March 2019 – FDA Support

FDA policy on Cosmetic recalls

What is a recall?

A recall is when a company withdraws its defective or contaminated products, from the market, that FDA considers to be in violation of laws, and that are likely to invoke a legal action such as seizure.

Role of FDA

Under FD&C Act, FDA does not have the authority to order a recall of cosmetic, but it may request a firm to do so. FDA is actively involved in:

Monitoring the progress of a recall by conducting own audit checks at wholesale or retail customers to verify the recall’s effectiveness.
Evaluating the product under recall and assigning a classification to indicate degree of hazard posed by the product.
Ensure a public notification is issued either by itself or by the firm.
Develop recall strategy or review one developed by the firm.
Ensure that the recalled products are destroyed or reconditioned suitably.

FDA classifies recalls under three categories:

Class I: for situations where products may cause serious health hazards or death
Class II: for situations where the product may cause temporary or medically reversible health consequence
Class III: for situations where product is not likely to cause adverse health consequences

Role of a Cosmetic Firm

When a product is found to be in violation, a cosmetic firm must:

Notify its customer
Notify FDA
Submit periodic recall status reports to appropriate FDA district office
Issue a public notification, if necessary
Destroy the products or act to bring them into compliance.

To minimize the damage caused by a product recall, a cosmetic firm must:

Prevent product adulteration and misbranding
Maintain a contingency plan in case a recall does happen
Assign production lot numbers to track the possible affected products
maintain adequate records to determine the location of products.

FDA has detailed regulatory procedures regarding what to expect if an FDA investigator conducts an inspection related to a recall. The objective of such inspection is to identify the root cause for the recall and to ensure that the firm has taken measures to prevent the reoccurrence of such problems and their cause. FDA takes the following steps:

Issue Notice of Inspection
Discuss problem with management
Investigate all circumstances which may affect products deficiency
Review records, logs for violative lots
Review firm’s quality control data
Determine if any actions are taken or planned to prevent similar occurrences.
Determine what actions are taken or planned for products still in commerce.

Liberty Management Group LTD is one of the leading FDA consulting groups in the USA. LMG provides assistance registrations, labels, and many more FDA regulations.

Namrata Gusain

FDA Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Published on March 20, 2019

Export Certificates for Food Products

Firms exporting food products from the United States are often asked by foreign customers or foreign governments to supply a certificate from FDA for products regulated by it providing official assurance that products exported to their countries can be marketed in the United States.

Types of export certificates issued by FDA:

Certificate to a Foreign Government – this certificate is available for conventional foods, food additives, food contact substances and infant formula products and states that a product may be marketed in and legally exported from US.
Certificate of Exportability – this certificate is available for conventional foods, food additives, food contact substances and infant formula products that cannot be marketed in US legally but may be legally exported.
Certificate of Free Sale – This certificate is only available for dietary supplements, medical foods and special dietary use foods.
Health certificates for collagen and gelatin products intended for export to the EU and Specified risk materials certificates for collagen and gelatin products intended for export to non-EU countries.

FDA will not issue an Export Certificate if

FDA has initiated an enforcement action against the product
The manufacturing facility is not cGMP compliant
The manufacturing facility is not FDA Registered
The manufacturing facility for which FDA has no inspectional information.

The facilities registered and listed with FDA are checked for cGMP compliance under an FDA inspection. For Export Certificates, FDA would use inspection and all other available information regarding a product or facility to make an attestation of compliance with cGMP regulations.

FDA fee for “Certificate to Foreign Government” and “Certificate of Exportability” is, $ 175 for 1st certificate, $ 155 for 2nd certificate and $ 100 for each subsequent certificate.

FDA does not charge a fee for “Certificates of Free Sale” or for “Health Certificates”.

Some foreign governments may question authenticity of an export certificate. There are two ways to authenticate an export certificate:

The exporter can request an apostille or authentication from the U.S. Department of State, or
For electronically issued certificates issued after April 2016, an official of a foreign government can use the unique Certificate ID, printed in the top left corner of every certificate, to independently verify whether the export certificate was issued by FDA.

Liberty Management Group LTD is one of the leading FDA consulting group in the USA. LMG provides assistance with Export Certificates, Registrations, Label compliance, and many more FDA regulations.

Namrata Gusain

FDA Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Published on March 13, 2019

FDA Import Alerts

An import alert is a notification from FDA to its field staff and public that the agency has substantial evidence on products that appear to be in violation of FDA regulations and that all future shipments of the such products are subject to Detention Without Physical Examination (DWPE) at the port of entry. These violations could be related to the product, manufacturer, shipper etc. Some examples of violations that may trigger import alerts are:

Product appears to be adulterated
Product appears to be misbranded
Manufactured, processed, or packed under insanitary conditions
The product is unapproved new drug
Foreign firm has refused FDA inspection
Forbidden or restricted for sale in the country in which it was produced or from which it was exported

Types of import alerts:

Country- or area-wide
Manufacturer/Product Specific
Shipper
Country/World Wide Alert

When FDA issues an import alert it is added to the red list. When the firms, products or countries have met the criteria for exemption from DWPE, they are added to green list. The firms, products or countries that are subject to intense surveillance or additional analyses are added to yellow list.

Every importer should check if the products being imported are subject to DWPE or not. Once a shipment is refused admission to the U.S., the importer has an opportunity to provide evidence to overcome the appearance of a violation. Such imported product, firm or country may remain in this status until FDA is convinced that the conditions to apparent violations have been resolved and that future entries will be FDA compliant.

Individual Import Alerts may include specific information regarding removal from DWPE. You should review the import alert specific to your alert and submit any and all documentation called for. You can access FDA’s Import Alerts here. FDA notifies the responsible parties that an imported product violates FDA regulations by issuing a Notice of Detention and Hearing. The notice provides a Respond By date to provide FDA with evidence to overcome the appearance of a violation.

Firms can seek expert guidance to make sure their product ingredients are approved and the labels are truthful and compliant with FDA regulations.

Liberty Management Group LTD is one of the leading FDA consulting groups in USA. LMG provides guidance with FDA registrations, label and ingredient compliance, and many more FDA regulations.

Namrata

FDA Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Published on March 06, 2019