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- FDA Issues Warning About Certain Products Containing Toxic Yellow Oleander
- FDA Finalizes Guidance for Ready-to-Eat Fresh-Cut Produce Operations under Preventive Controls for Human Food Rule
- FDA and NOAA Update Certification Procedures for Seafood Exported to the European Union
- Final Reminder: Submit Your Application in the VQIP Portal for FY2027 Benefits
- FDA Releases Additional Information ahead of Listeria Prevention Public Meeting
- FDA Reopens Public Comment Period for Request for Information on Butylated Hydroxytoluene
- FDA Announces Over-the-Counter Monograph Drug User Fee Rates for Fiscal Year 2027
- FDA Announces FY2027 FSMA User Fees for VQIP and TPP
- Outbreak Investigation of Salmonella: Eggs
- Investigation of 9-State Outbreak of Cyclospora Illnesses: Iceberg Lettuce
- FDA Launches Pilot Program to Incentivize Manufacturing of Animal Drug Products in the U.S.
- FDA Advises Human and Animal Food Facilities to Protect their Food Facility Registration Information
- Outbreak Investigation of Salmonella: Moringa Leaf Powder
- FDA Proposes Rule to Modernize Drug Manufacturing Registration
- FDA to Reopen Comment Period for BHT Request for Information
- FDA Announces Public Meeting on Listeria monocytogenes Prevention
- Outbreak Investigation of E. coli: Frozen Blueberries
- The FDA Advantage
- FDA Releases 2026 Human Foods Program Guidance Agenda
- Outbreak Investigation of Infant Botulism: Powdered Infant Formula (June 2026)
- FDA Expands Sunscreen Options for the First Time in 20 Years
- FDA Releases Report on Traceability Readiness Tabletop Exercises and Updated FAQS
- FDA continues to warn consumers about the dangers of skin lightening products
- FDA Announces Updates to Modernize, Strengthen Pesticide Monitoring Compliance Program
- FDA Reopens Comment Period for Two Petitions Pertaining to the Use of Solvents
- FDA Releases Discussion Paper Ahead of Traceability Public Meeting in June
- Safety Alert for Hepatitis A Virus: Concha Negra (Black Shell) Shell Meat (April 2026)
- FDA Publishes Final Guidance on Protein Quality Studies for Infant Formula
- FDA Finalizes Food Chemical Safety Post-Market Assessment Program
- FDA Launches One-Day Inspectional Assessments to Strengthen and Expand Oversight
- How FDA is Implementing Landmark Cosmetics Legislation to Positively Impact Public Health
- FDA Releases Results from Largest-Ever Testing of Infant Formula in the U.S.
- Managing FDA Recalls in 2026
- OTC Monograph Drug User Fee Amendments (OMUFA)
- Outbreak Investigation of E. coli O157:H7: Raw Cheddar Cheese
- FDA Announces Public Meeting on Challenges and Solutions for Lot-Level Traceability
- FDA Finds Six Additional Cosmetic Products Marketed as Gel Nail Polish Remover To Contain Methylene Chloride
- FDA Releases FY25 Sampling Results on Economically Motivated Adulteration in Honey
- Outbreak Investigation of E. coli O157:H7: Raw Cheddar Cheese
- Food Safety Culture Webinar
- FDA Announces OTC Monograph Drug Facility Fee Rates for Fiscal Year 2026
- FDA Issues Guidance on Form 483 Responses
- FDA Takes Steps to Improve Gluten Ingredient Disclosure in Foods
- FDA Withdraws Two Temporary COVID FSMA Guidances
- FDA Releases the CORE 2024 Annual Report: Investigations of Foodborne Outbreaks and Adverse Events in FDA-Regulated Foods
- FDA Launches New Adverse Event Look-Up Tool
- Outbreak Investigation of Infant Botulism: Infant Formula
- FDA Augments and Improves Infant Formula Resources to Enhance Transparency, Safety, and Access for American Families
- FDA Warns 30 Telehealth Companies Against Illegal Marketing of Compounded GLP-1s
- FDA Announces Public Meeting on Dietary Supplement Innovation and the Scope of Dietary Ingredients
- FDA Takes Several Actions Related to the Food Traceability Rule
- Outbreak Investigation of Extensively Drug-Resistant Salmonella: Moringa Powder
- FDA Launches Assessment of BHA, a Common Food Chemical Preservative
- FDA implements QMSR: Medical device inspections to be conducted under an updated process
- FDA Releases Human Food Program (HFP) 2026 Priority Deliverables
- Event Materials Available for the Virtual Public Meeting and Listening Sessions on Food Allergen Thresholds and Their Potential Applications
