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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. You may submit such information 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
-Dihydroxyspirostan-6-one

25-R-Spirostan-5A-Diol-6
-One-3-One

25R Spirostan-5a-diol-6
-one-3-one Decanoate

25R spirostan-5a-diol-6-one-3
-one undecanoate

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

BMPEA in Dietary Supplements

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
(common comfrey)

S. asperum
(prickley comfrey)

S. × uplandicum
(Russian comfrey)

Knitbone

Saracen's Root

Boneset

Bruisewort

Safety communication (July 2001) 2 2023/03
Cotinine HCl

Cotinine

1-methyl-5-(3-pyridinyl)-2
-pyrrolidinone

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

DMBA in Dietary Supplements

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
-2-picoline

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 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 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
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)

Chemtech Pharmics, Inc. NDIN 43 Response Letter (May 1999)

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

FDA and Kratom

Import Alert 54-15

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
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
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
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.



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