US FDA Registration – Page 2

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.

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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.

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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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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 1^st, 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.

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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:

FDA Registration: Manufacturers of infant formula are required to register with the FDA
Infant formula notification: Before marketing a new or reformulated formula, manufacturers must submit a notification for FDA review of formulation & labeling of the products.
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.
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.
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.
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.
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.
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.

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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:

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.

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

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What is Blanket No Changes Certification?

Companies that manufacture drug products are required to list their products with FDA and renew such listings annually. A Drug listing is a submission to FDA containing detailed information about a drug product, such as its proprietary name, active ingredients, dosage form, route of administration, and NDC number. It also includes details about the manufacturing facilities and labeling information.

A Blanket No Changes Certification of drug Listing is a declaration made by manufacturers and labelers to the US FDA certifying that there are no changes to their drug products listed with the FDA. This certification is submitted to the FDA annually.

A blanket no change certification is submitted to FDA electronically as per the regulatory requirements in an SPL format. SPL stands for Structured Product Labeling. SPL provides transparency and assurance to the agency that the products remain consistent with their previous submissions.

The purpose of this certification is to keep the FDA informed about the status of regulated products, and it helps FDA to ensure that the products on the market continue to be in compliance with their approved or cleared specifications.

Failure to submit or update these listings as required can lead to regulatory action, which includes misbranding and warning letters.

Liberty Management Group Ltd, provides assistance with drug establishment registration, NDC labeler code request, Drug listings, blanket no change certification and US agent service.

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What is SPL?

SPL stands for Structured Product Labeling. SPL is an XML-based document markup standard that provides a consistent way to format and organize information about a drug or cosmetic product, including its ingredients, labels and other details.

Drug & Cosmetic companies are required to submit product information to the FDA in SPL format. SPL is used for various FDA submissions related to FDA regulated products. It is designed to improve the accuracy and consistency of product information and make it easier for healthcare professionals, regulators, and the public to access and understand this information. Some of the key FDA submissions that utilize SPL include:

Drug Establishment Registration – Manufacturers of drug products must register their facilities with the FDA, and SPL is used for this purpose.
Drug Listing – Manufacturers and distributors of drug products are required to list their products with the FDA. SPL is used to provide comprehensive product information for the FDA’s NDC Directory.
Drug Renewals & Listing updates – Annual Drug renewals & any changes to a drug product’s label or listing info, must be submitted to the FDA using SPL.
Cosmetic Facility Registration – Manufacturers & processors of cosmetic products must register their facilities with the FDA, and SPL is used for this purpose.
Cosmetic Product Listing – A responsible person must list the cosmetic products with FDA by way of SPL submissions.
Cosmetic Renewals & Listing updates – Annual Cosmetic renewals & any changes to a cosmetic product’s label or listing info, must be submitted to the FDA using SPL.

Liberty Management Group Ltd can help with SPL preparation & submissions to FDA.

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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:

Facility Registration:

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.

Label & Ingredient Compliance:

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.

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WHAT INFORMATION MUST BE SUBMITTED IN COSMETIC FACILITY REGISTRATION AND COSMETIC PRODUCT LISTING UNDER MOCRA ACT?

According to FDA’s August 2023 draft guidance, following information will be required in Cosmetic Facility Registration:

Owner and/or operator of the facility
Facility Name, Address, Email & Telephone Number
US Agent (for non-US facilities) Name, Email & Telephone Number
FEI number or Facility Registration Number, if previously assigned
Brand names under which cosmetic products are sold
Product category
Responsible person for each cosmetic product
Type of submission (initial, amended, biennial renewal, or abbreviated biennial renewal)

The Cosmetic Product Listing shall contain:

Facility Registration Number of manufacturer
Name of Product
Responsible person Name & Telephone Number
Product Category
Ingredient List
Product listing number, if any, previously assigned by the FDA.
Type of submission (initial, update, abbreviated renewal)

The above information may change once FDA releases final guidance on MoCRA. Please visit our website for most updated information.

Liberty Management Group Ltd. provides assistance with MoCRA submissions.

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