FTC, NY AG Pursue Dietary Supplement Marketers for Allegedly Unsubstantiated Claims
201701.12
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FTC, NY AG Pursue Dietary Supplement Marketers for Allegedly Unsubstantiated Claims

On January 9, 2017, the Federal Trade Commission (“FTC”) and the New York State Attorney General (“NY AG”) charged the marketers of the dietary supplement Prevagen with making false and unsubstantiated claims about the product’s benefits. Prevagen’s marketers claimed the line of products improved memory and cognitive performance and was “clinically shown” to work. FTC…

DEA Designates CBD a Schedule I Controlled Substance; FDA Publishes Adverse Event Report Data; Senator Calls for Stronger NDI Enforcement
201701.04
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DEA Designates CBD a Schedule I Controlled Substance; FDA Publishes Adverse Event Report Data; Senator Calls for Stronger NDI Enforcement

Happy New Year! Last year ended with a bang, as DEA enacted a Final Rule to schedule marijuana extracts-including CBD-as controlled substances (see below). The new year brings questions: How will the Trump Administration affect FDA-regulated entities? Will FDA and other federal agencies continue to target ingredients used in dietary supplements? How can you avoid…

GNC to Ramp-Up Dietary Supplement Compliance Requirements; FDA Warns Company for Selling Sublingual Product as Supplement; FDA Says 1-Androsterone (1-DHEA) not a Dietary Ingredient
201612.12
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GNC to Ramp-Up Dietary Supplement Compliance Requirements; FDA Warns Company for Selling Sublingual Product as Supplement; FDA Says 1-Androsterone (1-DHEA) not a Dietary Ingredient

The latest top stories for the sports nutrition, dietary supplement, and cosmetics industries: GNC to Ramp-Up Dietary Supplement Compliance Requirements In the wake of a rash of liver injuries allegedly caused by USPlabs LLC’s OxyElite Pro in late 2013, government agencies began assessing dietary supplement retailers’ specific role in the health crisis and their more…

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…