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.

1,4-DMAA (full monograph under development)

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 (full monograph under development)

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

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.

DMAA

View commercial products containing DMAA.

Also Known As:

• 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

Note: Products containing this ingredient are considered adulterated.

DMBA (Methylpentane)

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

Note: Products containing this ingredient are considered adulterated.

DMHA (Octodrine)

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.

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
• 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

View commercial products containing Hordenine. 

Also Known As:

• Anhaline
• Eremursine
• N,N-Dimethyltyramine
• Peyocactine
• P-hydroxy-N,N-Dimethylphenethylamine
• 4-[2-(Dimethylamino)ethyl]phenol

Methylsynephrine (full monograph under development)

Also Known As:

• Oxilofrine
• P-Hydroxyephedrine

Note: Products containing this ingredient are considered misbranded.

N-Methyltyramine (full monograph under development)

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

Octopamine (full monograph under development)

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

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 (full monograph under development)

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.

Tianeptine (full monograph under development)

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

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.

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.

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 not been satisfied