Chill Out – CBD is everywhere

By Jennifer Keaveny

It seems lately that CBD is everywhere. The local coffee shop has CBD infused scones. The microbrewery down the street has a CBD beer. Your colleague is treating their migraines with CBD oil purchased online.  Being in the food and supplement testing industry for the past 13 years I have been able to watch the evolution of the Hemp and CBD market and how from a consumer perspective the lines are starting to blur between the traditional supplements and hemp and CBD products.

While it is clear that consumer demand is pushing this market forward the big issue is that Hemp derived CBD is not an approved dietary ingredient. This leaves the market in a bit of a regulatory black hole. The growth of this market has been said to be unprecedented by industry leaders with some estimates reaching as high as $16 billion by 2025. With the lack of regulations in this space how is the CBD market ensuring that there is quality and safety within the products?

It is apparent that there is buzz in the air with everyone in the food and supplement industry discussing CBD and Hemp.  From industry events to academic conferences the hot topic is CBD and Hemp. Not only are the side conversations and discussions being focused on hemp and CBD but I’ve seen a huge number of new entrants in the CBD space compared to last year. This includes established food and supplement companies who are exploring expanding their product lines to include CBD and Hemp.

While financial gains are driving the market growth it is becoming obvious is that safety and quality are becoming a large part of the conversation. The hemp plant has some unique properties that enable it to clean up the soil and environment around it.  Phytoremidiation is a term used to describe this process by scientist Ilya Raskin who tested hemp’s ability to accumulate heavy metals from soil in contaminated fields near Chernobyl in the 1990’s. While this is a promising aspect for environmental cleanup CBD producers want to ensure that the hemp that the CBD is being extracted from is clean from potential toxins in the environment such as heavy metals and pesticides. Residual solvents and microbiological testing also need to be considered due to various extraction and processing procedures.

In addition to potential contaminants the industry also needs to be mindful of the cannabinoid and terpene profile that is being claimed on each bottle of product. Each strain of hemp has a unique CBD fingerprint and it is important to ensure that the levels being claimed on the product are what are in there. This is especially important for THC from a legal perspective.

It is clear that this industry segment is not going away anytime soon. With the trends going towards safety and quality I am looking forward to see what the next 5 years brings for the CBD and Hemp market.

http://go.pardot.com/l/427292/2019-01-17/cbvxb9

The 5 Coolest Things We Did With Our Digital Portal (SampleKinect) This Year

By Nate Ensrud

A great digital tool can make a big difference in how you work with a vendor, and that’s definitely true with your contract laboratory.  Five years ago, we made our first attempt at building a great digital tool with the introduction of SampleKinect.  Since that time we’ve listened to our customers, and we’ve made several sets of changes, both big and small.  About a year ago, we mapped out the biggest set of changes yet, so here are the 5 things customers talked about the most to us.

  1. Streamlined Ordering

Customers told us that ordering was the toughest thing to do in SampleKinect, so we’ve built a guided order that makes it clearer and easier to get an order entered.  This includes separate steps for entering sample info, picking tests, and including specifications.  And now, each of those steps can be completed in one screen.

 

  1. Easier Repeat Ordering

For customers who work with Food Integrity and Innovation consistently, the easiest way to complete an order is to use previous samples, and simply copy the same sample info, test selections, and specifications.  This was always an option in SampleKinect, but we’ve made it easier to find with a shopping cart-style selection, and it’s now on the home page, to boot.

 

  1. Filtering Test Selections

We listened. Picking the right test for their sample was sometimes an unintended obstacle to completing an order, and they felt extra time was spent if they had to call their customer service associate (CSA). Good news! We’ve made it simpler. Users can now add the option to filter tests using the sample type. All they need to do is pick the type of sample to be tested, and then see only the tests that are applicable for that type of sample.

 

  1. Requesting Retests

One of the more common requests we have received from customers is to perform retesting on a sample or conduct an investigation and issue a report for out-of-specification results. Previously, this required a phone call or e-mail.  Well, we’ve greatly streamlined this process. We’ve added the option for customers to make these requests right in SampleKinect. Users can now see the results and quickly get retesting started and request an investigation report right in the SampleKinect tool.

