Information on Select Dietary Supplement Ingredients and Other Substances
A directory of FDA actions and communications
To help manufacturers, retailers, and consumers stay informed about ingredients and other substances found in products labeled as dietary supplements, we have put together this ingredient directory with links to FDA’s actions and communications. The agency’s actions and communications in this directory include FDA’s evaluation of health claims, safety communications, and compliance and enforcement actions. We encourage users of this directory to reference the linked action or communication for additional explanation about an ingredient’s use in dietary supplements. We will update the directory periodically to reflect new developments. As a reminder, FDA does not approve dietary supplements for safety and effectiveness. This directory is not intended to be a comprehensive list of all ingredients used in 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. If you have evidence that calls FDA’s views into question, we invite you to submit such information, along with your reasoning, to the FDA's Office of Dietary Supplement Programs.
For information about ingredients reviewed as part of new dietary ingredient (NDI) notifications, visit Submitted 75-Day Premarket Notifications for New Dietary Ingredients.
Ingredient Directory
| Ingredients | Other Known Names [a] | Agency Actions/ Statements |
Category [b] | Date [c] |
|---|---|---|---|---|
| 1,4 DMAA |
1,4-dimethylamylamine 1,4-dimethylpentylamine |
Safety Communication (December 2023) Hi Tech Pharmaceuticals Voluntary Recall (May 2021) |
3 | 2023/04 |
| 5-Alpha-Hydroxy-Laxogenin |
5-laxogenin 5a-Hydroxy-Laxogenin (25R)-3beta,5alpha 25-R-Spirostan-5A-Diol-6 25R Spirostan-5a-diol-6 25R spirostan-5a-diol-6-one-3 |
Constituent update and warning letters (May 2022) Advanced Nutritional Supplements LLC Warning Letter (May 2022) |
3 | 2023/03 |
| Acacia rigidula |
Vachellia rigidula Chaparro Prieto Blackbrush |
Acacia rigidula in Dietary Supplements Constituent update and warning letters (March 2016) |
7 | 2023/03 |
| Acadibol |
AC-262536 ACP-105 |
SARMs Safety Communication (April 2023) | 2 | 2024/02 |
| Acetaminophen |
Acetamide, N-(4-hydroxyphenyl)- Paracetamol Tylenol™ |
Procter and Gamble Warning Letter (October 2009) | 4 | 2023/04 |
| ALA Phosphate |
5-aminolevulinic acid phosphate NatuALA |
Neo ALA NDIN 1094 Response Letter (December 2018) | 4 | 2023/06 |
| Aminophylline |
Aminocardol Cardiomin Stenovasan Vasofilina Lasodex |
RT Naturals, LLC Warning Letter (July 2010) | 4 | 2023/04 |
| Anatabine |
Anatabloc |
Rock Creek Pharmaceuticals NDIN 840 Response Letter (August 2014) Star Scientific, Inc. Warning Letter (December 2013) |
3, 4 | 2023/04 |
| Andarine |
S-4 GTx-007 |
SARMs Safety Communication (April 2023) Umbrella Warning Letter (May 2021) |
2, 4 | 2024/02 |
| Aspirin |
Acetylsalicylic acid 2-Acetoxybenzoic acid 2-Carboxyphenyl acetate Kyselina 2-acetoxybenzoova |
Bayer HealthCare L.L.C Warning Letter (October 2008) | 4 | 2023/04 |
| Biotin |
Vitamin H Vitamin B7 |
Safety communication (November 2019) | 2 | 2023/03 |
| BMPEA |
R-beta-methylphenethylamine R-beta-methylphenethylamine HCl Beta-methylphenethylamine 2- phenyl-1-propanamine |
Constituent update and warning letters (April 2015) |
