Whitepaper: A Pet Project – Supporting Digestive Health in Companion Animals

According to the American Pet Products Association, more than 97 million U.S. households own at least one dog or cat. Americans will spend more than $70 billion this year on pet supplies and care.

The pet health supplement market is predicted to show continued growth as pet families want their dogs and cats to have the same preventive health options as they do. Download this whitepaper to learn how enzymes and probiotics help support digestive health for our furry friends.

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Whitepaper: Cultivate Your Success – How to Choose the Right Manufacturer for Your Probiotic Supplement Product

To take full advantage of the growth of the probiotic market, brand owners need to meet consumer demands for transparency and accountability—which is easily accomplished when partnering with the right manufacturer.

The retail value of the U.S. probiotics market is expected to climb 38 percent by 2021. Because they are living organisms, probiotics have unique handling needs at every stage of the manufacturing process. Some of these include environmental controls, batching, blending, packaging, storage and shipping. This whitepaper outlines key considerations for choosing a contract manufacturer that has expertise producing probiotic supplements.

  • Building construction, layout and monitoring are key components of environmental control.
  • About 30 steps are needed to properly turn probiotic material into a viable supplement.
  • Onsite testing and third-party verification contribute to quality control and assurance.

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Defining Microbiota and Microbiome

Many people now have heard the term “probiotics” and understand that they are beneficial for digestive, immune and overall health. Probiotics, as supplements and in yogurt, have been consumed knowledgeably for these general health benefits.

Two newer (to consumer) terms have now been showing up in health and mass media, “microbiota” and “microbiome.” And they are often misunderstood, and used incorrectly. We feel it is important to clarify what these mean, so that when we report about new strains of probiotics – and how they interact in the microbiota and potentially affect the microbiome – it will be more easily understood.

Microbiota refers to a bio-ecological community (that’s city-like) composed of multiple symbiotic, commensal and even pathogenic microorganisms. It’s like any community, with members that work to keep it whole, and of course, a “bad element;” but if, like healthy communities, that bad element can be kept in check, the community can function pretty well, even under duress. Commensal bacteria are part of the normal flora community in the oral cavity, and a commensal bacterium benefits from another without harming it.

The human microbiota is indeed like a city – it contains trillions of bacteria; it also contains fungi, viruses, protists (single celled organisms) and archaea (microbes without a cell nucleus or any membrane-bound organelles). The microbiota, in large part, resides in the gut.

The microbiota is impacted by diet and other lifestyle factors that the individual host practices. And, like fingerprints, the composition of microbiota is individualized, no two are exactly alike. Some people have fewer elements in their communities than others.

Meanwhile, the microbiome refers to the genes contained in the organisms comprising the microbiota – and these genes are also being studied in the same manner as the human genome. Researchers Grice and Segre in their published article “The Human Microbiome: Our Second Genome” (Annu Rev Genomics Hum Genet June 6, 2013), write, “Characterization and analysis of the human microbiome have been greatly catalyzed by advances in genomic technologies.”

Research in the past five years has suggested that there is an association between number of genes in the microbiome and diet. Several studies also associate a higher microbiome count with healthy weight range, less inflammation, lower risk of diabetes and a more effectively functioning immune system than individuals with a lower gene count. And typically, these studies have found that those with a less dense microbiome also regularly consumed red meats and more fat; while those with higher bacterial gene count tended to have a more plant-based diet.

The microbiota inside everyone is a living community and is impacted by the host’s diet (among other lifestyle factors), and there are certain foods that help populate and promote a healthy gut community. Overall, research has shown that glucosinolates found in cruciferous vegetables can help ensure certain pathogens are not allowed into the enclave, and insoluble fibers such as inulin ferment in the colon, creating new good neighbors. Beans are excellent as well, as they also serve to feed the community.

Not everyone can eat beans, or fermented foods, so this is where probiotic and enzyme supplements become valuable municipal employees for the microbiota community. A healthy microbiota is one of diversity, and probiotic (and prebiotic) supplements greatly enhance the composition and functionality of that community, while enzyme supplements help facilitate smooth and more effective digestion, which in turn, supports the community.

Is Your Supplement Company FSMA Compliant?

In a previous blog, we explained how the Food Safety and Modernization Act (FSMA), signed into law in 2011, grants the Food and Drug Administration (FDA) sweeping new powers to ensure public health and safety through preventative and proactive, rather than reactive, measures. The goal of the legislation is to combat contamination of foods and products made for consumption before they ever reach the public. The scope of the new regulations includes supplement manufacturers which must be FSMA compliant by the end of 2017 or 2018, depending on size. Will you be ready when the law kicks in? You should be.

