Food and Drug Administration

The US Food and Drug Administration (FDA) is a remarkable hybrid. Part regulatory agency, part public health agency, it sits at the intersection of science, law, and public policy. The FDA’s mission can be considered in the context of 2 broad dimensions: the products it regulates and its core functions. Both fall under the rubric of protecting and promoting the public health. The FDA’s remit is both broad and diverse: altogether, the agency has regulatory responsibility for >20% of the US economy. The products it is charged with overseeing through its various centers1 encompass food and cosmetics (regulated by the Center for Food Safety and Applied Nutrition); food and drugs for animals, including companion animals and animals used for food (regulated by the Center for Veterinary Medicine); and medical devices, drugs, and biologics (regulated by the Centers for Devices and Radiological Health, Drug Evaluation and Research, and Biologics Evaluation and Research, respectively). Tobacco products were added to the FDA’s portfolio by the Tobacco Control Act of 2009, and are overseen by the Center for Tobacco Products. Regardless of the specific product regulated, the FDA’s core mission remains the same: to protect the US population by helping to ensure the fundamental safety of the food Americans consume and the medical products prescribed by their clinicians. At the same time, this primary mission is complemented by a mandate to promote the public health by reviewing research and taking appropriate action on the marketing of regulated products in a timely manner. Not only do people need access to advances in nutrition and medical therapies, but also the American spirit is itself characterized by a strong current of scientific and technological innovation. At first glance, differences in these 2 priorities, protecting the public safety and promoting the public health through encouraging innovation, might …

The Cayman Islands have long offered safe harbor to financial institutions and tourists alike. (A British Overseas Territory, the Cayman Islands have no income tax, nonresident tax, capital gains tax, or corporate tax.1) Due to recent actions by the US Food and Drug Administration (FDA), the islands may, as well, enhance their reputation as safe harbor to companies developing stem cell treatments. More important, however, is the issue of whether actions by the FDA in relation to stem cell treatments mean that the agency has officially stepped over the line and, at least in this instance, is now regulating the practice of medicine. The FDA's primary charge is to ensure the safety, efficacy, and security of drugs, biological products, medical devices, the nation's food supply, cosmetics, and products that emit radiation.2 A drug includes “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.”3 The FDA states that this broad definition also includes therapeutic biological products such as cells and tissues.4 For almost 20 years, stem cells have been harvested, preserved, and reinfused to help patients recover from cancer treatments.5–8 Although devices for separating stem cells are within FDA jurisdiction,9 the FDA acknowledges it is not authorized to regulate the practice of medicine.10 It is, however, authorized to regulate drugs.4 So how do stem cells become drugs subject to FDA oversight? That question has been answered by a case involving Regenerative Sciences, Inc, a Colorado-based clinic that offers bone marrow–derived stem cell procedures to treat injuries and degenerative joint conditions.11 On July 25, 2008, the FDA notified Regenerative Sciences that, “based on information posted on your website, mesenchymal stem cells utilized in your Regenexx™ procedure are drawn from a patient's bone marrow, sent to a …

The U.S. Food and Drug Administration (FDA) is a part of the U.S. Department of Health and Human Services (HHS). It is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, tobacco products, cosmetics, products that emit radiation, and our nation's food supply. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science‐based information they need to use medicines and foods to improve their health. FDA also plays a significant role in the Nation's counterterrorism capability ( https://www.fda.gov/AboutFDA/WhatWeDo/default.htm ).

Reporting standards for adverse events after medical device use in the peripheral vascular system

The U.S. Food and Drug Administration (FDA) is a part of the U.S. Department of Health and Human Services (HHS). It is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science‐based information they need to use medicines and foods to improve their health ( http://www.fda.gov/opacom/morechoices/mission.html ).

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.