- FDA Takes Steps to Improve Gluten Ingredient Disclosure in Foods
- FDA Announces PreCheck Implementation Roadmap
- FDA Report Flags Uncertainty Over PFAS Safety in Cosmetics
- FDA VQIP FY2027 Portal Now Open for Importers
- PFAS in Food Update from 2024 Tests
- FDA Warns Retailers After ByHeart Formula Recall Fails to Protect Infants
- CORE Outbreak Investigation Table
- 2024 FDA Food Code Adoption by State | Restaurant Oversight
- Outbreak Investigation of Salmonella: Moringa Leaf Powder
- The Voluntary Qualified Importer Program (VQIP)
- Outbreak Investigation of Infant Botulism: Infant Formula
- FDA Issues Warning About Imported Cookware That May Leach Lead
- FDA Announces First Use of Import Certification Authority for Certain Shrimp and Spices Potentially Contaminated with Cesium-137
- FDA releases results on economically motivated adulteration (short weighting) in seafood
- FDA Proposes Revocation of Authorization for Orange B in Food
- More Ground Cinnamon Products Added to FDA Public Health Alert Due to Presence of Elevated Levels of Lead
- FDA Issues Warning About Imported Cookware That May Leach Lead
- FDA Launches Real-Time Adverse Event Reporting Dashboard for Cosmetic Products
- FDA News Release FDA Urges Nicotine Pouch Manufacturers To Use Child-Resistant Packaging
- FDA releases results on economically motivated adulteration (short weighting) in seafood
- Half-shell Oysters from Republic of Korea Potentially Contaminated with Norovirus
- FDA Update on Post-market Assessment of Chemicals in the Food Supply
- Submit Application in the VQIP Portal for FY2026 Benefits
- FDA Issues Warning About Imported Cookware That May Leach Lead
- FDA Announces New FDA PreCheck Program to Boost U.S. Drug Manufacturing
- FDA Commissioner Makary, USDA Secretary Rollins Celebrate Proposed Modernization of Orange Juice Regulations to Benefit American Growers
- FDA Issues Proposed Rule to Amend Standard of Identity for Pasteurized Orange Juice
- FDA Proposes to Extend Compliance Date for Food
- FDA Releases New Tool for Toxicity Screening of Chemicals in Food
- FDA Announces FY2026 User Fees for VQIP and TPP
- FDA Implementing Nationalized Entry Review Program – Important Changes Effective August 4, 2025
- RUF Releases Produce Safety Roadmap
- HHS, FDA and USDA Address the Health Risks of Ultra-Processed Foods
- FDA to Revoke 52 Obsolete Standards of Identity for Food Products
- FDA Issues Warning Letters to Firms Marketing Products Containing 7-Hydroxymitragynine
- Food Importer News from the U.S. FDA
- Notice to Industry on FDA Imports Review Exemption Change
- Notice to Industry on FDA imports review exemption change
- FDA Extends Comment Period for Proposed Method for Ranking Chemicals in Food for Post-market Assessments
- FDA Approves Gardenia (Genipin) Blue Color Additive While Encouraging Faster Phase-Out of FD&C Red No. 3
- FDA Encourages Food Manufacturers to Accelerate Phasing Out the Use of FD&C Red No. 3 in Foods Before 2027 Deadline
- FDA Updates General Food Labeling Requirements Compliance Program
- FDA to Issue New Commissioner’s National Priority Vouchers to Companies Supporting U.S. National Interests
- US Food and Drug Administration FDA Launches Agency-Wide AI Tool to Optimize Performance for the American People
- Fiscal Year 2025 OMUFA Facility User Fee Due Date
- Outbreak Investigation of Salmonella: Cucumbers
- FDA Approves Three Food Colors from Natural Sources
- FDA Advises Consumers, Retailers, and Distributors Not to Eat, Sell, or Serve Products from Pan-African Food Distributors Inc. dba East Africa Boutique LLC
- FDA Takes Action to Address Data Integrity Concerns with Two Chinese Third-Party Testing Firms
- FDA Alerts Industry and Consumers about Palm Leaf Dinnerware
- FDA Advances Robust, Transparent Post-Market Chemical Review Program to Keep Food Supply Safe and Healthy
- FDA Begins Action To Remove Ingestible Fluoride Prescription Drug Products for Children from the Market
- FDA 101: Product Recalls
- HHS, FDA Initiate Comprehensive Review of Nutrients in Infant Formula
- FDA Advises Consumers, Tattoo Artists, and Retailers to Avoid Using or Selling Certain Sacred Tattoo Ink Products Contaminated with Microorganisms
- FDA and NIH Announce Innovative Joint Nutrition Regulatory Science Program
- FDA Approves Three Food Colors from Natural Sources
