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Life Extension Magazine

LE Magazine June 2004
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Setting the Standard for Quality
The Life Extension Foundation continues to lead the industry in quality control and research
By Dave Tuttle
Photographs by Gerardo Somoza

Many people today are uncertain about how to choose the best nutritional supplements. Among the common questions asked: How can I be sure that the supplements I consume are as potent as advertised on the labels? How can I keep myself from being hoodwinked by supplement charlatans who care only about lining their pockets at my expense? The dilemma is real, but the solution is simple: Stick with a company that has an established track record of selling high-quality products.

Pharmaceutical-Grade Ingredients Matter
It all begins with the quality of the raw materials. “If you put garbage in, garbage comes out,” says Herb Schneider, the Life Extension Foundation’s technical director and chief quality control expert. “Many companies try to cut corners and save a few pennies by using inexpensive raw materials. But you can’t get a quality end product by starting with junk, any more than you can build a strong house on a foundation of quicksand.”

The Life Extension Foundation learned a long time ago that only a few ingredient suppliers can be trusted to consistently deliver pharmaceutical-grade ingredients. Life Extension works only with industry leaders, such as Roche for vitamins. While Roche is hardly the least expensive vitamin company around, members have come to recognize that you get what you pay for, and that bargain-basement supplements are not the best value. Saving a few cents by consuming diluted, mislabeled products is penny wise but pound foolish.

The Life Extension Foundation uses pharmaceutical-grade raw materials from Japanese and European suppliers. These companies have shown over the years that they share the Foundation’s commitment to quality, and that they do not want to risk their reputation by shortchanging their customers through mislabeling or diluting their products with adulterants. Unfortunately, some companies buy from the cheapest Chinese manufacturer they can find, figuring that consumers will never find out. Over time, however, consumers do find out, which is why there is such turnover in the supplement industry. Life Extension works with industry leaders that have proven experience and expertise in producing pharmaceutical-grade ingredients.

Avoiding the Most Common Scams
Several scams are common to the supplement industry. One of the most prevalent is referring to research about a nutrient in product advertising without supplying the amount of the nutrient that was shown to be effective.

Mohammed Rehan reviewing
analysis results from the high-pressure liquid chromograph.

An example of this deceptive practice is found in the prostate formulas now offered by many different companies. One of the key ingredients in these products is the bark of the Pygeum africanum tree, which acts though several mechanisms to alleviate and, in some cases, prevent benign prostatic hyperplasia. Studies performed with this bark clearly show that no less than 100 mg of pygeum is needed to produce the desired biological effect. Yet some companies advertise the benefits of this nutrient while only putting 10 mg of pygeum in their formulations—an amount far too small to achieve the necessary concentration. As if this were not bad enough, some raw material suppliers try to get around the high cost of pygeum by diluting it with sterols from other plants. Unless a manufacturer uses advanced testing to analyze the raw material, the supplier could easily get away with the scam. As noted later in this article, the cutting-edge testing procedures employed by the Life Extension Foundation are able to stop these scam artists cold.

Another common scam is to attempt to circumvent the Foundation’s quality-control procedures by adulterating products with substances that have the same melting point as the real nutrients. Unscrupulous supplement companies will submit their product authentication using a low-cost method known as the melting point procedure. This can produce a test result that makes it appear as though the formula contains a considerable amount of the real nutrients, when in fact much of it is adulterated. Some supplement companies do not really care, of course, as long as they can use it for cover in their documentation files. Life Extension, on the other hand, utilizes state-of-the-art testing instruments, such as high-pressure liquid chromatography and gas chromatography/mass spectrometry that reveal the inconsistencies hidden by the melting point procedure. These machines are very expensive but are essential to maintaining the Foundation as the quality leader in the supplement industry.

