Dr. Neale: ON SUPPLEMENTS

Dr Neale Heal with Dr. Neale

I get it. Really, I do. You may have been drawn in by the label and advertising. Claims of ORGANIC and 100% NATURAL does grab the eye. Or if Oprah or Dr. Oz showcase a product, forget about it, it gains some roots! A patient will ask “my opinion” on a product, “what’s your take on “fill in blank product?”  Well…

My immediate bias is that the product is probably “no good.” My bias is that it probably contains fillers, binders, synthetic vitamins, chemicals, in-active, non-absorbable, or incomplete forms of nutrients. It probably isn’t tested rigorously for reproducibility or constituent quality, or materials added aren’t acquired from a responsible/sustainable/certified source.

My ND-ness kicks in, too and I think that a product like this is born from a compilation of evidence-based constituents in isolated form. Then these isolated constituents are jam packed into one supplement to throw everything and the kitchen sink at the body to deliver “proven” results without actually taking the individual patient’s nutritional needs or digestive capacity or overall case into consideration. A one size fits all approach.

So, well before I even lay an eye on an ingredient label, I am ready to rip it apart. I recognize that this isn’t a neutral platform to evaluate a product from.

How does one truly critically evaluate a product on the spot? Though it’s taken me years to come to clarity around my answer to this question, my answer is definite. I – simply – cannot. And here’s why…

I love using herbs to facilitate movement in someone’s health. Herbal product manufacturing is complicated! [WARNING: serious supplement geeking out ahead.]

To quality.

US Current Good Manufacturing Practice (CGMP) for dietary supplement is vastly different from Australia’s Therapeutic Goods Administration (TGA) regulating body. The TGA’s standards are much more rigorous. All products made in Australia are produced at TGA-certified laboratories. Each product should have “quantified activity” testing to ensure consistent quality extracts with guaranteed minimum levels of active constituents. Only when all quality aspects of raw materials are confirmed should the product go to manufacturing.

To safety.

It is important that the manufacturer guards against substitution, adulteration and poor quality with strict testing regimes. The testing needs to evaluate herbs for species identity, plant part, color, aroma, texture, content of specified actives, microbial levels, amount of extraneous matter, pesticides and herbicides, heavy metals and aflatoxins. Every ingredient should go through thorough assessment for safety and toxicology.

To efficacy. 

We need products that are not only safe, but that are also efficacious and meet genuine health need. Herbal constituents and formulas should be studied to validate their efficacy through not only in vitro research, but also via clinical trials. These formulations should combine phytochemical, biochemical, clinical and traditional herbal knowledge to bring cutting-edge efficacy.

To manufacturing. 

After testing herbs need to be preserved in temperature controlled warehouses. The benchmark manufacturing process for producing the highest quality extracts is a method called 1:2 Cold Percolation. This process ensures that herbal constituents remain intact with only ethanol or purified water (or occasionally glycerol). Each herbal constituent requires different ethanol percentages for optimum extraction. Once the constituents are in liquid extraction there is an extensive process again using 1:2 Cold Percolation to evaporate the ethanol/water under vacuum. Heat and oxidation damage delicate herbal constituents. To make matters more complicated, each active constituent has it’s own optimal parameters for evaporation and drying. Each tablet batch should be tested for disintegration, friability, weight uniformity, and active constituents. The tablets should disintegrate in less than 30 mins for maximum efficacy.

To testing.

Herbs are naturally complex and not all are grown, harvested, dried, or stored in the same way. To manage the complexities of phytochemistry you need a team of scientists well trained in highly detailed testing to evaluate the product at various stages of manufacturing. Testing includes: High Performance Thin Layer Chromatography (HPTLC), Gas Chromatography (GC), Ultra High Performance Liquid Chromatography (UHPLC), Mass Spectrometry (MS), Ultraviolet/Visible Detector (UV-vis), and Fourier Transform Infrared Spectrometry (FTIR). These tests are used to ensure herbs are the correct species, plant part, have the active constituent profile and are free from contamination. For example, Golden Seal is a very expensive herb and has always been in short supply; thus it is commonly substituted with cheaper herbs that greatly affect efficacy. These cheaper species do not contain hydrastine; rather they contain only berberine and berberine related compounds. While Berberine is a potent antibacterial agent, it is hydrastine that is responsible for the trophorestorative effects of Golden Seal on mucous membranes. 

To research.

Product manufacturing should combine the best of science, traditional knowledge and current clinical knowledge to produce the most therapeutic herbal and nutritional solutions. Research is foundational in this journey. Manufacturing companies that employ those leaders and revolutionary minds pioneering herbal manufacturing are not only providing world class products, but they are advancing the medicine. For example, Echinacea! Echinacea is the most well known herbal support for the immune system, yet it is both misunderstood AND underestimated. There are MANY echinacea products available, which differ according to plant species, plant part, quality markers and dosage. Research that began in 2003 has now identified that lipophilic extracts of Echinacea are highest in alkylamides, the most desired active constituent. It was found that the root of Echinacea has the highest levels of alkylamides. The preferred species, Echinacea angustifolia and Echinacea purpurea have the highest levels of alkylamides. These alkylamides must be extracted using an alcohol percentage sufficiently high enough.

To innovation.

A new product development process should involve detailed examination of the clinical outcomes, phytochemistry and biological activity, analytical methodology, continuity of supply, economic sustainability, synergy of the final formula, and cost to the patient and practicality of final dose formulation. Clinical feedback trials involving a network of healthcare professionals should guide development and validation of new products.

To professional medicine.

Manufacturing companies should (in my opinion) show commitment to actively supporting natural health care professionals, those that are highly trained in prescribing herbal remedies.  They should invest in trials that fit a high standard of quality, innovative, and holistic herbal solutions, and the research should be conducted at a reputable research establishment. The company should regularly engage in professional seminars to advance the understanding and use of herbal products.

To ingredients. 

Manufacturing companies should assist growers with support on varietal selection, climactic and soil requirements, time of harvest, harvesting techniques, drying parameters and storage requirements. They should source organically grown and wild crafted herbs whenever feasible. They should work with growers to help cultivate endangered species and be able to think quickly on their feet to replace herbal constituents when species are under threat.

To sustainability. 

In addition to working with domestic large growers the manufacturing company should recognize the importance of supporting indigenous communities in quality and sustainability standards. Many communities depend on the the income of the herb crops for their well-being. Also the manufacturing company should employ a documented process to avoid using medicinal plants that are on the brink of becoming classified as endangered species. They should use a system to identify and classify the “threat” to particular herbs and once classified as such – steps should be taken immediately to find alternatives to overcome or reduce the threat. “Threatened” is not an official classification; rather it is determined by manufacturing companies based on information received from independent, reliable sources such as CITES (Convention on International Trade in Endangered Species of Wild Fauna and Flora), TRAFFIC (Wildlife Trade Monitoring Network) and United Plant Savers.