By María Fernanda Mandujano Morales, EAS Consulting Group Independent Consultant
Exporting food products from the United States to Mexico requires compliance with specific regulations—particularly NOM-051-SCFI/SSA1-2010, which governs front-of-pack and nutritional labeling for prepackaged foods and non-alcoholic beverages. This standard mandates warning seals, limits on marketing to children, and detailed ingredient and nutrition declarations, all designed to support public health and informed consumer choices.
Since 2021, all products subject to NOM-051 must undergo label evaluation by an Inspection Unit (Unidad de inspección UI). The UI must be accredited by the Mexican Accreditation Entity (EMA) and authorized by COFEPRIS, Mexico’s Federal Commission for Protection Against Sanitary Risks. There are two evaluation paths, depending on the product’s labeling status at import: the Dictamen de Cumplimiento and the Constancia de Cumplimiento.
As a member of the Certified Group and Food Safety Net Services, EAS clients have access to world-renowned testing laboratories that meet your organization’s sophisticated needs. In this column, you’ll hear about their capabilities, environmental challenges and more. We hope you’ll enjoy a look “under the microscope.”
One of the most challenging aspects of doing business in the U.S. is navigating the many and varied regulatory requirements of U.S. agencies.
When importing FDA-regulated food products into the USA, an FDA Notice of Action can be a challenging hurdle to overcome. It indicates potential non-compliance and may result in FDA detention, delaying or denying entry of your goods.
The U.S. FDA oversees the safety of more than $2.6 trillion worth of food, tobacco, and medical products, much of which is imported annually and manufactured in approximately 140,000 registered foreign facilities.
Tasked with ensuring public health and safety, the FDA has the authority to conduct product examinations and/or sample collections to ensure compliance with regulations and laws. Importers must be prepared for the FDA to execute this authority. Some inspections are routine, some are risk-based, and some are in response to increased vigilance because of past violations.
What is a Notice of Action Letter? How should responses be handled?
Interested in more food safety training? FSNS offers live and virtual education events.
Food Safety Net Services (FSNS) provides certified food safety training courses for food processing and manufacturing personnel. Our schedule includes both virtual (live, instructor-led) and in-person food safety courses at locations across the United States.
Our own Maged Sharaf has been invited to serve as a volunteer expert on the U.S. Pharmacopeia (USP) Healthcare Safety Quality and Nomenclature (HSQN) Expert Committee for the USP 2025-2030 cycle, making it his third 5-year cycle serving on the committee. Congratulations, Maged! Visit USP.org to learn more.
Presented by EAS Independent Consultant Gisela Leon With Pia-Felicitas Homann, Industrie- und Handelskammer
3-Day Virtual Presentation
Monday, August 25, 2025 – 8:30am – 1:30pm Central European Time
Tuesday, August 26, 2025 – 8:30am – 1:30pm CET
Thursday, August 28, 2025 – 8:30am to 1:30pm CET
Note that registration for this event is open until August 21, 2025.
There are countless differences between European and American legislation. This workshop will show you which differences are essential to note, which advertising promises will win you over, and which claims are more likely to put you in dangerous waters.
Elevating Allergen Testing: Capabilities, Challenges, and the Path Forward Tuesday, August 19, 2025 at 12pm ET
Food allergies are a growing public health concern, affecting millions and shaping the way food is produced, labeled, and regulated. As the regulatory landscape tightens and consumers demand safer, more transparent food options, accurate and robust allergen testing has never been more essential.
Certified Group invites you to a customer-focused webinar designed to empower food industry professionals with the latest knowledge on allergen detection. Discover cutting-edge technologies, industry challenges, and the evolving solutions that protect your brand and your consumers.
Join us to ensure your food products remain safe, compliant, and competitive in a changing world.
A new webinar covering an Overview of Regulatory Requirements for OTC Monograph Drugs presented by EAS Regulatory Services Manager Victoria Pankovich. Mark your schedules for Wednesday, September 17, 2025, and visit the EAS website to learn more.
Register for our webinar on A Guide to FSMA 204: Sorting Through the Confusion of the FDA’s New Traceability Rule for Added Food Safety happening September 24, 2025, at 1pm ET. Presented by EAS Consulting Group Senior Director Tim Lombardo and Independent Consultant Tom Bell.
EAS Consulting Group’s Drug GMP Compliance Seminar helps firms prepare for FDA enforcement by facilitating an understanding of compliance requirements for responsibilities of domestic and foreign firms who manufacture, label, pack or hold pharmaceuticals for sale in the US, including those involved with the testing, quality control and distribution of drugs.
Instructed by two cGMP experts with 30+ years combined industry experience, this intensive training program will help your firm stay on top of cGMP requirements.
View the agenda, course description, pricing, available discounts and more.
Registrants receive a Pharmaceutical GMP Regulation Pocket Guide and certificate of participation upon request.
Do you have a regulatory question or concern? Are you interested in seeing a particular topic covered in a future issue of eNews? We want to hear from you! Use the EAS Contact Us form to send a note or question to our team any time.
Get Notified When Trainings Are Scheduled
Are you looking for training in a particular industry or regulatory topic? Review our list of available topics and sign up to be notified when your course of interest is scheduled next.
We’re Hiring Independent Contractors!
EAS is always interested in broadening our industry experience and expanding our independent consultant team. If you’re interested in joining EAS as a 1099 contract employee, please email your CV to Dean Cirotta at dcirotta@easconsultinggroup.com.
Consultant Corner
EAS offers over 150 independent consultants strategically located around the globe whose expertise provide core value for clients.
Issue of the Month Author
María Fernanda Mandujano Morales
EAS Consulting Group, EAS Independent Consultant
María Fernanda Mandujano Morales is a highly motivated and committed Food Engineer with a strong background in food safety systems, international regulatory compliance (FDA, FSMA, USDA), product development, and operational leadership. She brings a hands-on approach to problem-solving, ensuring regulatory adherence and high standards of quality through collaborative, proactive project management.
.jpg?upscale=true&width=720&upscale=true&name=Featued-Image-Half-Compliance-Requirements-for-US-Food-Products-Commercialized-in-Mexico(Morales).jpg)
.jpg?upscale=true&width=720&upscale=true&name=Featured-Image-Half-Responding-to-an-FDA-Notice-of-Action-(Certified).jpg)
.jpg?upscale=true&width=1120&upscale=true&name=Feartured-Image-Half-2025-US-Labeling-for-Food-DS(IHK-Leon).jpg)
2.jpg?upscale=true&width=1120&upscale=true&name=Featured-Image-Half-Elevating-Allergen-Testing(CG-Alappat-Servello-Lombardo)2.jpg)
.jpg?upscale=true&width=1120&upscale=true&name=Featured-Image-Half-2025-OTC-Monograph-Drugs(Pankovich).jpg)
.jpg?upscale=true&width=1120&upscale=true&name=Featured-Image-Half-Guide-to-FSMA-204(Lombardo-Bell).jpg)
.jpg?upscale=true&width=1120&upscale=true&name=Featured-Image-Half-2024-Drug-GMP-(Blackwell-Hunter).jpg)
.jpg?upscale=true&width=1120&upscale=true&name=Featured-Image-Half-2024-Cosmetic-Safety-Substantiation(Brock).jpg)
.jpg?upscale=true&width=1120&upscale=true&name=Featured-Image-Half-Claims-Substantiation(Brock).jpg)
