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- 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
- #7836 (no title)
- 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
- USDA VS Permits
- Trade Promotion Organizations
- Distributors
- Manufacturers
- Exporters
- FDA Import Detentions
- U.S. FDA Medical Device Establishment Registration
- FDA Food Facility Registration
- FDA Food Regulatory Attorney
- FDA Compliance Attorney
- APHIS Application
- Get Your USDA Permit | Permits for USDA
- FDA Insights
- Assistance with FDA registration and compliance
- FDA Regulatory Law Firm
- FDA Device Registration
- Registration Letter
- FDA Recalls
- USDA Permit Compliance
- FDA Food Facility Registration
- FDA
- FDA Import Alert Removal
- EPA and CPSC Agency Requirements
- Our Approach
- Beverage Alcohol Compliance
- USDA Compliance
- Importers
- At a Glance
- Our Values
- Shelly Garg
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- Medical Devices
- OTC Drugs
- Cosmetic Regulatory
- Foods, Beverages and Dietary Supplements, Regulatory
- Our Firm
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- Privacy Policy & Terms of Service
- FDA Regulatory Compliance Lawyer
- 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
