Dietary Supplement Health And Education Act Research Articles

DSHEA 1994 – Celebrating 30 Years of Dietary Supplement Regulation in the United States

The Dietary Supplement Health and Education Act (DSHEA) of 1994 defined the FDA’s statutory authority to regulate dietary supplement products as a category of food in the United States. As we celebrate 30 years post-DSHEA, it is important to reflect on its significance for public health, influence on the continuously evolving and expanding product category, the current regulatory framework, and potential opportunities or modernizing oversight to ensure a strong and well-regulated marketplace. An estimated three-fourths of U.S. consumers report use of dietary supplements, and the product market has grown substantially since the passage of DSHEA, from approximately 4,000 products in 1994 to 80,000+ present day. This growth represents a current $60 billion domestic and $200 billion international market for dietary supplements. Scientists, public health officials, health care providers, patients, consumer advocacy organizations, and the U.S. Food and Drug Administration have all called for reform to what has been described as ‘outdated’ regulation of dietary supplements. Advancing at an even faster rate is published scientific evidence in the space. This special issue of the Journal of Dietary Supplements comprises a collection of articles authored by academicians, legal scholars, representatives of U.S. government agencies, and industry scientists that critically examine the successes, challenges, and opportunities for improving specific aspects of DSHEA and domestic health policy. This editorial provides historical context and milestones of dietary supplement regulation in the U.S. post-DSHEA and offers an overview of the research contained within the special issue. Advancing toward a more transparent and safer marketplace requires trustworthy supply chains, increased adherence to quality standards, additional labeling requirements, and enhancement of post-market surveillance. This special issue seeks to contribute to the broader understanding of dietary supplement regulation and its future direction.

TIME TO THINK “BOTSIMILAR”

Dear Reader, Ever since the Dietary Supplement Health and Education Act (DSHEA) was notified in the US in 1994, discussion on botanicals for wellness continues. Botanicals to be used for providing wellness health benefits opened up a large market for consumer benefits. Nations like India and China who have long documented history of safe use (HoSU) of botanicals started to explore the US market for supplements. Botanical products, mostly single herb based and their extracts formulated as tablets, capsules, liquids and in some cases food formats such as granules, powders, became the focus of innovations. Till 2016, India did not have any regulations for Nutraceuticals or Supplements. The industry innovated through the acquisition of traditional Ayurvedic licenses for such products. Bolstered by government support, which propelled regulatory amendments, allowing products to be labelled according to the destination country regulations, thereby driving growth in this sector

Narrative Review: The FDA's Perfunctory Approach of Dietary Supplement Regulations Giving Rise to Copious Reports of Adverse Events.

Background: The Food and Drug Administration (FDA) originated from the passage of the 1906 Pure Food and Drugs act aimed to rein in the long-standing abuse in the consumer product marketplace. The act was passed to prohibit interstate commerce of misbranded and adulterated foods, drinks, drugs. Thus, promoting the FDA's mission to protect the public health by regulating human and veterinary drugs, biological products, medical devices, food supply, cosmetics, and tobacco to ensure safety, efficacy, and security. Progressing further in 1994, the Dietary Supplement Health and Education Act (DSHEA) was established designating specific label requirements, providing regulatory framework, and authorizing the FDA to promulgate good manufacturing practices for dietary supplements. This act defined and classified "dietary supplements" and "dietary ingredients" as food requiring all over the counter products (OTC) products to consist of labeling that is easy to understand and meets the FDA quality, effectiveness, and safety standards. However, under the umbrella of OTC products, the FDA fell short in its regulation of the expansive dietary supplement market. The objective of this study is to discern how the lack of efficacy in the FDA's regulations of OTC dietary supplements inevitably inspired more harm than benefit. Methods: This review comprised of case studies including young adolescents and adult consumers who experienced adverse events from the use of dietary supplements. Products which showed highest prevalence in adverse event reports through the Food and Drug Administration CFSAN Adverse Event Reporting System (CAERS) included but not limited to; Vitamin E (vitamin derivative), Beta-sitosterol (plant sterol) Yohimbine, Kava Kava Kratom, Garcinia Cambogia, (herbal products) and OxyElite Pro (marketed weight loss product). The primary endpoint was evaluating the FDA's regulations on dietary supplement safety protocols. The secondary endpoint was assessing the actions of the FDA in response to these case events. Results: Overall, between 2004 to 2021, a total of 79,071 adverse events related to the use of dietary supplements were reported to the Center for Food Safety and Applied Nutrition. Vitamin E products for example, marketed for decades for their antioxidant benefits in turn have shown significant evidence of toxicity and an increased risk of bleeding outweighing its potential benefit. The FDA's response was simply implementing a label guideline update, yet this update had evidence of minimal effect as the number of cases gradually continued to increase. Likewise, herbal products such as Kava Kava, Yohimbine, Kratom, and Garcinia Cambogia, in addition to weight regulating products, such as OxyElite Pro and HydroxyCut, have been linked to organ failure, hepatic, renal, cardiac toxicity, and death respectively. The FDA merely responded through instating public consumer warnings of their effects with consumption and limited recalls of certain products. Conclusion: With the easy accessibility of these products, the general public is more inclined to its use without proper guidance and monitoring from their healthcare team, posing as a major concern for possible interactions, contraindications and unfavorable outcomes. With proper implementation of stringent regulations post findings from increased studies on efficacy and safety, cases of adverse events could have been reduced significantly or averted completely. The FDA's minimalistic efforts consisting of only post-marketing monitoring and retrospective actions of label modifying have time and time again shown flaws as seen in the growing series of reports. By emending the over-the-counter supplement review process to reflect that of prescription medication, the magnitude of adverse events can be diminished. The process should include preclinical research in addition to clinical research, FDA thorough examination of data prior approval and post marketing surveillance.

