Food

New Dietary Ingredients in Dietary Supplements - Background for Industry

The Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires that manufacturers and distributors who wish to market dietary supplements that contain "new dietary ingredients" notify the Food and Drug Administration about these ingredients. (See Section 413(d) of the FD&C Act, 21 U.S.C. 350b(d).) Generally, the notification must include information that is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing a new dietary ingredient will reasonably be expected to be safe under the conditions of use recommended or suggested in the labeling.

If you are a manufacturer or distributor, these pages provide a general overview of the following:

On July 5, 2011, FDA published a draft guidance that addresses these and other topics in more detail. See How to Submit Notifications for a New Dietary Ingredient for more information.


When to Notify FDA and What is a New Dietary Ingredient

What is a "new dietary ingredient?" 

The term "new dietary ingredient" means a dietary ingredient that was not marketed in the United States in a dietary supplement before October 15, 1994. (See section 413(d) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 350b(d)). There is no authoritative list of dietary ingredients that were marketed in dietary supplements before October 15, 1994. Therefore, manufacturers and distributors (you) are responsible for determining if an ingredient is a "new dietary ingredient" and, if not, for documenting either that a dietary supplement that contained the dietary ingredient was marketed before October 15, 1994, or that the dietary ingredient was marketed for use in dietary supplements before that date.

If you want to market a "new dietary ingredient" in a dietary supplement, you must be sure that the substance is considered to be a "dietary ingredient." (See section 201(ff)(1) of the FD&C Act (21 U.S.C 321(ff)(1)). A dietary ingredient is a vitamin; a mineral; an herb or other botanical; an amino acid; a dietary substance for use by man to supplement the diet by increasing total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of any of the above dietary ingredients.

In addition, the product containing the dietary ingredient must be a dietary supplement. (See section 201(ff) of the FD&C Act (21 U.S.C. 321 (ff)). The term "dietary supplement" means a product (other than tobacco) intended to supplement the diet that contains one or more dietary ingredients. A dietary supplement is limited to products that are intended for ingestion in tablet, capsule, powder, softgel, gelcap, liquid, or other form, that are not represented as conventional food or as the sole item of a meal or of the diet, and that are labeled as dietary supplements. Additionally, a product that contains an article that is an approved new drug or licensed biologic cannot be a dietary supplement unless the article was marketed as a dietary supplement or as a food before its approval as a new drug or licensing as a biologic. Dietary supplements also may not include articles that are authorized for investigation as a new drug or biologic (and for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public), unless the article was marketed as a dietary supplement or as a food before it was authorized for investigation.

You can find the statutory language of section 201(ff) of the FD&C Act (21 U.S.C. 321(ff)) by going to the Federal Food, Drug, and Cosmetic Act.

When must I notify FDA about a new dietary ingredient?

The FD&C Act provides that a dietary supplement that contains a new dietary ingredient shall be deemed adulterated under section 402(f) of the FD&C Act (21 U.S.C. 342(f)) unless it meets one of two requirements:

  1. The dietary supplement contains only dietary ingredients which have been present in the food supply as an article used for food in a form in which the food has not been chemically altered; or
  2. There is a history of use or other evidence of safety establishing that the dietary ingredient when used under the conditions recommended or suggested in the labeling of the dietary supplement will reasonably be expected to be safe and, at least 75 days before being introduced or delivered for introduction into interstate commerce, the manufacturer or distributor of the dietary ingredient or dietary supplement provides the FDA with information, including any citation to published articles, which is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing such dietary ingredient will reasonably be expected to be safe.

(See Section 413 of the FD&C Act (21 U.S.C. 350b) and section 402(f) of the FD&C Act (21 U.S.C. 342(f)).

In other words, if the dietary ingredient has not been present in the food supply as an article used for food in the same chemical form that you plan to use in your dietary supplement, you must show why you consider that the new dietary ingredient will reasonably be expected to be safe under the conditions recommended or suggested in the labeling.

If you are unsure whether a dietary ingredient is a "new dietary ingredient" under the FD&C Act you may still submit a notification to us. Importantly, if a notification is required for a product containing a new dietary ingredient and the product is marketed without the required notification, the product is adulterated as a matter of law. Regardless of whether you are required to submit a premarket notification, you are responsible for evaluating the safety of dietary ingredients you use, and you must ensure that dietary supplements you sell or distribute are not adulterated.

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Information About Submitting Notifications for New Dietary Ingredients (Who, What, Where, How)

Who needs to submit a notification?

You must submit a premarket notification if you are a:

  • manufacturer who intends to market a new dietary ingredient;

  • manufacturer who intends to market a dietary supplement that contains a new dietary ingredient;

  • distributor who intends to market a new dietary ingredient; or

  • distributor who intends to market a dietary supplement that contains a new dietary ingredient.

What information must the notification contain? 

