Raising The Standard
by Natalie Shamitko, Andrew Halpner, Ph.D.

    This issue of NutriNews is devoted to relevant topics in the area of dietary supplements to update you on the latest developments in the industry. This issue is a continuation in the series of "Raising the Standard" articles which periodically updates our readers on the quality measures that Douglas Laboratories has in place and addresses frequently asked questions about our products and the industry.

    With the passage of the Dietary Supplement Health and Education Act (DSHEA) in 1994, the public has been more easily able to purchase a wide variety of herbs, vitamins, minerals and other ingredients to support optimal health and supplement the nutrients that may be absent from or present at insufficient quantities in the diet. However, in the years since the passage, there has been a great deal of confusion surrounding the dietary supplement industry, especially in regards to quality, safety and accountability. The media often depicts the industry as unregulated, and is critical of the safety and efficacy of many products that reach the store shelves. While it is true that dietary supplements are not drugs or over-the-counter medications, they are regulated by the Food and Drug Administration (FDA). Although the FDA regulates supplements in a different manner compared with pharmaceuticals, it does have important regulatory authority, including the ability to remove unsafe products from the marketplace, as well as overseeing which ingredients can be sold legally as supplements. The FDA also monitors claims that are made about dietary supplements, as these claims can not include statements about treating or curing a disease. If such a claim is made, the product can be defined as a drug and the FDA has the authority to take enforcement action. One important topic that DSHEA addresses is the creation of manufacturing practices, known in the industry as Good Manufacturing Practices (GMPs), specific to the dietary supplement industry. These GMPs have been much anticipated, as it has been almost 12 years since the passage of DSHEA and they are still not finalized. In the Fall of 2005, there was talk that the GMPs were very close to being finalized and that they would be published near the first of the year. The beginning of 2006 came and went and as of this printing, the GMPs are not yet finalized. It does appear as though they are close; however, they may be caught between the FDA and Office of Management and Budget while they address the various fiscal ramifications that the passage of the GMPs could have on the industry.

    Unfortunately, the absence of industry-specific GMPs has contributed to the mistaken impression that manufacturing practices are unregulated. This is not the case at all, as the industry's top tier companies and trade organizations have developed extremely well-defined GMPs that are as stringent as, if not more so than the expected GMPs from the FDA. At Douglas Laboratories we go to great lengths and utilize numerous systems to ensure the quality and safety of the products that we sell.

    The emphasis that ISO 17025 accreditation places on method validation is of particular interest. Anyone can develop a method by which they analyze one or more compounds, but it is the validation of the method and the adherence to a set of tightly controlled procedures that is the key to being assured of accuracy and reproducibility. Of course, even a validated method will give you poor results if the instruments being used are not properly calibrated. Consequently, strict maintenance and calibration schedules are also in place for analytical instruments.

    In addition to microbiology, our facilities have both physical properties and chemical analysis laboratories that ensure raw materials and finished products meet specific standards of quality, purity and safety. The physical analysis laboratory tests the weight, thickness, hardness, and disintegration of finished products, making certain that capsules and tablets disintegrate and release their nutrients in a timely manner. Using highly sophisticated analytical instruments, including HPLC (High erformance Liquid Chromatography), ICP (Inductively Coupled Plasma, used for mineral analysis), GFAA (graphite furnace atomic absorption spectrophotometry, used for heavy metals testing) and an FT-IR (Fourier Transform Infrared spectrophotometer), the chemical analysis laboratories test for the measurement of various vitamins, minerals and herbals to ensure that our products meet our meticulous standards of quality, many of which exceed the limits defined in the USP. Findings from our laboratories have been compared with independent lab reports on many occasions and have consistently been on target. In fact, many independent laboratories are often quite surprised and impressed when they learn the depth of our analysis capabilities and experience.


New Analytical Equipment
    To further enhance our analytical capabilities we have upgraded our chemical analysis laboratory by purchasing new and more sensitive analytical equipment including a GFAA (Graphite Furnace Atomic Absorption spectrophotometer) and an FT-IR (Fourier Transform Infrared spectrophotometer). These new acquisitions allow us to measure additional analytes in both our raw materials and finished products. The GFAA is a highly sensitive instrument that can measure trace elements such as lead, arsenic and cadmium in the parts per billion range to ensure that our products meet the highest standards for quality and purity. The FT-IR is an interesting technology that is able to analyze raw materials to ensure the components match recognized standards.The addition of these two analytical instruments makes our laboratories one of the most comprehensive in the dietary supplement industry.

    As part of our commitment to quality, we provide trained, dedicated staff members to answer any technical questions our customers may have. Available during regular business hours, our technical team goes to great lengths to provide accurate, reliable information on hundreds of products. Not surprisingly, there are some common questions and concerns that many of our customers have. Some of these topics include concerns with fish oil, allergens, the presence of doping agents in products, pesticides in Ginseng and other concerns that are periodically mentioned in the media or by other supplement companies. Listed below, we’ve addressed some of our most frequently asked questions. As always, our customers are always free to call us with any technical questions.


How “pure” are our fish oil products?
    Fish oil supplements have been receiving a significant amount of attention lately for both their health benefits as well as claims regarding their purity and quality.

