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Optimizing the precision blending of supplements

Nutraceutical ingredients can be formulated into a wide variety of health-related products, including vitamins, supplements, mineral blends and foods like energy bars. Many of these formulations involve the fine blending of as many as 40 to 50 components, including powders and trace elements.

While nutraceuticals are not regulated like pharmaceuticals, the products still must substantiate label claims, and a number are tested in clinical studies like medicines.

Whenever a nutraceutical makes a label claim, like a specific recommended dietary allowance (RDA) or FDA allowances, vitamin percentages or active components, it must meet those criteria. Further, nutraceutical products must not only avoid doing harm, but also increasingly substantiate any claims or benefits.

One industry challenge is that the blending of solid ingredients is easier and more uniform if the ingredients are approximately the same size. However, it is difficult to create precise blends with trace ingredients (less than 1%) that are dissimilar in size and density. In some cases, this might require multiple key blends in a time-consuming and costly process.

Fortunately, with tumble blending equipment that is engineered to meet the requirements of the application, the process can be simplified to produce a precise, homogenous blend containing necessary components and trace elements in the specified amounts. Such blending can eliminate the need for key blends and produce a better distribution of active ingredients.

Limitations of Traditional Mixing Equipment

Traditional equipment such as plow, ribbon and paddle mixers, which use blades or paddles to push material, are limited to moving the material within the confines of their active area. The mechanics force the material bed outward, leaving dead spots inside the vessel where material moves more slowly or remains stationary. A stationary port at the bottom of such machines further isolates the material.

Another issue lies in the positioning of the intensifier bars, which should ideally be in the mixing zone, where every particle passes through. Many times, however, traditional mixers position intensifier bars in dead zones, resulting in material not being fluidized properly and active ingredients getting incorporated throughout the batch.

Traditional mixers can also waste expensive additives. Because additives initially contact only a small portion of material in the vessel, they get absorbed into the material bed, so more additives are usually needed to achieve the desired mix concentration, which increases cost.

Read The Full Article HERE

Product formulation with plant-based proteins

The increasing popularity of, and consumer demand for, plant-based foods has created a whole new set of challenges for product developers. Whether creating plant-based foods that eat like their animal protein counterparts or developing great tasting standalone plant-based products, the obstacles can be significant.

Formulating with plant proteins requires a juggling act when it comes to balancing the functionality, sensory impact, nutrition profile, regulatory status and cost impact of the various ingredients. Two main challenges unique to plant proteins include perfecting functional and sensory attributes.

Functional

Animal and plant proteins are very different in their structure and functionality. While animal proteins are fibrillar and fibrous and play primarily a structural role, plant proteins are less organized and are globular and play more of a functional role. This results in differences in analytical measures such as oil- and water-holding capacity, emulsion capacity/stability, and foaming capacity/stability along with corresponding functional differences in gelation, emulsification, water/fat retention, matrix formation, viscosity, etc.

Protein content and quality also differ significantly between animal and plant proteins. Animal-sourced proteins are complete—containing an adequate proportion of each of the nine essential amino acids. Plant-sourced proteins—with the exception of soy—typically are not complete proteins and must therefore be strategically blended with other complimentary proteins to achieve the desired amino acid composition.

Sensory

In addition to structural differences, plant proteins each have their own unique flavor volatiles that often require masking or manipulation. These volatiles can include earthy, grassy, beany, “green,” hay, cardboard and “dirty,” just to name a few. Texturally, plant proteins can differ significantly, with some being dry and chalky, and others being described as gritty or sandy.

In terms of adding flavors to plant proteins, one faces not only the challenges of masking the undesirable flavors mentioned above, but also is challenged with the flavor “dampening” (binding) effect that plant proteins have. Plant proteins will require bolder and more impactful flavors (and possibly a higher usage rate for seasonings and flavors) to compensate for this dampening effect.

