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.
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. The FDA estimates that nearly 1 in 6 people in the USA will get sick this year from foodborne diseases.
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.
- 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.
- 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.
- 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.
- 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.
- 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 Probiotics & Enzymes and Probiotics. Learn more about what you need to do comply here.
Dysbiosis is an imbalance between the beneficial “good” and pathogenic “bad” bacteria in the gut. In a normal, healthy gut, the beneficial bacteria should outnumber the pathogenic at a ratio of about 85:15. With that in mind, consumers are increasingly learning about the benefits of probiotic supplements and enhanced foods that contain advantageous microorganisms – microorganisms that can promote a healthier well-being. However, probiotic supplementation is not a one-size-fits-all approach, as consumers of different age groups may require specific blends of bacterial strains in order to achieve maximum benefit. It’s important for both consumers and suppliers to understand how probiotics support the health of children, adults, and seniors.
A child’s microbiome, an ecological community of microorganisms, develops in the womb and sets during early childhood. These good bacteria aid in food digestion and vitamin synthesis. With many parents’ efforts to sterilize their children’s environments, our society may have gone too far. “We’ve been in this crazed, antibacterial, antiseptic world where we think bacteria are the enemy, but the right bacteria are our friends,” said Dr. Vincent Pedre, an internist who specializes in gut health, in a recent piece in The Washington Times. According to a study in Pediatrics, the probiotic group Lactobacillus was found to be safe and effective in treating infectious diarrhea in children, and a study published in Pediatrics in 2007 found colicky infants who were given Lactobacillus improved in one week. In addition to potentially helping with specific health issues, probiotic supplements may help in the formation of a more balanced microbiome in children.
For adults, clinical trials suggest probiotic therapy could prove beneficial to the gastrointestinal system, where many individuals experience afflictions and maladies. Disorders relating to this part of the body are numerous and difficult to treat, which is why more and more adults are turning to probiotics for their natural health promoting properties. Allergy sufferers should also take note: a study published in the European Journal of Clinical Nutrition found allergy sufferers who took a supplement of a probiotic called B. lactis once a day for eight weeks felt better two months later compared to those who didn’t. The people on probiotics also had lower levels of pro-inflammatory markers.
In adult women, probiotics may support urogenital health. Lactobacilli strains of bacteria make it too acidic for harmful microorganisms to survive within the vagina. But antibiotics, spermicides, and birth control pills can cause an unbalance in a woman’s microbiome. Restoring the balance of microflora with probiotic treatments can be helpful in promoting a woman’s urology, according to Harvard Health.
Adults 50 years and older commonly have immune systems that are not as effective as they were during their physical prime. The composition and population of probiotic microorganisms within the digestive tract decline with age, with some studies showing friendly bacteria levels in the gut of a typical over 60-year-old at one thousandth the level of that of a younger adult. Older adults should reach for a probiotic supplement with the Bifidobacterium strain B. lactis, which can help in digestion. The strain B. infantis has shown benefits in easing inflammation.
As always, all individuals and parents should consult with their medical professional for guidance on how and when to use any sort of supplementation.
To maximize the effectiveness of probiotics, supplement products should be formulated with strains for individuals at different life stages. Deerland Probiotics & Enzymes & Probiotics is a leading specialty formulator and contract manufacturer of enzyme- and probiotic-based dietary supplements. To learn more about our products, visit DeerlandEnzymes.com.
Pets are members of the family. You care for the health of your beloved animals when they suffer from digestion problems – just as you would for anyone you love.
Due to their all-natural ingredients, organic probiotics and enzymes are becoming the solutions of choice for those looking to support the health of their pets.
Everything we do at Deerland starts with an enzyme or probiotic backbone. We are the experts in probiotics and enzymes, the leaders in the industry. By placing science at the forefront of everything we do, we will continue to blaze the trail into creating science-supported supplements for gut health. Recent research on the microbiome has shown its influence extends far beyond the gut, playing a crucial role in both our digestive and immune systems. At Deerland, we are driven to uncover more in this exciting area of research in the pursuit of overall wellness for the end users of our cutting-edge products.
Everything starts with science. We’re looking to create innovative formulations as trusted advisors to our customers. All of our products go into a person’s body, often a child’s, so we take what we do very seriously. Innovation sets us apart, and we have the ability to perform clinical testing and time-intensive studies. Though this approach comes at a high cost, at Deerland we prioritize research and development. The way we do things adds a lot of value to our customers, and we are proud of that. If we can make someone’s quality of life better, we’ve done our jobs.
When looking to develop a new supplement product, many formulators would like to begin their process without the intervention of a supplier, explains Scott Ravech, CEO of Deerland Probiotics & Enzymes & Probiotics. Often, they want to do their own research and build a formulation before getting anyone else involved. If you find yourself nodding, there’s good news: the YourBlend Formulator allows you to do just that.
A unique, custom enzyme and probiotic supplement builder tool used to meet our customers’ specific formulation needs, YourBlend allows users to design their own enzyme and probiotic products in the form of bulk powder, bulk capsules or finished bottled product – while learning a little something along the way. Watch below to learn more!
The industry’s leading manufacturer and supplier of nattokinase has announced the publication and noted approval of NSK-SD® nattokinase on the Union market as a novel food ingredient under the Article 1(2) of Regulation (EC) No 258/97. NSK-SD has been approved in all 28 EU member states and was featured in the Office Journal of the European Union. As expected, EFSA also noted that NSK-SD exhibits in vitro fibrinolytic activity and in vitro thrombolytic activity in animals when administered parenterally.
What is Nattokinase?
NSK SD® nattokinase is a potent fibrinolytic enzyme produced from the fermentation of boiled soybeans by B. subtilis. This process results in the traditional Japanese food, Natto, from where the enzyme gets its name.
NSK SD® nattokinase may help to normalize blood viscosity and pressure by degrading circulating fibrin. According to the manufacturer, NSK-SD® has been researched for more than 25 years, with results suggesting numerous circulatory benefits.
Here’s a link to the European law and all documentation associated with this approval of fermented soybean extract:
Washington, D.C., January 9, 2017—The Council for Responsible Nutrition (CRN), the leading trade association for the dietary supplement and functional food industry, and the International Probiotics Association (IPA), an international membership organization of probiotic companies, today announce the development of scientifically-based best practices guidelines for the labeling, storing, and stability testing of dietary supplements and functional foods containing probiotics. As probiotics are quickly gaining popularity, the guidelines are designed to ensure probiotic manufacturers can consistently create high-quality products that consumers can be confident in.
If current trends hold true, probiotic dietary supplements will be the fastest-growing supplement category in North America in 2016–2021, according to a presentation by market researcher Euromonitor at October’s SupplySide West trade show. During this time frame, North America’s probiotic supplement growth (55%) will also outpace the rest of the world’s (38%).
Read more at nutritionaloutlook.com.
FDA is expected to issue a revised draft document governing new dietary ingredient (NDI) notifications to the agency.
Industry sources described release of the document as “imminent” and said it could be unveiled in the coming weeks in response to criticisms that the July 2011 guidance poses undue burdens to companies and is contrary to the 1994 Dietary Supplement Health and Education Act (DSHEA).
Read more at naturalproductsinsider.com.