Are there any risks in taking dietary supplements?

This bi-weekly newsletter provided by the Office of Health and Constituent Affairs at the Food and Drug Administration (FDA) is intended to inform you of FDA-related information on a variety of topics, including new product approvals,significant labeling changes, safety warnings, notices of upcoming public meetings, proposed regulatory guidances and opportunity to comment, and other information of interest to patients and patient advocates. Subscribe or update your subscriber preferences. Volume 3 | Number 17 | August 21, 2013 Specialty Compounding Sterile Products: FDA Alert - Bacterial Infections Specialty Compounding, LLC is voluntarily recalling all lots of sterile medications within expiry. Note: an earlier version of this news release indicated that the recall applied to all unexpired sterile compounded products dispensed since May 9, 2013; however, the recall applies to any sterile medication that has not reached its expiration date, including all strengths and dosage forms. More information Original Announcement: FDA announces nationwide voluntary recall of all products for sterile use from Specialty Compounding FDA is alerting health care providers and patients of a voluntary nationwide recall of all products produced and distributed for sterile use by Specialty Compounding, LLC, Cedar Park, TX. There have been recent reports of bacterial bloodstream infections potentially related to the company's calcium gluconate infusions. All sterile use products produced and distributed by Specialty Compounding are being recalled and none of these products should be used by patients or administered to patients. Facilities, health care providers and patients who have received the products should immediately discontinue use, quarantine the products, and return the products to Specialty Compounding. According to information provided by the firm, the recalled products were distributed directly to patients nationwide, with the exception of North Carolina. Recalled products were also distributed directly to hospitals and physicians' offices in Texas. More information Recall: Aidapak Services LLC, Select Repackaged Pharmaceuticals due to Potential Incorrect Labeling Aidapak Services LLC, is conducting a voluntary recall of specific unit dose repackaged products sent to 25 hospital inpatient pharmacies in the States of Washington, Oregon, California, and Arizona for products listed on the company's website. The Firm voluntarily recalled these products to the hospital/user level after learning of possible incorrect labeling which could involve OTC, prescription, and dietary supplement products. Some of the products, if incorrectly labeled, could result in patients receiving drugs that were not prescribed, which could result in allergic reactions or other undesired effects. Pregnant women could receive a drug that they should not take or, as a result of receiving an incorrect medication, patients may not receive proper treatment of their disease or condition. This may pose serious or life-threatening risk to a patient's health. More information Recall: All Sterile Drug Products Made and Distributed by NuVision Pharmacy Dallas Facility Health care providers should not administer any NuVision Pharmacy sterile products to patients because the products' sterility is not assured. This alert follows the FDA's notice on May 18, 2013 recommending that health care providers and other health care professionals, including hospital staff, immediately check their medical supplies for NuVision Pharmacy sterile products, quarantine those products, and not administer them to patients. NuVision Pharmacy has repeatedly declined to recall its sterile products. FDA most recently issued a letter to NuVision on July 26, 2013, requesting an immediate recall of all lots of sterile products that have not passed their expiration dates produced at NuVision. In the letter, the FDA outlined poor sterile production practices observed by FDA investigators during an April 2013 inspection of NuVision's Dallas facility. FDA explained that those practices raised concerns about a lack of sterility assurance of NuVision's sterile drug products. FDA noted that if a drug product marketed as sterile contains microbial contamination, patients could be at risk for serious, potentially life-threatening infections. More information Drug Safety Communication: FDA requires label changes to warn of risk for possibly permanent nerve damage from antibacterial fluoroquinolone drugs taken by mouth or by injection FDA has required the drug labels and Medication Guides for all fluoroquinolone antibacterial drugs be updated to better describe the serious side effect of peripheral neuropathy. This serious nerve damage potentially