FDA Information on Select Dietary Supplement Ingredients and Other Substances

The U.S. Food and Drug Administration (FDA) created the Information on Select Dietary Supplement Ingredients and Other Substances resource to help users locate information about actions and communications from the FDA related to specific dietary ingredients and other ingredients used in products marketed as dietary supplements.

All information is based on the findings and regulations of the U.S. FDA. Uses and/or approval of these ingredients in dietary supplements in other countries may be different.

The following resource categorizes and summarizes the data from this Resource:

Ingredients that fall into multiple categories are grouped with the most serious category. Details on other relevant categories are included in the General Statement column.

To avoid confusion, this list does not contain the following items, although these items may be included on the FDA website:

 *This directory is not intended to be a comprehensive list of all ingredients used in dietary supplements and may not include all actions the FDA has taken with respect to a particular ingredient.*

 Last updated April 1, 2024

Adverse Effects/Safety Concerns

Ingredient

Other Names

General Statement

Clinical Concerns

1,4 DMAA

1,4-dimethylpentylamine DMAA can cause serious adverse effects and is considered an unsafe food ingredient in products marketed as dietary supplements. Products marketed as dietary supplements that contain this ingredient are considered adulterated. DMAA can narrow blood vessels and arteries and cause a corresponding increase in blood pressure.

Acadibol

AC-262536
ACP-105

Acadibol can cause serious or life-threatening health problems and cannot be legally marketed in the US as a dietary supplement or drug. Acadibol can increase the risk of heart attack or stoke, cause sleep disturbances, psychosis, hallucinations, liver injury and acute liver failure, sexual dysfunction, infertility, pregnancy miscarriage, and testicular shrinkage.

Andarine

S-4
GTx-007

Andarine can cause serious or life-threatening health problems and cannot be legally marketed in the US as a dietary supplement or drug. Andarine can increase the risk of heart attack or stoke, cause sleep disturbances, psychosis, hallucinations, liver injury and acute liver failure, sexual dysfunction, infertility, pregnancy miscarriage, and testicular shrinkage.

Biotin

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Vitamin H
Vitamin B7

Biotin can interfere with some lab tests and cause incorrect results. Of particular concern is the blood test for troponin, a clinically important biomarker to aid in the diagnosis of heart attacks. Biotin interference can cause a falsely low result for troponin. This may lead to a missed diagnosis and have potentially serious clinical implications. Biotin may be found in levels high enough to interfere with troponin tests in multivitamins, biotin supplements, and supplements for hair, skin, and nail growth.  Diagnosis of heart attack may be missed due to biotin interference with the blood test for troponin. 

Cesium chloride

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N/A Products containing cesium have significant safety risks, including heart toxicity and potential death. Products marketed as dietary supplements that contain this ingredient are considered adulterated. Use of cesium can cause potentially fatal cardiac arrythmias, hypokalemia (low potassium), seizures, syncope (fainting, unresponsiveness), and death.

Comfrey

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Symphytum officionale (Common comfrey)
S. asperum (Prickley comfrey)
S. x uplandicum (Russian comfrey)

Comfrey is a source of pyrrolizidine alkaloids which can cause serious adverse effects. Products marketed as dietary supplements that contain comfrey or other sources of pyrrolizidine alkaloids should be removed from the market and customers should be advised to immediately stop using the product. Comfrey contains pyrrolizidine alkaloids (PAs), which may cause acute or chronic liver toxicity.

DMAA

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1,3-DMAA
1,3-Dimethylamylamine
1,3-Dimethylpentylamine
2-Amino-4-methylhexane
2-Hexanamine, 4-methyl- (9CI)
4-Methyl-2-hexanamine
4-Methyl-2-hexylamine
Dimethylamylamine
Geranamine
Methylhexanamine
Methylhexanenamine

DMAA can cause serious adverse effects and is considered an unsafe food ingredient in products marketed as dietary supplements. Products marketed as dietary supplements that contain this ingredient are considered adulterated.

DMAA can narrow blood vessels and arteries and cause a corresponding increase in blood pressure.

Ephedrine alkaloids

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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. Ephedrine alkaloids in products marketed as dietary supplements present an unreasonable risk. Products containing this ingredient are considered adulterated. Ephedra can worsen heart failure, increase heart rate, and increase blood pressure which may result in stroke, heart attack, and death.

