Cognitive Function Products
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This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLAs) and labels for natural health product market authorization. It is not intended to be a comprehensive review of the medicinal ingredient.
Notes
- Text in parentheses is additional optional information which can be included on the PLA and product label at the applicant's discretion.
- The solidus (/) indicates that the terms and/or statements are synonymous. Either term or statement may be selected by the applicant.
Date
March 12, 2021
Proper name(s), Common name(s), Source information
Proper name(s) | Common name(s) | Source information | ||
---|---|---|---|---|
Source material(s) | Part(s) | Preparation(s) | ||
Anemone pulsatilla |
|
Anemone pulsatilla | Herb top | Dried1 |
Avena sativa |
|
Avena sativa | Seed | Dried |
Nepeta cataria |
|
Nepeta cataria | Herb top | Dried |
Matricaria chamomilla |
|
Matricaria chamomilla | Flower | Dried |
Panax quinquefolius |
|
Panax quinquefolius | Root | Dried |
Tilia cordata |
|
Tilia cordata | Flower | Dried |
Tilia platyphyllos |
|
Tilia platyphyllos | Flower | Dried |
Tilia x europaea |
|
Tilia x europaea | Flower | Dried |
Turnera diffusa | Damiana | Turnera diffusa |
|
Dried |
Withania somnifera |
|
Withania somnifera | Root | Dried |
References: Proper names: NHPID 2019; Common names: NHPID 2019; Source information: Bone 2003; Hoffman 2003; Bradley 1992; Williamson et al. 1988; BHP 1983; Remington and Wood 1918; BPC 1911.
1Do not use the fresh plant (Bone 2003; Hoffman 2003; Bradley 1992; BHP 1983).
Proper name(s) | Common name(s) | Source information | ||
---|---|---|---|---|
Source material(s) | Part(s) | Preparation(s) | ||
Eschscholzia californica | California poppy | Eschscholzia californica | Herb top | Dried |
Humulus lupulus |
|
Humulus lupulus | Strobile | Dried |
Hypericum perforatum |
|
Hypericum perforatum | Herb top | Dried |
|
|
Griffonia simplicifolia 1 | Seed | Dried |
Melissa officinalis |
|
Melissa officinalis | Herb top | Dried |
Passiflora incarnata |
|
Passiflora incarnata | Herb top | Dried |
Scutellaria lateriflora |
|
Scutellaria lateriflora | Herb top | Dried |
Stachys officinalis |
|
Stachys officinalis | Herb top | Dried |
Valeriana officinalis |
|
Valeriana officinalis |
|
Dried |
Withania somnifera |
|
Withania somnifera | Root | Dried |
References: Proper names: NHPID 2019; Common names: NHPID 2019; Source information: Hoffman 2003; Williamson et al. 1988.
1Isolate
Proper name(s) | Common name(s) | Source information | ||||
---|---|---|---|---|---|---|
Source ingredient(s) | Source material(s) | Organism group(s) | Part(s) | Preparation(s) | ||
(2R)-2-(Acetyloxy)-3-carboxy-N,N,N-trimethyl-1-propanaminium inner salt | Acetylcarnitine |
|
N/A | N/A | N/A | N/A |
Bacopa monnieri |
|
N/A | Bacopa monnieri | N/A | Herb top | Dried |
|
Choline alfoscerate | Choline alfoscerate1 | N/A | N/A | N/A | N/A |
Cod liver oil |
|
N/A | N/A |
|
Liver | N/A |
Eleutherococcus senticosus |
|
N/A | Eleutherococcus senticosus | N/A | Root | Dried |
Fish oil | Fish oil | N/A | N/A |
|
Whole | N/A |
Ginkgo biloba |
|
N/A | Ginkgo biloba | N/A | Leaf | N/A |
Panax ginseng |
|
N/A | Panax ginseng | N/A |
|
Dried |
Phosphatidylserine |
Phosphatidylserine |
N/A | Helianthus annuus 2 | N/A | Seed | N/A |
Phosphatidylserine-enriched soy lecithin1 | N/A | N/A | N/A | N/A | ||
Phosphatidylserine1 | N/A | N/A | N/A | N/A | ||
Rhodiola rosea |
|
N/A | Rhodiola rosea | N/A |
|
Dried |
Schizochytrium spp. | Schizochytrium Oil | N/A | Schizochytrium spp. | N/A | Whole | N/A |
References: Proper names: NHPID 2019; Common names: NHPID 2019; Source information: Yurko-Mauro et al. 2010; Calabrese et al. 2008; Bone 2003; De Jesus Moreno Moreno 2003; Parnetti et al. 2001; Barbagallo et al. 1994; Parnetti et al. 1993; Canal et al. 1991.
