Since its founding in 1980, Natural Alternatives International, Inc. (NAI) has been a preeminent developer and manufacturer of nutritional supplements. It has performed numerous clinical studies in the creation of new formulations and creates custom vitamin blends via its private-label contract manufacturing services. The San Marcos, California-based company has a fierce commitment to scientific integrity and quality in all the products it produces.
“The company started in my garage, in 1980, with an emphasis on identification and production of natural alternatives to dangerous synthetic drug agents and intermediates – with a focus on giving the human body the essential nutrients and micronutrients to achieve and sustain optimal health,” said Mark LeDoux, founder, Chairman and CEO of Natural Alternatives International.
The company has expanded from those humble beginnings and now boasts manufacturing facilities in San Diego County and Lugano, Switzerland as well as a sales office in Japan from which it serves customers worldwide.
“We have completed thirty-five years of operations with research and production facilities on two continents, have received various international quality certifications and enjoy a reputation for innovation and quality output of dietary supplements for some of the most demanding clientele,” LeDoux proudly said.
Prior to production, sample runs of new formulas are rigorously researched by the company’s team of scientists and tested to ensure purity, potency and label claim compliance. Products are also checked to make sure that ingredients do not interact negatively and that the ingredients are stable. In conjunction with private research facilities and universities, clinical studies of NAI’s own products are conducted and results published in prestigious peer-reviewed scientific journals.
The company recently secured its twenty-fourth patent on its amino acid beta-alanine, which NAI sells under the trademark of CarnoSyn® which has been the subject of over 55 clinical studies around the world.
Beta-alanine, a pre-cursor to carnosine, is important for carnosine synthesis within the muscles. This is vital for increasing athletic performance and reducing or eliminating muscle soreness and exhaustion as it neutralizes the hydronium ions that lead to fatigue. CarnoSyn® beta-alanine supplementation delays fatigue, improves endurance and boosts strength in muscle cells, thereby increasing athletic performance.
The benefits of beta-alanine supplementation were discovered by Dr. Roger Harris who has said, “CarnoSyn® beta-alanine contains no banned substances and is suitable for both competitive and professional athletes.” Research personnel at Natural Alternatives have participated in many scientific studies that have shown the benefits of its CarnoSyn® formulation.
“We have numerous clinical studies done to date on this material, which is an undertaking largely unheard of in our industry,” LeDoux said. “We are very excited about our intellectual property estate with sustained release CarnoSyn® in dealing with improving performance in the military as well as helping the elderly live happier, healthier and longer lives.”
At the twelfth annual conference of the International Society of Sports Nutrition (ISSN) this past summer, “The Effects of Beta-Alanine Supplementation on Elite Military Personnel” was presented by Dr. Jay Hoffman. The study examined how focus and performance can be improved in Special Forces military personnel through the use of beta-alanine. Further studies are ongoing.
The company joined with Nourish America and the National Foundation for Women Legislators (NFWL) to create ‘Operation Vital Nutrients’, an endeavor that gave members of the National Guard multi-vitamin supplements for a year.
Natural Alternatives International is a company that cares. The company has also teamed with the non-profit Vitamin Relief USA (VRUSA) and The Healthy Foundation by donating adult multi-vitamins and minerals for low-income families and people at risk for nutritional deficiencies. And its donation of children’s chewable vitamins following Hurricane Katrina, helped thousands of young victims maintain nutritional health.
Mr. LeDoux feels the reasons behind the success of his company are simple. “Do it right the first time and always tell the truth.” He says that simple principle has helped the company stay the course for thirty-five years.
It has engendered employee loyalty too. “I have had people with me for many years; one person just celebrated his twenty-fifth year with NAI. Our workforce is dedicated and exceptionally well trained and appropriately compensated.”
Natural Alternatives procures needed materials from around the world and is committed to using only the finest quality ingredients. Raw materials are kept in quarantine while being extensively tested to ensure specifications are met related to identity, heavy metals, efficacy and herbicide or pesticide contamination.
The company’s state of the art onsite laboratory continuously monitors the output of its production facility using best in class high technology equipment. All products are reviewed to ascertain uniformity and an adherence to standards under appropriate Federal and State regulatory oversight, not to mention International Standards for production. Every batch is checked for potency and purity to give customers the peace of mind that they are receiving products of the highest quality.
NAI stores product samples, certificates of analysis and lists of vendors and the lot numbers of raw materials in a retention room for at least five years and in some cases far longer. This allows the company to trace the origin of every element of every product should this ever become necessary, and also allows real-time stability evaluations based on product manufactured and stored in the ultimate consumer package. This added benefit instills extraordinary confidence in its clients worldwide.
Natural Alternatives not only develops and manufactures its own products utilizing Sustained Release CarnoSyn®, but the company is also an esteemed contract manufacturer. It has extensive experience in creating customized nutritional supplements for clients and is compliant with USFDA current good manufacturing practices (21 CFR 111).
In September of this year, it was announced that Natural Alternatives would be manufacturing nutraceutical products for the U.S. market on behalf of Australian company Gordagen Pharmaceuticals. The private company produces evidence-based nutraceuticals and pharmaceuticals. Gordagen’s first product is set to be sold in the U.S. next year with others to follow. Gordagen chose NAI based on its vast experience with supplements and its ability to handle the large batches of product needed.
“Gordagen is delighted to enter into an agreement with a manufacturer with significant capability, capacity and global reach,” said Gordagen Managing Director and CEO Dr. Glenn Tong. “NAI’s extensive knowledge of nutraceuticals and strong partnering philosophy will be a great support for Gordagen as we rapidly progress our U.S. market entry.”
NAI also has plans for expansion into the Australian market and is expanding its manufacturing and production in those areas to sell its products. “We are excited about the younger demographics in Australia and believe that will be an area of substantial growth opportunity for us in the years ahead,” LeDoux said. NAI is certified by the Therapeutic Goods Administration of Australia (TGA) which sets strict standards and tests and evaluates therapeutic products. Very few U.S. companies have secured TGA licensure, not to mention having held such licensure for almost 20 years.
The company thinks that better regulation to get the industry amateurs out of the nutraceutical market in the U.S. will vastly help enterprises such as NAI to prosper in the future.
“There are really multiple industries at the moment. There are those that are determined to do as they please as long as they can by flying under the radar, since, if they were to actually comply with federal law, they would not be merchandising what they do. There is another industry that is servicing mass-markets with adequate product, but which is largely commoditized. There is yet another marketplace where research, innovation, clinical evaluation and ‘pharma-light’ production reigns – and that is where NAI resides.”
The company works with reputable doctors and scientific researchers to develop formulations with proven abilities to improve or maintain health. It employs rigorous quality assurance testing and clinical research studies in an approach that both aids in marketing and gives consumers the confidence that the product they are purchasing does what it claims to do.
“One of our major concerns is the apparent lack of consumer confidence appearing in general in our industry,” LeDoux said. “We are working closely with government, regulators and industry trade groups to achieve a registry for dietary supplements not unlike the National Drug Code system overseen by the FDA.”
For the past thirty-five years, Natural Alternatives International has been a successful company and a force with which to be reckoned. Mr. LeDoux plans to keep the company growing by sticking to what has made it successful.
“You can succeed if you remain dedicated to excellence and are willing to continue reinvesting profits into your business. You just need a passion for excellence to coincide with mega trends in demographics in order to get started. We recognize our clients are also our friends, and we want to make sure we continue to earn their confidence in our abilities to help protect them from regulatory problems in the over forty markets we service.”