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 with Adverse Effects & Safety Concerns
Ingredients Considered Adulterated
Ingredients Considered Misbranded
Ingredients Not Considered a Dietary Supplement

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:

Approved or investigational drug ingredients;
Multi-ingredient products that were subject to an FDA finding because a drug ingredient was combined with a dietary ingredient without appropriate FDA approval as a new drug;
Ingredients subject to an FDA finding based on unsupported health claims made by one or more products.

*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 View Commercial Products	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 View Commercial Products	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 View Commercial Products	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 View Commercial Products	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 View Commercial Products	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 View Commercial Products	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 View Commercial Products	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 View Commercial Products	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 View Commercial Products	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 View Commercial Products	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 View Commercial Products	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 View Commercial Products	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 View Commercial Products	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 View Commercial Products	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 View Commercial Products	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 View Commercial Products	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 View Commercial Products	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.
Octopamine View Commercial Products	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 View Commercial Products	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 View Commercial Products	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 View Commercial Products	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 View Commercial Products	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 View Commercial Products	CBD	The FDA considers CBD to be an unapproved new drug and not a dietary supplement and is considering a new regulatory pathway.
Homotaurine View Commercial Products	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 View Commercial Products	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.

FDA Information on Select Dietary Supplement Ingredients and Other Substances

Acadibol

RAD-150

YK-11