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…

Rick Collins and CGM&B Sponsor IFBB New York Pro
201705.19
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Rick Collins and CGM&B Sponsor IFBB New York Pro

Rick Collins and his law partners at Collins Gann McCloskey & Barry will once again be sponsoring the IFBB New York Pro Bodybuilding Competition, taking place on Saturday, May 20th. This year’s event is being held at the Westchester County Center in White Plains, NY, and will be gathering hundreds of bodybuilders and fitness enthusiasts…

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…

Meet Rick Collins and Alan Feldstein at Natural Products Expo West
201703.07
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Meet Rick Collins and Alan Feldstein at Natural Products Expo West

Two of the attorneys in the Dietary Supplements Division of Collins Gann McCloskey & Barry will be attending Natural Products Expo West tomorrow and later this week – meeting with leaders in the dietary supplement industry and health/nutrition experts to discuss some of today’s most important issues surrounding dietary supplements, functional foods and natural products….

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…