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Dietary Supplement Ingredients and Raw Materials


NaturPro Scientific are experts in dietary supplement bulk raw materials and ingredients, especially botanicals and herbs.  We know how botanical and medicinal plants are grown, harvested, aggregated, processed, extracted and tested.

We are specialists in qualifying, testing and sourcing herbal dietary ingredients and botanical raw materials used in supplements, foods, pharmaceuticals and cosmetics.


Quick Facts on Bulk Supplement Ingredient Formats, Quality, Testing 

  1. Most raw materials are available as whole, cut, powdered or powdered extract. We recommend and specialize in fully standardized botanical extracts with full supply chain traceability and transparency, meeting the strictest global requirements.
  2. For non-botanicals, we suggest working directly with the manufacturer, and not with a distributor. All certificates of analysis should list the manufacturer’s name and the address of the manufacturing facility where the product was produced, or be accompanied by traceability documentation.
  3. Many raw materials are available as Certified Organic. Most products are naturally non-GMO.
  4. All materials may be tested at dedicated laboratories for the presence and amount of nutrients, potency, microbiology and pathogens, heavy metals, pathogens, 500+ pesticides, 100+ volatile organic compounds and solvents, food allergens and gluten, and mycotoxins.
  5. The testing plan is based on the material specification, which is typically based on the regulatory requirements of the country where the materials will be sold.
  6. We also recognize and actively seek out materials meeting various benchmarked quality standards, such as U.S. 21 CFR 111, USP <561> Articles of Botanical Origin and official pharmacopeial monographs, WHO Good Agricultural and Collection Practices (GACP), USDA Good Agricultural Practices, Fairtrade,  U.N. Forum on Sustainability Standards.

Dietary Supplement Ingredients and Raw Materials 

Here is a partial list of ingredients that we are able to qualify and develop for our clients:

Abies webbiana  (Talispatra)

Abrus precatorius (Rati Gunj)

Acacia arabica (Nilotica)

Acerola Cherry

Achyranthes aspera Seed (Apamarg)

Adhatoda vasica Leaf (Vasa, Adulsa)

Aegle marmelos Fruit (Bilva, Bel)

Aesculus hippocastanum L.

Aglaia roxburghiana Fruit (Priyangu)

Ajmud (Carum roxburgianum)

Allium sativum L.

Aloe ferox Miller

Aloe Gel (Ghrit Kumari)

Aloe vera

Alpha Lipoic Acid

Amalaki, Amla Fruit (Emblica officinalis)

Ambrette Seed (Latakasturi, Muskdana)

Amla Fruit Extract (Phyllanthus emblica)

Amorphophalms konjac

Andrographis Herb (Bhunimba, Kalmegh) Papda)

Andrographis paniculata

Angelica sinensis (Oliv.)Diels

Annatto (Shinduri)

Apple

Arctostaphylos uva-ursi L.

Argemone mexicana Herb (Swarnakshiri)

Argyreia nervosa Seed (Vriddhadaru)

Aristolochia indica Root (Pushkarmul)

Arjun Bark (Terminalia arjuna)

Arrowroot

Artemisia annua L.

Ascorbic Acid

Ascorbyl Palmitate

Ashok Bark (Saraca indica)

Ashwagandha Root (Withania somnifera)

Asparagus racemosus Root (Shatavari)

Astaxanthin

Asteracantha longifolia Seed (Talimakhana)

Astragalus membranaceus(Fisch.)Bge

Atibala Root (Abutilon indicum)

Azadiracta indica Bark (Neem)

Azadiracta indica Leaf (Neem)

B-3 Niacinamide USP

Bacopa monnieri Herb (Brahmi)

Bala Root (Sida cordifolia)

Baliospermum montanum (Danti)

Bamboo Manna (Vansrochan)

Barberry Stem Bark

Barley Grass (Yava)

Basil Leaf

Basil Seed (Sabja, Tukmaria)

Basil, Camphor (Karpur Tulsi)

Bauhinia tomentosa Bark (Kanchanar)

Beet Root

Berberis aristata Stem (Daru Haridra/Haldi)

Bergenia ligulata (Pashan Bheda)

Bhringraja Herb (Eclipta alba)

Bhumyamalaki Herb (Phyllanthus amarus)

Bhunimba Herb (Andrographis paniculata)

Bibhitaki, Baheda Fruit (Terminalia bellerica)

Bilberry (Vaccinium myrtillus L.) Fruit

Bilva, Bel Fruit (Aegle marmelos)

Biotin

Bishops Weed Seed (Ammi majus)

Bitter melon (Karvellak, Karela)

Black Cohosh

Blackberry

Blueberry

Boerhavia diffusa (Punarnava)

Bombax malabaricum (Mochras)

Borago officinalis L. (Borage)

Boswellia serrata (Frankincense, Shallaki)

Brahmi (Bacopa monnieri)

Bridelia retusa (Asana)

Broccoli (Brassica oleracea) Flower Powder

Broccoli Seed Ext BSPE-13-25

Bromelain

Bupleurum Root

Butea monosperma Bark (Palash)

Butea monosperma Flower (Palash)

Buxus sinica(Rehd.et Wils.)Cheng

Caesalpinia bonducella Seed (Lata Karanj)

Caesalpinia sappan (Patang, Sappan wood)

Calamus Root (Vacha, Bach)

Calendula Petals

Calotropis gigantea Root (Mandar, Aak)

Camellia sinensis (L.) O.Kuntze (Green Tea)

Camphor

Camptotheca acuminata

Cane Sugar

Capsicum annuum L.

