Products Liability Administrative Agency

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Court Strikes FDA Preapproval for Tobacco Product Labeling Changes

Court holds that FDA guidance cannot require preapproval for label modifications to existing tobacco products, but can require preapproval for quantity modifications....more

Responsible Corporate Officers’ Jail Sentences Upheld in Selling Contaminated Eggs

In an important decision, on July 6, 2016, the Eighth Circuit Court of Appeals affirmed the prison sentences imposed on Jack DeCoster, and his son, Peter, under the “responsible corporate officer” doctrine (aka Park doctrine)...more

Hot CPSC Jurisdictional Issues: Does the CPSC Have Regulatory Authority Over Amusement Park Rides and Guns?

In the wake of two tragic amusement park ride accidents in Kansas and Tennessee, and the ongoing political debate in America over gun safety issues, we felt it timely to help answer a question that continues to be asked in...more

Commercial Drones Set To Take Flight

On June 21, 2016, the Federal Aviation Administration (FAA) unveiled a landmark set of new rules for the commercial operation of small Unmanned Aircraft Systems (sUAS), more popularly known as drones. The new rules will take...more

Still Waiting—FDA Delays Rulemaking

The FDA recently announced that it would once again delay promulgation of its proposed rule for generic drug labeling obligations. This action followed introduction of a spending bill that would have blocked funding for the...more

Congress Sends Chemical Safety Reform Legislation to Be Signed into Law

The historic reform of the Toxic Substances Control Act overhauls the United States’ primary chemical safety law for the first time in 40 years. Following months of closed-door negotiations, the US House of...more

Senate Appropriations Bill Targets FDA Rulemaking Agenda

The Senate Appropriations Committee is looking to tinker with the Food and Drug Administration’s rulemaking agenda through its fiscal year 2017 funding bill for the Department of Agriculture and FDA (S. 2956). Passed...more

CPSC Announces Civil Penalty against Teavana; Commissioners Remain Divided on Civil Penalty Enforcement, Calculations, and...

On May 26, 2016 the U.S. Consumer Product Safety Commission (“CPSC”) announced through a Record of Commission Action (“RCA”) that Teavana Corporation (“Teavana”) has agreed to pay a $3.75 million civil penalty to resolve...more

Mark Your Calendars: BPA Prop 65 Warnings Required as of May 11, 2016; Styrene Also Added to the Prop 65 List

Earlier this month, California’s Office of Environmental Health Hazard Assessment (“OEHHA”) issued a Notice of Emergency Action to allow temporary use of a standard point-of-sale warning message for bisphenol A (“BPA”)...more

FDA Proposes Ban on Electrical Stimulation Devices for Aggressive or Self-Injurious Behavior

On April 25, the U.S. Food and Drug Administration published a proposed rule banning electrical stimulation devices (ESDs) used to treat aggressive or self-injurious behavior....more

The Continuing Saga Surrounding Magnet Sets: Proof of the CPSC's Determination to Eradicate Hazards to Children

The Consumer Product Safety Commission (CPSC) has made it very clear over the last several years that it takes hazards associated with rare earth magnet sets very seriously, primarily because the hazards affect children. Rare...more

Ninth Circuit: No Relief from Stay in General Mills’ Trans Fats Case Pending FDA Action

The Ninth Circuit will not review district court stays, the appeals court recently held, because they are not “final orders” subject to immediate appeal. On January 26, 2015, the Ninth Circuit granted General Mills’ motion to...more

FDA Classifies Transvaginal Pelvic Mesh As “High Risk” Medical Device

The U.S. Food and Drug Administration issued two final orders on Monday, January 4, 2016 to strengthen the data requirements for transvaginal surgical mesh devices that repair pelvic organ prolapse (POP). First, the agency...more

CPSC Launches New Portal to Guide Companies through Regulatory Maze

Has your business experienced difficulty identifying on the CPSC’s website which product safety regulations are potentially applicable to your products? In an effort to better guide industry, particularly new product makers...more

Food and Drug Newsletter - December 2015

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

Proposition 65: OEHHA Repeals and Re-Proposes Revisions to Proposition 65 Warning Regulations

On November 27, 2015, the California Office of Environmental Health Hazard Assessment (OEHHA) took two actions: (1) it withdrew its proposed rule issued on January 16, 2015, that would have repealed and replaced the existing...more

FDA Proposes Gluten-Free Labeling Standards for Fermented and Hydrolyzed Foods

On November 18, 2015, the FDA issued a proposed rule to set standards for making a “gluten-free” claim for foods that are fermented, hydrolyzed, or distilled, or that otherwise contain fermented or hydrolyzed ingredients....more

New FDA Guidance Doubles-Down on 1980 Fortification Policy and Potential Misbranding Risks of “Inappropriate Fortification”

FDA recently released its Guidance for Industry: Questions and Answers on FDA’s Fortification Policy (Guidance) to “clarify the existing policy” in response to questions FDA has received from the food industry, other federal...more

FDA Issues Final Food Biotechnology Labeling Guidelines for Plant Foods; Discourages “GMO Free” Claims

On November 19, 2015, FDA issued its final guidance for industry concerning the requirements for voluntarily indicating whether food products have or have not been derived from genetically engineered plants. The final...more

FDA Seeks Comments on the Meaning of “Natural”

On November 12, 2015, the U.S. Food and Drug Administration (FDA) requested comment on the use of the term "natural" in the labeling of human food products. The notice states that it is establishing "a docket to receive...more

The FDA Gets Pulled Into the "Natural" Labeling Fray: Surprise Move May Change the Food Fight

In a surprising change of tack, the U.S. Food and Drug Administration (FDA) announced Tuesday that it will accept public comments on the use of "natural" claims on food labels. The move, which may signal FDA's intention to...more

FDA’s Comment Period for “Natural” Food Labels Is Now Open

FDA took long-awaited and much-anticipated steps this week to address the requests of both consumers and food manufacturers and producers for guidance and regulation on use of the term “natural.” For years now, consumer...more

FDA Requests Public Comment on "Natural" Food Labels

The U.S. Food and Drug Administration this week issued a request for public comment on the use of the term "natural" in the labeling of food products. This represents the first time in 22 years that the FDA has indicated an...more

FDA Requests Public Comment on How “Natural” Claims Should be Regulated; Opening 90-Day Comment Period

FDA is requesting public comment on how “natural” claims should be regulated. The 90-day public comment period will open on November 12, 2015, when the FDA notice is published in the Federal Register. In particular, FDA...more

FDA Requests Comments on Use of Term "Natural" on Food Labeling

After years of litigation and controversy around use of the term "natural" on food labels, the U.S. Food and Drug Administration (FDA) is now seeking comments on the issue. This action has important implications for companies...more

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