caused by fluoroquinolones may occur soon after these drugs are taken and may be permanent. The risk of peripheral neuropathy occurs only with fluoroquinolones that are taken by mouth or by injection. Approved fluoroquinolone drugs include levofloxacin (Levaquin), ciprofloxacin (Cipro), moxifloxacin (Avelox), norfloxacin (Noroxin), ofloxacin (Floxin), and gemifloxacin (Factive). The topical formulations of fluoroquinolones, applied to the ears or eyes, are not known to be associated with this risk. More information Recall: Covidien Monoject Prefill Flush Syringes - Not Subjected To AutoClave Sterilization Process Or Mismatched Syringe Tip Cap, Syringe Label, Filled Volume And Wrapper Covidien announced that it has initiated a voluntary recall of certain lots of Monoject prefill flush syringes. This recall is being conducted due to the risk that a number of the syringes were filled with water but not subjected to the autoclave sterilization process. These products are labeled as either sodium chloride flush or heparin lock flush. Some of these syringes have the mismatched syringe tip cap, syringe label, filled volume and wrapper. However, for the sodium chloride flush syringes with matched tip cap, syringe label, filled volume and wrapper, there are no visual cues for the clinician to identify the problematic products. If non-sterile fluid is administered there is a health risk of life-threatening infection to the blood stream or other areas. Also if the clinician uses the heparin lock flush syringe containing only water on peripheral or venous catheters, the patency of the intravascular device may not be maintained and clotting may occur. This could result in non-functional intravenous access requiring the device to be replaced. More information Recall: CareFusion – Alaris PC unit (model 8015) with version 9.12 Keyboard Processor CareFusion has reported that if the Alaris PC unit (model 8015) voltage is 1.4 volts, rather than the 1.8 volts required for operation, the device could potentially experience a loss of communication between the PC Unit main Processor and Keyboard Processor. A device malfunction can result in the sudden unintended discontinuation of medications. This can lead to cause serious adverse health consequences, including death. More information Comunicaciones de la FDA sobre la seguridad de los medicamentos en español Descargo de responsabilidad: La FDA reconoce la necesidad de proporcionar información sobre seguridad importante en idiomas distintos al inglés. Hacemos lo mejor posible  para proporcionar  versiones en español precisas y oportunas de nuestras Comunicaciones de Seguridad de Medicamentos. Sin embargo, en caso que existiera discrepancias entre las versiones en ingles y en español, la información contenida en la versión en inglés es la que se considera como versión oficial. Si tiene alguna pregunta, por favor contáctese con Division of Drug Information en druginfo@fda.hhs.gov. Comunicaciones de la FDA MedWatch: The FDA Safety Information and Adverse Event Reporting Program For more important safety information on human drug and devices or to report a serious problem, please visit MedWatch. FDA recognizes the significant public health consequences that can result from drug shortages and takes tremendous efforts within its legal authority to address and prevent drug shortages. These shortages occur for many reasons, including manufacturing and quality problems, delays, and discontinuations. When issues are discovered by the company or the public and reported to FDA or are found by FDA upon inspection, FDA works closely with the firm to address risks involved to prevent harm to patients. FDA also considers the impact a shortage would have on patient care and access and works with the firm to restore supplies while also ensuring safety for patients. More information Drug Shortages Resolved During the Past 2 Weeks: Ibandronate Sodium (Boniva) Injection Pentamidine Isethionate Inhalent (NebuPent) Pentamidine Isethionate for Injection (Pentam 300) More information about drug shortages, drug shortages resolved, and drugs to be discontinued. Information about blood and biologic shortages, resolved shortages, and discontinuations FDA approves new drug to treat HIV infection FDA has approved Tivicay (dolutegravir), a new drug to treat HIV-1 infection. Tivicay is an integrase strand transfer inhibitor that interferes with one of the enzymes necessary for HIV to multiply. It is a pill taken daily in combination with other antiretroviral drugs. Tivicay is approved for use in a broad population of HIV-infected patients. It can be used to treat HIV-infected adults who have never taken HIV therapy (treatment-naïve) and HIV-infected adults who have previously taken HIV therapy (treatment-experienced), including