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.

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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.

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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.

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Types of FCE-SID Process Filing forms

Low-acid canned food

A low-acid canned food has the following characteristics:

      1. Equilibrium pH value greater than 4.6 and water activity greater than 0.85.
      2. Sealed in a hermetic (air-tight) container (i.e., secure against the entry of microorganisms).
      3. Receives a heat treatment for the purpose of achieving commercial sterility.
      4. Normally stored and distributed under non-refrigerated conditions.

Acidified food

An acidified food is a low-acid food to which acid(s) or acid food(s) are added for the purpose of reducing the pH to a finished equilibrium pH of 4.6 or below. It has a water activity greater than 0.85 and is stored and distributed under nonrefrigerated conditions.

FDA requires manufacturers and processors of low acid canned and acidified food products to submit Food Canning establishment registration using Form 2541 and to submit process filing using Form 2541d, e, f and g.

Form 2541d – Commercial processors who manufacture, process, or pack thermally processed low-acid foods packaged in hermetically sealed containers. Form FDA 2541d is intended for:

  • Low-acid food products where the growth of microorganisms is controlled through the application of heat to foods.

Form 2541e – Commercial processors who manufacture, process, or pack thermally processed acidified foods packaged in hermetically sealed containers

Form 2541f – Commercial processors who manufacture, process, or pack thermally processed low-acid foods packaged in hermetically sealed containers. Form FDA 2541f is intended for

  • Low-acid food products where the growth of microorganisms is controlled through the amount of water available for microbiological growth (i.e. “water control” products); and
  • Low-acid food products where the growth of microorganisms is controlled through multiple physical and/or physicochemical hurdles (i.e. “formulation control” products).

Form 2541g – Commercial processors who manufacture, process, or pack thermally processed low-acid foods packaged in hermetically sealed containers. Form FDA 2541g is intended for:

  • Low-acid foods where the growth of microorganisms is controlled through the application of heat to foods and where the processing involves use of aseptic processing and packaging

Liberty management Group Ltd. can help companies to file FCE and SID process filings with FDA.

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HOW TO FILE A DMF

DMF (Drug Master File) is a confidential & detailed submission to FDA.

There are several steps involved in filing a DMF with the US FDA:

1. Determine the Type of DMF

Identify the type of DMF you need to file (Type II, III, IV, or V).

2. Prepare the DMF Document

  • Cover Letter: Include a cover letter containing the type of DMF, the specific content included, and contact information.
  • Administrative Information: Provide the DMF holder’s and US Agent’s contact details.
  • Technical Content: This varies depending on the type of DMF. It includes manufacturing processes, specifications, testing methods, stability data, and other technical details.
  • References and Appendices: Include all relevant references, supporting documents, and appendices.

3. Format of Document

The DMF must be prepared according to the FDA guidelines on electronic submissions using the eCTD format.

4. Compile the Submission

  • Ensure all sections are complete and properly formatted.
  • Compile the document into eCTD format.

5. Obtain a Pre-Assigned Number

Request a pre-assigned application number for DMF from the FDA.

6. Submit the DMF

Submit the DMF electronically via the FDA’s ESG portal.

7. Pay the Fee

Type II DMF Submission from an API Manufacturer for a generic drug application need to pay FDA fees. There is no FDA fee for other types of DMF submissions.

8. Acknowledge Receipt

Once submitted, FDA will acknowledge receipt of the DMF.

9. Annual Updates and DMF amendments

  • Submit annual updates and amendments as needed.
  • Keep the FDA informed of any changes to the DMF’s content or contact information.

Liberty Management Group Ltd. can help you DMF submissions & US Agent service.

Namrata

Regulatory Consultant

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Drug Master Files

A Drug Master File (DMF) is a confidential and detailed document submitted to the US FDA by a drug manufacturer. It contains comprehensive information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products. DMF submission is not required by FDA regulation. DMF is solely submitted at the discretion of the DMF holder. A MDF is not approved or disapproved. Technical contents of a DMF may be reviewed only in connection with the review of an IND, NDA, ANDA, or an Export Application. DMF allows FDA to review this information to ensure the quality and safety of the drug products without disclosing proprietary information to the drug product’s sponsor.

The submission of a DMF can be made by:

  1. API manufacturers
  2. Excipient manufacturers:
  3. Container Closure System manufacturers
  4. Drug Product manufacturers

Types of DMF:

  1. Type I: Manufacturing Site, Facilities, Operating Procedures, and Personnel (discontinued since September 2010).
  2. Type II: Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product.
  3. Type III: Packaging Material.
  4. Type IV: Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation.
  5. Type V: FDA Accepted Reference Information

Non-US DMF applicants are required to appoint a US Agent in their DMF for FDA communication purpose.

Liberty Management Group Ltd. can help you DMF submissions & US Agent service.

Namrata

Regulatory Consultant

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FDA Food Facility Registration Definitions

FDA requires US and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the USA to register with FDA.