- FDA Announces Completion of First AI-Assisted Scientific Review Pilot and Aggressive Agency-Wide AI Rollout Timeline
- Front-of-Package Labeling Comment Period Extension
- OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2025 User Fees and Registration
- FDA Announces Expanded Use of Unannounced Inspections at Foreign Manufacturing Facilities
- US Food and Drug Administration HHS, FDA Announce Operation Stork Speed to Expand Options for Safe, Reliable, and Nutritious Infant Formula for American Families
- FDA Adds Firms to Import Alert Due to PFAS in Clams
- FDA Revokes Use of FD&C Red No.3 in Foods and Drugs
- FDA Announces Release of Long-Term National Strategy to Increase the Resiliency of the U.S. Infant Formula Market
- FDA Proposes Rule to Require Standardized Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products
- FDA Issues Letter to Retailers and Distributors Concerning Lead in Certain Imported Cookware
- FDA Releases Guidance on Voluntary Premarket Engagement for Foods Derived from Plants Produced Using Genome Editing
- FDA Announces European Union (EU) Requirements for All Honey and Other Apiculture Products Imported into the EU
- Podcast
- FDA Reminds OTC Hand Sanitizer Manufacturers of OMUFA Facility Fees for FY 2025
- USDA-FDA Seek Information About Food Date Labeling, Aim is to Provide Further Clarity, Transparency, and Cost Savings for U.S. Consumers
- FDA Updates Guidance for the Voluntary Qualified Importer Program (VQIP)
- FDA Seeks Public Input on Experiences with Export Certification in the Form of Lists (Export Lists) for Human Food Products
- FDA Proposes Ending Use of Oral Phenylephrine as OTC Monograph Nasal Decongestant Active Ingredient After Extensive Review
- FDA Human Foods Program: FY 2025 Priority Deliverables
- FDA Releases Supplement to the 2022 Food Code
- FDA Issues Draft Guidance on Tattoo Inks
- The FDA Updates Mycotoxins in Domestic and Imported Human Foods Compliance Program
- FDA Issues Warning About Certain Supplements Substituted with Toxic Yellow Oleander
- FDA Reminds Animal and Human Food Facilities to Register or Renew their Food Facility Registration (FFR) between October 1 and December 31, 2024
- FDA Releases Informational Video on Importing Seafood
- FDA is aware of concerns about tampon safety
- Cosmetic Product Listing Details
- Cosmetic Facility Registration Details
- FDA Announces New Sodium Reduction Targets in Phase II Efforts
- FDA Proposed Rule for Submission Tracking Numbers on E-Cigarette Imports
- FDA Issues Warning Letter to Austrofood: Ensuring Safety of Cinnamon Products
- FDA India Office Addresses Safety and Regulatory Issues for Herbal and Ayurvedic Products
- FDA Announces FY 2025 OTC Monograph Order Request (OMOR) Fee Rates
- FDA Updates: Fiscal Year 2025 User Fees, Health Alerts, and More
- FDA Warns Consumers Not to Use OPMS Black Liquid Kratom
- FDA Report on Fresh Herbs Sampling Assignment
- FDA Hosts Public Meeting on Home as a Health Care Hub
- FDA Issues Warning to Bimbo Bakeries USA Over Mislabeling Major Food Allergens
- Deadline for Registration and Listing of Cosmetic Product
- Retail Food Protection Center for Food Safety and Applied Nutrition
- Potential Device Failures of Plastic Syringes Made in China
- FDA issued an additional warning letter that describes violations related to the sale and distribution of unauthorized plastic syringes
- FDA and Customs Import Compliance
- Help with Removal from FDA Import Alert
- FDA Releases Data from the Agency’s 2023 Testing of Talc-Containing Cosmetic Products for Asbestos
- FDA Issues Draft Guidance on New Dietary Ingredient Notification Master Files for Dietary Supplements
- FDA Announces OTC Monograph Drug User Fee Program
- FDA Cosmetic Facility Registration
- FDA Revokes Standards of Identity and Quality for Frozen Cherry Pie
- FDA Cosmetic Product Listing
- Medical Device 510(k) Premarket Notification
- FDA Seeks $7.2 Billion to Enhance Food Safety and Nutrition, Advance Medical Product Safety, and Strengthen Public Health
- Summary of Recent FDA News and Updates
- FDA Alert Concerning Certain Cinnamon Products Due to Presence of Elevated Levels of Lead
- FDA Update on Post-market Assessment of Chemicals in the Food Supply
