Author: Namrata

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

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.

Namrata

Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

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:

  1. Drug Establishment Registration – Manufacturers of drug products must register their facilities with the FDA, and SPL is used for this purpose.
  2. 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.
  3. 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.
  4. Cosmetic Facility Registration – Manufacturers & processors of cosmetic products must register their facilities with the FDA, and SPL is used for this purpose.
  5. Cosmetic Product Listing – A responsible person must list the cosmetic products with FDA by way of SPL submissions.
  6. 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.

Namrata

Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

US FDA Cosmetics Responsible Person

As per US FDA’s new regulation for regulating cosmetic industry – MoCRA (Modernization of Cosmetics Regulation Act of 2022), FDA now requires cosmetic companies to register their facility and list the cosmetic products with FDA.

The FD&C Act defines cosmetics as articles intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance without affecting the body’s structure or functions. Some examples are listed here.

MoCRA defines a Responsible Person as 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.

Under MoCRA, the Responsible Person will have following responsibilities:

  • To obtain the relevant facility registration number or where small business exemption applies, the facility name & address, for each facility where its cosmetic products are manufactured or processed
  • Submit product listing for each marketed cosmetic product with FDA, including product ingredients, and provide any updates annually.
  • Reporting serious adverse events associated with the use of cosmetic products in the US to FDA within 15 business days. If the responsible person receives medical or other information about the adverse event within 1 year of the initial report to FDA, they must submit this new information to FDA within 15 business days.
  • To ensure and maintain records supporting adequate safety substantiation of their cosmetic products.

Liberty Management Group Ltd. provides assistance with Cosmetic Facility Registration and Cosmetic Product Listing.

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

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:

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

The Cosmetic Product Listing shall contain:

  1. Facility Registration Number of manufacturer
  2. Name of Product
  3. Responsible person Name & Telephone Number
  4. Product Category
  5. Ingredient List
  6. Product listing number, if any, previously assigned by the FDA.
  7. 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.

Namrata

Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us