Food & Dietary Supplements

FDA issued a proposed rule on September 28, 2022, to update the definition of “healthy” by specifying new criteria by which the term can be used in food labeling. As a result of the proposed changes, FDA expects more food in the marketplace will be able to make use of the “healthy” claim.

Continue Reading FDA Proposes Updated Rule for “Healthy” Foods

The nation’s reaction to the Coronavirus Disease (COVID-19) has been fierce—maybe unprecedented.  Information so far suggests that most COVID-19 illness is mild, yet the reaction from global markets has been drastic.  The US Food and Drug Administration (FDA) is closely monitoring the impact of the Coronavirus on the global drug supply chain and is focused on identifying and alleviating drug shortages before they happen.  The FDA also is using emergency measures to provide access to diagnostic tests and other medicines that would not otherwise be available to the public.
Continue Reading How FDA is Reacting to the Coronavirus, and 2020 Regulatory Priorities

The FDA actions that dominated 2019 demonstrated a shifting regulatory landscape for certain product types, such as e-cigarettes, foods and supplements containing cannabidiol (CBD), and digital health / machine learning enabled medical devices. FDA continued to take action to lower drug prices by focusing on approvals of competitive biosimilars and generic drugs, and FDA enforcement actions signaled the Agency’s ongoing interest in ensuring GMP compliance overseas.
Continue Reading FDA Year in Review: A Shifting Regulatory Landscape

This post was originally published on FoodDive.com.

When considering an acquisition of a food and beverage company, potential buyers of a company or its assets should pay particular attention to U.S. Food and Drug Administration requirements and their implications on the target’s business.

Buyers should be cognizant of the regulatory issues at the beginning of the process so that their risk can be assessed in the context of the transaction, and in turn, be addressed by specific representations, covenants and indemnification provisions in the transaction documents. The following considerations should be top of mind throughout the course of due diligence and negotiations. 
Continue Reading How FDA Considerations Impact Food and Beverage Acquisitions

*This article was originally posted in Law360 on June 4, 2019.

The much-anticipated public hearing last week at the U.S. Food and Drug Administration on cannabis and cannabis-derived compounds drew a wide audience of participants, with strong views on how the FDA should (or should not) regulate the controversial plant.

In an amazingly short period of time, hemp-derived products, including those containing cannabidiol, have moved from the fringe to the mainstream, from state-licensed dispensaries to traditional brick-and-mortar retailers. And yet, the FDA’s position has been clear — it is illegal to sell human food, pet food, dietary supplements and unapproved drugs that contain CBD.
Continue Reading What We Learned From FDA’s Public Hearing On Cannabis*

On May 1, 2019, AAFCO provided updated guidelines regarding the use of hemp in animal food, including how this market is affected by the Agricultural Improvement Act of 2018 (the “Farm Bill”). Although the AAFCO is not a government agency, its members are government agencies that represent the 50 states, the US Food and Drug Administration (FDA) Center for Veterinary Medicine, and the Canadian Food Inspection Agency. 
Continue Reading AAFCO Issues Updated Guidelines Regarding Hemp in Animal Food