Cassia absus (Chakshu)

Cassia angustifolia Vahi

Cassia fistula Fruit Pulp (Arghvadh, Bahava)

Cassia nomame(sibe.)L.Kitagawa

Cassia tora (Chakramard)

Catechu Bark (Khadir, Khair)

Cayenne Pepper Powder

Cedrus deodar Wood (Devdaru)

Celastrus paniculatus Fruit (Jyotismati)

Celery Seed (Apium graveolens, Ajmud)

Centella asiatica (Gotu kola) aerials

Chamomile Herb

Chamomilla recutita(L.)Rausch

Chaste Tree Berry

Chen Pi Extract

Chickweed (Stellaria Media Herb) Extract

Chlorophytum borivilium Root (Safed Musli)

Choline Bitartrate

Chrysin

Cimicifuga foetida L.

Cinnamomum zeylanicum (True or Ceylon cinnamon) bark

Cinnamon (Cinnamomum cassia) bark

Cinnamon Powder Low Oil

Cissampelos pareira (Patha)

Cissus quadrangularis Herb (Ashthisandhar)

Citric Acid Anhydrous USP/FCC

Citrullus colocynthis Fruit (Indravaruni) Citrus anrantium L.

Citrus aurantium L.

Citrus Bioflavonoids

Citrus Bioflavonoids Extract

Citrus paradisi Macfadyen

Clerodendron serratum Root (Bharangi)

Clitoria ternatea Herb (Aparajita)

Cnidium monnieri L.

Coenzyme Q10

Cola nitida(Vent.) Schott et Endl

Coleus barbatus Benth

Coleus forskohlii Root (Pashanbheda)

Commiphora mukul Resin (Guggul)

Commiphora myrrah Resin (Raktabol)

Convolvulus pluricaulis Herb (Shankhpushpi)

Coptis Chinensis Extract

Cordyceps sinensis Extract

Costus speciosus (Kustha)

Country Mallow, Indian Root (Atibala)

Cranberry Fruit Powder

Crataegus pinnatifida

Crataeva nurvala Wood (Vaiverna)

Croscarmellose Sodium

Curculigo orchioides Root (Musli)

Curcuma amada Root (Amra Haridra, Amba Haldi)

Curcuma aromatica (Van Haridra)

Curcuma zedoaria (Karchura)

Curcumin 95% Powder

Curry (Murraya koenigii) Leaf

Cyanocobalamin (Vitamin B12 1%)

Cyanocobalamin 0.1%, Vit B12

Cynara scolymus L

Cynodon dactylon (Durva)

Cyperus rotundus Root (Musta, Nagarmotha)

Datura metel Seed (Dhoorta, Dhatura)

Desmodium gangeticum Root (Shaliparni)

Dioscorea bulbifera Tuber (Varahi Kand)

D-Limonene

Dong Quai Extract

Echinacea purpurea Herb Extract

Eclipta alba Herb (Bhringraja)

Eleutherococcus Senticosus Root Extract

Embelia ribes Seed (Vidang)

Emblica officinalis Fruit (Amalaki, Amla)

Epimedium brevicorn

Equisetum arvense L.

Eucalyptus citridora Leaf (Nilgiri)

Euphorbia nerifolia Herb (Sudha)

Evodia rutaecarpa(Juss.)Benth

Evolvulus alsinoides Herb (Shankhpushpi)

Feronia limonia (Wood apple, Kapittha, Kaith)

Ficus benghalensis Bark (Banyan, Vata, Vad)

Ficus benghalensis Shoot (Vatankur)

Ficus racemosa Bark (Udumbara, Gular)

Ficus religiosa Bark (Ashwatha, Peepal)

Flax Seed Extract

Flaxseed Lignans Powder

Foeniculum vulgare Mill (Fennel)

Folic Acid 10%

Folium Artemisiae Argyi

Fructose DC

Fucus vesiculosus L.

Fumaria parviflora Seed (Yavan Parpat, Pitta Papda)

Galangal (Kulinjan)

Ganoderma lucidum (Leyss.ex Fr.)Karst

Garcinia cambogia Fruit Rind (Vrikshamla)

Garcinia mangostana L. (Mangosteen)

Gardenia gummifera (Nadihingu)

Gardenia jasminoides Ellis

Ginger Extract 5%

Ginger Root Powder

Ginkgo Biloba 24% Extract

Gloriosa superba Seed (Langli, Kalihari)

Glucosamine HCl (non-shellfish)

Glycine max(L.)Merr

Glycyrrhiza glabra L.

Gmelina arborea Root (Gambhari, Shivan)

Gokshur Fruit (Tribulus terrestris)

Gokshur Herb (Tribulus terrestris)

Gotu Kola Herb (Mandukparni, Brahmi) Pumpkin Seed

Grape (Citis vinifera) Seed

Green Coffee (Coffea arabica) Bean

Green Tea (Camellia sinensis) Leaf Ext

Green Tea 40% Decaffeinated Water Extracted

Green Tea PE Decaffeinated 40% EGCG

Griffonia Simplicifolia

Guar Gum

Guduchi, Amrita Herb (Tinospora cordifolia)

Guggul Resin (Commiphora mukul)

Gum arabic (Acacia arabica, A. nilotica)

Gymnema Leaf (Madhunashini, Shardunika, Gudmar)

Gymnema sylvestre

Gynostemma pentaphyllum (Thunb.) Makino

Hamamelis mollis Oliver

Haritaki, Harde (Terminalia chebula)

Harpagophytum procumbens DC

Hawthorn Leaf and Flower Ext 5.5 to 1

Hedychium spicatum Root (Sati, Kapur Kachri)

Helicteres isora Fruit (Avartini)

Hemidismus inducus (Anantmul)

Hemsleya amabilis Diels

Hemp Protein

Hemp Seed Oil

Hemp Extract (Cannabidiol, CBD)

Henna Leaf (Madayantika, Mehandi)

Herpestis moniera Herb (Brahmi)

Hesperidin

Hibiscus Flower (Japa, Jaswand) Sage

Hippophae rhamnoides L.

