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:

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:

Acacia rigidula

View commercial products containing Acacia rigidula.

Also Known As:

Note: Products containing this ingredient are considered adulterated.

Andarine (full monograph under development)

Also Known As:

BMPEA

View commercial products containing BMPEA.

Also Known As:

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:

Note: Products containing this ingredient are considered adulterated.

DMBA (Methylpentane)

View commercial products containing DMBA.

Also Known As:

Note: Products containing this ingredient are considered adulterated.

DMHA (Octodrine)

View commercial products containing DMHA.

Also Known As:

Note: Products containing this ingredient are considered adulterated.

Higenamine

View commercial products containing Higenamine. 

Also Known As:

Hordenine

View commercial products containing Hordenine. 

Also Known As:

Methylsynephrine

View commercial products containing Methylsynephrine.

Also Known As:

Note: Products containing this ingredient are considered misbranded.

N-Methyltyramine (full monograph under development)

Also Known As:

Octopamine (full monograph under development)

Also Known As:

Phenibut

View commercial products containing Phenibut.

Also Known As:

Note: Products containing this ingredient are considered misbranded.

Picamilon (full monograph under development)

Also Known As:

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:

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:


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