What does the FSMA mean for supplement companies?

Supplement companies must be aware of how the FSMA rules may impact them. For example, the Foreign Supplier Verification Programs (FSVP) rule stipulates that the same preventive safety standards apply to food and supplements consumed in the U.S. regardless of where they are produced. Under FSVP, importers must verify that their foreign suppliers meet applicable FDA safety standards. Foreign ingredient manufacturers will need, at a minimum, on-site audits to verify the levels of protection required under these preventive controls. Importers must also verify that ingredients are accurately labeled for allergens. More than half of the ingredients used to manufacture dietary supplements come from abroad, so strategic oversight is needed to ensure their compliance with U.S. safety standards.

Is a manufacturer of bulk dietary supplements exempted from the preventive controls for human food?

FSMA’s preventive controls rule, 21 CFR 117.5(e), exempts finished dietary supplements from the requirements for preventive controls and a supply-chain program if they are in compliance with 21 CFR 111, and with adverse event reporting. This exemption is specific to these two elements of Part 117, and only applies to finished dietary supplements in bulk form. It does not apply to the manufacturing, processing, packing, or holding of dietary ingredients, which are subject to the rule. Furthermore, ingredient manufacturers are not required to comply with 21 CFR Part 111 for dietary supplements.

How will the revised Current Good Manufacturing Practices (cGMPs) affect manufacturers?

The revised cGMPs contain general provisions that apply to supplement manufacturers if not otherwise covered by Part 111. Only finished dietary supplement products are exempted from subparts C and G of Part 117. Ingredient manufacturers must comply with the revised cGMPs, and also implement preventive controls and a supply-chain program to ensure the integrity of dietary ingredients received by supplement manufacturers.

In a nutshell, the FSMA puts into place mechanisms which will prevent safety problems before they occur. Check out www.fda.gov/food/guidanceregulation/fsma for more information regarding these rules. Here at Deerland Enzymes & Probiotics, steps have already been taken to ensure FSMA compliance. If you would like to meet with an expert and learn more, contact us here!

Taking A Bite Out of FSMA Compliance: How Upcoming Regulations Will Affect Food and Supplement Manufacturers

On January 4th 2011, the former President of the United States, Barack Obama, signed into law one of the most innovative and comprehensive revisions to food safety in almost eighty years. The Food Safety and Modernization Act (FSMA) represents a floor to ceiling remodel of how the FDA will approach and regulate food safety practices. This new set of regulations has already started to go into effect, and implementation will continue through 2019.[1]

Coupled with the need to protect America’s food source from potential bioterrorism, part of the reason for the introduction of FSMA was the spike in number and severity of food-borne illness outbreaks in the early 2000s. For example, in 2006 contaminated organic spinach let to the death of 3 people and sickened more than 200 others.  In 2007, contaminated peanut butter sickened more than 600 people; and, in 2008, imported peppers sickened more than 1400 people. In 2009, what could be the most horrific incident in recent history occurred when the Peanut Corporation of America shipped product that tested positive for salmonella, but passed a re-test.  They performed no investigation and did not clean the facility after the results were reported.  This contamination killed 8 people and sickened more than 500 others in 43 different states[2]. The FDA estimates that nearly 1 in 6 people in the USA will get sick this year from foodborne diseases.[3]

The changes posed in the new laws will affect not only traditional food companies, but supplement manufacturers as well. Are you and your team prepared for the upcoming changes?

There are several key ways that the FSMA will affect companies and further empower the FDA.

  1. The idea of proactive rather than reactive contamination efforts.

The FSMA grants the FDA the ability to conduct more thorough prevention-based efforts., requiring companies to put proactive, risked-based, prevention plans in place. For every manufactured product, the company must evaluate hazards, develop a written hazard analysis, validate and monitor preventative controls, and take necessary corrective actions.

  1. Mandatory recall authority.

For the first time, the FDA will be able to mandate companies recall products deemed unsafe. This provision will give the government real “claws” to tackle with potentially serious pathogen outbreaks. 

  1. Tougher importation food safety standards.

All importers now have a stated responsibility to ensure that foreign suppliers have adequate food controls in place. There are several other certifications that will impact quality control for high risk foods. If these requirements are not met, the FDA can block entry of these consumables.

