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The plight of the supplement industry - Poison in your pill

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 Posted 11/5/2013 11:53:09 AM
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No its not Transpower. 

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Post #10831
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 Posted 11/5/2013 1:23:00 PM
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1.  How many people have died taking supplements? [zero or very close to zero]

2.  How many people have died taking prescription drugs?  [thousands and thousands over the years]
Post #10832
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 Posted 11/5/2013 6:48:16 PM
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fastingly (11/5/2013)
Transpower (11/5/2013)
1.  How many people have died taking supplements? [zero or very close to zero]

2.  How many people have died taking prescription drugs?  [thousands and thousands over the years]




Which of these two industries has the most government regulation?

And additional government regulation benefits consumers how?



http://en.wikipedia.org/wiki/Regulatory_capture




Well this the problem. Whatever the original intentions were for the FDA it has lost it`s way. By the way the FOOD and DRUG ADMINISTRATION was in some important ways: NOT set up to protect people but rather to promote the interests of DRUG and FOOD producers. The author: Dr. Robin Cook MD has written extensively in his novels about all this. His novel " TOXIN " describes the meat industry for example. Read that book and you WILL be very concerned about eating HAMBURGER. The way hamburger is produced nowdays as many as 200 different animals meat is mixed together and dated meat is thrown in the mix so as not to lose money from meat that is no longer fit to legally sell. It is meat that is beyond it`s SELL BY date. And that the UNTREATABLE and ALWAYS FATAL mad cow disease is alive and NEVER reported on in the USA. That  is what the FDA has become. The Obama Admin. has done NOTHING I am aware of to improve any of this. He is off on some weird ARAB SPRING trip screwing up what little stability there was there in the middle east.   ...Oscar
Post #10835
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 Posted 11/6/2013 5:32:46 AM
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BHT is a supplement (a distant relative of vitamin E); it is not a prescription drug or poison.
Post #10837
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 Posted 11/6/2013 1:12:41 PM
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Life Extension has provided the following:

“DNA barcoding detects contamination and substitution in North American herbal products” A study published in the November issue of BMC Medicine journal raises the issue of quality in dietary supplements. In this study, researchers from the University of Guelph found that 33 of 44 herbal products tested were found to have substitutions and only 2 out of 12 companies had products without any substitution, contamination, or fillers.1  

In the following response we investigate the two primary issues raised by this study: dietary supplement quality and an unproven method of testing dietary supplements.

Dietary supplement quality

Although it is unfortunate that quality is a problem for many dietary supplement companies, Life Extension® provides products with the highest standards of quality in the dietary supplement industry.

Life Extension adheres to the most rigorous quality standards and ensures our products are assayed using validated testing methods to safeguard our customers against adulterants and ensure that our labels accurately reflect the ingredients in our products.

What follows is a series of detailed questions and answers related to Life Extension’s quality assurance procedures.

Q. What does Life Extension do to ensure the quality of its products?

A. We focus on three specific areas.

  • Raw Materials: Unlike other supplement companies, the ingredients that go into our supplements are not chosen based on cost. Instead they are chosen based on purity (to ensure contaminants such as microbes and heavy metals comply with regulatory and GMPs requirements), potency, and usage in successful scientific research.
  • Validation of the Efficacy of Ingredients by Scientific Research: We use ingredients and dosages that accurately replicate the most successful results obtained in scientific studies for maximum efficacy.
  • Manufacturing: Naturally, we are in strict compliance with current Good Manufacturing Practice (GMP) for manufacturing, packaging, and storage.

Q. Does the label accurately list exactly what’s in the bottle?

A. Yes. Active ingredients from patented,scientifically validated raw materials as well as final, finished products are verified using advanced analytical methods such as HPLC (high performance liquid chromatography), MS (mass spectrometry), etc., to ensure each and every product meets label claims in strict compliance with our demanding product specifications.

Q. When it comes to supplements, is cost an indicator of quality?

A. Where Life Extension is concerned, yes. Patented materials validated in scientific studies cost more — period. In contrast with many commercial brands focused on driving up margins by using the cheapest raw materials available, Life Extension collaborates with raw material suppliers who invest in scientific validation of their ingredients, which increases material costs. With Life Extension products, you get the quality you pay for.

Q: Can you provide more details on your quality control standards?

A: All of the products formulated by Life Extension are produced in accordance with Good Manufacturing Practice (or GMP) as set forth in 21 CFR Part 111 of the Food Drug and Cosmetics Act. Manufacturing facilities are periodically inspected by either the Food and Drug Administration or the United States Department of Agriculture. Facilities are inspected for their adherence toStandard Operating Procedures (SOPs), employee training, product specifications,and supplier/vendor qualification procedures. In addition, Life Extension performs periodic audits of manufacturers to ensure adherence to all regulatory requirements. Life Extension ensures that manufacturing SOPs are followed to ensure consistent product quality.