If you plan to market a dietary supplement that contains a new dietary ingredient and the new dietary ingredient has not been present in the food supply as an article used for food in a form in which the food has not been chemically altered,  you must submit to FDA, at least 75 days before the dietary ingredient is introduced or delivered for introduction into interstate commerce, information that is the basis on which you have concluded that a dietary supplement containing the new dietary ingredient will reasonably be expected to be safe.

On September 23, 1997, we published in the Federal Register a final rule that established regulations that you must follow when you make a premarket notification for a new dietary ingredient. The regulations are codified at 21 CFR 190.6. These regulations require that you submit an original and two (2) copies of the notification and all of its attachments. You must also provide in the notification:

  • Your name and complete address.
  • The name of the new dietary ingredient. If the new dietary ingredient is an herb or other botanical, you must include the Latin binomial name (including the author).
  • A description of the dietary supplement or dietary supplements that contain the new dietary ingredient, including the:
    • level of the new dietary ingredient in the product;
    • conditions of use of the product recommended or suggested in the labeling or if no conditions of use are recommended or suggested, the ordinary conditions of use; and
    • history of use or other evidence of safety establishing that the dietary ingredient, when used under the conditions recommended or suggested in the labeling of the dietary supplement, will reasonably be expected to be safe.
      • Any reference to published materials must be accompanied by reprints or photocopies.
      • Any material in a foreign language must be accompanied by a translation.
  • The signature of a person you designate who is responsible for the content of the notification and can be contacted if we have questions.

 
See How to Submit Notifications for a New Dietary Ingredient for more information.

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What type of information do I need to submit to provide a basis to conclude that the new dietary ingredient is reasonably expected to be safe?

You are not limited in what evidence you may rely on in determining whether the use of a new dietary ingredient will reasonably be expected to be safe. (See section 413(a)(2) of the FD&C Act (21 U.S.C. 350b(a)(2)). A dietary supplement containing a new dietary ingredient is adulterated unless there is a history of use or other evidence of safety establishing that the new dietary ingredient, when used under the conditions recommended or suggested in the labeling of the dietary supplement, will reasonably be expected to be safe. You are responsible for determining what information provides the basis for your conclusion. At a minimum, we recommend  that  you conduct a thorough search of the scientific literature and consider the evidence of safety found there, including an examination of adverse effects associated with the use of the ingredient. FDA is developing guidance with detailed recommendations on this topic and published a draft guidance for comment in 2011. 

Where do I send my premarket notification and who can I contact at FDA, if I have questions?

Division of Dietary Supplement Programs
Office of Nutrition, Labeling, and Dietary Supplements (HFS-810)
Center for Food Safety and Applied Nutrition
Food and Drug Administration
5100 Paint Branch Parkway
College Park, MD, 20740-3835
Telephone Number: (240) 402-2375

What happens after I submit a premarket notification for a new dietary ingredient to FDA?

Once you submit a premarket notification for a new dietary ingredient, we will acknowledge its receipt in writing within 75 days after we receive it. We will also notify you of the date it was received, which is the filing date for the premarket notification. For 75 days after the filing date, you cannot market (that is, introduce or deliver for introduction into interstate commerce) the new dietary ingredient or the dietary supplement that contains the new dietary ingredient.

We may contact you again if:

  • you did not provide all of the information required in the regulations (see 21 CFR §190.6),

  • we have questions about the information contained in the notification.

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FAILURE OF THE AGENCY TO RESPOND TO A NOTIFICATION DOES NOT CONSTITUTE A FINDING BY FDA THAT THE NEW DIETARY INGREDIENT OR THE DIETARY SUPPLEMENT THAT CONTAINS THE NEW DIETARY INGREDIENT IS SAFE OR IS NOT ADULTERATED UNDER SECTION 402 OF THE FD&C ACT.

We will not disclose the existence of, or the information contained in, your new dietary ingredient notification for 90 days after the filing date. After the 90th day, the information in your notification will be placed on public display in docket number 95S-0316 at FDA’s Dockets Management Branch, except for any information that is trade secret or confidential commercial information.

What new dietary ingredient notifications has FDA received and what is the status of each?

9/10/01 UPDATE to FDA's Table of New Dietary Ingredient Notifications (Docket #95S-0316)

The table below contains notification we received through March 2001. Other notification responses may be found on our Dockets Management Web site. More recent notifications are filed at http://www.regulations.gov  in docket 95S-0316.

The following table contains information on new dietary ingredient notifications we have received, including:

  • an identifying code number for the notification;

  • the name of the new dietary ingredient;

  • the name of the manufacturer or distributor;

  • the date the notification was received or "filed" by FDA; and

  • the status of the notification.

The information for each new dietary ingredient notification that is available using this Web site is the same information that is available at the Dockets Management Web site and the Division of Dockets Management (Dockets) under Docket number 95S-0316.  However, some of these notifications contain copyrighted material that can only be obtained through a Freedom of Information (FOI) request or viewed at Dockets. You may view the New Dietary Ingredient notifications inclusive of copyrighted material at:  Dockets Management Branch, Food & Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.  If you would like a hard copy or a copy on CD-ROM of a New Dietary Ingredient notification with the copyrighted material, you may submit an FOI request to: Freedom of Information Staff, Food & Drug Administration, 5600 Fishers Lane, HFI-35, Rockville, MD 20857. For information on how to submit an FOI request, you may wish to refer to "A Handbook for Requesting Information and Records from FDA". There is a cost for duplicating this material under the Freedom of Information Act.

