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Attorney General Sessions Rescinds Obama-Era Policies That Allowed State-Authorized Cannabis Activity to Flourish, Including Cole...

Earlier today, Attorney General Jeff Sessions issued a memorandum to all U.S. Attorneys in which he rescinded, effective immediately, several previous U.S. Department of Justice (DOJ) guidance documents related to marijuana...more

FDA Takes Further Actions to Encourage Digital Health Innovation, Issuing CDS, Medical Software, and SaMD Guidance Documents

Today, U.S. Food and Drug Administration (FDA or the Agency) Commissioner Dr. Scott Gottlieb announced that the Agency is issuing three new, significant policy documents to advance FDA’s approach to the development and...more

Menu Labeling Update: FDA Issues New Guidance, Plans to Implement Rule in May 2018

Yesterday, the U.S. Food and Drug Administration (FDA or the Agency) released a draft guidance, "Menu Labeling: Supplemental Guidance for Industry" (Draft Guidance). In the Draft Guidance, FDA addresses comments it received...more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

Medical Device Update: FDA Releases Device Change Final Guidances and Breakthrough Devices Draft Guidance, Qualifies First Device...

Yesterday, the U.S. Food and Drug Administration (FDA or the Agency) took a number of steps to “advance medical device innovation and help patients gain faster access to beneficial technologies,” as characterized by FDA...more

FDA Agrees to Enforce Menu Labeling Rule in May 2018, Delays New Nutrition Facts Label Compliance Deadline Until January 2020

As discussed previously, earlier this year, the U.S. Food and Drug Administration (FDA or the Agency) delayed its Menu Labeling Rule (the Rule) until May 7, 2018. FDA’s announcement in May came just one day before the Rule...more

FDA Commissioner Touts Seamless Clinical Trails, Use of Modeling and Simulation As Ways to Lower Drug Costs

In remarks at the Regulatory Affairs Professionals Society’s (RAPS) 2017 Regulatory Convergence Conference yesterday, U.S. Food and Drug Administration (FDA or the Agency) Commissioner Scott Gottlieb, M.D., spent considerable...more

FTC Remains Focused on Social Media Influencer Practices

This week, the Federal Trade Commission (FTC or the Commission) pursued enforcement action against a number of social media influencers over the influencers’ alleged failures to disclose material connections between...more

As Trump Calls for More “Made in USA” Products, FTC Ramps Up Claim Enforcement

During a campaign-style rally in Arizona last week, President Trump repeated his call for more products to be “Made in the USA.” Not surprisingly, the President did not address the standards that must be met in order for a...more

New York City Agrees To Delay Menu Labeling Until FDA Compliance Date

Late last week, groups representing restaurants, grocery stores, and convenience stores reached an agreement with New York City (the City) to ensure that the City will not enforce its analog of the U.S. Food and Drug...more

Menu Labeling Litigation Update: FDA Files Motion to Dismiss Suit Challenging Agency’s Rule Delay, Urges Southern District to...

This week, there were developments in two menu labeling lawsuits about which we reported previously: a lawsuit challenging the U.S. Food and Drug Administration’s (FDA or the Agency) delay of its menu labeling rule, and a...more

FDA Announces Major Tobacco Regulatory Policy Shift; Will Address Lowering Nicotine to Non-Addictive Levels, Delay Marketing...

On July 28, 2017, the U.S. Food and Drug Administration (FDA or the Agency) announced a new, comprehensive plan for tobacco and nicotine regulation that will place nicotine, and the issue of addiction, at the center of the...more

House Passes FDA Reauthorization Act; Would Reauthorize Key User Fee Programs and Lengthen Medical Device Malfunction Reporting...

Last week, the U.S. House of Representatives (the House) passed by voice vote the FDA Reauthorization Act of 2017 (FDARA or the Act). Introduced on May 16, 2017 by House Energy and Commerce Committee Chairman Greg Walden...more

FTC Continues to Implement Reform Agenda; Aims to Reduce Burdens of and Improve Transparency in Commission Investigations

The Federal Trade Commission (FTC or the Commission) announced a wave of reforms this week in line with Acting Chairman Maureen K. Ohlhausen’s mission to “aggressively” implement a Trump administration directive aimed at...more

Restaurants, Grocery Stores, and Convenience Stores Sue to Block New York City's Menu Labeling Rule

The U.S. Food and Drug Administration’s (FDA or the Agency) decision a couple of months ago to delay its Menu Labeling Rule until May 7, 2018 was met with mixed reactions from industry. While the National Association of...more

Trump Administration Delays Yet Another Food Rule: Revised Nutrition Facts Label Paused Indefinitely

On June 13, 2017, the U.S. Food and Drug Administration (FDA or the Agency) delayed indefinitely the Nutrition Facts and Supplement Facts Label and Serving Size rules (the Rules), which were set to go live on July 26, 2018...more

FDA Update: Menu Labeling Delay Suit, Research Oversight Change, UDI Compliance Date Delays, and Inspection Staff Reorganization

Within the past few weeks, the U.S. Food and Drug Administration (FDA or the Agency) has taken a number of actions that could impact nearly all of the industries it regulates, but in particular, companies in the medical...more

FDA in the Era of Trump: How the Agency and the Products it Regulates Could Fare

On April 11, 2017, White House Budget Director Mick Mulvaney announced that the Trump administration would be lifting a federal hiring freeze, which the President instituted on January 23, 2017. Unfortunately for current and...more

4/18/2017  /  FDA , HHS , OMB , Trump Administration

FDA to Exempt Over 1,000 Types of Medical Devices from Premarket Notification Requirements

On March 13, 2017, the U.S. Food and Drug Administration (FDA or the Agency) identified a list of 1,003 types of Class II medical devices that, when finalized, will be exempt from the Agency’s premarket notification (i.e.,...more

Menu Labeling Excluded From ACA Repeal and Replace Bill

The American Health Care Act (AHCA), released by House Republicans late on March 6, 2017, would repeal and replace certain portions of the Affordable Care Act (ACA). The legislation does not address section 4205 of the ACA,...more

NY State Supreme Court Upholds New York City’s Sodium Warning Rule

On February 10, 2017, the New York State Supreme Court, Appellate Division (the court), upheld New York City’s (the City) sodium warning rule (the Rule). The Rule requires covered establishments (i.e., chain food service...more

Hearing Aid Deregulation to Affect Wireless Device Industry and Create Compatibility Issues

Within the last week, both the U.S. Senate and the U.S. Food and Drug Administration (FDA or the Agency) have taken significant steps to deregulate a large portion of hearing aid devices. Despite the benefits that hearing...more

USDA Proposes Overhaul of Nutrition Facts Panel for Meat and Poultry Products

Earlier this month, the United States Department of Agriculture (USDA), Food Safety and Inspection Service (FSIS) issued a proposed rule to overhaul the nutrition facts panel for meat and poultry products. FSIS issued its...more

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