Author: Namrata

Pasta Sauce

Pasta sauces—a kitchen staple made from tomatoes, herbs, and other flavorful ingredients—are regulated by the U.S. Food and Drug Administration (FDA) to ensure they are safe from contamination and spoilage.

Facilities that manufacture, process, pack, or hold pasta sauces intended for consumption in the United States must complete Food Facility Registration with the FDA.

For low-acid or acidified pasta sauces, facilities are also required to obtain Food Canning Establishment (FCE) Registration and submit a Scheduled Process (SID) filing, in addition to standard Food Facility Registration.

The FDA defines Low-Acid Canned Foods (LACF) as any food (excluding alcoholic beverages) with a finished equilibrium pH greater than 4.6 and water activity greater than 0.85, when thermally processed in hermetically sealed containers.
Acidified foods are low-acid foods to which acid(s) or acid food(s) are added to achieve a finished equilibrium pH of 4.6 or below and water activity greater than 0.85.

A Scheduled Process specifies the exact time and temperature combinations, pH levels, container specifications, and other critical factors—such as heat penetration data—required to achieve commercial sterility. Each process must be developed and validated by a qualified Processing Authority for every product variation.

In addition, pasta sauce labels must comply with the FDA’s general food labeling requirements under 21 CFR Part 101. Labels must:

  • List all ingredients in correct order
  • Declare any major allergens
  • Include a Nutrition Facts panel
  • Avoid false or misleading claims that could result in misbranding

Liberty Management Group Ltd can help file Food Facility Registration, FCE and SID for your low acid canned and acidified food products and also help with label compliance.

Namrata

Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Certificate of Free Sale for Food and Dietary Supplements

For US exporters of food and dietary supplements, export certificates play a critical role in proving to foreign regulators that their products may be legally exported from the USA. Certificates such as the Certificate of Free Sale, Certificate to a Foreign Government, and Certificate of Exportability help smooth customs clearance and demonstrate compliance with the Federal FD&C Act.

What is a Certificate of Free Sale?

The Certificate of Free Sale is an FDA export certificate that confirms that certain products are regulated by FDA and meet the applicable requirements for marketing in the USA or, in specific circumstances, may be legally exported even if not marketed domestically.

The Certificate of Free Sale is available for Dietary supplements, Food for special dietary use and medical foods. The Certificate shows that these products can either legally be marketed in the US or qualify for legal export under the statute.

Other Common FDA Export Certificates for Foods

For Conventional foods and related products, below certificate options are available:

  • Certificate to a Foreign Government (CFG) – Available for conventional foods, food additives, food contact substances, infant formula, and seafood. The certificate is often requested where a foreign government wants assurance that the product is legally marketed in the USA.
  • Certificate of Exportability (COE) – Available for conventional foods, food additives, food contact substances, infant formula, and seafood that cannot be legally marketed in the USA. This certificate helps demonstrate that, although not sold domestically, the products satisfy FDA’s export provisions.

Liberty Management Group Ltd. provides assistance with Certificate of Free Sale and other export certificates.

Namrata

Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

FDA Label Compliance

Companies that manufacture, processes, packs, or holds food products for sale in the USA must comply with FDA food labeling regulations. This applies to packaged foods for human and animal consumption, and covers businesses of all sizes, from large multinational companies to small producers and importers.​

Label compliance is mandatory regardless of whether the product is manufactured domestically or internationally, and includes a range of products such as snacks, beverages, supplements etc. Companies making health or nutrition claims, such as healthy, gluten free etc., must meet strict FDA standards and may require additional documentation. Even products with proprietary formulas must disclose required information like allergens and core nutrition facts.​

Liberty Management Group Ltd. assists food businesses with label compliance by offering structured, professional label review services specifically designed to ensure product labeling meets all current FDA requirements and avoids costly enforcement actions.