Raw Materials

Product specification begins with the ingredients we qualify for use in our formulas. We evaluate the source data for these ingredients from well-established vendors with impeccable credentials when formulating our products. Working with high-quality, raw material suppliersallows us the opportunity to select the best options for product formulations.

All sourced raw materials and raw material vendors undergo an extensive qualification process by the highly experienced members of ourProduct Development, Quality Assurance/Quality Control (QA/QC), and Purchasing departments. All raw materials are evaluated according to our internal Raw Material Qualification SOP. Qualification must be approved at multiple steps in the process for each raw material to meet our stringent identity, purity andpotency requirements before a material is approved for use.

Once approved and purchased, all raw materials are received and placed “on hold,” pending release by QA/QC. Release by our QA/QCdepartment occurs only after samples of each lot of raw material passes evaluation according to the raw material specification criteria. Testing includes, but is not limited to, chemical identification [using Fourier transform infrared spectrophotometry (FTIR), ultraviolet (UV) or high performance thin layer chromatography (HPTLC)], physical characteristics, potency/strength confirmation, microbial analysis and other contaminants including heavy metals to verify and approve the Certificate of Analysis (COA) for each material. Complete COAs that meet our specifications are mandatory for every lot that is received for use in production. Material can only be released into inventory once it meets the applicable specifications. If materials do not meet ourspecifications at any step in the process, they are rejected and returned to the material supplier.

GMP (Good Manufacturing Practice) Production

Master production documents (also referred to as Master Manufacturing Records) are approved by Quality Control personnel and are kept on file at our manufacturing facilities. They are created from our Finished Product Specification Packets which are on file at Life Extension for every product under our brand.

Batch sheets (which are part of the master production documents) list all of the ingredients and the required quantity necessary toproduce one batch of product. Each lot number of ingredient, and amount weighed, are recorded on the batch record for traceability. Initials are required by the individual who measured the materials as well as a second individual responsible for review and verification to ensure accuracy. Additional checks and balances follow, including separate QA/QC inspection processes to ensure consistent product quality.

Weighed ingredients are then transferred to the blending department. Material is blended to maintain consistency and continues throughout the specific production process dependent on type of finished product [eg, softgels, encapsulated hard gelatin (or vegetarian) capsules,tablets, etc.].

In-process controls throughout production processes include line clearance (all production equipment that comes in contact with product must be cleaned according to mandated procedures between all production runs and verified to ensure sanitation has been performed prior to use), lot code verification, weight checks, and label as well as material checks – all of which are performed according to written procedures. Product samples are collected at different stages of production for appropriate chemical and microbiological testing as per the product specifications.

The finished product is transferred to the packaging department where empty packaging bottles are filled, sealed, labeled, stamped with a lot code and ‘use by’ date, put in cases, and stacked on pallets. Our packaging is designed to protect the integrity of the product and ensure the freshness of the product throughout its shelf life.

The finished product is placed on hold until QA/QCcompletes additional evaluation to ensure adherence to all SOPs. This includes review of the completed batch record and all pertinent tests required on the product specification. This ensures that all specifications set within the production process are accurate and within pre-defined parameters. After the evaluation has been completed, and the product has passed all requirements, test results are indicated on the COA and the product is released. These COAs are maintained on file for each production batch received at Life Extension andare available upon request.

Life Extension Product Labels

Product labels go through a comprehensive review and approval process. Labels comply with all applicable laws and regulations, andare periodically updated based upon the most recent nutritional science parameters for active ingredients. All necessary information is clearly indicated on all our product labels, as well as any pertinent allergen information.

Label storage is tightly controlled with limited access to only authorized personnel. All labeling is checked when initially received for physical size, color variation, wrinkles, condition, and copy versus approved sample. QA/QC personnel are authorized to approve or reject labels per our internal SOP. All labeling is counted and verified upon issuance and on returns for reconciliation purposes.

Finished Product Analysis

Each manufactured lot of finished product is tested usingstate-of-the-art testing equipment to ensure finished product quality, purity and potency. Different types of materials such as herbal extracts, minerals, vitamins, etc… require different laboratory testing equipment and/or methodologies to provide the most accurate results. Testing can include, but is not limited to, chemical analysis by high performance liquid chromatography(HPLC), ultraviolet/visible spectrophotometry (UV-Vis), gas chromatography (GC), and gas chromatography mass spectroscopy (GCMS). Physical analysis isperformed and active ingredients listed on the product label are confirmed. Microbiological analysis and heavy metal testing (by ICP-MS) is also completed on every production batch to ensure that all specifications are met.