3 | 2023/03 |
| Calcifediol |
25-hydroxycholecalciferol 25-hydroxy vitamin D3 Calcifediol anhydrous Dedrogyl Delakmin Didrogyl Rayaldee |
DSM Nutritional Products NDIN 945 Response Letter (April 2017) | 4 | 2023/04 |
| 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) |
1 | 2023/04 |
| Calcium in combination with Vitamin D | N/A | 21 CFR 101.72 Health claims: calcium, vitamin D, and osteoporosis | 1 | 2023/04 |
| Cannabidiol |
CBD |
FDA Regulation of Cannabis and Cannabis-Derived Products, Including Cannabidiol (CBD) Warning Letters and Test Results for Cannabidiol-Related Products |
4 | 2023/03 |
| Cesium chloride | N/A |
Cesium Chloride in Dietary Supplements Safety communication (February 2020) Constituent update and warning letters (October 2020) |
2, 6 | 2023/03 |
| Chlorzoxazone |
2-Hydroxy-5-chlorobenzoxazole 5-Chlorbenzoxazolin-2-on 5-Chloro-2-benzoxazolinone 5-Chloro-2-benzoxazolol 5-Chloro-2-hydroxybenzoxazole Biomioran |
West Coast Laboratories, Inc. Warning Letter (September 2014) Human Science Foundation Warning Letter (August 2014) |
4 | 2023/04 |
| Chromium Picolinate | N/A |
Qualified Health Claims: Letter of Enforcement Discretion – Chromium Picolinate and Insulin Resistance (August 2005) |
1 | 2023/04 |
| Comfrey |
Comfrey is a source of pyrrolizidine alkaloids. Symphytum officionale S. asperum S. × uplandicum Knitbone Saracen's Root Boneset Bruisewort |
Safety communication (July 2001) | 2 | 2023/03 |
| Cotinine HCl |
Cotinine 1-methyl-5-(3-pyridinyl)-2 |
Capsulean LLC NDIN 1122 Response Letter (September 2019) | 4 | 2023/04 |
| Dapoxetine |
Dapoxetinum |
Shoreside Enterprises, Inc. Warning Letter (December 2014) | 4 | 2023/04 |
| Diclofenac |
Dichlofenac Diclophenac Feloran Novapirina Olfen ProSorb-D Voltaren Zorvolex |
West Coast Laboratories, Inc. Warning Letter (September 2014) Human Science Foundation Warning Letter (August 2014) |
4 | 2023/04 |
| DMAA |
1,3-DMAA 1,3-Dimethylamylamine 1,3-Dimethylpentylamine 4-Methyl-2-hexanamine 4-Methyl-2-hexylamine Dimethylamylamine Geranamine Methylhexanamine Methylhexanenamine |
DMAA in Products Marketed as Dietary Supplements | 3 | 2023/03 |
| DMBA |
1,3-Dimethylbutylamine 4-Amino-2-Methylpentane Citrate 4-Amino Methylpentane Citrate Amperall AMP AMP Citrate 4-AMP Citrate 4-Methyl-2-Pentanamine |
Constituent update and warning letters (April 2015) |
7 | 2023/03 |
| DMHA |
1,5-Dimethylhexylamine 1,5-DMHA 2-amino-6-methylheptane 2-aminoisoheptane Octodrine |
DMHA in Dietary Supplements | 3 | 2023/03 |
| DMSA |
2,3-Dimercaptosuccinic acid 2,3-Dimercaptobutanedioic acid Succicaptal Suximer |
Northern Health Products Warning Letter (December 2016) Nutri-Dyn Midwest, Inc. Warning Letter (January 2016) |
4 | 2023/04 |
| Doxylamine |
2-Dimethylaminoethoxyphenylmethyl |
Arco Globus Trading, LLC et al. Warning Letter (December 2017) | 4 | 2023/04 |
| Eicosapentaenoic Acid and Docosahexaenoic Acid in combination |
EPA DHA Omega-3 fatty acids |
Qualified Health Claims: Letter re EPA and DHA and Reduced Risk of Coronary Heart Disease (September 2004) |
1 | 2023/04 |
| Ephedrine alkaloids |
Ephedrine alkaloid sources include raw botanicals (i.e., plants) and extracts from botanicals: Ephedra sinica Stapf Ephedra equisetina Bunge Ephedra intermedia var. tibetica Stapf Ephedra distachya L. Sida cordifolia L. Pinellia ternata (Thunb.) Makino Ma huang Ephedra Chinese Ephedra Epitonin Sea grape Yellow horse Joint fir Popotillo 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. | 5 | 2023/03 |
