March 5, 2015
Paul M. Coates, Ph.D.
Director, Office of Dietary Supplements
National Institutes of Health
6100 Executive Blvd., Room 3B01
Bethesda, MD 20892-7517
Re: Office of Dietary Supplements Strategic Plan 2010-2014 Progress Report
The Academy of Nutrition and Dietetics (the "Academy") is pleased to comment on the National Institutes of Health (NIH) Office of Dietary Supplements (ODS) "Strategic Plan 2010-2014 Progress Report" (the "progress report"). Representing more than 90,000 registered dietitian nutritionists (RDNs),1 dietetic technicians, registered (DTRs), and advanced-degree nutritionists, the Academy is the largest association of food and nutrition professionals in the United States and is committed to improving the nation’s health through food and nutrition across the lifecycle. Every day we work with Americans in all walks of life — from prenatal care through end of life care — providing nutrition care services and conducting nutrition research. We are committed to evidence-based strategies for improving the nation's health through food and nutrition.
The Academy supports the valuable contributions of the ODS in meeting the goals of its strategic plan and applauds its efforts to promote good science about dietary supplements to positively shape public health policy and help consumers make informed decisions about their own health care.
1. Use of Dietary Supplements
Americans have increased their use of dietary supplements over the past thirty years, with half of American adults using one or more within thirty days of responding to the National Health and Nutrition Examination Survey (NHANES).2 Americans purchased a staggering $30 billion worth of dietary supplements in 2011.3 In the absence of any strict regulation of dietary supplements by the Food and Drug Administration (FDA) similar to that applied to ensure the safety and efficacy of prescription drugs, ODS is an oasis for countless clinicians seeking reputable information and research for their patients. Continued research and training by ODS to expand the scientific knowledge base, combined with the expertise of dietetics practitioners, is necessary to help educate consumers on safe and appropriate selection and use of dietary supplements.
The Dietary Supplement Health and Education Act of 1994 (DSHEA) defines a dietary supplement, in part, as a product intended to supplement the diet that contains any of the following dietary ingredients: a vitamin; a mineral; an herb or other botanical; an amino acid; a dietary substance for use by humans to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, a constituent, extract, or combination of any ingredient mentioned above.4 The Academy believes that the best nutrition-based strategy for promoting optimal health and reducing the risk of chronic disease is to wisely choose a wide variety of nutrient-rich foods. This stance accords with the recent expert scientific report of the Dietary Guidelines Advisory Committee (DGAC), which stated, "The 2015 DGAC advocates achieving healthy dietary patterns through healthy food and beverage choices rather than with nutrient or dietary supplements except as needed."5
However, as a result of low intakes of nutrient-rich foods and sedentary lifestyles, many Americans may be meeting or exceeding their energy requirements while falling short of vitamin and mineral recommendations. Supplements thus have the potential to fill dietary gaps but, at the same time, also have the potential to increase intakes of some nutrients above Tolerable Upper Intake Levels (ULs) when consumers take high dose supplements or multiple products with the same ingredients—even when multivitamins (MVMs) are taken along with a diet rich in fortified foods. As daily intakes exceed the UL, risk of adverse health effects increase. The risk of exceeding ULs when taking dietary supplements is increased when accounting for national survey data that suggests that supplements may be taken by those who have healthful diets and lifestyles more often than those at a greater risk for vitamin and mineral inadequacies.6
2. Concerns Regarding Safety and Effectiveness
The Academy believes that Americans who purchase dietary supplements to address a nutritional deficiency or for other purposes should be able to have confidence in the safety, quality, and verifiability of the supplements they consume. The use of dietary supplements in the United States has continued to rise despite increasing concerns regarding their safety and effectiveness.