While the increasing popularity of food products made with plant proteins does present some new and unique challenges to the product developer, there are flavors, functional raw materials and processing methods that are available to successfully work through these challenges. Given the rapidly increasing consumer demand for new plant-based food products, flavor and functional ingredient suppliers are responding, and are constantly developing new solutions for food and beverage manufacturers.

Read The Full Article HERE

Applying the ‘E’ for joint health

Whether it’s an aging Boomer, an overworked Gen X weekend warrior or an active Millennial, maintenance joint health is increasingly a top daily concern. It’s a concern that spans generations and is driving consumers to seek out great information on natural solutions. Which raises the specter of the “E” in DSHEA.

That “E” stands for education. The concept behind the Dietary Supplement Health and Education Act of 1994 (DSHEA) was not only that dietary supplements were safe, but they are beneficial. That “E” stands for the opportunity to educate the consumer, and the law allows education to be available. Consider the critical discussion regarding claims for dietary supplements. That special allowance is present so that meaningful—as well as truthful and not misleading—educational information could be delivered to consumers.

Of course, there is a challenge with that when it comes to the topic of joint health. Even looking at this challenge from two widely different angles, the challenge is simple: Claims about joint health are tough to make. Add to this the desire to discuss the substantiated potential of some nutrients to affect minor pain and inflammation, but also the cost of such substantiation, and what we see in the market is more borrowed science that still doesn’t comply with the law.

FDA several years ago determined that inflammation claims were generally equivalent to disease claims, with few exceptions. When considering the limited potential for presenting acceptable pain relief claims and the preclusion of discussion of joint health, we have a claims quagmire. Substantiation alone for joint health support is challenging since most clinical endpoints would be either too long to measure realistically (populations with dietary components and statistically significant effect on joint health) and/or require evaluation of who would be considered “diseased” individuals. That substantiation, in FDA’s current thinking, is not appropriate.

However, I believe we can educate the consumer in those areas with the relative regulatory impunity; the emphasis in the approach lies in the “E” portion of the acronym and other allowances within the law.

Read The Full Article HERE

Certification Fatigue: Is it really a thing?

Yes, it is. No question. Just ask a few of your customers. It seems every month a new certification seal pops up. For the end consumer, excessive certifications are an alphabet soup of buttons and badges that make their eyes glaze over after a brief encounter with a digital or print ad, sell sheet or scrolling web page.

Do Certifications Add Value to Brands?

In moderation, certifications can add credibility and legitimacy to a brand offering. They also add an implied third-party endorsement, which matters greatly to end consumers. In the past decade, in particular, as transparency has become of greater concern for consumers and customers, certifications add a note of authenticity to a brand by assuring buyers the brand made the effort to validate for certain standards.

How Do Claims Differ from Certifications?

For many customers and consumers, the line between claims and certifications is increasingly blurred, mostly because marketers have invented their own terms and seals and wording that make it difficult to discern what is a legitimate third-party certification and what is “marketing speak.” Common claims include “no artificial ingredients,” “all natural,” “no high fructose corn syrup” or “clean label,” to name a handful. These can be marketing statements or claims, and while FDA, FTC or a class action lawyer might take offense to how a brand makes these assertions, most of them go unchecked without an agency enforcing compliance. Certifications are more formalized third-party endorsements with strict standards for compliance, such as USDA Organic, Non-GMO Project Verified or NSF certified. 

In terms of the role they play, claims primarily serve to address potential consumer concerns, dietary restrictions, or attract those on an elective diet regimen like ketogenic, paleo, vegan, gluten-free, etc.  Certifications serve to reinforce product or ingredient quality, and also to build trust and equity in the brand name.

What Causes Certification Fatigue?

