Dietary Supplement Ingredient Directory
Two types of ingredients may be used in dietary supplements – “dietary ingredients” and “other ingredients.” The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines a dietary ingredient as a vitamin; mineral; herb or other botanical; amino acid; dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of any dietary ingredient from the preceding categories.
Dietary supplements include such ingredients as vitamins, minerals, herbs, amino acids, and enzymes, and are typically marketed in forms such as tablets, capsules, softgels, gelcaps, powders, and liquids. Dietary supplements may also include other ingredients, such as fillers, binders, excipients, preservatives, sweeteners, and flavorings. These “other ingredients” are listed separately from dietary ingredients on the Supplement Facts label.
For information about publicly displayed new dietary ingredient notifications (NDINs) that we have reviewed to date, visit Submitted 75-Day Premarket Notifications for New Dietary Ingredients.
The manufacturer, packer, or distributor whose name appears on the label of a dietary supplement (the “responsible firm”) is required to record and report to FDA any reports it receives of serious adverse events associated with the use of its products. In addition, the responsible firm must keep records of any non-serious adverse event reports it receives.
Members of the dietary supplement industry may use the reporting form on the Safety Reporting Portal to meet the reporting requirements in section 761 of the FD&C Act.
Consumers who have experienced a health-related reaction or illness (also known as an adverse event) after consuming any dietary supplement should contact their medical professional. It is important for consumers, health care professionals, and industry members to report adverse events to FDA, so we can act to protect the public from unsafe products. You can report adverse events to FDA by visiting the How to Report a Problem page.
FDA encourages consumers with questions about dietary supplements to Submit An Inquiry, or to visit www.fda.gov/fcic for additional information.
Ingredient Directory
To help manufacturers, retailers, and consumers of dietary supplements stay informed about recent developments and locate information on FDA’s website quickly, we have put together an “ingredient directory” with links to FDA’s actions and communications with regard to particular dietary ingredients and other ingredients used in products marketed as dietary supplements. We will update the directory periodically to reflect new developments. The directory is not intended to be a comprehensive list of all ingredients used in products marketed as dietary supplements and may not include all actions the agency has taken with respect to a particular ingredient. We welcome additional feedback and information regarding these ingredients. You may submit such information to the FDA's Office of Dietary Supplement Programs.
| Ingredients | Other Known Names 1 | Agency Actions/Statements |
|---|---|---|
| 5-Alpha-Hydroxy-Laxogenin |
|
Constituent update and warning letters (May 2022) |
| Acacia rigidula |
|
Acacia rigidula in Dietary Supplements Constituent update and warning letters (March 2016) |
| Biotin |
|
Safety communication (November 2019) |
| BMPEA |
|
BMPEA in Dietary Supplements Constituent update and warning letters (April 2015) |
| Cannabidiol |
|
FDA Regulation of Cannabis and Cannabis-Derived Products, Including Cannabidiol (CBD) Warning Letters and Test Results for Cannabidiol-Related Products |
| Cesium chloride | N/A |
Cesium Chloride in Dietary Supplements Safety communication (February 2020) Constituent update and warning letters (October 2020) |
| Comfrey | Comfrey is a source of pyrrolizidine alkaloids | Safety communication (July 2001) |
| DMAA |
|
DMAA in Products Marketed as Dietary Supplements |
| DMBA |
|
Constituent update and warning letters (April 2015) |
| DMHA |
|
DMHA in Dietary Supplements |
| Ephedrine alkaloids | Ingredient sources include raw botanicals (i.e., plants) and extracts from botanicals. Ma huang, Ephedra, Chinese Ephedra, and epitonin are several names used for botanical ingredients, primarily from Ephedra sinica Stapf, Ephedra equisetina Bunge, Ephedra intermedia var. tibetica Stapf, and Ephedra distachya L. (the Ephedras), that are sources of ephedrine alkaloids. Common names for plants that contain ephedrine alkaloids include sea grape, yellow horse, joint fir, popotillo, and country mallow. | In 2004, FDA banned the sale of dietary supplements containing ephedrine alkaloids (compounds found in some Ephedra species) in the United States. See Final Rule Declaring Dietary Supplements Containing Ephedrine Alkaloids Adulterated Because They Present an Unreasonable Risk, 69 Fed. Reg. 6787 (Feb. 11, 2004), codified at 21 CFR 119.1. |
| Higenamine |
|
Constituent update and warning letters (May 2022) |
| Higenamine HCl |
|
Constituent update and warning letters (May 2022) |
| Hordenine |
|
Constituent update and warning letters (May 2022) |
| Hordenine HCl |
|
Constituent update and warning letters (May 2022) |
| Kava |
|
Safety communication (March 2002) |
| Kratom |
|
|
| Methylsynephrine |
|
Methylsynephrine in Dietary Supplements Constituent update and warning letters (March 2016) |
| N-acetyl-L-cysteine |
|
Citizen petition response (March 2022) Guidance for Industry: Policy Regarding N-acetyl-L-cysteine (August 2022) |
| Octopamine |
|
Constituent update and warning letters (May 2022) |
| Phenibut |
|
Phenibut in Dietary Supplements Constituent update and warning letters (April 2019) |
| Picamilon |
|
Picamilon in Dietary Supplements Constituent update and warning letters (November 2015) |
| Pure and Highly Concentrated Caffeine | N/A |
Pure and Highly Concentrated Caffeine Safety communication (April 2018) Guidance for Industry: Highly Concentrated Caffeine in Dietary Supplements (April 2018) |
| Pyridoxamine |
|
Citizen petition response (January 2009) |
| Red yeast rice |
|
Safety communication (August 2007) Pharmanex, Inc. v. Shalala, 221 F.3d 1151 (10th Cir. 2000) Pharmanex, Inc. v. Shalala, Case No. 2:97CV262K (D. Utah Mar. 1, 2001) |
| Tianeptine |
|
Tianeptine in Dietary Supplements Constituent update and warning letters (November 2018) |
| Vinpocetine |
|
Vinpocetine in Dietary Supplements |
1. This column includes commonly used names for each ingredient, but may not include all synonyms or other known names for an ingredient. In addition, some “other known names” may be ambiguous because some names are used for more than one ingredient.