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Labeling Solutions For New Bioengineered Food And Ingredients Regulations

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With concerns rising amongst citizens, the USDA issued the National Bioengineered Food Disclosure Standard (NBFDS) last month intended for manufacturers, importers, retailers and other entities in retail space for the disclosure of bioengineered food and ingredients on product labels. The move was made with a view to bring in more transparency and provide consumers with standardized formats to disclose information pertaining to bioengineered food products.

Earlier referred to as Genetically Modified Organisms (GMOs), the new Standard has come up with the term “Bioengineered” (BE) for genetically modified food products. The USDA defines bioengineered food and ingredients as food that contain genetic material that has been modified through in vitro recombinant deoxyribonucleic acid (DNA) techniques, and for which the modification could not otherwise be obtained through conventional breeding or found in nature. Under the new Standard, highly refined foods and ingredients like syrup, sugar and vegetable oils, without any detectable genetically modified material, are exempt from disclosure as food items that contain them will not be considered as bioengineered.  

What does this mean for food brands & manufacturers in terms of compliance with the regulation?

The USDA has laid down four channels that concerned entities can use for BE disclosure: (1) text, (2) symbol, (3) electronic or digital link or (4) text messages.

Out of these, electronic labels or digital links appear to be the quickest, possibly least disruptive method of quick compliance with the new regulation. Electronic BE foods disclosure can have some upsides; It is a sustainable, efficient and cost effective method to dispense valuable product data to consumers, while leveraging the smartphone technology and its ubiquitousness. It also supports changes to label content instantly without reprinting or having to change the entire packaging every time there is an update that needs to be shared with consumers, a useful feature to accommodate future changes in labeling standards.  

Electronic or digital disclosure can be achieved through a digital link or a scannable QR code placed on the product packaging, which on being scanned will take the user to the appropriate landing page containing the product data.

NBFDS stipulates that the BE symbol be placed in an immediately visible spot on this page, potentially looking something like this:

The SmartLabel™ program presents excellent scope to comply with these regulations. The SmartLabel™ initiative spearheaded by the GMA is already bringing in QR code based digital labeling practices, having added over 25,000 products under its helm. Not only does it provide expanded product information, but it also ensures content is delivered in a standardized format which is easy to break down and absorb by consumers.

The clock is ticking as concerned entities have till January 1, 2020 and January 1, 2021 for small food manufacturers,  to comply with and implement the new Standard, with the mandatory compliance date set at January 1, 2022. The urgency to begin exploring solutions for BE regulations compliance before the NBFDS takes full effect has begun and the time to act and implement a viable strategy is running out.

posted Jan 14 by Poulami Singha Roy

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Growing at a CAGR of 5.7%, the global clinical trials industry is set to be worth $65.2 billion by 2025 as per Grand View Research, Inc. Under the constant stress of a myriad of challenges like complex research designs, stringent and ever-changing regulations, greater demands for consumer transparency, packaging and printing as well as R&D in a highly competitive environment to test and launch authentic and effective drugs, Life science companies need to look for solutions to refine clinical trials management. With millions of people connected through their smartphones to the internet and consuming digital information in vast quantities, they may already have a readily available platform to capitalize on.

Technology could serve as the answer to rein in the rising costs incurred due to the various challenges as well as trim and polish up the supply chain. Digital labels enabled drugs with smart packaging is one upcoming technology which could help improve efficiencies with clinical trials management.

Enabling Clinical Trials Drugs as Smart Products

Smartening up drug products involves enabling them to be connected to the internet through Data matrix codes and an assigned IoT / internet ID and creating a digital twin for each product which can be used to send or receive information about the drug to patients or healthcare professionals. Accessible through any internet-enabled device, these codes on scanning trigger a digital interaction which takes the patient or participant to a product specific page often referred to as a digital label or electronic label. With a digital identity in place, a vast number of digital interactions are made possible.

So what kind of digital interactions are we talking about and how will they help streamline clinical trials management?

Improved Health Literacy and safer consumption practices

The sea of tiny text containing complex instructions and medical jargon on drug packaging can be baffling for many to comprehend. Lack of proficiency in one language could also prevent many from accessing correct medical information, leading to miscommunication and life-threatening risks. Clear and concise information is the key to improved health literacy and making better health decisions, and digitizing label content could provide a massive boost in this direction.

Designing attractive and easy to understand formats to convey relevant information, like expiry dates and dosage instructions using colour codes without worrying about lack of physical space on packaging, becomes a possibility through digital labels. Digital labeling provides a faster and smarter alternative to leafing through pages and pages of a booklet. Simple animations can also be incorporated to deliver relevant instructions, eliminating the language barrier factor.