THE FACT THAT A NEW DIETARY INGREDIENT IS LISTED IN THIS TABLE DOES NOT CONSTITUTE A FINDING BY FDA THAT A NEW DIETARY INGREDIENT OR A DIETARY SUPPLEMENT THAT CONTAINS A NEW DIETARY INGREDIENT IS SAFE OR IS NOT ADULTERATED UNDER SECTION 21 U.S.C. 342.  IN ADDITION, THE LISTING OF A NEW DIETARY INGREDIENT IN THIS TABLE DOES NOT MEAN THAT ANOTHER MANUFACTURER CAN LAWFULLY MARKET THE DIETARY INGREDIENT IN A DIETARY SUPPLEMENT.  EACH MANUFACTURER IS RESPONSIBLE FOR ENSURING COMPLIANCE WITH THE FD&C ACT.

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TABLE NOTES: The names of the new dietary ingredients are stated as reported to FDA in the notifications. The table states the names of the manufacturers or distributors of the new dietary ingredients that may be different from the submitters of the notifications. The filing date represents the date a notification was received by the FDA.

Key:

& = and; and = indicates two separate companies; c/o = care of; FDA = Food and Drug Administration; Let = letter; M = memorandum; N/A = not applicable; Rpt = report; Rpts = reports; Sup = supplement; Sups = supplements

