Do nutraceuticals require FDA approval?
“Nutraceutical” is a commercial term rather than a separate FDA product-approval category. If a nutraceutical is marketed in the United States as a dietary supplement, it generally does not require FDA premarket approval, but it must comply with the laws and regulations applicable to dietary supplements. Different rules can apply if the product is marketed as a conventional food or drug.
Answer
Whether a nutraceutical requires FDA approval depends on how the product is legally classified and marketed.
The term nutraceutical is commonly used for products containing vitamins, minerals, botanicals, amino acids, probiotics, or other ingredients intended for nutrition or wellness applications. However, U.S. regulatory requirements depend on whether the actual product qualifies as a dietary supplement, conventional food, drug, or another FDA-regulated category.
Nutraceuticals marketed as dietary supplements
Dietary supplements generally do not undergo FDA premarket approval.
The manufacturer or distributor is instead responsible for ensuring that the product:
• can be lawfully marketed
• is not adulterated
• is accurately labeled
• complies with applicable dietary-supplement CGMP requirements
• uses appropriate claims
• meets applicable adverse-event and recordkeeping requirements
• New Dietary Ingredients
An important exception involves certain New Dietary Ingredients (NDIs).
When required, the manufacturer or distributor must submit a premarket notification to FDA containing the basis for concluding that the ingredient is reasonably expected to be safe under its proposed conditions of use.
This notification generally must be submitted at least 75 days before the product is introduced into interstate commerce.
An NDI notification should not be described as FDA approval of the finished nutraceutical product.
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