Namrata – Page 4 – FDA Support

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:

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.
Personal consumption: If you are producing food products for personal consumption and not for distribution or sale, you are exempt from FDA registration.
Farms – Facilities that produce, harvest, pack, or hold raw agricultural commodities are exempt from registration. There are certain exceptions to this exemption.
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
Restaurants & Bars – Facilities that prepare and serve food for directly to consumers for immediate consumption are exempt from FDA registration.
Nonprofit food establishments
Fishing Vessels – Fishing Vessels engaged in the harvesting and transportation of raw seafood are exempt from registration. There are certain exceptions to this exemption.
Some foreign facilities, where food from such facility undergoes further processing by another facility outside US are exempt from FDA registratioln.
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

Drug Master File (DMF)

A Drug Master File (DMF) is a confidential submission to FDA to provide detailed information about the facilities, processes or articles used to manufacture, process, package or store human drugs.

DMF submissions are not mandatory and DMF applications are neither approved nor rejected by FDA. It is submitted by a drug manufacturer to provide confidential information about the drug’s quality, safety, and efficacy. The information submitted in a DMF is usually referenced only during the IND, NDA, ANDA or export application. A DMF contains technical information about a drug, including its chemical and physical properties, manufacturing processes, and analytical methods.

DMFs are often submitted by drug manufacturers to support the approval of their drug products. 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

Type I: Manufacturing Site, Facilities, Operating Procedures, and Personnel

Type II: Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product

Type III: Packaging Material

Type IV: Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation

Type V: FDA Accepted Reference Information

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

Namrata

Regulatory Consultant

support@libertymanagement.us

www.fdahelp.us

MOCRA – Modernization of Cosmetics Regulation Act of 2022

Recently US Congress passed the Consolidated Appropriations Act, bringing changes to how cosmetic products are regulated in the US. MOCRA or the Modernization of Cosmetics Regulation Act of 2022 provides regulatory authority to US FDA over cosmetic industry. Key requirements of MOCRA are as below:

Facility Registration

Manufacturers and processors must register their facilities with the FDA and renew such registration biennially. FDA no longer accepts VCRP registrations so Facilities that were registered under the VCRP program will have to register again under the new system.

Product Listing

A responsible person must list each marketed cosmetic product and ingredients with the FDA and must renew such listing annually.

Good Manufacturing Practices (GMP)

Cosmetic manufacturing and processing facilities must comply with GMP standards.

Product Labeling

Cosmetic product labels must adhere to new cosmetic labeling requirements.

Adverse Event Report

A responsible person is required to report serious adverse events associated with the use of cosmetic products in the US to the FDA. FDA will have access to adverse event reports during an inspection.

Product Safety Substantiation

A responsible person is required to ensure and maintain records supporting adequate safety substantiation for their products.

Mandatory Recall

FDA has the authority to order a mandatory recall, if deemed necessary, if the responsible person refuses to do so voluntarily.

A responsible person means the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product in accordance with section 609(a) of the FD&C Act or section 4(a) of the Fair Packaging and Labeling Act.

Liberty Management Group Ltd. can help you with Facility Registration, Product Listing, Label compliance and other FDA regulations.

Namrata

Regulatory Consultant

support@libertymanagement.us

www.fdahelp.us

Low Acid Canned Food and Acidified Food

Low-acid canned foods are foods with a finished equilibrium pH greater than 4.6 and a
water activity greater than 0.85, excluding tomatoes and tomato products having
a finished equilibrium pH less than 4.7. They are processed at high
temperatures in airtight containers to prevent contamination & growth of
harmful bacteria.

An acidified food is a low-acid food to which acid ingredients are added and which
has a finished equilibrium pH of 4.6 or below and a water activity greater than
0.85. This makes the food more acidic and creates an environment that is
unfavorable for the growth of microorganisms.

Low-acid canned foods & Acidified foods are regulated by the US FDA and
manufacturers and processors must follow strict guidelines for processing and labeling these
products.

Manufacturers and processors of Low-acid canned foods & Acidified foods must register with FDA
as a food facility, submit a Food Canning Establishment Registration &
process filing of such products.

FDA FCE (food canning establishment registration) is a process by which facilities
that engage in the commercial processing and packing of acidified and low-acid
canned foods must register with the US FDA.

Liberty Management Group Ltd. can help you with Food Facility Registration, FCE, label compliance and other FDA regulations.

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

UFI for FDA Food Facility Registrations

FD&C Act requires all domestic and foreign facilities that manufacture, process, pack or hold food for human or animal consumption in US to register with FDA. The FSMA Act amended the food facility registration requirements requiring food facilities to renew the registrations between Oct – Dec every even numbered year and to provide an FDA recognized Unique Facility Identifier (UFI) in their FDA registration. As per the regulation FDA will not confirm a facility’s new registration or renewal until FDA verified the accuracy of the UFI and verified that the facility-specific address associated with UFI matches with the facility’s information in registration.

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

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.
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.

In August 2018, FDA recognized Data Universal Numbering System D-U-N-S (DUNS) as an acceptable UFI for the food facility registration regulation. The DUNS number is assigned and managed by Dun & Bradstreet and is available free of charge.

Liberty Management Group Ltd can help you with biennial registration renewal and DUNS update. For assistance, please visit our website.

Namrata

Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Published on: September 07, 2022

Lead Acetate in Cosmetics

Since 1980 lead acetate has been considered a safe color additive for use in cosmetics for hair coloring. In 2017, a color additive petition requesting repeal of regulation that allows for the use of lead acetate in cosmetics was submitted. After carefully reviewing the submission and other relevant information, FDA concluded that there is no reasonable certainty of no harm from this use of lead acetate. On October 30, 2018, FDA published a final rule banning the use of Lead Acetate in cosmetic products intended for hair coloring. The rule is effective from December 03, 2018 and the industry has 12 months to make the transition and reformulate their products. Such products must comply with the requirements of 21 CFR 73.2396, including the specifications, uses and restrictions, and labeling requirements.

Hair dye products containing Lead Acetate are required to bear such a warning statement:

CAUTION: Contains lead acetate. For external use only. Keep this product out of children’s reach. Do not use on cut or abraded scalp. If skin irritation develops, discontinue use. Do not use to color mustaches, eyelashes, eyebrows, or hair on parts of the body other than the scalp. Do not get in eyes. Follow instructions carefully and wash hands thoroughly after each use.

Manufacturers and labelers of cosmetic products must comply with FDA labeling requirements otherwise their products are considered misbranded and are subject to detention.

Liberty Management Group Ltd. can help companies with labeling compliance. Our label experts check your labels against current labeling regulations and help you avoid detention and import refusals.

Namrata

Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Published on: September 25, 2019