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FAQs| American Dietary Supplements (2) – Do Dietary Supplements Require FDA Approval Before Marketing?

from CIRS by

We have collected frequently asked questions on the dietary supplement in the United States for your reference.

FDA,US,Dietary,Supplement,Approval,FAQ

Q1. What is a “new dietary ingredient” in dietary supplements?

The Dietary Supplement Health and Education Act (DSHEA, 1994) defined both “dietary ingredient” and “new dietary ingredient”. “Dietary ingredient” in dietary supplements is defined as any of the following: vitamins, minerals, herbs (botanicals), other plants, amino acids, or substances added to the diet to supplement the total intake, or any of these substances in concentrated forms, metabolites, components, extracts, or combinations. “New Dietary Ingredient” (NDI) refers to a dietary ingredient that meets the definition of a “dietary ingredient” but was not marketed in the United States before October 15, 1994.

Q2. Under what circumstances must manufacturers or distributors notify the FDA before selling a dietary supplement in the U.S.?

Under DSHEA, if a manufacturer or distributor intends to sell a dietary supplement containing “new dietary ingredient” in the U.S., they must submit a notification to the FDA at least 75 days before marketing the product.

Q3. Does the FDA regularly analyze the ingredients of dietary supplements?

No. The FDA has limited resources for analyzing the ingredients of foods, including dietary supplements. Therefore, it prioritizes resources to address public health emergencies and products that may pose a risk of harm or disease. The FDA also prioritizes products suspected of being adulterated, fraudulent, or otherwise violating regulations. Remaining resources are used for analyzing product samples collected during inspections of manufacturing facilities or from store shelves during routine market monitoring. The FDA does not conduct pre-market testing on dietary supplements. Consumers can contact the supplement manufacturer or commercial laboratories to have a product’s ingredients analyzed.

Q4. How can consumers obtain information about a specific dietary supplement?

Since dietary supplements do not require pre-market approval from the FDA, the agency typically does not know when new products are launched and cannot maintain a comprehensive list of all dietary supplements available in the U.S. If you want more information about a dietary supplement (including information not listed on the label), it is recommended that you contact the product’s manufacturer directly. The manufacturer’s or distributor’s name and address can be found on the product label.

Q5. How can consumers learn about the safety and other related aspects of a dietary supplement?

The FDA advises consumers to consult a healthcare professional before taking dietary supplements to avoid potential risks, such as interactions with medications or other supplements. Additionally, consumers should carefully read the product label before use.

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.

Further Information

FAQs| American Dietary Supplement (1) – How Do You Label A Dietary Supplement?

  

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