This commitment to quality also requires the Foundation to keep its guard up. Raw material suppliers sometimes submit samples that meet pharmaceutical standards, but then do not deliver the same high-quality material for use in the finished supplement. For this reason, Life Extension has all of the active ingredients in its products assayed before they go into individual capsules or tablets. Some time ago, a company that desperately wanted the Foundation’s business “guaranteed” that the materials it shipped would meet pharmaceutical standards. The company provided an impressive stack of documents showing that it would meet the Foundation’s exacting requirements. But when told that each of its shipments would not be accepted until it passed the Foundation’s advanced chemical analyses, the company decided that it would rather not work with Life Extension. This company was caught in the act, to the benefit of Foundation members.

Tableting machine

The Industry’s Best Testing Lab
Another way in which the Life Extension Foundation distinguishes itself is by operating a topnotch testing facility. Many companies avoid analyzing their products for purity and potency so they can fatten the bottom line. By contrast, the Foundation contributed to a $2.5 million laboratory that is the best among supplement companies. With 2,500 square feet of space and the latest in technology, the laboratory is committed to ensuring that all of the raw materials used in its products meet exacting standards. The lab also does extensive testing of supplements during the manufacturing process to ensure that they conform to specified criteria, and follows this up with further analysis of the finished product. This results in a Certificate of Analysis for every product that the Foundation sells.

“We have a very sophisticated lab with highly qualified people,” notes Schneider. “It functions just like the pharmaceutical company labs do. We test all of our raw materials using US Pharmacopoeia, Food Codex, and other appropriate compendia utilized by the major drug companies. Of course, we start with the best raw materials from European and Japanese sources. But we don’t stop there. We do extensive in-process testing during manufacturing as well as periodic testing for the physical characteristics of the products, such as color and tablet hardness. It’s a big job, and we take it very seriously.”

Schneider is not alone in his commitment. He is joined by quality control manager Manish Wadhwa, laboratory director Tahani Amer, and a staff that includes three supervising chemists, 12 chemists, a microbiologist, a technician, and numerous inspectors on the production line. Located in Bayshore, NY, the lab strives to constantly set new standards for excellence in quality control.

High-speed capsulating machine

State-of-the-Art Equipment
One of the lab’s main workhorses is the high-pressure liquid chromatography (HPLC) machine. This device assays the active ingredients in each test sample. Traditional HPLCs provide a two-dimensional printout showing peaks and valleys correlating to the specific chemical composition of a nutrient. Sometimes the peaks of one nutrient in a formulation overlap those of another, creating potential confusion. This uncertainty has been eliminated with the autodiiodoray detector, which provides a three-dimensional picture of the nutrient. With this advanced tool, the Foundation’s quality control has reached new heights. The lab now has ten HPLCs, which cost $25,000 each for the base model. The laboratory has also purchased the advanced Empower and Turbocram 6.2 software programs to help with the HPLC analyses, further enhancing the level of detail provided by these instruments.

Other advanced tools in the lab include the gas chromatograph/ mass spectrometry unit, which uses a flame ionization index to test for herbicides and pesticides, and the inductively coupled plasma unit to probe for heavy metals and minerals. “People want to be sure that their products are free from toxic metals and other pollutants,” adds Schneider, “and we go the extra mile to give them the peace of mind they deserve.”

The lab also has a device to determine the moisture balance between materials, along with equipment that measures how a capsule or tablet will dissolve and disintegrate within the body. A Dry Keeper Standards cabinet ensures the safe storage of materials whose integrity would be compromised by exposure to moisture. Additional testing machines include a pH meter, an atomic absorption unit, and a centrifuge. “Each of these devices gives us another way to analyze constituents,” notes Amer. “If we can’t determine something by one of these systems, we have the flexibility to try another approach.”

Inspecting and separating
capsules by hand.

Other equipment recently purchased by the lab includes a polarimeter, a device that measures the amount of polarized light and its angle of rotation in polarization; a titration unit, which provides volumetric analyses; and a more precise melting point analyzer. “These types of analytical tools have been used in the chemical and pharmaceutical industries for a long time,” explains Schneider. “But that hasn’t always been the case for natural products. We’re constantly expanding the procedures and methods we use to ensure that the supplements we sell provide the highest level of quality.”