| Folic Acid |
Folate Folacin |
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) [d] |
1 | 2023/04 |
| 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) |
1 | 2023/04 |
| Galantamine | Galantamine HBr | Life Enhancement Products, Inc. Warning Letter (October 2002) | 4 | 2024/02 |
| HCG |
Human chorionic gonadotropin APL (hormone) Biogonadil Follutein Pregnyl |
The hCG Drops, LLC Warning Letter (December 2011) Theoriginalhcgdrops.com Warning Letter (November 2011) |
4 | 2023/04 |
| Higenamine |
Norcoclaurine Demethylcoclaurine |
Constituent update and warning letters (May 2022) Ironmag Labs Warning Letter (May 2022) |
7 | 2023/03 |
| Higenamine HCl |
Norcoclaurine HCl Demethylcoclaurine HCl |
Constituent update and warning letters (May 2022) Advanced Nutritional Supplements LLC Warning Letter (May 2022) |
3 | 2023/03 |
| Homotaurine |
Acamprosate Tramiprosate 3-Amino-1-propanesulfonic acid 3-Aminopropanesulphonic acid 3-aminopropanesulfonic acid 3APS Alzhemed Aotal Regtect Zulex |
OVOS Natural Health, Inc. Citizen Petition Response (February 2011) |
3, 4 | 2023/04 |
| Hordenine |
N,N-dimethyltyramine p-hydroxy-N,N-dimethylphenethylamine para-hydroxy-N,N-dimethylphenethylamine 4-hydroxy-N,N-dimethylphenethylamine |
Constituent update and warning letters (May 2022) Ironmag Labs Warning Letter (May 2022) |
7 | 2023/03 |
| Hordenine HCl |
N,N-dimethyltyramine HCl p-hydroxy-N,N-dimethylphenethylamine HCl para-hydroxy-N,N-dimethylphenethylamine HCl 4-hydroxy-N,N-dimethylphenethylamine HCl |
Constituent update and warning letters (May 2022) Advanced Nutritional Supplements LLC Warning Letter (May 2022) |
3 | 2023/03 |
| Ibuprofen |
Advil Midol Motrin Nuprin |
West Coast Laboratories, Inc. Warning Letter (September 2014) Human Science Foundation Warning Letter (August 2014) |
4 | 2023/04 |
| Indomethacin |
Amuno Indocid Indocin Indomet 140 Indomethacin Hydrochloride Metindol Osmosin |
West Coast Laboratories, Inc. Warning Letter (September 2014) Human Science Foundation Warning Letter (August 2014) |
4 | 2023/04 |
| Kava |
kava kava kava Yangona Kava pepper Piper methysticum |
Safety communication (March 2002) | 2 | 2023/03 |
| Kratom |
Kratom Mitragyna speciosa |
2, 6 | 2023/03 | |
| L-DOPA |
Levodopa Larodopa L-3,4-dihydroxyphenylalanine |
RT Naturals, LLC Warning Letter (July 2010) | 4 | 2023/04 |
| LGD-4033 |
VK-5211 Anabolicum Ligandrol |
SARMs Safety Communication (April 2023) Infantry Labs, LLC/1 Nation Nutrition Warning Letter (October 2017) Panther Sports Nutrition Warning Letter (October 2017) |
2, 4 | 2024/02 |
| Lorcaserin |
Belvig Belviq AR-10A APD-356 |
HIS Enterprise Inc dba Adam’s Secret USA, LLC Warning Letter (January 2023) | 4 | 2023/04 |
| Magnesium | N/A | Constituent update and enforcement letter regarding qualified health claim (January 2022) | 1 |
2023/04 |
| Metformin |
Fluamine N,N-Dimethyldiguanide NNDG |
Amrutam Life Care Pvt. Ltd. Cyber Letter (July 2013) | 4 | 2023/04 |
| Methylsynephrine |
Oxilofrine p-hydroxyephedrine para-hydroxyephedrine 4-hydroxyephendrine |
Methylsynephrine in Dietary Supplements Constituent update and warning letters (March 2016) |