1Synthetic
2Isolate
Proper name(s) | Common name(s) | Source information | |||
---|---|---|---|---|---|
Source ingredient(s) | Source material(s) | Part(s) | Preparation(s) | ||
|
Caffeine |
|
N/A | N/A | N/A |
Ilex paraguariensis |
|
N/A | Ilex paraguariensis | Leaf | Dried |
Paullinia cupana | Guarana | N/A | Paullinia cupana | Seed | Dried |
References: Proper names: NHPID 2019; Common names: NHPID 2019; Source information: EMA 2013; ESCOP 2009; Bradley 2006; Kennedy et al. 2004; Taylor 2003; Barnes et al. 2002; BHP 1983.
1Synthetic
Proper name(s) | Common name(s) | Source information | |
---|---|---|---|
Source ingredient(s) | Preparation(s) | ||
|
|
|
N/A |
References: Proper names: NHPID 2019; Common names: NHPID 2019.
1Synthetic
Proper name(s) | Common name(s) | Source information | ||
---|---|---|---|---|
Source material(s) | Part(s) | Preparation(s) | ||
Bacopa monnieri |
|
Bacopa monnieri |
|
Dried |
Withania somnifera |
|
Withania somnifera | Root | Dried |
References: Proper names: NHPID 2019; Common names: NHPID 2019; Source information: Bone 2003; API 2001.
Proper name(s) | Common name(s) | Source information | |||
---|---|---|---|---|---|
Source ingredient(s) | Source material(s) | Part(s) | Preparation | ||
4-Aminobutanoic acid |
|
N/A | Lactobacillus hilgardii2 | Whole cell for biosynthesis | N/A |
4-Aminobutanoic acid1 | N/A | N/A | N/A | ||
|
L-Theanine |
N/A | Camellia sinensis2 | Leaf | N/A |
L-Theanine1 | N/A | N/A | N/A |
References: Proper names: NHPID 2019; Common names: NHPID 2019; Source information: Kanehira et al. 2011; Abdou et al. 2006; Yamakoshi et al. 2006.
1Synthetic
2Isolate
Proper name(s) | Common name(s) | Source information | ||
---|---|---|---|---|
Source material(s) | Part(s) | Preparation | ||
Asparagus racemosus |
|
Asparagus racemosus | Root | Dried |
Astragalus membranaceus |
|
Astragalus membranaceus | Root | Dried |
Eleutherococcus senticosus |
|
Eleutherococcus senticosus |
|
Dried |
Ganoderma lucidum |
|
Ganoderma lucidum |
|
Dried |
Glycyrrhiza glabra |
|
Glycyrrhiza glabra |
|
Dried |
Ocimum tenuiflorum |
|
Ocimum tenuiflorum | Leaf | Dried |
Panax ginseng |
|
Panax ginseng |
|
Dried |
Panax quinquefolius |
|
Panax quinquefolius | Root | Dried |
Rhodiola rosea |
|
Rhodiola rosea |
|
Dried |
Schisandra chinensis |
|
Schisandra chinensis | Fruit | Dried |
Tinospora cordifolia | Guduchi | Tinospora cordifolia | Stem | Dried |
Withania somnifera |
|
Withania somnifera |
|
Dried |
References: Proper names: NHPID 2019; Common names: NHPID 2019; Source information: Upton 2012; Winston and Kuhn 2008;Winston and Maimes 2007; WHO 2004; Bone 2003; Hoffman 2003; Thomsen 2002; Williamson 2002; Blumenthal et al. 2000; Upton 1999; WHO 1999; Bradley 1992; BHP 1983.
Route of Administration
Oral
Dosage Form(s)
This monograph excludes foods or food-like dosage forms as indicated in the Compendium of Monographs Guidance Document.
Acceptable dosage forms for any age category listed in this monograph for the specified route of administration are listed in the Compendium of Monographs Guidance Document.
Use(s) or Purpose(s) and Dose(s)
Note: Claims for traditional use must include the term "Herbal Medicine", "Traditional Chinese Medicine", or "Ayurveda".
Subpopulation(s)
Adults 18 years and older
Quantity(ies)
Refer to Tables 2.1 to 2.8. below.