A Comprehensive Study on Regulation of Herbal Drugs in India, US and European Union

The current investigation surveys the guidelines of natural medications in the India US and Europe and illuminates issues identified with their clinical preliminaries. Natural medications have been utilized for quite a while in various frameworks of wellbeing like Ayurveda, Yunani, Sidha and Homeopathy for treating number of infections. It is an exceptionally hard to perform clinical investigation on Hm’s medications in light of the fact that these medications are an unpredictable mix of dynamic fixings. It is subsequently hard to distinguish the fixing which is answerable for the remedial impact among different elements of Hm’s medications. The normalization of Hm’s medications is likewise a troublesome assignment. Notwithstanding every one of these issues are existing public interest has expanded towards natural medications in last two thirty years in light of their long history of treating the illness securely. The laws and guidelines for natural medications are distinctive in various nations. The WHO has expressed that every nation ought to have a framework to control Hm’s medications in their region. In Europe, the Committee on Herbal Medicinal Products (HMPC) was established in accordance with Regulation (EC) No 726/2004 and Directive 2004/24/EC, which introduced a simplified registration procedure for traditional herbal medicinal products in EU Member States. The primary obligation of HMPC is to assess and give approval for natural medications based on their wellbeing and adequacy. In US spices are delegated dietary enhancements after the presentation of the Dietary Supplement Health and Education Act (DSHEA) in1994. In US natural medications are sorted into two kinds, first is OTC Hm’s medications and medications which required NDA endorsement. In India the Department of AYUSH has made rules for quality improvement of natural substances. The current investigation audits the guidelines of herbal medications (Hm’s) in the India US and Europe illuminates issues identified with their clinical preliminaries.

Detection, hepatotoxicity, and tumorigenicity of pyrrolizidine alkaloids in Chinese herbal plants and herbal dietary supplements

Since the U.S. Congress passed the Dietary Supplement Health and Education Act (DSHEA) in 1994, herbal products, including herbal dietary supplements, represent the fastest growing segment of the vitamin, mineral supplements, and herbal products industry. To ensure consumer health protection, the quality and safety of raw herbal plants used for dietary supplement preparations have to be determined. To date, safety issues concerning the hepatotoxic and tumorigenic ingredients in many raw herbs and herbal dietary products are quite limited. Pyrrolizidine alkaloids are a class of hepatotoxic and tumorigenic phytochemicals present in more than 6000 plants and have been detected in herbal plants and dietary supplements. In this review, the human exposure, metabolic activation leading to hepatototoxicity and tumorigenicity of the pyrrolizidine alkaloid-containing Chinese herbal plants, and analytical methods used to identify and quantify pyrrolizidine alkaloids in herbal plants and commercial samples are discussed. Suggestions for future research are provided.

