We focus on three specific areas.
Life Extension was the first to embrace the concept of pharmaceutical quality materials & manufacturing standards by insisting that the raw materials utilized in our nutritional supplements were of the highest purity available and were consistently tested for any contaminants. However, since the Dietary Supplement Health and Education Act of 1994, regulators defined dietary supplements in a different way than pharmaceutical drugs, making the characterization of a “pharmaceutical grade” dietary supplement problematic. Thus, from a regulatory perspective the term “pharmaceutical” applies to drugs, which dietary supplements are not based on the definitions contained in the 1994 statute. Regrettably, some supplement companies continue to use “pharmaceutical grade” in advertising materials and on product labels in an effort to convey the idea of purity and quality. However, it is not a term regulatory agencies recognize to describe a dietary supplement product, it is misleading and should be avoided.
The Dietary Supplement Health and Education Act of 1994 requires dietary supplements to comply with cGMP which Life Extension rigorously adheres to. Life Extension is GMP registered with NSF International. This registration is based on rigorous bi-annual audits of our distribution operations and quality systems and indicates full compliance with applicable areas of 21 CFR Part 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. Life Extension is a leader in quality and purity testing and adherence to GMP regulations. We do not use meaningless or inappropriate marketing terms to describe our products.
Yes. All 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 accurately meets label claims in strict compliance with our demanding product specifications.
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.
They are inactive ingredients (excipients) that play a number of critical, essential roles in the manufacturing process including:
Claiming any product is “pure and free of excipients” can be deceptive advertising, too frequently used to draw attention away from inferior active ingredients! The right inactive ingredients used in the right way do important things … like ensuring that a tablet disintegrates in your GI tract rather than just passing through your system without benefit, or keeping a product from breaking down and being susceptible to microbes. Take Life Extension blueberry extract, for example. It contains AuroraBlue® wild-harvested, Alaskan blueberries. To retain their nutritional complexity, these berries are freeze-dried and carefully milled for capsule formulation. But being a whole fruit raw material, it tends to want to reconstitute itself with moisture, which would make it a breeding ground for bacteria. So Life Extension uses a drying excipient to keep the milled blueberry material dry, so it can safely deliver its superior nutritional value compared with other, less costly blueberry extracts in most commercial formulations.
All of the excipients Life Extension uses have earned GRAS (“Generally Regarded As Safe”) status … and are used sparingly. In many cases not using them compromises final product quality! Excipients are used in nutritional supplements to ensure uniform density of complex active materials, to achieve even dispersion of active ingredients, and to promote appropriate disintegration and/or dissolution of active ingredients inside your body … to name but a few of the critical roles played by excipients.
Stearic acid functions as a flow agent in the manufacture of quality products, and stearic acid also occurs naturally in the foods you eat. For example, four ounces of dark chocolate contain 3,625 mg of stearic acid; a cup of kidney beans contains 1,655 mg of stearic acid; an ounce of raw ground beef (grass-fed) contains 2,063 mg of stearic acid; and a half pound of lean raw turkey contains 1,642 mg of stearic acid. Even a tablespoon of allspice contains 1,513 mg of stearic acid! Our supplements, on the other hand, typically contain no more than 10 mg per capsule. We always use the lowest level of magnesium stearate possible.
Should I be concerned that products with soybean oil or lecithin are a hidden source of phytoestrogens?
While it is true that soy isoflavones are phytoestrogens, the amount of phytoestrogens in soybean oil or soy lecithin is so minute, the USDA lists it in foods as having zero value for isoflavones. To give you a frame of reference, Life Extension’s Fucoxanthin-Slim™ softgels contains only 0.0024 grams of soy lecithin per softgel, and thus no phytoestrogens.
Soybeans are an example of a crop that has used extensive genetic engineering to increase crop yield. The reality is that soybean oil and soy lecithin are highly processed derivatives of soy … far removed from their soy origin. Genetic modification doesn’t alter the entire plant… only a specific gene. Thus, specific molecules like soy lecithin are the same whether they come from a GMO or non-GMO soy source. However, due to our sensitivity to customer concerns, products with corn and soy-based active ingredients are in process of having the labels updated to list when soy and corn-derived active ingredients have been certified to be from non-GM food crops. As the labels are updated the information will be transferred to the product descriptions on our website and directory. Currently Life Extension already offers several premium quality non-GMO soy isoflavone extract products.
Gelatin does not contain MSG … but does contain about 0.03 grams of glutamic acid in one softgel. To put this small amount in perspective, a person ingests about 120 times more glutamic acid in a serving of asparagus, cabbage or tomatoes!
Sophisticated products require sophisticated delivery systems. The best companies choose the most effective finished form based on the characteristics of the raw materials, and the desired disintegration or dissolution characteristics of the finished product and the active ingredients.
The word “organic” conveys the perception of quality to consumers. But it actually relates to foods that are grown rather than products that are formulated. Many of our scientifically validated raw materials are not produced organically. Rather, our mandate includes rigorous testing and scrupulous processing. The objective is purity … both in terms of our raw materials and our finished products.
Other product questions or concerns?