 

  1. Status Checks from the Home Screen

Receiving an update on the status of their testing was something our customers wanted to know more easily. In short, when will they get their results?  Again, we’ve improved the ease for our users by adding a quick drop down for all in-progress orders that’s visible right from the home screen.  Now, it’s easy to check on expected timing as soon as you log into SampleKinect.

While we’ve spent the last year making some pretty big changes to SampleKinect, we’re not done.  We’d love to hear from you!  Customer feedback is the key to driving continued improvements in the tools we provide to you.  We plan to continue evolving the system as we become part of the Eurofins family.  So, if you have questions or feedback or requests for other changes, please contact your CSA or sales rep.

http://go.pardot.com/l/427292/2019-01-17/cbvxb9

 

A New Take On Innovation

A New Take on Innovation

By: Nate Ensrud

Working with a contract laboratory that focuses on innovation means you have a partner who will continue to deliver new ways to make your life easier. They can deliver better results, an improved experience, and enhance your output through meaningful partnership.

Innovation often means developing new methods – a trending ingredient, a previously unknown risk, new technology – but innovation also means something more. To us, it means that we are challenging ourselves to think critically about our testing, to discover the key that will unlock additional value for each of our customers. When seemingly unrelated innovations come together with this type of critical thinking, exciting things happen. Here’s one such story.

Let’s start, as we always do, with our customers. Truly listening to customers nearly always reveals the same critical factor to testing – time. Time is money, as they say, and the time that ticks by waiting to receive results from testing is a central concern. It impacts the ability of our customers to start using an ingredient in manufacturing, to release a product for sale, or to get their valuable products in the hands of their customers. We hear this time and again. Today, it is one of the first questions we ask about in our innovation planning: “Is there a way to take a test that may take three days to run and get it done in two days, or one day…or one hour?”

The topic of turnaround time in testing isn’t exactly a trending topic, but let’s talk about another challenge that is – sustainability. It’s not a buzzword. It is a central concern for every business, including for us and for our clients. Our long-term impact on the world around us weighs on our thoughts, now more than ever.  A laboratory may not be the first type of business or industry that comes to mind when discussing sustainability. After all, we don’t have big smokestacks or out of this world energy bills. Chemical use, however, is a huge component to running a large laboratory. Many are environmentally costly to produce. Like other industries, we seek ways to minimize our environmental impact while we continue to deliver results to our customers.

From these independent thoughts – turnaround time and sustainability — came one unique solution: Supercritical Fluid Extraction coupled with Supercritical Fluid Chromatography (SFE-SFC). Non-polar compounds can be difficult to test because they require complex, difficult extractions to prepare for testing. They are also incredibly common analytes of interest, because many vitamins and numerous contaminants are non-polar. The bottom line is this type of testing has historically involved lots of steps with lots of chemicals.

And now, here is the happy ending to the story of multiple challenges — SFE-SFC allows us to extract samples in a single step with minimal chemical waste, and because the steps are completed on the instrument, it means it’s done swiftly and efficiently. Just like we talked about in that discussion, the outcome of this innovation was indeed a test that started with two days of extraction and instrument time that can now be done in a matter of hours. Check, check and check!

Starting in 2019, Food Integrity and Innovation will offer this innovative testing utilizing the SFE-SFC technology on vitamins D2, D3, and K1 in supplement products. We’re also developing methods for common contaminants like patulin and aflatoxins, and we will continue applying this technology as often as is appropriate so that we can offer a host of faster testing with less environmental impact to our clients in the future. And you can bet, we’ll keep challenging ourselves, over and over, to think critically on behalf of our clients.

Beyond ID Testing

Link

Beyond ID Testing

The Need for Additional Testing Beyond ID Verification for Botanicals

 Specifications and Verification

There continues to be a focus within the dietary supplement industry on the requirement to confirm the identity of a dietary ingredient prior to use.  This has been near the top of FDA issued citations and many warning letters include this as an observation as well.  However, the industry has made great strides in this area from the inception of the dietary supplement cGMPS in 2007.  More companies have a better understanding for this requirement and the need for using scientifically valid methods for this https://blog.eurofinsfii.com/2019/01/scientifically-valid-id-testing-for-botanicals/.

