Possible Extension to Comply with New Labeling Rules; The Need to Reform or Replace Proposition 65; Rick Collins to Speak at Q1 Productions 2nd Annual Dietary Supplements: Regulatory Strategy
201710.10
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Possible Extension to Comply with New Labeling Rules; The Need to Reform or Replace Proposition 65; Rick Collins to Speak at Q1 Productions 2nd Annual Dietary Supplements: Regulatory Strategy

The latest top stories for the sports nutrition, dietary supplement, and cosmetics industries: Possible Extension to Comply with New Labeling Rules On June 13, FDA reported that it would extend the compliance dates for its Nutrition Facts (and Supplement Facts) final rules. The final rules were originally set to come into effect July 26, 2018,…

2017 Mr. Olympia Fitness and Performance Weekend; Pre-DSHEA Ingredient List Meeting Set for October 3, 2017; FDA Warns Total Nutrition, Inc.; Rick Collins to Speak at Supply Side West
201709.05
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2017 Mr. Olympia Fitness and Performance Weekend; Pre-DSHEA Ingredient List Meeting Set for October 3, 2017; FDA Warns Total Nutrition, Inc.; Rick Collins to Speak at Supply Side West

The latest top stories for the sports nutrition, dietary supplement, and cosmetics industries: 2017 Mr. Olympia Fitness and Performance Weekend Our firm will once again have a presence at one of the biggest and most prestigious bodybuilding and fitness events in the country. Rick Collins, Alan Feldstein and new firm associate Jay Manfre will travel…

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…