Complete COAs that meet specifications are mandatory for every production lot of product that is shipped to our customers.

When inspection and testing is performed, QA/QC personnelare authorized to approve or reject product if the finished product does notmeet established quality guidelines at any step in the process. Only if thefinished product meets specification is the product released for shipment.

An unproven method of testing dietary supplements


Currently, DNA barcode testingis an atypical technology with several problems.The American Botanical Council notes: “…the bar-coding technology it used could not always identify herbs that have been purified and highly processed.” Many herbal supplements are not simply ground, powdered herbs which would allow for accurate DNA testing.

Plant products contain several compounds, many of which interfere with the ability to perform accurate DNA testing. The authors noted: “Herbal products contain plant secondary metabolites that may prevent barcode success. Herbal extracts contain complicated mixtures of organic chemicals (for example, fatty acids, sterols, alkaloids, flavonoids, glycosides, saponins, tannins and terpenes) that often result in PCR inhibition.”

Also, degradation of DNA material, which commonly occurs, limits the effectiveness of this test; the authors noted: “In addition, degradation at primer binding sites may also contribute to differential amplification success of selected genes in samples with potentially degraded DNA. In the Baker et al. study, four dietary supplements could not be identified using the laboratory’s PCR amplification protocol, presumably because the DNA was degraded…”

“DNA barcoding” tests the DNA of plastid (organelles found in plant cells) barcode regions. The authors noted this may create problems in testing: “The use of only plastid barcode regions is problematic for testing herbal products. Previous studies have notsatisfied Hebert’s third criteria for a reliable barcode: sufficient nucleotide sequence variability to distinguish among closely related species.”

This technology may be incompatible with herbal formulas containing more than one plant. The authors noted, “Many herbal products contain mixtures, which are particularly difficult to barcode.”

Conflict of InterestThe researchers concluded, We suggest that the herbal industry should embrace DNA barcoding for authenticating herbal products through testing of raw materials used in manufacturing products.”


Because the University of Guelph offers DNA barcoding, a profit center for the institution, it is not surprising that the researchers suggest the dietary supplement industry broadly embrace the testing for authenticating herbal products.

Life Extension uses proven testing methodsDNA barcoding technology is an atypical testing method inthe industry; well-established, validated testing methods such as thin layer chromatography (TLC), high performance liquid chromatography (HPLC),ultraviolet/visible spectrophotometry (UV-Vis), gas chromatography (GC), andgas chromatography mass spectroscopy (GCMS) are preferred at this time.

1.      Newmaster SG, Grguric M, Shanmughanandhan D, etal. DNA barcoding detects contamination and substitution in North American herbal products. BCM Med. 2013; 11(1):222. [Epub ahead of print]



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Post #10843
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 Posted 11/7/2013 5:33:04 AM
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Excellent rebuttal, DDye.  Methodological issues continue to plague medical studies.
Post #10844
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 Posted 11/7/2013 12:48:08 PM
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BHT is still used as a preservative for cold cereals.  Thus, most of us are taking it whenever we have cold cereal!
Post #10846
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 Posted 11/7/2013 7:01:34 PM
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Almost all packaged cold cereals are garbage!  so highly processed and void of natural nutrients that they have to fortify them with synthetic vitamins and minerals before they are allowed to sell it as food.

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The case against dietary fats >>  CLICK HERE
Post #10847
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 Posted 11/7/2013 7:14:54 PM
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DDye,

Great article on the quality of life extension products. My question is why isn't the life extension foundation using that as their marketing strategy.? That right there is the unique selling proposition of Life Extension products!  Period! That article should be on the inside front cover of every issue of the life extension magazine from now. There should also  be a special website address on every bottle that links to quality control information online. Life extension should also do a video demonstrating all those detailed steps in the quality control process and put that online for everyone to view.

-Tom

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Seize every opportunity to put your best foot forward.

Anything worth doing is worth doing well.
If you don't stand for something, you will fall for anything
If everything seems under control you're just not going fast enough. - Mario Andretti
You can't expect to do business today, with yesterday's tools, and be in business tomorrow. - Author Unknown
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The case against dietary fats >>  CLICK HERE
Post #10848
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 Posted 11/8/2013 3:54:19 AM
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Most supplement companies use the same test procedures as LEF, so it wouldn't be a "unique selling proposition."  As for cold cereals, one has to choose carefully--I purchase those with 6 grams of protein per serving, with high fiber and relatively low fat.
Post #10852
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