Code No.
(PDF)
New Dietary Ingredient(s) Manufacturer or Distributor Filing Date Status
M 2 Stevia rebaudiana Bertoni
(stevia or stevia leaf)
Sunrider International, Inc. 7/7/95 Filed with comment
M 3 protoprotein nutraceutical Lab #PS-30 Foodsmith Corporation 7/10/95 Filed without comment
Rpt 1
(see Sup 8)
theobromine Tinos LLC 1/22/96 Filed with comment
(See Sup 8 for FDA comment letter.)
Rpt 2 tepozan
(Buddleja americana L.)
Malabar Productos Naturales S.C. De C.V. 2/7/96 Filed without comment
white sapote
(Casimiroa edulis)
Rpt 3 Lo Han Kuo Extract
(fruit extract of Siraitia grosvenorii S.)
HerbaSwy Laboratories, Inc. 3/4/96 Filed without comment
Rpt 4
(see Sup 9)
peptidase
(enzyme derived from bacteria in the genus Serratia)
(SerratiopeptidaseTM)
Specialty Enzymes and Biochemicals Company 5/17/96 Filed with comment
(See Sup 9 for FDA comment letter.)
Rpt 5 (part 1)
Rpt 5 (part 2)
Rpt 5 (part 3)
(see Sup 10)
bark extract of Pao Pereira tree,
Geissospermum vellosii
(Pao VTM)
VIVA (USA), Inc.
(later changed name to Natural Source International, Ltd.)
9/11/96 Filed with comment
(See Sup 10 for FDA comment letter.)
Rpt 6
(see Sup 11)
Trigonella foenum-graeceum L.(Fenugreek)
(debitterized and defatted powder from fenugreek seeds)
Kentucky Biosafety Consultants Inc. 9/17/96 Filed with comment
(See Sup 11 for FDA comment letter.)
Rpt 7 Garañona
(Castilleja canescens)
Malabar Productos Naturales S.C. De C.V. 10/16/96 Filed with comment
Simonillo
(Conyza filaginoides)
Cenizo
(Leucophyllum texanum)
Malabar
(Solanum verbascifolium)
Rpt 8
(see Sup 13)
Anacahuite
(Cordia boissieri D.C.)
Malabar Productos Naturales S.C. De C.V. 10/31/96 Filed with comment
(See Sup 13 for FDA comment letter.)
Gordolobo
(Gnaphalium berlandieri D.C.)
Rpt 9 ReaL Build
(nucleotide; RNA fragments from fermented E. coli)
Natural Source International, Ltd.
(formerly called VIVA (USA), Inc.)
3/10/97 Filed without comment
Rpt 10 Cuachalalate
(Amphipterygium adstringens)
Malabar Productos Naturales S.C. De C.V. 3/18/97 Filed without comment
Proudigious
(Brickellia cavanillesi)
Tarbush
(Flourensia cernua)
Rpt 11 Rauwolfia Vomitoria Afz. or
Rauwolfia Vomitoria
(from root bark of Rauwolfia vomitoria Afz.)
(ingredient of Rovol VTM)
Natural Source International, Ltd.
(formerly called VIVA (USA), Inc.)
3/21/97 Filed without comment
Rpt 12 vinpocetine
(vincamine derivative)
Amrion, Inc. 7/8/97 Filed without comment
Rpt 13 (see Sups 1 & 3) pokeweed mitogen
(mixture of proteins known as lectins from the pokeweed plant, Phytolacca americana L.)
Advanced Plant Pharmaceuticals, Inc. 8/1/97 Inadequate basis for reasonable expectation of safety
Rpt 14 7-keto DHEA acetate
(dehydroepiandrosterone (DHEA) metabolite)
General Nutrition Corporation and Humanetics Corporation 5/25/97 Filed without comment
Rpt 15
(see Sup 12)
Huperzine A
(Huperzia serrata extract)
General Nutrition Corporation and Marco Hi Tech JV Ltd. 9/2/97 Filed with comment
(See Sup 12 for FDA comment letter.)
Rpt 16 pinitol
(inositol derived from pine tree bark)
Humanetics Corporation 12/9/97 Filed without comment
Rpt 17 SeaGoldTM DHA-rich oil
(derived from heterotrophically grown marine microalgae Schizochytrium sp.)
Monsanto Company 12/22/97 Filed without comment
Rpt 18
(see Sup 2)
3, 3'-diindolylmethane (DIM) BioResponse LLC 8/19/97 Inadequate basis for reasonable expectation of safety
Sup 1 (see Rpt 13 & Sup 3) pokeweed mitogen (mixture of proteins known as lectins from the pokeweed plant, Phytolacca americana L.) Advanced Plant Pharmaceuticals, Inc. N/A Comment letter from an individual and FDA's response
Rpt 19 S-adenosylmethionine (SAMe)
(synthesized from methionine and adenosine triphosphate)
US Botanicals 10/21/97 Filed without comment
Rpt 20
(see Rpt 30)
Chancarro
(Cecropia obstusifolia Bert.)
Malabar Productos Naturales S.C. De C.V. 1/27/98 Inadequate basis for reasonable expectation of safety
Espinosilla
(Loeselia mexicana Lam. Brand)
Zoapatle
(Montanoa tormentosa Cerv.)
Pericón
(Tagetes lucida Cav.)
Tronadora
(Tecoma mollis H.B.K.)
Rpt 21 alpha-D(-)ribofuranose
(ribose)
Humanetics Corporation 10/28/97 Filed without comment
Rpt 22 isopropoxy isoflavone Technical Sourcing International, Inc. 11/24/97 Filed without comment
Rpt 23 methyltetrahydrofolate or
5-methyltetrahydrofolate (5-MTHF)
(active form of folate)
General Nutrition Corporation 2/26/98 Filed without comment
Rpt 24 galacto-oligosaccharides
(derived from lactose)
(ingredient of Elix'orTM)
EM Industries, Inc. 3/19/98 Filed without comment
Rpt 25 4-butyrolactone
(gamma-butyrolactone)
Unique Products Company 2/13/98 Inadequate basis for reasonable expectation of safety
Rpt 26 (part 1)
Rpt 26 (part 2)
Rpt 26 (part 3)
Rpt 26 (part 4)
ademetionine
