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 |
|---|---|---|
| 1,4 DMAA |
|
Hi Tech Pharmaceuticals Voluntary Recall (May 2021) |
| 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) |
| Acetaminophen |
|
Procter and Gamble Warning Letter (October 2009) |
| Aminophylline |
|
RT Naturals, LLC Warning Letter (July 2010) |
| Anatabine |
|
Rock Creek Pharmaceuticals NDIN 840 Response Letter (August 2014) Star Scientific, Inc. Warning Letter (December 2013) |
| Aspirin |
|
Bayer HealthCare L.L.C Warning Letter (October 2008) |
| Biotin |
|
Safety communication (November 2019) |
| BMPEA |
|
BMPEA in Dietary Supplements Constituent update and warning letters (April 2015) |
| Calcifediol |
|
DSM Nutritional Products NDIN 945 Response Letter (April 2017) |
| Calcium | N/A |
21 CFR 101.72 Health claims: calcium, vitamin D, and osteoporosis Qualified Health Claims: Letter Regarding Calcium and Colon/Rectal, Breast, and Prostate Cancers and Recurrent Colon Polyps (October 2005) |
| Calcium in combination with Vitamin D | N/A | 21 CFR 101.72 Health claims: calcium, vitamin D, and osteoporosis |
| 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) |
| Chlorzoxazone |
|
West Coast Laboratories, Inc. Warning Letter (September 2014) Human Science Foundation Warning Letter (August 2014) |
| Chromium Picolinate | N/A |
Qualified Health Claims: Letter of Enforcement Discretion – Chromium Picolinate and Insulin Resistance (August 2005) |
| Comfrey |
|
Safety communication (July 2001) |
| Cotinine HCl |
|
Capsulean LLC NDIN 1122 Response Letter (September 2019) |
| Dapoxetine |
|
Shoreside Enterprises, Inc. Warning Letter (December 2014) |
| Diclofenac |
|
West Coast Laboratories, Inc. Warning Letter (September 2014) Human Science Foundation Warning Letter (August 2014) |
| DMAA |
|
DMAA in Products Marketed as Dietary Supplements |
| DMBA |
|
Constituent update and warning letters (April 2015) |
| DMHA |
|
DMHA in Dietary Supplements |
| DMSA |
|
Northern Health Products Warning Letter (December 2016) Nutri-Dyn Midwest, Inc. Warning Letter (January 2016) |
| Doxylamine |
|
Arco Globus Trading, LLC et al. Warning Letter (December 2017) |
| Eicosapentaenoic Acid and Docosahexaenoic Acid in combination |
|
Qualified Health Claims: Letter re EPA and DHA and Reduced Risk of Coronary Heart Disease (September 2004) |
| Ephedrine alkaloids |
|
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. |
| Folic Acid |
|
21 CFR 101.79 Health claims: Folate and neural tube defects Qualified Health Claims: Letter regarding disclaimers for comparative folic acid and neural tube defects claim (April 2001) [2] |
| Folic Acid in combination with Vitamin B6 and Vitamin B12 | N/A |
Qualified Health Claims: Settlement Re Claim Relating to B Vitamins and Vascular Disease (May 2001) |
| HCG |
|
The hCG Drops, LLC Warning Letter (December 2011) Nutri Fusion Systems, Inc Warning Letter (November 2011) Natural Medical Supply, LLC dba HCG Complete Diet Warning Letter (November 2011) HCG Platinum, LLC Warning Letter (November 2011) HCG Diet Direct, LLC Warning Letter (November 2011) Theoriginalhcgdrops.com Warning Letter (November 2011) |
| Higenamine |
|
Constituent update and warning letters (May 2022) |
| Higenamine HCl |
|
Constituent update and warning letters (May 2022) |
| Homotaurine |
|
OVOS Natural Health, Inc. Citizen Petition Response (February 2011) |
| Hordenine |
|
Constituent update and warning letters (May 2022) |
| Hordenine HCl |
|
Constituent update and warning letters (May 2022) |
| Ibuprofen |
|
West Coast Laboratories, Inc. Warning Letter (September 2014) Human Science Foundation Warning Letter (August 2014) |
| Indomethacin |
|
West Coast Laboratories, Inc. Warning Letter (September 2014) Human Science Foundation Warning Letter (August 2014) |
| Kava |
|
Safety communication (March 2002) |
| Kratom |
|
|
| L-DOPA |
|
RT Naturals, LLC Warning Letter (July 2010) |
| LGD-4033 |
|
Infantry Labs, LLC/1 Nation Nutrition Warning Letter (October 2017) Panther Sports Nutrition Warning Letter (October 2017) |
| Lorcaserin |
|
HIS Enterprise Inc dba Adam’s Secret USA, LLC Warning Letter (January 2023) |
| Magnesium | N/A | Constituent update and enforcement letter regarding qualified health claim (January 2022) |