those who have been treated with other integrase strand transfer inhibitors. Tivicay is also approved for children ages 12 years and older weighing at least 40 kilograms (kg) who are treatment-naïve or treatment-experienced but have not previously taken other integrase strand transfer inhibitors. More information FDA approves first rapid diagnostic test to detect both HIV-1 antigen and HIV-1/2 antibodies FDA has approved the first rapid Human Immunodeficiency Virus (HIV) test for the simultaneous detection of HIV-1 p24 antigen as well as antibodies to both HIV-1 and HIV-2 in human serum, plasma, and venous or fingerstick whole blood specimens. Approved for use as an aid in the diagnosis of HIV-1 and HIV-2 infection, the Alere Determine HIV-1/2 Ag/Ab Combo test is also the first FDA-approved test that independently distinguishes results for HIV-1 p24 antigen and HIV antibodies in a single test. The test can be used by trained professionals in outreach settings to identify HIV-infected individuals who might not be able to be tested in traditional health care settings. The test does not distinguish between antibodies to HIV-1 and HIV-2, and is not intended to be used for screening of blood donors. More information For information on drug approvals or to view prescribing information and patient information, please visit Drugs@FDA or DailyMed. Guidance for Industry: Recommendations for Donor Questioning, Deferral, Reentry, and Product Management To Reduce the Risk of Transfusion-Transmitted Malaria The guidance document provides blood establishments that collect blood and blood components with recommendations for questioning and deferring donors of blood and blood components, allowing their reentry, and product management to reduce the risk of transfusion-transmitted malaria. More information Request for Comments: Draft Guidance for Industry on Expedited Programs for Serious Conditions - Drugs and Biologics The programs described in this guidance are intended to help ensure that therapies for serious conditions are approved and available to patients as soon as it can be concluded that the therapies' benefits justify their risks. The programs that are the subject of this guidance, fast track designation, breakthrough therapy designation, accelerated approval, and priority review. Comments are due by August 26, 2013. More information Request for Comments: Agency Information Collection Activities - Focus Groups About Drug Products as Used by FDA Focus groups provide an important role in gathering information because they allow for a more in-depth understanding of individuals' attitudes, beliefs, motivations, and feelings than do quantitative studies. FDA will use focus group findings to test and refine its ideas and to help develop messages and other communications, but will generally conduct further research before making important decisions such as adopting new policies and allocating or redirecting significant resources to support these policies. Comments are due by August 27, 2013. More information Reopening of Comment Period: Human-Immunodeficiency Virus-Focused Drug Development and Human Immunodeficiency Virus Cure Research FDA is reopening the comment period for the notice of public meeting entitled "Human Immunodeficiency Virus (HIV) Patient-Focused Drug Development and HIV Cure Research," published in the Federal Register of May 21, 2013. As part of Patient-Focused Drug Development, FDA is gathering input from HIV patients and patient advocates on current approaches to managing HIV, symptoms experienced because of HIV or its treatment, and issues related to HIV cure research. Comments are due by September 3, 2013. More information Request for Comments: Menthol in Cigarattes, Tobacco Products FDA is issuing this advance notice of proposed rulemaking (ANPRM) to obtain information related to the potential regulation of menthol in cigarettes. FDA is also making available its preliminary scientific evaluation of public health issues related to the use of menthol in cigarettes. The preliminary scientific evaluation indicates there is likely a public health impact of menthol in cigarettes. Comments are due by September 23, 2013. More information Request for Comments: Possible Role of Independent Third Parties in Industry-Sponsored Tobacco Product Research FDA is establishing a public docket for interested parties to submit to FDA comments on the Institute of Medicine's (IOM) recommendation regarding third-party governance of industry-sponsored tobacco product research. FDA is interested in receiving information on whether some form of third-party governance should be considered for other types of industry-sponsored tobacco product research, including research to support premarket tobacco product applications