Your legal team sends an urgent alert – FDA just published a proposed rule that could fundamentally change your labeling requirements, compliance costs, or market access. The comment period closes in 60 days. You know you need to respond, but where do you start? What makes a comment actually influential rather than just another submission […]
How to Prepare for FDA and USDA Rulemaking and Public Comment Read More »
Your FSIS inspector flags a sanitation issue during routine review. FDA issues a warning letter citing preventive controls violations. USDA questions your animal-raising label claims. Any of these compliance failures can trigger enforcement escalation – from warning letters to civil penalties, suspension of operations, or mandatory recalls. The regulatory framework governing food and agriculture operations
Government Compliance and Risk Management in Food & Agriculture Read More »
Your food products meet every safety standard. Your food date labeling complies with current regulations. Yet consumers are throwing away millions of dollars worth of your perfectly safe products because they misunderstand the dates printed on your packaging. I know this because the regulatory disconnect around date labeling has created a compliance vacuum that damages
Your marketing claims meet industry standards. Your labeling passed internal review. Yet you’ve received an FDA Warning Letter, an FTC demand letter, or worse – notification that the Department of Justice is investigating potential criminal misbranding charges. I know this because enforcement against food, supplement, and consumer product advertising has intensified dramatically in 2025-2026. FDA
Your production schedule just got derailed by an FDA inspection observation. Your quality team is scrambling to understand why procedures you’ve followed for years suddenly don’t meet current Good Manufacturing Practice requirements. And now you’re facing questions from executives about potential warning letters and what they mean for your business. I’ve seen this pattern repeatedly
Your product launches are delayed. Your labeling team just received contradictory guidance from two different federal agencies. And now you’re facing questions from your legal department about which food labeling laws actually apply to your products. I’ve guided food manufacturers through this exact compliance maze for years – and the confusion isn’t your fault. FDA
Food Labeling Laws: FDA vs USDA Requirements and Enforcement Risks Read More »
In late March 2025, The U.S. Department of Health and Human Services (“HHS”) announced that it would cut 3,500 full-time Food and Drug Administration (“FDA”) positions. HHS claimed that those cuts would be focused on “streamlining operations and centralizing administrative functions” and “not affect drug… reviewers, nor… impact inspectors.” The positions that FDA
Examining FDA’s New Alternative Tools for Drug Pre-Approval and Pre-License Inspections Read More »
Modernizing Food Standards of Identity (SOI) has been on United States Food and Drug Administration’s (FDA) radar for the last 20 years, but there has been very little movement on the subject until this past year. On Wednesday, FDA announced that it is revoking the Standard of Identity (SOI) for French Dressing, which is the
On July 1st, the Federal Trade Commission voted 3-2 to publish the final Made in USA Labeling Rule in the Federal Register. The rule is consistent with – and essentially codifies – its prior 1997 Enforcement Policy Statement on U.S. Origin Claims, and provides the agency with enforcement tools to combat fraudulent claims. The rule
FTC to Issue Final Rule to Combat “Made in USA” Fraud Read More »
Earlier this month, the Department of Health and Human Services (HHS) published a proposed rule that would require sunset dates for its regulations, including regulations under its agencies like the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS). The proposed rule, “Securing Updated and Necessary Statutory Evaluations Timely,” flew
HHS’s Last Ditch Policy Moves – What is the End Game? Read More »
The FDA is currently posting updates in a Q&A format on its Food Safety and the Coronavirus Disease 2019 (COVID-19) webpage. The Q&A provides information to food production/processing facilities and retail food establishments regarding best practices during the ongoing public health emergency. For example, the website provides some salient advice on social distancing in food
FDA COVID-19 Food Safety Q&A Read More »
Today the FDA issued a guidance to provide temporary flexibility regarding the packaging and labeling of shell eggs sold to consumers in retail food establishments. Temporary Policy Regarding Packaging and Labeling of Shell Eggs Sold by Retail Food Establishments During the COVID-19 Public Health Emergency: Guidance for Industry (Apr. 2020) The guidance essentially permits retailers
Complete Label Exemption for Shell Eggs During Pandemic Read More »
The Food and Drug Administration (FDA) has issued a guidance to chain restaurants and similar retail food establishments (“covered establishments”) that sell standard menu items covered under the menu labeling provisions of section 403(q)(5)(H) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to provide flexibility regarding these menu labeling requirements during the COVID-19
Menu Labeling Flexibility for Covered Establishments During Pandemic Read More »
A qualified health claim is one of the few tools FDA gives food and supplement companies to link an ingredient to a reduced disease risk on a label. For EPA and DHA omega-3s, FDA authorizes two sets of qualified health claim language covering coronary heart disease and hypertension – but the enforcement discretion letters that
EPA and DHA Qualified Health Claims: A Compliance Guide for Food and Supplement Labels Read More »
FDA does not set a single caffeine cap for dietary supplements. The rules sit across multiple statutes and regulations – the Dietary Supplement Health and Education Act (DSHEA), 21 CFR Part 182, the FD&C Act’s adulteration provisions, and FDA’s guidance on highly concentrated caffeine products. For supplement manufacturers, the real compliance risk is not “how