As a case in point, the lab recently added a microbiology section and hired a microbiologist to run it. This section tests for organisms such as yeast, mold, microbes, and pathogens. Newly assembled equipment includes an incubator, a laminated hood to protect workers and carry off any contaminants, an autoclave (steam sterilizer), and an apparatus to produce the ultra-pure water needed for microbiological media and solutions. The lab has also purchased a stability chamber to simulate the environmental conditions that could affect product viability, such as temperature and humidity. With this new device, the lab can ensure that the products the Foundation sells will retain their specified potency under any circumstances in which members are likely to use them.

“This microbiology lab gives us greater control over these testing procedures, since we no longer have to send things out for analysis,” says Amer. “By doing these tests in-house, we can make sure that every last detail is handled to our exacting standards, providing greater added value for our members.”

The goal of all this testing is to ensure that the Foundation’s members get the finest supplements available. The lab keeps Certificates of Analysis on file for all of its products, and members can request a copy of this detailed information if they want to confirm the purity and potency of a particular supplement. It is all part of the Foundation’s commitment to excellence.

Voluntary Compliance with GMP
The FDA has established standards with which all pharmaceutical companies must comply in their manufacturing operations. These standards, called Good Manufacturing Practices or GMP, set specific criteria for essential aspects of the manufacturing process such as cleanliness, record retention, and waste disposal. One might think that all supplement companies have to comply with these practices, as their products are consumed orally even though a prescription is not needed. Under current law, however, the makers of dietary supplements are exempt from GMP. Because compliance with these standards is expensive, many companies are unwilling to conform to the requirements voluntarily. Life Extension’s commitment to excellence demands that it meets all GMP criteria, whether the law requires it or not.

For technical director Herb Schneider, who came to Life Extension after decades of experience in the pharmaceutical industry, compliance with GMP is standard operating procedure. “Frankly, it’s hard to imagine not complying with these practices, which set criteria that any respectable manufacturer should want to adhere to anyway. We operate like a pharmaceutical company, even though we’re not compelled to do so. It’s cheaper to not follow the guidelines, of course, but we do it voluntarily to achieve the highest level of quality.”

GMP covers every facet of the manufacturing operation. Cleanliness is paramount, as most of the products in question are ingested. Everything from dress requirements to dust control is regulated to ensure a safe, unadulterated product. The standards for quality control testing are specified, as are inspection criteria for components (such as bottles and caps) and the raw materials arriving at the manufacturing facility. Production control procedures are outlined, as are sanitary requirements and waste disposal methods. Microbiological testing standards are also part of GMP, which even covers such items as label standards, record retention, and housekeeping. Adhering to FDA standards requires running a tight ship, and FDA inspectors can arrive unannounced at any time. It is with great pride that the Life Extension Foundation can boast that it has never failed an FDA inspection at its manufacturing facilities.

Herb Schneider and Tahani Amer reviewing analysis of mineral content from inductively coupled plasma.

The Best Supplements Available
While there is no shortage of companies selling dietary supplements these days, finding a company that does not cut corners at the expense of its customers is another matter. In an industry in which an FDA-approved manufacturing facility is often the exception, there is little to protect the consumer from those who more are interested in squeezing profits from the bottom line than in promoting your health. It is caveat emptor—let the buyer beware.

The Life Extension Foundation’s goal is to prolong the healthy human life span. The Foundation strives to provide the highest level of member satisfaction by using only pharmaceutical-grade raw materials. This is followed up with extensive assays of both the raw materials and finished products before they are delivered to members. The Foundation voluntarily utilizes Good Manufacturing Practices to ensure the utmost in cleanliness, purity, and potency. While this is not the easiest, quickest, or cheapest way to manufacture and sell products, it does allow the Foundation to achieve its goal of providing members with the very best supplements available.

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