Increasingly, effective marketing outreach has revealed (often the hard way) that when it comes to brand education, sometimes less is more. A target audience member only has so much time and attention to devote to a brand message, and the more information crammed into each point of contact, the more likely consumers or customers are to tune out or move on or delete or click “close.” Brands that “over share” are often not the ones that successfully engage consumers because, frankly, they are throwing way too much at an audience that likely doesn’t care.  Smart marketers are selective in what they share and where they share it. This applies to certifications as well. I would argue a stream of 10 miniscule certification seals or logos is dramatically less effective than three or four key certifications that mean something to the customers or consumers who buy or consider buying that brand.

In addition, detailed certifications don’t belong on the principal display panel (PDP) of a label. They belong on the brand’s website or literature where they can be showcased and explained. Because, let’s be honest, the majority of consumers likely can’t define what non-GMO means, and non-GMO and USDA Organic are commonly confused even though they are not at all the same thing. If all the money spent educating consumers about these big time certifications is producing lackluster results, it should cause concern about the other dozen claims and seals plastered all over every piece of marketing communication.

Read The Full Article HERE

GMP standards evolve for supplement manufacturers

Supplement contract manufacturers are critical in the supplement industry as evidenced by the regulatory actions taken over the last decade. This decade of increased awareness for the element that best helps maintain a robust industry has dramatically changed the landscape. The implementation and enforcement of GMPs (good manufacturing practices) for dietary supplements is the impetus for this shifted landscape. That change continues even though what we are experiencing is a fermata relative to manufacturing scrutiny. This kind of pause in regulatory activity among contract manufacturers is temporary.

The first decade of de facto enforcement of the dietary supplement GMPs is complete. Contract manufacturers should not be getting warning letters detailing inadequate responses to inspectional observations regarding basic GMPs. Yet, warning letters continue to be issued to outlier companies that still cannot perform the basics.

Manufacturers that demonstrate quality and compliance in the industry must understand that the regulations detail “good manufacturing practices” not “perfect manufacturing practices.” While these regulations represent the minimum standard, they are not a complete definition of procedure, process or performance expected during daily operations. They are, however, subject to interpretation, and this is where the future lies.

While operation may run smoothly and fully comply with the regulations—based on past inspections and a lack of regulatory activity—more will be expected. Even without outstanding regulatory issues, contract manufacturers have opportunities for improvement or optimization. The status quo isn’t enough. FDA expects continuous quality improvement. The next rounds of inspections will delve deeper into the level of compliance outlined in GMP regulations, but also against FDA’s view and interpretation of them. Manufacturers can anticipate inquiries into how specifications are established and at what stage of manufacture are they applied. The next rounds of inspections will want to know how the identity of a dietary ingredient is affirmed through adequate testing. FDA will seek to understand the basis that a test method is scientifically valid. The next rounds of inspections will want to know more about the specifications for the identity, purity, strength and composition of the finished, packaged product. The devil will be in the details.

The common practice of exempting one or more specifications from testing at the finished product stage of manufacturing needs to be justified. That means controlled data and documentation. Details are needed on the identity of any blend of materials a contract manufacturer receives. Details are needed on the determination of critical control points exist within the manufacturing process.

Continual improvements in GMPs will be more closely evaluated in the laboratory area, if a contract manufacturer tests products itself or works with a contract lab. FDA will want to know how that laboratory is qualified, and the agency may note the location of the laboratory for follow-up.

Read The Full Article Here

All natural products imports from China face higher tariffs

An already tariff-weary natural products industry will face elevated tariffs on nearly all ingredients and materials sourced from China, if a fresh 10% increase on the remaining US$300 billion in imports from China goes into effect Sept. 1, as promised by President Trump in his ongoing trade war.

The Trump Administration proposed the tariffs earlier this summer and held public hearings in June. However, the tariffs were put on hold after Trump and China President Xi Jinping met at the G20 Economic Summit in Japan in late June.

The tariffs would include the remaining imports from China not on the earlier three lists of punitive tariffs, some of which have elevated from an initial supplemental 10% to 25%.

