Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

        Dietary Supplements

Dietary Supplement Ingredient Directory Home
          Food
          Dietary Supplements
          Dietary Supplement Ingredient DirectoryDietary Supplements Dietary Supplement Ingredient Directory
  	
        Subscribe to Email Updates
    Share
    Post
    Linkedin

    Email
    PrintTwo types of ingredients may be used in dietary supplements – “dietary ingredients” and “other ingredients.” The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines a dietary ingredient as a vitamin; mineral; herb or other botanical; amino acid; dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of any dietary ingredient from the preceding categories.

Dietary supplements include such ingredients as vitamins, minerals, herbs, amino acids, and enzymes, and are typically marketed in forms such as tablets, capsules, softgels, gelcaps, powders, and liquids. Dietary supplements may also include other ingredients, such as fillers, binders, excipients, preservatives, sweeteners, and flavorings. These “other ingredients” are listed separately from dietary ingredients on the Supplement Facts label.

For information about publicly displayed new dietary ingredient notifications (NDINs) that we have reviewed to date, visit Submitted 75-Day Premarket Notifications for New Dietary Ingredients.

For Industry

The manufacturer, packer, or distributor whose name appears on the label of a dietary supplement (the “responsible firm”) is required to record and report to FDA any reports it receives of serious adverse events associated with the use of its products. In addition, the responsible firm must keep records of any non-serious adverse event reports it receives.

Members of the dietary supplement industry may use the reporting form on the Safety Reporting Portal to meet the reporting requirements in section 761 of the FD&C Act.

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 FDA, so we can act to protect the public from unsafe products. You can report adverse events to FDA by visiting the How to Report a Problem page.

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

Ingredient Directory

To help manufacturers, retailers, and consumers of dietary supplements stay informed about recent developments and locate information on FDA’s website quickly, we have put together an “ingredient directory” with links to FDA’s actions and communications with regard to particular dietary ingredients and other ingredients used in products marketed as dietary supplements. We will update the directory periodically to reflect new developments. The directory is not intended to be a comprehensive list of all ingredients used in products marketed as dietary supplements and may not include all actions the agency has taken with respect to a particular ingredient. We welcome additional feedback and information regarding these ingredients. You may submit such information to the FDA's Office of Dietary Supplement Programs.

Ingredients
			Other Known Names [1]
			Agency Actions/
			Statements1,4 DMAA
			1,4 dimethylpentylamine
				1,4-dimethylpentylamine
			Hi Tech Pharmaceuticals Voluntary Recall (May 2021)5-Alpha-Hydroxy-Laxogenin
			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
			Constituent update and warning letters (May 2022)Acacia rigidula
			Vachellia rigidula
				Chaparro Prieto
				Blackbrush
			Acacia rigidula in Dietary SupplementsConstituent update and warning letters (March 2016)Acetaminophen
			Acetamide, N-(4-hydroxyphenyl)-
				Paracetamol
				TylenolTM
			Procter and Gamble Warning Letter (October 2009)ALA Phosphate
			5-aminolevulinic acid phosphate
				NatuALA
			Neo ALA NDIN 1094 Response Letter (December 2018)Aminophylline
			Aminocardol
				Cardiomin
				Stenovasan
				Vasofilina
				Lasodex
			RT Naturals, LLC Warning Letter (July 2010)Anatabine
			Anatabloc
			Rock Creek Pharmaceuticals NDIN 840 Response Letter (August 2014)

			Star Scientific, Inc. Warning Letter (December 2013)Aspirin
			Acetylsalicylic acid
				2-Acetoxybenzoic acid
				2-Carboxyphenyl acetate
				Kyselina 2-acetoxybenzoova
			Bayer HealthCare L.L.C Warning Letter (October 2008)Biotin
			Vitamin H
				Vitamin B7
			Safety communication (November 2019)BMPEA
			R-beta-methylphenethylamine
				R-beta-methylphenethylamine HCl
				Beta-methylphenethylamine
				2- phenyl-1-propanamine
			BMPEA in Dietary SupplementsConstituent update and warning letters (April 2015)Calcifediol
			25-hydroxycholecalciferol
				25-hydroxy vitamin D3
				Calcifediol anhydrous
				Dedrogyl
				Delakmin
				Didrogyl
				Rayaldee
			DSM Nutritional Products NDIN 945 Response Letter (April 2017)Calcium
			N/A
			21 CFR 101.72 Health claims: calcium, vitamin D, and osteoporosis