Holarrhena antidysenterica Bark (Kutaj)

Holy Basil Leaf (Tulsi)

Honey

Hops Extract Powder

Hops Powder

Horse Chestnut Extract  20%

Horsetail Shavegrass

Humulus lupulus L.

Huperzia serrata (Huperzine-A)

Hydrocotyle asiatica Herb (Mandukparni)

Hypericum perforatum L.

Indian Goosebery Fruit (Amalaki, Amla)

Indigo Leaf (Neelini, Neel)

Indole-3-Carbinol

Inositol

Ipomoea digitata Tuber (Kshri Vidari)

Japanese Knotweed Extract

Jasmine Flower (Mallika)

Jatamansi Root (Nardostachys jatamansi)

Jatropha curcas

Jujube Seed

Kanchanar Bark (Bauhinia tomentosa)

Korean Ginseng (Panax ginseng)

Kutki Root (Picrorhiza kurroa)

Lagerstroemia speciosa (L.) Pers

Laminaria japonica Arsch

L-Arginine

Lavandula pedunculata L.

L-Carnitine Fumarate

L-Citrulline

L-Cysteine

Lemon Bioflavonoid Complex

Lemon Peel

Lemongrass

Lentinus edodes (Berk.)sing

Lepidium sativum Seed

Leptadenia reticulata (Jivanti)

L-Glutamine

Licorice Extract, Deglycyrrhizinated (Glycyrrhiza Glabra)

Linum usitatissimum L.

Lllicium verum Hook.f

Lotus (Padam, Neel Kamal)

L-Selenomethionine

Lycium barbarum L. (Goji berry)

Maca root

Madder, Indian Root (Manjistha)

Madhuca india (Madhuka)

Magnesium Carbonate

Magnesium Gluconate

Magnesium Lactate

Magnolia Bark

Magnolia officinalis Rehd. et Wils

 

Manganese Gluconate

Marigold Flower (Zendu)

Marjoram

Marshmallow Root Ext 4:1

Melissa officinalis L. (Lemon Balm)

Mentha haplocalyx Briq

Mesua ferra Stamen (Nagkeshara)

Mexican Poppy Herb (Argemon mexicana)

Milk Thistle Seed Extract 80% silymarin

Momordica charantia (Bitter Melon)

Moringa oleifera (Shigru, Sahijan)

Motherwort Powder Extract  6.5:1

Mucuna pruriens

N-Acetyl L-Cysteine

Narcissus pseudonarcissus L.

Neem

Nettle Root

Niacin

Noni (Morinda citrifolia) Fruit

Nyctanthes arbortristis Leaf (Parijat, Harsingar)

Oenothera erythrosepala Borb

Olive Leaf Extract

Opuntia dillenii

Orange Peel

Orange Powder

Oregano

Oregon Grape Root Extract 4:1

Oroxylum indicum Root (Shyonak, Tetu)

Oroxylum indicum(L.)Vent

Orris, Indian Root (Pushkarmula)

Panax Ginseng Extract

Papaya Leaf

Parsley

Passion Flower Ext

Patchouli Leaf

Pepper, Long Fruit (Pippali)

Pepper, Long Root (Pippali)

Perilla frutescens(L.)Britt

Perilla Seed Extract

Periwinkle Herb (Sadaphuli)

Phellodendron amurense (Berberine HCl)

Phellodendron amurense Rup

Phosphatyl Serine 30%

Phyllanthus amarus Herb (Bhumyamalaki)

Phyllanthus emblica Fruit (Amalaki, Amla)

Picrorhiza kurroa Root (Katuka, Kutki)

Picrorhiza kurroa Root Extract

Pinus massoniana Lamb

Pinus massoniana Lamb

Piper betle Leaf (Nagvalli, Paan)

Piper Methysticum

Piper nigrum L.

Pistacia integerrima (Karkatshringi)

Plantain Flour

Pluchea lanceolata Root (Rasna)

Plumbago zeylanica Root (Chitrak)

Polygonum cuspidatum Root Extract 50%

Pomegranate Fruit Extract

Pomegranate Flower

Pongamia pinnata (Karanj)

Poppy Seed (Post Dana)

Potassium Sulfate

Potassium bicarbonate

Pregelatinized Starch

Premna integrifolia Root (Agnimantha)

Prune Skin Extract

Psoralea corylifolia Seed (Bakuchi, Bavchi)

Psyllium Husk (Isaphgula, Isabgol)

Pterocarpus marsupium Wood (Vijaysar)

Pueraria lobata (Willd.)

Pueraria Root Extract 40% Isoflavones

Pueraria tuberose Tuber (Vidari)

Pumpkin Seed Powder – Steam Treated

Punarnava Root (Boerhavia diffusa)

Punica granatum L.

Pyridoxine Hydrochloride

Quercetin Anhydrous Granular

Quercetin Anhydrous Powder GRAS

Quercetin Dihydrate

Quercetin Dihydrate Powder

Quercus infectoria (Mayaphal, Majuphal)

Randia dumetorum (Madanphal)

Raspberry Fruit Powder

Rauwolfia serpentine Root (Sarpagandha)

Red Clover Extract

Red Yeast Rice

Rhamnus purshiana

Rhodiola rosea

Rhus succedanea (Karkatshringi)

Riboflavin (Vitamin B2)

Rice Protein Hydrolysate

Rodiola Rosea 5%

Rose Petal (Shatpatri, Gulab)

Rosemary Ext 95%

Rosmarinus officinalis L.

