduct of “generally recognized as safe” (GRAS) determinations, Neltner et al1 fundamentally misunderstand the legal framework that governs the use of substances in food. The authors draw on principles regarding conflicts of interest that were articulated by the Institute of Medicine in the context of medical education, research, and practice. Nowhere do the authors explain why it is approprijamainternalmedicine.com
ate to apply those principles in the context of a GRAS determination by a food manufacturer. It is not appropriate. In conducting a GRAS determination, a food manufacturer is not recommending a course of therapy to a patient or rendering an opinion on whether the Food and Drug Administration (FDA) should approve a drug. Rather, the manufacturer is exercising a responsibility explicitly conferred by the Federal Food, Drug, and Cosmetic Act. That law authorizes a manufacturer to determine whether the proposed use of a substance in food is GRAS (ie, whether the proposed use of the substance is safe and whether there exists general recognition among qualified experts of such safety). There is no question on whose behalf the manufacturer is acting. If the manufacturer errs in its GRAS determination, the manufacturer is subject to substantial civil and criminal liability. In some instances, it may be desirable for a manufacturer to convene a panel of experts to assess whether there exists general recognition of safety. Even in those instances, the ultimate responsibility for a GRAS determination rests with the manufacturer. A manufacturer therefore has strong incentives to seek out the most highly qualified food toxicologists (not food technologists) and other appropriately qualified experts to help the manufacturer determine whether there exists general recognition of safety among such experts. In the end, what the authors appear to object to is the fact that Congress chose to establish the GRAS statutory provision that charges manufacturers with the responsibility of determining when it applies. In the more than 50 years since the law was enacted, that choice has proven wise. Manufacturers have adhered to the law and regulations in order to facilitate innovations that have contributed to the production of safe, nutritious, and affordable food, and the FDA has been left free to focus its limited resources on matters that merit the agency’s attention. Leon Bruner, DVM, PhD Author Affiliation: Science and Regulatory Affairs, The Grocery Manufacturers Association, Washington, DC. Corresponding Author: Leon Bruner, DVM, PhD, Senior Vice President for Scientific and Regulatory Affairs, Grocery Manufacturers Association, 1350 I St NW, Ste 300, Washington, DC 20005 ([email protected]). Conflict of Interest Disclosures: None reported. 1. Neltner TG, Alger HM, O’Reilly JT, Krimsky S, Bero LA, Maffini MV. Conflicts of interest in approvals of additives to food determined to be generally recognized as safe: out of balance. JAMA Intern Med. 2013;173(22):2032-2036.
To the Editor The article by Neltner et al1 raises concerns about the integrity of the “Generally Recognized as Safe” (GRAS) process. The United States has the most robust assessment of food ingredient safety in the world. The current GRAS process relies on scientific expert consensus, publicly available information, and clinical data. GRAS ingredients have been consumed for decades, and none has compromised public health. Under the current self-affirmation GRAS process, expert reviewers are selected for their academic credentials and experience as specified in the statutes,2 promulgated in 1997 and JAMA Internal Medicine February 2014 Volume 174, Number 2
Copyright 2014 American Medical Association. All rights reserved.
Downloaded From: http://archinte.jamanetwork.com/ by a Ndsu Library Periodicals User on 05/23/2015
299
