Ernst & Young (E&Y) indicated in a report released on Monday, January 22, 2018, that more than 10 percent of initial coin offering (ICO) funds are lost or stolen in hacker attacks (almost $400 million), and that...more
Within the past few weeks, the U.S. Food and Drug Administration (FDA or the Agency) has, among other things:
Issued a Draft Guidance to strengthen public warning and notification of recalls of foods, drugs, medical...more
Earlier today, Attorney General Jeff Sessions issued a memorandum to all U.S. Attorneys in which he rescinded, effective immediately, several previous U.S. Department of Justice (DOJ) guidance documents related to marijuana...more
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
Yesterday, the U.S. Food and Drug Administration (FDA or the Agency) released a draft guidance, "Menu Labeling: Supplemental Guidance for Industry" (Draft Guidance). In the Draft Guidance, FDA addresses comments it received...more
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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