FDA Caffeine Regulations for Dietary Supplements Read More »
Last week, the Food and Drug Administration (“FDA”) published a notice in the Federal Register implementing additional requirements for medical devices under the 21st Century Cures Act (“Cures Act”). Section 3059 of the Cures Act requires FDA to publish a list of reusable device types that must include validated instructions for use, in addition
FDA implements 21st Century Cures Act Requirements for Reusable Devices Read More »
This past week FDA made a number of Warning Letters available on its website, with issues ranging from Juice HACCP to cGMPs for finished pharmaceuticals. A Warning Letter is informal and advisory, with the aim to achieve voluntary compliance and to establish prior notice. It communicates the agency’s position on a matter, but it does
Warning Letters Update Read More »
We have blogged and hosted numerous webinars on FDA regulation of mobile medical apps (see here, here, here, here and here); but if you are an app developer, you should be aware that FDA is not the only agency looking at your app. The Federal Trade Commission (FTC) may also be watching how you promote your app. In fact, on February 23, 2015 the
Who Regulates the Advertising of Your App? Read More »
Earlier this month, FDA’s Center for Devices and Radiological Health issued its FY 2015 Proposed Guidance Development and Focused Retrospective Review of Final Guidance. CDRH lists 28 guidance documents in total. The “A-list” includes both draft and final guidances that CDRH intends to publish by January 2016, and the “B-list” includes guidance documents that it intends to
CDRH’s 2015 Weather Forecast Predicts A Storm of Guidance Documents Read More »
OFW Law Celebrates 35 Years of Successes in Drug/Healthcare Privacy Practices (Part III) In celebrating 35 years of practice, OFW Law’s Drugs, Biologics, and Controlled Substances and Healthcare Privacy practice groups are taking a look back to share some highlights throughout the years. Parts I and II focused on Hatch-Waxman and medical privacy laws, while
The Realized Benefits of User Fees Read More »
Ackee fruit is one of the most heavily regulated food imports entering the United States. The FDA maintains a standing import alert – Import Alert 21-11 – that authorizes automatic detention of all ackee products at U.S. ports of entry unless the manufacturer has earned placement on the agency’s approved Green List. For Caribbean food
What Importers Must Know About FDA Regulation of Ackee Fruit Products Read More »
Over the past several months, we have received several questions regarding how HIPAA interacts with the FCC’s implementation of rules under the Telephone Consumer Protection Act (TCPA). Specific questions center around when authorization may be required for calling cell phones or sending text messages to cell phones that include health-related content, such as a reminder
HIPAA, the TCPA and Robodialing Read More »
Since January 1, it seems that the Center for Devices and Radiological Health (CDRH) has been out of the agency’s spotlight, and even FDA’s “News & Events” webpage has been lacking in its reporting of medical device related activity. This is not to say that there have been no recent developments in the last eighteen
What’s New at CDRH? Read More »
The Department of Health and Human Services (HHS) revealed in court filings yesterday that it expects to issue guidance regarding prescription refill reminder programs before September 23, 2013. It also stated that it will not enforce the restrictions in its new HIPAA Privacy Rule regarding refill reminders and other communications about drugs or biologics until
On September 27, 2007, President George W. Bush signed into law H.R. 3580, the Food and Drug Administration Amendments Act of 2007 (“FDAAA”). FDAAA both enhances and curtails FDA’s authority in many respects. Specifically, FDAAA removes a requirement that manufacturers of Class I devices and Class II devices that are not permanently implantable, life supporting,
Adverse Event Reporting for Medical Devices and the Law: Where Has FDA Gone Wrong? Read More »
You have probably heard that on May 6, 2013, FDA issued a proposed rule requiring warning labels to be affixed to tanning beds. It has been all over the news – FDA’s Center for Device and Radiological Health (CDRH) was like a moth to a tanning bed light bulb, touting its latest warning requirement to
Warning: FDA Tightens Up Regulations for Tanning Beds Read More »
“[Final guidance] should be out by the end of the fiscal year” said Christy Foreman, Director of the Office of Device Evaluation, in her testimony before the House Oversight and Investigations Subcommittee on March 21, 2012. Ms. Foreman’s testimony can be viewed at the committee website, here. In July 21, 2011, FDA released draft guidance
Mobile Medical Application Guidance From FDA is Coming Read More »
At the end of 2012, 850 million users worldwide were on Facebook, more than one million websites have integrated with Facebook and 34 percent of U.S. marketers have generated leads using Twitter. You can see more social media statistics at the Huffington Post here. Guidance on legal compliance moves far more slowly than the innovation
FTC Offers Updates Guidance on Social Media; Still Waiting on FDA Read More »
Changes could be coming for medical device labeling regulations. On January 7, 2013, the Food and Drug Administration (“FDA”) announced in the Federal Register a public workshop and solicitation of comments concerning “Accessible Standardized Medical Device Labeling.” The Federal Register notice can be viewed here and the public workshop will be held on April 29 and
Is Standardized Device Labeling On The Way? Read More »
When the comment period closed on November 7, the Food and Drug Administration’s (FDA) proposed rule on Unique Device Identification (“UDI”) generated a total of 221 comments by various stakeholders. Although the FDA has come a long way since it first sought comments on the use of an identifier system in 2006, a review of the comments
Everyone has an Opinion on Unique Device Identification Read More »