			Qualified Health Claims: Letter Regarding Calcium and Colon/Rectal, Breast, and Prostate Cancers and Recurrent Colon Polyps (October 2005)Calcium in combination with Vitamin D
			N/A
			21 CFR 101.72 Health claims: calcium, vitamin D, and osteoporosisCannabidiol
			CBD
			FDA Regulation of Cannabis and Cannabis-Derived Products, Including Cannabidiol (CBD)Warning Letters and Test Results for Cannabidiol-Related ProductsCesium chloride
			N/A
			Cesium Chloride in Dietary Supplements

			Safety communication (February 2020)

			Constituent update and warning letters (October 2020)Chlorzoxazone
			2-Hydroxy-5-chlorobenzoxazole
				5-Chlorbenzoxazolin-2-on
				5-Chloro-2-benzoxazolinone
				5-Chloro-2-benzoxazolol
				5-Chloro-2-hydroxybenzoxazole
				Biomioran
			West Coast Laboratories, Inc. Warning Letter (September 2014)

			Human Science Foundation Warning Letter (August 2014)Chromium Picolinate
			N/A
			Qualified Health Claims: Letter of Enforcement Discretion – Chromium Picolinate and Insulin Resistance (August 2005)Comfrey
			Comfrey is a source of pyrrolizidine alkaloids
			Safety communication (July 2001)Cotinine HCl
			Cotinine
				1-methyl-5-(3-pyridinyl)-2-pyrrolidinone
			Capsulean LLC NDIN 1122 Response Letter (September 2019)Dapoxetine
			Dapoxetinum
			Shoreside Enterprises, Inc. Warning Letter (December 2014)Diclofenac
			Dichlofenac
				Diclophenac
				Feloran
				Novapirina
				Olfen
				ProSorb-D
				Voltaren
				Zorvolex
			West Coast Laboratories, Inc. Warning Letter (September 2014)

			Human Science Foundation Warning Letter (August 2014)DMAA
			1,3-DMAA
				1,3-Dimethylamylamine
				1,3-Dimethylpentylamine
				4-Methyl-2-hexanamine
				4-Methyl-2-hexylamine
				Dimethylamylamine
				Geranamine
				Methylhexanamine
				Methylhexanenamine
			DMAA in Products Marketed as Dietary SupplementsDMBA
			1,3-Dimethylbutylamine
				4-Amino-2-Methylpentane Citrate
				4-Amino Methylpentane Citrate
				Amperall
				AMP
				AMP Citrate
				4-AMP Citrate
				4-Methyl-2-Pentanamine
			DMBA in Dietary Supplements

			Constituent update and warning letters (April 2015)DMHA
			1,5-Dimethylhexylamine
				1,5-DMHA
				2-amino-6-methylheptane
				2-aminoisoheptane
				Octodrine
			DMHA in Dietary SupplementsDMSA
			2,3-Dimercaptosuccinic acid
				2,3-Dimercaptobutanedioic acid
				Succicaptal
				Suximer
			Northern Health Products Warning Letter (December 2016)

			Nutri-Dyn Midwest, Inc. Warning Letter (January 2016)Doxylamine
			2-Dimethylaminoethoxyphenylmethyl-2-picoline
			Arco Globus Trading, LLC et al. Warning Letter (December 2017)Eicosapentaenoic Acid and Docosahexaenoic Acid in combination
			EPA
				DHA
			Qualified Health Claims:  Letter Re Eicosapentaenoic Acid and Docosahexaenoic Acid and Reduction of Blood Pressure in the General Population (June 2019)

