Food Irradiation is it the Global Food Preservation Method for Future?

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.

What Are the Current Findings Concerning Arsenic in Foods?

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 …

Successful Investigational New Drug Preparation without Reinventing the Wheel

T he new Food and Drug Administration (FDA) commissioner, Jane E. Henney, M.D., who received Senate confirmation on 21 October, will be facing a host of complex issues concerning agency policies and programs when she takes office. Her handling of these issues will be watched closely by scientists in academia, government, and industry. The greatest attention will be paid to the speed and efficiency of the agency's new drug approval process, but considerable importance will be attached to such matters as monitoring product safety, pediatric research, barriers to dissemination of data on new uses for marketed drugs, and the impact of genomics on drug development and use. A recurring debate concerns the speed with which the FDA approves the marketing of new drugs and biopharmaceuticals. Recent withdrawals of several drugs from the market because of serious adverse reactions stirred the passions of those who believe that the public is best served by a slow, cautious, and demanding regulatory agency. In contrast, patients with diseases not well treated by currently marketed medicines want an FDA that efficiently evaluates data on drug safety and efficacy and grants approval as soon as the evidence suggests that the drug, when marketed, is likely to do more good than harm. Another issue concerns the recent FDA Modernization Act of 1997 (FDAMA). [*][1]The act addresses the desirability of pediatric research before new drug approval when a drug is likely to be prescribed for children. The reward for such research is a 6-month prolongation of market exclusivity or patent life, seemingly an important benefit for sponsors. Pediatric research, however, ordinarily first requires evidence from adults that safety and efficacy requirements are met. If such research delays drug approval until the studies are completed, these delays may offset any prolongation of market protection granted. Although FDAMA set out guidelines for allowing firms to circulate reprints of published articles describing new uses for marketed drugs, these guidelines have not diminished industry's long-standing frustration over the FDA's usual vetoing of such practices. However, the issue has been rendered moot by a recent court decision that this sort of censorship by the FDA deprives firms of their constitutional freedoms. The FDA will almost certainly appeal the decision. If it stands, the FDA's monitoring of reprint dissemination will be closely watched with regard to how the agency differentiates between persuasive scientific data and unjustifiable hype. There is a discrepancy in how the agency regulates “direct-to-consumer” advertisements for “traditional” remedies such as St. John's wort and other botanicals and for pharmaceutical products. For traditional remedies, marketing firms are free to advertise their products as they deem appropriate, as long as they make no promise of therapeutic benefit and indicate clearly that the material has not been approved by the FDA for therapeutic use. This level of agency oversight is less stringent than for pharmaceutical compounds, whose health claims must be accompanied by full disclosure of side effects and risks associated with the use of the product. This incongruity is surrealistic and, with the public's growing interest in traditional therapies, may prove troublesome for the FDA. Other controversial and politically contentious issues facing Henney include regulations dealing with human cloning experiments, tobacco, and the abortifacient RU486, as well as improvements in the agency's system for monitoring adverse drug reactions, the level of funding for internal agency research, and flexibility in the “substantial evidence” standards for drugs used to treat life-threatening illnesses. Another challenge will ensue from President Clinton's recent executive order establishing a high-level council to oversee the U.S. food supply in response to concerns about the frequent outbreaks of illness, some fatal, caused by such harmful food-borne substances as the 0157:H7 strain of E. coli bacteria. Gaining Senate confirmation has been the first hurdle for Henney, but there will be many more as she settles into her new role. [1]: #fn-1

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

Regulation of assisted reproductive technologies in the United States

The future of drug safety: What the IOM report may mean to the emergency department

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, …

Progress of food irradiation in the United States

A review of the safety of cold pasteurization through irradiation

Food irradiation in the United States: irradiation as a phytosanitary treatment for fresh fruits and vegetables and for the control of microorganisms in meat and poultry

Multisociety guideline on reprocessing flexible GI endoscopes: 2016 update

Old Drugs, New Concerns

Editor's note: This series of four editorials arose from a meeting sponsored by the Food and Drug Administration (FDA) and the University of Pennsylvania in October 2009 with a focus on chronic pain after surgery. The editorials describe a new initiative from the FDA to establish a private-public partnership to bring new research and knowledge of study design with the goal of safely accelerating analgesic drug design, a brief review of the woeful lack of research in animal models of persistent pain after surgery, an opinion piece regarding important elements of study design to test therapies to prevent this persistent pain, and a discussion of the magnitude of effect required to be meaningful to patients.