Category Archives: Product Safety

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FDA Approves Genetically Engineered Atlantic Salmon as Safe and Effective for Human Food and Releases Related Draft Guidance on Voluntary Labeling

On Thursday, November 19th, the Food & Drug Administration (FDA) announced that it had approved an application for AquAdvantage Salmon, a type of Atlantic Salmon that has been genetically engineered to grow to market size more quickly than other salmon.  The agency regulates genetically engineered (GE) animals such as AquAdvantage Salmon under the new animal … Continue Reading

FDA Publishes Guidance on Food, Beverage, and Dietary Supplement Additives

On January 14, the Food and Drug Administration (“FDA”) published a guidance document entitled Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements, with the goal of reminding industry: (1) about the Federal Food, Drug and Cosmetic Act’s requirements governing substances added to conventional foods, including beverages; and (2) that those same requirements … Continue Reading

FDA Sets 10 ppb Action Level for Inorganic Arsenic in Apple Juice

The Food and Drug Administration (FDA) has issued a draft guidance document entitled Arsenic in Apple Juice: Action Level in which it announces an action level of 10 ppb for inorganic arsenic in apple juice. This action level is consistent with the 10 ppb limit for arsenic set by the Environmental Protection Agency for drinking … Continue Reading

FDA Announces Final Rule Banning BPA from Infant Formula Packaging

The Food and Drug Administration (“FDA”) announced last week the publication of a final rule banning bisphenol-A (“BPA”) from use in infant formula packaging – a decision made based on proof of industry abandonment rather than safety concerns. In July 2012, then-U.S. Representative Edward J. Markey filed a food additive petition seeking to amend the … Continue Reading

Handy Health Tracking Mobile App…Or Regulated Medical Device?

The use of mobile apps for health purposes has created new questions for users, developers, and regulators regarding the balance between convenience, expanded health care, and public safety. The line between apps that are useful tools for accessing health information and those that are considered medical devices can be unclear but is very important for … Continue Reading

DHHS and FDA Officials Respond to Medical Device Mobile Application Regulatory Concerns on Final Day of Hearings

The House Subcommittee on Oversight and Investigations concluded a three-day series of hearings regarding medical device mobile applications (“MMAs”) on Thursday morning. Our posts regarding the first two hearings are here and here. The focus of day three was to hear testimony from key FDA and DHHS officials who have responsibilities relating to MMAs and … Continue Reading

Day 2 of Medical Device Mobile App Hearings Focuses on Patient Benefits

The Health Subcommittee of the House of Representatives Energy and Commerce Committee held a second day of hearings regarding medical device mobile applications (“MMAs”) on Wednesday. Our post regarding the first day of hearings can be found here. The focus of day two was “Health Information Technologies: How Innovation Benefits Patients.” The subcommittee heard from … Continue Reading

IOM Report on Counterfeit Drugs Released

On February 13, 2013, the Institute of Medicine of the National Academies (IOM) released its report Countering the Problem of Falsified and Substandard Drugs. The report identifies causes and recommends strategies to address the problem of substandard and falsified drugs. The IOM first distinguishes public health concerns of falsified and substandard drugs from the intellectual … Continue Reading

Far-reaching PCA Criminal Indictments: A Harbinger for Things to Come Under the Food Safety Modernization Act?

Last week, the Department of Justice brought a sweeping indictment against several former Peanut Corporation of America executives alleging egregious, and intentional, violations of food safety laws that caused the salmonella peanut outbreak of 2008. The government charged four individuals who allegedly directed the scheme in an indictment that contains 76 counts of conspiracy, wire … Continue Reading

Heightened FDA Activity Related to OTC Drugs Expected in 2013

According to the 2013 unified agenda for the Department of Health and Human Services, FDA plans to recommend several changes to U.S. OTC drug labeling, safety monitoring, and manufacturing standards in 2013 which may impact future marketing and product development strategies for consumer products. Forthcoming FDA proposals include the following:  Proposed Monograph Modifications  Amending the … Continue Reading

There’s an App For That: FDA Clears iPhone iExaminer App

FDA recently granted clearance to a new telemedicine product – the Welch Allyn iExaminer – which, when used in conjunction with the iPhone, allows users to capture, send, store, and receive high resolution images of the eye. According to the manufacturer’s 510(k) submission, the iExaminer is cleared for prescription use only and is intended to … Continue Reading

FDA Publishes Proposed Rules on Preventive Controls and Produce Safety Under the Food Safety Modernization Act

Sarah Roller, Kristi Wolff, and Donnelly McDowell co-authored this blog post. The Food and Drug Administration (FDA) published yesterday two long-awaited and lengthy proposed rules related to food safety standards–“Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food” and “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human … Continue Reading