Rublaceae.Corynant.Yohimbine

Rubus chingli Hu

Rue Herb (Ruta graveolens)

Ruscus aculeatus L.

Rutin

Safed Musli Root (Chlorophytum borivilium)

Safflower Seed

Salacia chinesis (Saptarangi)

Salix alba L.

Salvia Extract, 1% Dan Shen

Salvia Sclare L.

Sambucus williamsii Hance

Sappan Wood (Patang)

Saraca indica Bark (Ashok)

Sarperia (Rauwolfia serpentina)

Sarsaparilla, Indian (Anantmul)

Saw Palmetto Ext 45%

Schisandra chinensis(Turcz.)Baill

Scindapsus officinalis (Gajpippli)

Seabuckthorn (Hippophae rhamnoides)

Selenium

Semecarpus anacardinum Nut (Bhallatak)

Senna Leaf (Markandika, Sanai)

Serenoa repens (Saw palmetto)

Sesame Seed (Til)

Sesamum indicum L.

Shankhpushpi Herb (Convolvulus pluricaulis)

Shatavari Root (Asparagus racemosus)

Sheabutter officinalis

Shorea robusta (Raal)

Sida cordifolia Root (Bala)

Sida rhombifolia Root (Mahabala)

Silybum marianum(L.)gaertn

Sisymbrium officinale L.

Skullcap Root Extract

Soap Nut (Arishtak, Reetha)

Sodium Ascorbate Granular 99%

Sodium Copper Chlorophyllin

Solanum indicum Root (Brihati)

Solanum lycopersicum L

Solanum nigrum Root (Kakmachi)

Solanum xanthocarpum Fruit (Kantakari)

Sophora alopecuroides L.

Sophora japonica L.

Sophora subprostrata

Sorbus aucuparia L.

Soy Isoflavones

Spent Hops (Polyphenol Rich Hops Pellets)

Sphaeranthus indicus Herb (Mundi)

Spikenard, Indian Root (Jatamansi)

Spilanthes acmella Root (Akarkarbha)

Spirulina

St John’s Wort

Stereospermum suaveolens Root (Patala)

Stevia Leaf Extract (Rebaudioside A)

Strychnos potatorum (Nirmali)

Sunflower

Symplocos racemosus Stem (Lodhra)

Syzygium cumini Seed (Jambu, Jamun)

Tagetes erecta L. (Marigold)

Tamarind Fruit

Tamarindus indica L.

Tarragon (Artemisia dracunculus)

Taxus baccata L

Tea, Black

Terminalia arjuna Bark (Arjuna)

Terminalia bellerica Fruit (Bibhitaki, Baheda)

Terminalia chebula Fruit (Haritaki, Harde)

Thiamine Hydrochloride

Thyme

Thymus mongolicus Ronn

Tinospora cordifolia Stem (Guduchi, Amrita, Galo)

Trachycarpus fortunei(Hook.)H.Wendl)

Tribulus terrestris Fruit (Gokshur, Gokhru)

Trichosanthes cucumerina Root (Patol)

Trifolium pratense L.

Tulsi Leaf (Ocimum sanctum)

Turmeric (Curcuma longa) Root Extract

Turmeric Root Powder

Vaccinium myrtillus L.

Valerian Root ext 0.8%

Valeriana wallichi Root (Sugandha bala, Tagar)

Vanadium Citrate 0.5%

Vanilla Bean

Vasa, Adulsa Leaf (Adhatoda vasica)

Viola odorata Leaf (Banafsa)

Vitex negundo Herb (Nirgundi)

Vitex trifolia L.

Vitis vinifera L.

Voacango africana Stapf

Watercress Herb Ext. 4:1 Steam Treated (non irradiated)

Wheat Grass

White Willow Bark 15%

Withania somnifera (Ashwagandha)

Wormwood Plant Ext 5%, 8:1

Xylitol (Foods)

Zanthoxylum bungeanum Maxim

Zinc Chelate (Tasteless) 10%

Zinc Citrate 32%

Zingiber officinale Roscoe (Ginger) root

Ziziphus jujube

Here are ingredient of concern listed on FDA’s website:

Nootropic Supplement Product Development


Development of nootropic supplements as products supporting brain and cognitive health requires a focus on efficacy, quality and purity. Regulatory compliance and safety of ingredients for nootropics are key factors in developing formulas and products.

Facts on Nootropic Supplement Product Development:

  1. NaturPro Scientific assists in the development, sourcing, testing and production of nootropic ingredients and products.
  2. Focus, attention, memory and alertness are all clinical endpoints measured for nootropics.
  3. Nootropics may come in the form of capsules, powders, beverages, tea bags, tablets, liquids and even foods.
  4. Caffeine is one of the most widely consumed nootropics.
  5. Here’s an example of a proprietary Nootropic Tea Formula or NooTea.

What are Nootropics?

From Wikipedia:

Nootropics (pronunciation: /n.əˈtrɒpks/ noh-ə-trop-iks)—also called smart drugs or cognitive enhancers—are drugs, supplements, or other substances that improve cognitive function, particularly executive functions, memory, creativity, or motivation, in healthy individuals.[1][2] The use of cognition-enhancing drugs by healthy individuals in the absence of a medical indication is one of the most debated topics among neuroscientists, psychiatrists, and physicians which spans a number of issues, including the ethics and fairness of their use, concerns over adverse effects, and the diversion of prescription drugs for nonmedical uses, among others.[1][3][4] Nonetheless, the international sales of cognition-enhancing supplements exceeded US$1 billion in 2015 and the global demand for these compounds is still growing rapidly.[5]

The word nootropic was coined in 1972 by a Romanian psychologist and chemist, Corneliu E. Giurgea,[6][7] from the Greek words νους (nous), or “mind”, and τρέπειν (trepein), meaning to bend or turn.[8]

Nootropic Safety and Side Effects

Many ingredients used in nootropic supplements are synthetic substances not found in nature or our food supply. These may be considered unapproved drugs. Central nervous system stimulants and plant alkaloids are also areas of concern for safety, due to their impact on the brain. Many CNS stimulants are considered toxic to the liver and other organs. It is essential that nootropic ingredients are supported by safety studies and a long history of human use, in addition to GRAS (generally recognized as safe) or other suitable safety assessments as determined by regulations.

