Sheppard Mullin litigators recently published an article in Food Manufacturing outlining USDA’s sweeping changes to its organic regulations. Entities that wish to continue utilizing the USDA Organic label must comply with USDA’s new regulations by March 19, 2024.
Continue Reading Implications of the USDA’s New Organic Rule

On April 5, 2023, the U.S. Food and Drug Administration (“FDA”) announced its decision to withdraw the approval of Makena® hydroxyprogesterone caproate injection (“Makena”) – a drug that was approved in 2011 to reduce the risk of preterm birth in certain pregnant women.[1] The final decision followed a hearing and appeal process that took nearly three years, and cited the failure of post-approval studies to prove the drug’s effectiveness as the reason for the withdrawal.[2] …
Continue Reading Withdrawal of Drug Approval Highlights Risk of Accelerated Approval Pathway

The U.S. Food and Drug Administration’s (“FDA”) approval of the commonly-used abortion medication, Mifepristone, has been curtailed following dueling federal court decisions in Texas and Washington. Just days after a Texas federal judge’s ruling suspended the FDA’s approval of the drug, the U.S. Department of Justice (the “DOJ”) asked the Fifth Circuit to grant an emergency or administrative stay of that decision. Although the Fifth Circuit did grant temporary, albeit limited, relief, the court maintained that Mifepristone could only be prescribed in the first seven weeks of pregnancy, under a physician’s supervision, and the drug cannot be sent by mail.
Continue Reading Access to Abortion Pill in Limbo: Navigating the Intricacies of FDA Approval as well as Conflicting Federal Court Rulings

On March 24, 2023, FDA issued its draft guidance for industry regarding the use of “Dietary Guidance Statements” on food labeling. FDA defines “Dietary Guidance Statements” as voluntary labeling statements, images, or words used on food packaging that convey that the food item is part of, or contributes to, a “nutritious dietary pattern.” As noted by FDA, Dietary Guidance Statements provide manufacturers with an additional set of messages that can be used on-pack, beyond nutrient content claims or “healthy” claims. FDA has issued the guidance as part of its wider effort to create a healthier food supply for Americans and ensure consumers have…
Continue Reading “Dietary Guidance Statements” in Food Labeling: What You Need to Know About FDA’s Latest Draft Guidance for the Food Industry

On March 29, 2023, and March 30, 2023, the U.S. Food & Drug Administration (“FDA”) issued a series of FAQs[1] and a guidance document[2] clarifying the agency’s intended implementation of the Consolidated Appropriations Act of 2023 (the “Omnibus”), which amended Section 524B of the Food, Drug & Cosmetics Act (the “FD&C Act”) to require the demonstration of cybersecurity safeguards in pre-market submissions for certain medical devices.[3] …
Continue Reading FDA To Require Demonstration of Cybersecurity Safeguards for Pre-Market Submissions of Certain Medical Devices

On March 1, 2023, the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration (FDA) published its first untitled letter of the year to Thomas Advanced Medical LLC (Thomas)[1] for marketing human cells, tissues, or cellular or tissue-based products (HCT/Ps)[2] without FDA premarket review. The letter described Thomas’ marketing of products derived from human umbilical cord, umbilical cord blood and amniotic tissue as “regenerative therapy solutions” or “stem cell derived biological product” to treat various diseases and conditions including cardiac disease, Alzheimer’s, Parkinson’s, lung disease, diabetes and COVID-19.
Continue Reading FDA Issues First Untitled Letter of the Year to HCT/P Manufacturer

The Food and Drug Administration (FDA) has released draft guidance for the labeling of plant-based milk alternatives, which could have a significant impact on the way these products are marketed and sold. The proposed guidance suggests that manufacturers and distributors of increasingly popular oat, almond, cashew, soy and other milk alternatives should be allowed to use the term “milk” to describe their products despite the fact these products have no actual dairy content. …
Continue Reading FDA Draft Guidance Signifies Acceptance of the Term “Milk” to Describe Plant-Based Alternatives

On Thursday, February 23, the Office of the Inspector General for the Department of Health and Human Services (“OIG”) issued its first Advisory Opinion (“AO”) of the new year – OIG AO No. 23-01 – permitting a drug manufacturer to provide financial assistance for transportation, lodging, meals, and other out-of-pocket expenses to eligible patients receiving the manufacturer’s drug (the “Arrangement”). Overall, OIG concluded that: (1) the risk of fraud and abuse presented by the manufacturer’s Arrangement was sufficiently low under the Federal anti-kickback statute; and (2) the remuneration offered under the Arrangement was not likely to influence a beneficiary to…
Continue Reading OIG Advisory Opinion Alert: Medical Flights for Patient Access

On January 31, 2023, the U.S. Food and Drug Administration (FDA) published a Warning Letter[1] to RightEye, LLC (RightEye), the manufacturer of the RightEye Vision System, for misbranding and adulteration. The RightEye Vision System is a Class II Nystagmograph medical device which is cleared under its 510(k) notification for the following indication: “recording, viewing, and analyzing eye movements in support of identifying visual tracking impairment in human subjects.”[2] …
Continue Reading FDA Issues Warning Letter to RightEye, LLC For Misbranding and Adulteration

The Sheppard Mullin Life Sciences Team decided to take a different approach to our year-end review. We surveyed and considered issues most important to our clients, asking the experts across the various specialties in our Life Sciences Practice the following question: What do life sciences companies need to keep top of mind in 2023?
Continue Reading 2023 Top-of-Mind Issues for Life Sciences Companies

On December 15, the U.S. Food and Drug Administration (FDA) issued a draft guidance, titled “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection” (the “Inspection Draft Guidance”), which clarifies the types of behaviors that FDA considers to be inappropriately delaying, denying, limiting, or refusing access to an inspection, each of which constitutes adulteration of a drug or device under the Federal Food, Drug, and Cosmetic Act (FDCA).[1] The Inspection Draft Guidance clarifies certain behaviors described in FDA’s previous guidance on the subject (the “2014 Guidance”) and, most significantly, expands the…
Continue Reading FDA Expands Inspection Guidance to Apply to Device Manufacturers

The U.S. Food and Drug Administration (FDA) has extended the comment period for its proposed new “healthy” regulations for food packaging. The new deadline for comments is February 16, 2023. The 50-day extension follows requests from stakeholders to allow additional time for interested persons to submit comments to the proposed regulations. …
Continue Reading Comment Period for “Healthy” Regulations Extended; But Consumer Class Actions Targeting “Health Halos” May Continue

As we take a breather during the holiday whirlwind, we wanted to flag for readers a recent development in advertising and promotion regulation that FDA quietly released nearly a month ago. In a Memorandum issued on October 27 (the “Memorandum”), the Food and Drug Administration (“FDA” or the “Agency”) indicated that it will now permit certain COVID-19 drugs that have been granted Emergency Use Authorization (“EUA”) to make claims of safety and efficacy in print, advertising, and promotional materials, pursuant to certain limitations.
Continue Reading FDA Lightens Promotional Restrictions for Certain COVID-19 Drugs with Emergency Use Authorization