FDA Regulatory Approval Lab

World Food Connection partners with tenured global FDA expert Registrar Corp to provide a comprehensive solution for food manufacturers and importers to understand, comply with and file for FDA Regulatory Approval and associated processes.

- - Save time, resources and costly errors by outsourcing your FDA approval and submittal processes to proven FDA experts
  - Flexible a-la-carte or flat fees based on your specific needs.

Services:

- - U.S. FDA U.S. Agent Registration
  - Prior Notice Registration
  - Food Labeling and Ingredients Review
  - U.S. FDA Food Safety and FSMA Consulting
  - Detention Assistance
  - Food Canning Establishment Registration + Process Filings (FCE/SID)
  - U.S. FDA Food Contact Substances (FCS)

Connect with our FDA experts for support in English.

Comunícate con nuestros expertos de la FDA y obtén ayuda en español.

By outsourcing their FDA submission filings and processes to World Food Connection’s brokerage partner, clients save time, costly errors and resources, offloading operational motions to trusted providers. Further, our key role as an aggregator to some of the major specialty food retailers and providers in the U.S. like RANGEme and Whole Foods, and representative to innovative healthy and organic food brands make us uniquely poised to partner with producers and get their items noticed and picked up in the U.S. specialty food market and beyond.

Connect with our FDA experts for support in English.

Comunícate con nuestros expertos de la FDA y obtén ayuda en español.

Descarga y escucha nuestro webinar para aprender cómo preparar tu producto y exportarlo con éxito hacia los Estados Unidos.

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FDA NEWS

FDA to Provide Flexibility to Manufacturers to Increase Infant Formula Supplies May 16, 2022
FDA issued a guidance to manufacturers of infant formula to announce the agency’s intention to temporarily exercise enforcement discretion, on a case-by-case basis, for certain requirements that apply to infant formula.
FDA
FDA Issues Final Guidance for Seeds Used for Sprouting May 13, 2022
The FDA issued a final guidance titled “Reducing Microbial Food Safety Hazards in the Production of Seed for Sprouting: Guidance for Industry.”
FDA
FDA Sends Warning Letters to Multiple Companies for Illegally Selling Adulterated Dietary Supplements May 11, 2022
FDA sent warning letters to multiple companies for selling adulterated dietary supplements that contain, in some cases, new ingredients for which FDA has not received premarket notifications.
FDA
FDA Issues Draft Guidance on Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens May 2, 2022
FDA issued a draft guidance for FDA staff and other stakeholders titled Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act.
FDA
FDA Releases Final Rule for Added Fluoride Levels in Bottled Water May 2, 2022
Today the U.S. Food and Drug Administration issued its final rule for added fluoride levels in bottled water titled Beverages: Bottled Water.
FDA
FDA Issues Updated Guidance on Compliance and Date for Providing an Acceptable Unique Facility Identifier (DUNS number) for the Foreign Supplier Verification Programs May 2, 2022
FDA issued an updated guidance for industry, Compliance with Providing an Acceptable Unique Facility Identifier for the Foreign Supplier Verification Programs for Food Importers Regulation .
FDA
FDA Issues the Accredited Third-Party Certification Program: Questions and Answers: Draft Guidance for Industry May 2, 2022
The FDA is announcing the availability of a draft guidance for industry entitled The Accredited Third-Party Certification Program: Questions and Answers: Guidance for Industry.
FDA
FDA Issues Draft Guidance to Industry on Action Levels for Lead in Juice April 27, 2022
FDA issued draft guidance to industry providing action levels for lead in single-strength (ready to drink) apple juice and in other single-strength juices and juice blends.
FDA
FDA and Stop Foodborne Illness to Co-Host Third Food Safety Culture Webinar April 27, 2022
The FDA and Stop Foodborne Illness, a non-profit public health organization, are announcing a third webinar in their collaborative series that explores food safety culture.
FDA
FDA Releases Draft Guidance on Enforcement Discretion for Certain NAC Products April 21, 2022
FDA is announcing the availability of a draft guidance on FDA’s policy regarding products labeled as dietary supplements that contain N-acetyl-L-cysteine (NAC).
FDA