Is a dietary supplement just a dietary supplement? It can easily appear that way, especially with thousands of different brands of dietary supplements on the market today. Pharmacies, supermarkets and other retail outlets are setting up in-house "supplement stores" and virtually every highly circulated print publication and news program is touting the benefits of nutritional supplementation. Propelling the explosion of health awareness and the ongoing quest for "anti-aging", hundreds of studies are emerging about the benefits of nutrient supplementation. Some of these tell us what we have known for years (it is believed that the ancient Egyptians recognized a nutrient, vitamin A, that can prevent night blindness).

Today, taking nutritional supplements has become so commonly accepted as a way of improving health and preventing the effects of aging that it is not surprising that the vitamin business has become a $40 billion dollar a year global industry. So the question is no longer Do nutritional supplements work?, but rather How can I tell one product from the next? The answer is one simple word that may be difficult to define--QUALITY.

At Nutrition Dynamics, Inc., great lengths are taken to ensure that every supplement leaving the laboratory is the highest quality available. The quality starts with a team of PhDs that specialize in Pharmaceutics and Nutrition. Rigorous quality control standards have been set and are adhered to throughout every step of the manufacturing process. Our manufacturing and packaging facilities occupy more than 140,000 square feet and three testing laboratories. The facility is regularly inspected by state, FDA and international regulatory agencies. The state of the art equipment and technology yield high volumes of product 24 hours a day 7 days a week. This includes high speed tablet presses that can produce more than 10 million tablets daily, encapsulating machines that output more than 600,000 capsules every hour and complete turnkey packaging that includes bottling with tamper proof induction sealing and daily convenience packs. In house testing laboratories include Microbiology, Physical Properties Testing and Analytical Analysis, including HPLC (high performance liquid chromatography), UV/VIS (ultraviolet/visible), spectrophotometry and ICP (inducted coupled plasma testing).

The Raw Materials

Raw materials come from all over the world. The vendors used are the most reputable in the industry. When possible, USP, FCC (Food Chemical Codex), NF (National Formulary) and pharmaceutical grade are used. Once sourced, only the best available materials that are accompanied by certificates of analysis (COA) are received into the facility. The "vendor-supplied COA", however, does not suffice for passing the material through to formulation and manufacturing. Each and every raw material is quarantined until it passes a battery of tests including in-house microbial testing, which conforms to USP XXIII specifications. This includes a series of microbial testing procedures which make certain that the material is within USP specifications for yeast, mold, and free of E.coli, salmonella, and other contaminants that may be present in raw materials. It is also important in selected materials to test for heavy metals (such as lead and aresenic) contamination. In addition to these rigorous test conducted on-site, often raw material is sent for independent testing and verification to an outside laboratory.

The Manufacturing Process

We use a cold process manufacturing technique. This method promotes content uniformity and potency within each batch of product. It is the preferred technique of manufacture over wet granulation, which exposes the material to heat and moisture. Cold process assures and protects the physio-chemical integrity of the nutrients. In addition to written SOPs (Standard Operating Procedures) that comply with nGMPs (nutritional Good Manufacturing Practices) in all steps of manufacturing, there is a quality control cross-checking procedure that is implemented throughout the entire process. This way, more than one person checks the accuracy of each phase throughout the course of production. For every product lot number, retained samples are taken from each batch. Frequently the product is tested for active constituents, and analysis is conducted to make sure that it meets label claim throughout the product's shelf life. In-process quality control teams constantly monitor quality and provide on-site training around the clock. At Douglas Laboratories, there are no preservatives, corn, wheat, starch, yeast or artificial additives added to the product. Also, tablets are coated without using artificial waxes, colors, or sugar coatings.

In-House Testing Method for Quality Assurance

Our products meets and exceeds USP/NF (United Stated Pharmacopea/National Formulary) specifications where applicable. The USP XXIII is recognized as the authority for guidelines of vitamins, minerals, and pharmaceuticals. It outlines the standards of identity, strength, quality, purity, packaging and lableing. For instance, the USP specifications for disintegration of coated tablets states that it must not exceed 45 minutes in water at 37 degrees Celsius. Our Ultra Preventive tablets, for example, disintegrate at approximately 30 minutes. This information is provided on Certificates of Analysis, which are available.

HPLC, or High Performance Liquid Chromatography, is a very specific method of analysis that is accepted as one of the best ways to quantitate the amounts of vitamins and other compounds in the product. HPLC may be coupled with UV (ultra violet) testing. UV testing may also be done alone. ICP, or Inducted Coupled Plasma, testing is used to quantify the mineral contents. Highly trained laboratory technicians and quality control experts conduct all of this analysis.

The Finished Product

Once produced, each and every capsule and tablet undergoes a visual inspection process to ensure that they are free from any physical defects. And again, microbial testing is performed on finished product to verify that USP XXIII microbial limits for nutritional supplements are met. To protect the integrity of the product, unbreakable high density polyethylene (HDPE) bottles are used to guard against light and excessive exposure to heat and moisture. These bottles meet USP XXIII specifications and are made frm a widely and easily recycled material.

The HDPE bottles are more environmentally friendly than glass, which requires a large amount of fossil fuels for recycling that contribute to polluting the environment. Tamper proof safety seals are put on each bottle and double-checked before the lid goes on and the product moves to the next phase.

The last step of the process is the step that the consumer sees first-the label. Either pressure sensitive or hot glue labels are adhered to the bottles. Our labeled product has the Supplement Facts format and is compliant with the Dietary Supplement Health and Education Act guidelines for consumer friendly labeling. (See How to Read a Supplement Facts Label).

Y2K Compliance is Not an Issue

The new, sophisticated custom computerized software program that is fully integrated controls all of the processes and is compliant for the year 2000. These efficient programs feature every aspect of the processes including electronic order entry, electronic monitoring of product processes from raw material purchasing to scheduling, and finished product inventory. With this precise system, the laboratory is able to make batches that are produced based on predicted demand size. This keeps excess inventory from sitting on the shelves and provides the consumer with the freshest product available.

Stored in tightly controlled conditions of temperature, humidity and light, the nutritional supplements manufactured are not stored for more than 3 months. The entire 140,000 square feet facility is air conditioned and temperature and humidity controlled 24 hours a day, 7 days a week. Quarterly inventory maintenance is conducted to assure freshness. Most of our time sensitive formulas are only one week old when they are shipped. The longer shelf life products are no more than three months old when shipped. Often after 3 months, excess product may be used for relief donations. A few recent donations from the manufacturing facility include orphanages in Haiti, the Baltic Islands, and Calcutta, India.