This week, DEA announced it has entered into a settlement agreement with Morris & Dickson Co., LLC (“Morris & Dickson”), resolving the protracted dispute born out of a May 2, 2018 Order to Show Cause (“OTSC”) and Immediate...more
We recently reported that several state legislatures are considering bills to establish vapor product directories this year — namely Florida, Indiana, Missouri, and Virginia. Throughout January and early February, similar...more
In anticipation of the US Food and Drug Administration (FDA) budget request for Fiscal Year (FY) 2025, this alert provides an overview of the agency’s most recent priorities as outlined in FDA’s FY 2024 budget, found here....more
This year, several state legislatures will consider bills to establish vapor product directories. Amid heightened scrutiny of illicit vapor products by the U.S. Food and Drug Administration (FDA), these product directory...more
The Food and Drug Administration’s Center for Tobacco Products (“CTP”) has released a strategic plan intended to guide the Center’s activity for the next five years. While the strategic plan highlights the laudable goals of...more
In December, the U.S. Food and Drug Administration (FDA) issued warning letters to online retailers for reportedly selling unauthorized e-cigarette products. Consistent with the Center for Tobacco Products’ (CTP) recent...more
Manufacturers of e-cigarettes find themselves in a challenging regulatory environment to obtain U.S. Food and Drug Administration (FDA) marketing approval of flavored products. On October 12, 2023, the FDA denied premarket...more
With the swipe of a pen, California Governor Gavin Newsom starts the California Food Safety Act countdown to a 2027 statewide ban on four popular food additives. Starting January 1, 2027, companies manufacturing, selling,...more
Last week, the California legislature approved Assembly Bill 418, the California Food Safety Act (AB 418), which is headed to Governor Gavin Newsom to sign or veto by October 14, 2023....more
On August 22, 2023, the Troutman Pepper Tobacco + Nicotine Team attended the Food and Drug Administration’s Center for Tobacco Products (“CTP”) virtual listening session on the development of CTP’s strategic plan. We...more
Last month, the FDA’s Office of Cosmetics and Colors issued a Draft Guidance encouraging tattoo ink manufacturers and distributors to recognize situations in which these products may become contaminated with microorganisms,...more
The California Assembly has passed a first-in-the-nation bill banning the use of five food additives, including Red Dye No. 3 and titanium dioxide, in food products manufactured, sold or distributed in the state. The...more
FDA Proposes Changes to Standards of Identity for Foods Including Salt- The U.S. Food and Drug Administration (FDA) has issued a proposed rule that would change the standards of identity (SOIs) for foods that include salt to...more
LEGISLATION, REGULATIONS & STANDARDS - California Lawmakers Introduce Legislation to Ban Five Food Additives - California lawmakers have introduced first-in-the-nation legislation seeking to ban five food...more
LEGISLATION, REGULATIONS & STANDARDS - USDA Proposes Rule Limiting 'Made in the USA' Claims for Meat, Poultry and Eggs - The U.S. Department of Agriculture (USDA) has issued a proposed rule that would tighten who can label...more
A study published February 27, 2023, in the journal Nature Medicine has purportedly found possible links between erythritol and major adverse cardiovascular events such as heart attack or stroke. Erythritol is an artificial...more
LEGISLATION, REGULATIONS & STANDARDS - FDA Announces Update on Human Foods Program Restructuring - The U.S. Food and Drug Administration (FDA) has issued a news release with an update on the restructuring of its Human Foods...more
The U.S. Food and Drug Administration (FDA) has announced the availability of draft guidance for industry on labeling plant-based milk alternatives. The guidance indicates that plant-based milk alternatives can be labeled as...more
A salmonella outbreak that sickened hundreds brought the largest criminal penalty ever imposed following a criminal conviction in a food safety case. Our Food & Beverage and White Collar, Government & Internal Investigations...more
Shook Senior Counsel Talks FDA on NOSH Podcast - NOSH has interviewed Shook Senior Counsel John Johnson for an episode of its podcast. The episode discusses the implications of the December 2022 Reagan-Udall Foundation...more
LEGISLATION, REGULATIONS & STANDARDS - Evaluation of FDA Human Foods Program Finds Culture of “Constant Turmoil” - An independent review commissioned by the U.S. Food and Drug Administration (FDA) of the Human Foods Program...more
The U.S. Food and Drug Administration (the FDA) issued marketing denial orders (MDOs) to JUUL Labs for all of its products currently marketed in the United States. As a result of this MDO, JUUL must stop selling and...more
Academic institutions and faculty engaged in developing novel drug therapies are navigating an increasingly complex compliance landscape. ...more
In a signal to industry that the period for education and enforcement discretion related to the Foreign Supplier Verification Programs (FSVP) may be concluding, the Food and Drug Administration (FDA) recently issued its first...more
The U.S. Food and Drug Administration (FDA) recently issued the first Warning Letter addressing violations of the Foreign Supplier Verification Program (FSVP) rule, one of the seven major FDA Food Safety Modernization Act...more