Important definitions:

  1. Facility – any establishment, structure, or structures under one ownership at one general physical location that manufactures, processes, packs, or holds food for consumption in the USA.
  2. Domestic facility – any facility located in the USA, the District of Columbia, or the Commonwealth of Puerto Rico that manufactures, processes, packs, or holds food for consumption in the USA.
  3. Foreign facility – any facility other than a domestic facility that manufactures/processes, packs, or holds food for consumption in the USA.
  4. Manufacturing/processing – making food from one or more ingredients, or synthesizing, preparing, treating, modifying or manipulating food, including food crops or ingredients.
  5. Holding – storage of food and includes activities performed incidental to storage of a food. Holding facilities could include warehouses, cold storage facilities, storage silos, grain elevators, and liquid storage tanks.
  6. Packaging – placing food into a container that is directly in contact with the food.
  7. Packing – placing food into a container other than packaging the food and includes re-packing and activities performed incidental to packing or re-packing a food.
  8. Trade name – other names under which the facility conducts business or is known by.
  9. US Agent – person residing or maintaining a place of business in the USA and who is designated as agent by a foreign facility.
  10. The US Agent acts as a communications link between FDA and the foreign facility for both emergency and routine communications. The US Agent will be the person FDA contacts when an emergency occurs, unless the registration specifies another emergency contact.
  11. FDA will consider the US Agent the equivalent of the registrant for purposes of sharing information and communications.
  12. Registrant – the owner, operator, or agent in charge of a facility that manufactures, processes, packs, or holds food for consumption in the USA.

Liberty Management Group Ltd. can help you with FDA registration & US Agent service.

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What information is required in the FDA registration of a food facility?

As per 21 CFR 1.232, the following information is required for US and non-US food facility registrations:

  • Facility name, address, phone number and email address
  • DUNS number
  • Preferred mailing address, phone number & email address, if different from facility
  • Parent company name, address, phone number & email address (if the facility is a subsidiary of the parent company)
  • Facility Emergency contact name, phone number & email address
  • All alternate names the facility uses
  • US Agent name, address, phone number & email address
  • Name, address, phone number & email address of the owner, operator, or agent in charge
  • Applicable food product categories of any food manufactured, processed, packed, or stored at the facility
  • The types of activity at the facility for each food product category
  • A statement in which the owner, operator, or agent in charge provides an assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act
  • A statement in which the owner, operator, or agent in charge certifies that the information submitted is true and accurate. If the individual submitting the form is not the owner, operator, or agent in charge of the facility, the registration must also include a statement in which the individual certifies that the information submitted is true and accurate, certifies that he/she is authorized to submit the registration, and identifies by name, address, phone number & email address, the individual who authorized submission of the registration.

Liberty Management Group Ltd. can help you with FDA registration & US Agent service.

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ISO 9001 Certification

ISO 9001 certification is an internationally recognized standard for quality management systems  developed by the International Organization for Standardization (ISO). It outlines the criteria for establishing, implementing, maintaining, and continually improving an effective quality management system within an organization.

An organization may choose to implement 9001 for its entire operations or for a particular department.

The ISO 9001 standard is based on several quality management principles, including a strong customer focus, the involvement of top management, a process approach, and continual improvement.

Organizations that achieve ISO 9001 certification have demonstrated their ability to consistently provide products and services that meet customer and regulatory requirements. Certification involves an independent assessment by a certification body to ensure that the organization’s quality management system complies with the requirements of the ISO 9001 standard.

ISO 9001 certification is applicable to organizations of all sizes and industries, from manufacturing and service providers to non-profit organizations and government agencies. It can enhance credibility, improve processes, increase customer satisfaction, and provide a competitive advantage in the marketplace.

Liberty Management Group Ltd can help organizations with ISO 9001 consultation, documentation, implementation & certification

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Drug Master File

A Drug Master File or (DMF) is a confidential submission to the US FDA that provides detailed information about facilities, processes, or components used in the manufacturing, processing, packaging, and storing of drugs.

The DMF is submitted by a manufacturer, supplier, or developer of an API (active pharmaceutical ingredient), excipient, or packaging material, and it allows them to provide information to the regulatory authority without disclosing the information to their customers or competitors.

A DMF is referenced in a drug application, such as an ANDA or NDA Application, by the applicant who intends to use the information contained in the DMF to support their own application. The regulatory authority can then review the information in the DMF as part of the evaluation of the drug application.

The purpose of a DMF is to provide information to the regulatory authority, without disclosing proprietary information to the public, to support the regulatory review process of a drug product. This allows the regulatory authority to evaluate the quality, safety, and efficacy of the drug product without needing to disclose confidential information to third parties.

DMF submissions are not mandatory and DMF applications are neither approved nor rejected by FDA. DMFs are subject to strict confidentiality requirements and are not publicly available.

DMF holders are required to notify FDA of any changes in the contents of DMF, authorized parties, transfer of ownership etc. An annual report must be submitted every year listing all changes since the previous annual report. Foreign DMF holders are required to appoint a US Agent in their submissions.

Types of Drug Master Files:

  1. Type I: Manufacturing Site, Facilities, Operating Procedures, and Personnel
  2. Type II: Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product
  3. Type III: Packaging Material
  4. Type IV: Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation
  5. Type V: FDA Accepted Reference Information

Liberty Management Group Ltd. can help you with DMF original and annual report submissions & US Agent service.

Namrata

Regulatory Consultant

support@libertymanagement.us

www.fdahelp.us