FDA FCE/SID Registration for Acidified and Low-Acid Canned Foods

In addition to FDA Food Facility Registration, the U.S. FDA requires manufacturers of shelf-stable products—such as canned, bottled, jarred, or vacuum-packed goods—to complete a Food Canning Establishment (FCE) registration if the products are classified as Low-Acid Canned Foods (LACF) or Acidified Foods (AF).

To comply with FDA regulations, manufacturers must also submit a scheduled process, known as a Process Filing, for each individual product, as well as for each product style, container size, container type, and processing method. Each filing is assigned a unique Submission Identifier (SID), which is required for FDA compliance and U.S. import approval.

In short: To legally import Acidified or Low-Acid Canned Foods into the United States, manufacturers must hold both an FCE and SID for each product.

FCE/SID Compliance Exceptions

In many cases, it may not be clear whether a product qualifies as LACF or AF—or whether it is exempt from FCE/SID registration.

To avoid costly FDA import detentions and border delays, it’s essential to consult with experts who understand these regulatory nuances.

Unsure if your product falls under FCE/SID requirements?
Feel free to reach out to the PTFP Regulatory Team if you have any questions or need further assistance.

PTFP’s FCE/SID Registration Services

If your company manufactures Acidified or Low-Acid Canned Foods, PTFP (Premium Terra France Pharmaceutical LLC) can help ensure your Food Canning Establishment (FCE) is correctly registered and that your scheduled processes (SIDs) are filed properly with the FDA.

By working with PTFP, you gain:

• Expert preparation and filing of FCE and SID submissions
• One year of free consultation for any new products you may wish to add
• Confidence in full FDA compliance during import and distribution in the U.S.

Feel free to reach out to the PTFP Regulatory Team if you have any questions or need further assistance.

U.S. FDA Food, Beverage and Dietary Supplement Labeling Requirements

On May 20, 2016, the U.S. Food and Drug Administration (FDA) released updated regulations for the labeling of food, beverage, and dietary supplement products. These changes include significant updates to the Nutrition Facts panel, Daily Values, serving sizes, and other label elements.

On May 20, 2016, the U.S. Food and Drug Administration (FDA) released updated regulations for the labeling of food, beverage, and dietary supplement products. These changes include significant updates to the Nutrition Facts panel, Daily Values, serving sizes, and other label elements.

Under the current FDA guidelines, all such products must display Nutrition Facts in a format that meets strict FDA requirements—covering layout, font, nutrient naming conventions, precise quantity declarations, and percentage daily value calculations.

Incorrect or non-compliant labels are among the leading causes of FDA import delays and detentions.

PTFP’s FDA Label Review Services

PTFP offers expert FDA label and ingredient compliance reviews for food and dietary supplement products, focusing on:

• Nutrition Facts Panel
  • Determining serving sizes based on U.S. metric system
  • Creating a compliant and accurate Nutrition Facts panel
• Ingredient Statement
  • Reviewing and revising ingredient order and terminology
  • Ensuring compliance with FDA naming conventions and clarity for consumers
• Labeling Claims
  • Evaluating nutrient content claims (e.g., “low fat,” “high in fiber”)
  • Verifying organic, natural, fresh, pasteurized, and health-related claims
• Label Layout & Format
  • Recommending label size, shape, and formatting to meet U.S. standards
  • Redesigning labels for compliance and professional appearance
• Additional Key Areas
  • Allergen declarations
  • Structure/function claims
  • Nutrient content claims and disclaimers

U.S. FDA Color Additive Requirements

The U.S. Food and Drug Administration (FDA) enforces strict regulations on the use of color additives in food, beverage, and dietary supplement products. All color additives must be clearly declared on product labels, and the use of any unapproved color additive is a direct violation of FDA regulations.

Batch Certification & FDA Compliance

For any color additive used in foods, beverages, or dietary supplements, FDA requires one of the following:

• Batch Certification by the FDA
• Or an official exemption from certification

To obtain batch certification, manufacturers must submit a sample from each production batch of the color additive, along with corresponding documentation. FDA will then conduct a chemical analysis and issue certification if the color additive meets its stringent quality and safety standards.

PTFP’s Support for FDA Color Additive Compliance

Premium Terra France Pharmaceutical LLC (PTFP) provides professional guidance to food, beverage, and supplement manufacturers in evaluating and securing FDA-compliant color additive use.

Our services include:

• Initial Assessment: Review of your color additive to determine whether batch certification or exemption applies.
• Regulatory Navigation: Step-by-step assistance in preparing and submitting documentation for batch certification.
• Ongoing Support: Continued compliance support for new formulations and future batches.

Want to ensure your color additives meet FDA regulations?
Feel free to reach out to the PTFP Regulatory Team if you have any questions or need further assistance.

