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Manufacturers › Food & Drug Regulations

Venable LLP

FDA and USDA Call for a Definition of Ultra-Processed Foods

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On July 23, 2025, the U.S. Food and Drug Administration (FDA) and U.S. Department of Agriculture (USDA) announced a joint Request for Information (RFI) to gather information and data to help establish a federally recognized...more

Holland & Knight LLP

Out with the Old: FDA to Revoke 52 Standards of Identity – What Food Companies Need to Know

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The U.S. Food and Drug Administration (FDA) announced a final rule on July 16, 2025, revoking 52 standards of identity (SOIs) for food products that it deems obsolete. The FDA currently maintains more than 250 SOIs, and this...more

Akin Gump Strauss Hauer & Feld LLP

FDA Adds a Dose of Clarity to the NDIN Process

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Recently, the U.S. Food and Drug Administration (FDA) released two educational videos and a supplemental fact sheet to guide dietary supplement manufacturers and distributors through the New Dietary Ingredient Notification...more

Quarles & Brady LLP

FDA Issues Broad Exemptions from DSCSA Enhanced Drug Distribution Security Requirements

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On October 9, 2024, the Food and Drug Administration (“FDA”) issued a document that provides exemptions to the enhanced drug distribution security requirements (enhanced requirements) required by section 582(g) of the Food,...more

Knobbe Martens

Antitrust Lawsuit Brought Against Drug Manufacturer Based on Its Allegedly Improper Listing of Device Patents in the FDA’s Orange...

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As we recently discussed, the Federal Trade Commission (“FTC”) sent warning letters to certain drug manufacturers regarding their purportedly improper listing of device patents in the Food and Drug Administration’s (“FDA”)...more

Quarles & Brady LLP

340B Developments in 2024 – Litigation and Legislation

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Although we are only two and a half months in, 2024 has already seen its fair share of impactful 340B developments on both the litigation and legislative fronts....more

Jones Day

FDA on Board With Continuing Remote Inspections

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The Food and Drug Administration ("FDA") recently issued revised draft guidance on remote regulatory assessments ("RRAs")—voluntary or mandatory examinations of food, drug, device, and tobacco establishments and/or their...more

Quarles & Brady LLP

Amidst Ongoing Manufacturer Restrictions, 340B Covered Entities and Contract Pharmacies Get Creative

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Although 340B-participating covered entities likely don’t need the reminder, numerous manufacturers continue to significantly restrict 340B pricing available via traditional “bill to/ship to” contract pharmacy models, with...more

Quarles & Brady LLP

Drug Supply Chain Security Act Compliance Extended But Trading Partners Should Still Prepare Now

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On Friday, August 25th, the Food and Drug Administration (“FDA”) issued a guidance document extending the November 27, 2023 enforcement deadline for drug and device manufacturers, wholesale distributors, dispensers, and...more

Quarles & Brady LLP

FDA Announces Guidance for DSCSA Process to Request a Waiver, Exception, or Exemption

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On Friday, August 4th, the Food and Drug Administration (“FDA”) announced the availability of a final guidance document, titled “Waivers, Exceptions, and Exemptions From the Requirements of Section 582 of the Federal Food,...more

Gardner Law

Do you know when to report a medical device complaint?

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Whether you manufacture a Class I elastic bandage or a Class III deep-brain stimulation device, understanding when to report a medical device complaint is critical and is also required for all FDA regulated medical devices....more

MoFo Life Sciences

Rulings, FDA Guidance May Help Food Cos. In Protein Suits

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Originally published by Law360, Claudia Vetesi, Nicole Ozeran, and Lena Gankin authored an article discussing a wave of protein-labeling lawsuits hitting food manufacturers, alleging that their products’ front-label protein...more

Mintz - Consumer Product Safety Viewpoints

Does CPSC or FDA Have Jurisdiction Over Your Consumer Product?

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As our readers know, we write about legal developments that affect companies involved in manufacturing, importing, distributing, and/or selling “consumer products.” In many cases, these products fall squarely within the...more

Mintz - Consumer Product Safety Viewpoints

FDA Determines Artificial Trans Fat Are No Longer “Generally Recognized as Safe”; Must Be Removed From Human Food By June 2018

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Acting to finalize a tentative decision from 2013, FDA announced on June 15, 2015 that it was issuing a declaratory order that will require manufacturers to remove partially hydrogenated oils (PHOs) from processed foods over...more

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