FDA Launches New Directory of Ingredients Used in Products Marketed as Dietary Supplements

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. You may submit such information to the FDA’s Office of Dietary Supplement Programs.

February 24, 2024

Source: United States Food and Drug Administration

For information about ingredients reviewed as part of new dietary ingredient (NDI) notifications, visit Submitted 75-Day Premarket Notifications for New Dietary Ingredients.

Ingredients	Other Known Names [a]	Agency Actions/ Statements	Category [b]
1,4 DMAA	1,4-dimethylamylamine1,4-dimethylpentylamine	Safety Communication (December 2023)Hi Tech Pharmaceuticals Voluntary Recall (May 2021)	3
5-Alpha-Hydroxy-Laxogenin	5-laxogenin5a-Hydroxy-Laxogenin(25R)-3beta,5alpha -Dihydroxyspirostan-6-one25-R-Spirostan-5A-Diol-6 -One-3-One25R Spirostan-5a-diol-6 -one-3-one Decanoate25R spirostan-5a-diol-6-one-3 -one undecanoate	Constituent update and warning letters (May 2022)Advanced Nutritional Supplements LLC Warning Letter (May 2022)	3
Acacia rigidula	Vachellia rigidulaChaparro PrietoBlackbrush	Acacia rigidula in Dietary SupplementsConstituent update and warning letters (March 2016)	7
Acadibol	AC-262536ACP-105	SARMs Safety Communication(April 2023)	2
Acetaminophen	Acetamide, N-(4-hydroxyphenyl)-ParacetamolTylenol™	Procter and Gamble Warning LetterExternal Link Disclaimer (October 2009)	4
ALA Phosphate	5-aminolevulinic acid phosphateNatuALA	Neo ALA NDIN 1094 Response Letter (December 2018)	4
Aminophylline	AminocardolCardiominStenovasanVasofilinaLasodex	RT Naturals, LLC Warning LetterExternal Link Disclaimer (July 2010)	4
Anatabine	Anatabloc	Rock Creek Pharmaceuticals NDIN 840 Response Letter(August 2014)Star Scientific, Inc. Warning LetterExternal Link Disclaimer (December 2013)	3, 4
Andarine	S-4GTx-007	SARMs Safety Communication(April 2023)Umbrella Warning Letter (May 2021)	2, 4
Aspirin	Acetylsalicylic acid2-Acetoxybenzoic acid2-Carboxyphenyl acetateKyselina 2-acetoxybenzoova	Bayer HealthCare L.L.C Warning LetterExternal Link Disclaimer (October 2008)	4
Biotin	Vitamin HVitamin B7	Safety communicationExternal Link Disclaimer(November 2019)	2
BMPEA	R-beta-methylphenethylamineR-beta-methylphenethylamine HClBeta-methylphenethylamine 2- phenyl-1-propanamine	BMPEA in Dietary SupplementsConstituent update and warning letters (April 2015)	3
Calcifediol	25-hydroxycholecalciferol25-hydroxy vitamin D3Calcifediol anhydrousDedrogylDelakminDidrogylRayaldee	DSM Nutritional Products NDIN 945 Response Letter (April 2017)	4
Calcium	N/A	21 CFR 101.72 Health claims: calcium, vitamin D, and osteoporosisQualified Health Claims: Letter Regarding Calcium and Colon/Rectal, Breast, and Prostate Cancers and Recurrent Colon PolypsExternal Link Disclaimer (October 2005)	1
Calcium in combination with Vitamin D	N/A	21 CFR 101.72 Health claims: calcium, vitamin D, and osteoporosis	1
Cannabidiol	CBD	FDA Regulation of Cannabis and Cannabis-Derived Products, Including Cannabidiol (CBD)Warning Letters and Test Results for Cannabidiol-Related Products	4
Cesium chloride	N/A	Cesium Chloride in Dietary SupplementsSafety communication (February 2020)Constituent update and warning letters (October 2020)	2, 6
Chlorzoxazone	2-Hydroxy-5-chlorobenzoxazole5-Chlorbenzoxazolin-2-on5-Chloro-2-benzoxazolinone5-Chloro-2-benzoxazolol5-Chloro-2-hydroxybenzoxazoleBiomioran	West Coast Laboratories, Inc. Warning LetterExternal Link Disclaimer (September 2014)Human Science Foundation Warning LetterExternal Link Disclaimer (August 2014)	4
Chromium Picolinate	N/A	Qualified Health Claims: Letter of Enforcement Discretion – Chromium Picolinate and Insulin ResistanceExternal Link Disclaimer (August 2005)	1
