Just about everyone has something to say about a natural remedy or healthy food and beverage he or she tried or heard about, and it’s often positive. How can a consumer product brand not want to jump in?
There are many statistics out there showing vibrant growth year after year. According to the Council for Responsible Nutrition (CRN), in a release on Oct. 8, 2018, new market research “reaffirms trust and confidence” of American consumers. The report, conducted by Ipsos Public Affairs, found that 75 percent of American adults take supplements—compared to 65 percent in 2009. This doesn’t bring in the emergence of continued consumption of nutra-foods and beverages (eg, probiotic cereals and beverages containing CBD that induce relaxation and calm). The beauty is that consumers integrate all these into their daily lives to remain healthy.
It all begins with an idea immediately followed by R&D (research and development) the critical component that makes the difference between market success and market failure. Part of this process is navigating the regulatory environment. “R&D is critical to innovation and bringing new products that can benefit consumer health. Whether a formulation utilizes known ingredients or novel ingredients, science and regulatory must go hand in hand,” said Amy Mozingo, director of regulatory operations, GRAS Associates (a Nutrasource company).
In agreement is Ned Becker, CEO of Columbia Nutritional, a dietary supplement contract manufacturer in Washington. “Innovation in the dietary supplement space is a vital part of the growth of brands,” he stated. “Consumers are placing a greater emphasis on requiring higher quality, scientifically verified ingredients and products.”
Whether it is a botanical-infused breakfast bar, or a plant protein powder that helps hasten post-workout recovery, to anything in between, Joshua Baisley, vice president of clinical design and delivery, Nutrasource, advised to “start with the end in mind.” Figure out the desired product, its positioning and its claims—marketing, scientific, structure/function.
Also important to know, Mozingo stressed, compiling existing scientific literature to substantiate formulation development is typically the beginning of the process because the ingredient form and amount used must be justified through conclusions found in adequate scientific data to substantiate a claim.
If novel/branded ingredients are included in the formulation, Baisley continued, good clinical data in healthy populations is of critical importance. Two questions to answer about the research are: Was the study adequately powered to reach statistically significance in results? Do the results clearly support the desired claim?
Regulatory compliance of all ingredients in the formulation should be reviewed very early on. Identifying where the product is intended to be launched is key. Is the intended market the U.S. only, or is an international launch planned? This is very important as requirements for safety and efficacy vary in different jurisdictions. It may be necessary to conduct further clinical research on the finished formulation rather than relying on individual ingredient information. Nutrasource specializes in collaborating with companies in early stages on product development plans, providing a GAP analysis and executable plan to ensure preclinical and clinical requirements meet the objectives of the product profile, ensuring the formulation and claims for labeling meet the regulatory requirements for the U.S., Canadian and other international markets, and can assist with any part of the process.
At the contract manufacturing end, explained Becker, there are several factors that need to be addressed when developing a new product. Columbia Nutritional, he said, has developed a collection form and a new product onboarding process that captures all key information and then follows a refined process to ensure the finished product matches the brand’s concept.
“From price/cost targets to label claims to delivery forms, packaging details, testing requirements, stability study needs, etc., there is tremendous detail behind every development phase,” he explained. Once the specific product criteria are outlined, we go through theoretical formulation and engineering steps to provide a preliminary formula proposal. Once agreed upon, we move into a pilot production phase to ensure the engineering of the product will be transferred to our equipment to confirm its ability to run efficiently. All final specifications are then built and mutually signed off on before we generate the first commercial batch.”
There is a fast-filling graveyard of products representing good ideas and ethical missions, but which died on their way to market. Experts offer a few pitfalls to avoid. One, said Mozingo, is rushing to market without adequate safety proof, and/or regulatory and claims substantiation, which adds great risk to the company, not to mention the product. “Brand integrity is worth the time and investment to do it right the first time,” she said.