  1. Increased ability to conduct inspections and assure compliance.

To help fulfill this portion of FSMA, the FDA is looking to hire hundreds of additional personnel. These staff members will have an enhanced ability to check-up on manufacturers and sign off on compliance measures.

  1. Increased cooperation between inter-governmental departments.

Washington is pushing for better collaboration between its governing bodies. This means that food safety issues may now be handled and shared between previously separate entities.

In addition to these five changes, the FMSA will also call for food safety plans, food defense plans, biennial registration with the FDA, and a reportable food registry.

Supplement manufacturers must be prepared for these coming changes. Compliance with new FSMA standards is already happening at companies like Deerland Enzymes and Probiotics. Learn more about what you need to do comply here.

 

[1] https://www.fda.gov/food/guidanceregulation/fsma/ucm517545.htm
[2] https://www.cdc.gov/salmonella/2009/peanut-butter-2008-2009.html
[3] https://www.cdc.gov/foodsafety/foodborne-germs.html

Navigating FODMAPs

It appears that every few years brings a new food term. Typically, this results from new scientific understanding (or validation) of how foods affect the human organism, and are relevant to a significant portion of the population.

“FODMAP” is an acronym that just sounds quirky. For many people, FODMAPs — Fermentable Oligosaccharides, Disaccharides, Monosaccharides and Polyols – cause distracting levels of gastric upset, often to the point of the need to hide out by a bathroom until the noisy storm passes over and out.

FODMAPs are a family of short-chain carbohydrates (sugars), and they are quite abundant in varying degrees in foods that are considered otherwise nutritious and that support good health. These foods include dairy (lactose), fruit (fructose and polyols), fibrous vegetables (fructans) and any sugar alcohol. Many of these food-based FODMAPs are also considered prebiotics. Unfortunately, the prebiotic effect cannot be realized for those with FODMAP intolerance.

For those people with an intolerance, FODMAPs are incompletely absorbed in the gastrointestinal tract and can be easily fermented by gut bacteria, thus causing various levels of intolerance. These sugars also exert an osmotic effect, increasing fluid movement into the large bowel. The fermentation and osmosis caused by these undigested sugars are a cause of symptoms such as gas, pain, and diarrhea.

Compounding the issue is the fact that the level of discomfort is not always the same – sometimes a piece of fruit will cause just a mild annoyance, while other times, it is more severe. This causes some people to become confused as to what not to eat, and thus, frequently shun foods that are packed with nutrients (macro and micro) that the body needs to maintain health.

Important to note: many individuals who believe their lower GI issues stem from gluten may actually be sensitive to the sugar alcohols in the wheat instead! This is an important distinction that may reveal itself by the supplements taken to resolve gluten sensitivity or resolve FODMAP sensitivity.

This does not have to be the case: FODMAPs that can maraud one’s GI tract can be tamed. There is a simple two-part strategy.

One: Consider that you may have gut dysbiosis, which is an imbalance of intestinal bacteria; this status frequently leads to poor digestive function as well as a host of symptoms. It also exacerbates intolerance to FODMAPs. Tiny protuberances lining the small intestine called villi help with nutrient absorption, and dysbiosis can affect the healthy functioning of villi. Deerland’s ThioZymeGI is a noteworthy solution as it can help restore proper balance of small intestine bacteria colonies by lowering levels of aggressive bacteria such as E. coli and Bacteroides and empowering the body’s natural defense mechanisms to control them. This unique combination of essential oils, chelators and enzymes has been shown in in vitro testing to decimate the E. coli population, reducing it from one million colonies down to only 10,000, while not impacting good bacteria colonies such as B. subtilis.

Two: An enzyme supplement can help on a day-to-day basis, enabling you to consume all those good foods that naturally have FODMAPs. A multi-carbohydrase enzyme supplement that contains amylase, glucoamylase, cellulase, lactase and invertase works to break down the FODMAPs, so that they’re able to be absorbed in the small intestine, and therefore not available as a food source for gas-producing bacteria in the colon.

Many people have just accepted the fact that they are unable to eat certain foods, and are missing out on healthy foods like fruits and vegetables. However, this doesn’t have to be your “normal”. Enzyme and probiotic supplementation can help, depending on your level of FODMAP intolerance. You could be eating some, or more of, the healthy foods you’ve avoided because of your symptoms. With the right supplement, perhaps you can have your fruits and eat them too!

