Tag: Register with FDA

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

RESPONSIBILITIES OF A US AGENT

All foreign food facilities that engage in manufacture, pack or holding of food for human or animal consumption in US are required to register with FDA and identify a US Agent on their registration.

All foreign drug establishments that manufacture, repack, or re-label drug products and import or offer for import drug products to the US must register with the FDA and identify a US Agent on their registration.

All foreign medical device establishments engaged in the manufacture, preparation, propagation, compounding, or processing of a medical device imported into the US must identify a US Agent on their FDA registration.

The responsibilities of a US Agent include:

  • Assisting FDA in communications with the foreign establishment,
  • Responding to questions concerning the foreign establishment’s products that are imported or offered for import into the US.
  • Assisting FDA in scheduling inspections of the foreign establishment
  • If FDA is unable to contact the foreign establishment directly or expeditiously, FDA may provide information or documents to the US Agent, and such an action shall be equivalent to providing the same information or documents to the foreign establishment.

Each foreign establishment must appoint only one US Agent. The foreign establishment must provide the name, address, telephone number, fax number, and e-mail address of the US Agent.

The US Agent will need to accept such appointment timely. The US Agent must reside or maintain a place of business in US. They must be available to answer the phone during normal business hours.

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

Namrata

Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Food Additives

Food additives are substances the intended use of which results or may result, directly or indirectly, in its affecting the characteristics of a food. For hundreds of years, people are adding different ingredients to foods.

Some uses of food additives are:

  • Improve or maintain freshness of safety: Preservatives help to slow down food spoilage that may occur because of air, fungi, mold, bacteria or yeast. They may also help regulate contamination that may cause foodborne illnesses. Antioxidants prevent foods that contain oils from becoming stale or developing off flavor.
  • Improve or maintain nutritional content – Minerals, Vitamins, Fiber etc. are added to some foods to increase their nutritional value and to provide for the nutrition that may be lost during cooking or processing.
  • Improve Taste, Texture or Appearance – Food colors are added to food to make it look fresh and tasty. Emulsifiers and stabilizers give foods desired texture and consistency. Leavening agents are used in baking products to aid rising. Certain additives are added to control acidity or alkalinity of foods.

Manufacturers of Food additives are required to register with FDA.

Liberty Management Group Ltd. can help you register your facility with US FDA.

Namrata

Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us