The process addresses the key components that determine whether a food label is considered compliant or misbranded under FDA regulations. Clients receive feedback and  drafts labels to simplify implementing required changes.​

Different label review service types:

  • Basic Label Review: Checks for presence and correctness of essential features such as statement of identity, net content, ingredient list, business address, country of origin, product category, foreign language, and serving size.
  • Standard Label Review: Includes all Basic review items plus detailed review of standard of identity, comprehensive ingredient review, interpretation of claims, warning letters relevant to the product, and full nutrition facts evaluation. Action points and suggested draft label are included.
  • Advanced Label Review: Expands on the Standard review with a detailed comments file, marking required corrections directly on the existing label for client clarity and easy application.

Failure to comply can result in import refusals, detentions, product recalls, or other enforcement actions by the FDA, so regular review and updates to labeling are critical.​

Namrata

Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

FEI – FDA Establishment Identifier

An FEI is an FDA system generated unique number used to identify a firm, establishment, or facility involved in manufacturing, packing and distribution of FDA-regulated products. The FEI helps the FDA track inspections, facility registrations, and other regulatory activities.

FEI is different from DUNS or EIN.

FEI for Drugs

  • Both US and foreign drug manufacturing or processing facility must register with the FDA and is assigned an FEI after registration.
  • FEI enables FDA to track inspections, regulatory compliance, recalls, and other enforcement actions for that establishment location.

FEI for Medical Devices

  • Manufacturers, contract manufacturers, foreign exporters, initial importers, relabelers, repackagers must register with the FDA and are assigned an FEI upon registration.
  • FEI enables FDA to track inspections, regulatory compliance, recalls, and other enforcement actions for that establishment location.

FEI for Food

  • The FEI helps the FDA with communication, inspection planning, and tracking facility-related activities during food safety investigations.
  • The FEI is distinct from the food facility registration number, which is an 11-digit FDA-assigned number assigned after registration.

FEI for Cosmetics 

  • The FEI is the required facility registration number used by the FDA to identify cosmetic product facilities in its database.
  • Obtaining an FEI is the first step toward registering a cosmetic facility with the FDA. You must have an FEI before submitting a facility registration.
  • The FEI links the facility registration to product listing submissions, which must include the FEI of each facility manufacturing or processing the cosmetic products.
  • The FEI number does not expire. Once assigned, the FEI remains valid and does not require renewal.
  • The FEI is different from cosmetic facility registration, which must be renewed biennially to maintain compliance.

Liberty Management Group Ltd can help facilities with FDA Regulations for all above product categories.

Namrata

Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

MoCRA

MoCRA stands for the Modernization of Cosmetics Regulation Act of 2022. It expands the FDA’s authority over cosmetics, introduces mandatory registration, safety, and reporting requirements, and aims to strengthen public health protections for cosmetic products.

Key aspects of MoCRA include:

  • Facility Registration: Cosmetic manufacturers and processors must register their facilities with the FDA and update such registration biennially.
  • Product Listing: A responsible person must list every marketed product (including ingredients) and renew such listing annually.
  • Good Manufacturing Practices (GMP): The law requires compliance to GMPs, which sets standards for product safety and quality in manufacturing.
  • Adverse event reporting: Manufacturers must track and report any serious adverse health incidents linked to their products.
  • Safety substantiation: Companies must do all safety testing and keep evidence.
  • Labeling requirements: Product labels must be FDA compliant.

Certain Small businesses may be exempt from some MoCRA requirements, although exemptions do not apply to products intended for use in the eyes, injected, or otherwise specifically regulated under FDA drug regulation.

Liberty Management Group Ltd can help facilities with FDA Registration & product listing and label compliance.

Namrata

Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

FDA Prior Notice

Prior Notice refers to a US FDA requirement under which any food imported into the US must be notified to the FDA before it arrives. This helps the FDA protect the food supply from bioterrorism and other threats.

What Products Require Prior Notice?