Becker asserted that one of the biggest mistakes his team typically sees is a brand wanting to “overload” a capsule/tablet with high active levels of ingredients that may challenge the size limitations of capsule shells or tablet tooling. Other aspects often overlooked, he added, are the physical characteristic issues of individual ingredients, as well as the combined ingredients. The physical characteristics such as density, particle size, moisture content and even potential variability in color from lot to lot can make an impact in how the formula will perform in the manufacturing process.
Also, there’s no need to believe that only all branded, proprietary ingredients are always superior to generics. When formulating, many generic ingredients make sense and cut back on cost if need be. “When published scientific literature can adequately substantiate a claim for a generic raw material, using a generic raw material would make sense,” Mozingo noted. “If a branded ingredient has gold standard clinical trials that show benefits above and beyond what currently exist for similar generic raw materials, then using the branded ingredient (at the same levels in which the benefits were achieved) add value to the product, justifying higher cost.”
Ingredient sourcing may cause anxiety as there are thousands to choose from.
According to TIC Gums, an Ingredion Company, in its article “Formulating Made Simple,” ingredient sources matter because “Consumers continue to show increased interest in the sources and purposes of the ingredients on their food labels. Those same consumers are also seeking foods perceived to be more healthful with such attributes as boosted levels of protein, vitamins and minerals. This combination of added nutritional elements with a limited label declaration intensifies the complexities formulators face.”
As a contract manufacturer, Becker said, Columbia Nutritional recommends new and improved ingredients and supply sources when necessary or desired. “We invest in gathering proper documentation to support all claims and dosing levels to ensure regulatory and quality requirements are being met. The raw material qualification process we perform ensures our customers that we have conducted our due diligence to help reduce their liability and meet agreed upon finished product specifications.”
Becker added that when determining whether to use a branded ingredient over generic, consider the position of the product and what claims you want to make about and on the product packaging. “Cost also can make a big impact, as branded ingredients are typically a premium, but most likely has clinical studies performed on their material that will allow the marketer to reference. If the consumer doesn’t see a true point of differentiation and views the material as a commodity, then the branded ingredient may not make financial sense.”
Color is an ingredient and an often overlooked one. Colors impact emotions and also generate recognition. For example, yellow is often attributed to citrus both in looks and flavor.
GNT Group, The Netherlands, recently announced it launched a new range of EXBERRY liquid and powdered red colors for foods and beverages. These new hues provide higher color intensities and contain just two raw materials, helping food and beverage manufacturers achieve shorter, cleaner ingredient lists.
According to Sonja Scheffer, GNT product manager, the new reds deliver colors that are 50 percent more intense, which means they can be used in lower amounts, resulting in reduced cost-in-use. The new EXBERRY reds include shades such as “Vivid Red,” “Purple Plum,” “Veggie Red” and “Brilliant Pink,” and are made from fruits and vegetables including carrots, blackcurrants, radishes, blueberries and sweet potatoes. All are suitable for vegetarians and vegans, kosher parve approved and halal compliant.
Texture or “mouthfeel” is also a critical part of formulation of new products, notably foods and some beverages. For example, TIC Gum’s Simplistica is a system that combines ingredients such as hydrocolloids, starches, plant proteins, among others to meet optimal ingredient functionality. TIC Gums created two prototype formulations with unique label needs: a snickerdoodle cookie using Simplistica BK 6202 and a coconut milk yogurt using Simplistica YG 3206. Innova Market Insights noted that 13 percent of consumers seek “free from” claims in their dairy-free yogurt—also, 25 percent of consumers enjoy plant-based dairy alternatives more than once a week. And, when it comes to snickerdoodles—well, many people love a sweet snack but still want it to be “better for you,” according to Innova Market Insights, as cited by TIC Gums—36 percent of consumers find gluten-free label claims important. They also seek reduced sugar and protein content.
These are examples that just touch the surface of significant things that need to be considered when entering the ever-widening and deepening ocean of natural health supplements, food and beverages. Everyone loves a new brand and a new product! NIE