a. Safety Concerns
A 2009 report from the US Government Accountability Office (GAO) stated that "according to experts, consumers are not well-informed about the safety and efficacy of dietary supplements and have difficulty interpreting labels on these products."7 The GAO further expressed concern that the uninformed use of dietary supplements may expose consumers to health risks.8 The FDA monitors safety, in large part, by collecting reports on adverse events from consumers, health professionals, and manufacturers through their MedWatch program—The FDA Safety Information and Adverse Event Reporting Program.9 A 2013 GAO report indicated that more than 6,000 reports of health problems, also known as adverse event reports (AER), relating to supplements were received by the FDA during the years 2008 to 2011, and this amount was considered to be underestimated.10
Safety concerns regarding the use of dietary supplements also arise from the possibility that the dietary supplements, when combined with prescription drugs, will interact with the prescription drug and either cause harm or reduce its efficacy.11 A study published online in the Journal of the Academy of Nutrition and Dietetics found that adults were "two and a half times more likely" to use dietary supplements while taking prescription medication compared to adults without a diagnosed medical condition.12 Consumers are often motivated to initiate a dietary supplement regimen after a cancer diagnosis, with cancer survivors frequently continuing to use dietary supplements for myriad reasons.13 Notably, only 23% of dietary supplements were reported to be used upon the recommendation of a physician or other health care provider.14 Thus, consumers not only use the vast majority of dietary supplements without a recommendation from qualified experts, but "most botanical supplement users do not report [their use of supplements] to their health care providers."15
Serious harm has occurred of late. A 2013 hepatitis outbreak traced to a tainted supplement struck 72 people in 16 states, killing one woman and requiring three more people to require liver transplants.16 An infant in a Connecticut hospital died in December 2014 after receiving a popular probiotic supplement contaminated with yeast.17 The Academy enthusiastically supports ODS's efforts to ensure the safety of dietary supplements sold in the United States.
b. Quality and Effectiveness Concerns
The Academy commends ODS for its research on very important areas such as Vitamin D, Folate and B12, its Iodine Initiative, and inborn errors of metabolism, which should advance scientific understanding and likely improve health. In a time of increasing health care costs, rising rates of chronic disease, and the need to find effective prevention strategies, we support ODS's intention to "[f]oster research on the role of dietary supplements in health promotion and disease risk reduction." It is an appropriate use of resources for ODS to identify whether and to what extent various dietary supplements might effectively prevent diseases or other chronic conditions.
In June 2007, the FDA, with authority granted under DSHEA, published a final rule establishing current Good Manufacturing Practices for dietary supplements.18 This rule establishes regulations that require the consistent manufacturing of products with regard to identity, purity, strength, and composition.19 Companies are responsible for ensuring their products meet quality standards, including being accurately labeled (e.g., products contain the ingredients in the amounts stated on their labels) and free from contaminants (e.g., bacteria, pesticides, glass, lead, and other heavy metals) and foreign materials.20 Despite these efforts, however, news stories raise significant concerns about the accuracy and verifiability of dietary supplements sold across the country. One report concluded that "DNA tests show that many pills labeled as healing herbs are little more than powdered rice and weeds"21 and studies show high doses of toxic metals such as lead, arsenic, and mercury were present in over twenty percent (20%) of randomly tested Ayurvedic herbal medications.22 The New York State Attorney General recently "accused four major retailers . . . of selling fraudulent and potentially dangerous herbal supplements" for stocking products lacking DNA of the herbs and botanicals listed on the product labels.23 ODS's efforts with "Formal Product Integrity Evaluations" and "Development of Spectral Fingerprinting Methods for Rapid Characterization and Authentication of Botanical Dietary Supplements" may be used to ensure the integrity of dietary supplements not just used in research, but those sold to consumers as well.