Uses or Purposes1 | Medicinal Ingredients | Methods of preparation | Doses/day2 |
---|---|---|---|
(Traditionally) used in Herbal Medicine to help relieve restlessness and/or nervousness (nervine/calmative) |
Anemone pulsatilla (Pasqueflower) |
Dry, Powder, Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid extract) | 0.03-0.6 grams dried herb top, per day |
Non-Standardized Aqueous Extracts (Dry extract, Decoction, Infusion) | 0.1-0.9 grams dried herb top, per day | ||
Avena sativa (Oat) | Dry, Powder, Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid extract) | 0.6-20 grams dried seed, per day | |
Matricaria chamomilla (German chamomile) | Dry, Powder, Non-Standardized Extracts (Dry extract, Tincture, Fluid extract, Decoction, Infusion) | 1.5-24 grams dried flower, per day | |
Nepeta cataria (Catnip) | Dry, Powder, Non-Standardized Extracts (Dry extract, Tincture, Fluid extract, Decoction, Infusion) | 1.2-12 grams dried herb top, per day | |
Panax quinquefolius (American ginseng) | Dry, Powder, Non-Standardized Extracts (Dry extract, Tincture, Fluid extract, Decoction, Infusion) | 0.5-12 grams dried root, per day | |
Tilia cordata (Small-leaf linden) | Dry, Powder, Non-Standardized Extracts (Dry extract, Tincture, Fluid extract, Decoction, Infusion) | 1.5-12 grams dried flower, per day | |
Tilia platyphyllos (Large-leaf linden) | Dry, Powder, Non-Standardized Extracts (Dry extract, Tincture, Fluid extract, Decoction, Infusion) | 1.5-12 grams dried flower, per day | |
Tilia x europaea (European Linden) | Dry, Powder, Non-Standardized Extracts (Dry extract, Tincture, Fluid extract, Decoction, Infusion) | 1.5-12 grams dried flower, per day | |
Turnera diffusa (Damiana) | Dry, Powder, Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid extract) | 1.5-4 grams dried leaf/leaf and stem, per day | |
Traditionally used in Ayurveda to balance aggravated Vata (nervine) | Withania somnifera (Ashwagandha) | Dry, Powder, Non-Standardized Extracts (Dry extract, Tincture, Fluid extract, Decoction, Infusion) | 2-6 grams dried root, per day |
1References consulted for the uses or purposes: Bone 2003; Hoffman 2003; Ellingwood 1983; Felter and Lloyd 1983; Grieve 1971.
2References consulted for the doses: CNF 2012; Bone 2003; Hoffman 2003; Bradley 1992; Williamson et al. 1988; BHP 1983; Ellingwood 1983; Felter and Lloyd 1983; Remington and Wood 1918; BPC 1911.
Uses or Purposes1 | Medicinal Ingredients | Methods of preparation | Doses/day2 |
---|---|---|---|
(Traditionally) used in Herbal Medicine to help relieve restlessness and/or nervousness (calmative) |
Eschscholzia californica (California poppy) | Dry, Powder, Non-Standardized Extracts (Dry extract, Tincture, Fluid extract, Decoction, Infusion) | 0.2-3 grams dried herb top, per day |
Humulus lupulus (Hops) | Dry, Powder, Non-Standardized Extracts (Dry extract, Tincture, Fluid extract, Decoction, Infusion) | 0.5-6 grams dried strobile, per day | |
Melissa officinalis (Lemon balm) | Dry, Powder, Non-Standardized Extracts (Dry extract, Tincture, Fluid extract, Decoction, Infusion) | 0.4-13.5 grams dried herb top, per day | |
Passiflora incarnata (Passionflower) |
Dry, Powder, Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid extract) | 0.25-8 grams dried herb top, per day | |
Non-Standardized Aqueous Extracts (Dry extract, Decoction, Infusion) | 1-8 grams dried herb top, per day | ||
Scutellaria lateriflora (Skullcap) |
Dry, Powder, Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid extract) | 0.25-12 grams dried herb top, per day | |
Non-Standardized Aqueous Extracts (Dry extract, Decoction, Infusion) | 3-12 grams dried herb top, per day | ||
Stachys officinalis (Wood betony) | Dry, Powder, Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid extract) | 2-4 grams dried herb top, per day | |
(Traditionally) used in Herbal Medicine to help relieve restlessness and/or nervousness (calmative) | Hypericum perforatum (St. John's wort) | Dry, Powder, Non-Standardized Extracts (Dry extract, Tincture, Fluid extract, Decoction, Infusion) | 2-12.6 grams dried herb top, per day; Not to exceed 4.2 grams per single dose |
Used in Herbal Medicine to help relieve restlessness and/or nervousness (calmative) AND/OR (Used in Herbal Medicine to) help(s) relieve sleep disturbances associated with mood imbalance |
Hypericum perforatum (St. John's wort) | Standardized Extracts (Dry extract) | 600-1800 milligrams of extract, per day, standardized to 3-6% hyperforin and/or 0.12-0.28% hypericin; Not to exceed 600 milligrams of extract per single dose |
Used as a sleep aid/to help promote sleep | L-5-Hydroxytryptophan (L-5-HTP) | Isolate | 100-200 milligrams, per day |
(Traditionally) used in Herbal Medicine to relieve restlessness and/or nervousness (calmative) |
Valeriana officinalis (Valerian) |
Dry, Powder, Non-Standardized Extracts (Dry extract, Tincture, Fluid extract, Decoction, Infusion) | 0.3-12 grams dried root/root and rhizome, per day; Not to exceed 3.6 grams per single dose |
Standardized Extracts (Dry extract, Tincture, Fluid extract, Decoction, Infusion) | 0.3-12 grams of dried root/r root and rhizome, per day; Not to exceed 3.6 grams per single dose and:
|
||
Traditionally used in Ayurveda as a sleep aid and/or to balance aggravated Vata (nervine) | Withania somnifera (Ashwagandha) | Dry, Powder, Non-Standardized Extracts (Dry extract, Tincture, Fluid extract, Decoction, Infusion) | 2-6 grams dried root, per day |
1References consulted for the uses or purposes: Tobyn et al. 2010; Williamson et al. 1988.