			Qualified Health Claims:  Letter re EPA and DHA and Reduced Risk of Coronary Heart Disease (September 2004)Ephedrine alkaloids
			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.
			In 2004, FDA banned the sale of dietary supplements containing ephedrine alkaloids (compounds found in some Ephedra species) in the United States. See Final Rule Declaring Dietary Supplements Containing Ephedrine Alkaloids Adulterated Because They Present an Unreasonable Risk, 69 Fed. Reg. 6787 (Feb. 11, 2004), codified at 21 CFR 119.1.Folic Acid
			Folate
				Folacin
			21 CFR 101.79 Health claims: Folate and neural tube defects

			Qualified Health Claims:  Letter regarding disclaimers for comparative folic acid and neural tube defects claim (April 2001) [2]Folic Acid in combination with Vitamin B6 and Vitamin B12
			N/A
			Qualified Health Claims:  Settlement Re Claim Relating to B Vitamins and Vascular Disease (May 2001)HCG
			Human chorionic gonadotropin
				APL (hormone)
				Biogonadil
				Follutein
				Pregnyl
			The hCG Drops, LLC Warning Letter (December 2011)

			Nutri Fusion Systems, Inc Warning Letter (November 2011)

			Natural Medical Supply, LLC dba HCG Complete Diet Warning Letter (November 2011)

			HCG Platinum, LLC Warning Letter (November 2011)

			HCG Diet Direct, LLC Warning Letter (November 2011)

			Theoriginalhcgdrops.com Warning Letter (November 2011)Higenamine
			Norcoclaurine
				Demethylcoclaurine
			Constituent update and warning letters (May 2022)Higenamine HCl
			Norcoclaurine HCl
				Demethylcoclaurine HCl
			Constituent update and warning letters (May 2022)Homotaurine
			Acamprosate
				Tramiprosate
				3-Amino-1-propanesulfonic acid
				3-Aminopropanesulphonic acid
				3-aminopropanesulfonic acid
				3APS
				Alzhemed
				Aotal
				Regtect
				Zulex
			OVOS Natural Health, Inc. Citizen Petition Response (February 2011)

			Chemtech Pharmics, Inc. NDIN 43 Response Letter (May 1999)Hordenine
			N,N-dimethyltyramine
				p-hydroxy-N,N-dimethylphenethylamine
				para-hydroxy-N,N-dimethylphenethylamine
				4-hydroxy-N,N-dimethylphenethylamine
			Constituent update and warning letters (May 2022)Hordenine HCl
			N,N-dimethyltyramine HCl
				p-hydroxy-N,N-dimethylphenethylamine HCl
				para-hydroxy-N,N-dimethylphenethylamine HCl
				4-hydroxy-N,N-dimethylphenethylamine HCl
			Constituent update and warning letters (May 2022)Ibuprofen
			Advil
				Midol
				Motrin
				Nuprin
			West Coast Laboratories, Inc. Warning Letter (September 2014)

			Human Science Foundation Warning Letter (August 2014)Indomethacin
			Amuno
				Indocid
				Indocin
				Indomet 140
				Indomethacin Hydrochloride
				Metindol
				Osmosin
			West Coast Laboratories, Inc. Warning Letter (September 2014)

			Human Science Foundation Warning Letter (August 2014)Kava
			kava
				kava kava
				Piper methysticum
			Safety communication (March 2002)Kratom
			Kratom
				Mitragyna speciosa
			FDA and Kratom

			Import Alert 54-15L-DOPA
			Levodopa
				Larodopa
			RT Naturals, LLC Warning Letter (July 2010)LGD-4033
			VK-5211
				Ligandrol
			Infantry Labs, LLC/1 Nation Nutrition Warning Letter (October 2017)

			Panther Sports Nutrition Warning Letter (October 2017)Lorcaserin
			Belvig
				Belviq
				AR-10A
				APD-356
			HIS Enterprise Inc dba Adam’s Secret USA, LLC Warning Letter(January 2023)Magnesium
			N/A
			Constituent update and enforcement letter regarding qualified health claim (January 2022)Metformin
			Fluamine
				N,N-Dimethyldiguanide
				NNDG
			Amrutam Life Care Pvt. Ltd. Cyber Letter (July 2013)Methylsynephrine
			Oxilofrine
				p-hydroxyephedrine
				para-hydroxyephedrine
				4-hydroxyephendrine
			Methylsynephrine in Dietary Supplements