“Natural” is not synonymous with “Safe”: Toxicity of natural products alone and in combination with pharmaceutical agents

During the 25 years since the US Congress passed the Dietary Supplement Health and Education Act (DSHEA), the law that transformed the US Food and Drug Administration's (FDA's) authority to regulate dietary supplements, the dietary supplement market has grown exponentially. Retail sales of herbal products, a subcategory of dietary supplements, have increased 83% from 2008 to 2018 ($4.8 to $8.8 billion USD). Although consumers often equate “natural” with “safe”, it is well recognized by scientists that constituents in these natural products (NPs) can result in toxicity. Additionally, when NPs are co-consumed with pharmaceutical agents, the precipitant NP can alter drug disposition and drug delivery, thereby enhancing or reducing the therapeutic effect of the object drug(s). With the widespread use of NPs, these effects can be underappreciated. We present a summary of a symposium presented at the Annual Meeting of the Society of Toxicology 2019 (12 March 2019) that discussed potential toxicities of NPs alone and in combination with drugs.

The history of efforts to regulate dietary supplements in the USA.

This review examines the emergence of dietary supplements and how the Food and Drug Administration (FDA) attempted to regulate these, beginning with the arrival of vitamins and how these were managed under the 1906 Food and Drugs Act, and ending with the seismic influence of the 1994 Dietary Supplement Health and Education Act (DSHEA). Included are the impact of major laws, key court decisions, and the construction of the FDA's supplement actions and rules from the 1920s to the 1990s for products that were neither drugs nor typical foods. Stiff resistance to the regulations by supplement manufacturers, trade associations, politicians, and especially the public at large is an important part of this story. The paper closes with the passage of DSHEA and how it literally changed the definition and parameters of control of dietary supplements. Copyright © 2015 John Wiley & Sons, Ltd.

Consumers' perceptions of the dietary supplement health and education act: implications and recommendations.

In 1994, the United States Congress passed the Dietary Supplement Health and Education Act (DSHEA). The regulatory framework for dietary supplements created by DSHEA has led to significant misperceptions regarding consumers' understanding of the safety and efficacy of supplements. Research shows that consumers erroneously believe that: (1) supplements are approved by the government, (2) supplements have been tested for safety and effectiveness, (3) the content of supplements is analyzed, and (4) manufacturers are required to disclose known adverse effects to consumers. Furthermore, labelling requirements that are intended to provide transparency to consumers are relatively ineffective. The following four recommendations are offered for reforming DSHEA: (1) only allow structure-function claims that are supported by research evidence, (2) require manufacturers to list known adverse effects on the labels of dietary supplements, (3) require that the Food and Drug Administration analyzes the content of dietary supplements and (4) restrict the definition of dietary ingredients. These recommendations would bring DSHEA to more closely align with consumer expectations regarding the regulation of dietary supplements and would likely provide a safer landscape for the use of supplements. Copyright © 2015 John Wiley & Sons, Ltd.

Twenty Years of the Dietary Supplement Health and Education Act—How Should Dietary Supplements Be Regulated? ,

The Dietary Supplement Health and Education Act (DSHEA) of 1994 defines the FDA’s statutory authority to regulate dietary supplement products in the United States. The dietary supplement industry has rapidly expanded since 1994, presenting an obvious need for “DSHEA 2.0.” Current regulations surrounding dietary supplements have been increasingly and reasonably scrutinized, given their widespread use by over one-half of the US population as well as highly publicized safety concerns over the past 20 y. As the market continues to expand and evolve, so too must the laws that protect consumers from potential harm and misleading communication. This article is meant to begin a scientific dialogue on how regulations may be improved to provide both ease of access and safer products to the consumer by focusing on 4 topics: premarket approval, label claims, current Good Manufacturing Practices, and adverse event reporting.

US Dietary Supplement Labeling Rules and the Possibility of Medical Cost Reduction.

US dietary supplements classified as foods are regulated under the Dietary Supplement Health and Education Act (DSHEA) and other rules. After the DSHEA established in 1994, the supplement market grew by about 4 times and reached $32 billion as of 2012. One of the major reasons for this market expansion is that consumers can recognize functions of the supplements by the structure/function (S/F) claims. S/F claims must not be false or misleading, and must be based upon reliable scientific evidence, especially clinical studies. At the same time, disclaimers must be shown on the package, which are "These statements have not been evaluated by the Food and Drug Administration (FDA). These products are not intended to diagnose, treat, cure or prevent any disease." Both the FDA and Federal Trade Commission (FTC) are responsible for label claims and advertisement of dietary supplements. S/F claims are not medical claims, but these may have impact on people's mindset to be healthier. Recent research shows utilizing dietary supplements in 4 major areas with 10 popular ingredients could hypothetically reduce medical costs by over $50 billion in the US in the period of 2013-2020. Predicted fewer health problems and reduced medical cost information will further increase awareness of supplement usage and thus may raise quality of life. These may reduce the medical cost significantly, if the products are used appropriately with sufficient consumer education.