3 | 2023/03 |
| N-acetyl-L-cysteine |
NAC N-acetylcysteine Acetyl Cysteine Acetylcysteine |
Citizen petition response (March 2022) Guidance for Industry: Policy Regarding N-acetyl-L-cysteine (August 2022) |
4 | 2023/03 |
| Naproxen |
Aleve Anaprox Methoxypropiocin Naprosin Naprosyn Naproxen Sodium Proxen Sodium Naproxenate Synflex |
West Coast Laboratories, Inc. Warning Letter (September 2014) Human Science Foundation Warning Letter (August 2014) |
4 | 2023/04 |
| Nerium oleander |
Oleandrin Corrigen Foliandrin Folinerin Neriol Neriolin Neriostene |
Phoenix Biotechnology, Inc. NDIN 1157 Response Letter (August 2020) Ozelle Pharmaceuticals, Inc NDIN 37 Response Letter (December 1998) |
2, 4 | 2023/04 |
| N-Methyltyramine |
Methyl-4-tyramine 4-[2-(Methylamino)ethyl]phenol p-(2-Methylaminoethyl)phenol 4-Hydroxy-N-methylphenethylamine NMT |
Carbon Fire, LLC Warning Letter (March 1, 2024) | 7 | 2024/05 |
| NMN |
Nicotinamide mononucleotide β-NMN |
Inner Mongolia Kingdomway Pharmaceutical Limited NDIN 1259 Response Letter and Supplemental Response Letter (October 2022, November 2022) | 4 | 2023/04 |
| Octopamine |
para-octopamine p-octopamine alpha-(Aminoethyl)-p-hydroxybenzyl alcohol beta-hydroxytyramine Norsympathol Norsynephrine Octopamina |
Constituent update and warning letters (May 2022) Max Muscle Warning Letter (May 2022) |
7 | 2023/03 |
| Ostarine |
Enobosarm MK-2866 GTx-024 Ostabolic |
SARMs Safety Communication (April 2023) Infantry Labs, LLC/1 Nation Nutrition Warning Letter (October 2017) Panther Sports Nutrition Warning Letter (October 2017) |
2, 4 | 2024/02 |
| Phenibut |
fenibut phenigam PhGaba PGaba Phenibut HCl Phenylgam Phenyl-GABA Phenygam 4-Amino-3-phenylbutyric acid |
Phenibut in Dietary Supplements Constituent update and warning letters (April 2019) |
3 | 2023/03 |
| Phosphatidylserine | N/A |
Qualified Health Claims: Update Re Phosphatidylserine and Cognitive Function and Dementia (November 2004) [e] Qualified Health Claims: Letter Re Phosphatidylserine and Cognitive Dysfunction and Dementia (May 2003) |
1 | 2023/04 |
| Picamilon |
pikatropin pikamilon nicotinyl-gamma-aminobutyric acid nicotinoyl-GABA |
Picamilon in Dietary Supplements Constituent update and warning letters (November 2015) |
3 | 2023/03 |
| Piroxicam |
Feldene Piroftal Rosiden Roxicam |
West Coast Laboratories, Inc. Warning Letter (September 2014) | 4 | 2023/04 |
| Plant stanol esters | N/A | 21 CFR 101.83 Health claims: plant sterol/stanol esters and risk of coronary heart disease (CHD) | 1 |
2023/04 |
| Procysteine |
Cystox Oxothiazolidine carboxylate, L- Koprosteine |
Scientific Systems NDIN 907 Response Letter (March 2016) | 4 | 2023/04 |
| Psyllium husk | N/A | Qualified Health Claims: Psyllium Husk and a Reduced Risk of Type 2 Diabetes (June 2014) | 1 |
2023/04 |
| 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) |
2, 5 | 2023/03 |
| Pyridoxamine |
Pyridoxamine hydrochloride Pyridoxylamine |
Citizen petition response (January 2009) | 4 | 2023/03 |
| RAD-150 |
TLB-150 Benzoate |
SARMs Safety Communication (April 2023) | 2 | 2024/02 |
| Red yeast rice |
Red yeast rice is produced by fermentation of a yeast (Monascus purpureus) on rice. It is a source of monacolins, including monocolin K (also known as lovastatin, the active pharmaceutical ingredient in Mevacor). Monacolin K Lovastatin |