and other submissions to FDA, as well as research designed to contribute to general knowledge regarding tobacco products. Comments are due by September 30, 2013. More information Request for Comments: Frequently Asked Questions About Medical Foods - Second Edition The draft guidance, when finalized, will represent FDA's current thinking on medical foods. This draft guidance provides responses to additional questions regarding the definition, labeling, and availability of medical foods and updates to some of the existing responses. Comments are due by October 15, 2013. More information Request for Comments: Minimizing Risk for Children's Toy Laser Products This guidance is to inform manufacturers of laser products, FDA headquarters and field 67 personnel, and the public, of the Center for Devices and Radiological Health's (CDRH) 68 current thinking on the safety of children's toy laser products. Lasers with outputs above 69 certain levels that are operated in an unsafe and uncontrolled manner may cause injury to the 70 user and/or others within range of the laser beam. This is a particular concern for lasers 71 intended for entertainment purposes, especially when intended to be used as toys by children. Comments are due by November 5, 2013. More information FDA awards contract to develop promising new technology to test radiation countermeasure FDA has awarded a $5.6 million contract to Harvard University's Wyss Institute for Biologically Inspired Engineering to apply its  breakthrough organs-on-chips technology to assess medical countermeasures for treating acute radiation syndrome (ARS), also known as radiation sickness. Organs-on-chips are microchips that mimic the functions of and tissue structures present in living organs, such as the lung, heart and intestine. The technology replicates the interactions between the living tissues within human organs on chips the size of a thumb drive. Under the contract, Wyss Institute scientists will develop models of radiation damage in lung, gut and bone marrow organs-on-chips and then use these models to test candidate medical countermeasures. More information FDA Goes 3-D, by Steven K. Pollack, Ph.D., Director of FDA's Office of Science and Engineering Laboratories (OSEL) at FDA's Center for Devices and Radiological Health, and James Coburn, M.S., Research Engineer in OSEL A hospital in Michigan implants a 3-D printed medical device into a 3-month-old boy with a rare bronchial condition and saves a young life. A man has 75 percent of his skull replaced with a 3-D printed implant. 3-D printing—the process of making a three-dimensional solid object of virtually any shape from a digital model—is making headlines these days, and the technology, once considered the wave of the future, is rapidly becoming part of the present. To read the rest of this blog, see FDA Voice Blog, August 15, 2013. On the Road with Mike Taylor: Day 1 - Touring the Pacific Northwest, by Michael R. Taylor, FDA's Deputy Commissioner for Foods and Veterinary Medicine I am touring Idaho, Oregon and Washington this week with a team of FDA colleagues to learn about agriculture in this part of the country and to discuss with farmers, representatives of the food industry, agricultural extension scientists, and state agriculture officials the most effective ways to keep produce safe for you and your family. In January 2013, FDA proposed the Produce Safety Rule mandated by the 2011 FDA Food Safety Modernization Act (FSMA). This rule will set science-based safety standards for the production and harvesting of fruits and vegetables. Here in the Pacific Northwest, the proposed regulations of particular concern relate to the quality of irrigation water. Although this part of the country is high desert, we have been driving by acres and acres of farmland, lush with a great diversity of crops. And this bounty is only possible because of irrigation systems managed by and for growers. The contrast is stark when you see land that isn't irrigated – it's dry, brown and strewn with sagebrush. To read the rest of this Day 1 blog, see FDA Voice Blog, August 12, 2013.  