Kava

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Kava
Kava kava
Piper methysticum
Ava
Ava pepper
Awa
Intoxicating pepper
Kava pepper
Kava root
Kawa
Kawa kawa
Kew
Piper methysticum Forst.f.
Piper methysticum G. Forst.
Sakau
Tonga
Wurzelstock
Yangona

Kava-containing products have been associated with severe liver injury, including hepatitis, cirrhosis, and liver failure. People with liver disease or taking other products that can affect the liver should consult their healthcare provider before using. People using a kava-containing dietary supplement that experience symptoms of liver disease (yellowing of the skin or whites of the eyes, brown urine, light-colored stools, unusual tiredness) should also consult their healthcare provider. Kava has been associated with severe liver injury, including hepatitis, cirrhosis, and liver failure.

Kratom

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Mitragyna speciosa

Kratom can cause addiction and/or other serious adverse effects. This substance is a new dietary ingredient (NDI) and products marketed as dietary supplements that contain this ingredient are considered adulterated. Kratom use has been linked to aggression, hallucinations, delusions, vomiting, seizures, liver damage, severe withdrawal, and death.

Pure and Highly Concentrated Caffeine

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N/A

Pure and highly concentrated caffeine products should be avoided. These products have caused severe adverse effects, including rapid or erratic heartbeat, seizures, or death. Some products marketed as dietary supplements that contain this ingredient are considered adulterated. Pure and highly concentrated caffeine products have caused severe adverse effects, including rapid or erratic heartbeat, seizures, or death.

RAD-150

TLB-150 Benzoate

RAD-150 can cause serious or life-threatening health problems and cannot be legally marketed in the US as a dietary supplement or drug. RAD-150 can increase the risk of heart attack or stoke, cause sleep disturbances, psychosis, hallucinations, liver injury and acute liver failure, sexual dysfunction, infertility, pregnancy miscarriage, and testicular shrinkage.

S-23

CCTH-methylproprionamine

S-23 can cause serious or life-threatening health problems and cannot be legally marketed in the US as a dietary supplement or drug. S-23 can increase the risk of heart attack or stoke, cause sleep disturbances, psychosis, hallucinations, liver injury and acute liver failure, sexual dysfunction, infertility, pregnancy miscarriage, and testicular shrinkage.

Testolone

Vosilasarm
RAD-140

Testalone can cause serious or life-threatening health problems and cannot be legally marketed in the US as a dietary supplement or drug. Testalone can increase the risk of heart attack or stoke, cause sleep disturbances, psychosis, hallucinations, liver injury and acute liver failure, sexual dysfunction, infertility, pregnancy miscarriage, and testicular shrinkage.

Tianeptine

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Tianeptine sulfate
Tianeptine sodium powder
Tianeptine acid
Tianaa
Tianna green
Tianna red
Tianna white

Tianeptine can cause serious adverse effects. Products marketed as dietary supplements that contain this ingredient are considered adulterated. Tianeptine has been associated with cases of addiction, abuse, withdrawal, and serious adverse effects including death.

YK-11

YK-11-OA

YK-11 can cause serious or life-threatening health problems and cannot be legally marketed in the US as a dietary supplement or drug. YK-11 can increase the risk of heart attack or stoke, cause sleep disturbances, psychosis, hallucinations, liver injury and acute liver failure, sexual dysfunction, infertility, pregnancy miscarriage, and testicular shrinkage.
Adulterated

Ingredient

Other Names General Statement 

5-Alpha-Hydroxy-Laxogenin

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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

This substance is subject to the new dietary ingredient (NDI) notification requirements, but notification has not been submitted to the FDA. Products marketed as dietary supplements that contain this ingredient are considered adulterated.

Acacia rigidula

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Vachellia rigidula
Chaparro prieto
Blackbrush

This substance is subject to the new dietary ingredient (NDI) notification requirements, but notification has not been submitted to the FDA. Products marketed as dietary supplements that contain this ingredient are considered adulterated.

DMBA

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1,3-Dimethylbutylamine
2-Amino-4-methylpentane citrate
4-Amino-2-methylpentane citrate
4-Amino methylpentane citrate
Amperall
AMP
AMP citrate
4-AMP citrate
4-Methyl-2-pentanamine

This substance is subject to the new dietary ingredient (NDI) notification requirements, but notification has not been submitted to the FDA. Products marketed as dietary supplements that contain this ingredient are considered adulterated.

DMHA

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1,5-Dimethylhexylamine
1,5-DMHA
2-amino-5-methylheptane
2-amino-6-methylheptane
2-aminoisoheptane
2-Heptylamine, 6-methyl-
2-Isooctyl amine
2-Metil-6-amino-eptano
6-Amino-2-methylheptane
Amidrine
Octodrine
Vaporpac

This substance is considered an unsafe food ingredient. Products marketed as dietary supplements that contain this ingredient are considered adulterated.

