201608.11
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FDA Releases New Draft NDI Guidance; FDA Warns for Trade-Show Literature; President Signs GMO-Labeling Bill

The latest top stories for the sports nutrition / dietary supplement industry: FDA Releases New Draft New Dietary Ingredient Notification Guidance Today, FDA announced the release of its new, draft New Dietary Ingredient (“NDI”) guidance document, which replaces its previous, July 2011 draft. Please stay tuned for updates as we digest this lengthy new guidance….

201606.08
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FDA Updates Nutrition and Supplement Facts Panels; Cosmetics Claims Under Increasing Scrutiny

The latest top stories for the sports nutrition / dietary supplement industry: FDA Updates Nutrition and Supplement Facts Panels On May 20, FDA finalized its rule updating Nutrition and Supplement Facts Panels. This is FDA’s first major overhaul of food labels in over 20 years. FDA intends the updated label to reflect new scientific information…

201601.13
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FDA Targets cGMP Violations and Seizes Kratom Supplement

The latest top stories for the sports nutrition / dietary supplement industry: FDA Enforcement In a warning letter dated December 10, 2015, FDA warned Dherbs Health Emporium, Inc. for promoting its supplements for conditions that cause them to be misbranded and unapproved new drugs and for not following current Good Manufacturing Practices (cGMPs). FDA writes…

201512.22
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FDA Announces Creation of Office, Warns Companies for Disease Claims

The latest top stories for the sports nutrition / dietary supplement industry: FDA Organizational Change On December 21, FDA announced the creation of the Office of Dietary Supplement Programs (ODSP), elevating FDA’s supplement program from a division within the Office of Nutrition Labeling and Dietary Supplements. The dietary supplement program’s elevation to an office “will…

201512.10
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Picamilon Targeted: FDA Warns Five Companies for Using the Ingredient

Here are the recent enforcement actions and claims against purportedly non-compliant dietary supplement companies: FDA After months of rumblings about the substance picamilon (see our October 26 Enforcement Report), on November 30 FDA issued five warning letters to dietary supplement companies that sold the ingredient. FDA also created a webpage stating its position on the…

201510.26
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Oregon Attorney General Pursues Supplement Retailer GNC

In today’s regulatory climate, where FDA, FTC, state attorneys general, industry self-regulatory organizations, class action lawyers, and even individual U.S. Senators are leading a patchwork of crusades against dietary supplement companies, it is vital to keep up to date with the latest enforcement efforts and trends.  Every two weeks, we send out an email that…

201509.24
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28 Year Prison Sentence Related to Food, Drug, and Cosmetic Act Violations

In today’s regulatory climate, where FDA, FTC, state attorneys general, industry self-regulatory organizations, class action lawyers, and even individual U.S. Senators are leading a patchwork of crusades against dietary supplement companies, it is vital to keep up to date with the latest enforcement efforts and trends.  Every two weeks, we send out an email that…

201509.09
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FDA Finds Pure Powdered Caffeine to be Unsafe

In today’s regulatory climate, where FDA, FTC, state attorneys general, industry self-regulatory organizations, class action lawyers, and even individual U.S. Senators are leading a patchwork of crusades against dietary supplement companies, it is vital to keep up to date with the latest enforcement efforts and trends. Every two weeks, we send out an email that gives…