First Case of Fatal Renal and Fulminant Hepatic Failure From Muscle Building Supplements

Introduction: We present a case of a 46 -year-old African American man who developed acute kidney and liver failure from oral intake of muscle building supplements. Serologies for viral hepatitis, autoimmune hepatitis, primary biliary cirrhosis, Wilson’s disease, alpha 1 antitrypsin deficiency, genetic testing for hemochromatosis, and imaging were unrevealing. Liver biopsy was suggestive of drug-induced hepatitis. Kidney biopsy was suggestive of acute kidney injury. During the hospital course, his liver function showed mild improvement, but renal function worsened, requiring hemodialysis. He ultimately expired from massive retroperitoneal bleeding as a complication of kidney biopsy via internal jugular vein in the setting of severe uncontrolled coagulopathy. Discussion: The protein supplement that our patient consumed consisted of Carnosyn (brand name for beta-alanine) 1,600 mg and astrogin 25 mg. The daily recommended dose was 2 tablets, twice daily, the equivalent of 6,400 mg of beta- alanine and 100 mg of astrogin. It is possible that the supplement had additional ingredients that were not disclosed on the label or higher doses than indicated. It has been reported in the past that many such supplements contain toxic heavy metals like lead, mercury, cadmium, or selenium in them. Furthermore, these supplements are usually self-prescribed with unknown consequences to unsuspecting consumers,which leads to delays in diagnosis and treatment. In 1994, the Dietary Supplement Health and Education Act (DSHEA) was implemented, under which a supplement manufacturer alone is responsible for determining that the dietary supplements are safe and need not have FDA approval. This led to unprecedented growth and sales of the dietary supplements. Many such supplements are mislabeled, accidentally or intentionally, and they often contain ingredients that are harmful to the body. In 2008, 2 products were withdrawn from the market, as they were found to contain approximately 200 times more selenium than their labels indicated. The dietary supplement Oxylite Pro was recalled because it contained aegeline, an untested substance that led to hepatic failure. We report the first case of combined renal and hepatic failure secondary to a carnosyn/astrogin composite. As our case indicated, the FDA and U.S. government should reconsider the merit of DSHEA and re-institute more strict regulation in the mass production and distribution of such supplements.

Evaluation of food composition and safety in nutraceutical products from green tea (Camellia sinensis) by uhplc-orbitrap-ms and gc-qqq-ms/ms

Nutraceuticals consumption has increased in the global market. One of the problems related to their development is the appearance of fraudulent products. Therefore, the Food and Drug Administration (FDA) approved in 1994 the law Dietary Supplement Health and Education Act (DSHEA). Another issue relies on the fact that nutraceuticals are produced from herbal concentrates, so the occurrence of pesticides used during herbal production is possible. In the European Union (EU), Regulation EC 396/20051 control pesticide residue levels, but only in raw material.