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) |
4 | 2023/03 |
| S-23 |
CCTH-methylproprionamine |
SARMs Safety Communication (April 2023) | 2 | 2024/02 |
| Sarcosine |
N-methyglycine Magnesium Sarcosylate Sarcosine Hydrochloride Sodium Sarcosinate |
Hsiu-Mei Chao NDIN 389 Response Letter (March 2017) | 4 | 2023/04 |
| Sibutramine |
Meridia Reductil Didesmethylsibutramine sibutramine hydrochloride |
X2 Zero Corporation Warning Letter (December 2016) Shaping Beauty, Inc. Warning Letter (July 2011) |
4 | 2023/04 |
| Sildenafil |
Acetildenafil Desmethyl Sildenafil Homosildenafil Hydroxyhomosildenafil Revatio Viagra |
Thirsty Run LLC / US Royal Honey LLC Warning Letter (July 2022) MS Bionic Warning Letter (May 2017) Kanec USA, Inc. Warning Letter (October 2010) |
4 | 2023/04 |
| Tadalafil |
Cialis Adcirca |
1am USA Incorporated dba Pleasure Products USA Warning Letter (July 2022) MS Bionic Warning Letter (May 2017) Kanec USA, Inc. Warning Letter (October 2010) |
4 | 2023/04 |
| Terazosin |
Blavin Flumarc Fosfomic Vasomet |
USA Far Ocean Group Inc./Health & Beauty Group Inc. Warning Letter (October 2012) | 4 | 2023/04 |
| Testolone |
Vosilasarm RAD-140 |
SARMs Safety Communication (April 2023) | 2 | 2024/02 |
| Tianeptine |
Tianeptine sulfate Tianeptine sodium powder Tianeptine acid |
Tianeptine in Dietary Supplements Health Fraud Scams – Tianeptine (February 2024) Consumer Update (February 2022) |
2, 3 | 2023/03 |
| Vardenafil |
Levitra Staxyn Vivanza |
Biogenix USA, LLC Warning Letter (December 2014) | 4 | 2023/04 |
| Vinpocetine |
Ethyl Apovincaminate Common Periwinkle Vinpocetine Lesser Periwinkle extract Vinca minor extract Periwinkle liquid extract Periwinkle aerial parts extract |
Vinpocetine in Dietary Supplements | 2 | 2023/03 |
| 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) | 1 | 2023/04 |
| 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) | 1 | 2023/04 |
| Vitamin D in combination with calcium | N/A | 21 CFR 101.72 Health claims: calcium, vitamin D, and osteoporosis | 1 | 2023/04 |
| YK-11 | YK-11-OA | SARMs Safety Communication (April 2023) | 2 |
2024/02 |
a. 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.
b. FDA actions/communications on each of the ingredients in this directory generally fall within one or more categories, numbered below and included in this column:
- 1. Ingredient is the subject of an authorized health claim or qualified health claim
- 2. Ingredient is the subject of a safety communication
- 3. Ingredient is not a “dietary ingredient” under section 201(ff)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
- 4. Ingredient is excluded from the dietary supplement definition under section 201(ff)(3) of the FD&C Act
- 5. Dietary ingredient has not met the safety standard in section 402(f)(1)(A) of the FD&C Act
- 6. New dietary ingredient has not met the safety standard in section 402(f)(1)(B) of the FD&C Act
- 7. New dietary ingredient requiring a premarket safety notification under section 413(a)(2) of the FD&C Act but for which no notification has been submitted
c. This column includes the date (YYYY/MM) that a listing was added to the directory or updated.
d. 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.).
e. 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.