Although MVM supplementation can be effective in helping meet recommended levels of some nutrients, evidence has not proven them to be effective in preventing chronic disease. A study published in 2009 from the Women's Health Initiative found no association between MVM supplementation and cancer or cardiovascular disease risk or total mortality in postmenopausal women.24 In 2006, a National Institutes of Health State-of-the-Science Panel reviewed evidence, including an evidence-based review of literature that was limited to randomized controlled studies, on the health benefits and risks of MVM supplements (defined as "any supplement containing three or more vitamins and minerals but no herbs, hormones, or drugs, with each component at a dose less than the Tolerable Upper Intake Level").25 The panel concluded that evidence, at the time, was insufficient to determine whether or not taking MVM supplements was beneficial in preventing chronic disease in generally healthy people.26
A recent article in Annals of Internal Medicine reviewing the existing scientific literature concluded:
The large body of accumulated evidence has important public health and clinical implications. Evidence is sufficient to advise against routine supplementation, and we should translate null and negative findings into action. The message is simple: Most supplements do not prevent chronic disease or death, their use is not justified, and they should be avoided. This message is especially true for the general population with no clear evidence of micronutrient deficiencies, who represent most supplement users in the United States and in other countries.27
The United States Preventive Services Task Force evidence review of "Vitamin and Mineral Supplements in the Primary Prevention of Cardiovascular Disease and Cancer" found:
In conclusion, we found no evidence of an effect of nutritional doses of vitamins or minerals on CVD, cancer, or mortality in healthy individuals without known nutritional deficiencies for most supplements we examined. In most cases data are insufficient to draw any conclusion, although for vitamin E and β-carotene a lack of benefit is consistent across several trials. We identified 2 multivitamin trials that both found lower overall cancer incidence in men. Both trials were methodologically sound, but the lack of an effect for women (albeit in 1 trial), the borderline significance in men in both trials, and the lack of any effect on CVD in either study makes it difficult to conclude that multivitamin supplementation is beneficial.28
The Academy notes that evidence on supplemental calcium and vitamin D in relation to bone health has been more favorable, particularly in older women. The National Institutes of Health State-of-the-Science Panel on MVM supplements concluded that when used in combination, calcium and vitamin D supplements increase bone mineral density and decrease risk of hip and nonvertebral fracture in postmenopausal women.29 An evidence based analysis of the literature on vitamin D and bone health outcomes found that vitamin D-3 (700 to 800 IU daily) with calcium (500 to 1,200 mg) resulted in small increases in bone mineral density and reduced fall risk in older adults and reduced risk of fractures in elderly women living in nursing homes.30 In addition, we note that folic acid—the supplement form of folate—reduces the likelihood of a common birth defect when taken during pregnancy.
3. ODS Communications
ODS provides an exceptionally important service in making up-to-date knowledge about dietary supplements publicly available. We applaud the continued efforts to keep current the expert-reviewed Fact Sheets on vitamins, minerals and botanicals that include information on medication interactions and signs and symptoms of deficiency and toxicity, which we recognize is a complicated enterprise. The Fact Sheets are informative, easy to read resources that help Academy members remain current on developments in dietary supplement research to provide the best care for our patients and clients. In addition, we support ODS's valuable work on the International Bibliographic Information on Dietary Supplements (IBIDS) Database and Computer Access to Research on Dietary Supplements (CARDS) database of federally-funded research projects pertaining to dietary supplements.
The Academy encourages ODS to develop more population-specific communications targeted to caretakers of children up to age eighteen, perhaps enhancing its YouTube channel, newsletters, and brochures to reach a wider population with additional multilingual and multicultural features addressing botanicals relevant to specific demographic groups.
4. Additional Opportunities for Research and Collaboration
The Academy supports the efforts of ODS in providing seminars and training for intramural scientists, including "proposals that stimulate dietary supplement research where it is lacking or lagging and to clarify gaps." We note the successes ODS has leveraging their research funding with other NIH units to maximize areas of study. Recognizing significant budgetary constraint preclude ODS from optimally fulfilling its mission, the Academy enthusiastically supports increases in funding for these important endeavors and has communicated our support with policymakers.
a. Pediatric Treatments
Members report a need for evidence-based guidelines to offer families of children with chronic illnesses, particularly cancer diagnoses, who are considering turning to botanicals and herbal supplements as an adjunct to conventional active treatment. The Academy notes the potential for negative interactions between some supplements and chemotherapy agents. We encourage ongoing collaboration with Botanical Research Centers and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) in areas specifically related to the prevalence and effective use of botanical in pediatric cancer patients and survivors. The benefit of having more evidence-based resources on the efficacy and safety of the use of new and emerging preparations cannot be understated.