Even though the industry focus in the area of identity verification has increased, it is also necessary to consider additional testing that is required for ingredients and finished products to fully comply with the regulations.

21 CFR 111.70 specifies that the following specifications must be established and verified for each component used in dietary supplements:

  • Identity
  • Purity, strength, and composition
  • Limits for contaminants

The above specifications also must be established and verified for each dietary supplement that is manufactured.  The best way to ensure specifications are met for ingredients and finished products is to test using an appropriate, scientifically valid method.

Botanical Products

Dietary supplement products containing botanicals have increased in popularity and because of this there has been much discussion within industry about how to accurately verify the identity of these dietary ingredients.  There are a variety of techniques including DNA barcoding, HPTLC and HPLC that all are appropriate in certain situations.  Aside from identity, the industry must be aware that specifications must be made for potential contaminants, and these specifications must be verified, ideally by testing.  As botanicals are very complex and diverse, understanding your ingredients is critical to ensure the appropriate specifications are developed.  Unfortunately, there is not a single method that will test for all potential contaminants so each potential contaminant must be identified and tested for using an appropriate method.  These potential contaminants will vary depending on material, but in general the following are most common for all botanicals and could be used as a starting point:

  • Heavy Metals (Arsenic, Lead, Cadmium, Mercury)
  • Pesticides
  • Residual Solvents – if ingredient is an extract
  • Microbiological

 

Other potential contaminants could be those from economically motivated adulteration.  This may include adding a “filler” to a botanical, replacing some of the target material with a cheaper botanical, or adding a pharmaceutical-type ingredient to improve the efficacy of a product.

As you can see, testing botanicals goes well beyond the id verification. Review your product to understand what additional tests may be needed to ensure quality and safety needed to ensure quality, safety, and compliance with applicable regulations.

Click here to learn more.

 

 

 

What does Agile Innovation really mean?

Ed Collins, Director, and Joyce Lizzi, Senior Director
Eurofins Food Integrity & Innovation, Sensory, Consumer Research and Product Design

The food and beverage sector, with its shifting and fragmenting consumer tastes, has started to use Agile principles that originated in the technology space.  The benefits of Agile Innovation are simple yet enticing – products that consumers love, delivered more quickly.  The principles sound basic, foundational even: Engage consumers early and often.  Refine and iterate rapidly. Collaborate as a team.  However, companies routinely struggle to apply these principles in their organization.

The race to market success in the food and beverage sector is often being led by newer, smaller, more nimble companies1. Large, established CPG companies who previously had a successful model have discovered that the success was largely based on scale. They were experts at executing stage-gate processes that were consistent and repeatable.

These established companies have responded by reducing R&D and new product development budgets. This has equated to some of the lowest R&D spends by percentage in any industry2, but companies have not adjusted their new product launch expectations. This leaves battered R&D and new product development organizations under more pressure with fewer resources than ever.

Could it be that the distinct and separate roles and detailed processes employed by these large organizations, the same processes that moved them forward previously, are now holding them back?

The answer seems simple, but simple isn’t always easy.  Even companies that are aware of the issue and try to bring Agile into their organization are failing.  The same disconnected, disparate functions, fear of early prototyping and consumer engagement, and focus on traditional metrics that stifle innovation combine to stifle Agile efforts as well.  To really succeed, companies need to look outside their organization.

Enter Eurofins Food Integrity & Innovation.  Bringing all of the pieces together in one place, our Agile Innovation process fits the changing landscape and successful solutions emerge. Focused expertise across all aspects of the process — product development, culinary , consumer insights, sensory evaluation, food safety, pilot scale-up and process development – produce a level of collaboration that is difficult to obtain when the roles of key functions have conflicting objectives.

With a unique position of having that rare combination of expertise in nimble processes, technical depth and broad expertise across the development spectrum, Food Integrity and Innovation becomes more than a vendor that only does what you ask. It has become a partner that thinks with you every step of the way.

We have had the opportunity to partner with some of the largest companies in the food and beverage market on product design projects. One case study reveals a company that identified an opportunity to enter a growing beverage space, an area they had no expertise, but needed to get to market faster than they ever had before.  They wanted help.