			Constituent update and warning letters (March 2016)N-acetyl-L-cysteine
			NAC
			Citizen petition response (March 2022)

			Guidance for Industry: Policy Regarding N-acetyl-L-cysteine (August 2022)Naproxen
			Aleve
				Anaprox
				Methoxypropiocin
				Naprosin
				Naprosyn
				Naproxen Sodium
				Proxen
				Sodium Naproxenate
				Synflex
			West Coast Laboratories, Inc. Warning Letter (September 2014)

			Human Science Foundation Warning Letter (August 2014)NMN
			Nicotinamide mononucleotide
			Inner Mongolia Kingdomway Pharmaceutical Limited NDIN 1259 Response Letter and Supplemental Response Letter (October 2022, November 2022)Octopamine
			para-octopamine
				p-octopamine
				alpha-(Aminoethyl)-p-hydroxybenzyl alcohol
				beta-hydroxytyramine
				Norsympathol
				Norsynephrine
				Octopamina
			Constituent update and warning letters (May 2022)Oleandrin
			Nerium Oleander
				Corrigen
				Foliandrin
				Folinerin
				Neriol
				Neriolin
				Neriostene
			Phoenix Biotechnology, Inc. NDIN 1157 Response Letter (August 2020)Ostarine
			Enobosarm
				MK-2866
				GTx-024
			Infantry Labs, LLC/1 Nation Nutrition Warning Letter (October 2017)

			Panther Sports Nutrition Warning Letter (October 2017)Phenibut
			fenibut
				phenigam
				PhGaba
				PGaba
				Phenibut HCl
				Phenylgam
				Phenyl-GABA
				Phenygam
				4-Amino-3-phenylbutyric acid
			Phenibut in Dietary Supplements

			Constituent update and warning letters (April 2019)Phosphatidylserine
			N/A
			Qualified Health Claims:  Update Re Phosphatidylserine and Cognitive Function and Dementia (November 2004) [3]

			Qualified Health Claims: Letter Re Phosphatidylserine and Cognitive Dysfunction and Dementia (May 2003)Picamilon
			pikatropin
				pikamilon
				nicotinyl-gamma-aminobutyric acid
				nicotinoyl-GABA
			Picamilon in Dietary Supplements

			Constituent update and warning letters (November 2015)Piroxicam
			Feldene
				Piroftal
				Rosiden
				Roxicam
			West Coast Laboratories, Inc. Warning Letter (September 2014)Plant stanol esters
			N/A
			21 CFR 101.83 Health claims: plant sterol/stanol esters and risk of coronary heart disease (CHD)Procysteine
			Cystox
				Oxothiazolidine carboxylate, L-
				Koprosteine
			Scientific Systems NDIN 907 Response Letter (March 2016)Psyllium husk
			N/A
			Qualified Health Claims: Psyllium Husk and a Reduced Risk of Type 2 Diabetes (June 2014)Pure and Highly Concentrated Caffeine
			N/A
			Pure and Highly Concentrated Caffeine

			Safety communication (April 2018)

			Guidance for Industry: Highly Concentrated Caffeine in Dietary Supplements (April 2018)Pyridoxamine
			Pyridoxamine hydrochloride
				Pyridoxylamine
			Citizen petition response (January 2009)Red yeast rice
			Monacolin K
				Lovastatin
				Red yeast rice is a source of lovastatin and monacolin K
			Safety communication (August 2007)

			*Pharmanex, Inc. v. Shalala*, 221 F.3d 1151 (10th Cir. 2000)

			*Pharmanex, Inc. v. Shalala*, Case No. 2:97CV262K (D. Utah Mar. 1, 2001)Sarcosine
			N-methyglycine
				Magnesium Sarcosylate
				Sarcosine Hydrochloride
				Sodium Sarcosinate
			Hsiu-Mei Chao NDIN 389 Response Letter (March 2017)Sibutramine
			Meridia
				Reductil
				Didesmethylsibutramine
				sibutramine hydrochloride
			X2 Zero Corporation Warning Letter (December 2016)