The Not-So-Subtle Clinical Results of B. subtilis DE111®

Probiotics, as science continues to reveal, are as individual as people. Each strain has a range of unique proficiencies, allowing for condition-specific support and relevance in modern lifestyles.

One particularly exciting strain is a genome-sequenced and clinically tested strain of Bacillus subtilis (called DE111), a probiotic spore that concentrates its actions on bolstering immune function and digestive stability by, in part, controlling microbial populations (acting as a competitive exclusionary agent). It also has a unique ability to form spores that protect the microbes from harsh conditions through to the destination where they can germinate robustly – the GI tract.

Here is a characteristic that makes DE111 attractive – its spore-forming action ensures this probiotic remains viable in a wide range of pH and temperatures, ensuring its efficacy and stability in an array of health products consumers are gravitating toward, such as foods and beverages. Even as functional foods grow in number and in appeal, consumers still heavily rely on supplements in the form of capsules to obtain the nutrients they deem important.

A clinical trial recently conducted on DE111 showed that in capsule form, the probiotic was well tolerated and efficacious. In the study, 41 healthy college students consumed one capsule per day that contained approximately 5 billion colony forming units (CFU) of B. subtilis DE111 in addition to their usual diets. Blood levels of important biomarkers were measured. Markers of systemic acceptance, such as CRP and liver enzymes, remained within acceptable ranges and the participants reported that GI symptoms and bowel habits improved with probiotic capsule consumption. In addition, the DE111 supplement resulted in a significant effect on gut microflora measured prior to and after capsule consumption.

What we at Deerland found very interesting is that, during the course of the study, the volunteers underwent finals, a time notorious for high stress and poor eating habits. As we all know, it only takes a few days for high-stress and junk food to aggravate our GI systems. We are inspired by these study results as we can see how DE111 is even able to maintain healthy levels of cholesterol, glucose and triglycerides through times of high stress.

This study adds to a considerable cache of safety studies, including genome mapping, antibiotic resistance analysis and gene transfer analysis. As such, DE111 is Non-GMO Project Verified, and has been approved by Health Canada with the issuance of a Natural Product Number (NPN 80077102).

The Prebiotic Definition Debate

Language is interesting to many people beyond professional linguists, and as well it should be. Definitions often morph and we change how we use words.

“Prebiotics” is a great example, I believe. As food science evolves, revealing how a food ingredient works selectively in the human body, this growing content of research affects the definition. This is important to discuss and consider because it is not just a marketing term, it has true biological effects. Therefore, it also has regulatory considerations, an impact on the manufacturing of foods, beverages and supplements, as well as on healthcare professionals and consumers.

There are some in the industry who staunchly believe that only a small group of fibers and carbohydrates (sugars) may be deemed a prebiotic, and nothing else can carry this moniker. We argue respectfully that this is not the case. Indeed, there are other naturally existing compounds that also function as prebiotics. Narrowing the prebiotic definition so that it excludes all other, non-sugar compounds would only be beneficial to those in the industry who have a vested interest in having prebiotics exclusive to fibers and carbohydrates.

In 1995, researchers Glenn Gibson and Marcel Roberfroid introduced the prebiotic concept in a landmark paper in the Journal of Nutrition. They defined a prebiotic as “a non-digestible food ingredient that beneficially affects the host by selectively stimulating the growth and/or activity of one or a limited number of bacteria in the colon, and thus improves host health.” Although this original definition has been revised multiple times, the main features have mostly been retained. The 2008 FAO definition, for example, describes a prebiotic as a “nonviable food component that confers a health benefit on the host associated with modulation of the microbiota.”

I attended an NIH conference about the topic of non-traditional prebiotics. What piqued my interest was that NIH was seeking to fund research on prebiotics by function not class. Prebiotics were discussed as being more than the complex sugars – for the purpose of this conference, they were considered to be any non-digestible food ingredient that beneficially affects the host by selectively stimulating the growth and/or activity of one or a limited number of bacteria in the colon, thereby improving the resilience of the host’s health. In other words, prebiotics should be defined not only as a class, such as complex sugars, but by their function; to modulate the microbiota in a way that promotes the health of the host.

Now it becomes clear to see that dramatically restricting what is considered a prebiotic by class (some fibers and carbs) while shutting others out that function as prebiotics such as lactoferrin, almond lipids, and bacteriophages to name a few – is limiting at the expense of total human microbiome health.