| Metformin |
|
Amrutam Life Care Pvt. Ltd. Cyber Letter (July 2013) |
| 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) |
| Naproxen |
|
West Coast Laboratories, Inc. Warning Letter (September 2014) Human Science Foundation Warning Letter (August 2014) |
| NMN |
|
Inner Mongolia Kingdomway Pharmaceutical Limited NDIN 1259 Response Letter and Supplemental Response Letter (October 2022, November 2022) |
| Octopamine |
|
Constituent update and warning letters (May 2022) |
| Oleandrin |
|
Phoenix Biotechnology, Inc. NDIN 1157 Response Letter (August 2020) |
| Ostarine |
|
Infantry Labs, LLC/1 Nation Nutrition Warning Letter (October 2017) Panther Sports Nutrition Warning Letter (October 2017) |
| Phenibut |
|
Phenibut in Dietary Supplements Constituent update and warning letters (April 2019) |
| Phosphatidylserine | N/A |
Qualified Health Claims: Update Re Phosphatidylserine and Cognitive Function and Dementia (November 2004) [3] Qualified Health Claims: Letter Re Phosphatidylserine and Cognitive Dysfunction and Dementia (May 2003) |
| Picamilon |
|
Picamilon in Dietary Supplements Constituent update and warning letters (November 2015) |
| Piroxicam |
|
West Coast Laboratories, Inc. Warning Letter (September 2014) |
| Plant stanol esters | N/A | |
| Procysteine |
|
Scientific Systems NDIN 907 Response Letter (March 2016) |
| Psyllium husk | N/A | Qualified Health Claims: Psyllium Husk and a Reduced Risk of Type 2 Diabetes (June 2014) |
| 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) |
| Sarcosine |
|
Hsiu-Mei Chao NDIN 389 Response Letter (March 2017) |
| Sibutramine |
|
X2 Zero Corporation Warning Letter (December 2016) Nutrishop of Brick, Inc. Warning Letter (June 2014) Slim Beauty USA Warning Letter (January 2014) Dolphin Intertrade Corporation Warning Letter (August 2013) Zi Xiu Tang Success, LLC Warning Letter (May 2013) Nutri Fusion Systems, Inc. Warning Letter (November 2011) Shaping Beauty, Inc. Warning Letter (July 2011) |
| Sildenafil |
|
MS Bionic Warning Letter (May 2017) X2 Zero Corporation Warning Letter (December 2016) R Thomas Marketing/Just Enhance Warning Letter (July 2015) Shoreside Enterprises, Inc. Warning Letter (December 2014) Nova Products, Inc. Warning Letter (September 2014) Kanec USA, Inc. Warning Letter (October 2010) |
| Tadalafil |
|
1am USA Incorporated dba Pleasure Products USA Warning Letter (July 2022) Shopaax.com Warning Letter (July 2022) MKS Enterprise, LLC Warning Letter (July 2022) Thirsty Run LLC / US Royal Honey LLC Warning Letter (July 2022) MS Bionic Warning Letter (May 2017) American Lifestyle Warning Letter (June 2015) Biogenix USA, LLC Warning Letter (December 2014) Shoreside Enterprises, Inc. Warning Letter (December 2014) Nova Products, Inc. Warning Letter (September 2014) U.S.A Far Ocean Group LLC/Health & Beauty Group Inc. Warning Letter (October 2012) Kanec USA, Inc. Warning Letter (October 2010) |
| Terazosin |
|
USA Far Ocean Group Inc./Health & Beauty Group Inc. Warning Letter (October 2012) |
| Tianeptine |
|
Tianeptine in Dietary Supplements Constituent update and warning letters (November 2018) |
| Vardenafil |
|
Biogenix USA, LLC Warning Letter (December 2014) |
| Vinpocetine |
|
Vinpocetine in Dietary Supplements |
| Vitamin B6 in combination with Folic Acid and Vitamin B12 | N/A |
Qualified Health Claims: Settlement Re Claim Relating to B Vitamins and Vascular Disease (May 2001) |
| Vitamin B12 in combination with Folic Acid and Vitamin B6 | N/A |
Qualified Health Claims: Settlement Re Claim Relating to B Vitamins and Vascular Disease (May 2001) |
| Vitamin D in combination with calcium | N/A |
21 CFR 101.72 Health claims: calcium, vitamin D, and osteoporosis |
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.
2. The claim and disclaimers in this letter were incorporated into a settlement agreement as part of the voluntary dismissal of a lawsuit against FDA in June 2001. Pearson v. Thompson, No. 00-2724 (GK) (D.D.C.).
3. The November 2004 letter reevaluated the scientific evidence for the qualified health claim in the May 2003 letter of enforcement discretion but did not change the qualified health claim itself.