Category: Food Regulations

FDA Clearance vs FDA Registration

FDA Clearance & FDA Registration are two separate processes associated with the US FDA.

FDA clearance is a process specific to medical devices. It is applicable to low or moderate risk devices that are categorized by FDA as Class I or Class II. This process is also called 510(k) clearance.

When a manufacturer intends to market a new medical device, they may submit a 510(k) premarket notification to the FDA. This submission demonstrates that the new device is substantially equivalent to an FDA cleared device. In FDA clearance, FDA evaluates whether the new device is substantially equivalent to the predicate device in terms of intended use, technological characteristics, and performance. If the FDA determines that the device is substantially equivalent, it is cleared for marketing.

FDA registration is required for for various FDA Regulated products, including medical devices, food, drug and cosmetics. FDA registration is for facilities or establishments that are involved in the manufacturing, processing, packing, or holding of FDA regulated products.

Companies engaged in above activities must register their facilities with the FDA. This includes providing information about the types of products manufactured, processes used, and other relevant details. Registration is a requirement for companies involved in the production and distribution of FDA Regulated products. It helps the FDA keep track of facilities and facilitates inspections to ensure compliance with regulatory standards. Upon successful registration, the facility is assigned an FDA registration number.

Liberty Management Group Ltd. can help you with FDA clearance for medical devices and FDA registration for Drugs, Cosmetic, Medical Devices & Food.

Namrata

Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

INFANT FORMULA


US FDA regulates infant formula ensuring that it is safe and provides all the required nutrients for the healthy growth and development of infants.

The FDA regulatory requirements for infant formula are:

  1. FDA Registration: Manufacturers of infant formula are required to register with the FDA
  2. Infant formula notification: Before marketing a new or reformulated formula, manufacturers must submit a notification for FDA review of formulation & labeling of the products.
  3. Ingredients: Manufacturers must ensure that the formula provides the essentials nutrients to infants. FDA has established certain ingredient requirements. These requirements include the types and amounts of proteins, fats, carbohydrates, vitamins, and minerals that must be present.
  4. GMP – Infant formula manufacturers must adhere to GMP regulations to ensure the quality and safety of their products. This includes proper handling of raw materials, quality control testing, and sanitation procedures.
  5. Testing: Manufacturers are required to conduct appropriate tests to contain certain contaminants, such as microbiological contaminants, heavy metals, and pesticides, in infant formula and to ensure that their product meets FDA established safety standards.
  6. Labeling Requirements: Infant formula labels must be FDA compliant. The label must contain accurate & clear information about the products. Labels must include specific nutritional information, usage instructions, and warnings. Health claims and nutrient content claims are also subject to strict guidelines.
  7. Inspections and Audits: FDA conducts inspections of infant formula manufacturing facilities to verify compliance with regulations. Such inspections may occur regularly to ensure ongoing adherence to safety and quality standards.
  8. Recalls and Market Withdrawals: In the event of a safety concern or non-compliance with regulations, the FDA has the authority to request a recall or market withdrawal of infant formula to protect public health.

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

Namrata

Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

What is DUNS number? Why is it important to obtain DUNS?

The Data Universal Numbering System or DUNS number is a unique 9-digit identification number provided by Dun & Bradstreet (D & B). The DUNS Number is location specific. So, each distinct physical location of an entity (such as branches, divisions, and headquarters) may be assigned a separate DUNS number.

All domestic and foreign food facilities are required to provide a Unique Facility Identifier (UFI) when registering with FDA. Currently DUNS number is the only acceptable UFI recognized by FDA.

FDA intends to conduct the verification process for UFI as below:

  1. For new registrations – Once the registration is submitted, FDA will verify the accuracy of UFI. FDA will not confirm the registration or provide a registration number until verification is complete.
  2. For biennial renewals – Once the renewal is submitted, FDA will verify the accuracy of UFI. FDA will not confirm the renewal until verification is complete.

DUNS number for FDA purposes is free of cost. Facilities registering with FDA must obtain a DUNS number first. DUNS requests may take up to 30 days.

Liberty Management Group Ltd can help you with FDA registrations, renewals and DUNS lookup. For assistance, please visit our website www.fdahelp.us

Namrata

Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

How does FDA regulate Dietary Supplements?

Manufacturers and sellers of dietary supplements in the US must comply with various FDA requirements to ensure the safety, quality and labeling of products being offered for sale in the US.

