Does the FDA approve cosmetic products or companies?

Cosmetics are articles that are intended to be rubbed, poured, sprinkled, sprayed or applied to human body for cleansing, beautifying, or altering appearance.

FDA does not approve cosmetic products or companies. Facilities that are engaged in manufacturing, processing & distribution of cosmetic products are required to comply with below FDA requirements under FDA’s MoCRA regulation.

Cosmetic products and ingredients do not need FDA premarket approval. However, FDA can enforce action against cosmetic products on the market that are not in compliance with the law. It is the responsibility of cosmetic manufacturers or distributors to ensure the safety of their products.

If the FDA determines that a product is adulterated or misbranded, there are several actions the agency might take namely; criminal penalties, detention at port or file in an injunction to prevent the company from manufacturing the product.

Liberty Management Group LTD  provides assistance with Cosmetic Product Registration, Cosmetic Product Listing, Label Review and other FDA regulations.

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What does a US Agent do?

A US FDA Agent acts as a domestic representative for foreign establishments that are engaged in the manufacturing, processing, packaging, or holding of FDA regulated products, such as food, drugs, medical devices &, cosmetics.

The role of the US Agent is primarily to serve as a point of contact between the FDA and the foreign establishment.

Key responsibilities of a US Agent may include:

  1. Assisting FDA to communicate with foreign establishment including responding to inquiries, submitting required documentation, and facilitating inspections.
  2. Serving as a liaison for regulatory compliance matters, including ensuring that the foreign establishment meets FDA regulatory requirements for the products they are dealing in.
  3. Facilitating the submission of required registrations, listings, and other regulatory submissions to the FDA.
  4. Coordinating with the FDA in the event of product recalls, adverse events, or other safety issues related to products manufactured or distributed by the foreign establishment.
  5. Keeping the FDA updated of any changes that are relevant to the foreign establishment’s operations, such as changes in ownership, new manufacturing processes, or product formulations.

The US Agent plays a critical role in helping foreign establishments navigate the regulatory requirements of the FDA and ensuring compliance with US laws and regulations governing the safety and quality of FDA regulated products.

Liberty Management Group Ltd. can be your US Agent and help with registration & other FDA requirements.

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Low Acid Canned Foods & Acidified Foods

The US FDA regulates both Low Acid Canned Foods (LACF) and Acidified Foods (AF).

  1. Low-Acid Canned Foods (LACF):

LACF are low in acid content which provides a conducive environment for the harmful bacteria to grow. FDA regulated LACF products under regulation 21 cfr Part 113.

Manufacturers & processors of LACF are required to register their facility with FDA as a Food Canning Establishment & submit the scheduled process filing for each LACF product. Scheduled process filing provides details of steps in production, time taken, temperatures and other parameters that are necessary to ensure the product’s safety.

  1. Acidified Foods (AF):

Low Acid foods to which acids or acid foods are added to bring the pH level to 4.6 or less are called Acidified foods. Acidified foods are regulated by FDA under 21 cfr Part 114.

Like LACF, AF processors must also register their facility with FDA as Food Canning Establishment & file scheduled process filing for each AF product.

Scheduled process filing for acidified foods include details on the type and amount of acid added, processing times and temperatures.

FDA conducts regular inspections of LACF and AF facilities to ensure regulations are complied with.

Liberty Management Group Ltd. can help you with compliance with FDA requirements for LACF & AF products.

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Regulatory Consultant

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http://www.fdahelp.us

Key Terms under MoCRA

FDA requires every person that owns or operates a facility that engages in the manufacturing or processing of a cosmetic product for distribution in the US to submit cosmetic facility registration with FDA.

FDA also requires that for each cosmetic product, the responsible person must submit to FDA a cosmetic product listing.

Key terms under MoCRA:

CONTRACT MANUFACTURER — a facility that manufactures or processes a cosmetic product on behalf of another entity.

COSMETIC PRODUCT– a preparation of cosmetic ingredients with a qualitatively and quantitatively set composition for use in a finished product.

DUNS NUMBER — The Data Universal Numbering System (DUNS) number is a unique nine-digit identification number issued by D&B. The DUNS Number is sites specific. Therefore, each distinct physical location of an entity (such as branches, divisions, and headquarters) may be assigned a DUNS number.

FACILITY – any establishment (including an establishment of an importer) that manufactures or processes cosmetic products distributed in the United States.

Excluding:

  • Beauty shops and salons
  • Cosmetic product retailers
  • Hospitals, physicians’ offices, and health care clinics
  • Public health agencies and other nonprofit entities that provide cosmetic products directly to the consumer
  • Entities (such as hotels and airlines) that provide complimentary cosmetic products to customers incidental to other services
  • Trade shows and other venues where cosmetic product samples are provided free of charge
  • An establishment that manufactures or processes cosmetic products that are solely for use in research or evaluation, including for production testing and not offered for retail sale
  • An establishment that solely performs one or more of the following with respect to cosmetic products:
  • Labeling
  • Relabeling
  • Packaging
  • Repackaging
  • Holding
  • Distributing

FEI – FDA Establishment Identifier – It is also known as the Firm or Facility Establishment Identifier. The FEI number is a unique identifier assigned by the FDA to identify firms associated with FDA-regulated products. FDA intends to use a facility’s FEI number as the cosmetic product facility’s registration number.