In addition, we support ODS's efforts researching and collaborating on supplement interventions for inborn errors of metabolism to help our members remain the experts in helping parents and patients in the treatment of these diseases. We also encourage ODS to provide additional research and analysis on DHA and EPA impacting brain development of young infants and toddlers and collaboration with the Institute of Medicine and others to establish DRIs and/or AIs for DHA and EPA.
b. Mary Frances Picciano Dietary Supplement Practicum
The Academy was disappointed to learn that the highly-regarded Mary Frances Picciano Dietary Supplement Practicum was canceled for 2015 due to budget constraints and we support its reintroduction in the future. Academy members who have attended report that "the wealth of knowledge gained was unparalleled to any amount of research into the topics that we would be able to accomplish on our own." The Academy notes that clinical dietitians working with pediatric patients and families with chronic illnesses are often the gatekeepers of the information for many of the supplements families give to their children in hopes of a cure. We hope that ODS will be able to procure funds to continue this practicum and perhaps have the ability to develop additional tracts that is tailored to pediatric clinicians who work with patients and families who include these integrative therapies and botanicals into their medical care plans.
5. Role of RDNs and Dietary Supplements
Dietary supplement sales have increased significantly in the United States over the past decade without assured consultation about supplements with a physician or other health care provider.31 Given safety and efficacy concerns, dietetics professionals are increasingly needed to provide recommendations to patients/clients regarding the use of specific supplements. Given our education and training in diet and nutrition, registered dietitian nutritionists are uniquely positioned to meet this need.
The Academy believes that the roles and responsibilities of dietetics practitioners related to supplementation include:
- assessing nutritional status of clients to determine likelihood of inadequate or excessive intake of vitamins and minerals;
- evaluating the potential benefit or harm of nutrient supplementation given a client's nutritional and health status;
- evaluating the safety of a nutrient supplement given the form, dose, its potential for interaction with food, other dietary supplements and over-the-counter and prescribed medications;
- educating clients as to the potential benefit of receiving nutrients through conventional and fortified foods;
- recommending nutrient supplementation when food intake is inadequate;
- evaluating research regarding nutrient supplementation; and
- being aware of regulatory, legal, and ethical issues of recommending and selling of nutrient supplements.32
The Academy appreciates the opportunity to comment on ODS's Strategic Plan Progress Report. We recognize the importance of the mandates and mission of ODS and the value of its work to date, and recognize the contributions of RDNs at ODS. As one of the first professional groups to embrace evidence-based practice, the Academy created the world’s first evidence-analysis nutrition library and produces guides for condition-specific nutrition care. Please contact either Mary Pat Raimondi at 202-775-8277 ext. 6007 or by email at email@example.com or Pepin Tuma at 202-775-8277 ext. 6001 or by email at firstname.lastname@example.org with any questions or requests for additional information.
Mary Pat Raimondi, MS, RDN
Vice President, Strategic Policy and Partnerships
Academy of Nutrition and Dietetics
Pepin Andrew Tumin, Esq.
Director, Regulatory Affairs
Academy of Nutrition and Dietetics
1 The Academy recently approved the optional use of the credential "registered dietitian nutritionist (RDN)" by "registered dietitians (RDs)" to more accurately convey who they are and what they do as the nation's food and nutrition experts. The RD and RDN credentials have identical meanings and legal trademark definitions.
2 Bailey RL, Gahche JJ, Miller PE, Thomas PR, Dwyer JT. Why US adults use dietary supplements. JAMA Intern Med. 2013;173(5):355-61. (Internal citations omitted.)
3 Considering a post-DSHEA world. Nutrition Business Journal. 2012;17:1-9. Accessed March 6, 2015.
4 Dietary Supplement Health and Education Act of 1994. Public L No. 103-417 (codified at 42 USC 287C-11).
5 Scientific Report of the 2015 Dietary Guidelines Advisory Committee. Office of Disease Prevention and Health Promotion website. Accessed March 2, 2015.
6 Bailey RL, Gahche JJ, Miller PE, Thomas PR, Dwyer JT. Why US adults use dietary supplements. JAMA Intern Med. 2013;173(5):355-61.
7 Dietary supplements: FDA should take further actions to improve oversight and consumer understanding (November 2009). US Government Accountability Office Web site. Accessed March 2, 2015.
9 MedWatch: The FDA Safety Information and Adverse Event Reporting Program. US Food and Drug Administration Web site. Accessed March 4, 2015.
10 United States Government Accountability Office.Dietary Supplements: FDA May Have Opportunities to Expand Its Use of Reported Health Problems to Oversee Products. March 2013. Accessed March 6, 2015.
