201504.16
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FDA Warns Kind, LLC over Misbranding Violations

You’re at the checkout counter of your local grocery store, and you’re craving a snack. You’re about to grab a chocolate bar from the bookshelf-sized repository of candy in your checkout lane, but then you spot a Kind fruit-and-nut bar. You think to yourself that you really should choose the healthier option, so you ditch…

201504.03
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BREAKING NEWS: State Attorneys General Call for “Comprehensive Congressional Inquiry into the Herbal Supplements Industry”

This morning, a coalition of attorneys general, including New York’s Attorney General Schneiderman, sent a letter to four congressional leaders to “urge [them] to launch a comprehensive congressional inquiry into the herbal supplements industry, and to weigh a more robust oversight role for the Food and Drug Administration.” This letter comes approximately two months after…

201503.10
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New York Attorney General Forms Coalition to Further Investigate Quality Control Issues in the Supplement Industry

New Coalition May Lead to Increased FDA Inspections New York Attorney General Eric Schneiderman is expanding his investigation into the supplement industry, today announcing the formation of a coalition designed to further investigate supplements and ensure that supplement companies are complying with the law. With the attorney general’s office noting that problems in the industry…

201412.23
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“The Tan Sheet” Reports Announcement of DoJ’S Commitment to Criminal Prosecution of Individuals in the Dietary Supplement Industry

As reported in a cover story in “The Tan Sheet”, individuals at dietary supplement companies will be facing increased scrutiny and the potential for criminal charges in the months ahead. The article, “DoJ Aims To ‘Do Something About’ Crime in FDA-Regulated Industries,” reports on a warning from Department of Justice (DoJ) Consumer Protection Branch Director…

201410.10
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Red Bull and False Advertising Claims: What Impact Will the Red Bull Settlement Have on Labeling/Marketing of Functional Foods, Supplements, and Beverages?

As lawsuits against food, dietary supplement, and beverage companies for false advertising claims appear to be on the rise, perhaps none has made more headlines than Red Bull and the company’s just-announced $13 million settlement in response to a class action lawsuit surrounding false advertising claims. Advertising is a complex part of marketing and is…

201407.30
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“The Tan Sheet” Reports on Increased FDA Warning Letters Sent to Supplement Firms

More GMP Inspectors Reviewing Adverse Event Reporting Data and Finding Violations of AER Reporting Requirements The cover story of the July 21st edition of “The Tan Sheet” reports on the rise in warning letters being sent to supplement firms as a result of violations of adverse event reporting (“AER”) requirements found during good manufacturing practices…

201406.30
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POM Sues Coca-Cola for Unfair Competition through Deceptive Labeling

By Rick Collins and Christopher Mango*   Industry should prepare for more litigation as a result of the U.S. Supreme Court’s recent decision in POM, LLC v. Coca-Cola Company.  One of Coca-Cola’s products, alleged to be a pomegranate-blueberry juice blend, was advertised, displayed, and sold with the words “pomegranate” and “blueberry” displayed prominently on its…

201404.29
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FDA Issues Final Rule Prohibiting Nutrient Content Claims for Certain Omega-3 Fatty Acids

FDA has just finalized its 2007 proposed rule prohibiting nutrient content claims for the omega-3 fatty acids docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA).  The final rule also prohibits some claims for alpha-linolenic acid (ALA), while taking no action with respect to other such claims for ALA. A nutrient content claim is a statement on…

201401.10
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The Federal Trade Commission’s New Year’s Resolution: Take Down Deceptive Weight-Loss Supplements

in FDA, FTC

Just days into 2014, the Federal Trade Commission (“FTC”) made headlines by announcing enforcement actions against four weight-loss companies.  As a result of this so-called “Operation Failed Resolution,” the companies—HCG Diet Direct, Sensa Products, L’Occitane, and LeanSpa—must pay a collective total of $34 million to refund consumers who may have been misled by their ads. …

201311.18
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What Dietary Supplement Companies Need To Know About Claims Substantiation And FDA/FTC Compliance: Important Information for Supplement Companies from Alan Feldstein’s Presentation at Supply Side West

On November 14th, Alan Feldstein, Of Counsel to Collins, McDonald & Gann, spoke about claim substantiation for dietary supplements at Supply Side West in Las Vegas.  Here are some of the highlights from Alan’s speech: To be successful, supplement companies must advertise the effects of their products by making claims.  Stronger claims may require more…