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Warning Letters

EU Competition Newsletter - March 2018

by Bryan Cave on

Early attention to the antitrust considerations of a given transaction can go a long way towards promoting the chances of timely or even early clearance of a transaction. As an initial matter, parties should focus their...more

2017 Year in Review: FDA Office of Prescription Drug Promotion Warning and Untitled Letters

by King & Spalding on

In 2017, the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) issued a total of five enforcement letters that cited violations related to the advertising and promotion of prescription...more

Resale Price Maintenance and Restrictions on Online Selling Still Dominate CMA Concerns

by Bryan Cave on

The Competition and Markets Authority (CMA), the principal UK competition regulator, maintains a register of competition law advisory and warning letters it sends to businesses it believes could be breaching competition law....more

FDA, FTC Try to Stop Opioid Cessation Products

Marketers of opioid cessation products received warning letters from the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC), cautioning them about unproven claims for the treatment of opioid addiction...more

Dietary Supplement & Cosmetics Legal Bulletin | February 2018

FDA Issues Draft Guidance for Homeopathic Drug Products - The U.S. Food and Drug Administration (FDA) has issued draft guidance, "Drug Products Labeled as Homeopathic," that would prioritize enforcement and regulatory...more

Labeling and Manufacturing Compliance for Dietary Supplements is About More than Avoiding Characterization as a Drug

by Arnall Golden Gregory LLP on

We are all accustomed to seeing Warning Letters issued by the Food and Drug Administration for products marketed as dietary supplements that make claims that the Agency believes cause the product to be an unapproved new drug...more

FDA & FTC Issue Joint Warning Letters to Companies Marketing Products to Overcome Opioid Addiction and Withdrawal

by Kelley Drye & Warren LLP on

The FDA & FTC today posted warning letters to 11 marketers and distributors of opioid cessation products, alleging that such products were unapproved new drugs that violated the Federal Food, Drug and Cosmetic Act (FDCA) and...more

Get by with a Little Help from My Friends (Maybe Not): FDA Reiterates Reliance on Others Doesn’t Ensure Regulatory Compliance

by Arnall Golden Gregory LLP on

Here we go again. The Food and Drug Administration issued a Warning Letter on December 13, 2017, to a Korean pharmaceutical company for non-compliance with current Good Manufacturing Practice requirements. What caught our eye...more

No Regulations for Love and Vice Versa

A warning letter from FDA back in September 2017 complained about a bakery including “love” in its list of ingredients for its bread: The letter goes on, While regulation is a necessary evil, ridiculous incidents such as this...more

#TheFTCisWatchingYou: Influencers, Hashtags and Disclosures 2017 Year End Review

by Patrick Law Group, LLC on

Influencer marketing, hashtags and proper disclosures were the hot button topic for the Federal Trade Commission (the “FTC”) in 2017, so let’s take a look at just how the FTC has influenced Social Media Influencer Marketing...more

FDA 2017 Year in Review: Therapeutic Products, Part 2

Yesterday we started off our year-end series of blog posts with the first part of a review of FDA’s actions for 2017 in the therapeutic products space. Part 1 recapped Commissioner Gottlieb’s initiative to tackle drug...more

Bridging the Week - December 2017 #2

by Katten Muchin Rosenman LLP on

First Cash-Settled Bitcoin Futures Contract Begins Trading on CFTC-Overseen Exchange; Industry Organization Bemoans Self-Certification Process: The CBOE Futures Exchange commenced trading of Bitcoin Futures last night –...more

Investing Under the Influence? SEC Issues Warning Letters to Celebrities and Social Influencers

by Kelley Drye & Warren LLP on

Earlier this month, the Securities and Exchange Commission (SEC) issued a warning to celebrities and social influencers who use social media to encourage consumers to invest and/or purchase stocks. Recent celebrity...more

FDA Warns Companies Marketing Unsubstantiated Marijuana-Derived Products That Claim to Treat or Cure Cancer

Earlier this week, the U.S. Food and Drug Administration (FDA or the Agency) issued Warning Letters to four companies – Greenroads Health, Natural Alchemist, That’s Natural! Marketing and Consulting, and Stanley Brothers...more

Love Is Not An Ingredient

by Fox Rothschild LLP on

Last month, the Food & Drug Administration (“FDA”) sent a lengthy warning letter to Nashoba Brook Bakery, a bakery based in Massachusetts, identifying a number of alleged violations of food regulations and labeling...more

AGG Food and Drug Newsletter - October 2017

by Arnall Golden Gregory LLP on

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

You Can’t Change That: FDA Reiterates Risk of Delegating Responsibility in Quality Agreements

by Arnall Golden Gregory LLP on

In the span of three weeks, the Food and Drug Administration issued Warning Letters to two dietary supplement companies, in part, for relying, to their detriment, on quality agreements. We discussed another similar Warning...more

EU & Competition Law Update – October 2017

by Bryan Cave on

When is a private company considered a public body and subject to the EU procurement rules? A recent European Court of Justice (“ECJ”) case has thrown up a novel legal issue which will be of interest to all public...more

I Won’t Back Down: Another Company Refuses to Permit FDA to Inspect

by Arnall Golden Gregory LLP on

Not long ago, we wrote about a company that refused to permit an FDA investigator to conduct an inspection. Well, here we go again. Apparently a fan of the late, great Tom Petty, the company told the agency, “I won’t back...more

FDA Scolds Company Claiming to Bake with Love

by Faegre Baker Daniels on

Where’s the love? Apparently, not at the FDA. On September 22 the FDA issued Warning Letter CMS# 532236 to Nashoba Brook Bakery, of Concord, Mass. Among several infractions cited in the letter was one for the misbranding...more

EU Retail News - September 2017

by Bryan Cave on

UK Competition Authority Warns Creative Sector About Price Fixing and Information Sharing - On 12th September 2017 the UK Competition Authority,the Competition and Markets Authority ("CMA") sent an open letter to...more

These Flakes Can’t Fake it – FDA Says They’re Not Medical Foods

by Arnall Golden Gregory LLP on

FDA recently issued a warning letter to a medical food manufacturer for several violations of the Federal Food, Drug, and Cosmetic Act (FDCA). The violations were discovered during FDA’s inspection of the facility. FDA said...more

Continuing Coverage of FDA’s Crackdown on Stem Cell Clinics: Florida Clinic Cited for Unapproved Marketing and Inadequate...

by Hogan Lovells on

On the same day that FDA’s Commissioner, Dr. Scott Gottlieb, announced new policy initiatives regarding stem cell therapies and regenerative medicine, FDA announced stepped up enforcement in this area and posted a warning...more

AGG Food and Drug Newsletter - September 2017

by Arnall Golden Gregory LLP on

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

Recent Warning Letters from FDA about Medical Devices: Investigational Device Exemptions and Lack of Marketing Authorization are...

by Arnall Golden Gregory LLP on

Over the past several months, the Food and Drug Administration (FDA) has issued several Warning Letters related to Investigational Device Exemption (IDE) requirements and misbranding. An IDE allows an investigational device...more

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