OSS Middle East throw USA agent issues Certificates of FDA Registration for food facilities with a valid FDA registration. For food facilities that are not registered with FDA, and help organization to get FDA Approved
OSS can help you find the optimal solution for your needs. Our team for FDA consultants and partners counts with an extensive industry experience (medical devices, cosmetics, pharmaceuticals, food and end-consumer) to assist your company to meet FDA compliance and regulatory goals.
FDA Registration Services for Food, Drug, Medical Device and Cosmetics manufacturing.
FDA registration is a mandatory requirement for food, drug, and medical device facilities. Registration for cosmetics is not mandatory.
The FDA regulates a wide range of products, including foods (except for aspects of some meat, poultry and egg products, which are regulated by the U.S. Department of Agriculture); human and veterinary drugs; vaccines and other biological products; medical devices intended for human use; radiation-emitting electronic products; cosmetics; dietary supplements, and tobacco products.
Food Businesses Subject to FDA Regulation
FDA regulates all foods and food ingredients introduced into or offered for sale in interstate commerce, with the exception of meat, poultry, and certain processed egg products regulated by the U.S. Department of Agriculture (USDA).
The Center for Food Safety and Applied Nutrition (CFSAN), works with FDA field offices to ensure that the nations’ food supply (except meat, poultry and some egg products, which are regulated by USDA) is safe, sanitary, wholesome, and honestly labeled and that cosmetic products are safe and properly labeled.
Examples of Food businesses NOT regulated by FDA:
- Retail food establishments (i.e. grocery stores, restaurants, cafeterias, and food trucks), which are regulated by state and local governments.
- Farmers markets
Good Manufacturing Practice Requirements:
Current Good Manufacturing Practice (cGMP) regulations require that food offered for sale or introduced into interstate commerce be produced under safe and sanitary conditions.
Certain food commodities have additional requirements because of inherent hazards, particular attributes, or specific manufacturing processes. For instance, certain egg producers must follow the Egg Safety Final Rule in order to reduce the spread of Salmonella Enteritidis, a known pathogen of eggs.
Food manufacturers are responsible for developing labels (including nutrition information) that meet legal food labeling requirements. All labeling of FDA-regulated food products must be truthful and not misleading. Proper labeling, including nutrition labeling and labeling for the major food allergens, is required for most prepared foods.
Note: The labels of food products sold in U.S. interstate commerce must be in English. However, foods distributed solely in Puerto Rico may bear labels in Spanish instead of English. See Compliance Policy Guide Sec. 562.750 Labeling of Food Articles Distributed Solely in Puerto Rico.
Requirements governing the labeling of foods:
- Federal Food, Drug, and Cosmetic Act (FFD&C Act)External Link Disclaimer
- Fair Packaging and Labeling ActExternal Link Disclaimer
- Nutrition Labeling and Education Act
- Food Allergen labeling and Consumer Protection Act of 2004
- FDA’s regulations on food labeling – 21 CFR 101
- Food Labeling and Nutrition Overview
- Food Labeling Guide
- Food Allergens Labeling Information
- Small Business Nutrition Labeling Exemption
- Labeling & Nutrition Guidance Documents & Regulatory Information – Topic–Specific Labeling Information
- Manufacturers may choose to hire a commercial laboratory to perform analyses of foods to determine nutrient content. FDA cannot recommend any particular laboratory.
- The United States Department of Agriculture’s Food Nutrient Database can be used to develop appropriate nutrient information for products. This information may be used in conjunction with food product recipes to calculate nutrition information required for food labels.
- FDA’s Nutrition Labeling Manual provides technical instructions to manufacturers about how to develop and use nutrition databases for food products.
FDA registration is required to sell products in the USA?
Yes, for most of the products, FDA facility registration is mandatory before marketing the products in the USA. However, US FDA registration requirements vary based on the product category.
Here is the summary of the FDA registration cost and timeline.
FDA US Agent is required for foreign facility FDA registration purposes. US Agents acts as a point of contact to FDA to communicate with the foreign manufacturer.
What information is required for FDA registration?
You have to complete the online form on our website. There is not additional document or information required for FDA registration.
FDA approval means the review of the safety, efficacy, or equivalency data of the product.
FDA registration is not the same as FDA approval. FDA approval is not required for food, dietary supplements, most class I medical devices, or OTC drugs. However, you may have to comply with general requirements such as labeling, food safety regulations, or GMP for each product category.
However, FDA approval is required for prescription drugs, class II and class III medical devices, and food additives.
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