  • Food and beverages for humans or animals.
  • Dietary supplements
  • Raw agricultural products intended for consumption
  • Food ingredients and additives

What foods do not require Prior Notice:

Homemade goods for personal use, or non-food items, don’t require prior notice.

What Must Be Included in the Prior Notice?

  • Identity of the food
  • Manufacturer FDA Registration
  • Shipper and country of origin
  • Estimated arrival date and time
  • Port of entry and carrier details
  • US recipient or importer

When Must It Be Submitted?

  • By land: At least 2 hours before arrival
  • By air: At least 4 hours before arrival
  • By sea: At least 8 hours before arrival
  • By international mail: Before the package is sent

Who can Submit Prior Notice

Anyone with information about the shipment.

What Happens If You Don’t File It?

  • Shipments may be refused entry, detained, or destroyed
  • The importer may face penalties or enforcement actions

Liberty Management Group Ltd can help facilities with FDA Registration & prior notice submissions.

Namrata

Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

DUNS requirement for FDA registration

A DUNS Number (Data Universal Numbering System Number) is a unique 9-digit identifier for businesses, issued by Dun & Bradstreet (D&B). It helps verify a company’s identity and establish a business credit file.

A valid DUNS Number is required for FDA registration. The DUNS number serves as a unique facility identifier (UFI), helping the FDA verify business locations and prevent duplicate or fraudulent entries.

Different types of registrations in FDA:

1. Food Facility Registration

  • The Food Safety Modernization Act (FSMA) requires domestic and foreign food facilities to provide a valid DUNS number when registering or renewing their registration with the FDA. This includes facilities that manufacture, process, pack, or hold food for consumption in the U.S.

2. Drug Establishment Registration

  • For domestic and foreign drug establishments, the FDA requires a DUNS number when registering an establishment or when creating a user fee account to make OMUFA, PDUFA & GDUFA payments.

3. Medical Devices Establishment Registration

  • A DUNS number is typically needed for foreign establishments registering their medical devices with the FDA and for creating user fee account to make MDUFA payments to FDA.

Liberty Management Group Ltd can help look up if a facility has a DUNS number or guide to obtain a new DUNS number along with FDA registration.

Namrata

Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

DIETARY SUPPLEMENTS

FDA registration is not required for dietary supplements. However, facilities involved in the production of dietary supplements must register with the FDA. Key points:

  1. Manufacturers, packers, and distributors of dietary supplements must register their facilities with the FDA. This is part of the Food Facility Registration process, which is required under the Bioterrorism Act of 2002.
  2. The registration helps the FDA monitor the supply chain and trace products if there’s a safety concern.
  3. The registration must be updated if any information in registration changes
  4. The registration must be renewed every even numbered year,
  5. Product registration is not required. Dietary supplement manufacturers do not need to register each product with the FDA before selling it, unlike drugs or medical devices. Instead, it’s the responsibility of the manufacturer to ensure the product is safe and labeled according to FDA guidelines.
  6. If a dietary supplement contains a new dietary ingredient (an ingredient not marketed in the U.S. before 1994), the manufacturer must notify the FDA about the ingredient before it is marketed.

Liberty Management Group Ltd. can help you with FDA registration.

Namrata

Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Does FDA cancel Food Facility Registrations?

Food Facility Registration is an FDA requirement for all domestic and foreign facilities that manufacture, process, pack, or hold human or animal food for consumption in the USA. US FDA can cancel or revoke a food facility registration under certain circumstances. If an FDA registered facility fails to meet the FDA’s requirements, the FDA has the authority to suspend or cancel that registration.

