All Funk's cited study suggests is that 300 mg "Bacopa" does not work. Or maybe just the combination of ginkgo and bacopa don't work together; or the dose of bacopa could be too low. Also -- they do not seem to mention what percent bacosides the bacopa was standardized to. Or how exactly it was standardized. Standardization is an major issue of concern for producers of botanical products -- and if the company does not state their methodology, it's a toss up if they got it right. That's why I prefer to use Sabinsa's products. As I may have mentioned before, they have World Health Organization (WHO) and OU (Orthodox Union Kosher) certification on their whole operation -- and are considered among the most respected producers of botanical products and specialty chemicals in the entire world.
Here is a link to the bacopin website:
http://www.bacopin.com/Once again, a commercial statment from their current president, Todd Norton.
What are the major problems with quality control facing the natural products industry?
Todd Norton, president, Sabinsa Corp.: One--the lack of generally accepted assay methods and reporting of active ingredient percentages. There is a significant problem in this industry with companies buying ingredients and relying solely on what is reported on the product certificate of analysis to assure quality. Some ingredients report an assay based on HPLC, and others report it based on UV or gravimetric or something else. Either way, the results are bound to differ. Take guggul extract, for example. Sabinsa offers a minimum 2.5 percent Guggulsterone Z&E content in our Gugulipid product, as shown in clinical studies to be responsible for therapeutic benefits. We measure our guggulsterone content by HPLC to be precise. We compete against other generic guggul extracts that claim to offer 10 percent guggulsterones, yet when pressed on the method of analysis used to determine this percentage, the answer is either by UV, or "I don't know." So, what levels of guggulsterone Z&E do they really contain? And what is it exactly that constitutes the 10 percent assay? Now let's fast forward to the retail shelf. If two guggul products are side by side and one claims 10 percent while the other claims 2.5 percent guggulsterones, assuming they are similarly priced, which one will the consumer likely buy? Some manufacturers, when seeking the higher potency listed on a competitor's label then feel compelled to modify their product also. Does anybody along the way ask the question whether the jump to a higher assay is practical, necessary or possible in the first place? Sadly, the matter is best summed up by a comment made by industry consultant Jay Jacobowitz: "It's remarkable that in our industry it is 'news' when potency matches label claims."
Two--the lack of substantiated agreement on what actives are responsible and in what percentages for certain health benefits in botanicals. Look no further than to the media-beating this industry took over St. John's wort not long ago. After all, as long as it's St. John's wort, it's all the same, isn't it?
And third--too much downward pressure on pricing. I am a firm believer that in most instances you get what you pay for. The trend toward constantly chasing the lowest price is taking an adverse toll on product quality. What is basically happening is the barriers to entry to be a supplier of ingredients keep getting lowered, yet industry manufacturers increasingly expect suppliers to provide more documentation, product testing and marketing support. This is an inverse relationship, and it only can last for so long before something gives.
My father worked in the poultry industry for nearly 20 years. His company adopted the following motto and I think it is appropriate: "The bitterness of poor quality will remain long after the sweetness of low price is forgotten." Sound words of wisdom for any industry, especially one professing to transform the "snake oil" persona that shows up repeatedly in the mass media. Quality, or the lack thereof, does come with a price. It is up to the industry to decide where they will pay.
What types of QC certifications do you hold?
Sabinsa is the sales and marketing arm for our manufacturing operation SAMI Labs Inc., which is located outside the United States. SAMI Labs recently obtained World Health Organization (WHO) certification for its manufacturing operations.
How did you determine whether to hold a QC certification, and what does it offer you and your customers in the marketplace?
Sabinsa has a number of agents worldwide that represent our product line, many of which are affiliated with the European Union. We felt that WHO certification would best serve our diverse customer base and be universally recognized in the major international markets where we have a presence.
What do you do to ensure the quality of the raw materials you supply?
People need to remember that we are dealing with plant products that can, and do, change depending on which region they come from and the season in which the are harvested. The Sabinsa/SAMI operation is 100 percent vertically integrated. In some instances we control the cultivation of certain botanicals, and go so far as to provide our farmers with the seedling plants to ensure the right species is grown. When purchasing raw materials from outside sources, such as small villages or collection groups, we have a procurement team that travels with a portable testing equipment to quickly assess the identity and potency. If further testing is required we send the materials to our lab in the corporate office. Based on these results we either purchase or we dont.
What types of tests do you conduct on raw materials, and how do you determine the testing methods used?
The first thing to do is confirm with an identity test, usually thin layer chromatography (TLC), that you have the correct species of plant. Once confirmed, and before production begins on any of our standardized extracts, we first determine the assay value of our starting material. From here we can determine if any modifications are required to our manufacturing process. The whole idea of a standardized botanical extract is to provide the same percentage of active constituents from batch to batch. Testing the finished material varies depending on what the product is standardized for. Wherever possible an HPLC method of analysis is recommended due to the high degree of accuracy and reproducibility it offers. This is a good method to use when you want to identify a specific compound. Some products, however, contain a mixture of compounds that provide the activity. The methods generally used for testing in these instances are UV spectrophotometry or gravimetric. These methods identify compounds that are similar in chemical structure, thereby giving a cumulative percentage of their presence in the material. The methodology used is a function what you are testing for in the product. There are also other sophisticated methods and equipment available that can test for things like residual solvents and pesticide levels.
Edited by nootropikamil, 18 May 2006 - 06:51 PM.
LongeCity