Comfrey	Comfrey is a source of pyrrolizidine alkaloids.Symphytum officionale (common comfrey)S. asperum (prickley comfrey)S. × uplandicum (Russian comfrey)KnitboneSaracen’s RootBonesetBruisewort	Safety communicationExternal Link Disclaimer (July 2001)	2
Cotinine HCl	Cotinine1-methyl-5-(3-pyridinyl)-2 -pyrrolidinone	Capsulean LLC NDIN 1122 Response Letter (September 2019)	4
Dapoxetine	Dapoxetinum	Shoreside Enterprises, Inc. Warning LetterExternal Link Disclaimer (December 2014)	4
Diclofenac	DichlofenacDiclophenacFeloranNovapirinaOlfenProSorb-DVoltarenZorvolex	West Coast Laboratories, Inc. Warning LetterExternal Link Disclaimer (September 2014)Human Science Foundation Warning LetterExternal Link Disclaimer (August 2014)	4
DMAA	1,3-DMAA1,3-Dimethylamylamine1,3-Dimethylpentylamine4-Methyl-2-hexanamine4-Methyl-2-hexylamineDimethylamylamineGeranamineMethylhexanamineMethylhexanenamine	DMAA in Products Marketed as Dietary Supplements	3
DMBA	1,3-Dimethylbutylamine4-Amino-2-Methylpentane Citrate4-Amino Methylpentane CitrateAmperallAMPAMP Citrate4-AMP Citrate4-Methyl-2-Pentanamine	DMBA in Dietary SupplementsConstituent update and warning letters (April 2015)	7
DMHA	1,5-Dimethylhexylamine1,5-DMHA2-amino-6-methylheptane2-aminoisoheptaneOctodrine	DMHA in Dietary Supplements	3
DMSA	2,3-Dimercaptosuccinic acid2,3-Dimercaptobutanedioic acidSuccicaptalSuximer	Northern Health Products Warning LetterExternal Link Disclaimer (December 2016)Nutri-Dyn Midwest, Inc. Warning LetterExternal Link Disclaimer (January 2016)	4
Doxylamine	2-Dimethylaminoethoxyphenylmethyl -2-picoline	Arco Globus Trading, LLC et al. Warning LetterExternal Link Disclaimer (December 2017)	4
Eicosapentaenoic Acid and Docosahexaenoic Acid in combination	EPADHAOmega-3 fatty acids	Qualified Health Claims:  Letter Re Eicosapentaenoic Acid and Docosahexaenoic Acid and Reduction of Blood Pressure in the General Population (June 2019)Qualified Health Claims:  Letter re EPA and DHA and Reduced Risk of Coronary Heart DiseaseExternal Link Disclaimer(September 2004)	1
Ephedrine alkaloids	Ephedrine alkaloid sources include raw botanicals (i.e., plants) and extracts from botanicals:Ephedra sinica StapfEphedra equisetina BungeEphedra intermedia var. tibetica StapfEphedra distachya L.Sida cordifolia L.Pinellia ternata (Thunb.) MakinoMa huangEphedraChinese EphedraEpitoninSea grapeYellow horseJoint firPopotilloCountry 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
Folic Acid	FolateFolacin	21 CFR 101.79 Health claims: Folate and neural tube defectsQualified Health Claims: Letter regarding disclaimers for comparative folic acid and neural tube defects claimExternal Link Disclaimer (April 2001) [d]	1
Folic Acid in combination with Vitamin B6 and Vitamin B12	N/A	Qualified Health Claims:  Settlement Re Claim Relating to B Vitamins and Vascular DiseaseExternal Link Disclaimer (May 2001)	1
HCG	Human chorionic gonadotropinAPL (hormone)BiogonadilFolluteinPregnyl	The hCG Drops, LLC Warning LetterExternal Link Disclaimer (December 2011)Theoriginalhcgdrops.com Warning LetterExternal Link Disclaimer (November 2011)	4
Higenamine	NorcoclaurineDemethylcoclaurine	Constituent update and warning letters (May 2022)Ironmag Labs Warning Letter(May 2022)	7
Higenamine HCl	Norcoclaurine HClDemethylcoclaurine HCl	Constituent update and warning letters (May 2022)Advanced Nutritional Supplements LLC Warning Letter (May 2022)	3
Homotaurine	AcamprosateTramiprosate3-Amino-1-propanesulfonic acid3-Aminopropanesulphonic acid3-aminopropanesulfonic acid3APSAlzhemedAotalRegtectZulex	OVOS Natural Health, Inc. Citizen Petition Response (February 2011)Chemtech Pharmics, Inc. NDIN 43 Response Letter (May 1999)	3, 4
