Re:
Sabinsa's Bacopin 50%: I have been trying to get this back in stock for a month or so. I spoke with Sabinsa yesterday and was informed that their recent shipment is being inspected by FDA. Also, the US representative I am working with is going out of town for a week, so he won't be back in town until next week; so there may be more delays than expected. In the mean time, if you are just fiending Bacopa, I am sure AOR's or Jarrow's are both properly standardized. It doesn't have to be Sabinsa's Bacopa necessarily, but theirs is probably the best available. If you are interested in purchasing a generic Bacopa product, just check the COA (if you are buying a bulk powder) to see what company made it. If there is no company name on the Certificate of Analysis, who knows what it is, where it was made, or its purity. If there is a company name on the COA: ask that company how they ensure their product is standardized correctly. There is too much of a cash incentive for vendors to sell you crap; and if you don't test the product, you have no idea what you are ingesting.
Click below to see a Sabinsa COA:
http://nootropics.ip...-1117064084.jpgSabinsa's website:
http://www.sabinsa.com/There are many problems with the dietary supplement market. Current data suggests that
at least one third of the dietary supplements on the US market are not able to meet their label claim or are otherwise contaminated. Check
Consumerlab.com to see the latest independent testing results of dietary supplements on the US market. Sign up there and you will be amazed at how many so called "high quality" brands aren't able to deliver what they claim on the label; not to mention, many are contaminated with lead (or other heavy metals), which can dramatically lower intelligence. Having this market unregulated has advantages though...I can sell high quality products for pretty cheap because there are no significant barriers to entry of this market; and supplements do not require a prescription, like they do in the EU. Sabinsa is a worldwide company with many representatives in the European Union, and their ingredients are used in several regulated products in the EU. Sabinsa also has WHO (World Health Organization) and OU (Orthodox Union) Kosher certification on their whole operation.
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.
http://www.acsu.buff...etyefficacy.htmA study of ginseng products found tremendous variability, with as little as 12% and as much as 328% of the active ingredient in the bottle, compared to the information on the label
(Am J Clin Nutr. 2001. 73. 1101-1106)A study of 59 Echinacea products from retail stores analyzed by thin layer chromotography showed that 6 contained no measurable Echinacea and only 9 of the 21 preparations labelled as standardized extracts actually contained in the sample the content listed on the label. Overall, the assay results were consistent with the labelled content in only 31 of the 59 preparations
(Arch Intern Med. 2003. 163. 699-704). When the FDA announced in 2003 a proposed rule to establish good manufacturing practices for supplements, the FDA cited data that 5 of 18 soy and/or red clover supplements contained only 50-80% of the quantity of isoflavones stated on the label, and 8 of 25 probiotic products contained less than 1% of the live bacteria claimed on the label.
In 1998 the California Department of Health reported in a letter published in the New England Journal of Medicine that 32% of Asian patent medicines sold in that state contained undeclared pharmaceuticals or heavy metals, including ephedrine ( a stimulant), chlorpheniramine (an antihistamine), methyltestosterone (an anabolic steroid), phenacetin (a pain killer), lead, mercury, and arsenic
(N Engl J Med. 1998. 339. 847). A study in which 500 Asian patent medicines were screened for the presence of heavy metals and 134 drugs found that 10% were contaminated
(Bull Environ Contam Toxicol. 2000. 65. 112-119). A study in which all unique Ayurvedic herbal medicine products were purchased from all stores within 20 miles of Boston City Hall found that 14 of 70 products (20%) contained heavy metals and that if taken as recommended by the manufacturer, each of these 14 products could result in heavy metal intakes above published regulatory standards
(JAMA. 2004. 292. 2868-2873).Adulteration of imported Chinese dietary supplements sold in Japan is responsible for 622 cases of illness, 148 hospitalizations, and 3 deaths
(Report of the Japanese Ministry of Health, Labor, and Welfare. September 20, 2002). A 2002 Bastyr University study of 20 probiotic supplements found that 16 contained bacteria not listed on the label, 6 contained organisms that can make people sick, and 4 contained no live organisms.
PC-SPES was removed from the market in 2002 after it was determined that it was adulterated with the prescription blood thinner, warfarin.
http://www.acsu.buff...etyefficacy.htm
Edited by nootropikamil, 09 June 2006 - 04:32 PM.