Key FDA requirements are:

Facilities manufacturing, packing, or storing dietary supplements must register with the FDA. Registration helps the FDA identify and monitor industry participants. Registration must be renewed biennially, and any changes to facility information must be updated.

Dietary supplement labels must be truthful and not misleading. Labels must accurately represent the product’s ingredients, content, and intended use. A Supplement Facts panel must be included on the label, providing information on serving size, ingredients, and nutrient content per serving. Allergen labeling is required to inform consumers of the presence of major food allergens, if applicable. Dietary supplement manufacturers are prohibited to make drug claims such as treat, cure, diagnose, or prevent diseases.

  • Current Good Manufacturing Practices (GMP):

Dietary supplement manufacturers are required to follow GMP regulations. GMP regulations establish standards for the production, packaging, labeling, and storage of dietary supplements. Compliance with GMP helps ensure that dietary supplements are manufactured consistently and meet quality standards. Facilities must maintain detailed records and establish quality control procedures.

  • New Dietary Ingredients (NDIs):

Manufacturers intending to use a new dietary ingredient (an ingredient not marketed in the U.S. before October 15, 1994) must submit a notification to the FDA at least 75 days before marketing the product. The notification must include evidence demonstrating that the NDI is reasonably expected to be safe for use in dietary supplements.

  • Adverse Event Reporting:

Manufacturers and distributors of dietary supplements are required to submit reports to the FDA regarding any serious adverse events associated with their products.

  • Imports:

The FDA regulates imported dietary supplements to ensure they meet the same safety and labeling standards as domestically produced supplements. Imported supplements may be subject to inspection and testing at US ports of entry.

  • Enforcement:

The FDA can take enforcement actions against manufacturers and distributors that violate regulations, including issuing warning letters, initiating recalls, and seizing products.

Liberty Management Group Ltd. provides assistance with FDA registration and label compliance.

Namrata

Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

US FDA Certificate of Free Sale

A Certificate of Free Sale (COFS) is a document issued by US FDA that certifies that a dietary supplement, food for special dietary use, or medical food meets all the regulatory requirements for sale and distribution and is either legally sold in the US or can be legally marketed from US.

COFS is used primarily for products intended for export to foreign countries, and it provides assurance to foreign buyers or regulatory authorities that the product is safe, of high quality, and complies with US regulations.

The COFS typically includes information about the product, its manufacturer, exporter and destination country.

Manufacturers looking to obtain a COFS from the FDA will need to submit an application, along with product labels and applicable fees. The FDA reviews the application and, if everything is in order, issues the certificate.

Depending on the nature of the product and the requirements of the importing country, you may also need to provide other documentation to the FDA upon request.

Export Certificate requests are usually processed within a few days, but the processing time may vary depending on the number of products on application, completeness of application and FDA’s regulatory workload.

Certificate of Free Sale have a validity of 2 years and they can be verified on FDA website.

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

Facilities exempt from FDA Food Facility Registration

Owner, operator, or agent in charge of domestic and foreign facilities engaged in manufacturing, processing, packing, or holding of food and dietary supplement for human or animal consumption in the US are required to register with FDA, unless such facility is exempt from the requirement to register by the regulation.

Examples of facilities exempt from registration requirement are:

  1. Home Based business – a domestic or foreign home based business that meets customary expectations for a private residence that is also used to manufacture, process, pack, or hold food need not be registered.
  2. Personal consumption: If you are producing food products for personal consumption and not for distribution or sale, you are exempt from FDA registration.
  3. Farms – Facilities that produce, harvest, pack, or hold raw agricultural commodities are exempt from registration. There are certain exceptions to this exemption.
  4. Retail Food Establishments – Facilities that sell food products directly to consumers are generally exempt from FDA food facility registration, for e.g., grocery stores, supermarkets, restaurants, food trucks, etc
  5. Restaurants & Bars – Facilities that prepare and serve food for directly to consumers for immediate consumption are exempt from FDA registration.
  6. Nonprofit food establishments
  7. Fishing Vessels – Fishing Vessels engaged in the harvesting and transportation of raw seafood are exempt from registration. There are certain exceptions to this exemption.
  8. Some foreign facilities, where food from such facility undergoes further processing by another facility outside US are exempt from FDA registratioln.
  9. Facilities regulated exclusively by USDA.

Facilities looking to register with FDA can reach out to Liberty Management Group Ltd. for assistance. We can help you with registration & other FDA regulations.