Standard reference materials for dietary supplement analysis

IntroductionThe National Institute of Standards and Technology (NIST), theNational Institutes of Health Office of Dietary Supplements(NIH-ODS), and the Food and Drug Administration (FDA) areworkingincollaborationtoproducedietarysupplementStandardReference Materials (SRMs). Efforts began following the crea-tion of the NIH Office of Dietary Supplements by the DietarySupplement Health and Education Act (DSHEA) of 1994 [ 1]and the establishment of the NIH-ODS Analytical Methods andReference Materials Program (AMRM) in 2002 [ 2]. AMRM isresponsible for ensuring that quality calibration materials andmatrix-based certified reference materials (CRMs) are availableto dietary supplement laboratories along with rugged, precise,and accurate analytical methods [ 3–7]. More recently, as of June2010, the current Good Manufacturing Practices (cGMPs) pub-lished by the FDA are required for all dietary supplementsproduced in the United States [8] The cGMPs require thatproducts be evaluated for identity, purity, and strength as wellas for contaminants (toxic elements, bacteria, persistentorganic pollutants, and other toxins) and adulterants (eitherunintentional or economically motivated), placing increasedemphasis on the importance of the development of dietarysupplementSRMs.NISTstaffareoftenaskedaboutthestatusof new and existing SRMs; this manuscript is designed toprovide an update on the dietary supplement Standard Refer-ence Materials Program. The Certificates of Analysis foravailable SRMs can be found at nist.gov/SRMs [9] and canbe searched for by keyword or SRM number. The brief de-scriptions of different dietary supplements are all taken fromthe NIH-ODS factsheets [10].Material selectionThere are a number of considerations that factor into theprioritization of materials for the development of dietary sup-plement SRMs. Dietary supplement materials (matrices andtarget analytes) are ranked by an AOAC committee based onthe availability of and need for analytical methods and refer-ence standards. The order of the production of the SRMs isbasedontheneedsoftheNIHandtheFDA,informationfromtheAOACingredientrankingsubgroup(IRS)prioritylist,themarket share, and potential safety considerations associatedwith individual dietary supplements.Botanical dietary supplement SRMs have been developedatNISTassuitesofmaterialsinordertorepresenttherangeofchallenges that may be encountered during analysis.Depending on the product, the suite may consist of a rawbotanical material, an extract, and a finished product (e.g.,ground or whole tablets). Significantly different formulationswith different analytical intricacies may also be added to thesuite. For example, the suite of ephedra-containing materialsconsisted of Ephedra sinica Stapf, Ephedra sinica Stapf Na-tive Extract, Ephedra sinica Stapf Commercial Extract,Ephedra-Containing Solid Oral Dosage Form, and Ephedra-Containing Protein Powder. The plant material presented thegreatest extraction challenges. The extracts and tablets repre-sented the commercially available products with a range of

Dietary Supplements—Regulatory Issues and Implications for Public Health

IN OCTOBER 1994, PRESIDENT CLINTON SIGNED INTO LAW the Dietary Supplement Health and Education Act (DSHEA), and 17 years later, health experts, policy makers, and industry lobbyists continue to spar over the legislation. Classifying dietary supplements as a subcategory of food, DSHEA allowed supplement manufacturers to market products without submitting proof of safety or efficacy to the US Food and Drug Administration (FDA). Currently, for a tainted or otherwise hazardous product to be removed from the supplement marketplace, an agency such as the FDA or the Drug Enforcement Administration must offer evidence that the product is unsafe, contains a controlled substance, or is absent ingredients listed on the product label after the product has appeared in retail outlets. For US health professionals, the fact that more than 150 million US residents use dietary supplements should be a point of concern as many users will almost certainly forgo conventional medical treatment in favor of using products that may offer no medicinal value and taking health advice from medically untrained sales representatives. Counterintuitively, DSHEA became law 5 years after the L-tryptophan amino acid disaster of 1989, in which 38 individuals died and 1500 sustained adverse reactions. When the FDA appeared heavy-handed in its response to the supplement catastrophe, industry lobbyists began applying pressure to lawmakers, especially those with a vested political interest in the economic success of supplement companies. US Senator Orrin Hatch, representing Utah, a major producer of dietary supplements, responded to industry appeals by coauthoring DSHEA and shepherding it through Congress. In doing so, Hatch sought to help manufacturers enjoy the freedom they had profited from during the 1980s after the Proxmire Amendment of 1976 barred the FDA from using potency levels to classify dietary supplements as drugs. To date, no public official has defended the interests of the supplement industry to a similar extent. In 2009, a US Government Accountability Office (GAO) report found that “consumers are not well-informed about the safety and efficacy of dietary supplements and have difficulty interpreting the labels on these products.” In fact, one of the most significant problems with DSHEA is that it allows structure and function claims to appear on product labels; as long as products do not claim to treat, prevent, or cure specific diseases, they can enter and remain in the marketplace. The concern is that consumers may not differentiate between technical descriptions and marketing language and may attempt to use dietary supplements in place of medicines that have been tested in rigorous trials. To that end, a 2010 GAO investigation found that sellers of dietary supplements may actually encourage consumers to substitute supplements for physician-prescribed medications. In preparing its 2010 report, the GAO investigated 22 retailers of herbal dietary supplements, hiring an accredited laboratory to examine 40 single-ingredient supplements for the presence of lead, arsenic, mercury, cadmium, and assorted pesticides. Although none of the supplements qualified as having an acute toxicity hazard, trace amounts of at least 1 contaminant were found in 37 of 40 products. According to the GAO, more troubling than the contaminants was the dubious and potentially hazardous advice offered to investigators who had posed as elderly customers. The GAO gathered written materials from online retailers, observing claims of treating, preventing, and curing conditions such as diabetes, cancer, and cardiovascular disease. Among the more egregious marketing efforts were claims that garlic could be taken in place of high blood pressure medication and that ginkgo biloba could be used to treat Alzheimer disease, depression, and impotence. Studies conducted by the National Center for Complementary and Alternative Medicine have shown that ginkgo biloba, in particular, does not reduce the risk of cancer nor does it prove effective in reducing high blood pressure among older adults. Careful review of National Center for Complementary and Alternative Medicine studies reveals a similar lack of efficacy for garlic, chromium picolinate, and St John’s wort. On occasion, policy makers have attempted to address at least some of the problems associated with dietary supplements. For example, citing the 2009 GAO report, Senators John McCain and Byron Dorgan introduced the Dietary Supplement Safety Act (S 3002) in February 2010. Although this act did not propose significant changes in efficacy assessment, it would have required supplement

