Tag: FDA registration

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

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

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:

  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.

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

CBD in Foods and Dietary Supplements

There has been growing interest in the development of consumer products derived from cannabis and its components including CBD-Cannabidiol. FDA has found that many companies are marketing products containing CBD that may put consumers health at risk.

By far FDA has approved only one drug containing CBD for treatment of seizures. But FDA has found that many other CBD containing products are being sold in market, some as dietary supplements. As per FD&C Act, if a substance is an active ingredient (such as THC or CBD) in a drug that has been approved by FDA or is the subject of an IND – Investigational New Drug, for which substantial investigations have been instituted, then products containing such substance are excluded from the definition of dietary supplements. Exclusion from the definition of dietary supplement means that it is prohibited to market such products as dietary supplements.

If a product contains ingredients from such a part of cannabis plant that does not contain THC or CBD, then it may be marketed as a dietary supplement however it must comply with all applicable laws and regulations governing dietary supplement products. Such manufacturers who wish to market dietary supplement that contain new dietary ingredients that were not marketed in US before October 15, 1994 must notify FDA about these ingredients demonstrating that such supplement is safe under the conditions of recommended usage suggested in the labeling. In addition to NDI-New Dietary Ingredient notification, compliance to labeling and cGMP requirements specific to dietary supplements must be met.

If a non-THC or non-CBD ingredient derived from a cannabis plant is added to food products, such food ingredients are subject to premarket review and approval by FDA unless the substance is GRAS -Generally Recognized as Safe, by the experts under the conditions of its intended use. FDA has so far received and accepted only 3 GRAS notifications for hemp seed ingredients. Food companies that wish to use cannabis derived ingredients in their food products must abide by the laws and regulations including food additive petitions and GRAS notifications.

It is important to know the regulatory status of an ingredients that is added to any food or supplement. Liberty Management Group Ltd. can help you with Ingredient compliance, FDA registration, Label compliance and other FDA regulations.

Namrata

FDA Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Published on: August 14, 2019

Cosmetics vs Drugs

Cosmetics are defined by FD&C Act as articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance. For example, skin moisturizers, perfumes, lipsticks, fingernail polishes, cleansing shampoos, hair colors, and deodorants etc.

Drugs, on the other hand, are defined as articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and articles (other than food) intended to affect the structure or any function of the body of man or other animals.

Some products meet the definition of both cosmetic and drugs. For example, a cleansing shampoo is a cosmetic as its intended use is to cleanse the hair. An antidandruff treatment is a drug as its intended use is to treat dandruff. As a result, an antidandruff shampoo would fall under both cosmetic as well as drug. Another example is that of a toothpaste with fluoride, anti-perspirant deodorants, moisturizer with sun protection claims.

A product’s intended use is determined based on either the claims made on the label, advertisements, company website, general perception about the product in consumers mind or by the ingredients present in the product.

The FDA requirements of cosmetics and drugs are different. Below is an outline of the key differences:

  1. FDA approval – FDA does not approve cosmetics except for color additives. On the other hand, every new drug needs an approval or conformity to FDA’s OTC monograph.
  2. GMP – FDA has no set regulations for cosmetic GMP. There are only guidelines that cosmetic companies need to refer to. But for drug companies, FDA has laid clear regulations that drug companies need to comply with.
  3. FDA registration – Cosmetic registrations are voluntary. Drug Registrations and listings are mandatory.
  4. Labels – Cosmetic labels need to comply with cosmetic labeling regulations while OTC Drug labels require compliance to OTC drug labeling regulations and combination drugs requires compliance to regulations specific to combination product labeling.
  5. NDC number: Drug products are required to have a labeller code while cosmetics are exempt from the requirement

Liberty Management Group Ltd provides assistance with FDA Registration for Drugs and Cosmetic Establishments, Label compliance, US Agent service and many more FDA regulations.

Namrata

FDA Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Published on: July 31, 2019

Food Date Labeling

All packaged foods are required to bear labeling as per FDA regulations. There are mandatory elements of labels which must be present. Some elements of labels are not made mandatory by FDA, but some labelers may choose to adopt them.

Under the Federal Law, manufacturers of packaged foods are not required to place quality-based date labels on their products except for infant formula. Manufacturers may choose to voluntary put date labels on their product but as there are no uniform descriptions used on food labels for dating in USA, a wide variety of phrases are used for product dating such as “Use before”, “Sell By”, “Expires on”, “Best By” etc. to describe the dates to indicate when a food may be at its best quality. On survey in 2007, FDA found that most consumers are not able to distinguish between different date labeling phrases.