As we began the partnership, the first step was to bring together a small, cross-functional team with expertise in product development, culinary, sensory, consumer research, food safety, and process development.  They worked together, bringing shared knowledge and a singular focus. Next, consumers were engaged early – much earlier than in a traditional development process.  In a matter of a few days and weeks, rapid protocepts were developed, refined and vetted, and put in front of consumers for immediate feedback.

The product protocepts born out of this process balanced consumer preferences and the client’s tight nutritional and ingredient guardrails.  Throughout sensory discovery and prototyping and development Covance kept a keen eye on designing a great product that could be produced at mass market scale. Finally, products were developed for market launch and passed full consumer validation research.  At the test market stage, the products were the top-performing SKUs in the category.

The outcome? From a company that had a routine development time of 18+ months, the successful nationwide launch was conducted 9 months after project kickoff.  Quite a feat. The client was thrilled.

We have the expertise to guide companies through Agile product development in a true collaborative manner.

The unique blend offered by Food Integrity and Innovation is one of deep technical expertise in each of the skillsets required for innovation – consumer and sensory insights, creativity, product development, process development, and food safety. All one team who are all in on one result.  In the end, the products that are developed are on-trend, loved by consumers and ready for production.

To contact us please click the link below:

http://go.pardot.com/l/427292/2019-01-17/cbvxb9

 

1Lauster, S., & Veldhoen, S. (2016, December 21). 2017 Consumer Packaged Goods Trends. Retrieved March 30, 2018, from https://www.strategyand.pwc.com/trend/2017-Consumer-Packaged-Goods-Trends

2The Changing Landscape of Consumer Packaged Goods. (n.d.). Retrieved March 30, 2018, from https://www.cbinsights.com/research-cpg-trends-transcript

Scientifically Valid ID testing for Botanicals

Scientifically Valid ID testing for Botanicals
Jeff Stassi, Senior Program Development Manager
 
From the onset of the dietary supplement GMPs (21 CFR Part 111) back in 2007, a focus has been, and continues to be, on the mandatory requirement to confirm the identity of a dietary ingredient prior to use.  This requirement was at or near the top of citations issued by FDA for non-compliance as it became obvious that firms were unable or unwilling to understand the process by which to create identity specifications and to perform the appropriate analysis. Now over a decade later, the industry is getting better but still has issues related to this requirement.  One area that continues to be most problematic is using appropriate tests and examinations for herbal/botanical ingredients.  As we have discussed in previous webinars on this subject, we remind you of the definition of a scientifically valid method is one that is accurate, precise and specific for its intended use.
 
The FDA places an emphasis on the use of scientifically valid methods in the GMPs in 111.320, it reads:

 

  • You must verify that the laboratory examination and testing methodologies are appropriate for their intended use
  • You must identify and use an appropriately scientifically valid method for each established specification for which testing or examination is required to determine whether he specification is met.

 

It is also a big part of 111.75:

 

  • Before you use a component you must:
  • (i) Conduct at least one appropriate test or examination to verify the identity of a dietary ingredient, unless you petition the agency under paragraph (a)(1)(ii) of this section and the agency exempts you from such testing;

 

 
As botanical ingredients continue to increase in popularity and more people begin to rely on them for their health benefits, you can rest assured that the FDA will take a closer look as it is their sole mission to keep the food supply safe for the consumer.  So establishing a reliable quality control system for these types of ingredients is extremely important and an emphasis on proper testing is paramount.
So how does a firm establish the appropriate identity testing plan?
First you must understand the tools in the toolbox.  There are a number of techniques that when used appropriately can identify, or help identify herbal ingredients.  These techniques fall mainly into these categories:

 

  • Macroscopic and microscopic examinations
  • Organoleptic (color, odor, appearance, taste, smell)
  • Genetic (DNA)
  • Chemical analysis
  • Spectroscopy
  • Chromatography

 

