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Is Your Brand FDA Acquisition-Ready? The Regulatory Checklist Every Founder Should Complete Before Due Diligence

Your Marketing Team Created a Viral Claim. Did They Also Create an FDA Enforcement Risk?

FDA Warning Letter, Form 483, or Inspection Observation? Do Not Panic. Do Not Hit Reply. Do This Instead.

Your Product Is Detained at the Port. Your Inventory Is Stuck. Your Customers Are Waiting. Now What?

The Hidden FDA Problems That Can Destroy Your Next Funding Round, Acquisition, or Exit

FDA’s Updated 2026 Human Foods Guidance Agenda

Your Wellness Device Is Smarter Than Ever. Is It Still a “Wellness” Product?

FDA Form 483 Response Strategy

FDA Expands OTC Sunscreen Options

FDA import enforcement operates along a predictable—but unforgiving—continuum: detention, refusal, and, in repeat cases, import alert placement.

FDA Import Detentions, Refusals, and Import Alerts

FDA’s New Inspection Playbook (and Why You Should Care)

One Day, Big Impact

Using AI Tools in FDA Compliance

Using AI Tools in FDA Compliance

FDA inspections don’t arrive with much ceremony. There’s no buildup—just a badge, a few introductions, and then a steady stream of questions about your documents, your systems, and your people.

The FDA Called. They’d Like to See Everything

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents the most consequential update to U.S. cosmetics regulation since the Federal Food, Drug, and Cosmetic Act was enacted in 1938.

MoCRA in Practice

What They Are, How to Avoid Them, and How to Mitigate Successfully

Liquidated Damages for FDA‑Regulated Products

FDA Scrutiny on Honey Fraud Intensifies

The Sticky Truth

FDA’s PFAS Cosmetics Report Forever Chemicals, Federal Oversight, and the Changing Regulatory Landscape

FDA’s PFAS Cosmetics Report

FDA Launches Unified Adverse Event Monitoring System (AEMS), Expanding Safety Surveillance and Regulatory Oversight

FDA Launches Unified Adverse Event Monitoring System (AEMS), Expanding Safety Surveillance and Regulatory Oversight

The Color of Compliance

Love, Labels, and Selling Self-Care Without Selling an Unapproved Drug

Preparing for FDA’s 2026 Human Foods Priorities: Transparency is the New Flavor

FDA’s New Cosmetic Recall Power What Brands Need to Know Now

FDA’s New Cosmetic Recall Power

New Year, New Guidance

FDA’s Annual Device Registration Renewal Is Back Online — and the Clock Is Ticking to December 31 (Yes, it’s that time of year again — compliance season!)

FDA’s Annual Device Registration Renewal Is Back Online — and the Clock Is Ticking to December 31

Format Risk in the Era of Foodified Beauty

A Fine Line Between SPF and Soufflé

The Ongoing Impact of the Government Shutdown on FDA and Regulated Industry — and What Companies Should Prioritize

Regulatory Limbo

Dashboard Confessional

FDA Launches Nationalized Entry Review Program

FDA Launches Nationalized Entry Review Program

Court Upholds FDA’s Authority Over Homeopathic Drugs, Leaving Industry with Few Remedies

Court Upholds FDA’s Authority Over Homeopathic Drugs, Leaving Industry with Few Remedies

Not Quite Food, Not Quite Fiction FDA Seeks Definition for Ultra-Processed Foods in Major Regulatory Shift

Not Quite Food, Not Quite Fiction

Stars, Stripes, and Substantiation

Stars, Stripes, and Substantiation

Knock, Knock, It’s the FDA

Crayon Box Clean-Up: FDA Approves Three Natural Food Colors

Crayon Box Clean-Up: FDA Approves Three Natural Food Colors

When International Compliance Gets a Pop Quiz!

FDA May Be Turning Down the Heat on Inspections, But Food Safety is Still on the Burner A Closer Look at the Potential Inspection Shift, State Oversight and How to Stay Compliant

FDA May Be Turning Down the Heat on Inspections, But Food Safety is Still on the Burner

Strategic Guidance for FDA-Regulated Companies

Navigating FDA Regulations Amid 2025 Trump-Era Trade Policies

Beauty Secrets Revealed What FDA’s Latest Cosmetic Data Means for the Beauty Biz

Beauty Secrets Revealed

The Growing Trend of States to Ban Food Dyes What It Means for the Regulated Industry

The Growing Trend of States to Ban Food Dyes

Totally Cool, Inc. Gets the Freeze-Out from the FDA Following Food Safety Violations

Totally Cool, Inc. Gets the Freeze-Out from the FDA Following Food Safety Violations

The Ultimate Permit Tag-Team Navigating USDA and FDA Regulations

The Ultimate Permit Tag-Team

How to Handle Import Rejection Like a Pro

FDA Doesn’t Send Love Letters

Global Implications and Compliance in the Age of MoCRA

Global Implications and Compliance in the Age of MoCRA

FDA Revokes Approval for Red No. 3 in Foods and Dietary Supplements

FDA’s Regulation and Updated Definition of “Healthy”

FDA's Tighter Grip on Talc and Asbestos Testing

The FDA’s New Year’s Resolution

FDA’s Photo Policy Snaps Back

Say Cheese or Say Trouble?