(synthesized from methionine and adenosine triphosphate)
General Nutrition Corporation 3/13/98 Filed without comment
Rpt 27 katsuobushi oligopeptide
(peptide obtained from therolysin-digested Katsuobushi (dried bonito))
General Nutrition Corporation 3/13/98 Filed without comment
Rpt 28 creatine pyruvate SKW Trostberg AG 3/31/98 Filed without comment
Rpt 29 Seaprose-S
(semi-alkaline proteinase from Asperigillus melleus)
General Nutrition Corporation 4/28/98 Filed without comment
Sup 2
(see Rpt 18)
3, 3'-diindolylmethane
(DIM)
BioResponse LLC N/A Company withdrew its notification; not a new dietary ingredient
Rpt 30
(see Rpt 20)
Chancarro
(Cecropia obstusifolia Bert.) (resubmission)
Malabar Productos Naturales S.C. De C.V. 5/15/98 Filed without comment
Espinosilla
(Loeselia mexicana Lam. Brand)
(resubmission)
Filed without comment
Zoapatle
(Montanoa tormentosa Cerv.)
(resubmission)
Inadequate basis for reasonable expectation of safety
Perción
(Tagetes lucida Cav.)
(resubmission)
Filed without comment
Tronadora
(Tecoma mollis H.B.K.)
(resubmission)
Filed without comment
Sup 3
(see Rpt 13 & 
Sup 1)
pokeweed mitogen
(mixture of proteins known as lectins from the pokeweed plant, Phytolacca americana L.)
Advanced Plant Pharmaceuticals, Inc. N/A Comment letter from an individual and FDA's response
Rpt 31
(see Let 1)
Lactobacillus casei
(clearans strain)
La Vida Corporation
(later changed name to Hata Biotics, Inc.)
5/15/98 Filed without comment
Rpt 32 S-adenosylmethionine (SAMe)
(synthesized from methionine and adenosine triphosphate)
Nutramax Laboratories, Inc. 5/27/98 Filed without comment
Rpt 33 root of Imperata cylindrica
(ingredient of LingDanWangTM capsule)
P & Y American Dietary Supplements, Inc. and Ling Dan Wang Health Foods 9/22/98 Inadequate basis for reasonable expectation of safety
whole plant of Isodon glaucocalyx
(ingredient of LingDanWangTM capsule)
Ganoderma lucidum
(ingredient of LingDanWangTM capsule)
Let 1
(see Rpt 31)
Lactobacillus casei
(clearans strain)
Hata Biotics, Inc.
(formerly called La Vida Corporation)
N/A Letter informed FDA of company's name change.
Rpt 34 vinpocetine
(vincamine derivative)
Leiner Health Products 10/20/98 Filed without comment
Rpt 35 hydroxycitric acid
((-)-hydroxycitric acid or (-)HCA)
(synthetically produced)
Pemby Ltd. c/o HOB Ireland Ltd. 11/3/98 Filed without comment
Rpt 36 Danshen Root, Salvia miltiorrhiza Bge.
(contains active ingredient of tanshinone)
(ingredient of DanshengtongTM)
XILI U.S.A. 11/13/98 Inadequate basis for reasonable expectation of safety
Rpt 37 Nerium oleander extract
(ingredient of Oleander Extract Caplets and Anvirzel®)
Ozelle Pharmaceuticals, Inc. 12/1/98 Inadequate basis for reasonable expectation of safety
Rpt 38
(see Sup 4)
Huperzine A
(Hyperzia serrata extract)
Kingchem Inc. 11/16/98 Inadequate basis for reasonable expectation of safety
Rpt 39 myellia of Cordyceps sinensis
(extract of cultured mushroom)
(ingredient of Cordrin CapsuleTM)
P & Y American Dietary Supplements, Inc. 11/18/98 Filed without comment
Rpt 40 Monacolin 8000F
(main component is Monacolin J)
(fungal derivative of Monascus pilosus)
General Nutrition Corporation 1/20/99 Filed without comment
Rpt 41
(see Rpt 73)
ProenOtheraTM
(polyphenolic seed extract of the evening primrose plant, Oenthera biennis)
Humanetics Corporation 5/5/99 Inadequate basis for reasonable expectation of safety
Rpt 42
(see Sup 5)
extract of Ganoderma lucidum, Chinese black mushroom
(ingredient of LDW Liver Nurishing CapsuleTM)
P & Y American Dietary Supplements, Inc. 2/12/99 Inadequate basis for reasonable expectation of safety
root extract of Imperata cylindrical, Lemon grass
(ingredient of LDW Liver Nurishing CapsuleTM)
Sup 4
(see Rpt 38)
Huperzine A
(Hyperzia serrata extract)
(resubmission)
Kingchem Inc. 2/22/99 Filed without comment
Rpt 43 acetyl-homotaurine
(acamprosate)
Chemtech Pharmics, Inc. 3/11/99 Not a dietary supplement
Rpt 44 chicken sternal cartilage Chicken Cart, Inc. 3/15/99 Filed without comment
Rpt 45
(see Rpt 50)
Haematococcus algae
(Haematococcus pluvialis algae)
(source of carotenoid astaxanthin)
Cyanotech Corporation 3/22/99 Inadequate basis for reasonable expectation of safety
Sup 5
(see Rpt 42)
extract of Ganoderma lucidum, Chinese black mushroom
(ingredient of LDW Liver Nurishing CapsuleTM)
(resubmission)
P & Y American Dietary Supplements, Inc. 3/23/99 Inadequate basis for reasonable expectation of safety
root extract of Imperata cylindrical, Lemon grass
(ingredient of LDW Liver Nurishing CapsuleTM)
(resubmission)
Rpt 46 vinpocetine
(vincamine derivative)
Leiner Health Products 3/24/99 Filed without comment
Rpt 47 vinpocetine
(vincamine derivative)
General Nutrition Corporation 4/16/99 Filed without comment
Rpt 48 vinpocetine