Richer and more meaningful research data

Smart packaging enabled drug products can help researchers maintain and keep track of research variables in a more meaningful manner. These products can form a two-way channel between participants and researchers, allowing more rapid and easier collection and transfer of responses and modification of variables if needed.

Digital Consent forms

Smart drug products can facilitate the collection of consent forms digitally, making it a smoother and simpler process for participants in clinical trials. Participants will have the opportunity to go through all information, which would be available digitally through the product’s smart packaging, before providing their consent electronically against that specific dose with the help of a smartphone.

Manage changes in regulations and study protocols

Life science companies are required to navigate through and comply with strict and intricate regulations which are constantly liable to changes. They also need to deal with changes in study protocols like expiry dates and IFUs or the addition of another country for testing during clinical trials on a regular basis.

Giving an IoT based digital identity to their products empowers them to easily make updates and changes to desired products on batch and serial levels, reducing the need for reprinting and repackaging.

Smart packaging is Green!

Not only will digital labeling facilitate the distribution of large quantities of information in easy-to-read formats, they will also drastically reduce the volume of materials that go into producing packaging. By being able to electronically and remotely update label content, companies will also be able to cut down on waste as well as huge costs otherwise incurred due to repackaging and reprinting.

Customer engagement

Smart drug products can forge the bridge that brings Life science companies closer to their customers. By digitizing and simplifying label content for easier consumption by lay people, they are demonstrating their desire to empower patients to make better and informed choices regarding their health. Better informed customers are more likely to support research, resulting in better recruitment and retention of participants for clinical trials.

Life science companies need to turn to technology in order to tackle the various challenges faced by the clinical trials industry. Smart packaging and IoT enabled Smart Products can facilitate the way into the future of clinical trials by transforming it into a more efficient system with reduced human-errors while establishing an enriched and more meaningful relationship between industry and patients.

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Approximately 1.3 billion tonnes or one-third of the food produced in the world for human consumption gets wasted every year, amounting to a loss of roughly $680 billion in industrialized countries. More than 40% of this waste and loss occurs at the retail and consumer level.

There are a multitude of ways to tackle this problem.  On analyzing where food wastage occurs at the retail level, one of the factors that comes up is overstocking. Overstocking generally occurs as a result of inaccurate demand forecasting resulting in the accumulation of unused stocks. Under the aegis of the Industry 4.0 movement, we are seeing a revolution in big data and analytics as more and more brands and manufacturers are employing IoT powered demand sensing technology to better anticipate demand and streamline production and supply chains. But what if we take this one step further?

The industry 4.0 espouses a connected and automated ecosystem which was first undertaken in the manufacturing sector. Going by the term Industrial Internet of Things (IIoT), it involves incorporating sensors and AI into the physical assets on the manufacturing floor, collecting, storing and transmitting a wide range of data. Level sensors are being used for management of liquid asset inventories, the working condition of a machine being monitored with sensors analyzing its temperature and vibrations as well as sensors instantly tracking and alerting to a breakdown or malfunction. Sensor technology has reshaped industrial manufacturing by creating seamless and automated intelligent systems.

However, applications of IoT and sensor technology need not be bound to the confines of the manufacturing sector. For the Retail sector and CPG industry, IoT suggests possibilities beyond just an enriched shopping experience at a brick and mortar store. IoT powered technology possesses enormous potential to solve inventory management issues, especially overstocking and waste reduction.  

Currently, a lot of brands are using predictive analytics on the basis of demand sensing which involves collecting and combining data from multiple sources in real time throughout the supply chain to better assess the demand for certain products. Smart shelves equipped with sensors to detect the addition and removal of items placed on them are also gaining momentum with retailers to monitor and update their inventory in real time. These smart shelves are also capable of recognizing cases of low stock and alerting management, thus freeing up store employees to engage with customers. But what if the data collection does not stop at the shelf? What if brands could have access to real time data on the consumption habits of its consumers?

A crossover of level sensors from industrial plants to food packaging could provide a  solution for this purpose where smart food packaging can play a major role in providing the interface to gather more information of such nature. A liquid level sensor implanted into the packaging of a juice bottle could detect when the bottle is empty and store that information against a digital twin or instance of the bottle stored online. The particular brand can access all this information in real time through the digital twin. Data of this nature opens up new perspectives into understanding consumer behavior and consumption patterns. It can then be used to more accurately predict demand and pinpoint locations where this demand will occur. Having a clearer picture of when a particular product will be in demand, manufacturers will be able to better plan production cycles as well as manage distribution channels. Stores will be able to have the right product, in the right amount, at the right time, avoiding overstocking and thereby reducing wastage due to spoilage.