Common scenarios in which the FDA might cancel or suspend food facility registration:

  1. Failure to submit Registration correctly – FDA may cancel a registration if they find the information to be inaccurate or duplicate.
  2. Failure to renew Registration – Food facilities are required to renew their registration every two years. If a facility fails to do so, the FDA may cancel the registration. In such case, facilities must re-register prior to exporting.
  3. Failure to Comply with FDA Regulations – If a facility fails to comply with FDA regulations, such as food safety requirements or FSMA, the FDA may revoke or suspend its registration. Non-compliance could include violations like:
  • Failing to meet sanitation standards.
  • Inadequate hazard analysis and lack of proper food safety procedures.
  • Failure to comply with the FSVP for foreign facilities.
  • Failure to Respond to an FDA Inspection – If a facility undergoes an FDA inspection and the inspection reveals significant violations or non-compliance, the FDA can revoke or suspend the registration.
  • Product Recalls or Serious Safety Issues – FDA may cancel a food facility’s registration if serious safety issues arise, such as the facility being involved in recalls, foodborne illness outbreaks, or repeated non-compliance with GMP regulations.
  • Failure to Cooperate with FDA Investigations – If the FDA is conducting an investigation and the facility does not cooperate (e.g., not providing records or access to information), the FDA may suspend or cancel the facility’s registration.

Consequences of a Canceled or Suspended Food Facility Registration

If the FDA cancels or suspends a food facility’s registration, it has serious implications for the business:

  • Inability to Import Food: A canceled or suspended registration means the facility cannot import food into the US until the registration is reinstated.
  • Business Interruption: The facility will be unable to legally manufacture, process, pack, or hold food for U.S. consumption, which can significantly disrupt business operations.
  • Legal and Financial Consequences: In some cases, a facility may face penalties, fines, or other legal consequences if its registration is canceled due to violations or non-compliance.

How to Avoid Cancellation of Food Facility Registration

  • Timely renewal of your registration (every two years).
  • Compliance with all applicable FDA regulations, including food safety practices, labeling requirements, and FSMA regulations.
  • Proper documentation and recordkeeping

Liberty Management Group Ltd. can help you with FDA registration, re-registration, and renewals.

Namrata

Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

FDA Food Facility Biennial Registration Renewal

FDA requires all registered domestic and foreign food and dietary supplement facilities to renew their FDA registration every two years. This applies to all the facilities that manufacture, process, pack, or store food, beverages, or dietary supplements intended for consumption in the USA.

  1. Initial Registration: Any facility that manufactures, processes, packs, or holds food for human or animal consumption in the US must register with FDA.
  2. Registration Renewal: FDA registration must be renewed between October 1 and December 31 of every even-numbered year. Next renewal period is October – December 2024.
  3. Purpose of FDA Registration: FDA registration helps the FDA to regulate food facilities effectively and share important information related to food safety.
  4. Penalties: FDA registrations that are not timely renewed get cancelled and shipments of such facilities are refused admission into US

Biennial renewal of food facility registration with the FDA is important for several reasons:

Up-to-date Information:

The biennial renewal process helps the FDA maintain accurate and up-to-date information about facilities. This includes the address, contact details, and the types of activities conducted at the facility. Accurate data is essential for the FDA to respond quickly in case of a food safety issue.

Food Safety:

The renewal process supports the FDA’s ability to monitor and inspect food facilities to ensure compliance with food safety standards. This is crucial for preventing foodborne illnesses and ensuring that food products entering the US market are safe for consumption.

Compliance with FSMA:

FSMA mandates the registration and regular renewal of food facilities. Failure to renew registration can lead to a facility being considered non-compliant, which may result in legal actions, such as the refusal of food shipments, or being prohibited from distributing food in the US.

Efficient Communication:

Up-to-date registration information helps ensure that the FDA can communicate efficiently with facilities in case of emergencies, such as recalls, outbreaks, or other food safety concerns. Efficient communication is key to mitigating risks and protecting public health.

Preventing Market Disruptions:

Timely renewal helps prevent disruptions in the supply chain. If a facility fails to renew, it may face legal or logistical hurdles that may prevent its products from entering the US market, causing potential losses and supply issues.

Liberty management Group Ltd. can help companies with FDA Registration and biennial registration renewal.

Namrata

Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us