From Wikipedia: “The main concern with pharmaceutical drugs is adverse effects, and these concerns apply to cognitive-enhancing drugs as well. Long-term safety data is typically unavailable for some types of nootropics[9] (e.g., many non-pharmaceutical cognitive enhancers, newly developed pharmaceuticals and pharmaceuticals with short-term therapeutic use). Racetams—piracetam and other compounds that are structurally related to piracetam—have few serious adverse effects and low toxicity, but there is little evidence that they enhance cognition in individuals without cognitive impairments.[22][23] While addiction to stimulants is sometimes identified as a cause for concern,[24] a very large body of research on the therapeutic use of the “more addictive” psychostimulants indicate that addiction is fairly rare in therapeutic doses.[25][26][27] On their safety profile, a systematic review from June 2015 asserted, “evidence indicates that at low, clinically relevant doses, psychostimulants are devoid of the behavioral and neurochemical actions that define this class of drugs and instead act largely as cognitive enhancers.”[28]

In the United States dietary supplements may be marketed if the manufacturer can show that it can manufacture the supplement safely, that the supplement is indeed generally recognized as safe, and if the manufacturer does not make any claims about the supplement’s use to treat or prevent any disease or condition; supplements that contain drugs or for which treatment or prevention claims are made are illegal under US law.”

Types of Nootropics (From Wikipedia):

Stimulants

Miscellaneous

  • l-Theanine – A 2014 systematic review and meta-analysis found that concurrent caffeine and l-theanine use has synergistic psychoactive effects that promote alertness, attention, and task switching;[43] these effects are most pronounced during the first hour post-dose.[43]
  • Tolcapone – a systematic review noted that it improves verbal episodic memory and episodic memory encoding.[44]
  • Levodopa – a systematic review noted that it improves verbal episodic memory and episodic memory encoding.[44]
  • Atomoxetine – can improve working memory and aspects of attention when used at an optimal dose.[33]

Dietary supplements

  • Bacopa monnieri – A herb sold as a dietary supplement. There is some preliminary evidence for memory-enhancing effects.[45]
  • Panax ginseng – A review by the Cochrane Collaboration concluded that “there is a lack of convincing evidence to show a cognitive enhancing effect of Panax ginseng in healthy participants and no high quality evidence about its efficacy in patients with dementia.”[46] According to the National Center for Complementary and Integrative Health “Although Asian ginseng has been widely studied for a variety of uses, research results to date do not conclusively support health claims associated with the herb.”[47] According to a review published in the journal “Advances in Nutrition”, multiple RCTs in healthy volunteers have indicated increases in accuracy of memory, speed in performing attention tasks and improvement in performing difficult mental arithmetic tasks, as well as reduction in fatigue and improvement in mood.[48]
  • Ginkgo biloba – An extract of Ginkgo biloba leaf (GBE) is marketed in dietary supplement form with claims it can enhance cognitive function in people without known cognitive problems. Studies have failed to find such effects on memory or attention in healthy people.[49][50]

Racetams

Racetams, such as piracetam, oxiracetam, and aniracetam, are structurally similar compounds, which are often marketed as cognitive enhancers and sold over-the-counter. Racetams are often referred to as nootropics, but this property of the drug class is not well established.[51] The racetams have poorly understood mechanisms of action; however, piracetam and aniracetam are known to act as positive allosteric modulators of AMPA receptors and appear to modulate cholinergic systems.[52]

According to the US Food and Drug Administration, “Piracetam is not a vitamin, mineral, amino acid, herb or other botanical, or dietary substance for use by man to supplement the diet by increasing the total dietary intake. Further, piracetam is not a concentrate, metabolite, constituent, extract or combination of any such dietary ingredient. […] Accordingly, these products are drugs, under section 201(g)(1)(C) of the Act, 21 U.S.C. § 321(g)(1)(C), because they are not foods and they are intended to affect the structure or any function of the body. Moreover, these products are new drugs as defined by section 201(p) of the Act, 21 U.S.C. § 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling.”[53]

Null findings in systematic reviews

  • Omega-3 fatty acids: DHA and EPA – two Cochrane Collaboration reviews on the use of supplemental omega-3 fatty acids for ADHD and learning disorders conclude that there is limited evidence of treatment benefits for either disorder.[54][55] Two other systematic reviews noted no cognition-enhancing effects in the general population or middle-aged and older adults.[56][57]
  • B vitamins – no cognition-enhancing effects in middle-aged and older adults.[57]
  • Vitamin E – no cognition-enhancing effects in middle-aged and older adults.[57]
  • Pramipexole – no significant cognition-enhancing effects in healthy individuals.[44]
  • Guanfacine – no significant cognition-enhancing effects in healthy individuals.[44]
  • Clonidine – no significant cognition-enhancing effects in healthy individuals.[44]
  • Ampakines – no significant cognition-enhancing effects in healthy individuals.[44]
  • Fexofenadine – no significant cognition-enhancing effects in healthy individuals.[44]
  • Salvia officinalis – Although some evidence is suggestive of cognition benefits, the study quality is so poor that no conclusions can be drawn from it.[58]

Natural Product Formulation and Development


Formulating a health product, whether dietary supplement or food, is a lot more than just picturing a combination of ingredients that go well together.

