FDA Dietary Supplement Ingredient Advisory List
According to the FDA, the ingredients listed below appear to be, or are confirmed to be, unlawful ingredients in dietary supplements for one or more of the following reasons:
- the ingredient appears to be excluded from use in a dietary supplement
- the ingredient does not appear to be a dietary ingredient and does not appear to be either an approved food additive or generally recognized as safe for use
- the ingredient appears to be subject to the requirement for pre-market notification, but the requirement has been satisfied
FDA Dietary Supplement Ingredient Advisory List for ingredients appearing to be unlawful in dietary supplements.
FDA Dietary Supplement Products & Ingredients for ingredients confirmed to be unlawful in dietary supplements.
Consumers may wish to avoid purchasing or consuming dietary supplements that include these ingredients.
To find out more about commercial products containing these ingredients, as well as potential safety and effectiveness concerns, click on the ingredient name to access the Natural Medicines ingredient monograph.
1,3-DMAA
View commercial products containing 1,3-DMAA.
Also Known As:
- 1,3-Dimethylamylamine
- 1,3-Dimethylpentylamine
- 2-Amino-4-Methylhexane
- 2-Hexanamine, 4-methyl- (9CI)
- 4-Methyl-2-Hexanamine
- 4-Methyl-2-Hexylamine
- Dimethylamylamine
- DMAA
- Geranamine
- Methylhexanamine
- Methylhexanenamine
Note: Products containing this ingredient are considered adulterated.
1,4-DMAA
View commercial products containing 1,4-DMAA.
Also Known As:
- 1,4 Dimethylamylamine
- 1,4 Dimethylpentylamine
Acacia rigidula
View commercial products containing Acacia rigidula.
Also Known As:
- Vachellia rigidula
- Chaparro Prieto
- Blackbrush
Note: Products containing this ingredient are considered adulterated.
Andarine
View commercial products containing Andarine.
Also Known As:
- GTx 007
- GTX-007
- Propanamide, 3-(4-(acetylamino)phenoxy)-2-hydroxy-2-methyl-N-(4-nitro-3-(trifluoromethyl)phenyl)-, (2S)-
- SARM S-4
- S-3-(4-acetylaminophenoxy)-2-hydroxy-2-methyl-N-(4-nitro-3-trifluoromethylpheanyl)propionamide
- S-4 cpd
Bismuth Nitrate
View commercial products containing Bismuth Nitrate.
Also Known As:
- Bismuth(III) nitrate
- Bismuth trinitrate
- Nitric acid, bismuth(3+) salt
- Bismuth trinitrate pentahydrate
- Bismuth(III) nitrate pentahydrate
BMPEA
View commercial products containing BMPEA.
Also Known As:
- βMePEA
- R-beta-methylphenethylamine
- R-beta-methylphenethylamine HCl
- Beta-methylphenethylamine
- β-methylphenylethylamine
- 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
Note: Products containing this ingredient are considered misbranded.
Caffeine, Pure Powdered
Note: Products containing caffeine in less concentrated forms are not included as part of this list.
Cesium Chloride
View commercial products containing Cesium.
Also Known As:
Note: Products containing this ingredient are considered adulterated.
DMBA
View commercial products containing DMBA.
Also Known As:
- 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
- Methylpentane
Note: Products containing this ingredient are considered adulterated.
Dimethylhexylamine (DMHA)
View commercial products containing DMHA.
Also Known As:
- 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
Note: Products containing this ingredient are considered adulterated.
Methylsynephrine
View commercial products containing Methylsynephrine.
Also Known As:
- Oxilofrine
- P-Hydroxyephedrine
Note: Products containing this ingredient are considered misbranded.
N-Methyltyramine
View commercial products containing N-Methyltyramine.
Also Known As:
- NMT
- Methyl-4-Tyramine
- N-Methyltyramine
- P-(2-Methylaminoethyl)Phenol
- N-Methyl-Tyramine
- 4-Hydroxy-N-Methylphenethylamine
- P-(2-(Methylamino)Ethyl)Phenol
- P-(2-Methylaminoethyl)-Phenol
Phenibut
View commercial products containing Phenibut.
Also Known As:
- Fenibut
- Phenigam
- PhGaba
- Phenigamma
- Phenygam
- 4-Amino-3-Phenylbutanoic Acid
- β-(aminomethyl)benzenepropanoic Acid
- Beta-(Aminomethyl)hydrocinnamic Acid
- β-Phenyl-γ-Aminobutyric Acid
Note: Products containing this ingredient are considered misbranded.
Picamilon
View commercial products containing Picamilon.
Also Known As:
- Pikatropin
- Pikamilon
- Nicotinyl-Gamma-Aminobutyric Acid
- Nicotinyl-GAB
Note: Products containing this ingredient are considered misbranded. Picamilon is used as a prescription drug in Russia for various neurological conditions. It is not approved as a drug in the U.S.
Sodium Tetrachloroaurate
View commercial products containing Sodium Tetrachloroaurate.
Also Known As:
- EINECS 239-241-3
- Gold chloride sodium
- Gold sodium chloride
- Hydrochloroauric acid, sodium salt
- Natrium tetrachloroauratum
- Sodium chloroaurate
- Sodium gold chloride
- Sodium gold (III) chloride
- Sodium tetrachloroaurate (1-)
- Sodium tetrachloroaurate (3+)
- Tetrachloroaurate (1-) sodium
- Tetrachloroauric (3+) acid, sodium salt
- UNII-7FT6QUT299
Sulbutiamine
View commercial products containing Sulbutiamine.