(vincamine derivative)
Pharmavite Corporation 5/12/99 Filed without comment
Rpt 49
(see Rpt 76)
Agaricus blazei Murrill extract
(Himematsutake extract)
Iwade Research Institute of Mycology Co., Ltd. 5/24/99 Inadequate basis for reasonable expectation of safety
Rpt 50
(see Rpt 45)
Haematococcus algae
(Haematococcus pluvialis algae)
(source of carotenoid astaxanthin)
(resubmission)
Cyanotech Corporation 5/25/99 Filed without comment
Rpt 51 ImmunoRx (Munogen)
(killed and freeze-dried lysates and bacterial bodies of Lactobaccillus bulgaricus and Respivax (Munostin) that consists of Streptococcus pneumoniae, Neisseria catarrhalis, Streptococcus pyogenes, Haemophilus influenzae, Staphylococcus aureus, and Klebsiella pneumoniae)
New Age Health Technologies, Inc. 6/10/99 Not a dietary supplement
Rpt 52 Ganoderma lucidum spore powder
(Enhanvol Ganoderma Sporo-Pollon (100%))
Green Power Health Products International Company, Ltd. 6/28/99 Filed without comment
Rpt 53
(see Rpt 62)
vincamine
(Vinca minor L. (periwinkle) derivative)
General Nutrition Corporation 6/30/99 Inadequate basis for reasonable expectation of safety
Rpt 54 plant stanol fatty acid esters McNeil Consumer Healthcare 8/20/99 Filed without comment
Let 2 Essence of Mushroom
(Yun-zhi, Coriolus vericolor)
Winsor Health Products, Ltd. 1/7/97 Inadequate basis for reasonable expectation of safety
Rpt 55 Huperzine A
(Huperzia serrata extract)
Solgar Vitamin and Herb 9/30/99 Filed without comment
Rpt 56 Respivax
(killed and freeze-dried lysates and bacterial bodies of Streptocococcus pneumoniae, Neisseria catarrhalis, Streptococcus pyogenes, Haemophilus influenzae, Staphylococcus aureus, and Klebsiella pneumoniae)
N/A/T/O International 10/4/99 Not a dietary supplement
Rpt 57 Lo Han Kuo Fruit Extract
(fruit extract of Siraitia grosvenorii (swingle) C. Jeffrey)
Nature's Marvel International 10/6/99 Not a dietary supplement
Rpt 58 Huperzine A
(Huperzia serrata extract)
Pharmavite Corporation 11/17/99 Filed without comment
Rpt 59
(see Sup 6)
L-Se-methylselenocysteine (SeMC)
(nonprotein amino acid)
PharmaSe, Inc. 10/20/99 Inadequate basis for reasonable expectation of safety
Rpt 60 Leci-GHA
(choline alfoscerate-enriched phospholipid)
Lucas Meyer, Inc. 9/20/99 Inadequate basis for reasonable expectation of safety
Sup 6
(see Rpt 59)
L-Se-methylselenocysteine (SeMC)
(nonprotein amino acid)
(resubmission)
PharmaSe, Inc. 12/6/99 Filed without comment
Rpt 61
(see Rpt 91)
humifulvate
(complex of mainly humic and fulvic acids derived from Hungarian peat)
(ingredient of humifulvate complex (HFC) and Humet®-R syrup)
Corvina Natural Products, Inc. 1/11/00 Inadequate basis for reasonable expectation of safety
Rpt 62
(see Rpt 53)
vincamine
(Vinca minor L. (periwinkle) derivative)
(resubmission)
General Nutrition Corporation 1/20/00 Inadequate basis for reasonable expectation of safety for use with children or for use longer than 6 months
Rpt 63 D-Ribose (ribose) Leiner Health Products 1/21/00 Filed without comment
Rpt 64 Cornus officinalis
(Fructus Corni, asiatic cornelian, cherry fruit)
(ingredient of Metelline)
Mr. Gongjun Ji 2/22/00 Inadequate basis for reasonable expectation of safety
Cuscuta epithymum
(Dodder seed)
(ingredient of Metelline)
ground antelope horn
(ingredient of Metelline)
ground tortoise shell
(ingredient of Metelline)
Lygodium japonicum Sw.
(Spora Lygodii)
(ingredient of Metelline)
Proia cocos Wolf.
(pochymacocos Frio., Indian Bread)
(ingredient of Metelline)
Radix Astragali
(Milkvetch Root)
(ingredient of Metelline)
Radix Rehmanniae
(Rehmannia glutinosa Libosch.)
(Chinese Foxglove Root)
(ingredient of Metelline)
Rpt 65 (part 1)
Rpt 65 (part 2)
Haematococcus algae
(Haematococcus pluvialis algae)
(source of carotenoid astaxanthin)
(ingredient of a dried algal meal, softgels or other dietary supplement named Asta FactorTM or NutraxanTM Asta)
Aquasearch, Inc. 2/22/00 Filed without comment
Rpt 66 S-adenosylmethionine (SAM-e)
(synthesized from methionine and adenosine triphosphate)
Leiner Health Products 3/16/00 Filed without comment
Rpt 67
(see Rpt 80)
Troxerutin (3',4',7-tris(hydroxyethyl)rutin)
(flower bud extract of Chinese Scholartree, Sophora japonica L.)
(flavonoid derivative of the biflavonoid rutin)
Nutratech, Inc. 3/27/00 Inadequate basis for reasonable expectation of safety
Rpt 68
(see Rpt 83)
Diosmin
(bioflavonoid derivative of hesperidin)
Nutratech, Inc. 4/5/00 Inadequate basis for reasonable expectation of safety
Rpt 69 Kalanchoe pinnata (Landmarck) Persoon
(Q'ora Wayra)
(ingredient of Temporal Tension Extract)
Isula Rain, Inc. 4/19/00 Inadequate basis for reasonable expectation of safety
Ruta chalepensis L.
(Ruta)
(ingredient of Temporal Tension Extract)
Rpt 70 Number not used

