Under Contract

Tweet

When considering new products or relaunches, contract manufacturers help guide brand marketers to success.

Contract manufacturers really do know it all—well, at least when it comes to the dietary supplement industry, they are on the frontlines of the regulatory environment, trends and technology.

There have been interesting areas of growth, as several have witnessed. According to Chris Martin, vice president of operations for Georgia-based Deerland Enzymes, consumer buying patterns are frequently affected by both condition and age, and the company, he said, continues to see its customers seek more “robust, condition-specific product formulations.” Brand marketers are increasingly looking to include enzymes and complementary ingredients that will work together to support a specific health condition. “Digestive health is a good example; one robust formula to support digestion can include enzymes, probiotics, prebiotics and even botanicals, vitamins and minerals. These types of product formulations are ideal, freeing the consumer from having to take several different single-ingredient supplements as part of their daily regimen.”

Further, Martin sees the digestive segment of our market is growing at a higher rate than the supplement industry as a whole because research into the gut microbiomeand how it affects overall health is accelerating. “Many researchers believe that supporting digestive health and restoring the integrity of the gut barrier will be one of the most important goals of health professionals in the 21st century,” he added.

Emek Blair, PhD, chief scientist for Valimenta Labs of Colorado, observed that increased absorption and bioavailability segment is “outpacing the industry, at large, dramatically.” Products such as liposomes and other high bioavailability delivery systems provide market differentiation through increased performance. He added that significant science supporting these products allow for fact-based marketing to connect with consumers.

Brand marketers seeking to add new products or renovate existing lines have numerous exciting opportunities available to them. There are also several considerations to keep in mind.

John Altenberg, vice president of sales for California-based Vit-Best Nutrition, advised to have a clearly defined consumer position. When choosing a contract manufacturer, he said, “priority factors should include demonstrated and consistent quality processes and outcome, a culture that seeks and provides solutions, direct industry experience, and management that conveys trust.”

Consumers expect consistent taste and appearance in their favored products, as well as a continual stream of diversity, according to Jan Thoele, executive vice president of SternMaid America, Illinois. If a product fails to meet consumer standards or satisfy expectations, they will quickly find an alternative. “For manufacturers, this means focusing on quality, reproducibility and operational flexibility,” he said. This requires state-of-the-art equipment, complete control over the production process and formulas, contamination prevention and full documentation of every batch that leaves the plant.

According to Martin, a prime objective should be achieving efficacious synergy with complementary ingredients. It takes extensive knowledge and experience working with enzymes and/or probiotics when formulating for supplements. Further, when formulating a multi-component supplement blend, challenges may be arise in fitting effective doses of all the ingredients into a predefined amount of space (capsule). “Also, ease of swallowing is a key concern among consumers, and we address this issue by formulating with very concentrated enzymes and/or probiotics, which reduces the size of the capsule or tablet,” he said.

Although FDA (U.S. Food and Drug Administration) compliance, cGMP (current good manufacturing practice) certifications, and high quality/purity are a given, noted Blair, it is always helpful to have a common thread throughout the product line such as “made in an allergen-free facility” or “made in a gluten-free facility” as those are areas of increasing consumer demand.

Raw materials, he added, are important details to be aware of. “What type of ingredients are being sourced by the manufacturer? For instance, when using magnesium citrate, is it magnesium citrate fortified with magnesium oxide or is 100 percent reacted magnesium citrate?” This impacts quality and efficacy.

Changing Regulatory Environment

There are several significant upcoming regulations and issues that will likely impact production.

According to Thoele, this September, the majority of food producers and manufacturers needed to have a food safety plan in place that has been prepared by a preventive controls qualified individual (PCQI). The PCQI, he explained, is a qualified individual who has successfully completed a training program in the development and application of risk-based preventive controls, which is in line with FDA’s Food Safety Modernization Act (FSMA). The PCQI ensures that both customer and regulatory expectations are met during the manufacturing process. “The simple steps of requiring preventive controls and, at the same time, food manufacturers to have a PCQI, facilitates supplier control for our customers,” Thoele said.

By 2017, pointed out Martin, dietary supplement manufacturers must be compliant with the FSMA. “For companies like ours who have made investments to achieve and sustain GMP compliance, quality really shouldn’t be impacted all that much,” he assured. “On the other hand, for those companies who have not been strictly adhering to GMP guidelines (and unfortunately there are still some out there), clearly the quality of their products will be impacted. For that reason, I believe that ultimately these new regulations will change the way many companies do business, and in turn improve the overall quality of the end products for the consumer.”

Martin reported that are two main additions that Deerland Enzymes will make in order to comply with FSMA. Food defense training is a food safety and defense plan that will be required for all employees; its goal is to empower employees to help guard against any type of adulteration, whether intentional or in process.

“Another significant addition will be video cameras and monitors installed in all production areas; Deerland Enzymes has already begun the evaluation to plan for installation ahead of the federally mandated deadline,” he related.