Hordenine	N,N-dimethyltyraminep-hydroxy-N,N-dimethylphenethylaminepara-hydroxy-N,N-dimethylphenethylamine4-hydroxy-N,N-dimethylphenethylamine	Constituent update and warning letters (May 2022)Ironmag Labs Warning Letter(May 2022)	7
Hordenine HCl	N,N-dimethyltyramine HClp-hydroxy-N,N-dimethylphenethylamine HClpara-hydroxy-N,N-dimethylphenethylamine HCl4-hydroxy-N,N-dimethylphenethylamine HCl	Constituent update and warning letters (May 2022)Advanced Nutritional Supplements LLC Warning Letter (May 2022)	3
Ibuprofen	AdvilMidolMotrinNuprin	West Coast Laboratories, Inc. Warning LetterExternal Link Disclaimer (September 2014)Human Science Foundation Warning LetterExternal Link Disclaimer (August 2014)	4
Indomethacin	AmunoIndocidIndocinIndomet 140Indomethacin HydrochlorideMetindolOsmosin	West Coast Laboratories, Inc. Warning LetterExternal Link Disclaimer (September 2014)Human Science Foundation Warning LetterExternal Link Disclaimer (August 2014)	4
Kava	kavakava kavaYangonaKava pepperPiper methysticum	Safety communicationExternal Link Disclaimer (March 2002)	2
Kratom	KratomMitragyna speciosa	FDA and KratomImport Alert 54-15	2, 6
L-DOPA	LevodopaLarodopaL-3,4-dihydroxyphenylalanine	RT Naturals, LLC Warning LetterExternal Link Disclaimer (July 2010)	4
LGD-4033	VK-5211AnabolicumLigandrol	SARMs Safety Communication(April 2023)Infantry Labs, LLC/1 Nation Nutrition Warning LetterExternal Link Disclaimer(October 2017)Panther Sports Nutrition Warning LetterExternal Link Disclaimer (October 2017)	2, 4
Lorcaserin	BelvigBelviqAR-10AAPD-356	HIS Enterprise Inc dba Adam’s Secret USA, LLC Warning Letter (January 2023)	4
Magnesium	N/A	Constituent update and enforcement letter regarding qualified health claim (January 2022)	1
Metformin	FluamineN,N-DimethyldiguanideNNDG	Amrutam Life Care Pvt. Ltd. Cyber Letter (July 2013)	4
Methylsynephrine	Oxilofrinep-hydroxyephedrinepara-hydroxyephedrine4-hydroxyephendrine	Methylsynephrine in Dietary SupplementsConstituent update and warning letters (March 2016)	3
N-acetyl-L-cysteine	NACN-acetylcysteineAcetyl CysteineAcetylcysteine	Citizen petition response (March 2022)Guidance for Industry: Policy Regarding N-acetyl-L-cysteine(August 2022)	4
Naproxen	AleveAnaproxMethoxypropiocinNaprosinNaprosynNaproxen SodiumProxenSodium NaproxenateSynflex	West Coast Laboratories, Inc. Warning LetterExternal Link Disclaimer (September 2014)Human Science Foundation Warning LetterExternal Link Disclaimer (August 2014)	4
NMN	Nicotinamide mononucleotideβ-NMN	Inner Mongolia Kingdomway Pharmaceutical Limited NDIN 1259 Response Letter and Supplemental Response Letter(October 2022, November 2022)	4
Octopamine	para-octopaminep-octopaminealpha-(Aminoethyl)-p-hydroxybenzyl alcoholbeta-hydroxytyramineNorsympatholNorsynephrineOctopamina	Constituent update and warning letters (May 2022)Max Muscle Warning Letter (May 2022)	7
Nerium oleander	OleandrinCorrigenFoliandrinFolinerinNeriolNeriolinNeriostene	Phoenix Biotechnology, Inc. NDIN 1157 Response Letter (August 2020)Ozelle Pharmaceuticals, Inc NDIN 37 Response Letter (December 1998)	2, 4
Ostarine	EnobosarmMK-2866GTx-024Ostabolic	SARMs Safety Communication(April 2023)Infantry Labs, LLC/1 Nation Nutrition Warning LetterExternal Link Disclaimer(October 2017)Panther Sports Nutrition Warning LetterExternal Link Disclaimer (October 2017)	2, 4
Phenibut	fenibutphenigamPhGabaPGabaPhenibut HClPhenylgamPhenyl-GABAPhenygam4-Amino-3-phenylbutyric acid	Phenibut in Dietary SupplementsConstituent update and warning letters (April 2019)	3
Phosphatidylserine	N/A	Qualified Health Claims: Update Re Phosphatidylserine and Cognitive Function and DementiaExternal Link Disclaimer (November 2004) [e]Qualified Health Claims: Letter Re Phosphatidylserine and Cognitive Dysfunction and DementiaExternal Link Disclaimer(May 2003)	1