2References consulted for the doses: Williamson et al. 1988.
Uses or Purposes1 | Medicinal Ingredients | Methods of preparation | Doses/day2 |
---|---|---|---|
Helps support cognitive health and/or brain function |
Acetylcarnitine | N/A | 1.5-4 grams, per day |
Bacopa monnieri (Bacopa) | Standardized Extracts (Dry extract) | 300 milligrams of extract, per day, standardized to 40-55% bacosides | |
Cod liver oil | Standardized fixed oil | 18 years: 0.77-3.7 grams Cod liver oil, per day And 100-1,258 milligrams EPA + DHA including at least 100 milligrams DHA, per day And 138-2,800 micrograms RAE (vitamin A), per day And 1.15-23.12 micrograms vitamin D3, per day 19 years and older: |
|
L-alpha-Glycerophosphorylcholine (Choline alfoscerate) | N/A | 1.2 grams, per day | |
Fish oil |
Standardized fixed oil |
18 years: 100-2,500 milligrams EPA and DHA including at least 100 milligrams DHA, per day |
|
19 years and older: 100-5,000 milligrams EPA and DHA including at least 100 milligrams DHA, per day |
|||
Phosphatidylserine | N/A | 300 milligrams, per day | |
Schizochytrium oil | Standardized fixed oil | 200-2,000 milligrams DHA, per day | |
Used in Herbal Medicine to help improve mental performance after periods of mental exertion | Eleutherococcus senticosus (Eleuthero) | Dry, Powder, Non-Standardized Extracts (Dry extract, Tincture, Fluid extract, Decoction, Infusion) | 0.91-6 grams dried root, per day |
Helps to enhance cognitive function and/or memory in adults | Ginkgo biloba (Ginkgo) | Standardized Extracts (Dry extract) | 80-240 milligrams of extract, per day (50:1; quantity crude equivalent 4 - 12 g of dried leaves) and:
|
(Used in Herbal Medicine to) help(s) support cognitive function and/or reduce mental fatigue (in cases of mental stress) |
Panax ginseng (Panax ginseng) |
Dry, Powder, Non-Standardized Extracts (Dry extract, Tincture, Fluid Extract, Decoction, Infusion) | 0.5-9 grams dried root/ rootlet, per day |
Standardized Extracts (Dry extract) | 200-600 milligrams of extract, per day; standardized to 4-7% total ginsenosides; Not to exceed 9 grams of dried root/rootlet, per day | ||
(Used in Herbal Medicine) (to) help(s) support cognitive function (such as mental focus and mental stamina) |
Rhodiola rosea (Rhodiola) |
Tincture | 1.2-1.8 grams of dried root/root and rhizome, per day |
Standardized Extracts (Dry extract) | 144-680 milligrams of extract, per day; Not to exceed 200 milligrams per single dose and:
|
1References consulted for the uses or purposes: Morgan and Stevens 2010; Yurko-Mauro et al. 2010; Calabrese et al. 2008; Malaguanera et al. 2008; De Jesus Moreno Moreno 2003; Parnetti et al. 2001; Stough et al. 2001; Thal et al. 2000; Barbagallo et al. 1994; Pettegrewet al. 1994; Parnetti et al. 1993; Sano et al. 1992; Canal et al. 1991; Spagnoli et al. 1991.
2References consulted for the doses: Jensen et al. 2010; Morgan and Stevens 2010; Quinn et al. 2010; Yurko-Mauro et al. 2010; Calabrese et al. 2008; Malaguanera et al. 2008; De Jesus Moreno Moreno 2003; Parnetti et al. 2001; Stough et al. 2001; Thal et al. 2000; Barbagallo et al. 1994; Pettegrewet al. 1994; Parnetti et al. 1993; Sano et al. 1992; Canal et al. 1991; Spagnoli et al. 1991.
