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OTC Drug Regulatory Paradigm Open to Stakeholder Feedback Until July 10
June 14, 2016 | Blog | By Joanne Hawana
Continuing a discussion that began in 2014, on June 10, 2016 FDA hosted a public meeting on the potential development of a user fee program for OTC (over-the-counter, or nonprescription) drug products marketed pursuant to the Agency's monograph system.
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Senate Appropriations Bill Targets FDA Rulemaking Agenda
June 8, 2016 | Blog | By Sam Rothbloom
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).
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CPSC Reaches Second Civil Penalty Agreement in As Many Weeks; Sunbeam Products to Pay $4.5 Million to Resolve Late Reporting Allegations
June 6, 2016 | Blog
The U.S. Consumer Product Safety Commission (CPSC) is set to announce yet another civil penalty settlement. Sunbeam Products d/b/a Jarden Consumer Solutions (Sunbeam or the Company) has agreed to pay a $4.5 million civil penalty to resolve charges that it knowingly failed to immediately report certain defects and an unreasonably risk of serious injury involving some of the company’s coffeemakers.
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CPSC Reaches Second Civil Penalty Agreement in As Many Weeks; Sunbeam Products to Pay $4.5 Million to Resolve Late Reporting Allegations
June 6, 2016 | Blog
The U.S. Consumer Product Safety Commission (CPSC) is set to announce yet another civil penalty settlement. Sunbeam Products d/b/a Jarden Consumer Solutions (Sunbeam or the Company) has agreed to pay a $4.5 million civil penalty to resolve charges that it knowingly failed to immediately report certain defects and an unreasonably risk of serious injury involving some of the company’s coffeemakers.
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FDA Finally Decides that "Evaporated Cane Juice" Is Misleading Consumers
June 2, 2016 | Blog | By Richard Maidman
Evaporated cane juice, a term usually used to inform about sweeteners derived from the fluid extract of sugar cane, is present on the ingredient lists of many products we see on grocery store shelves.However, newly finalized FDA guidance on use of the term “evaporated cane juice” (“ECJ”) as an ingredient in food labels may change things.
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CPSC Announces Civil Penalty against Teavana; Commissioners Remain Divided on Civil Penalty Enforcement, Calculations, and Transparency
May 31, 2016 | Blog
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 charges that it knowingly failed to immediately report that certain glass tea tumblers could “explode, shatter or break during normal use.”
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California Plaintiffs Say that Size Matters: Consumer Fraud Class Action Challenges Slack-Fill in Protein Products
May 27, 2016 | Blog
According to named plaintiffs in a consumer fraud action filed in December in the Southern District of California, size matters when making it comes to making a purchase. In fact, Plaintiffs claim that the average consumer’s purchasing decision is “heavily dependent” on the size of the package.
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USDA Increases Cane Sugar Imports to Meet Demand for Non-GE Products
May 23, 2016 | Blog | By Russell Kott
On May 17, 2016, the U.S. Department of Agriculture (“USDA”) announced that it is allowing an additional 200,000 short tons of cane sugar imports to meet food manufacturers’ increasing demand for non-genetically modified sugar products.
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When Does A CPSC Late Reporting Violation First Accrue?
May 19, 2016 | Blog
After filing a Section 15(b) report and conducting a recall with the U.S. Consumer Product Safety Commission (CPSC), companies frequently ponder whether the CPSC believes the company timely filed its report under Section 15(b) of the Consumer Product Safety Act (CPSA) and, if not, whether the CPSC will launch an investigation that could lead to a civil penalty action.
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CPSC Chairman Vows that Every CPSC Voluntary Corrective Action Will Be Called a “Recall”
May 17, 2016 | Blog
According to the Philadelphia Inquirer, CPSC Chairman Elliot Kaye announced in a meeting with consumer advocates that the agency will never again allow a company conducting a voluntary corrective action to call it anything other than a “recall.”
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Just as the Comment Period for "Natural" Ends, FDA Announces Intent to Re-Examine What It Means to Be a "Healthy" Food
May 12, 2016 | Blog | By Joanne Hawana
As any company making and selling food products knows, late last year FDA requested information and comments regarding the appropriate use of the term "natural" for food - the Agency asked what types of processing make that claim misleading, or does the food have to be completely unprocessed?
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Mark Your Calendars: BPA Prop 65 Warnings Required as of May 11, 2016; Styrene Also Added to the Prop 65 List
April 28, 2016 | Blog | By Russell Kott
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”) exposures from canned and bottled foods and beverages.
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"GMO" Labeling Food Fight: How Vermont's Act 120 Is Pressuring An Entire Industry
April 26, 2016 | Blog | By Lyzzette Bullock
On July 1, 2016, Vermont's Act 120 will require food manufacturers to indicate in the labeling of all products regulated by FDA when the food has been produced with the use of genetic engineering (GE).
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What is CPSC’s Statute of Limitations for Civil Penalties? That’s a Gabelli Question
April 21, 2016 | Blog
After filing a Section 15(b) report and conducting a recall with the Consumer Product Safety Commission (“CPSC”), it is not uncommon for a company to wonder whether it timely filed its report under the Consumer Product Safety Act (“CPSA”). A question sometimes asked of us is how much time must pass before the company can feel confident that the agency is not going to initiate a timeliness investigation or civil penalty action.
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Maple Syrup Trade Organization Seeks FDA Regulation of "Maple" Products
April 20, 2016 | Blog | By Richard Maidman
I haven't met many people who don't love maple syrup. Its versatility knows few bounds – traditional pancake or waffle topper, lemonade, salad, and doughnuts come to mind. As you might imagine, the maple syrup industry actively works to protect its product, especially when it comes to alleged imposters.
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Zen Magnets Claims “90% Victory” Against CPSC in Magnet Recall Litigation
April 15, 2016 | Blog
On March 25, 2016, Administrative Law Judge Dean Metry found that the U.S. Consumer Product Safety Commission ("CPSC") case counsel did not prove that high powered, small rare earth magnets (“SREMs”) (1) are defective as sold by Zen Magnets ("Zen"); and (2) constitute a substantial product hazard when sold with appropriate warnings, including proper age recommendations (click here for decision and order).
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A Decade Later, Rules for the Sanitary Transportation of Food Finally Finalized by FDA
April 14, 2016 | Blog | By Sam Rothbloom
Last week, FDA finalized new food safety regulations seeking to ensure the sanitary transport of human and animal food, as required under the Food Safety Modernization Act (FSMA).
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"Multi-Agency Interactive Tool" Available for Developers of Health Apps
April 8, 2016 | Blog | By Joanne Hawana
It seems as though 2016 may become the year that industry receives a plethora of helpful interactive portals from Federal Agencies.
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Post-Senate Vote, Major Food Manufacturers Choose to Label Genetically Engineered Foods
March 29, 2016 | Blog | By Sam Rothbloom
In the wake of the Senate’s defeat of legislation that would have preempted state-mandated GE ingredient labeling on food products, a new trend is emerging, as one food manufacturer after another announces that they will voluntarily label bioengineered ingredients contained in their national food product lines.
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National Retailer Settles FTC Native Advertising Complaint
March 26, 2016 | Blog | By Richard Maidman
The potential pitfalls of native advertising were on display this month at the Federal Trade Commission (FTC). The agency reported that national retailer Lord & Taylor settled with it on charges that the company improperly paid for native advertisements.
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