GAO Report on Safety of Food Imports Recommends FDA Revise Approach to Comparability Assessments of Foreign Governments

In response to a request from Senators Rockefeller, Snowe, Cantwell, and Inouye, the Government Accountability Office (GAO) released a report yesterday addressing obstacles that FDA may face in implementing certain provisions of the Food Safety Modernization Act (FSMA) designed to ensure the safety of food imports. The report identifies several obstacles to the implementation of … Continue Reading

FDA Finalizes Guidance on New Categories for Food Facility Registrations under FSMA and Opens Online System for Biennial Registration

FDA has finalized an earlier released draft guidance providing additional information regarding food facility registrations required by section 415 of the Federal Food, Drug, and Cosmetic Act (FDCA). The guidance establishes new categories for food facilities as mandatory fields in the food facility registration form. At the same time, FDA announced that its biennial registration … Continue Reading

California Court Allows State Law Claims Against Medtronic to Proceed; Rejects Preemption Argument

The Superior Court for the County of Los Angeles ruled earlier this week in Cabana v. Stryker Biotech, LLC that a products liability action arising out of the off-label use of Medtronic’s INFUSE Bone Graft medical device could proceed by rejecting Medtronic’s summary judgment motion. Medtronic had argued that plaintiff’s claims were both expressly and impliedly … Continue Reading

GAO Report Encourages FDA to Strengthen Its Food Advisory and Recall Process

In January 2011, the FSMA amended the Federal Food, Drug, and Cosmetic Act to give the Food & Drug Administration (FDA) authority to order the recall of all food products when a company fails to voluntarily recall the products. Until passage of this act, FDA could ask companies to voluntarily recall adulterated or misbranded food … Continue Reading

FDA Proposed Rule Would Place New Labeling and Reporting Requirements on Medical Device Manufacturers

On July 10, 2012, the Food and Drug Administration (“FDA”) published a proposed rule implementing Federal Food, Drug, and Cosmetic Act (“FD&C Act”) provisions establishing a unique device identification system for medical devices over the next seven years. The rule would require medical device manufacturers—including a specification developer, a single-use device reprocessor, a convenience kit … Continue Reading

FSIS Releases Residue Prevention Compliance Guide

The USDA Food Safety and Inspection Service has posted a new Compliance Guide on its website to prevent drug residue in livestock slaughter operations. FSIS has also made changes to its Residue Repeat Violator List and its testing of animals from producers under injunction from FDA for practices that have led to drug residue violations. … Continue Reading

FDA Issues Phthalate Draft Guidance For Pharmaceutical Products

In early March, the Food and Drug Administration (FDA) issued draft guidance recommending that the “pharmaceutical industry avoid the use of [dibutyl phthalate (DBP)] and [di(2-ethylhexyl) phthalate (DEHP)] in [Center for Drug Evaluation and Research (CDER)]-regulated drug and biologic products,” including prescription and nonprescription products, because of “potential human health risks associated with exposure to … Continue Reading

Preparing for the New FSMA Food Defense Standards

Protecting the US food supply from intentional adulteration requires coordination at all levels of government and throughout the private sector. Companies engaged in the manufacture, importation, distribution or storage of food for the U.S. market will be interested in a new article published by the Food and Drug Law Institute that provides an introduction to … Continue Reading

APHIS Announces New Process for Determination of Nonregulated Status for Genetically Engineered Organisms

On February 29, 2012, the Animal and Plant Health Inspection Service (APHIS) within the U.S. Department of Agriculture (USDA) announced that it was changing the process by which it considers petitions for the determination of nonregulated status for genetically engineered organisms in order to facilitate increased public involvement at early stages of the process. The … Continue Reading

Recent FDA Testing Shows Lead in Lipsticks, Agency Maintains Levels are Safe

Recent Food and Drug Administration (FDA) test results show that detectible amounts of lead continue to be found in lipstick, but do not present a safety risk to product consumers. According to the recent FDA test data, lead levels in some products have risen since FDA initiated its testing program in 2007. Reports of lead … Continue Reading

Food Safety Working Group Releases 2009-2011 Progress Report

The Federal Food Safety Working Group (“FSWG”) yesterday released a progress report highlighting the groups accomplishments over the last two years and outlining priorities for the future. Established by President Obama in 2009, the FSWG is responsible for building a modern food safety system. Secretary for Health and Human Services Kathleen Sebelius noted in a … Continue Reading

Health and Human Services Inspector General Report Identifies Shortcomings in FDA Oversight of State Food Inspections

On December 14, 2011, the Inspector General of the Department of Health and Human Services issued a report finding that the Food and Drug Administration (FDA) failed to properly oversee food facility inspections conducted by states because FDA had not ensured the requisite number of inspections and failed to follow-up appropriately when inspections occurred. The … Continue Reading