Dietary Supplement Services for the United States
The Food and Drugs Administration (FDA) in the U.S. requires all Dietary Supplements to be regulated under the Dietary Supplement Health and Education Act of 1994. Manufacturers of Dietary Supplements must ensure that their products are safe and accurately labelled.
The FDA can take action against any manufacturer selling a product that appears to be adulterated or misbranded.
U.S. FDA Dietary Supplements Regulations
Register your establishment with FDA
The first step in ensuring that your product can be sold in the U.S. is to register your business with the FDA. Cosmereg can assist you with this process, to ensure that your business and your products fulfill the United States FDA Registration Requirements.
The FDA works with Customs and Border Protection (CBP) to decide which foods or products containing foodstuffs can be imported into the country. The FDA Prior Notice is an electronic form that must be submitted before any food products or products containing food can be shipped to the U.S. Prior Notice is also required for deliveries of dietary supplements. Cosmereg can help you to manage your Prior Notice forms quickly and efficiently, to avoid delays in shipments to the U.S.
FDA Product Compliance
The FDA has strict guidelines for the manufacture and sale of dietary supplements in the U.S. Cosmereg can help to guide you through the registration process and ensure continued compliance with regulations.
FDA cGMP Compliance
The FDA also regulates manufacturing practices for many products sold within the U.S. The Current Good Manufacturing Practices (cGMPs) are designed to ensure the quality of human pharmaceuticals in the U.S. Certain dietary supplements may also be subject to these regulations, depending on their purpose and intended use. Cosmereg can help to ensure that your business and your products comply with these standards.
New Dietary Ingredient (NDI) Assessment and Notification Filing
In accordance with the Federal Food, Drug and Cosmetic Act, any company wishing to market dietary supplements that include ‘New Dietary Ingredients’ must notify the FDA. These notifications must include information about the safety of the new ingredient in the situation in which is it intended to be used. Cosmoreg can assist your company in compiling and submitting this information to the FDA.
Adverse Event Reporting
It is the responsibility of the FDA to protect U.S. citizens from unsafe products. It is the responsibility of the manufacturer to inform the FDA of any adverse events that could potentially be associated with their products. Cosmoreg can help your business to locate and complete the necessary documentation on the Safety Reporting Portal, as stipulated in section 761 of the Federal Food, Drug and Cosmetics Act.
Dietary Supplement Label Review and Health Claim Substantiation
Manufacturers and vendors of dietary supplements are responsible for ensuring that they are safe and accurately labelled, in accordance with DSHEA and FDA regulations. Claims that dietary supplements can have an impact on human health must be substantiated. Cosmereg can help you to review product labelling and health claims, in accordance with FDA regulation.
Provide US agent service
Foreign manufacturers who wish to sell their dietary supplements on the U.S. market must register with the FDA via a US FDA Agent. These agents act as an intermediary between the FDA and the manufacturer and are the first point of contact for the FDA. Cosmereg can provide a U.S Agent service to any clients wishing to expand their business to the U.S. market.
Does the FDA approve dietary supplements?
FDA approval is not required for the sale of food, beverages or dietary supplements. However, the FDA does regulate these products and their manufacturers are required to register with the FDA before they are able to distribute their products in the US. It is the responsibility of the manufacturer to ensure that products are safe and correctly labelled.
What information is required on a dietary supplement label?
Five essential pieces of information must be included on the container or packaging of any dietary supplements:
- The name of the product (statement of identity)
- The net quantity of the contents of the container
- Nutritional Information
- Manufacturer’s details (name and location of business)
We offer other Services for the United States
Any foreign company that wished to sell food or beverage products, medical devices, cosmetics or drugs in the U.S. must do so via an authorized U.S. Agent.
U.S. FDA regulates all cosmetic products that are intended to be sold and used in the US.
In the U.S. the FDA regulates all food and beverage products that are intended for human or animal consumption.