Month: December 2023

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