Keeping Fish Fresh and Regulations Fresher Navigating FDA’s New Scombrotoxin Standards

Keeping Fish Fresh and Regulations Fresher

Witch’s Brew and Candy Hues: The Bewitching World of FDA-Approved Halloween Candy Colors

Witch’s Brew and Candy Hues

Navigating the FDA’s High Seas of Foreign Supplier Verification Program (FSVP) Inspections

Warning Letters Ahoy!

Medical Device Facility Registration and Food Facility Registration

Tick Tock, Don’t Get Blocked (Entries)!

FDA Investigates Tampon Safety

FDA Investigates Tampon Safety

Navigating USDA Permits for FDA Regulated Products

Double Trouble!

Herbs, Hocus Pocus and the FDA Navigating FDA’s Complex Regulation of Homeopathic and Ayurvedic Products

Herbs, Hocus Pocus and the FDA

Fee-Fi-Fo-FDA: New Device Fees on the Horizon!

Fee-Fi-Fo-FDA: New Device Fees on the Horizon!

FDA Issues Warning Letters to Companies Selling Delta-8 THC Products in Kid-Friendly Packaging

FDA Issues Warning Letters to Companies Selling Delta-8 THC Products in Kid-Friendly Packaging

Unlocking International Markets The Magic of FDA Export Certificates Including New Requirements for Dairy Exports to India

Unlocking International Markets

FDA’s Foods Program: A Star-Spangled Update!

FDA’s Foods Program: A Star-Spangled Update!

It’s Getting Hot in Here!

Sip Happens-The Wild Waters of an FDA Recall

Sip Happens

The Importance of Conducting a Regulatory “Check-Up”: Ensuring FSVP Compliance and Passing an FDA FSVP Inspection, Regulatory Check-Up

FDA FSVP Inspections and Warning Letters on the Rise, oh my!

FDA’s New Final Rule on LDTs A Paradigm Shift in the Regulation of Diagnostic Devices

FDA’s New Final Rule on LDTs

Blush, Brush and MoCRA!

Blush, Brush and MoCRA!

The FDA Import Detention Marathon An Endurance Test of Paperwork and Patience

The FDA Import Detention Marathon

510(k) Premarket Notification Process

FDA’s Updated Approach to the 510(k) Premarket Notification Process for Medical Devices

FDA Intensifies Scrutiny on Honey Amid Rising Concerns of Economic Adulteration

Show me the Honey!

Toxic Yellow Oleander in Certain Supplements Receives Updated FDA Warning

Don’t Try to Beat this Yellow!

FDA, OTC Monograph Drug User Fee Program

FDA’s OTC Monograph Drug User Fee Program

FDA’s Import Alert for Chemical Contaminants Including PFAS Implications for Food Industry and Businesses

FDA’s Import Alert for Chemical Contaminants Including PFAS

Streamlining Pathways to FDA Medical Device Market Clearance/Approval

Streamlining Pathways to FDA Medical Device Market Clearance/Approval

Dietary Supplements and New Dietary Ingredient Notifications (NDINs) FDA Issues Final Guidance on Updated Procedures and Timeframes

Dietary Supplements and New Dietary Ingredient Notifications (NDINs)

FDA Medical Device Establishment Registration FDA Proposes Modifications to Medical Device User Fee Small Business Qualification and Certification Register medical device at garg-Law.com

FDA Medical Device Establishment Registration

Effective Implementation of USDA’s Strengthening Organic Enforcement (SOE) Final Rule Is Just around the Corner garg-law.com

USDA’s Strengthening Organic Enforcement (SOE) Rule

Celebrating Valentine’s Day with Aromatherapy Products or “Love” as an Ingredient in your Granola? A Quick Look at FDA’s Regulation of Cosmetics vs. OTC Drugs and FDA-Approved Ingredients Garg-law.com

Celebrating Valentine’s Day with Aromatherapy Products or “Love” as an Ingredient in your Granola?

A Game of Red Light, Green Light: A Look at FDA Import Alerts

A Game of Red Light, Green Light: A Look at FDA Import Alerts

Heads Up Medical Device (and Cosmetic Device) Manufacturers and Importers!