Higenamine

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Norcoclaurine
Demethylcoclaurine

This substance is subject to the new dietary ingredient (NDI) notification requirements, but notification has not been submitted to the FDA. Products marketed as dietary supplements that contain this ingredient are considered adulterated.

Higenamine HCl

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Norcoclaurine HCl
Demethylcoclaurine HCl

This substance is subject to the new dietary ingredient (NDI) notification requirements, but notification has not been submitted to the FDA. Products marketed as dietary supplements that contain this ingredient are considered adulterated.

Hordenine

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N,N-dimethyltyramine
P-hydroxy-N,N-dimethylphenethylamine
Para-hydroxy-N,N-dimethylphenethylamine
4-hydroxy-N,N-dimethylphenethylamine

This substance is subject to the new dietary ingredient (NDI) notification requirements, but notification has not been submitted to the FDA. Products marketed as dietary supplements that contain this ingredient are considered adulterated.

Hordenine HCl

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N,N-dimethyltyramine HCl
P-hydroxy-N,N-dimethylphenethylamine HCl
Para-hydroxy-N,N-dimethylphenethylamine HCl
4-hydroxy-N,N-dimethylphenethylamine HCl

This substance is subject to the new dietary ingredient (NDI) notification requirements, but notification has not been submitted to the FDA. Products marketed as dietary supplements that contain this ingredient are considered adulterated.

N-Methyltyramine

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Methyl-4-tyramine
4-[2-(Methylamino)ethyl]phenol
p-(2-Methylaminoethyl)phenol
4-Hydroxy-N-methylphenethylamine
NMT

This substance is subject to the new dietary ingredient (NDI) notification requirements, but notification has not been submitted to the FDA. Products marketed as dietary supplements that contain this ingredient are considered adulterated.

Octopamine

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Para-octopamine
P-octopamine
Alpha-(Aminoethyl)-p-hydroxybenzyl alcohol
Beta-hydroxytyramine
Norsympathol
Norsynephrine
Octopamina

This substance is subject to the new dietary ingredient (NDI) notification requirements, but notification has not been submitted to the FDA. Products marketed as dietary supplements that contain this ingredient are considered adulterated.
Misbranded

Ingredient

Other Names

General Statement

BMPEA

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R-beta-methylphenethylamine
R-beta-methylphenethylamine HCl
Beta-methylphenethylamine
1-amino-2-phenylpropane
2-phenylpropan-1-amine
2-phenylpropylamine
Alpha-benzylethylamine
1-phenyl-1-methyl-2-aminoethane
Beta-methylbenzeneethanamine
Beta-phenylpropylamine
2-phenyl-1-propanamine

BMPEA is not a constituent of Acacia rigidula and does not fit the definition of a dietary ingredient. Products labeling this as a dietary ingredient are considered misbranded.

Methylsynephrine

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Oxilofrine
P-hydroxyephedrine
Para-hydroxyephedrine
4-hydroxyephendrine

This substance does not meet the definition of a dietary ingredient or other ingredient that can be used in a dietary supplement. Products labeling this as a dietary ingredient are considered misbranded.

Phenibut

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Fenibut
Phenigam
PhGaba
PGaba
Phenigamma
Phenylgam
Phenyl-GABA
Phenygam
4-Amino-3-phenylbutyric acid
Beta-(aminomethyl)benzenepropanoic acid
Beta-(Aminomethyl)hydrocinnamic acid
Beta-phenyl-gamma-aminobutyric acid

This substance does not meet the definition of a dietary ingredient or other ingredient that can be used in a dietary supplement. Products labeling this as a dietary ingredient are considered misbranded.

Picamilon

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Pikatropin
Pikamilon
Nicotinyl-gamma-aminobutyric acid
Nicotinoyl-GABA

This substance does not meet the definition of a dietary ingredient. Products labeling this as a dietary ingredient are considered misbranded.
Not Considered Dietary Supplement

Ingredient

Other Names

General Statement

Cannabidiol

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CBD The FDA considers CBD to be an unapproved new drug and not a dietary supplement and is considering a new regulatory pathway. 

Homotaurine

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Acamprosate
Tramiprosate
3-Amino-1-propanesulfonic acid
3-Aminopropanesulphonic acid
3-Aminopropanesulfonic acid
3APS
Alzhemed
Aotal
Regtect
Zulex

This substance does not meet the definition of a dietary ingredient or other ingredient that can be used in a dietary supplement.

N-acetyl-L-cysteine

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NAC This product is not considered to be a dietary supplement. However, unless safety-related or other concerns arise, the FDA intends to exercise enforcement discretion for otherwise lawfully marketed dietary supplements containing this ingredient.