The challenges for industry include how to deal with the elevated costs and possibly find non-Chinese sources of ingredients, whether another country or creating domestic supply. However, finding new sources can be nearly impossible for some ingredients, especially agricultural items that grow in certain climates and conditions. Further, it can take years to develop domestic sources of materials and ingredients that were almost exclusively imported for years and decades.

Read The Full Article HERE

GMP and FSMA rules compel close supply chain supervision

Supply chain management involves the careful oversight and organized handling of a product’s development flow, from purchase and receipt of the raw materials to its manufacturing, testing, label development, labeling, packaging and distribution processes with the various service providers in each segment of the supply chain.

Supply chain management is crucial for contract manufacturer selection because of FDA’s recent focus on the requirements under the Food Safety Modernization Act (FSMA), signed into law in 2011—rules that require firms to register their food facility in response to the Bioterrorism Act of 2002. The Act additionally gives FDA the ability to provide critical attention to “improved information management” to help protect the food supply. Under FSMA requirements, firms are required to have a written supply chain program. Not only “food firms,” but dietary supplement firms (i.e., own label distributors and contract manufacturers) as well, must comply per 21 Code of Federal Regulations (C.F.R.) 117 Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food – Subpart G – Supply Chain Program.

In brief, Subpart G is comprised of eight sections:

  1. §117.405—Listing the requirements to establish a supply chain program;
  2. §117.410—General requirements applicable to the program;
  3. §117.415—Responsibilities of facilities that manufacture/process a raw material or other ingredient that it receives from a supplier (known as a “receiving facility”);
  4. §117.420—Use of approved suppliers;
  5. §117.425—Determination of appropriate supplier verification activities (including determining the frequency of conducting the activity);
  6. §117.430—Conducting supplier verification activities for raw materials and other ingredients;
  7. §11435—Performing onsite audits;
  8. §117.475—Records documenting the supply-chain program.

In addition to these regulations, FDA issued a guidance document [link “guidance document” to https://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM583490.pdf] in November 2017 to assist the industry in understanding the necessary roles and responsibilities and areas of enforcement.

Read The Full Article HERE

Seeing suppliers as true partners is key to successful business continuity planning

A business continuity plan is essential for every company, but this is especially important for contract manufacturers that depend on outside sources for ingredients and packaging components. With the globalization of the industry, and the way the nutraceuticals industry’s supply chain works across international boundaries, and with late delivery potentially causing a halt in the manufacturing process, contract manufacturers must have plans in place to ensure smooth operation. Contract manufacturers rely on raw material vendors and packaging suppliers to make products, so it is imperative that the finished brands know that their contract manufacturers have a plan to deal with out-of-stock situations. Addressing any issue, whether it is from a distribution error or logistical delay, manufacturers must continue to provide brands with consistent on-time delivery.

The industry must adhere to GMPs (good manufacturing practices) and proactively mitigate risk. This means not only making primary suppliers accountable to very high standards (i.e., strict incoming raw material requirements), but also pre-qualifying secondary and tertiary suppliers.

Working with suppliers closely to verify that raw material requirements are being met is a key factor, but the relationship also has other benefits. A well-researched and reliable supply chain should lead to excellent two-way communication. For example, being warned promptly of any likely delays or issues gives more visibility and extra time to make other arrangements, which means contract manufacturers can continue to supply products on time.

Both consumers and brand owners have an understandable increased interest in the integrity of the supply chain for nutraceuticals. The types of ingredients that go into the product and the fillers or additives used are increasingly drawing consumer attention. For example, consumers want to know if supplements are vegetarian, non-genetically modified organism (GMO) and/or natural. These issues are more acute for brand owners, and they need assurances about the ingredient’s purity and identity as well as heavy metals and microbial content to ensure the highest quality finished product.

Building a true partnership with suppliers means they look after contract manufacturers’ interests and communicate information about new, trending ingredients so that manufacturers can continue to innovate for brand owners. In fact, through these partnerships on many occasions, contract manufacturers are among the first to hear of new ingredients coming to market.