Also see: Day 2 - FDA Voice Blog, August 14, 2013; Day 3 - FDA Voice Blog, August 15, 2013; Day 4 - FDA Voice Blog, August 16, 2013; and Day 5 - FDA Voice Blog, August 20, 2013. FDA advisory committee meetings are free and open to the public. No prior registration is required to attend. Interested persons may present data, information, or views, orally at the meeting, or in writing, on issues pending before the committee. Other types of meetings listed may require prior registration and fees. Click on "More information" for details about each meeting. Public Workshop: Trial Designs and Endpoints for Liver Disease Secondary to Nonalcoholic Steatohepatitis Dates: September 5-6, 2013 This workshop will provide a forum to discuss the key issues in the design of clinical trials of drugs for the treatment of liver disease secondary to NAFLD. Stakeholders, including industry sponsors, those from academia, patients with NAFLD-associated liver disease, and FDA, will be engaged to address challenging issues related to selection of endpoints and assessment methodologies in clinical trials. Trial design strategies and possible candidates for endpoints will be explored. The state of knowledge of the natural history of NAFLD will also be discussed. More information Joint Meeting of the Gastrenterology-Urology Panel and the Radiological Devices Panel of the Medical Devices Advisory Committee Date: September 9, 2013 The Office of the Commissioner will convene the joint committee to discuss current evidence on the risks and benefits of computed tomography colonography for screening of asymptomatic patients for colorectal cancer. The joint committee will provide advice that will assist FDA's consideration of evolving research on this topic and inform the Agency's continuing regulation of these devices. More information Pediatric Ethics Subcommittee of the Pediatric Advisory Committee Dates: September 9-10, 2013 The committee will meet to discuss ethical issues in pediatric product development, including medical counter measures, focusing on the concepts of minimal risk, disorder or condition, and exposure of pediatric subjects to risks. More information Public Meeting: FDA Patient Network Annual Meeting - Demystifying FDA: An Exploration of Drug Development Date: September 10, 2013 This meeting will serve as a forum for FDA's patient stakeholders and the general public, including health professionals, academia, and industry to learn about regulatory issues related to drug development, analyze where in the process patient input may be most practical and most valuable, and explore practicable approaches to incorporating meaningful patient input that will represent broad patient perspectives in medical product development and regulatory decision-making. More information Pulmonary-Allergy Drugs Advisory Committee Meeting Date: September 10, 2013 The committee will discuss the new molecular entity new drug application (NDA) 203975, for umeclidinium and vilanterol powder for inhalation (proposed trade name Anoro Ellipta), sponsored by Glaxo Group (d/b/a/GSK) for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema. More information Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting Dates: September 11-12, 2013 On September 11, 2013, during session I, the committee will discuss and make recommendations regarding the proposed classification of external cardiac compressor (ECC) devices. During session II, the committee will discuss and make recommendations regarding classification of external pacemaker pulse generators (EPPGs), one of the remaining preamendments class III devices. Also during session II, FDA will be seeking feedback from the committee regarding classification of triple chamber pacing system analyzers (PSAs) with external pacing capability. On September 12, 2013, the committee will discuss and make recommendations regarding the proposed classification of membrane lung for long-term pulmonary support systems. More information Onocologic Drugs Advisory Committee Meeting Date: September 12, 2013 The committee will discuss supplemental biologics license application 125409/51, with the trade name PERJETA (pertuzumab) injection, application submitted by Genentech, Inc. The proposed indication (use) for this product is in combination with trastuzumab and docetaxel for the neoadjuvant treatment of patients with human epidermal growth factor receptor 2 (HER2)-positive, locally advanced, inflammatory, or early stage breast cancer (tumor greater than 2 cm in diameter) as part of a complete early breast cancer regimen containing either fluorouracil, epirubicin, and cyclophosphamide or carboplatin. More information Public Workshop: The Patient Preference Initiative - Incorporating Patient Preference Information into the Medical Device Regulatory Processes Dates: September 18-19, 2013 The purpose of this workshop is to discuss ways to incorporate patient preferences on the benefit-risk trade-offs of medical devices into the full spectrum of the Center for Devices and Radiological Heath (CDRH) regulatory decision making. It also aims to advance the science of measuring treatment preferences of patients, caregivers, and health care providers. More information Ophthalmic Devices Panel of the Medical Devices Advisory Committee Meeting Date: September 19, 2013 The committee will discuss, make recommendations, and vote on information regarding the premarket approval application for