According to USDA, in USA, 30 percent of food is lost or wasted at retail or consumer level. This implies that about $161 billion worth of food is thrown away every year in USA. US FDA believes that food wastage is due to consumers fears about food safety and their misunderstanding of the meaning of terms on packaged food labels.

FDA has recently issued an advisory letter to the food industry supporting standardizing of voluntary date labeling if the date is simply used for quality not safety. Such standardization can provide consumers with information that is easy to understand.

FDA strongly supports manufacturers use of phrase “Best if used by” when they choose to apply a quality date label. This makes consumer understand that the date label is about quality of product not its safety and thus do not have to be discarded after the date if stored adequately. If the products have changed noticeably in color, smell or texture, consumers may avoid eating them.

To ensure your product labels are FDA compliant, you can use LMG’s label review service. Our experienced label team goes over each element of label with you in detail resulting in a fully compliant label.

Namrata

FDA Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Published on: June 19, 2019

Who needs to register with FDA?

Owners, operators or agent in-charge of domestic as well as foreign facilities that are engaged in manufacturing, processing, packing or holding for human or animal foods for consumption in USA are required to register with FDA unless exempt from the requirement to register under 21 CFR 1.226.

Facilities that are exempt are:

  1. Farms
  2. Restaurants
  3. Retail Food Establishments e.g. grocery stores
  4. Nonprofit Food Establishments
  5. Fishing Vessels
  6. Facilities that manufacture/process, pack, or hold food entering US solely for the purpose of exportation or trans-shipment to another country
  7. Private residence of individuals
  8. Post Offices, Freight Forwarders

While registering a facility with FDA, the owner, operator or agent in-charge is required to provide accurate Facility info including the names of Emergency contact, Products, Trade names under which it conducts business and US Agent for the purpose of FDA communications. Also, 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.

If a facility is required to register with FDA, they must register before beginning manufacturing, processing, packing, or holding operations in USA.

In addition to registration, all registered facilities are also required to renew FDA registration between Oct -Dec every even numbered year. FDA will consider a registration for a food facility to be expired if the registration is not renewed as required. Such registration will be cancelled and removed by FDA from its system.

Staring Oct 2020, FDA will mandate submission of UFI (Unique Facility Identifier) for all food facilities. This UFI will be required for all new registrations as well as registration renewals. FDA will not confirm your registration or provide you with a registration number until FDA verifies the accuracy of your facility’s UFI and verifies that the facility-specific address associated with the UFI is the same address associated with your registration.

Liberty Management Group Ltd provides assistance with FDA Registration, Biennial Renewals, US Agent service and many other FDA regulations.

Namrata

FDA Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Published on: June 06, 2019

Dietary Supplement Advisory List

To market dietary supplements in US, manufacturers need to be FDA registered and ensure that their product ingredients are safe and approved by FDA.

In public interest, the FDA has unveiled an online tool, Dietary Supplement Ingredient Advisory List, that alerts the public when FDA identifies any ingredients that do not appear to be lawful ingredients in dietary supplements.

The new list can be used by consumers who do not wish to purchase any dietary supplements that contain questionable ingredients as well as manufacturers or distributors who wish to avoid selling supplements with such ingredients in their products.

Inclusion on the Dietary Supplement Ingredient Advisory List does not mean that FDA has determined the ingredient to be unsafe. Ingredients are added to this list on the basis of preliminary assessment enabling FDA to communicate to public while it completes a final determination regarding such ingredients. The reasons based on which an ingredient may be added to the list are:

  1. The ingredients appear to be excluded from use in a dietary supplement
  2. The ingredient does not appear to be a dietary ingredient, or does not appear to be an approved food additive or GRAS for use, or
  3. The ingredient appears to be subject to the requirement for pre-market notification, but the requirement has not been met

The list is not exhaustive, and ingredients may be added to or removed from the list as and when FDA deems fit.

This new list is a step in the FDA’s ongoing effort to strengthen and regulate the dietary supplement market and better protect consumers from unsafe products.

To ensure that the ingredients that the manufacturers are adding to their products or planning to add to their products are safe and not questionable, an ingredient and label review service of LMG can be availed.

Liberty Management Group Ltd has been serving clients across the world with FDA registrations, label and ingredient compliance and many more FDA regulations. Our technical experts have in-depth knowledge of FDA regulations and guide you every step of the way regarding all FDA regulations.

Namrata

FDA Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Published on: May 22, 2019