- FDA Releases Guidance on Voluntary Premarket Engagement for Foods Derived from Plants Produced Using Genome Editing
- The US Food and Drug Administration FDA on Samples for Food Testing Used as Evidence for the Release of Certain Fish and Fishery Products
- FDA Issues Draft Guidance on Sampling Recommendations for Seafood Subject to DWPE
- FDA Proposes Rule to Revoke Regulation Allowing the Use of Brominated Vegetable Oil (BVO) in Food
- FDA Proposes Amendments to its Regulation for Prior Notice of Imported Human and Animal Food
- Start Registration
- FDA Proposes Rule Aimed at Helping to Ensure Safety and Effectiveness of Laboratory Developed Tests
- FDA Issues Updated Compliance Program for Infant Formula
- FDA Issues Draft Guidance on Registration and Listing of Cosmetic Product Facilities and Products
- Liquidated Damages
- FDA Registration
- Cosmetic Facility Registration: A Comprehensive Guide
- Garg Law attends White House
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- FDA Import Detentions
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- FDA Food Facility Registration
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- Get Your USDA Permit | Permits for USDA
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- FDA Recalls
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- FDA Food Facility Registration
- FDA
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- EPA and CPSC Agency Requirements
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- Importers
- At a Glance
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- FDA Regulatory Compliance Lawyer
- FDA Import Refusals
- FDA’s GRAS Glow-Up
- FDA Midyear 2026 Review
- USDA’s Bioengineered Food Disclosure Rules Head Back to the Drawing Board
- FDA Says: Guard Your Food Facility Registration Like a Password
- 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 Detentions, Refusals, and Import Alerts
- One Day, Big Impact
- Using AI Tools in FDA Compliance
- The FDA Called. They’d Like to See Everything
- MoCRA in Practice
- Liquidated Damages for FDA‑Regulated Products
- The Sticky Truth
- FDA’s PFAS Cosmetics Report
- 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
- New Year, New Guidance
- FDA’s Annual Device Registration Renewal Is Back Online — and the Clock Is Ticking to December 31
- A Fine Line Between SPF and Soufflé
- Regulatory Limbo
- Dashboard Confessional
- FDA Launches Nationalized Entry Review Program
- Court Upholds FDA’s Authority Over Homeopathic Drugs, Leaving Industry with Few Remedies
- Not Quite Food, Not Quite Fiction
- Stars, Stripes, and Substantiation
- Knock, Knock, It’s the FDA
- 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
- Navigating FDA Regulations Amid 2025 Trump-Era Trade Policies
- Beauty Secrets Revealed
- The Growing Trend of States to Ban Food Dyes
- Totally Cool, Inc. Gets the Freeze-Out from the FDA Following Food Safety Violations
- The Ultimate Permit Tag-Team
- FDA Doesn’t Send Love Letters
- 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”
- The FDA’s New Year’s Resolution
- Say Cheese or Say Trouble?
- Keeping Fish Fresh and Regulations Fresher
- Witch’s Brew and Candy Hues
- Warning Letters Ahoy!
- Tick Tock, Don’t Get Blocked (Entries)!
- FDA Investigates Tampon Safety
- Double Trouble!
- Herbs, Hocus Pocus and the FDA
- 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
- Unlocking International Markets
- FDA’s Foods Program: A Star-Spangled Update!
- It’s Getting Hot in Here!
- Sip Happens
- FDA FSVP Inspections and Warning Letters on the Rise, oh my!
- FDA’s New Final Rule on LDTs
- Blush, Brush and MoCRA!
- The FDA Import Detention Marathon
- FDA’s Updated Approach to the 510(k) Premarket Notification Process for Medical Devices
- Show me the Honey!
- Don’t Try to Beat this Yellow!
- FDA’s OTC Monograph Drug User Fee Program
- FDA’s Import Alert for Chemical Contaminants Including PFAS
- Streamlining Pathways to FDA Medical Device Market Clearance/Approval
- Dietary Supplements and New Dietary Ingredient Notifications (NDINs)
- FDA Medical Device Establishment Registration
- USDA’s Strengthening Organic Enforcement (SOE) Rule
- 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
- Heads Up Medical Device (and Cosmetic Device) Manufacturers and Importers!
- What’s Coming Down the Pike for Foods and Cosmetics, you ask?