the ReSure Sealant sponsored by Ocular Therapeutix, Inc. The ReSure Sealant is an in situ formed hydrogel that is applied topically to clear corneal incisions to create an adherent temporary, soft and lubricious sealant. The ReSure Sealant proposed indication for use is the intraoperative management of clear corneal incisions with a wound leak demonstrated by Seidel test, and for prevention of postoperative fluid egress following cataract or intraocular lens placement surgery. More information Pediatric Advisory Committee Meeting Dates: September 19-20, 2013 The pediatric advisory committee (PAC) will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act (Pub. L. 107-109) and the for Pediatric Research Equity Act (Pub. L. 108-155). More information Food Advisory Committee Meeting Dates: September 23-24, 2013 The Committee will meet to discuss detection signals for noteworthy chemical hazards in foods, dietary supplements, and cosmetics and consider possible sources of in formation, data on chemical hazards, and how FDA's Center for Food Safety and Applied Nutrition might recognize and best take advantage of those data. More information Public Meeting: Narcolepsy Patient-Focused Drug Development Date: September 24, 2013 FDA is conducting a public meeting on Patient-Focused Drug Development for narcolepsy. FDA is interested in obtaining patient input on the impact of narcolepsy on daily life and the available therapies for narcolepsy. More information Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting Date: September 25, 2013 The committee will discuss optimal strategies for the evaluation, interpretation, and communication of drug-drug interaction (DDI) information. FDA will seek input on: (1) best practices in DDI communication through prescription drug product labels (i.e., "package inserts"), namely: a) appropriate format for presentation (e.g. tables, graphs, text) of DDI information; b) level of detail of DDI study results; and c) appropriate wording for clinical recommendations based on empirical data vs. anticipated interactions; (2) appropriate criteria for determining whether or not to describe DDI information derived from the literature in product labels; and (3) how package insert information on DDIs is used by various end-users (e.g., prescribers, dispensers, DDI database curators) in decision making and/or communication. More information The FDA/European Medicines Agency Orphan Product Designation and Grant Public Workshop Date: October 4, 2013 This workshop is intended to provide valuable information about the FDA and European Medicines Agency (EMA) Orphan Drug Designation programs, the FDA Humanitarian Use Device (HUD) Designation program, and the FDA Orphan Products Grant program to participants representing pharmaceutical, biotechnology, and device companies, as well as academics. More information Public Workshop: Synergizing Efforts in Standards Development for Cellular Therapies and Regenerative Medicine Products Date: October 7, 2013 The purpose of the public workshop is to bring together a broad range of stakeholders to discuss current and future standards development activities involving cellular therapies and regenerative medicine products. More information Endocrinologic and Metabolic Drugs Advisory Committee Meeting Date: October 16, 2013 The committee will discuss the supplemental new drug application 202057/S-005, VASCEPA (icosapent ethyl) capsules, submitted by Amarin Pharmaceuticals Ireland Ltd. VASCEPA is currently approved as monotherapy for the treatment of severe hypertriglyceridemia. This supplemental application proposes concomitant use with an inhibitor of HMG-CoA reductase (statin) to reduce triglycerides, non-high density lipoprotein cholesterol, apolipoprotein B, low-density lipoprotein cholesterol, total cholesterol, and very low density lipoprotein cholesterol in adults with mixed dyslipidemia and coronary heart disease (CHD) or a CHD risk equivalent. More information Anti-Infective Drugs Advisory Committee Meeting Date: October 17, 2013 The purpose of this meeting is to discuss susceptibility interpretive criteria for systemic antibacterial drugs and for dosing recommendations in product labeling. We will seek input on the role of pharmacokinetic data in setting susceptibility interpretive criteria. We will also discuss revising dosing recommendations in product labeling based on pharmacokinetic data and clinical safety and efficacy data. More information Anti-Infective Drugs Advisory Committee Meeting Date: October 18, 2013 The committee will discuss the safety and effectiveness of new drug application (NDA) 204684, miltefosine capsules, submitted by Paladin Therapeutics, Inc., for the proposed indication of treatment of patients with visceral (involving internal