Uses or Purposes1 | Medicinal Ingredients | Methods of preparation | Doses/day2 |
---|---|---|---|
Helps (temporarily) to promote alertness and wakefulness, and to enhance cognitive performance |
1,3,7-Trimethylxanthine (Caffeine) | N/A | 100-400 milligrams, per day; and 100-200 milligrams per single dose |
Ilex paraguariensis (Yerba mate) | Standardized Extracts (Dry extract, Tincture, Fluid extract, Decoction, Infusion) | Extract corresponding to a maximum Quantity Crude Equivalent of 6 grams dried leaf, per day and not exceeding 150 milligrams caffeine, per day; and providing 100-150 milligrams caffeine per single dose | |
Paullinia cupana (Guarana) | Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid extract) | Extract corresponding to a maximum Quantity Crude Equivalent of 3 grams dried seed, per day and not exceeding 200 milligrams caffeine per day; and providing 100-200 milligrams caffeine per single dose | |
Used in Herbal Medicine to help temporarily promote alertness and wakefulness, and to enhance cognitive performance |
Ilex paraguariensis (Yerba mate) |
Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid extract) | Extract corresponding to a Quantity Crude Equivalent of 3-6 grams dried leaf, per day and not exceeding 150 milligrams caffeine per day |
Standardized Aqueous Extracts (Dry extract, Decoction, Infusion) | Extract corresponding to a Quantity Crude Equivalent of 2-6 grams dried leaf, per day and not exceeding 150 milligrams caffeine per day | ||
Paullinia cupana (Guarana) | Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid extract) | Extract corresponding to a Quantity Crude Equivalent of 1-3 grams dried seed, per day and not exceeding 200 milligrams caffeine per day |
1References consulted for the uses or purposes: EMA 2013; EMA 2010; ESCOP 2009; Bradley 2006; Christopher et al. 2005; Kennedy al. 2004; Taylor 2003; Barnes et al. 2002; Kamimori et al. 2000; Zwyghuizen- Doorenbos et al. 1990.
2References consulted for the doses: Health Canada 2018; EMA 2013; Health Canada 2012; EMA 2010; ESCOP 2009; Bradley 2006; Taylor 2003.
Uses or Purposes1 | Medicinal Ingredients | Methods of preparation | Doses/day2 |
---|---|---|---|
Helps to decrease cognitive fatigue due to physically stressful situations (e.g. extended wakefulness, exposure to cold, excessive noise) | L-Tyrosine | N/A | 10-20 grams, per day; Not to exceed 10 grams per single dose |
1References consulted for the uses or purposes: Neri et al. 1995.
2References consulted for the doses: Mahoney et al. 2007.
Uses or Purposes1 | Medicinal Ingredients | Methods of preparation | Doses/day2 |
---|---|---|---|
Traditionally used in Ayurveda for memory enhancement |
Bacopa monnieri (Bacopa) | Dry, Powder, Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid extract) | 1-6.5 grams dried whole plant/herb top, per day |
Withania somnifera (Ashwagandha) | Dry, Powder, Non-Standardized Extracts (Dry extract, Tincture, Fluid extract, Decoction, Infusion) | 2-6 grams dried root, per day | |
Helps support memory | Bacopa monnieri (Bacopa) | Standardized Extracts (Dry extract) | 300 mg of extract, per day, standardized to 40- 55% bacosides |
1References consulted for the uses or purposes: Barbhaiya et al. 2008; Stough et al. 2008; Raghav et al. 2006; Murthy 2004; Roodenrys et al. 2002; API 2001.
2References consulted for the doses: Bone 2003; API 2001.
Uses or Purposes1 | Medicinal Ingredients | Methods of preparation | Doses/day2 |
---|---|---|---|
Helps to temporarily promote relaxation |
4-Aminobutanoic acid (GABA) | N/A | 50-3,000 milligrams, per day; Not to exceed 750 milligrams per single dose |
L-Theanine | N/A | 200-250 milligrams, per day |
1References consulted for the uses or purposes: Kanehira et al. 2011; Abdou et al. 2006.
2References consulted for the doses: Kanehira et al. 2011; Powers et al. 2007; Yamakoshi et al. 2006.
Uses or Purposes1 | Medicinal Ingredients | Methods of preparation | Doses/day2 |
---|---|---|---|
Used in Herbal Medicine as an Adaptogen to help increase energy and resistance to stress (e.g. in case of mental and physical fatigue related to stress) |
Asparagus racemosus (Shatavari) | Dry, Powder, Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid extract) | 2-6 grams dried root, per day |
Astragalus membranaceus (Astragalus) | Dry, Powder, Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid extract) | 2-4.8 grams dried root, per day | |
Eleutherococcus senticosus (Eleuthero) |
Dry, Powder, Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid extract) | 1-6 grams dried root/root and rhizome, per day | |
Non-Standardized Aqueous Extracts (Dry extract, Decoction, Infusion) | 2-3 grams dried root/root and rhizome, per day | ||
Ganoderma lucidum (Reishi) |
Dry, Powder, Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid extract) | 1.5-6 grams dried cultured mycelium/ fruiting body/mycelium, per day | |
Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid extract) | 1.5-6 grams of dried cultured mycelium/ fruiting body/mycelium, per day and not to exceed 40 % polysaccharides | ||
Decoction, Decoction concentrate | 3-15 grams dried cultured mycelium/ fruiting body/mycelium, per day | ||
Decoction Standardized, Decoction concentrate Standardized | 3-15 grams dried cultured mycelium/ fruiting body/mycelium, per day and not to exceed 40 % polysaccharides | ||
Glycyrrhiza glabra (Licorice) | Dry, Powder, Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid extract) | 0.6-6 grams dried root/root and stolon, per day | |
Ocimum tenuiflorum (Holy basil) |
Dry, Powder, Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid extract) | 2-3 grams dried leaf, per day | |
Non-Standardized Aqueous Extracts (Dry extract, Decoction, Infusion) | 4.2-28 grams dried leaf, per day | ||
Panax ginseng (Panax ginseng) |
Dry, Powder, Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid extract) | 0.5-3 grams dried root/rootlet, per day | |
Non-Standardized Aqueous Extracts (Dry extract, Decoction, Infusion) | 0.5-2 grams dried root/rootlet, per day | ||
Panax quinquefolius (American ginseng) |
Dry, Powder, Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid extract) | 1-3 grams dried root, per day | |
Non-Standardized Aqueous Extracts (Dry extract, Decoction, Infusion) | 6-9 grams dried root, per day; Not to exceed 3 grams per single dose | ||
Rhodiola rosea (Rhodiola) |
Non-Standardized Ethanolic Extracts (Dry extract) | 144-400 milligrams of dry extract and a Quantity Crude Equivalent (QCE) of 216-2,000 milligrams of dried root/root and rhizome, per day; Not to exceed 200 milligrams of dry extract and a QCE of 1 gram of dried root/root and rhizome, per single dose | |
Tincture | 1.2-1.8 grams of dried root/root and rhizome, per day | ||
Standardized Extracts (Dry extract) | 144-680 milligrams of extract, per day; Not to exceed 200 milligrams per single dose and:
|
||
Schisandra chinensis (Schisandra) |
Dry, Powder, Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid extract | 1.2-6 grams dried fruit, per day | |
Non-Standardized Aqueous Extracts (Dry extract, Decoction, Infusion) | 1.5-6 grams dried fruit, per day | ||
Tinospora cordifolia (Guduchi) |
Dry, Powder, Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid extract) | 0.9-3 grams dried stem, per day | |
Decoction, Decoction concentrate | 20-30 grams dried stem, per day | ||
Withania somnifera (Ashwagandha) | Dry, Powder, Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid extract | 2.5-6.5 grams dried root/whole plant, per day | |
(Used as an Adaptogen) (to) help(s) (to) temporarily relieve symptoms of stress (such as mental fatigue and sensation of weakness) |
Rhodiola rosea (Rhodiola) |
Non-Standardized Ethanolic Extracts (Dry extract) | 144-400 milligrams of dry extract and a Quantity Crude Equivalent (QCE) of 216-2,000 milligrams of dried root/root and rhizome, per day; Not to exceed 200 milligrams of dry extract and a QCE of 1 gram of dried root/root and rhizome, per single dose |
Tincture | 1.2-1.8 grams of dried root/root and rhizome, per day | ||
Standardized Extracts (Dry extract) | 144-680 milligrams of extract, per day; Not to exceed 200 milligrams per single dose and:
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Traditionally used in Ayurveda as Rasayana (rejuvenative tonic) | Asparagus racemosus (Shatavari) | Dry, Powder, Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid extract) | 3-6 grams dried root, per day |
1References consulted for the uses or purposes: Upton 2012; Winston and Maimes 2007; Mills and Bone 2005; API 2004; WHO 2004; Bone 2003; Hoffman 2003; Thomsen 2002; Williamson 2002; Blumenthal et al. 2000; Upton 1999; WHO 1999; Bradley 1992.
2References consulted for the doses: Upton 2012; Winston and Maimes 2007; Mills and Bone 2005; API 2004; WHO 2004; Bone 2003; Hoffman 2003; Thomsen 2002; Williamson 2002; Blumenthal et al. 2000; Upton 1999; WHO 1999; Bradley 1992.
Direction(s) for use
See Table 4 below.
Combination rules and restrictions
All medicinal ingredients included in this monograph may be combined across all groups, with the following restrictions:
Use or Purpose Restrictions
- A use or purpose statement is only acceptable if at least one medicinal ingredient associated with that statement is present at a dose at or above the minimum daily dose listed in Table 2.
- Medicinal ingredients which do not meet the minimum daily dose for a use or purpose statement will be considered as acceptable complementary medicinal ingredients in product formulations.
- Traditional claims: When traditional claim(s) is/are made, each traditional claim must be preceded with the medicinal ingredient(s) that support(s) it, unless it is a single medicinal ingredient product.
- If products contain caffeine (Group 4), sedative/relaxation claims are not permitted.
- If products contain sedatives (Group 2), alertness claims are not permitted.
Rules for Caffeine
- The maximum amount of total caffeine permitted from all ingredients in the product is 400 mg/day, and 200 mg per single dose.
- The maximum daily amount of caffeine permitted for each medicinal ingredient must be respected. Please see Table 2 above.
- If the total amount of caffeine provided by the combination of ingredients in the product (e.g. Yerba mate and Guarana) is equal to or higher than 100 mg/day, risk statements from the NNHPD Caffeine Monograph are required. Please see Table 4 below.
- Additional synthetic caffeine added to Guarana and/or Yerba mate extracts must be represented as a separate medicinal ingredient.
Rules for sedatives
- When combining L-5-HTP, St. John's Wort, and/or Passionflower, an additional risk statement is required. Please see Table 4 below.
- If ingredients are combined within Group 2 (Ingredients with sedative action), the sum of the percentages of the maximum daily reference dose must not exceed 100%, for all ingredients contributing to support the claim. Please see Table 3 below.
Additive Indication | Group 2 (e.g. Traditionally used in Herbal Medicine as a sleep aid) | ||
---|---|---|---|
Medicinal Ingredients | Maximum Daily Recommended Dose on PLA form | Maximum Daily Monograph Reference Dose | Percentage of the Maximum Daily Monograph Reference Dose (%) |
Eschscholzia californica (California poppy) | 0.5 g | 3 g | 0.5/3 = 16.67% |
Humulus lupulus (Hops) | 4 g | 6 g | 4/6 = 66.66% |
Hypericum perforatum (St John's wort) | 0.5 g | 12.6 g | 0.5/12.6 = 3.96% |
Sum of percentages | 87.3% |
The calculations are performed as follows:
- Percentage of the Maximum Daily Monograph Reference Dose = [(Maximum Daily Recommended Dose on PLA form) / (Maximum Daily Monograph Reference Dose)] x 100%
Safety assessment - Sum of Percentages:
- In the example above, the sum of Percentages of the Maximum Daily Monograph Reference Dose is 87.3%, which is less than 100%. Safety of the combination of ingredients is therefore supported.
Duration(s) of Use
See Table 4 below.
Risk Information
Consult Table 4 for appropriate statements related to each medicinal ingredient. The medicinal ingredients in Table 4 are associated with the required numbered statements below.
- As per the respective NNHPD monograph.
Duration(s) of Use
- Ayurvedic bacopa claim only: Use for at least 6 weeks to see beneficial effects.
- Products providing 300 mg or more GABA per day: Consult a health care practitioner/health care provider/health care professional/doctor/physician for use beyond 4 weeks.
Caution(s) and warning(s)
- Consult a health care practitioner/health care provider/health care professional/doctor/physician if symptoms persist or worsen.
- Consult a health care practitioner/health care provider/health care professional/doctor/physician prior to use if you are pregnant or breastfeeding.
- Consult a health care practitioner/health care provider/health care professional/doctor/physician prior to use if you are pregnant.
- Consult a health care practitioner/health care provider/health care professional/doctor/physician prior to use if you are breastfeeding.
- Stop use if you experience severe stomach and/or intestinal irritation.
- Do not use if you have gastrointestinal irritation.
- Consult a health care practitioner/health care provider/health care professional/doctor/physician prior to use if you have a urinary tract disorder and/or kidney disease.
- Consult a health care practitioner/health care provider/health care professional/doctor/physician prior to use if you have liver disease, kidney disease and/or a seizure disorder.
- Consult a health care practitioner/health care provider/health care professional/doctor/physician prior to use if you have high blood pressure.
- Products providing 300 mg or more GABA per day: Do not use with alcohol.
- Consult a health care practitioner/health care provider/health care professional/doctor/physician prior to use if you have glaucoma, and/or overactive bladder syndrome (detrusor instability).
- Avoid taking with health products or foods that contain caffeine and/or increase blood pressure (e.g. medications, coffee, tea, colas, cocoa, guarana, mate, bitter orange extract, synephrine, ocotopamine, ephedra, ephedrine).
- This product is not intended as a substitute for sleep.
- Combination of ingredients resulting in a total caffeine content of more than 300 mg per day: Consult a health care practitioner/health care provider/health care professional/doctor/physician prior to use if you are of childbearing age.
- Stop use and consult a health care practitioner/health care provider/health care professional/doctor/physician if you experience any of the following symptoms within a few hours after taking this product: changes in mental state such as restlessness or confusion, increased heart rate, enlarged pupils, loss of muscle coordination, sweating, shivering and/or gastrointestinal symptoms such as nausea, vomiting, diarrhea.
Contraindication(s)
- Do not use this product if you are pregnant or breastfeeding.
- Do not use this product if you are pregnant.
Known adverse reaction(s)
- May cause digestive problems.
Medicinal Ingredients | Risk Information | Durations of Use | Directions for use |
---|---|---|---|
1,3,7-Trimethylxanthine (Caffeine) | 1 | 1 | |
4-Aminobutanoic acid (GABA) | 4, 5, 13 | 3 | |
Acetyl-L-Carnitine (Acetylcarnitine) | 5, 11, 21 | ||
Asparagus racemosus (Shatavari) | 6 | ||
Astragalus membranaceus (Astragalus) | 1 | ||
Avena sativa (Oat) | 4 | ||
Bacopa monnieri (Bacopa) | 5, 21 | 2 | |
Cod liver oil | 1 | ||
Eleutherococcus senticosus (Eleuthero) | 1 | 1 | |
Eschscholzia californica (California poppy) | 1 | ||
Fish oil | 1 | ||
Ganoderma lucidum (Reishi) | 1 | 1 | |
Ginkgo biloba (Ginkgo) | 1 | 1 | |
Glycyrrhiza glabra (Licorice) | 1 | 1 | |
Humulus lupulus (Hops) | 1 | ||
Hypericum perforatum (St. John's wort) | 1 | 1 | |
Ilex paraguariensis (Yerba mate) | 5, 12 | ||
L-5-Hydroxytryptophan (L-5-HTP) | 1 | 1 | |
L-alpha-Glycerophosphorylcholine (Choline alfoscerate) | 5 | ||
L-Theanine | 1 | ||
L-Tyrosine | 1 | 1 | 1 |
Matricaria chamomilla (German chamomile) | 1 | ||
Melissa officinalis (Lemon balm) | 1 | ||
Nepeta cataria (Catnip) | 1 | ||
Ocimum tenuiflorum (Holy basil) | 1 | ||
Panax ginseng (Asian ginseng) | 1 | 1 | |
Panax quinquefolius (American ginseng) | 1 | ||
Passiflora incarnata (Passionflower) | 1 | ||
Paullinia cupana (Guarana) | 5, 12 | ||
Phosphatidylserine | 1 | ||
Anemone pulsatilla (Pasqueflower) | 4, 8, 9, 10, 19 | ||
Rhodiola rosea (Rhodiola) | 1 | ||
Schisandra chinensis (Schisandra) | 7, 20 | ||
Scutellaria lateriflora (Skullcap) | 1 | ||
Stachys officinalis (Wood Betony) | 4, 5 | ||
Tilia cordata (Small-leaf linden) | 1 | ||
Tilia platyphyllos ((Large-leaf linden)) | 1 | ||
Tilia x europaea (European linden) | 1 | ||
Tinospora cordifolia (Guduchi) | 5 | ||
Turnera diffusa (Damiana) | 4, 7, 20 | ||
Valeriana officinalis (Valerian) | 1 | ||
Withania somnifera (Ashwagandha) | 1 | ||
Combination of ingredients resulting in a total caffeine content of 100 mg/day or more (e.g. Yerba mate and Guarana) | as per the caffeine monograph | ||
Combination of two or more of the following ingredients: L-5-HTP, St John's Wort, and/or Passionflower | 18 |
References consulted: EMA 2013; Gardner and McGuffin 2013; Fiebich et al. 2011; AMR 2010; Morgan and Stevens 2010; Okun et al. 2010; ESCOP 2009; Calabrese et al. 2008; CPS 2008; Cornelis and El-Sohemy 2007; Powers et al. 2007; Bain et al.2006; Bradley 2006; Bui et al. 2006; Mills et al. 2006; Shils et al. 2006; Turner et al. 2006; Bouchard et al. 2005; Chandrasekaran et al. 2005; Haller et al. 2005; Noordzij et al. 2005; FDA 2004; Nathan et al. 2004; Bone 2003; Erner et al. 2003; Avisar et al. 2002; Barnes et al. 2002; Berardi et al. 2002; Thomsen 2002; Brinker 2001; Nathan et al. 2001; Stough et al. 2001; Arya et al. 2000; Vahedi et al. 2000; Jee et al. 1999; Mester et al. 1995; Bradley 1992; Zimmerman 1992; Creighton and Stanton 1990; Rai et al. 1990; FDA 1988; Jefferson 1988.
Non-medicinal ingredients
Must be chosen from the current Natural Health Products Ingredients Database (NHPID) and must meet the limitations outlined in the database.
Storage conditions
Products containing Cod liver oil, Fish oil or Schizochytrium oil
- Refrigerate after opening (except when encapsulated) (Senanayake and Fichtali 2006; Wille and Gonus 1989).
- Store in airtight container, protected from light (Ph.Eur. 2012; USP 35 2012).
Specifications
- The finished product specifications must be established in accordance with the requirements described in the Natural and Non-prescription Health Products Directorate (NNHPD) Quality of Natural Health Products Guide.
- The medicinal ingredient must comply with the requirements outlined in the NHPID.
- For the following ingredients please see the respective NNHPD monograph for additional quality requirements: Astragalus, American ginseng, Cod liver oil, Eleuthero, Fish oil, German chamomile-Oral, Gingko biloba, Hops, Licorice, Panax ginseng, St John's wort, L-Tyrosine, L-Theanine, Valerian.
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