Also Known As:
- Sulbutiamina
- Sulbutiaminum
- Arcalion
- Bis(1-(2-isobutyryloxyethyl)-2-(N-((4-amino-2-methyl-5-pyrimidinyl)methyl)formamido)-1-propenyl)disulfid
- Bis(1-(4-amino-2-methyl-5-pyrimidinyl)-2-formyl-3,9-dimethyl-8-oxo-2-aza-7-oxa-3-decen-4-yl)disulfid
- Bisibuthiamine
- Bisibutiamin
- Bisibutiamine
- BRN 0741531
- EINECS 221-937-3
- N,N'-(Dithiobis(2-(2-hydroxyethyl)-1-methylvinylene))bis(N-((4-amino-2-methyl-5-pyrimidinyl)methyl)formamide)diisobutyrate (ester)
- O,O'-Diisobutyrylthiamine disulfide
- O-Isobutyroylthiamine disulfide
- UNII-42NCM1BW43
- Vitaberin
Tianeptine
View commercial products containing Tianeptine.
Also Known As:
- Tianeptine sulfate
- Tianeptine sodium powder
- Tianaa
- Tianna Green
- Tianna Red
- Tianna White
Note: Products containing this ingredient are considered adulterated. Tianeptine is used as a prescription drug in some European, Asian, and Latin American countries, but is not approved as a drug in the U.S.
Vinpocetine
View commercial products containing Vinpocetine.
Also Known As:
- Ethyl Apovincaminate
- Common Periwinkle Vinpocetine
- Lesser Periwinkle extract
- Vinca minor extract
Ingredients Removed From the Advisory List
The FDA removed the following ingredients from the advisory list after determining that these substances are actually new dietary ingredients (NDIs). However, an NDI notification is still required before these ingredients can be lawfully included in a dietary supplement product.
Higenamine
View commercial products containing Higenamine.
Also Known As:
- Isoquinolin-6,7-diol, 1,2,3,4-tetrahydro-1-[4-hydroxybenzyl]-
- DL-Demethylcoclaurine
- Norcoclaurine
- (+-)-Norcoclaurine
- (+-)-Demethylcoclaurine
- (+-)-O-Demethylcoclaurine
- (R)-Higenamine
- (R,S)-Norcoclaurine
- 1-(4-hydroxybenzyl)-1,2,3,4-tetrahydroisoquinoline-6,7-diol
- 1-[(4-hydroxyphenyl)methyl]-1,2,3,4-tetrahydroisoquinoline-6,7-diol
- 1-(p-hydroxybenzyl)-6,7-dihydroxy-1,2,3,4-tetrahydroisoquinoline
- 1-(4-Hydroxybenzyl)-1,2,3,4-tetrahydro-6,7-isoquinolinediol
- 6,7-Isoquinolinediol, 1,2,3,4-tetrahydro-1-((4-hydroxyphenyl)methyl)-, (+-)-
- 6,7-dihydroxy-1-(4-hydroxybenzyl)-1,2,3,4-tetrahydroisoquinoline
- (+-)-1,2,3,4-Tetrahydro-1-((4-hydroxyphenyl)methyl)-6,7-isoquinolinediol
Hordenine
View commercial products containing Hordenine.
Also Known As:
- Anhaline
- Eremursine
- N,N-Dimethyltyramine
- Peyocactine
- P-hydroxy-N,N-Dimethylphenethylamine
- 4-[2-(Dimethylamino)ethyl]phenol
Octopamine
View commercial products containing Octopamine.
Also Known As:
- Alpha-(Aminoethyl)-4-Hydroxybenzenemethanol
- Alpha-(Aminoethyl)-P-Hydroxybenzyl Alcohol
- Alpha-Aminoethyl-4-Hydroxybenzylalkohol
- Analet
- Benzenemethanol, Alpha-(Aminomethyl)-4-Hydroxy-
- Norden
- Norfen
- Norphen
- Norsympathol
- Norsympatol
- Norsynephrine
- Octapamine
- Octopamina
- Octopaminum
- P-Hydroxyphenylethanolamine
- P-Norsynephrin
- Paraoxyphenyl Aminoethanol
- WV 562-Isooctyl Amine
- 1-(P-Hydroxyphenyl)-2-Aminoethanol
The FDA removed the following ingredients from the advisory list after determining that these substances do not appear to be dietary ingredients and do not appear to be either approved food additives or generally recognized as safe for use.
5-Alpha-Hydroxy-Laxogenin
View commercial products containing 5-Alpha-Hydroxy-Laxogenin.
Also Known As:
- 5a-Hydroxy-Laxogenin
- (25R)-3beta,5alpha-Dihydroxyspirostan-6-one
- Spirostan-6-one, 3,5-dihydroxy-, (3beta,5alpha,25R)-
- Spirostan-6-one, 3,5-dihydroxy-, (3b,5a,25R)-
- (2AR,2'R,4S,5'R,6aR,6bS,8aS,8bR,9S,11aS,12aS,12bS)-2a,4-dihydroxy-5',6a,8a,9- tetramethylicosahydrospiro[naphtho[2',1':4,5]indeno[2,1-b]furan-10,2'-pyran]-2(11aH)-one
- 25R,5alpha-Spirostan-3beta,5-diol-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
- Laxogenin
Although this list reflects ingredients for which the FDA has made a preliminary assessment, it is not an exhaustive list of ingredients that may or may not be lawfully included in dietary supplements. Ingredients may be added to or removed from the list as the FDA continues its evaluation.
The FDA welcomes additional feedback and information, including information that may support or refute the FDA's preliminary assessment regarding the ingredients on the Dietary Supplement Ingredient Advisory List. You may submit such information to the FDA's Office of Dietary Supplement Programs.