NaturPro can manage all or parts of the process for natural product formulation and development — from seed to shelf — for dietary supplement and health food products.

 Top 10 Product Development Tools:  Product development requires a ‘toolbox’ of analysis including the following

  1. Financial (costing, budgets, pricing, inventory requirements, profitability)
  2. Regulatory status and safety assessment
  3. Market analysis, positioning & competitive forces.
  4. Ingredient Readiness, supplier verification, availability, quality and cost
  5. GMP’s, specifications, and analytical testing
  6. Clinical substantiation and claims
  7. Intellectual property development and freedom to operate
  8. Distribution channel & sales
  9. Manufacturability and shelf stability
  10. Contract manufacturer advocacy: qualification, negotiation and management

 

 

Food and Supplement Claims with Confidence


Labeling laws and truthful claims are not just critical for protecting the consumer, and they also ensure a level playing field for participants. Even during times of stalled regulatory clarity and enforcement, there is still the ‘golden rule’: do unto others by ensuring product labels are truthful and not misleading.

As we know in this era of alternative facts, it’s easy to make a claim, but harder to verify it with facts and science. (Go science.) But science has a problem. Even when fully developed, it rarely provides the full 100% confidence that may be required to change beliefs and opinions. (Boo, science.)

First example: identity claims. Many are aware that the identity of dietary ingredients need to be stated on the product label, and the specification. What is often missed is that verification through analytical tests to confirm identity are required on every batch of dietary ingredients – a minimum requirement under GMP.

Unfortunately, many identity methods miss the mark for validity and fitness for purpose – also a minimum requirement under GMP which tends to be overlooked. But if an ID method does not detect the presence or absence of common adulterants for a particular material, then how is it meeting the minimum requirement? How is it considered suitable for its purpose? In most cases, more work is needed: an adulterants review, developing and adopting multiple methods that determine a material’s identity, and adequate supplier qualification are all keys to providing a more reliable assurance of identity. The ‘totality’ approach to assuring identity is especially helpful when non-specific or indirect measures are used, like those based on infrared spectroscopy or thin layer chromatography.

Health claims also require scientific evidence. (Go science.) Here the standards are more clear, but not without some confusion. It is pretty clear that the U.S. scientific establishment plus judge and jury has decided that animal data, anecdotes and traditional use are not scientific, and therefore are not sufficient evidence to support a health claim. Past that, there’s some gaps in minimum requirements, and ask ten experts to get ten opinions (One or two studies? Published or not?). But most agree that well-designed human studies, with differences in treatment versus control groups different to more than a 95% confidence limit (known as p<0.05) are the path to health claims substantiation. This arbitrary statistical cutoff can be criticized, too, because when p=0.051 (a confidence of 94.9%), a product is deemed no more effective than placebo. The difference is the line between effective supplement and worthless snake oil. This confuses even most scientists, but it does set a pass/fail that can be evenly applied.

Science is becoming increasingly useful in the verification of content claims. Now that analytical tools can quantify at picomolar concentrations, almost down to the molecule, content claims can be powerful and truthful if investments are made in developing and verifying them. On the other hand, content claims are increasingly policed by consumer groups and class action attorneys, so a failure to verify content claims can be painful. In one recent example, the kombucha tea industry has been hit hard by a series of settlements involving mislabeling of alcohol, sugar and antioxidant content, and exploding bottles. Debate over which test methods were suitable for ethanol (one of the most frequently analyzed substances) led to an industry-wide effort to validate a method specific for kombucha. The validation in kombucha compositions was the last step required in order to rule out the slim possibility that kombucha contained unique matrix interferences that could make it difficult to measure with reliability. As a participant in the project, validation results from our partner laboratories showed a GC-FID method commonly used for ethanol in foods and beverages was indeed fit for purpose. After approval by the AOAC scientific expert review panel, the method is now becoming adopted by the kombucha industry as a standard method.

While not all methods require this kind of validation, the process is the key part to pay attention to. First you need to verify the test method. Then you verify the product against the claim you want to use, with the verified test method. Then you can put the claim on your label. In that order.

Here’s another catch about claims: your evidence is only so good as it verifies the claim. Picture an ingredient made on the same manufacturing line as a common allergen. Is a test report and supplier checklist from last year sufficient on its own to prove that a new shipment you just received is allergen-free? Maybe, maybe not. The best test method in the world will not make up for a lack in understanding whether you should reasonably expect the same results with the new lot as you did before. Verification is not just about testing.

Regardless, for those who are interested in verifying label claims, hopefully we can all agree that there should be rules, and the same rules should apply to everyone. What should also be agreed is that whether claims are truthful and misleading should be based on science and facts, not beliefs and opinions. Go, science!

 

By: Blake Ebersole

Published in Natural Products Insider, 2017

 

Historical Food and Supplement Adulterant List


Historical Food and Supplement Adulterant List

Adulteration of food and agricultural materials has a long history. Below is a list in-progress of references citing adulteration of food and dietary ingredients in recent times (publications in the past ~30 years).  The intent of this list to promote awareness for historical adulterants in natural products. NOTE: This list is for comprehensive and historical reference only.

Access Historical Food and Supplement Adulterant List

New Omega-3 Technologies Evolving


Emerging sources and technologies for omega-3, omega-6 and healthy fats:

We didn’t need to add butter to coffee to demonstrate the importance of fats as energy in the diet, but maybe it helped. The concept that there are healthy fats other than omega-3’s and 6’s may present a challenge to market growth. Fortunately, the quality problems that plagued the sector for years have moved on. We no longer need to worry how to clean up fish oil, and make it taste like key lime pie.  But where to go from here?

