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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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