British chef and food activist Jamie Oliver ignited a firestorm in January 2011 when he mentioned on the Late Show with David Letterman that castoreum, a substance used to augment some strawberry and vanilla flavorings, comes from what he described as “rendered beaver anal gland.”1 The next year, vegans were outraged to learn that Starbucks used cochineal extract, a color additive derived from insect shells, to dye their strawberry Frappuccino® drinks2 (eventually, the company decided to transition to lycopene, a pigment found in tomatoes3). Although substances like castoreum and cochineal extract may be long on the “yuck factor,”4 research has shown them to be perfectly safe for most people; strident opposition arose not from safety issues but from the ingredients’ origins. But these examples demonstrate that the public often lacks significant knowledge about the ingredients in foods and where they come from. This is not a new development; the public relationship to food additives has a long history of trust lost, regained, and in some cases lost again. The Federal Food, Drug, and Cosmetic (FD&C) Act of 19385 was passed shortly after the deaths of 100 people who took an untested new form of a popular drug, which contained what turned out to be a deadly additive.6 The new law was consumer oriented and intended to ensure that people knew what was in the products they bought, and that those products were safe. The law has been amended over the years in attempts to streamline and bring order to the sprawling task of assessing and categorizing the thousands of substances used in foods, drugs, and cosmetics. One result of this streamlining is that under current U.S. law, companies can add certain types of ingredients to foods without premarket approval from the thin-stretched Food and Drug Administration (FDA). In other words, there are substances in the food supply that are unknown to the FDA. In 2010 the Government Accountability Office (GAO) concluded that a “growing number of substances … may effectively be excluded from federal oversight.”7 Is this a problem? The answer depends on whom you ask.

“Black box” 101: How the Food and Drug Administration evaluates, communicates, and manages drug benefit/risk

A recent Food and Drug Administration (FDA) proposal aims to speed the evaluation process for new high-risk medical devices that are intended to address unmet medical needs,1 much like existing expedited approval processes, such as the humanitarian device exemption rule for devices intended to treat rare diseases. Such programs are strongly supported by the medical device industry and some patient advocacy groups, which have criticized the FDA for being too stringent in its evidentiary requirements for investigational devices, leading to delays in the approval of potentially helpful products.2–4 For example, in 2011, the FDA approved a transcatheter aortic valve replacement system that demonstrated significant improvements over conventional treatment options for selected patients with severe aortic stenosis.5,6 However, the United States was the 43rd country to approve the device, roughly 4 years after the European Union.7 Yet expedited approval for high-risk medical devices raises the possibility that these devices will not be as effective as predicted in their limited premarket testing or that they could cause unanticipated harms after approval.8 Of course, well-studied devices may present unexpected safety concerns years after approval,9,10 and even the most rigorous conventional premarket approval process will result in some devices later found to be unsafe or ineffective.11–13 Safety of approved medical devices and the proper scope of premarket testing remain contentious issues after recalls of several widely used devices, including popular models of implantable cardioverter defibrillator leads14,15 and metal-on-metal hip implants.16 Inherent limitations in premarket testing, along with the prospect of lowered evidentiary standards for expedited device reviews, place greater pressures on postapproval monitoring of devices to follow clinical performance and to identify emerging public health problems. Medical device manufacturers routinely perform this sort of vigilance, …

Successful Investigational New Drug Preparation without Reinventing the Wheel

The US Food and Drug Administration (FDA) oversees the development of agents to diagnose, cure, mitigate, treat, or prevent cancer. The FDA’s mission statement is “The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health” [1]. The FDA accomplishes its mission through meetings with individual investigators and sponsors, review of investigational new drug (IND) and new drug applications (NDA), facilities inspections, approval of marketing and licensing applications, and the administration of grant programs.

Food safety shake-up needed in the USA

What Are the Current Findings Concerning Arsenic in Foods?

What's new on nutrition labeling at the United States Food and Drug Administration?