Heads Up Medical Device (and Cosmetic Device) Manufacturers and Importers!

What’s Coming Down the Pike for Foods and Cosmetics, you ask? FDA Showcases New Regulation Portal for Food + Cosmetics Program

What’s Coming Down the Pike for Foods and Cosmetics, you ask?

What Should I Really Be Doing Now to Tone and Brighten for FDA Cosmetics Compliance?

MoCRA Readiness

Initiate and Execute an FDA Recall to Quickly Remove Potentially Violative Product

How to Initiate and Execute an FDA Recall

An Early Holiday Present! FDA (FINALLY) Announces Opening of Cosmetics Direct Portal for Electronic Registration and Listing of Cosmetic Product Facilities and Products

An Early FDA Holiday Present!

FDA Revisiting Classification of Wound Dressings and Liquid Wound Washes, more at FDA Regulatory Law Firm garg-law.com

FDA Revisiting Classification of Wound Dressings and Liquid Wound Washes

FDA-Screens-Incoming-Shipments-of-Cinnamon-for-Lead-Contamination---as-a-Result-of-Recalled-Apple-Cinnamon-Fruit-Pouches-FDARegulatory-Law-Firm-garg-law.com

A Sprinkle of Holiday (Lead-Free) Cinnamon Spice?

Update on FDA Cosmetic Product Facility Registration and Cosmetic Product Listing Requirements – Enforcement Delayed by 6 Months

Enforcement Delayed by 6 Months

Tis the Season for Cosmetic Registration and Product Listing (with a Slight Delay) FDA Regulatory Law Firm garg-law.com

Tis the Season for Cosmetic Registration and Product Listing (with a Slight Delay)

FDA Issues Warning to Avoid Purchase or Use of 26 Eyedrops Products from Several Major Brands due to Risk of Eye Infection

FDA Issues Eyedrops Products Warning

check and ensure that those decorative contact lenses, and Halloween makeup are FDA compliant

Celebrating Halloween With a Goulish Glow?

MoCRA and Recordkeeping

If it’s Not in Writing, it Doesn’t Exist!

2023 FDA Device Registration Renewal, garg-law.com, FDA

It’s that Special Time of Year Again! FDA Device Registration Renewal

FDA Releases Updated Draft Guidance on the Preventive Controls for Human Food Rule Food Allergen Program and Acidified Foods

FDA Releases Updated Draft Guidance

Avoid Blushing and Don’t Let GMP Violations Add to Your Highlight: Prepping for a MoCRA and FDA Cosmetics Inspection

Avoid Blushing and Don’t Let GMP Violations Add to Your Highlight

Moving the Needle and Modernizing the 510(k) Process

Moving the Needle and Modernizing the 510(k) Process

FDA Inspections on the Rise: What to Expect and How to Prepare

FDA Inspections on the Rise

Casting a Wider Net for Safer Seafood? FDA Announces Regulatory Partnership Arrangement with Ecuador

Casting a Wider Net for Safer Seafood?

Up, Up and Up! FDA Announces New Medical Device User Fees for FY 2024

Up, Up & Up!

Title 2: What You Need to Have in Place Now for MoCRA Cosmetic Product Substantiation

Can’t Conceal This!

BREAKING NEWS: FDA Issues Draft Guidance on Cosmetic Facility Registration and Product Listing

BREAKING NEWS: FDA Issues Draft Guidance on Cosmetic Facility Registration and Product Listing

Open Sesame: Updates on Sesame Allergen Labeling

Open Sesame: Updates on Sesame Allergen Labeling

What is a U.S. Customs Liquidated Damages Claim, also known as Notice of Penalty or Liquidated Damages? Avoid and Mitigate U.S. Customs Liquidated Damages and Penalties garg-law.com

CBP Liquidated Damages, Penalties, & Fines…oh my!

Cosmetic Facility Requirements: Ensuring Product Manufacturing Success

Cosmetic Facility Requirements: Ensuring Product Manufacturing Success

Mid Summer Grillin’! Fire up the…Cell Incubator? FDA and USDA Regulatory Updates on Lab Grown Meat

Mid-Summer Grillin’! Fire up the…Cell Incubator?