    Concerns have been raised that fish oils may be contaminated with heavy metals or other toxins. Fish oil used by Douglas Laboratories is taken from clean, unpolluted waters and prepared using a molecular distillation method that serves to eliminate heavy metals and other potential contamination. The fish used to create our fish oil products are primarily wild-caught sardines and anchovies that come from the cold waters of the Atlantic and Pacific oceans. A quality fish oil product should be derived from fish taken from clean water, processed via a method using molecular distillation, and supply a significant amount of omega-3 fatty acids. Mercury, lead, arsenic, and cadmium should all be < 0.1 ppm. We have independently tested our fish oil products and have found that heavy metals are below 0.1 ppm, the limit of detection.

Do any of our products contain any corn, wheat gluten, soy protein, yeast, milk/dairy sugar, salt, artificial colors, flavors or preservatives?
    With increased awareness of food allergens, many customers do inquire about possible allergens in our products. Nearly all of our products do not contain these ingredients. However, a few products would contain them, such as whey protein isolate or soy isoflavone-containing products. Our labels do clearly state whether these ingredients are present in a product. Likewise, our excipients also do not contain these types of ingredients.

Are there any banned athletic substances in our products?
    The presence of substances in dietary supplements that are banned by various athletic organizations around the world has become an increasing concern for athletes. The World Anti-Doping Agency has been at the forefront of preventing doping in athletics in general with specific attention to the Olympics. The World Anti-Doping Agency publishes an annual list of prohibited substances. We have reviewed this list, and based on the 2006 Prohibited List of the World Anti-Doping Code, Douglas Laboratories does not handle any of the compounds on this list at our facility where we manufacture tablets, capsules and powders.

Are pesticides a concern in Ginseng?
    Pesticides can be a concern in certain herbal products, but are of particular concern in various species of Ginseng. Fungisides are often used in the growing process and can end up in the finished product unless careful processes and procedures are followed. The EPA has set limits on acceptable levels for certain pesticides, but not for all. For example, although the European Pharmacopoeia and USP have set a limit of 1 ppm for quintozene (a commonly used fungicide also known as pentachloronitrobenzene), this limit does not apply to the U.S. dietary supplement market as the EPA has not determined any acceptable limit. Consequently, the current acceptable limit for quintozene is zero. Given this concern about quintozene and other pesticides including lindane (also known as gamma-BHC) and procymidone, one must be very diligent in the testing of Ginseng. Every lot of American and Korean Ginseng is sent for independent pesticide analysis to ensure the product is free of contamination. Figure 1 shows a complete analysis of pesticides in one of our American Ginseng raw materials in which no pesticides are detectable. Douglas Laboratories does not accept any Ginseng material in which any of these pesticides are above the limit of detection.

Negative Studies Mentioned in the Media
    Recently, several large-scale studies on popular dietary supplements have been publicized in the media, often with headlines that indicated the studied materials had a negative or insignificant effect on health. While this type of sensational reporting certainly draws attention to the popularity of supplements, it does not adequately discuss the limitations of these studies and in some cases, shows gross misunderstanding and misreporting of the studies’ findings. We’ve addressed some of the recent controversial studies that have made headlines with the hope of putting their results in better perspective.

Calcium and the Women’s Health Initiative
    The Women’s Health Initiative, a large-scale government sponsored trial (N Engl J Med 2006;354(7)684-696) was designed to look at the ability of calcium and vitamin D to prevent hip and other fractures. Over 36,000 women were recruited for the trial and were randomly assigned to take 1,000 mg of calcium (from calcium carbonate) and 400 IU of vitamin D daily or placebo. The participants were then followed for 7 years. If one only read the media reports regarding the findings of this study, one might think that calcium and vitamin D did not significantly reduce fracture risk as compared to placebo, and may have increased the risk of developing kidney stones. However, as is often the case with 30 second media sound bites, this is a misleading conclusion and not the full story. Several flaws call the study into question, including:

Glucosamine, Chondroitin and Arthritis
    The Glucosamine/Chondroitin Arthritis Intervention Trial (GAIT) (N Engl J Med 2006;354(8):795-808), a double-blind placebo controlled trial, was designed to test 5 different interventions in persons identified with painful knee arthritis. The five arms of the trial included:

    The study concluded that while celecoxib helped to reduce pain, compared to placebo, glucosamine, chondroitin sulfate and the combination of the two ingredients did not have a significant overall benefit. Consequently, many major news sources picked up this story and reported such headlines as “Supplements Fail to Ease Arthritis” and “No Overall Benefit for Mild Arthritis from Supplements.” However, the media conveniently overlooked an important finding of the study. In the group with moderate to severe knee arthritis, glucosamine and chondroitin were shown to significantly reduce pain as compared to placebo. Several limitations have been cited with the study including the type of glucosamine used (glucosamine HCl was used, instead of the more common and oft-studied glucosamine sulfate) and the fact that acetaminophen was allowed to be used in conjunction with all 5 trial arms.

The Douglas Difference
    Douglas Laboratories takes great pride in our uncompromising approach to providing you with products that meet the highest levels of quality. We constantly evaluate evolving technologies to incorporate into the development and manufacture of new and existing products. Douglas Laboratories’ unparalleled quality, manufacturing flexibility, decades of experience, breadth of product line and cutting edge technology are indeed raising the standard by which to measure dietary supplements within the industry.

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