organs), mucosal (involving areas such as inside the mouth and nose), and cutaneous (involving the skin) leishmaniasis, an infection caused by a parasite. More information Public Workshop: Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics Dates: October 21-22, 2013 FDA Center for Drug Evaluation and Research, in cosponsorship with the American College of Gastroenterology, the American Gastroenterological Association, the Crohn's and Colitis Foundation of America, Inc., the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition, and the Pediatric IBD Foundation, is announcing a 2-day public workshop entitled "Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics (GREAT II)." The purpose of this workshop is to provide a forum to consider issues related to endpoints that can support drug development in the following disease areas: Pediatric and adult inflammatory bowel diseases. More information Cellular, Tissue and Gene Therapies Advisory Committee Meeting Dates: October 22-23, 2013 On October 22, 2013, and the morning of October 23, 2013, the committee will discuss oocyte modification in assisted reproduction for the prevention of transmission of mitochondrial disease or treatment of infertility. On October 23, 2013, from approximately 11:15 a.m. to 11:30 a.m., the committee will hear updates on guidance documents issued from the Office of Cellular, Tissue and Gene Therapies, Center for Biologics Evaluation and Research (CBER), FDA. On October 23, 2013, from 12:30 p.m. to approximately 5:00 p.m. the Committee will discuss considerations for the design of early-phase clinical trials of cellular and gene therapy products. More information FDA is announcing a conference for representatives of Health Professional Organizations. Topics on the agenda include FDA Updates, an overview of FDA's Network of Experts (public/private partnerships), and a FDA Town Hall. More information Please visit FDA's Advisory Committee page to obtain advisory committee meeting agendas, briefing materials, and meeting rosters prior to the meetings. You may also visit this page after meetings to obtain transcripts, presentations, and voting results. For additional information on other agency meetings please visit Meetings, Conferences, & Workshops. Dietary Supplements: What You Need to Know You've heard about them, have probably used them, and have even recommended them to friends or family. But how much do you really know about dietary supplements? Yes, some can be beneficial to your health — but taking supplements can also involve health risks. Some common dietary supplements include Acidophilus, Echinacea, Fiber, Ginger, Glucosamine and/or Chonodroitin Sulfate, Minerals, Omega-3 Fatty Acids, St. John's Wart, Saw Palmetto, and Vitamins. What are dietary supplements? What are the benefits of dietary supplements? Are there any risks in taking supplements? Who's responsible for the safety of dietary supplements? What should I do if I have a reaction to a dietary supplement? How can I find out more about the dietary supplement I'm taking? How can I be a smart supplement shopper? Answers to these questions and other information Preparing for the 2013-2014 Flu Season The flu (influenza) is a contagious respiratory illness caused by influenza viruses that infect the nose, throat, and lungs. It can cause mild to severe illness, and at times can lead to death. The Centers for Disease Control and Prevention (CDC) says "Take 3" actions to fight the flu: Take time to get a flu vaccine. Take everyday preventive actions to stop the spread of germs. Take antiviral drugs if your doctor prescribes them. See 2013-2014 Flu Season - CDC for more information. FDA's Contributions to Advancing New Technologies for Developing Safe and Effective Influenza Vaccines The infrastructure of FDA's scientific and regulatory processes contributes greatly to the availability of millions of doses of seasonal flu vaccine every year, contributing to flu pandemic preparedness for the future. FDA's Center for Biologics Evaluation and Research's (CBER's) expertise, including the areas of research, vaccine manufacturing, and regulatory science, continue to facilitate the availability of safe and effective vaccines for the United States. For the past several years, CBER has been working to anticipate and address challenges associated with using new technologies in the development and licensure of vaccines to prevent the flu. Evaluation of new flu vaccine candidates is based on existing knowledge and experience with regard to currently licensed flu vaccines, as well as state-of-the-art science. More information FDA's Vaccines and Related Biological Products Advisory Committee met in Rockville, Maryland, on February 27, 2013, to select the flu viruses for the composition