Former President of Dietary Supplement Brand Sentenced to Prison; FDA Warns Companies for Making Disease Claims
201707.24
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Former President of Dietary Supplement Brand Sentenced to Prison; FDA Warns Companies for Making Disease Claims

The latest top stories for the sports nutrition, dietary supplement, and cosmetics industries: Former President of Dietary Supplement Brand Sentenced to Prison Last week, Derek Vest, who pleaded guilty to introducing misbranded food into interstate commerce, was sentenced to 18 months in federal prison. The court also entered a $2.5 million judgment against Mr. Vest….

Supplement Experts Report Creatine Is Safe and Effective; FDA Warns Companies Selling “Synthetic Steroids” in Supplements; FDA Extends Compliance Dates for Nutrition Facts Final Rules
201706.21
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Supplement Experts Report Creatine Is Safe and Effective; FDA Warns Companies Selling “Synthetic Steroids” in Supplements; FDA Extends Compliance Dates for Nutrition Facts Final Rules

The latest top stories for the sports nutrition, dietary supplement, and cosmetics industries: Supplement Experts Report Creatine Is Safe and Effective Media and regulators frequently demonize the dietary supplement creatine monohydrate. Early this year, a study in Pediatrics elicited alarming press over minors’ widespread access to creatine. The study and the media covering it called…

FDA Warns Companies for Making Cancer Claims; Supplement Firm Recalls Products “tainted with anabolic steroids and steroid like substances”
201705.12
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FDA Warns Companies for Making Cancer Claims; Supplement Firm Recalls Products “tainted with anabolic steroids and steroid like substances”

FDA Warns Companies for Making Cancer Claims FDA recently sent 14 warning letters and 4 online advisory letters to companies, including dietary supplement marketers, for allegedly claiming their products prevent, diagnose, treat, or cure cancer. Some of the claims at issue are: “proven effective against: AIDS . . . Cancer (all types) . . ….

Court Finds Against Hi-Tech Pharmaceuticals in DMAA Lawsuit: “[P]roducts . . . containing DMAA are adulterated”
201704.05
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Court Finds Against Hi-Tech Pharmaceuticals in DMAA Lawsuit: “[P]roducts . . . containing DMAA are adulterated”

By Rick Collins and David Torreblanca On April 3, the United States District Court for the Northern District of Georgia granted the Food and Drug Administration’s (“FDA”) summary judgment motion and denied Hi-Tech Pharmaceuticals, Inc.’s (“Hi-Tech”) motion. This decision (temporarily) concludes the parties’ long-fought battle over the legal status of products containing 1,3 Dimethylamylamine, better…

Department of Justice Enjoins Dietary Supplement Manufacturer’s Operations; FDA Issues Warning Letters over Alleged CGMP Violations
201702.10
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Department of Justice Enjoins Dietary Supplement Manufacturer’s Operations; FDA Issues Warning Letters over Alleged CGMP Violations

The latest top stories for the sports nutrition, dietary supplement, and cosmetics industries: Department of Justice Enjoins Dietary Supplement Manufacturer’s Operations Last month, the Department of Justice (“DoJ”) filed a consent decree of permanent injunction against VivaCeuticals Inc., doing business as Regeneca Worldwide, and its CEO to prevent alleged violations of the Federal Food, Drug,…

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…