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
Product Safety
FDA Publishes Guidance on Food, Beverage, and Dietary Supplement Additives
By Kelley Drye on
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…
FDA Sets 10 ppb Action Level for Inorganic Arsenic in Apple Juice
By Kelley Drye on
The Food and Drug Administration (FDA) has issued a draft guidance document entitled Arsenic in Apple Juice: Action Level in which it announces an action level of 10 ppb for inorganic arsenic in apple juice.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…
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…
Handy Health Tracking Mobile App…Or Regulated Medical Device?
By Kristi Wolff on
Posted in Enforcement, FDA, FTC, Medical Devices, Product Labeling & Marketing, Product Safety, Regulation
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…
DHHS and FDA Officials Respond to Medical Device Mobile Application Regulatory Concerns on Final Day of Hearings
By Kristi Wolff on
Posted in DHHS, Enforcement, FDA, Medical Devices, Product Labeling & Marketing, Product Safety, Regulation
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…
Day 2 of Medical Device Mobile App Hearings Focuses on Patient Benefits
By Kristi Wolff on
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…
IOM Report on Counterfeit Drugs Released
By Kelley Drye on
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…
Far-reaching PCA Criminal Indictments: A Harbinger for Things to Come Under the Food Safety Modernization Act?
By Sarah Roller on
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…
Heightened FDA Activity Related to OTC Drugs Expected in 2013
By Kelley Drye Warren on
Posted in Cosmetics, DHHS, Drugs, Enforcement, FDA, Product Labeling & Marketing, Product Safety, Regulation, Uncategorized
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
…