D iagnostic tests are essential for accelerating health solutions. The discovery of significant variants and the availability of reliable diagnostic tests afford patients and clinicians a range of benefits from an end to the diagnostic odyssey to better treatment options and improved health. Test developers believe that obtaining approval from the Food and Drug Administration (FDA) for diagnostic tests would make their development time-consuming and costly. As a result, the majority of tests are categorized as laboratory-developed tests (LDTs). LDTs are manufactured and administered within a single laboratory, and are therefore subject to regulation by the Clinical Laboratory Improvement Amendments (CLIA) of Centers for Medicare and Medicaid Services (CMS). In 2014, the FDA posted a draft guidance for comment on the subject of regulating LDTs. This is pursuant to Section 1143 of the Food and Drug Administration Safety and Innovation Act (FDASIA) (Energy and Commerce Committee, 2014). Specifically, the FDA described a premarket review process that would require confirmation of the analytical and clinical validity of new LDTs before the lab is permitted to administer those tests. Comments were accepted until early 2015. In the spring of 2015, the FDA announced the establishment of the FDA/CMS Task Force on LDT Quality Requirements to oversee changes to the LDT regulatory landscape (Shuren and Conway, 2015). This movement toward increased oversight of LDTs has sparked debate among stakeholders, a debate that resurfaced in the context of the House Energy and Commerce Committee’s 21st Century Cures Act (Energy and Commerce Committee, n.d.). When the objectives of the 21st Century Cures Act were first under discussion, the House Energy and Commerce Committee released a white paper seeking feedback with regard to how the act should approach and establish FDA oversight of LDTs. Stakeholders from public health nonprofit organizations, disease advocacy organizations, professional societies, research groups, and private companies responded. The stakeholders provided wide-ranging reasons for their opposition of introducing FDA regulation of LDTs in the 21st Century Cures Act. Some stated that increased regulation of LDTs would impede innovation. They described these challenges as including detrimental delays in the process of bringing the test to the consumer, challenging pathways to iteratively improving the test over time, and higher costs to the healthcare system. Some stakeholders described concern that tests might be required to undergo a regulatory pathway akin to medical devices approved by the FDA. Others argued that the risk associated with a diagnostic test is not similar to the risk that a medical device imposes (Energy and Commerce Committee, n.d.). In various comments, stakeholders described the fact that LDTs have been considered standard-of-care procedures for years, used frequently by healthcare providers under practice of medicine laws without any documented harm to patients. They expressed concern that if FDA oversight of LDTs were to shift, providers might no longer be permitted to administer many of these tests, despite their long-proven safety and effectiveness in bringing diagnosis to affected individuals (Energy and Commerce Committee, n.d.). Supporters of FDA oversight of LDTs assert that the FDA has permission to regulate LDTs through the Medical Device Amendments of 1976 (Ray, 2015). Supporters also hold that FDA oversight of LDTs will benefit the diagnostic industry. Before the results of an LDT can be released, the administering laboratory must meet the CLIA’s specified performance metrics. Although this CLIA assessment does evaluate the LDT’s reliability, the process is not as comprehensive as the validity assessment associated with FDA approval process. For example, the CLIA review process does not necessitate clinical trials to be performed prior to marketing an LDT (Centers for Medicare and Medicaid Services, 2015). Supporters of FDA oversight believe that this allows diagnostic tests to be administered to patients before aggregating adequate information to understand the test’s safety and accuracy. Supporters also suggest that tighter regulation procedures will attract investors who might otherwise be dissuaded by the risk of investing in an LDT that, due to minimal regulation, ultimately fails to predict as expected. The resultant increased opportunities for funding would promote innovation in the diagnostic testing sphere. As of this writing, the most recent version of the 21st Century Cures Act was approved in the House of Representatives on July 10, 2015. Despite the committee’s request for feedback and the resulting white paper debate, there appears to be no information included in the act that directly addresses LDTs. The draft version of the bill, released on January 26, 2015, did include a subtitle devoted to ‘‘Modernizing Regulation of Diagnostics,’’ though the content under