Dietary Supplement Ingredient Advisory List

The FDA Dietary Supplement Ingredient Advisory List is intended to quickly alert the public when the FDA identifies ingredients that do not appear to be lawfully included in products marketed as dietary supplements. Information about other ingredients and dietary supplement products that have been the subject of FDA action and/or statements can be found on the FDA Dietary Supplement Products & Ingredients page. For additional information about FDA’s evaluation of ingredients that were previously included in the Dietary Supplement Ingredient Advisory List, see Updates to the Ingredient Advisory List below.

Dietary Supplement Ingredient Advisory List

The ingredients listed below do not appear to be lawful ingredients in dietary supplements.

Retailers, manufacturers, and other businesses may wish to avoid selling, making, or distributing dietary supplements that include any of the below ingredients.

Consumers may wish to avoid purchasing or consuming dietary supplements that include these ingredients (click on the arrow next to each ingredient name to see common synonyms).

1,4-DMAA

1,4-DMAA also known as:

1,4 dimethylamylamine
1,4 dimethylpentylamine

Andarine

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

Bismuth nitrate also known as:

Bismuth(III) nitrate
Bismuth trinitrate
Nitric acid, bismuth(3+) salt
Bismuth trinitrate pentahydrate
Bismuth(III) nitrate pentahydrate

N-Methyltyramine

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

Sodium tetrachloroaurate

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

Sulbutiamine also known as:

Sulbutiamine
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

Inclusion on the Dietary Supplement Ingredient Advisory List does not necessarily indicate that the FDA has determined that the ingredient is unsafe; it means FDA is taking steps to further evaluate the ingredient.

Ingredients are added to the Dietary Supplement Ingredient Advisory List based on a preliminary evaluation by the FDA. This preliminary evaluation indicates that an ingredient may not lawfully be in dietary supplements for reasons including:

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; or
the ingredient appears to be subject to the requirement for pre-market notification, but the requirement has not been satisfied.

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 this list as the FDA continues its evaluation. To see a list of selected ingredients and dietary supplement products that the FDA has taken action on or has issued statements about, visit the FDA Dietary Supplement Products & Ingredients page.

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.

Sign up for email updates to receive the most recent updates and changes to the Dietary Supplement Ingredient Advisory List.

Updates to the Ingredient Advisory List

The following ingredients have been removed from the Ingredient Advisory List because, based on available information, the ingredients fall into one of the three categories described above:

5-Alpha-Hydroxy-Laxogenin

5-Alpha-Hydroxy-Laxogenin also known as:

5-Alpha-Hydroxy-Laxogenin
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

Higenamine

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
6,7-Dihydroxy-1-[(4-hydroxyphenyl)methyl]-1,2,3,4-tetrahydroisoquinoline
(+-)-1,2,3,4-Tetrahydro-1-((4-hydroxyphenyl)methyl)-6,7-isoquinolinediol

Hordenine

Hordenine also known as:

anhaline
eremursine
N,N-dimethyltyramine
peyocactine
p-hydroxy-N,N-dimethylphenethylamine
4-[2-(Dimethylamino)ethyl]phenol

Octopamine

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

FDA is not aware of any evidence that would call into question its current conclusion about these ingredients, but interested parties may present FDA with any evidence bearing on this issue. For additional information about these ingredients, see the following links:

For Consumers

Consumers who have experienced a health-related reaction or illness (also known as an adverse event) after consuming any dietary supplement should contact their medical professional. It is important for consumers, health care professionals, and industry members to report adverse events to the FDA, so we can act to protect the public from unsafe products. You can report adverse events to the FDA by visiting the How to Report a Problem page.

The FDA encourages consumers with questions about dietary supplements to Submit An Inquiry, or to visit www.fda.gov/fcic for additional information.