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? …

201310.21
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The Attack on Industry Continues as Newsday Proclaims “Problems Persist in Supplement Industry”

This weekend’s Newsday featured an article lamenting the perceived under-regulation of dietary supplement companies.  Citing contaminated products and discussing the “poisons” in supplements, the article is sure to alarm consumers.  However, the reality is that dietary supplements are heavily regulated, and the vast majority of supplements are no more harmful than any other food. The statement…

201309.18
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Industry Stakeholders Question FDA’s Cost Estimate for NDI Notifications

The dietary supplement industry continues to wait for FDA to publish a revised guidance on New Dietary Ingredients (NDI) and NDI notifications (NDINs).  But recently, the Agency estimated that preparing an NDIN should take only twenty hours and incur no capital costs.  FDA explained that its estimate isolates the time and expense of researching the safety…

201308.01
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Sen. Durbin Likely to Reintroduce the Dietary Supplement Labeling Act

Dietary supplement regulations have been a hot topic on Capitol Hill lately.  Earlier this week, Sen. Dick Durbin, D-Ill., announced that he will reintroduce the Dietary Supplement Labeling Act along with Sen. Richard Blumenthal, D-Conn. According to the Natural Products Association, “Sen. Durbin explained that this legislation will require more information on dietary supplement labels….

201307.18
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Update on Revised NDI Guidance

It remains unclear when FDA will issue its revised NDI guidance, but industry groups and members of Congress continue to put pressure on the agency to take action. “In a July 9 letter to Commissioner Margaret Hamburg, 18 House members said they ‘encourage the agency to continue its efforts to bring clarity to’ NDIs.”  This…