All of these tools serve an important purpose in herbal identity testing, but only when applied in a scientifically valid way.  The more processed an ingredient becomes, the more complex it becomes to identify it. So understanding the tools and when to apply them is an important piece of the puzzle, and one tool may not get the job done. You certainly would not pull a screwdriver out of a toolbox to drive a nail in the wall. 
Secondly, it is important to understand how and when to use the tools at your disposal. A key step is to establish appropriate specifications on the ingredients you purchase so that the testing process can flow much more easily. Confirming these specifications through appropriate scientifically valid methods will help assure the quality of the finished product.  Remember, it may take more than one test to identify the material. In the industry it is known as an orthogonal approach, but it really comes down to performing as many tests or examinations as it takes to confirm 100% identity.  If a visual examination can identify an ingredient with 100% certainty, then that is scientifically valid and you will need no further analysis.  As ingredients are further processed, the likelihood of using only organoleptic techniques would not be appropriate and will require more sophisticated techniques. This may be the more complicated part for compliance as many firms do not have the proper scientific expertise to completely understand the ingredient and the testing that may go into it.  Use a laboratory that has that expertise and will work with you to establish the appropriate program.
 In summary, when producing quality products and minimize your risk of non-compliance, here are  some key points to consider:

 

  • Create a well-designed identity testing program
  • Create identity specification for all incoming ingredients
  • Use an orthogonal approach where needed
  • Use reputable suppliers for quality ingredients
  • Use only scientifically valid methods

 

Want to discuss scientifically valid testing specific to your product? Contact us at the link below!

http://go.pardot.com/l/427292/2019-01-17/cbvxb9

How Ready are Your Ready-to-Eat Products for the FDA Listeria Control Guidelines?

Welcome to a series of informational blogs where I will describe, decode and demystifyFDA Listeria control guidelines the FDA  “Control of Listeria monocytogenes (Lm) in Ready-to-Eat Foods: Guidance for Industry  Draft Guidance” (henceforth, The Guidance). These blogs will offer translations of The Guidance for minimizing Listeria incidence in your ready-to-eat (RTE) production environment and products. In this series, I will provide a section-by-section analysis translating the FDA recommendations into usable English and offering techniques to go above and beyond for those that are so inclined.  Continue reading

New FDA Labeling Regulations are Here – Are you Prepared?

Preparing for the New Nutrition Facts Panel Rules: 10 Tips for the Food Industry
Posted by Dan Berg, Food Scientist, Senior Client Program Development Manager

Most food manufacturers have less than 18 months to meet the FDA’s new rules regarding the revision of Nutrition and Supplement Facts Labels. At Covance, our food scientists have noticed that many manufacturers appreciate additional guidance on these amendments.

Based on commonly asked questions we’ve received in several key areas, we created this article to help educate manufacturers on how to meet the new regulations in the Nutrition Facts and Supplement Facts labels.

Continue reading

Solving Culinary Challenges with Custom Study Solutions

I am a scientist, and sometimes my workspace is more like a kitchen. For over 30 years, I’ve led custom research studies for companies needing scientific evidence that their food products are safe. Often that means meticulously recreating food Covance Food Safety Testing Heat Kill Studymanufacturing processes in the lab.

The importance of this work is obvious—ensuring food safety is critical for companies to protect consumers and their brand reputations. Although some situations require in-plant studies, with which Covance can also assist, there are reasons for conducting these studies in the lab rather than on-site.  Laboratory studies minimizeisruptions to manufacturing operations.  More importantly, they also avoid potentially introducing pathogens, spoilage organisms or surrogates into the plant during testing. Critically, they definitively yield scientifically valid results. Continue reading

A New Level of Brand Protection: Five Things You Need to Know About PDE5 Inhibitor Adulterants

The adulteration of dietary supplements with synCovance Supplement Testingthetic phosphodiesterase type 5 (PDE5) inhibitors can cause serious adverse health risks. Covance has introduced a new non-targeted analysis method using liquid chromatography-high resolution mass spectrometry (LC-HRMS) for screening and identification of known and novel PDE5 inhibitors in dietary ingredients and supplements, leading the industry and our clients to a new level of brand protection.

Below are five things you need to know about PDE5 inhibitors in sexual enhancement supplements and how to screen for these dangerous adulterants. Continue reading