Namrata

Regulatory Consultant

support@libertymanagement.us

www.fdahelp.us

Re-Registration of Food Facility Registrations & UFI Requirement

As per FDA regulation, food facilities that are registered with FDA are required to renew such registration between Oct – Dec every even numbered year (2022, 2024, 2026…). If a facility fails to renew the registration by the deadline, FDA will consider such registration as expired & remove it from the FDA system.

Such facilities that wish to market their products in US will need to re-register with FDA. Facilities looking to re-register due to incomplete biennial renewal will need to provide their old FDA registration number on new application & FDA will reassign the same registration number to them. If the registration was cancelled because of any other reason, facilities will need to submit a new registration & will be assigned a new FDA registration number.

Beginning October 1, 2020, domestic and foreign facilities will need to provide a UFI (Unique Facility Identifier) recognized as acceptable to FDA in existing and new food facility registrations. Currently, FDA recognizes DUNS (Data Universal Numbering System) as the only acceptable UFI for the food facility registrations. FDA will not confirm a facility’s biennial renewal or assign a registration number if a valid DUNS number is not provided on registration.

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

Namrata

Regulatory Consultant

support@libertymanagement.us

www.fdahelp.us

RESPONSIBILITIES OF A US AGENT

All foreign food facilities that engage in manufacture, pack or holding of food for human or animal consumption in US are required to register with FDA and identify a US Agent on their registration.

All foreign drug establishments that manufacture, repack, or re-label drug products and import or offer for import drug products to the US must register with the FDA and identify a US Agent on their registration.

All foreign medical device establishments engaged in the manufacture, preparation, propagation, compounding, or processing of a medical device imported into the US must identify a US Agent on their FDA registration.

The responsibilities of a US Agent include:

  • Assisting FDA in communications with the foreign establishment,
  • Responding to questions concerning the foreign establishment’s products that are imported or offered for import into the US.
  • Assisting FDA in scheduling inspections of the foreign establishment
  • If FDA is unable to contact the foreign establishment directly or expeditiously, FDA may provide information or documents to the US Agent, and such an action shall be equivalent to providing the same information or documents to the foreign establishment.

Each foreign establishment must appoint only one US Agent. The foreign establishment must provide the name, address, telephone number, fax number, and e-mail address of the US Agent.

The US Agent will need to accept such appointment timely. The US Agent must reside or maintain a place of business in US. They must be available to answer the phone during normal business hours.

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

Namrata

Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Food Additives

Food additives are substances the intended use of which results or may result, directly or indirectly, in its affecting the characteristics of a food. For hundreds of years, people are adding different ingredients to foods.

Some uses of food additives are:

  • Improve or maintain freshness of safety: Preservatives help to slow down food spoilage that may occur because of air, fungi, mold, bacteria or yeast. They may also help regulate contamination that may cause foodborne illnesses. Antioxidants prevent foods that contain oils from becoming stale or developing off flavor.
  • Improve or maintain nutritional content – Minerals, Vitamins, Fiber etc. are added to some foods to increase their nutritional value and to provide for the nutrition that may be lost during cooking or processing.
  • Improve Taste, Texture or Appearance – Food colors are added to food to make it look fresh and tasty. Emulsifiers and stabilizers give foods desired texture and consistency. Leavening agents are used in baking products to aid rising. Certain additives are added to control acidity or alkalinity of foods.

Manufacturers of Food additives are required to register with FDA.

Liberty Management Group Ltd. can help you register your facility with US FDA.

Namrata

Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

DIETARY SUPPLEMENT LABELS

Dietary supplements are products that contain dietary ingredients and are in the form of pills, tablets, capsules, gummies, soft gels, liquids & powders intended to supplement a conventional diet. Dietary ingredients include vitamins and minerals, herbs and botanicals, amino acids, enzymes, live microbials and concentrates, metabolites, constituents, extracts, or combinations of dietary ingredients.

Manufactures and distributors of dietary supplements and dietary ingredients are responsible for the safety and labeling of their products before they market their products in US. FDA prohibits marketing of products that are adulterated or misbranded.

FDA requires labels of dietary supplements to comply with FDA labeling regulations. FDA may exercise enforcement action if dietary supplement label is found to be violating FDA’s regulations. Companies looking to sell dietary supplements in USA must adhere to Dietary supplement labeling regulations and register their manufacturing, packing or storage facility with FDA.

Liberty Management Group Ltd can help you with FDA registration and label compliance.

Namrata

Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Published on: February 08, 2023