Jeff Brown. Can you answer the following Quality Assurance questions? Thank you. Randall
Does your company meet the following quality assurance protocols (please answer each section with as much detail as you can spare):
(1) Monitor the production and manufacturing of product from processing and inspection, to encapsulation and packaging.
(2) Utilize manufacturing facilities that qualify to:
(a) Meet OTC pharmaceutical standards.
(b) Pass inspection by and receive certification as meeting NNFA(National Nutritional Foods Association) Good Manufacturing Practices, to ensure the purity and potency of every product.
(c) Demonstrate Intent: To verify the identity, potency and stability of the ingredients used in supplements as a key to establishing the integrity of the processing system. Please note that Assaying by formulation or piggybacking off a sub-contracted vendor's certificate of analysis does not always hold the sophistication needed to demonstrate due diligence.
3) In the case of herbal ingredients, is there oversight by your company (or it's contracted manufacturers) with the sourcing of their botanical ingredients:
(a) Monitoring of their growing, harvesting and processing procedures.
(b) Botanical processing protocols (ingredient composition) that assures "standardized herbal extracts" to guarantee potency and quality. Standardized extracts are comprised of measurable compounds that are responsible for positive health outcomes – the best of science applied to healing herbs. Where "standardization" is not supported by science, what are the highest industry standards for the production of the whole herb products that are adopted (what botanical standardization criteria).
(4) List or publish evidence showing that your manufactured end product (for sale to the public) has undergone clinical studies to validate it's effectiveness?
(5) Does product carry the USP or NF seal, thereby meeting the US Pharmacopoeia (USP) or National Formulary (NF) standards for that product. Among other things, these standards cover potency, minimum dosage, and purity from contamination.
(6) Does product carry the BioFIT trademark, thereby demonstrating that the product has passed biological assay testing, which means that it displays biochemical activity that is consistent with having the corresponding effect in the human body.
(7) Clearly define values for Dissolution and Bioavailability (absorption) of products?
--- Definition of Dissolution: Dissolution is the portion of an ingredient, usually expressed as a percentage, that dissolves in the human digestive tract, thereby making it available for absorption in the body.
--- Definition of Bioavailability: Bioavailability (absorption) is a measure of the digestibility of a dietary supplement into the bloodstream. Bioavailability is important because it indicates the degree to which consumption of a substance affects the level (status) of that substance in your body. A substance with poor bioavailability could have little or no impact and therefore provide no benefit.
--- The combined effect of dissolution and absorption determines how much of a consumed ingredient ends up in the bloodstream.
(8) Quality Assurance test methods per INA MVP methods (Institute for Nutraceutical Advancements).
(9) If your company lacks any of the above protocols, do you intend to pursue them in any form or fashion?