Influence of the Dietary Supplement Health and Education Act on Consumer Beliefs About the Safety and Effectiveness of Dietary Supplements

The authors conducted two studies to examine the influence of the U.S. Dietary Supplement Health and Education Act (DSHEA) on consumer beliefs about the safety and effectiveness of dietary supplements. Study 1 manipulated information about Food and Drug Administration (FDA) approval in the context of a dietary supplement designed to improve immune system functioning. Study 2 tested the effect of an educational intervention designed to improve knowledge about the DSHEA. Results of Study 1 highlighted deficits in consumer knowledge about FDA regulation of dietary supplements. Results also showed that information about FDA approval failed to have a statistically significant effect on beliefs about safety or effectiveness of the dietary supplement. Results of Study 2 showed that participants who were educated about the regulation of dietary supplements under the DSHEA rated dietary supplements as less safe and less effective than did participants in the control condition. The authors discuss the implications for consumers in the United States and for public policy.

Application of Epidemiological Data for Decision Making: Health Claims

The Nutrition Labeling and Education Act (NLEA), which amended the Federal Food, Drug, and Cosmetic Act in 1990, authorized the use of health claims that are based on significant scientific agreement in food labeling. In 1994, the Dietary Supplement Health and Education Act (DSHEA) defined dietary supplements and created a legal framework for use of claims that is similar to the regulation of foods. Health claims describe the relationship between a substance (food or food component) and reduction of the risk of a disease or health-related condition; they are not intended as claims to cure, treat, mitigate, or prevent disease, which are considered drug claims. Since the enactment of the NLEA, the FDA has developed a process to evaluate scientific evidence in support of health claims. In 1999, the FDA published Guidance for Industry: Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements. As a result of a series of court cases, the agency developed a process for qualified health claims that characterizes the quality and strength of scientific evidence because these claims are not based on significant scientific agreement. Since 2003, the FDA has published several letters of enforcement discretion for qualified health claims that illustrate the agency's approach to evaluating the scientific literature when the strength of the evidence is not consistent with significant scientific agreement. In 2007, the agency published the draft Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims that further outlined the FDA's approach to evaluating scientific evidence for health claims. In January 2009, the final guidance was posted and replaced the 1999 guidance document as well as the interim guidance related to qualified health claims. The final guidance specifically addresses the use of observational data in the evaluation of health claims and describes the criteria used by the agency in the evaluation of such data. A copy of the guidance can be found on the FDA Web site (http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabelingNutrition/ucm073332.htm). The guidance highlights some of the challenges that must be considered for the agency to use observational data to draw scientific conclusions on the relationship between a specific substance and disease or health-related condition for the health claim under review. This article is not subject to US copyright law.