MANUFACTURING OR PROCESSING OF A COSMETIC PRODUCT – means engaging in one or more steps in the making of any cosmetic product by chemical, physical, biological, or other procedures, including manipulation, sampling, testing, or control procedures applied to the product.

OPERATOR – a person who has management authority over an establishment.

OWNER – a person who has an ownership interest in an establishment.

RESPONSIBLE PERSON – 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.

SMALL BUSINESSES — means responsible persons, and owners and operators of facilities, whose average gross annual sales in the U.S. of cosmetic products for the previous 3-year period is less than $1,000,000, adjusted for inflation, and who do not engage in the manufacturing or processing of certain cosmetic products:

  • Cosmetic products that regularly come into contact with mucus membrane of the eye under conditions of use that are customary or usual
  • Cosmetic products that are injected
  • Cosmetic products that are intended for internal use
  • Cosmetic products that are intended to alter appearance for more than 24 hours under conditions of use that are customary or usual and removal by the consumer is not part of such conditions of use that are customary or usual.

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

Namrata

Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

FDA’s Food Facility Registration Regulation

Domestic and foreign facilities that manufacture, process, pack, or hold food intended for human or animal consumption in the US must register with FDA.

WHY It’s Required: To help FDA to determine the location and source of a potential or actual bioterrorism incident or an outbreak of food-borne illness and allow FDA to notify quickly facilities that may be affected.

WHICH Facilities Must Register: Domestic and foreign food manufacturers, processors, packers, and storage facilities that handle food for consumption in the US.

WHAT is Food:

Some Examples of Foods that Require Facility Registration:

  • Dietary supplements
  • Infant formula
  • Beverages
  • Fruits and vegetables
  • Seafood
  • Dairy products
  • Eggs
  • Bakery goods
  • Chocolate
  • Food for animals

WHEN Facilities Must Register: Before your facility begins to manufacture, process, pack, or hold food for consumption in the United States.

WHO May Register: The owner, operator, or agent in charge of a facility, or an individual authorized by one of them, may register that facility.

WHAT is US Agent: Foreign facilities must designate a US Agent, who lives or maintains a place of business in the US and is physically present in the US, for purposes of communication between the facility and FDA.

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

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Regulatory Consultant

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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.

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Regulatory Consultant

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http://www.fdahelp.us

COSMETIC PRODUCT LISTING

As per MoCRA, a responsible person is required to list each marketed cosmetic product intended for sale in the US with FDA and update such listing regularly.

A responsible person is the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label.

A cosmetic product listing will require detailed information about the product, its ingredients, including any fragrances, flavors, or colors.

For Cosmetic products marketed on or before December 29, 2022, the listing is due by no later than July 1st, 2024. Any updates must be submitted annually. FDA expects the product listing for a cosmetic product first marketed after December 29, 2022, to be submitted within 120 days of marketing the product.

MoCRA exempts certain small businesses from facility registration and product listing requirements.

However, such exemptions do not apply to facilities that manufacture or process, or responsible persons for, the following cosmetic products:

  • Products that regularly come into contact with mucus membrane of the eye under customary or usual conditions of use.
  • Products that are injected.
  • Products that are intended for internal use.
  • Products that are intended to alter appearance for more than 24 hours under customary or usual conditions of use and removal by the consumer is not part of such conditions of use.

Some Exemptions also exist for certain products and facilities that are subject to requirements for drugs and medical evices.

Liberty Management Group Ltd. can help you with registration or listing under FDA MoCRA regulations.

Namrata

Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

COSMETIC FACILITY REGISTRATION

As per MoCRA, owner or operator of a facility that manufactures or processes cosmetic products for US distribution must register with FDA, whether the facility is located in the US or abroad. Registration requires certain information to be provided to FDA, such as all brand names under which the cosmetic products are manufactured or processed in the facility are sold, the product category or categories, and the responsible person for each cosmetic product manufactured or processed at the facility. A responsible person is the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label.

A manufacturing facility needs to submit only one facility registration regardless of whether that facility manufactures or produces cosmetic products for themselves or on behalf of multiple responsible persons.

This requirement excludes certain beauty shops, salons, and retailers and establishments that only perform labeling, relabeling, packaging, repackaging, holding, and distributing of cosmetic products.

Facilities that manufactured or processed cosmetic products on or before December 29, 2022, must register by July 1st, 2024. Facilities that engaged in manufacturing or processing after December 2022 must register within 60 days of first engaging in such activity or by July 1st, 2024, whichever is later.

Facilities registrations must be renewed biennially. Registration must be updated with new information within 60 days of such a change.

FDA has launched new submission portal to facilitate registration.

Liberty Management Group Ltd. can help you with registration under FDA MoCRA regulations.

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