The US Food and Drug Administration and Cardiovascular Medicine: Reflections and Observations.

What’s the Latest on Acrylamide?

What Are the Current Findings Concerning Arsenic in Foods?

Direct-Acting Antivirals for Chronic Hepatitis C: Can Drug Properties Signal Potential for Liver Injury?

Successful Investigational New Drug Preparation without Reinventing the Wheel

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

US Food and Drug Administration and European Medicines Agency Launch Good Clinical Practices Initiative

Safety concerns at the FDA

Food manufacturing and the allergic consumer: accidents waiting to happen.

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.

Regulatory and Clinical Expert Perspective of the 2022 FDA Draft Guidance “Celiac Disease: Developing Drugs for Adjunctive Treatment to a Gluten-Free Diet”

“Black box” warning: Wake-up call or overreaction?

Annals of the New York Academy of SciencesVolume 691, Issue 1 p. 259-261 The Absence of a Synergistic Protective Effect of β3-Carotene and Vitamin E on Skin Tumorigenesis in Mice L. A. LAMBERT, L. A. LAMBERT US Food and Drug Administration, Center for Food Safety and Applied Nutrition, HFS-128, 200 C Street SW, Washington, DC 20204Search for more papers by this authorW. G. WAMER, W. G. WAMER US Food and Drug Administration, Center for Food Safety and Applied Nutrition, HFS-128, 200 C Street SW, Washington, DC 20204Search for more papers by this authorR. R. WEI, R. R. WEI US Food and Drug Administration, Center for Food Safety and Applied Nutrition, HFS-128, 200 C Street SW, Washington, DC 20204Search for more papers by this authorS. LAVU, S. LAVU US Food and Drug Administration, Center for Food Safety and Applied Nutrition, HFS-128, 200 C Street SW, Washington, DC 20204Search for more papers by this authorA. KORNHAUSER, A. KORNHAUSER US Food and Drug Administration, Center for Food Safety and Applied Nutrition, HFS-128, 200 C Street SW, Washington, DC 20204Search for more papers by this author L. A. LAMBERT, L. A. LAMBERT US Food and Drug Administration, Center for Food Safety and Applied Nutrition, HFS-128, 200 C Street SW, Washington, DC 20204Search for more papers by this authorW. G. WAMER, W. G. WAMER US Food and Drug Administration, Center for Food Safety and Applied Nutrition, HFS-128, 200 C Street SW, Washington, DC 20204Search for more papers by this authorR. R. WEI, R. R. WEI US Food and Drug Administration, Center for Food Safety and Applied Nutrition, HFS-128, 200 C Street SW, Washington, DC 20204Search for more papers by this authorS. LAVU, S. LAVU US Food and Drug Administration, Center for Food Safety and Applied Nutrition, HFS-128, 200 C Street SW, Washington, DC 20204Search for more papers by this authorA. KORNHAUSER, A. KORNHAUSER US Food and Drug Administration, Center for Food Safety and Applied Nutrition, HFS-128, 200 C Street SW, Washington, DC 20204Search for more papers by this author First published: December 1993 https://doi.org/10.1111/j.1749-6632.1993.tb26188.xAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Volume691, Issue1Carotenoids in Human HealthDecember 1993Pages 259-261 RelatedInformation

GFR Decline as an End Point in Trials of CKD: A Viewpoint From the FDA

Medical Device Safety Communications (MDSCs) are used by the US Food and Drug Administration (FDA) to convey important new safety information to patients and health care professionals. The sources of initial safety signals that trigger MDSCs have not been described previously. To assess the sources of initial safety signals that trigger publication of MDSCs and the potential associations among MDSC data source, type of safety issue, and subsequent FDA action. In this cross-sectional study, all MDSCs published on the FDA website between January 1, 2011, and December 31, 2019, were assessed. The MDSC characteristics, sources of initiating safety signals, regulatory approval or clearance pathways of the related medical devices, and subsequent FDA actions were collected from the FDA website. The main outcome was the distribution of sources of initial safety signals that led to publication of MDSCs. Secondary aims included exploration of potential associations among safety signal sources (direct reporting vs other), type of safety issue (death vs other), and FDA action (withdrawal vs other). A total of 93 MDSCs were evaluated. Median time from device approval to MDSC posting was 10 years (interquartile range, 6-16 years). The most common data sources that triggered MDSCs were direct reports to the FDA through the Medical Device Reporting (MDR) program (44 of 93 [47%]) followed by regulator-initiated assessments (32 [34%]). Common safety issues included patient injury (25 [27%]), potential wrong diagnoses (19 [20%]), and death (18 [19%]). Frequent FDA action after MDSC posting included recommendation for increased vigilance and caution (47 [51%]), complete device withdrawal (12 [13%]), and warnings of specific lots or clinics (12 [13%]). There was a statistically significant correlation between direct reports of adverse events to the FDA through the MDR program and risk of death as a safety issue (14 of 44 [32%] for direct reporting vs 4 of 49 [8%] for any other data sources, P = .007). In this cross-sectional study, the most common source of initial safety signals that triggered MDSCs was direct reports of real-world adverse events to the FDA through the MDR program. The delayed detection of postmarketing adverse events highlights the importance of proactive identification of emerging device-related safety issues.

Alterations in surgical technique after FDA statement on power morcellation