Complementary and Alternative Medicines

Older adults are the largest per capita consumers of prescription medications and over-the-counter complementary and alternative medicines in the United States. A recent study identified that older adults are using more drugs than 5 years ago, including drugs newly released on the market as well as dietary supplements, known as complementary and alternative medicines. One study found that about 13% of adults aged 65 years or older used an herbal product within the previous 12 months. Increased use has resulted from increasing evidence supporting the health benefits of dietary supplements, such as omega-3 fish oils, in reducing cardiovascular events. Nahin and colleagues studied the relationship between prescription medications and dietary supplements by analyzing medication use in patients aged 75 years or older enrolled in the Ginkgo Evaluation of Memory (GEM) study. Dietary supplements were defined according to the 1994 Dietary Supplement Health and Education Act and included vitamins, minerals, herbs or other botanicals, and amino acids. In the study, investigators found that 82.5% of patients used at least 1 dietary supplement, and 54.5% used 3 or more. The average number of prescription medications used per patient was 3.5 which was similar to the average number of dietary supplements. The majority (83%) of prescription medication users also used supplements. The most commonly used dietary supplements were a multivitamin; iron; vitamins E, C, D, B, and A; calcium; glucosamine and chondroitin; zinc; magnesium; garlic; ginkgo biloba; saw palmetto; and echinacea. Complementary and alternative medicines are considered dietary supplements. In 1994, Congress passed the Dietary Supplement Health and Education Act (DSHEA), which defined a dietary supplement. Dietary supplements cannot be labeled with health claims but can be labeled with statements of

Diabetes and Dietary Supplements

A s the incidence of diabetes increases to epidemic proportions, people with diabetes are turning more and more to alternative therapies to help manage this condition, despite the availability of numerous traditional therapies. In fact, Americans spent almost $34 billion out of pocket on complementary and alternative products, practitioner visits, and materials in 2007, according to data from the National Health Interview Survey.1 It is important for health care practitioners not only to be aware of what dietary supplements their patients are taking, but also to understand how these supplements work and their possible side effects. First, it is helpful to be familiar with some terminology. The acronym CAM stands for “complementary and alternative medicine.” According to the National Center for Complementary and Alternative Medicine, CAM consists of medical and health care systems, practices, and products that are not generally considered part of conventional medicine. Examples of CAM therapies include acupuncture, biofeedback, chelation therapy, yoga, hypnosis, reiki or energy healing, massage, dietary therapies, meditation, tai chi, and dietary supplements. Complementary medicine is used along with conventional medicine, whereas alternative medicine is used in place of conventional medicine. In the United States, 38% of adults (or 4 in 10) and 12% of children (or 1 in 9) use some form of complementary medicine. People with diabetes are ~ 1.6 times more likely to use CAM therapies than people without diabetes.2 Dietary supplements are one form of oral CAM therapy. The Dietary Supplement Health and Education Act (DSHEA) of 1994 defines a dietary supplement as a “product taken by mouth that contains a dietary ingredient intended to supplement the diet.” These dietary ingredients may consist of “vitamins, minerals, herbs, amino acids, and other botanicals and substances such as enzymes, organ tissues, glandulars, and metabolites.” Dietary supplements can take various forms, …

FDA Regulation of Dietary Supplements and Requirements Regarding Adverse Event Reporting

In 1994, the Dietary Supplement Health and Education Act (DSHEA) amended the Federal Food, Drug, and Cosmetic Act (FDC Act) to set up a distinct regulatory framework for what we now call dietary supplements. The DSHEA was passed with the intent of striking a balance between providing consumers access to safe dietary supplements to help maintain or improve their health and giving the US Food and Drug Administration (FDA) authority to regulate and take action against manufacturers of supplements or supplement ingredients that present safety problems, are presented with false or misleading claims, or are adulterated or misbranded. This article will present FDA's recent experience in collecting and evaluating dietary supplement adverse event data for the purpose of assuring the public that the dietary supplements they purchase are safe.

Quality Assurance and Safety of Herbal Dietary Supplements

Since the U.S. Congress passed the Dietary Supplement Health and Education Act (DSHEA) in 1994, use of herbal products has been growing rapidly worldwide. To ensure consumer health protection, the quality and safety of herbal plants, particularly those used for dietary supplement preparations, must be determined. To date, toxicological data on the identification of genotoxic and tumorigenic ingredients in many raw herbs and their mechanisms of action are lacking. Thus, identification of carcinogenic components in herbal plants is timely and important. In this review, the issues of quality control and safety evaluation of raw herbs and herbal dietary supplements are discussed. Two examples of tumorigenicity and mechanism of tumor induction are discussed: aristolochic acid and riddelliine, both of which have been detected in Chinese herbal plants. It is proposed that an organized effort with international participation on cancer risk assessment should be actively pursued so that the safety of commercial herbal plants and herbal dietary supplements can be ensured.