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The Food and Drug Administration (FDA) recently issued both draft and final guidance regarding food allergen labeling requirements. The draft guidance document, Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5), updates the previous (fourth) edition with new and revised guidance concerning food allergen labeling. FDA also issued a final guidance document with the same title in order to preserve questions and answers that were unchanged from the previous (fourth) edition, which was published in 2004 and last updated in 2006.
As we predicted, earlier today, 100 industry organizations submitted a request to the Federal Trade Commission (FTC) to extend the comment period for its proposed rule banning noncompetes nationwide by an additional 60 days. According to the letter, “[t]he regulated community should be given sufficient time to assess the potential consequences of the rulemaking and develop insightful comments for the Commission to consider.” The letter further states:
On January 24, 2023, FDA published a notice in the Federal Register entitled, “Clarification of Orphan-Drug Exclusivity Following Catalyst Pharms., Inc. v. Becerra.”[1] In brief, the Catalyst decision by the 11th Circuit Court of Appeals[2] concerned FDA’s application of the Orphan Drug Act (21 USC 360cc(a)), and in particular the extent of the 7-year orphan drug market exclusivity (ODE) provided with an orphan drug’s approval. The ODE, per the Orphan Drug Act prevents FDA from approving another applicant’s same drug for “the same disease or condition.”
On November 18, 2022, the Alliance Defending Freedom (“ADF”), a conservative legal group, filed a motion with the federal district court in the Northern District of Texas against the U.S. Food and Drug Administration (“FDA”) to withdraw approval of Mifepristone, an FDA-approved drug used to end pregnancies in the first trimester.[1] While this case addresses access to a single product and was prompted by abortion opponents’ efforts to eliminate access to medication abortion, a loss for FDA in this case could have far broader implications.
On January 5, 2023, the Federal Trade Commission (“FTC”) released a Notice of Proposed Rulemaking with a proposed rule that would almost universally prohibit the use of non-competes by employers. The proposed rule would prohibit employers from (1) entering into or attempting to enter into non-competes with their workers; (2) maintaining pre-existing non-competes; and (3) representing to a worker that the worker is subject to a non-compete.
The FTC is accepting comments on the proposed rule through March 20, 2023 and this comment period could be subsequently extended. Based on comments received, the FTC will consider whether to revise the rule before publishing a final version. In its current form, the final rule would take effect 60 days after its publication in the Federal Register and employers would have 180 days to comply. Read more…
With unpredictable weather at an all-time high, cities and municipalities are facing increased claims resulting from pedestrian falls. Even on sunny days, cities are not immune from potential risks, as was the case in a recent decision rendered by the Court of Quebec in Unlusoy v. Ville de Sainte-Anne-de-Bellevue 2022 QCCQ 9681. As highlighted by the Court, an effective and well-executed maintenance plan combined with credible and trustworthy employees can help protect against claims whenever an unfortunate accident occurs on the city’s territory.
The top advertising and marketing issues this year are largely focused on one theme: Protection. Marketers will need to be aware of various trends that could threaten their intellectual property rights, reputations and market shares. Meanwhile, regulators are focusing on ensuring consumers — especially children — are protected from dark patterns, privacy breaches, false claims and other unscrupulous marketing practices.
Below are the issues that marketers must be aware of in 2023 and, in some cases, address immediately.
Top 10 Issues for 2023
1. Artificial Intelligence Artificial intelligence (AI) is an increasingly popular tool used to create a variety of content — including images, sounds, and text. AI platforms can generate content from text prompts, images and other materials uploaded to the platform. Read more…
In this episode of the Diagnosing Health Care Podcast: The Dobbs v. Jackson Women’s Health Organization decision, which effectively removed the federal constitutional protections for abortion, triggered a series of changes for health care providers and patients alike across the nation with respect to abortion services.
What additional implications are there for certain aspects of clinical trials and research?
On this episode, Epstein Becker Green attorneys Kate Heffernan, Marylana Helou, and Megan Robertson discuss how the changing state laws and regulations post-Dobbs may impact clinical research in different ways for different stakeholders.
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The Diagnosing Health Care podcast series examines the business opportunities and solutions that exist despite the high-stakes legal, policy, and regulatory issues that the health care industry faces. Subscribe on your favorite podcast platform.
The High Court of Delhi recently adjudicated upon a case that involved an appeal from Armasuisse (a Federal Agency of the Swiss Federation) against orders of the Indian Trade Marks registry granting trademark registrations to a private Indian company for the marks SWISS MILITARY and
As featured in #WorkforceWednesday: This week, we explain how New Jersey’s WARN Act (officially known as the “Millville Dallas Airmotive Plant Job Loss Notification Act”) is set to become the strictest and most punitive in the nation.
TGS Baltic is a leading law firm with offices in Vilnius (Lithuania), Riga (Latvia), Tallinn, and Tartu (Estonia). Currently, TGS Baltic unites 31 partners and 11 associate partners in the three Baltic States.
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