FDA Releases Update of Priority Guidance Topics

FDA Releases Update for the FDA Foods Program

Prep + Prime for MoCRA

Prep + Prime for MoCRA

Don't spend the Summer in Detention! A Guide to Avoiding FDA Import Refusal

Summer is for Vacation, not Detention: A Guide to Avoiding FDA Import Refusal and Detention

Protecting Your Sunny Side Up A Look at FDA’s Regulation of Sunscreen

Protecting Your Sunny Side Up

A-Look-at-FDA-Enforcement-Policy-on-Major-Food-Allergen-Labeling-and-Cross-Contact

FDA Food Allergen Labeling and Cross-Contact

USDA VS Permits, PPQ Permits and EANs

USDA VS Permits, PPQ Permits and EANs

In Case You Haven’t Heard FDA’s Regulation of OTC Hearing Aids vs. PSAPs

In Case You Haven’t Heard

Ongoing-Scrutiny-Over-Kratom--Challenges-as-a-Bulk-Dietary-Ingredient-and-as-a-Dietary-Supplement

Ongoing Scrutiny Over Kratom

No-Cheers-with-the-The-Champagne-of-Beers---Garg-Law-PLLC---Shelly-Garg-–-stock.adobe.com

No Cheers with the “The Champagne of Beers”

Is it a Food? Is it a Cosmetic?: No! FDA Reminds Consumers that Hand Sanitizers are Regulated as Over-the-Counter Drugs

Is My Hand Sanitizer a Food? A Cosmetic?

FDA OTC Drug Reform and The CARES Act

OTC Drug Reform & The CARES Act

Infant-Formula-Market-Resiliency-garg-law.com

Infant Formula Market Resiliency

The-Modernization-of-Cosmetics-Regulation-Act-MoCRA-garg-law.com

FDA Roundup: The Latest Activity

FDA Regulation of Human Food Made from Cultured Animal Cells and Updates on FDA’s Imported Seafood Program

FDA Regulation of Human Food Made from Cultured Animal Cells and Updates on FDA’s Imported Seafood Program

FDA Roundup: A Look at the Latest FDA Activity

FDA Roundup: A Look at the Latest FDA Activity

Got (Almond, Soy, Oat, Cashew, Pea…) Milk?: FDA Issues Draft Labeling Recommendations for Plant-Based Milk Alternatives garg-law.com

Got (Almond, Soy, Oat, Cashew, Pea…) Milk?

What you Need to Know about FDA Device Regulation: Marketing Sunglasses, Bandages, Hospital Equipment, Pregnancy Test Kits, Cosmetic Devices, Personal Lubricants and More

What you Need to Know about FDA Device Regulation

USDA Ushers Organic Regulation Changes for the First Time in Over 30 Years

USDA Ushers Organic Regulation Changes for the First Time in Over 30 Years

How to Prepare and Execute an FDA Regulated Recall

How to Prepare and Execute an FDA Regulated Recall

Modernization-of-Cosmetics-Regulation-Act-of-2022-garg-law.com

Kicking off the New Year with New FDA Happenings

FDA-Approved-garg-law.com

FDA Roundup: A Look at the Latest FDA Activity

FDA Issues Seven Warning Letters to Dietary Supplements Claiming to Treat Cardiovascular Disease

FDA Flexes Enforcement Muscle

DA’s Proposal for Increasing Color Certification Fees

FDA’s Proposal for Increasing Color Certification Fees

Checking-FDA-Facility-Registration-Renewals-garg-law.com

Checking it twice: FDA Facility Registration Renewals!

FDA Welcomes 2022/2023 VQIP Participants

FDA Welcomes 2022/2023 VQIP Participants

Factors Constituting FDA Refusal of Inspection

Factors Constituting FDA Refusal of Inspection

Uptick-in-FDA-Warning-Letters-over-FSVP-Violations-Read-at-garg-law.com

FSVP Warning Letters on the Rise

FDA-Clear-up-Mixed-Messaging-on-what-is-Healthy-Read-at-garg-law.com

FDA’s modernized approach to nutrition

Old-Europe-Cheese-voluntary-recall-of-Brie-cheeses-Read-at-garg-law.com

Old Europe Cheese’s recall of Brie cheeses

food facilities that are required to register with the FDA

Three Cheers for FDA Food Facility Registration Renewal

FDAs-Recognition-of-System-Vulnerabilities-in-its-Infant-Formula

A look at FDA’s Newly Issued Internal Report

FDA has issued a number of Import Alerts across various FDA product categories

One, Two, Three Strikes, and you’re…on an FDA Import Alert!

Foods, Seafood, Enforcement, FDA News

Behind the Scenes with ORA

Import surveillance for Cosmetic Products: Color me Beautifully, and Compliantly!

Color me Beautifully and Compliantly!

The Push to Modernize Cosmetic Regulation: The Latest on Cosmetic’s Makeover

The Latest on Cosmetic’s Makeover

Family-Dollar-Announces-Voluntary-Recall-garg-law.com

Family Dollar Announces Voluntary Recall

FDA recently published a Warning Letter to dietary supplement manufacturer Oregons Wild Harvest.jpg

Dietary supplements gone Wild