			Nutrishop of Brick, Inc. Warning Letter (June 2014)

			Slim Beauty USA Warning Letter (January 2014)

			Dolphin Intertrade Corporation Warning Letter (August 2013)

			Zi Xiu Tang Success, LLC Warning Letter (May 2013)

			Nutri Fusion Systems, Inc. Warning Letter (November 2011)

			Shaping Beauty, Inc. Warning Letter (July 2011)Sildenafil
			Acetildenafil
				Desmethyl Sildenafil
				Homosildenafil
				Hydroxyhomosildenafil
				Revatio
				Viagra
			MS Bionic Warning Letter (May 2017)

			X2 Zero Corporation Warning Letter (December 2016)

			R Thomas Marketing/Just Enhance Warning Letter (July 2015)

			Shoreside Enterprises, Inc. Warning Letter (December 2014)

			Nova Products, Inc. Warning Letter (September 2014)

			Kanec USA, Inc. Warning Letter (October 2010)Tadalafil
			Cialis
				Adcirca
			1am USA Incorporated dba Pleasure Products USA Warning Letter (July 2022)

			Shopaax.com Warning Letter (July 2022)

			MKS Enterprise, LLC Warning Letter (July 2022)

			Thirsty Run LLC / US Royal Honey LLC Warning Letter (July 2022)

			MS Bionic Warning Letter (May 2017)

			American Lifestyle Warning Letter (June 2015)

			Biogenix USA, LLC Warning Letter (December 2014)

			Shoreside Enterprises, Inc. Warning Letter (December 2014)

			Nova Products, Inc. Warning Letter (September 2014)

			U.S.A Far Ocean Group LLC/Health & Beauty Group Inc. Warning Letter (October 2012)

			Kanec USA, Inc. Warning Letter (October 2010)Terazosin
			Blavin
				Flumarc
				Fosfomic
				Vasomet
			USA Far Ocean Group Inc./Health & Beauty Group Inc. Warning Letter (October 2012)Tianeptine
			Tianeptine sulfate
				Tianeptine sodium powder
				Tianeptine acid
			Tianeptine in Dietary Supplements

			Constituent update and warning letters (November 2018)Vardenafil
			Levitra
				Staxyn
				Vivanza
			Biogenix USA, LLC Warning Letter (December 2014)Vinpocetine
			Ethyl Apovincaminate
				Common Periwinkle Vinpocetine
				Lesser Periwinkle extract
				Vinca minor extract
				Periwinkle liquid extract
				Periwinkle aerial parts extract
			Vinpocetine in Dietary SupplementsVitamin B6 in combination with Folic Acid and Vitamin B12
			N/A
			Qualified Health Claims:  Settlement Re Claim Relating to B Vitamins and Vascular Disease (May 2001)Vitamin B12 in combination with Folic Acid and Vitamin B6
			N/A
			Qualified Health Claims:  Settlement Re Claim Relating to B Vitamins and Vascular Disease (May 2001)Vitamin D in combination with calcium
			N/A
			21 CFR 101.72 Health claims: calcium, vitamin D, and osteoporosis

1. This column includes commonly used names for each ingredient but may not include all synonyms or other known names for an ingredient. In addition, some “other known names” may be ambiguous because some names are used for more than one ingredient.

2. The claim and disclaimers in this letter were incorporated into a settlement agreement as part of the voluntary dismissal of a lawsuit against FDA in June 2001. *Pearson v. Thompson*, No. 00-2724 (GK) (D.D.C.).

3. The November 2004 letter reevaluated the scientific evidence for the qualified health claim in the May 2003 letter of enforcement discretion but did not change the qualified health claim itself.

                                                                                  Content current as of:
      07/12/2023
                  
                   
Regulated Product(s)
		 Dietary SupplementsDietary Supplement Ingredient Directory
 SUBSCRIBE
                      Get regular FDA email updates delivered on this topic to your inbox.
    Enter your email address to subscribe:
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop