What are practitioner-only products?
& | vital.ly founder & Educator
3rd Nov, 2021Article

herbs

What are "practitioner-only-products"?

It can be confusing. Some "practitioner-only" brands are only available through qualified health care practitioners. Others seem to be available from eBay.

The idea behind the "practitioner-only" designation is simple. The majority of "practitioner-only" brands focus on producing higher quality, more potent products. Such products are manufactured to maximise impact and effectiveness, and therefore should only be accessed under the supervision of a qualified health professional.

Naturopaths and nutritionists for example, are trained in herbs and nutrients. They understand how the ingredients will affect you. Taking advice from a health professional on what products to take ensures safety risks are minimised and products are appropriate for your individual health needs.

This is not to say all "retail" products are inferior. When we provide examples below, this is simply to illustrate the fact "practitioner-only-products" are typically more effective, higher quality and should be taken with a specific context in mind.

Quality

What does this mean? Practitioner products are generally of a higher quality, and more potent, but how is this defined? Within both the broad retail and "practitioner only" categories, quality can vary significantly due to many factors including active ingredients, manufacturing methods, encapsulation, dosage, molecular weight, excipients used, conditions a plant is cultivated in and supporting evidence (1). To keep things simple we're going to focus on 3 key areas:

  • Ingredients
  • Bioavailability
  • Excipients

Ingredients 

Along with the importance of co-factors and ingredients being at a therapeutic dose, mineral absorption and bioavailability may be enhanced by the form the mineral comes in. Chelated minerals are minerals bound to a chelating agent which is designed to enhance their absorption in your body. An amino acid chelated mineral is a mineral (like calcium) that has been molecularly attached to an amino acid. Common amino acids used to make mineral chelates include aspartic acid, lysine and glycine. In general, animal studies indicate that chelated minerals are absorbed more effectively (5).

Bioavailability

Bioavailability is influenced by many factors from both the host (human) and from the supplement itself. Bioavailability refers to how efficiently your body can use a nutrient.  The commonly accepted definition of bioavailability is the proportion of the nutrient that is digested, absorbed and metabolised through normal pathways. 

It has also long been recognised that gut microbes contribute to the biosynthesis and bioavailability of vitamins and nutrients.  Maintaining a healthy gut is vitally important for proper nutrient synthesis and absorption as the gut microbiota synthesises certain vitamins and nutrients (2).

Bioavailability is also influenced by other factors including diet, nutrient concentration, nutritional status, health, and life-stage (3).

Excipients

Excipients selected for product formulation vary across the pharmaceutical and complementary medicine industries. The role of the excipient should not be underestimated, particularly when it comes to generic pharmaceuticals. A number of pharmaceutical excipients are known to have side effects or contraindications. For example, excipients may make up to 90% of a product formulation and may be synthetic or sourced from plants or animals (4).

Depending on the medication/supplement type, excipients may be nil to low. Powders and capsules generally require fewer excipients than tablets due to binding and coating ingredients required for a tablet.

Each excipient serves a specific purpose for the proper performance of the supplement dose and form, i.e. capsule, tablet, powder or liquid.

Effectiveness and accessibility 

As practitioner products are generally more potent, this lends itself to supervised use under the instruction of a qualified health professional. As such, practitioner only products are not as accessible to the general public. Indeed practitioner only products are designed specifically for dispensing by a healthcare professional in accordance with section 42AA of the Therapeutic Goods Act 1989 1.

1st comparison - retail (Brand A Calcium) vs practitioner-only (Brand B Calcium)

Ingredient types

Calcium supplements contain different kinds of calcium salts. Each salt contains varying amounts of elemental calcium. The most common calcium supplements are calcium carbonate (40% elemental calcium) or calcium citrate (21% elemental calcium).

More is not necessarily always best when it comes to certain nutrients. Calcium absorption is optimal when a person consumes no more than 500 mg at a time (6).

Absorbtion

The human body must be able to absorb calcium so that it is bioavailable and effective. An abnormally high calcium concentration can cause health problems and require medical treatment. Although dietary calcium is generally safe, excessive calcium does not provide extra bone protection.

Calcium Carbonate, also known as Chalk, Creta or CaCO3, consists of 40% Calcium and 60% Carbonic Acid.  It is derived from coral, limestone or marble and is the form of calcium present in egg shell, dolomite, and oyster shell.

Side effects

Calcium carbonate supplements tend to be cheaper, contain the highest amount of elemental calcium and is often associated with gastrointestinal side effects, including constipation, flatulence, and bloating. 92,000 adverse events have been recorded for calcium carbonate with the occurrence of constipation increased with calcium carbonate treatment (1,200 mg/d) in a 5-year, double-blind, placebo-controlled study (7).

Calcium carbonate requires more hydrochloric acid for its absorption than other forms of calcium and can also deplete the body's hydrochloric acid supplies. 

Studies have also shown, calcium carbonate and other preparations of calcium ( bone meal, dolomite) may contain contaminants such as lead, aluminium, arsenic, mercury and cadmium (8).

 

Retail Brand A Calcium

Practitioner-only Brand B Calcium

Form of calcium

Calcium carbonate

Calcium glycinate

Formula

Calcium carbonate 600 mg

Vitamin D3 500 IU 

 

Calcium glycinate dihydrate 838 mg equiv. calcium 150 mg

Menaquinone 7 (Vitamin K2) 30 μg

Cholecalciferol 2.5 μg equiv. vitamin D3 100 IU

Taurine 15 mg

Lysine hydrochloride 15 mg

Excipients

croscarmellose sodium  

dl-alpha-tocopherol     

hydrogenated soya oil

hydrolysed gelatin

macrogol 3350             

magnesium stearate

maize starch                

maltodextrin

polyvinyl alcohol         

purified talc 

silicon dioxide             

sucrose

sunset yellow FCF aluminium lake

titanium dioxide          

 

acacia
ascorbyl palmitate
carnauba wax
colloidal anhydrous silica

croscarmellose sodium

d-alpha-tocopherol
glycerol
guar gum
lecithin
magnesium stearate
maize starch
maltodextrin
pregelatinised maize starch

purified water
silicified microcrystalline cellulose

silicon dioxide
sucrose

Retail Brand A excipients

  • Sunset yellow FCF aluminium lake is a petroleum-derived orange azo dye. It’s full chemical name is disodium 2-hydroxy-1-(4-sulfonatophenylazo)naphthalene-6-sulfonate. It can be converted to the corresponding aluminium lake, leading to an additional exposure to aluminium (JECFA, 2004). Individuals generally sensitive to foods or other compounds may react at dose levels within the acceptable daily intake (ADI) (9).
  • Hydrogenated soybean oil. Hydrogenation removes the necessary essential fatty acids contained within the original oil. It is a process in which liquid unsaturated fat is turned into a solid fat by adding hydrogen, resulting in  a transfat. This process is often used to extend shelf life and save money. Transfats have been shown to increase the risk of coronary heart disease (10).

Practitioner-only Brand B ingredients & excipients:

  • Calcium glycinate
    • Glycine's small size and neutral charge make it ideal for facilitating the delivery of minerals within the body; increasing its ease of absorption (11).
    • The body efficiently absorbs individual amino acids and due to its neutral charge and small molecule size, glycine has been identified as a sufficiently small enough molecule to carry minerals into the cells.
    • This formulation has D3 which increases the amount of calcium that the intestines can absorb from food and is extracted from organic lichen. Vitamin K2 enables binding to the bone matrix. Taurine regulates intracellular calcium homeostasis ( prevent calcium overload).   Lysine enhances intestinal absorption of calcium and contributes to a positive calcium balance.
  • Colloidal anhydrous silica is produced synthetically from sodium silicate. It is used to allow powder to flow freely when tablets are processed.
  • Acacia is a complex polysaccharide and a pharmaceutical excipient obtained from plants of Acacia Senegal (L) or other species of Acacia. It is used as a suspending and emulsifying agent, as an adhesive and binder
  • Carnauba wax is used for tablet coatings and binding. It comes from the leaves of the Copernicia prunifera palm grown only in Brazil.

 

2nd comparison - retail (Brand A Vitamin D3 1000IU) vs practitioner-only (Brand B Vitamin D 1000IU)

Vitamin D3 is cholecalciferol and comes from animal-based sources.

 

Retail Brand A Vitamin D3 1000IU

Practitioner-only Brand B Vitamin D capsule 1000IU

Formula

colecalciferol .025 mg

Cholecalciferol 25 μg

Excipients

gelatin

glycerol

iron oxide black

iron oxide red

mixed (low-alpha type) tocopherols concentrate

purified water

soya oil

dl-alpha-tocopherol

gelatin

glycerol

purified water

rice bran oil

vegetable oil

Retail Brand A Vitamin D3 1000IU capsule (Retail) ingredients & excipients

  • Iron oxide black and red are inexpensive and durable pigments in paints, coatings and colored concretes. When used as a food coloring, it has E number 172. E172 contain nanosized particles. There is increasing concern that these nanoparticles could exert major adverse effects by accumulating in several organs rather than being metabolised. Research has identified that E172 food additives induce gastrotoxicity, hepatotoxicity and alterations in gut microbiota, with most evidence indicating that oxidative stress is the main mechanism of toxicity (12).

Practitioner-only Brand B Vitamin D capsule 1000IU (Practitioner only)

  • Gelatin is animal protein from cow or pig. Gelling agent used to assist coating the outside of capsules making them easier to swallow. The World Health Organisation (WHO) has ruled that gelatin has been transformed to such an extent from its original source, it is permissible for those with religious dietary restrictions (13).
  • Glycerol is a low glycaemic index sweetener and preservative with antimicrobial properties, and is a useful alternative to ethanol

How can I access “practitioner only products”? 

If you are not currently working with a healthcare professional, you can find a practitioner here.

References
1In Australia, the Therapeutic Goods Administration (TGA) regulates all vitamins for safety and quality. www.tga.gov.au
2Pressman P, Clemens RA, Hayes AW. Bioavailability of micronutrients obtained from supplements and food: A survey and case study of the polyphenols. Toxicology Research and Application. January 2017.
3Michael, Hambidge. (2010). Micronutrient Bioavailability: Dietary Reference Intakes and a Future Perspective. The American journal of clinical nutrition. 91. 1430S-1432S. 10.3945/ajcn.2010.28674B.
4Haywood, A., & Glass, B. (2011). Pharmaceutical excipients - where do we begin? Australian Prescriber, 34(4), 112–114.
5Goff JP. Invited review: Mineral absorption mechanisms, mineral interactions that affect acid-base and antioxidant status, and diet considerations to improve mineral status. J Dairy Sci. 2018 Apr;101(4):2763-2813. doi: 10.3168/jds.2017-13112. Epub 2018 Feb 4.
6U.S Department of Health & Human Services. National Institutes of Health. Dietary Supplement Facts Sheets. Calcium. [Internet]. 2021. [ cited 2021. September 5th]. Available from:https://ods.od.nih.gov/factsheets/Calcium-Consumer/
7Li K, Wang XF, Li DY, et al. The good, the bad, and the ugly of calcium supplementation: a review of calcium intake on human health. Clin Interv Aging. 2018;13:2443-2452. Published 2018 Nov 28.
8Roberts HJ. Potential toxicity due to dolomite and bonemeal. South Med J. 1983 May;76(5):556-9.
9J. König. Food colour additives of synthetic origin. Colour Additives for Foods and Beverages, 2015 2.2.2 Sunset Yellow
10Iqbal MP. Trans fatty acids - A risk factor for cardiovascular disease. Pak J Med Sci. 2014;30(1):194-197. doi:10.12669/pjms.301.4525
11Pérez-Torres I, María Zuniga-Munoz A, Guarner-Lans V. Beneficial effects of the amino acid glycine. Mini reviews in medicinal chemistry. 2017;17(1):15-32.
12Estefany I. Medina-Reyes, Carolina Rodríguez-Ibarra, Alejandro Déciga-Alcaraz, Daniel Díaz-Urbina, Yolanda I. Chirino, José Pedraza-Chaverri. Food additives containing nanoparticles induce gastrotoxicity, hepatotoxicity and alterations in animal behavior: The unknown role of oxidative stress. Food and Chemical Toxicology, Vol 146, 2020.
13World Health Organisation. Regional Office for the Eastern Mediterranean. 17th July 2001. http://www.immunize.org/talking-about-vaccines/porcine.pdf