of the flu vaccine for the 2013-2014 U.S. flu season. During this meeting, the advisory committee reviewed and evaluated the characteristics of recent flu outbreaks, responses to 2012-2013 vaccines, and the availability of candidate flu strains and reagents. The committee recommended that the trivalent (3 flu strains) formulation flu vaccine for the U.S. 2013-2014 flu season contain the following: an A/California/7/2009 (H1N1)-like virus; an (H3N2) virus antigenically like the cell-propagated prototype virus A/Victoria/361/2011; a B/Massachusetts/2/2012-like virus. The committee also recommended that quadrivalent (4 flu strains) influenza vaccines contain the above three strains and the following additional B strain: a B/Brisbane/60/2008-like virus  For more information, see FDA's Web site Vaccine Safety and Availability. More Consumer Updates For previously published Consumer Update articles that are timely and easy-to-read and cover all FDA activities and regulated products. More information Artículos en Español Estos artículos para los consumidores incluyen información sobre la Administración de Medicamentos y Alimentos (FDA, Food and Drug Administration) y consejos para llevar una vida saludable. Artículos en Español Center for Food Safety and Applied Nutrition The Center for Food Safety and Applied Nutrition, known as CFSAN, carries out the mission of FDA. The Center provides services to consumers, domestic and foreign industry and other outside groups regarding field programs; agency administrative tasks; scientific analysis and support; and policy, planning and handling of critical issues related to food and cosmetics. More information Food Facts for You The Center for Food Safety and Applied Nutrition, known as CFSAN, issues food facts for consumers to keep you and your family safe. More information Protecting Bees from Devastating Disease Honey bees are big money makers for U.S. agriculture. These social and hardworking insects produce six hive products – honey, pollen, royal jelly, beeswax, propolis, and venom – all collected and used by people for various nutritional and therapeutic purposes. Honey, of course, is the most well-known and economically important hive product. According to the U.S. Department of Agriculture's (USDA) National Agriculture Statistics Service, honey bees made more than 148 million pounds of honey last year. With the cost of honey at a record high at about $1.73 per pound, that's a value of over $256 million. More information Animal Health Literacy Animal Health Literacy means timely information for the benefit of all animals and their humans. With continuous communication and outreach, the Center for Veterinary Medicine (CVM) strives to enhance the public trust, promote safe and effective use of the animal health products we regulate, and share our scientific endeavors. CVM provides reliable, science-based information to promote animal and human health. More information CVM Pet Facts The Center for Veterinary Medicine (CVM) issues medical and feeding fact sheets to keep your pets healthy and safe. More information Have a question about what the Center for Drug Evaluation and Research (CDER) does? Ask Janet Woodcock, M.D., Director, CDER, FDA FDA will select some of your questions to answer each month. Due to the volume of e-mails we receive, we won't be able to answer each question in this format. We may edit your questions for brevity or clarity. More information To read questions and answers, see MailBag. FDA Basics Each month, different centers and offices at FDA will host an online session where the public can ask questions to senior FDA officials about a specific topic or just listen in to learn more about FDA. More information Educational Videos FDA Food Safety and Modernization Act: An FDA Primer The Rulemaking Process: An FDA Primer What is Regulatory Science Taking Acetaminophen Safely healthfinder.gov Welcome to healthfinder.gov, a government Web site where you will find information and tools to help you and those you care about stay healthy. More information Tobacco Products Resources for You Federal resources to help you quit using tobacco products and to help you learn more about youth tobacco prevention, effective treatment for nicotine addiction, and tobacco research and statistics. More information An interactive tool for educating patients, patient advocates, and consumers on how their medications – both prescription and over-the-counter ­– and medical devices move from the realm of idea to the realm of the marketplace. More information

---

Subscriber Services:
Manage Preferences  |  Unsubscribe  |  Help with this service

Stay Connected:

---

This email was sent to buzzhairs.health@blogger.com using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420