Hopefully the benefits of omega-3’s will continue to be found from the hundreds of clinical studies in progress.  But no dietary ingredient exists in a vacuum, and there are ways to further optimize omega-3’s beyond the old standbys.  For example, phospholipids naturally present in krill oil have been shown to increase the absorption of DHA, allowing for a lower dose substantiated for phospholipid-rich krill oil. This is nature’s way of optimizing absorption. Both phospholipids and omega-3 are stored in cell membranes, where they serve similar roles.  It is reasonable to think there might be a benefit to consuming both together, beyond the increased bioavailability. Are there better optimized combinations of phospholipids and cofactors which closer represent the nutrient profile of salmon, and may be even more beneficial?  Perhaps.

Meanwhile, man continues to create products based on nature, inspired by milk emulsions and small intestine micelles, developing ways that (at least theoretically) increase the body’s ability to assimilate nutrients.  But some caution is to be given with the re-emergence of New Dietary Ingredient guidance. If NDI’s are to be taken literally, any dietary ingredient having a different composition than one marketed before 1994 requires a notification to FDA. So, it’s probably a good idea to start putting together the safety assessments that will be required for omega-3 ingredients and technologies that were not around before 1994.

Back to the clinicals. In addition to the hundreds already published, there are more than 250 clinical trials listed on clinicaltrials.gov for omega-3, which are just getting started.  You name the health condition and it’s probably represented.  Add on the current study conducted by the U.S. Army, to determine if krill oil improves cognitive performance of soldiers. Out of all the supplements (and likely drugs) possible for a study like this, omega-3’s were selected.  With all this interest, there must be some evidence that the stuff works.

For product development, in case a high-quality omega-3 source is not sexy enough on it’s own, the literature is abound with examples of combinations of omegas with other nutrients.  DHA with EPA and GLA have led to improvements in multiple studies on people with cognitive impairment.  Look for the cannabis craze to result in combinations of hemp seed oil, rich in both omega-6, to be balanced with omega-3 sources like flax and krill. And stearidonic acid (18:4 n-3) from echium and Buglossoides arvensis may be a cofactor to help improve absorption of DHA and other omega-3’s.

Combinations of omega-3 with ingredients that are not necessarily fat soluble may be trending. In a 2014 placebo-controlled study, a probiotic blend and omega-3 combination increased HDL and lowered insulin resistance better than either alone.  The addition of Vitamin E and C to DHA has been researched in clinical trials, and several studies have observed the benefits of statins with omega-3.  Omega-3 blood levels may also affect whether B-vitamins can slow the brain’s decline during aging.  And their addition with Vitamin D has been shown to improve symptoms in people with mental illness. So there is some basis to believe omega-3’s are able to potentiate the effects of both water-soluble and fat-soluble nutrients, likely in different ways.

Our understanding of the relationships between PUFA, fat metabolism and inflammation has created many connections with pathways regulated by other nutrients. Thinking in terms of focused nutrition, a combination of omega-3’s with other sources of healthy fats such as MCT, at a certain dose and balance could provide optimal brain nutrition for certain people.   The addition of other cofactors along the arachidonic acid and inflammatory pathways, in addition to mediators along the endocannabinoid pathways may provide systemic support for the pathways which rely on a steady stream of fatty acids as signaling molecules.

New sources of omega-3 are likely to pop up as they always have. Perilla, new types of microalgae, and plants like canola bred to produce greater amounts of omega fatty acids are in the pipeline.  And a few consumer product categories are starting to emerge as opportunities for fortification with omega-3. Meal replacement powders and liquids are beginning to see omegas being added successfully, benefitting from new powdering and emulsion technologies.  The infusion of omega-3 into food products like eggs, chickens and even prepared foods has been achieved through integration of DHA-rich algae or flaxseed into animal feed.  Thanks to long-term and growing interest, the omega-3 rich products of today don’t look or taste anything like grandmother’s cod liver oil, but are just as healthy.

By: Blake Ebersole

First published in Natural Products Insider, October 2016

References

  1. http://www.hindawi.com/journals/mi/2014/348959/tab1/
  2. http://www.eurekalert.org/pub_releases/2014-05/bawh-nss050114.php
  3. http://www.ncbi.nlm.nih.gov/pubmed/12837515
  4. http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1676-26492011000400007
  5. http://content.iospress.com/articles/journal-of-alzheimers-disease/jad150777
  6. http://www.hindawi.com/journals/ije/2013/361895/
  7. https://www.army.mil/article/172714/omega_3_study_aims_to_give_soldiers_a_cognitive_advantage
  8. http://www.foodingredientsfirst.com/news/Waitrose-Launch-Omega-3-Rich-Chicken-As-Alternative-To-Unpopular-Oily-Fish.html
  9. http://www.fasebj.org/content/26/1_Supplement/125.6
  10. http://www.ncbi.nlm.nih.gov/pubmed/26793308

Opportunities to Improve Cannabis Dosing and Quality


The safety and history of cannabis consumption for food and medicine is unparalleled as a natural product. Combined with the Internet of cannabis anecdotal evidence, it’s hard to think of something so well-researched, but so poorly understood.

IMG_0893

The science on both the positives and negatives of cannabis is solid and growing. A Medline search for “cannabis” lists 14,000 studies, including 814 clinical trials. In a 2015 JAMA meta-analysis of 37 high-quality clinical trials on cannabis totaling 2,563 subjects, the eight trials which measured its effects on pain found it “very effective.” Evidence of cannabis’s benefits for nausea and vomiting was also found in three clinical trials, mirroring its use in folk medicines for ages. Cannabis was also effective in well-designed human trials for spasticity in MS, improving appetite in HIV/AIDS and wasting diseases as well as ocular pressure in glaucoma.

