U.S. FDA LABELING REQUIREMENTS
The most important matter before import to the US market is to check the product label compliance. Most of the product’s detention by the FDA are due to mistakes present in the label where the FDA will consider them as misbranded products. To avoid product detention, we strongly recommend a label compliance check made through our professional safety assessor to remove all doubts of having a no compliant label.
Choose Service
Below you can find all labeling review services per product intended use. Each product intended use has different labeling requirements.
Dietary supplement, food and beverage ingredients and label compliance check
New FDA label regulation entered into force recently for Dietary Supplements, Food and Beverage. Businesses must update their FDA labeling to meet the extensive changes required by the FDA. In addition, for Dietary Supplements is very important to check if any pre-market approval is necessary based on the marketing claims and intended use of the product. Cosmereg can assist you to comply with the FDA labeling guidelines.
Cosmetic ingredients and label compliance check
FDA cosmetic regulations have strict laws regarding both the ingredients and labeling of cosmetic products. Some cosmetics are even classified as drugs, making the requirements even stricter and more difficult to comply with. Cosmereg can assist you in FDA cosmetic labeling requirements and ingredient compliance by cross-referencing your labeling against the Code of Federal Regulations, the FDA Labeling Manual, and more.
Medical Device label compliance check
In Medical devices, It is necessary to include certain information in the label that are required by the FDA such as instruction for use, warning sentences, service manual for users safety reasons. Cosmereg label compliance check ensuring that your product meets all of the FDA requirements.
Dietary supplement, food and beverage ingredients and label compliance check
New FDA label regulation entered into force recently for Dietary Supplements, Food and Beverage. Businesses must update their FDA labeling to meet the extensive changes required by the FDA. In addition, for Dietary Supplements is very important to check if any pre-market approval is necessary based on the marketing claims and intended use of the product. Cosmereg can assist you to comply with the FDA labeling guidelines.
Cosmetic ingredients and label compliance check
FDA cosmetic regulations have strict laws regarding both the ingredients and labeling of cosmetic products. Some cosmetics are even classified as drugs, making the requirements even stricter and more difficult to comply with. Cosmereg can assist you in FDA cosmetic labeling requirements and ingredient compliance by cross-referencing your labeling against the Code of Federal Regulations, the FDA Labeling Manual, and more.
Medical Device label compliance check
In Medical devices, It is necessary to include certain information in the label that are required by the FDA such as instruction for use, warning sentences, service manual for users safety reasons. Cosmereg label compliance check ensuring that your product meets all of the FDA requirements.
Drug and OTC ingredients and label compliance check
As per FDA labeling regulations, in Drugs label, It is necessary to affix the drug facts table indicating the active ingredients, product intended use, detailed warnings and dosage instructions. Cosmereg can assist to review compliance of your durg/OTC label.
Drug and OTC ingredients and label compliance check
As per FDA labeling regulations, in Drugs label, It is necessary to affix the drug facts table indicating the active ingredients, product intended use, detailed warnings and dosage instructions. Cosmereg can assist to review compliance of your durg/OTC label.