Natural Products Insider

JUL-AUG 2019

INSIDER is the leading information source for marketers, manufacturers and formulators of dietary supplements, healthy foods and cosmeceuticals. Since 1997, INSIDER has been serving the needs of the global nutrition industry.

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38 INSIDER July /August 2019 One of the many challenges associated with creating supplement formulas that meet consumer demands is including the amount of active compounds that is scientifi cally shown to impart health benefi ts. Adding effi cacious doses of ingredients to supplements comes with cost implications and dosage size constraints, both that lead to unfortunate alternative choices. For consumer safety, brands must also apply rigorous scientifi c standards for purity, potency and effi cacy in designing these products. Some companies suggest a nominal inclusion of a popular substance only to regret it once the product makes it to commerce. For example, having a base supplement of vitamins and minerals, and including a small quantity of natural phytochemicals, e.g., lutein or zeaxanthin—to convey a sense that this product is intended to help people with ocular challenges—can lead to consumers not experiencing their anticipated benefi ts. When the science indicates a specifi c dose demonstrates positive results, but brands place in micrograms instead of milligrams, consumers can be disappointed with the lack of results. One 2006 study conducted on lutein in elderly patients with or without age-related macular degeneration (AMD) was reported in 2007 in Investigative Ophthalmology & Visual Science (47[12]:5227-5233). The fi ndings showed the concentrations of serum levels of lutein were dose dependent, and a later study found lutein more benefi cial than beta carotene in addressing ADM, a signifi cant concern among the population (Ophthalmology. 2012;119[11]:2282-2289). Another area that bears scrutiny is the adoption of proprietary blends, which should list the components of the blend by weight in descending order of concentration. However, if the product is intended to convey benefi ts based on research demonstrating a minimal concentration of the nutrient or nutrients, the consumer doesn't know whether these minimal levels are present in the proprietary blend. Companies making products should utilize doses of nutrients that align with the research fi ndings of peer-reviewed published studies. Greater emphasis should be placed on studies with more than a handful of participants, or studies that have replicated prior fi ndings on different populations. Another example of this is in the product known as CarnoSyn beta-alanine (from Natural Alternatives International Inc.). While many companies deploy this patented and FDA new dietary ingredient notifi cation (NDIN, #1103) product in their pre- or post-workout supplements, the disclosure of dosage is often not readily evident, particularly if the material is presented in a proprietary (nondisclosed) blend. The research is clear that the minimal daily intake required for amateur football players to receive a benefi t is 3.2 grams (3,200 milligrams) per day (J Int Soc Sports Nutr. 2012;9:39). Taking a product with less than this amount does not equate with the effi cacy found in the more than 50 scientifi c studies. Brands should not offer products that don't list key ingredients by content per dose, nor should they make claims that aren't supported by evidence determined in clinical trials conducted on the exact formulation. FTC has been actively enforcing truth in advertising laws against several companies that have made signifi cant claims, apparently without adequate substantiation. The category loosely known as probiotics, with freeze-dried bacterial organisms—often attributed to strains utilized to create yogurt or other milk byproducts such as kefi r—has been exploding in popularity. However, experts are concerned with the potential lack of viability of these products if they are not handled carefully in temperature- and humidity-controlled environments, or if they are stored in hot conditions that could lead to these fragile organisms dying. While considerable research has been conducted on many of these strains, challenges remain to provide consumers with viable products. Packages that declare how many millions or billions of these tiny organisms were present at the time of the product being produced are important, but what is vitally important is the number of live organisms the consumer expects when he or she consumes the product at or near the end of the shelf life. Clearly, great care must be exhibited during the processes from creation of the culture, to freeze-drying, blending, encapsulation, packaging and transporting to the end user. Spikes in temperature in the supply chain can render the product of limited value, so the entire supply chain from producer to consumer needs to be monitored. The proof of the value of the product rests with the happy consumer who receives the expected benefi ts. In a world of caveat emptor (let the buyer beware), producers need to know consumers are inclined to support and embrace products that provide effi cacious doses of desired nutrients as these consumers seek to extend their healthy lifestyles. Failing to recognize this key reality can lead to unfortunate outcomes and a decline in business success. Mark A. LeDoux is founder, chairman and chief executive offi cer of Natural Alternatives International Inc. (, an organization established in 1980 with facilities in the U.S. and Switzerland engaged in the research, design and manufacture of nutritional supplement programs and products for multinational clients. LeDoux has been a proud member since 1980 of the Natural Products Association (NPA) based in Washington, currently serving as chairman of its board of directors. Contract Manufacturing: Efficacious Doses Using Scientific Substantiation to Ensure Efficacious Nutrient Doses by Mark A. LeDoux

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