Moreover, it is always good practice for brands to ask their contract manufacturers about their relationships with suppliers. Brands should ask questions about the strength and length of their relationships, and inquire about the systems they have to check beyond the certificate of analysis (CoA) that is normally provided by the vendor. Another important question to ask is if contract manufacturers use a trust and verify policy with ingredient suppliers; i.e., do contract manufacturers test incoming batches and undertake onsite audits at least once every two years?

Read The Full Article HERE

Where is innovation in sports supplements?

Food and beverage delivery have grabbed much of the cool factor attention in the sports nutrition market. However, the most bang for the buck is still in supplement form, which can deliver higher amounts of beneficial ingredients for building muscle and improving recovery/adaptations, among other body goals. Where supplement brands have a tougher task in innovating delivery—will gummies infiltrate the sports supplement space?—they can create unique products in areas such as formulation and flavor.

How is your brand innovating in the sports supplements market? NEXTY Awards at SupplySide West 2019 is a chance for such brands and products to win recognition for quality innovation.

Flavor licensing is one area where some brands are winning consumers. While pre-workouts that break free from the usual common citrus flavors to bring candy or mocktail flavors, for example. Protein powders that go beyond the Neopolitan ice cream flavors to bring a wider array of dessert (think pie) and indulgent flavors (e.g. crème brulee and hazelnut latte).  

Industry market specialist Josh Schall, J. Schall Consulting, explained Man Sports first introduced flavors based on famous candy brands like Sour Patch Kids and Starburst, but the company had to use similar sounding names. Then Ghost Nutrition licensed actual consumer brands such Warheads, Swedish Fish and Chips Ahoy. Licensing flavors is part of what Schall calls creating an exclusive experience for consumers.

Schall and Ghost CEO Dan Lourenço will present during SupplySide West’s sports summit, Finding New Pathways in Sports Nutrition, on Wed. Oct. 16 in Las Vegas.

Novel and emerging ingredients may also help sports supplement brands standout. This is a bit harder to do on the protein side, even with the slight whey protein tweaks like native and grass-fed whey. New Hope’s NEXT data analysis (based on Expo West exhibitors) has shown a big dip in innovation in the whey, casein and milk protein categories, with more opportunity for these ingredients in food and beverage. Egg protein was the only animal protein showing positive innovation numbers in supplements. Most protein innovation activity in supplements was on the plant side, with pea and rice dominating and hemp lagging—a real opportunity area, NEXT said.

Read The Full Article HERE

Food and supplement industries battle sharply higher tariffs

The dietary supplement and food industries face continued tariff challenges, including a recent increase to 25% for many dietary ingredients imported from China and new retaliatory tariffs from India on nuts and produce coming from the U.S. Industry leaders, including several trade associations, have fought the tariffs via Congress, submitting comments and participating in public hearings on the China tariffs, but exclusion from the tariffs is far from a guarantee.

President Donald Trump and China president, Xi Jinping, agreed at the G-20 economic summit in Japan on June 29 to refrain from imposing any new tariffs while they restart trade talks. This puts a halt to the pending List 4 tariffs that would essentially cover the approximately US$300 billion in remaining imports from China not included in the first three lists of tariffs, including several dietary ingredients—many other dietary ingredients appeared in List 3.

While the Trump administration approved an exclusion process that will apply to the many dietary ingredients already subject to the higher tariffs, the exclusions for the earlier waves of tariffs were few and took a long time to process.

At G-20, Trump also spoke to India’s Prime Minister Nerendra Modi about the recently enacted tariffs by India on nuts and produce imports from the U.S., including apples, walnuts and almonds. The tariffs were widely seen as retaliation for the early June removal of India as a U.S. preferred trade partner—the Trump administration said India did not give the U.S. “equitable and reasonable access to its markets.”

Read The Full Article HERE

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