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…

201502.18
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Claim Substantiation Post-POM

Do you now always need at least two randomized and well-controlled human clinical trials (RCTs) to substantiate your claims? We may have an answer from the U.S. Court of Appeals for the D.C. Circuit, which in January 2015 issued its highly anticipated opinion in POM Wonderful, LLC v. F.T.C. First, the bad news, at least…

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…

201412.19
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New Steroid Law (DASCA) Goes Into Effect

On December 18, 2014, President Obama signed the Designer Anabolic Steroid Control Act of 2014 – DASCA for short. Several years in the making, DASCA cracks down on the over-the-counter “prohormone” segment of the sports nutrition supplement market. 25 New “Anabolic Steroids.” DASCA lists 25 steroidal compounds as newly criminalized anabolic steroids. [Note that most…

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…

201407.02
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What’s in Your Protein? Nitrogen Spiking in the Sports Nutrition Industry

On July 1, 2014, a consumer class action complaint was filed in the Federal District Court for the Central District of California against a dietary supplement company alleging that two of their whey protein products were misleading consumers as to protein content.  Protein content is indirectly determined by testing the nitrogen content of the product. …

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…

201311.06
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How Do YOU Handle Adverse Event Reports?

Suppose that somebody calls your dietary supplement company to report that he experienced shortness of breath and heart palpitations shortly after taking one of your products.  He is en route to the hospital, and he believes that your product is to blame.  Who at your business takes this call?  How does he or she respond? …