FDA Foreign Supplier Verification Program FSVP & Produce Safety

The Foreign Supplier Verification Program (FSVP) is a key regulatory requirement under the U.S. FDA’s Food Safety Modernization Act (FSMA) of 2011. It is designed to ensure that all imported food products meet U.S. safety standards and are safe for American consumers.

What is FSVP?

FSVP requires U.S. importers to verify that their foreign suppliers are producing food under conditions that provide the same level of public health protection as those required under the U.S. Federal Food, Drug, and Cosmetic Act (including Hazard Analysis and Risk-Based Preventive Controls [HARPC] and the Produce Safety Rule).

Key obligations include:

• Appointing an FSVP Importer (also referred to as an FSVP Agent) for each food shipment entering the U.S.
• Establishing and maintaining FSVP procedures for verifying supplier safety practices
• Ensuring that the food meets applicable U.S. safety standards through documented processes

The FSVP Importer must be a U.S.-based entity and is typically the owner or consignee of the product. If no such party exists at the point of entry, a designated U.S. agent can assume this role, provided a written statement of consent is signed.

FSVP Agent Information Required for U.S. Entry

The U.S. Customs system (ACE) requires that the following details about the FSVP Agent be submitted at the time of importation:

• Name, address, and contact information
• DUNS number
• Written statement of authorization

Note: An FSVP Agent is not the same as a U.S. Agent for FDA Food Facility Registration or a customs broker.

Who Is Exempt from FSVP?

Some product categories may be partially or fully exempt from FSVP, including:

• Juice and seafood regulated under HACCP
• Meat, poultry, and egg products regulated by USDA
• Alcoholic beverages and their specific ingredients
• Personal consumption or research-use foods

However, many exemptions are narrow, and some companies may still be subject to HARPC requirements, thereby falling indirectly under FSVP. It’s important to conduct a proper assessment.

PTFP’s FSVP Services for Foreign Exporters

If you are a foreign food producer, exporter, broker, or manufacturer, PTFP can act as your official FSVP Agent in the United States. Our process includes:

• Reviewing your product safety and quality documents
• Conducting a full compliance evaluation of your product(s)
• Handling all FSVP recordkeeping, correspondence, and FDA inquiries
• Providing a secure online portal for uploading and managing compliance records

By appointing PTFP as your FSVP Agent, your company will transfer full regulatory responsibility for FDA’s FSVP compliance to us.

PTFP’s FSVP Services for U.S. Importers

U.S. importers must maintain strict documentation under FSVP, including:

• Qualified Individual (QI) records
• Supplier compliance verification reports
• Food Safety Plan & Hazard Analysis documentation
• Corrective action plans, when necessary
• GMP (Good Manufacturing Practice) compliance records

PTFP’s food safety experts—trained in FDA FSVP protocols—can:

• Serve as your designated Qualified Individual (QI)
• Review, build, or update your FSVP compliance systems
• Maintain all required documents for potential FDA audits or inspections

FDA’s Produce Safety Rule

The Produce Safety Rule, part of FSMA, outlines minimum standards for the growing, harvesting, packing, and holding of fresh fruits and vegetables, aimed at preventing microbial contamination.

Covered areas include:

• Worker hygiene and training
• Equipment, facilities, and sanitation
• Agricultural water quality
• Soil amendments
• Production of sprouts

This rule applies to both domestic and foreign farms. FDA has published a compliance schedule and exemption guide, but determining applicability can be complex.

Need help understanding whether FSVP or Produce Safety Rules apply to your business?
Contact PTFP today for a free consultation and let our experts guide your compliance journey.

Lab Testing & USDA Organic Certification

PTFP has established a robust network of FDA-compliant commercial laboratories strategically located across the U.S. and internationally. Whether you are a domestic or foreign company in the food, beverage, pet food, animal health, or dietary supplement industries, we can connect you with trusted laboratory partners for high-quality testing services.

Our partner labs offer a wide range of analytical capabilities, from wet chemistry and quantitative PCR to advanced microbiological and contaminant analysis, ensuring full compliance with FDA regulatory standards.

Common FDA-Compliant Testing Services:

• Allergen Testing
• Nutrition Facts Panel Analysis
• Contaminant Screening (Heavy metals, pesticides, etc.)
• GMO Testing
• Microbiological Testing
• Stability & Shelf-Life Studies

Need help? Click the Start button to request lab testing support from PTFP.

USDA Organic Certification & Organic Labeling Assistance

Organic certification is a regulated process required for producers who wish to market their food and agricultural products as “organic” in the United States. This includes seed suppliers, farmers, processors, and distributors.

Currently, the USDA has authorized over 80 domestic and international certifying agents who are accredited to certify businesses according to USDA organic standards.

If you are a foreign company looking to obtain the USDA Organic seal, PTFP can facilitate your certification by connecting you with our network of accredited certifying partners both in the U.S. and abroad. We guide you through every step of the certification and labeling process to ensure full compliance and successful organic market entry.