Rpt 71 (part 1)

Rpt 71 (part 2)

Rpt 71 (part 3)

Acicarpha tribuloides Jussieu
(Estrella kiska)
(ingredient of 7-Day Urinary Cleanse #3)
Isula Rain, Inc. 4/21/00 Inadequate basis for reasonable expectation of safety
Schkuria pinnata Lam.
(Canchalagua)
(ingredient of 7-Day Purity Cleanse #1 and 7-Day Digestive Cleanse #2)
Geranium filipes Killip
(chili-chili)
(ingredient of 7-Day Urinary Cleanse #3)
Mutisia acuminata Ruiz & Pav.
(Chinchircoma)
(ingredient of 7-Day Digestive Cleanse #2)
Equisetum bogotense Kunth
(Cola de caballo)
(ingredient of 7-Day Purity Cleanse #1,
7-Day Digestive Cleanse #2,
7-Day Urinary Cleanse #3,
GBDR Health Extract, and Muscle Health Extract)
Stachys pusilla (Wedd.) Briq.
(Hierba de cáncer)
(ingredient of 7-Day Urinary Cleanse #3)
Bursera graveolens (Kunth) Triana & Planch.
(palo santo)
(ingredient of 7-Day Purity Cleanse #1)
Chuquiraga spinosa Less.
(wamanpinta)
(ingredient of 7-Day Urinary Cleanse #3)
Desmodium molliculum (Kunth) DC.
(Runa manayupa)
(ingredient of 7-Day Urinary Cleanse #3)
Oenothera rosea L'Hér. ex Aiton
(Yawar chonca)
(ingredient of 7-Day Purity Cleanse #1)
Perezia coerulescens Wedd.
(valeriana)
(ingredient of Andean Serenity)
Piper alveolatum Opiz (Piper sp.)
(Matico)
(ingredient of 7-Day Digestive Cleanse #2)
Salvia sagittata Ruiz & Pav.
(Saliva real)
(ingredient of 7-Day Digestive Cleanse #2)
Sanguisorba minor Scop.
(Pimpinela)
(ingredient of Andean Serenity)
Satureja revoluta (Ruiz & Pav.) Briq.
(Té de indio)
(ingredient of Muscle Joint Health Extract and
7-Day Urinary Cleanse #3)
Tessaria integrifolia Ruiz & Pav.
(Pájaro bobo)
(ingredient of 7-Day Digestive Cleanse #2 and GBDR Health Extract)
Rpt 72 Ellaginol
(extract of red raspberry, Rubus ideaus L.)
(rich in ellagic acid)
Audax, Inc. 4/27/00 Filed without comment
Rpt 73
(see Rpt 41)
ProenOtheraTM
(polyphenolic seed extract of the evening primrose plant, Oenthera biennis)
(resubmission)
Humanetics Corporation 4/27/00 Inadequate basis for reasonable expectation of safety
Rpt 74 Phaffia rhodozyman
(yeast product and source of the carotenoid astaxanthin)
(ingredient of AstaXin®)
Igene Biotechnology, Inc. 5/4/00 Inadequate basis for reasonable expectation of safety for use with children or for long-term use.
Rpt 75 Huperzine A
(Huperzia serrata extract)
NOW Foods 5/23/00 Filed without comment
Rpt 76 (part 1)
Rpt 76 (part 2)
(see Rpt 49)
Agaricus blazei Murrill extract
(Himematsutake extract)
(resubmission)
Iwade Research Institute of Mycology Co. Ltd. 5/23/00 Inadequate basis for reasonable expectation of safety
Rpt 77 tall oil phytosterols
(ingredient of ReducolTM)
Novartis Consumer Health, Inc. 6/19/00 Filed without comment
Rpt 78
(see Sup 7)
Lactobacillus reuteri (strain ATCC 55730) McNeil Consumer Healthcare 7/6/00 Inadequate basis for reasonable expectation of safety for use with infants and young children
Rpt 79 Cotinine
(1-methyl-5-(3-pyridinyl)-2-pyrrolidinone)
(extract from Australian Corkwood Tree, Duboisia hopwoodii)
Pharmaco Behavioral Associates, Inc. 8/4/00 Not a dietary supplement
Rpt 80
(see Rpt 67)
Troxerutin Complex
(mixture of hydroxyethyl derivatives of the biflavonoid rutin of which troxerutin is a major component)
(resubmission)
Nutratech, Inc. 8/7/00 Filed without comment
Rpt 81
(see Rpt 96)
zeaxanthin
(carotenoid)
(ingredient of Zeaxanthin 5% TG)
Roche Vitamins, Inc. 8/8/00 Inadequate basis for reasonable expectation of safety
Rpt 82 Mozuku Fucoidan or Fucoidan
(sea kelp extract)
Ocean Treasure Foods, Inc. 8/17/00 Inadequate basis for reasonable expectation of safety
Sup 7
(see Rpt 78)