11 Sood A, Sood R, Brinker FJ, Mann R, Loehrer LL, Wahner-roedler DL. Potential for interactions between dietary supplements and prescription medications. Am J Med. 2008;121(3):207-11.
12 Farina EK, Austin KG, Lieberman HR. Concomitant dietary supplement and prescription medication use is prevalent among US adults with doctor-informed medical conditions. J Acad Nutr Diet. 2014;114(11):1784-90.e2.
13 Bailey RL, Gahche JJ, Miller PE, Thomas PR, Dwyer JT. Why US adults use dietary supplements. JAMA Intern Med. 2013;173(5):355-61. (Internal citations omitted.)
16 Anahad O'Connor, New York Attorney General Targets Supplements at Major Retailers. New York Times. February 3, 2015. Accessed March 5, 2015.
18 Current good manufacturing practice in manufacturing, packaging, labeling, or holding operations for dietary supplements. Final Rule. 21 CFR Part 111 (2007).
19 Dietary supplement Current Good Manufacturing Practices (CGMPs) and Interim Final Rule (IFR) facts. Food and Drug Administration Web site. Accessed March 6, 2015.
20 Current good manufacturing practice in manufacturing, packaging, labeling, or holding operations for dietary supplements. Final Rule. 21 CFR Part 111 (2007).
21 Anahad O'Connor, Herbal Supplements Are Often Not What They Seem. New York Times, Accessed March 6, 2015.
22 See, e.g., Saper RB, Phillips RS, Sehgal A, et al. Lead, mercury, and arsenic in US- and Indian-manufactured Ayurvedic medicines sold via the Internet. JAMA. 2008;300(8):915-23; Saper RB, Kales SN, Paquin J, et al. Heavy metal content of ayurvedic herbal medicine products. JAMA. 2004;292(23):2868-73.
23 Anahad O'Connor, New York Attorney General Targets Supplements at Major Retailers. New York Times. February 3, 2015. Accessed March 5, 2015.
24 Neuhouser ML, Wassertheil-Smoller S, Thomson C, Aragaki A, Anderson GL, Manson JE, Patterson RE, Rohan TE, van Horn L, Shikany JM, Thomas A, LaCroix A, Prentice RL. Multivitamin use and risk of cancer and cardiovascular disease in the Women’s Health Initiative cohorts. Arch Intern Med. 2009;169:294-304.
25 National Institutes of Health State-of-the-Science conference statement: Multivitamin/multimineral supplements and chronic disease prevention. Ann Intern Med. 2006; 145:364-371.
27 Guallar E, Stranges S, Mulrow C, Appel LJ, Miller ER. Enough Is Enough: Stop Wasting Money on Vitamin and Mineral Supplements. Ann Intern Med. 2013;159:850-851. doi:10.7326/0003-4819-159-12-201312170-00011. (Emphasis added.)
28 Fortmann SP, Burda BU, Senger CA, Lin JS, Whitlock EP. Vitamin and mineral supplements in the primary prevention of cardiovascular disease and cancer: An updated systematic evidence review for the U.S. Preventive Services Task Force. Ann Intern Med. 2013;159(12):824-34. (Internal citations omitted.)
29 National Institutes of Health State-of-the-Science conference statement: Multivitamin/multimineral supplements and chronic disease prevention. Ann Intern Med. 2006; 145:364-371.
30 Cranney A, Horsley T, O'Donnell S, Weiler HA, Puil L, Ooi DS, Atkinson SA, Ward LM, Moher D, Hanley DA, Fang M, Yazdi F, Garritty C, Sampson M, Barrowman N, Tsertsvadze A, Mamaladze V. Effectiveness and Safety of Vitamin D in Relation to Bone Health. Evidence Report/Technology Assessment No. 158. Rockville, MD: Agency for Healthcare Research and Quality; 2007. AHRQ Publication No. 07-E013.
31 Bailey RL, Gahche JJ, Miller PE, Thomas PR, Dwyer JT. Why US adults use dietary supplements. JAMA Intern Med. 2013;173(5):355-61.
32 Available at: www.jandonline.org/article/S0002-8223(09)01696-4/pdf.. Accessed March 6, 2015.