Picamilon	pikatropinpikamilonnicotinyl-gamma-aminobutyric acidnicotinoyl-GABA	Picamilon in Dietary SupplementsConstituent update and warning letters (November 2015)	3
Piroxicam	FeldenePiroftalRosidenRoxicam	West Coast Laboratories, Inc. Warning LetterExternal Link Disclaimer (September 2014)	4
Plant stanol esters	N/A	21 CFR 101.83 Health claims: plant sterol/stanol esters and risk of coronary heart disease (CHD)	1
Procysteine	CystoxOxothiazolidine carboxylate, L-Koprosteine	Scientific Systems NDIN 907 Response Letter (March 2016)	4
Psyllium husk	N/A	Qualified Health Claims: Psyllium Husk and a Reduced Risk of Type 2 DiabetesExternal Link Disclaimer (June 2014)	1
Pure and Highly Concentrated Caffeine	N/A	Pure and Highly Concentrated CaffeineSafety communication (April 2018)Guidance for Industry: Highly Concentrated Caffeine in Dietary Supplements (April 2018)	2, 5
Pyridoxamine	Pyridoxamine hydrochloridePyridoxylamine	Citizen petition response (January 2009)	4
RAD-150	TLB-150 Benzoate	SARMs Safety Communication(April 2023)	2
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 KLovastatin	Safety communicationExternal Link Disclaimer (August 2007)Pharmanex, Inc. v. Shalala, 221 F.3d 1151 (10th Cir. 2000)External Link DisclaimerPharmanex, Inc. v. Shalala, Case No. 2:97CV262K (D. Utah Mar. 1, 2001)External Link Disclaimer	4
S-23	CCTH-methylproprionamine	SARMs Safety Communication(April 2023)	2
Sarcosine	N-methyglycineMagnesium SarcosylateSarcosine HydrochlorideSodium Sarcosinate	Hsiu-Mei Chao NDIN 389 Response Letter (March 2017)	4
Sibutramine	MeridiaReductilDidesmethylsibutraminesibutramine hydrochloride	X2 Zero Corporation Warning LetterExternal Link Disclaimer (December 2016)Shaping Beauty, Inc. Warning LetterExternal Link Disclaimer (July 2011)	4
Sildenafil	AcetildenafilDesmethyl SildenafilHomosildenafilHydroxyhomosildenafilRevatioViagra	Thirsty Run LLC / US Royal Honey LLC Warning Letter (July 2022)MS Bionic Warning LetterExternal Link Disclaimer (May 2017)Kanec USA, Inc. Warning LetterExternal Link Disclaimer (October 2010)	4
Tadalafil	CialisAdcirca	1am USA Incorporated dba Pleasure Products USA Warning Letter (July 2022)MS Bionic Warning LetterExternal Link Disclaimer (May 2017)Kanec USA, Inc. Warning LetterExternal Link Disclaimer (October 2010)	4
Terazosin	BlavinFlumarcFosfomicVasomet	USA Far Ocean Group Inc./Health & Beauty Group Inc. Warning LetterExternal Link Disclaimer (October 2012)	4
Testolone	VosilasarmRAD-140	SARMs Safety Communication(April 2023)	2
Tianeptine	Tianeptine sulfateTianeptine sodium powderTianeptine acid	Tianeptine in Dietary SupplementsHealth Fraud Scams – Tianeptine(February 2024)Consumer Update (February 2022)	2, 3
Vardenafil	LevitraStaxynVivanza	Biogenix USA, LLC Warning LetterExternal Link Disclaimer (December 2014)	4
Vinpocetine	Ethyl ApovincaminateCommon Periwinkle VinpocetineLesser Periwinkle extractVinca minor extractPeriwinkle liquid extractPeriwinkle aerial parts extract	Vinpocetine in Dietary Supplements	2
Vitamin B6 in combination with Folic Acid and Vitamin B12	N/A	Qualified Health Claims: Settlement Re Claim Relating to B Vitamins and Vascular DiseaseExternal Link Disclaimer(May 2001)	1
Vitamin B12 in combination with Folic Acid and Vitamin B6	N/A	Qualified Health Claims: Settlement Re Claim Relating to B Vitamins and Vascular DiseaseExternal Link Disclaimer(May 2001)	1
Vitamin D in combination with calcium	N/A	21 CFR 101.72 Health claims: calcium, vitamin D, and osteoporosis	1
YK-11	YK-11-OA	SARMs Safety Communication(April 2023)	2

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.