Regardless, most cannabis patients don’t need a meta-analysis to believe in the relief their medicine gives them. Like it or not, for so many people, cannabis improves physical, mental and emotional well-being during difficult or terminal health issues. And its recreational use by normal, healthy people is overall a low public health risk compared to alternatives like alcohol. Thus, many believe access to high-quality cannabis products for both medical and recreational use should not be out of reach.

However, the usefulness of cannabinoids is often limited by its side effect profile. Adverse events noted in a small percent of subjects consuming high-THC cannabis included dizziness, dry mouth, fatigue, euphoria, disorientation, drowsiness, confusion, loss of balance, and hallucination. The use of high-THC products can be habit-forming, and it remains unclear whether they are beneficial or harmful for people with schizophrenia.

The stigma and psychoactive effects of THC are no help for its adoption as medicine and as a dietary supplement. But many feel that a key reason preventing widespread medical adoption of cannabis is the lack of requirements to analyze and control dosage forms.

Laws in the states where cannabis is legal, and products developed in those markets, have attempted to control dosing better than before. Today, many believe that controlled dosage forms of cannabinoids, including cannabidiol (CBD) are required for any real progress to maximize cannabis’s health benefits.

Another area ripe for improvement is in the analysis of product purity (and impurities). In the states, although all cannabis products are required to list test results from an approved lab on all product labels (representing a step up on food and supplement requirements), the reliability of these test results are in question. In a JAMAcommunication recently published, 75 products from California, Colorado, and Washington State were tested for cannabinoid content. Not surprisingly, 60 percent of products contained less THC than listed on the label, based on strict tolerance limits of +/- 10%.

The cannabis experiment is leading to vibrant debate and rapid change, setting the stage for what is to come. Although many unanswered questions remain, we are starting to see the future of a natural, safe and effective health product that adheres to strict yet sensible standards.

References:
1. JAMA. 2015 Jun 23-30;313(24):2456-73.
2. PMID: 23685330, 23307069, 23042808, 21307846, 22716148

By: Blake Ebersole

This article was previous published by Natural Products Insider in October 2015

Education on Lab and Method Qualification at Supplyside


There are thousands of variations of analytical methods used for natural products.  Not all of them are fit for purpose, failing to meet a central requirement for dietary supplement cGMP’s.

Access slides on Lab and Method Qualification

Identity methods for botanical products are especially problematic, as demonstrated by the mass confusion set off by the NY A.G.

And manufacturers and contract labs are stuck in the middle of a supply chain that can lack an understanding of the source or processing method, which are important factors for labs to determine appropriate methods.

The talk presents challenges and best practices for method selection and validation against established guidance from AOAC International. A process for lab qualification, method development and ‘red flags’ will also be presented.

When: October 5, 2016

Where: Supplyside West at the Mandalay Bay Conference Center

Access the slides here

NaturPro Supports AOAC Official Method for Ethanol in Kombucha


NaturPro Scientific presented method validation data leading to a unanimous vote for adoption of first action Official Method status at the 130th Annual Meeting of AOAC International, September 18-21, 2016.

The Official Method status is thought to be the first method to demonstrate scientific validity for ethanol in kombucha under peer review, and is the result of a truth-in-labeling initiative supported by industry.

Kombucha is a fermented tea marketed for probiotic properties, which is expected to continue 25% yearly growth, to nearly $2 billion by the year 2020.

The validation data has been submitted to the Journal of AOAC for publication.

A preliminary validation study, including data from multiple laboratories, is available here. 

NDI, GRAS and Supplement Safety Assessment


The objective of NDI and GRAS  for supplements and foods is to provide a baseline evaluation of the safety aspects of an ingredient.

FDA issued draft guidance on the NDI and final guidance on the updated GRAS requirement in August 2016. The guidances are likely to require a significant amount of information related to safety and quality of dietary ingredients to be compiled and evaluated by scientific experts.

Four Steps to Compliance:

1. Determine the most likely regulatory status of your ingredient:  ODI, NDI, GRAS or other based on a preliminary review of regulatory status and toxicology data.
2. Compile a master file of all your safety and quality documents supporting the new CFR 117 and the new FDA guidances. Most master files are more than a hundred pages long, including references.
3. Have the master file reviewed for gaps according to the regulatory status. Perform a risk assessment to safety, quality or brand presented from the analysis.
4. Chart a plan of action to meet the requirements.
Toxicology and safety studies are expensive to conduct, so you need to know if your ingredients need to go through the new GRAS Notification process, require a NDI Notification, and also carry any specific risk for adulteration or contamination. Take care of these elements, and you can be fairly sure that you will not be blind sided by regulators, consumers, or class action attorneys.

A pre-assessment is typically conducted quickly to determine the appropriate strategy and level of risk.  Contact us to determine the best strategy for you.

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For more detail, here is a framework of basic requirements for a safety assessment

  1. Clinical, Medicinal and Food Use 
    1. In country to market
    2. Global
  2. Regulatory Status
    1. ODI or NDI (if ingredient used for supplement)
    2. GRAS
    3. Other
  3. Toxicity Summary
    1. History of human consumption in foods/supplements including dosage amount and composition
    2. LD50/acute toxicity/chronic/subchronic toxicity studies
    3. Bioavailability and ADME
    4. Clinical trials
    5. Other (genotoxicity, carcinogenicity, reproductive toxicity etc)
    6. Case reports, AER and Drug Interaction Review
  4. Dietary Supplement Manufacturing Risk Review (or CMC, Chemistry/Manufacturing/Control)

    1. Chemical and Nutritional Characterization
      1. Literature review
      2. Specification, Certificate of Analysis, ID and contaminants
    2. Manufacturing Facility GMP evaluation (self-assessment and audits)
    3. Potential adulterants and their controls

Contact us for more information.