Lactobacillus reuteri (strain ATCC 55730) McNeil Consumer Healthcare N/A Company letter stated that its dietary supplement was not intended for use by infants and children under 2 years of age.
Rpt 83
(see Rpt 68)
Diosmin Complex
(mixture of 90% diosmin & 10% hesperidin)
(resubmission)
Nutratech, Inc. 8/21/00 Filed without comment
Sup 8
(see Rpt 1)
theobromine Tinos LLC N/A FDA comment letter on Rpt 1
Sup 9
(see Rpt 4)
peptidase Specialty Enzymes and Biochemicals Company N/A FDA comment letter on Rpt 4
Sup 10
(see Rpt 5)
bark extract of the Pao Pereira tree,
Geissospermum vellosii
(Pao VTM)
VIVA (USA), Inc.
(later changed name to Natural Source International, Ltd.)
N/A FDA comment letter on Rpt 5
Sup 11
(see Rpt 6)
Trigonella foenum-graeceum L. (Fenugreek)
(debitterized and defatted powder from fenugreek seeds)
Kentucky Biosafety Consultants Inc. N/A FDA comment letter on Rpt 6
Sup 12
(see Rpt 15)
Huperzine A
(Huperzia serrata extract)
General Nutrition Corporation and Marco Hi Tech JV Ltd. N/A FDA comment letter on Rpt 15
Rpt 84
(see Let 4)
GMM
(Glucose Metabolism Modulator)
(extract from malted barley, poaceae, hordeum vulgare)
VanDrunen Farms/VDF FutureCeuticals 9/6/00 Not a dietary supplement
Rpt 85
(see Let 3)
Resveratrol
(extract of Polygonum cupidatum)
Solgar Vitamin and Herb 9/13/00 Inadequate basis for reasonable expectation of safety
Rpt 86 Heme Iron Polypeptide (HIP)
(extracted from bovine red blood cells)
(brand names are Fenergy, Toraem or Proferrin)
Colorado Biolabs, Inc. 10/17/00 Filed with comment
Rpt 87
(see Rpt 95)
calcium salt of L-5-methyltetrahydrofolate
(L-5-methyl-THF)
(folic acid derivative)
Merck KGaA 10/12/00 Inadequate basis for reasonable expectation of safety
Rpt 88 Type II Collagen
(Colloral® Type II Collagen)
(from chicken sternal cartilage)
AutoImmune Inc. 11/20/00 Filed without comment
Sup 13
(see Rpt 8)
Anacahuite
(Cordia boissieri D.C.)
Malabar Productos Naturales S.C. De C.V. N/A FDA comment letter on Rpt 8
Gordolobo
(Gnaphalium berlandieri D.C.)
Rpt 89 isoquercetin
(quercetin-3-glocoside)
Merck KGaA 12/28/00 Filed with comment
Rpt 90 Salacia oblonga (Celastaceae) extract NutriScience Innovations, LLC 12/22/00 Not a dietary supplement
Let 3
(see Rpt 85)
Resveratrol
(extract of Polygonum cupidatum)
Solgar Vitamin and Herb N/A Comment letter from the company
Rpt 91
Rpt 91 (Attachment 1)
Rpt 91 (Attachment 2)
Rpt 91 (Attachment 3)
Rpt 91 (Attachment 4)
Rpt 91 (Attachment 5)
Rpt 91 (Attachment 6)
Rpt 91 (Attachment 7)
(see Rpt 61)
humifulvate
(complex of mainly humic and fulvic acids derived from Hungarian peat)
(ingredient of humifulvate complex (HFC) and Humet®-R syrup)
(resubmission)
Corvina Natural Products, Inc. 12/6/00 Filed with comment
Rpt 92 S-adenosylmethionine (SAM-e)
(synthesized from methionine and adenosine triphosphate (ATP))
Pharmavite Corporation 2/8/01 Filed with comment
Rpt 93 N-Acetyl-L-Hydroxyproline (AHYP)
(Oxaceprol, ingredient of AHP 200®)
(amino acid derivative)
Kyowa Hakko U.S.A., Inc. 2/9/01 Not a dietary supplement
Rpt 94 porcine relaxin
(hormone produced by ovaries of pregnant pigs)
Sky BioHealth Solutions, Inc. 1/1/01 Not a dietary supplement
Rpt 95
(see Rpt 87)
calcium salt of L-5-methyltetrahydrofolate
(L-5-methyl-THF)
(folic acid derivative)
(resubmission)
Merck KGaA 3/13/01 Filed without comment
Let 4
(see Rpt 84)
GMM (Glucose Metabolism Modulator)
(extract from malted barley, poaceae, hordeum vulgare)
VanDrunen Farms/VDF FutureCeuticals N/A Company request and FDA's response
Rpt 96
(see Rpt 81)
zeaxanthin
(carotenoid)
(ingredient of Zeaxanthin 5% TG)
(resubmission)
Roche Vitamins, Inc. 3/22/01 Filed without comment

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