- MoCRA Readiness
- How to Initiate and Execute an FDA Recall
- An Early FDA Holiday Present!
- FDA Revisiting Classification of Wound Dressings and Liquid Wound Washes
- A Sprinkle of Holiday (Lead-Free) Cinnamon Spice?
- Enforcement Delayed by 6 Months
- Tis the Season for Cosmetic Registration and Product Listing (with a Slight Delay)
- FDA Issues Eyedrops Products Warning
- Celebrating Halloween With a Goulish Glow?
- If it’s Not in Writing, it Doesn’t Exist!
- It’s that Special Time of Year Again! FDA Device Registration Renewal
- FDA Releases Updated Draft Guidance
- Avoid Blushing and Don’t Let GMP Violations Add to Your Highlight
- Moving the Needle and Modernizing the 510(k) Process
- FDA Inspections on the Rise
- Casting a Wider Net for Safer Seafood?
- Up, Up & Up!
- Can’t Conceal This!
- BREAKING NEWS: FDA Issues Draft Guidance on Cosmetic Facility Registration and Product Listing
- Open Sesame: Updates on Sesame Allergen Labeling
- CBP Liquidated Damages, Penalties, & Fines…oh my!
- Cosmetic Facility Requirements: Ensuring Product Manufacturing Success
- Mid-Summer Grillin’! Fire up the…Cell Incubator?
- FDA Releases Update for the FDA Foods Program
- Prep + Prime for MoCRA
- Summer is for Vacation, not Detention: A Guide to Avoiding FDA Import Refusal and Detention
- Protecting Your Sunny Side Up
- FDA Food Allergen Labeling and Cross-Contact
- USDA VS Permits, PPQ Permits and EANs
- In Case You Haven’t Heard
- Ongoing Scrutiny Over Kratom
- No Cheers with the “The Champagne of Beers”
- Is My Hand Sanitizer a Food? A Cosmetic?
- OTC Drug Reform & The CARES Act
- Infant Formula Market Resiliency
- FDA Roundup: The Latest Activity
- 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
- Got (Almond, Soy, Oat, Cashew, Pea…) Milk?
- What you Need to Know about FDA Device Regulation
- USDA Ushers Organic Regulation Changes for the First Time in Over 30 Years
- How to Prepare and Execute an FDA Regulated Recall
- Kicking off the New Year with New FDA Happenings
- FDA Roundup: A Look at the Latest FDA Activity
- FDA Flexes Enforcement Muscle
- FDA’s Proposal for Increasing Color Certification Fees
- Checking it twice: FDA Facility Registration Renewals!
- FDA Welcomes 2022/2023 VQIP Participants
- Factors Constituting FDA Refusal of Inspection
- FSVP Warning Letters on the Rise
- FDA’s modernized approach to nutrition
- Old Europe Cheese’s recall of Brie cheeses
- Three Cheers for FDA Food Facility Registration Renewal
- A look at FDA’s Newly Issued Internal Report
- One, Two, Three Strikes, and you’re…on an FDA Import Alert!
- Behind the Scenes with ORA
- Color me Beautifully and Compliantly!
- The Latest on Cosmetic’s Makeover
- Family Dollar Announces Voluntary Recall
- Dietary supplements gone Wild
★★★★★
Working with Shelly on various new product launches over the last couple of years has been seamless. Quick and clear guidance is always what we get.
I've been working with Shelly and her team at Garg law for a little while now and they are fantastic! Very responsive, professional and they certainly get things done. Extremely satisfied with their service and highly recommend.
Ms Garg helped my company navigate an FDA import issue. She achieved an excellent result, was very responsive and professional, and managed to keep the project within budget. She is a stellar attorney.
I have been using Shelly Garg as FDA Counsel for 10+ years, since she was at another international law firm. While we continued to use the previous firm she was at (mainly due to the process required to change firms), we realized the quality of counsel was not the same. We have since been using Garg Law and the ease of use and trust in the knowledge was back instantly. Shelly has the skills to help me understand the regulations (by translating into layman's terms) and risks in a manner that is specific to my business. She is also extremely timely in her responses which is critical when we have a deadline mandated by the FDA. Many other attorneys cite the regulations which l've already read, but need further counsel. In my opinion, this demonstrates Shelly's in-depth knowledge of the regulations, how they pertain to the law, and how they are applicable IRL. Shelly's personable approach and pleasant manner in communication makes it very easy to have been work with her and have productive discussions on the best next steps. She truly has a passion iternational for all things FDA and I've learned so much from her.