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…

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…

201309.26
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FDA Cracks Down as Industry Continues to Struggle with Ingredient Specifications

Under the 2007 supplement Good Manufacturing Practices (“GMP”) final rule, as well as the pending Food Safety Modernization Act regulations, supplement companies must set out specifications to identify an ingredient’s source and lifecycle.  Industry has struggled to comply with the GMPs in this area.  Since April 15, 2013, FDA has issued at least six Warning Letters…

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…

201308.20
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THE LATEST COVER STORY ON SUPPLEMENTS: The Industry Braces Itself as FDA Claims Consumers are “Put at Risk by Supplement Companies’ Manufacturing Woes”

Today’s Newsday features a negative cover story on the supplement industry – noting that a top FDA official has claimed that “about 70 percent of the nation’s supplement companies have run afoul of the US Food and Drug Administration’s manufacturing regulations over the past five years.” With its attention-grabbing headlines stating “Buyer Beware” and “The…