We at Deerland, experts in research and production of probiotics, prebiotics and enzymes, are very comfortable with the well-conceived definition that Gibson and Roberfroid crafted 20 years ago, and so is the FDA, based on its use of the same description. And we believe that the definition should remain the same but the manner in which it is used should change with the times – to not be so exclusive, to include any other natural-origin ingredient that research shows acts in the manner of a prebiotic. By this expansion of what constitutes a prebiotic, we can help people more easily achieve a good state of health and well-being.

State-Of-The-Art Facility Accommodates Growing Demand for High Quality Probiotic Supplements

Deerland Enzymes & Probiotics recently expanded its manufacturing capabilities by opening a new, state-of-the-art facility dedicated to providing the optimal environment for handling probiotics. The new Deerland Probiotics facility is truly innovative, designed to accommodate the growing demand for high quality probiotic supplements. It features stringent temperature and humidity controls in the production zone, 24/7 wireless temperature monitoring and alert system, best-in-class insulated roof and epoxy flooring, a vapor barrier, low carbon footprint, and Sanisteel® wall panels with antibacterial properties. Its multiple laboratory spaces are designed for research, development and prototyping as well as testing of spore and non-spore probiotic strains. The dedicated walk-in freezer for probiotics raw material storage and linear floor plan ensures ingredient potency and safety.

Customers absolutely expect and deserve a facility of this caliber. Those who come in for a tour leave with a real sense of security and quality, and immediately see that this facility offers multiple layers of innovation all designed to create the best products possible. Customers partner with Deerland to create products that are safe and efficacious, and this facility is a key part of what makes these partnerships so effective. Watch below to learn more!

Go Glutalytic®: Enzymes Clinically Shown to Lessen Impact of Gluten

Wheat, rye and barley are certainly considered healthy foods, as they are low glycemic and contain beneficial vitamins and minerals- but for about 18 million Americans, these seemingly innocent grains unleash a boogeyman – gluten, a protein that is highly prominent in them. When an individual with gluten sensitivity or intolerance ingests gluten, it causes his/her immune system to act up in the small intestine, barring the absorption of key nutrients. Some of the complaints of discomfort after eating wheat or other gluten-containing foods are mostly GI-related, such as bloating, constipation, cramping and diarrhea. Others include head fog, low mood, and lack of energy.

A team of researchers led by Dr. Martin Hudson and Colin King at the Kennesaw State University Department of Biology found that a proprietary enzyme supplement reduced the intensity of symptoms caused by gluten ingestion. In the 2014 double-blind, randomized, placebo-controlled study, entitled, “Glutalytic® Clinical Trial for Normal Consumption of Gluten Containing Foods,” the researchers sought to clarify if the enzyme supplement had any impact on the reduction of symptoms from gluten consumption in those who were gluten intolerant.

At commencement of the four-week study, the participants had the highest frequency of symptoms. When Glutalytic was consumed as a supplement, the participants exhibited the least number of symptoms. The frequency, and severity of all symptoms were reduced when Glutalytic was administered. The data showed a statistically significant improvement when compared to the placebo group in the following categories: pain, bloating, emptying of bowels, hunger pains, stomach “rumbling,” lower energy levels, headaches, and food cravings.

In a second study in October of 2015, entitled, “Tolerance and Efficacy of Glutalytic®: A Randomized, Double-Blind, Placebo-Controlled Study”, 37 adults took either placebo or three capsules of Glutalytic daily for 30 days. The researchers used a comprehensive metabolic panel to evaluate C-reactive protein and gliadin antibody (igG, igA, EIA) levels and GI symptoms for tolerance and efficacy of the supplement.

Researchers found that at the end of the study, there were statistically significant decreases in IgA, an antibody that shows an immune response, and CRP, an indicator of inflammation levels. Further, the Glutalytic group also reported significant declines in several symptoms, most dramatically, GI reflux. And, interestingly, the supplement group also reported a reduction of cravings. This may be because when gluten is inhibited in the small intestine, more nutrients are absorbed and the body is sufficiently sated.

Collectively these study results are encouraging, especially for those consumers who do have gluten intolerance or gluten insensitivity, as well as for those who feel they may occasionally experience gluten-induced discomforts. Glutalytic has exceptional merit for those who cannot tolerate gluten. Because this protein is so prevalent, those who are highly sensitive may have symptoms just from cross-contamination in a commercial kitchen. And although more and more restaurants are offering gluten-free foods, gluten-free is not as ubiquitous as a sufferer would like, and therefore supplements featuring Glutalytic can provide peace of mind and much more confidence in eating.