In Blair’s view, One of the most significant regulations that has started taking effect is the new RDA (recommended daily allowance) and facts panel that will be required by 2018–2019. “Every brand owner needs to create a plan to transition to the new regulations by their deadlines. Without being active, you could find your products out of compliance overnight,” he warned.

What’s New

Blair reported that Valimenta Labs recently published the first peer-reviewed clinical trial showing that its liposomal technology, using liposomal vitamin C, increases absorption of vitamin C and prevents oxidative damage during ischemia reperfusion injury (the type of injury that is experienced during cardiac events). This article appeared in the Journal of Nutrition and Metabolic Insight and a summary is on the company website. In tandem, he added, Valimenta Labs launched its liposomal vitamin C, in 30-packet boxes.

“More clinical studies will be coming out on our liposomal glutathione in regards to mercury and heavy metal detoxification along with data on liposomal curcumin and other ingredients,” he revealed. “And we are the only liposomal manufacturer that is cGMP certified specifically for liposome manufacturing.

Recently, SternMaid America’sfood safety management system has been certified according to FSSC 22000, noted Thoele. “On a product-by-product basis, we can also offer non-GMO (genetically modified organism), gluten-free, vegan, kosher and halal certified foods. And, furthermore, we will soon receive a certificate for the manufacture of organic products. We’re also in the process of obtaining current good manufacturing practice certification.

Additionally, Sternmaid America invested in another blending machine for pilot trials and for the production of batch sample quantities (25-200 kg). The facility will start production by the end of 2016. An extension of its co-packaging capabilities is also planned.

To accommodate the growing demand for high quality probiotic supplements, Deerland Enzymes is expanding its manufacturing capabilities by opening a new, state-of-the-art facility dedicated to probiotic supplement manufacturing. The new facility will be focused solely on producing probiotics in their ideal environment.

According to Martin, the state-of-the-art facility will feature strict environmental control of temperature and humidity, enhanced by sophisticated thermal and airtight building materials. Production suites are constructed of a cleanroom system in which the walls themselves have antibacterial properties. The warehouse includes a walk-in freezer for storage of finished goods, and refrigerated storage of raw materials. The linear flow floor plan design of the facility eliminates over-handling and waste, from raw material receipt to finished goods storage.

Deerland Enzymes is continuing to invest in clinical studies and develop science-backed formulations. At press time, Martin reported, the company completed double-blind, placebo-controlled, randomized clinical studies for DE111, Glutalytic and ProHydrolase, and others are currently underway. “The entire supplement industry is going through a time which could be characterized as a ‘clinical revolution,’ in which the demand for clinical validation for dietary supplement products has never been higher,” he observed.

The industry continues to innovate because that’s what consumers are demanding. Whether it’s a completely new product or line, or a renovation of such, contract manufacturers are more able now than ever to ensure your brand’s success of safe and efficacious products. NIE

Sidebar:

What’s Trending

Contract manufacturers often see trends develop and can predict to an extent what may have staying power, which can certainly validate brand marketers’ investments in production.

Jan Thoele, executive vice president, SternMaid America, Illinois, is seeing personalized nutrition as gaining in appeal and therefore, there are some strong opportunities in this space. And, he believes that it is simply a matter of evolution: “Today, everything is personalized—the internet, advertising, etc., so why not nutrition? Why take a multivitamin product, for example, when your doctor or nutritionist has discovered that you only have a vitamin A and E deficiency, for example?” he commented.

Personalized nutrition, he added, offers manufacturers the chance to develop an ongoing relationship with consumers. This benefits both suppliers, who can build a loyal customer base, and consumers, who obtain what they deem is a valuable personalized service. “More and more people are putting a much stronger focus on what they eat. What with ‘clean label,’ organic and vegan growth, consumers are increasingly aware of what constitutes a healthy diet,” he observed.

Chris Martin, vice president of operations for Deerland Enzymes of Georgia is seeing three product categories in increasing demand—gummies, gluten-free supplements and protein supplements.

He reported that an increasing number of the company’s customers are interested in using flavored gummies as a delivery system. Consumers are more likely to stick with taking their supplements when they look forward to enjoying them in the form of a gummy. Its probiotic, DE111 strain of Bacillus subtilis remains viable under a wide temperature range and processing conditions because of its spore-forming ability, making it a good choice for products like gummies.

“Many of our customers have begun to focus on developing products for those with gluten sensitivity, many of whom experience symptoms that manifest in multiple ways. Deerland Enzymes’ Glutalytic swiftly breaks down gluten proteins and it targets both the internal and external peptide bonds of gluten,” Martin said.

“Protein supplements continue to grow in popularity,” he continued. “While whey has been a mainstay, the demand for plant-based proteins such as soy, rice, hemp and pea is on the rise. ProHydrolase has been shown in two clinical studies to break down protein into smaller peptides in order for it to be used by the body for muscle recovery as intended, and also reduce potential for digestive discomfort.”

For More Information:
Deerland Enzymes, (800) 697-8179
SternMaid America, (630) 270-1100
Valimenta Labs, (970) 825-5173
Vit-Best Nutrition, (714) 832-9700