However, the main barrier to adopting connected products on such a large magnitude is the lack of cheap and small sensors in the market. For an operation of this nature to be successful, we would require sensors that could be embedded into packaging without altering or affecting the properties and appearance of the product in any manner. These sensors would also need to be very affordable to be mass produced for millions of everyday consumer products.

Nonetheless, current research in sensor development looks promising. Rvmagnetics has already come up with what they claim to be the world’s smallest sensor. Based on microwire technology and magnetic fields, the thin as hair sensor is capable of sending accurate and real time data regarding physical quantities like temperature, pressure, torsion, position etc. Even though these sensors have been developed for the industrial sector, it is an encouraging start towards the idea of adapting IIoT sensor technology for the retail atmosphere.

Technology bolstered by the IoT platform can not only improve business practices, but positively impact the lives of everyday people, reduction of food wastage being a part of it. Within the broader context of the Industry 4.0, sensor driven technology is just part of the journey towards the digital transformation of the physical world, but a part that holds limitless potential and scope for waste reduction and streamlining demand-supply chains in the retail sector. But it is the manufacturing sector where the ideals of the industry 4.0 have flourished the most. Retailers could take a leaf out of their book and bring sensors used in factories into the brick and mortar stores for smarter inventory management solutions. For this to become a reality, we need to see a bigger shift in existing beliefs and ideology in order to prioritize research into industrial level sensors that can be applied to the packaging on food products sitting on the shelves in retail stores.

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According to the estimates of World Health Organisation (WHO), 1 million people globally lose their lives due to falsified medicines. It is the most lucrative of all counterfeiting businesses, netting in  150-200 billion euros per year. In order to put a stop to this trend, the EU introduced a scheme, which went live on 9 February 2019, for the identification and serialisation of individual packs of medicine. The serialisation scheme has been initiated under the EU’s Falsified Medicines Directive (FMD) of 2011 in an effort to fight counterfeiting of drugs through regulation (1) which was issued in 2016 and establishes safety features for packaging on medical products and devices. The primary focus for the regulation was that all packaging on pharmaceutical products need to carry a unique identifier for individual packs or boxes.

This is an example of how packaging can do much more than their traditional roles of dispensing product information and protecting the contents from external environmental conditions like changes in temperature and moisture. With the EU defining standards for serialisation of pharmaceutical packaging, there is an opportunity for the industry to go a step further and use this serial item identifier to exchange more information via smart packaging and IoT connected smart products. The serialised identifier and data matrix code on the packaging can be used to power other innovative digital interactions and applications. Here, we will take a look at some extended applications for product serialisation and smart packaging that can help brands, manufacturers and consumers alike.

Supply Chain Integrity

Product serialisation on batch and individual levels offers more than just compliance to regulations. When combined with digital twins, it is an excellent means to keep track of all supply chain operations, track and trace data and more. Serialisation will involve establishing a unique identification for each individual pack of medicine and communicate the same to all participants down the supply chain. A digital twin works in a similar fashion, maintaining a unique identity and an associated digital record of each product throughout its lifecycle. This means that manufacturers can access information regarding products more quickly, including their associated distribution records, and easily track a product to the source during any product holds or recall situation.

Smart packaging will not just involve the upgrading of all packaging, but dedicated investments into a data aggregation system and software solutions in order to identify, maintain and connect serialised numbers and label content to the aggregator. These investments are an opportunity for brands and manufacturers to develop and implement smart packaging solutions for their pharmaceutical products as well as enjoy simpler, more transparent and cost-effective supply chains and stock control.

Interactive Packaging For Safer Medical Practices

Product serialisation and smart packaging can go beyond enhancing supply chain operations. They can transform the way healthcare professionals and patients interact with their medicines and medical devices. Smart packaging with digital labels on them, that can be scanned by smartphones and other similar devices, can contribute immensely to better health literacy and patient compliance. It is estimated that non-adherence to medication annually costs the EU 125 billion euros and causes 200,000 deaths.

A product’s digital twin can easily store relevant information without any space limitations, information which is easily accessible through a smartphone app. This information can range from dosage, expiry dates, number of tablets left, reminders to take medicine and additional instructions from doctors to detailed and easy to understand IFUs. It can also provide an interface for healthcare professionals to remotely update any changes or collect reliable and richer data such as side effects and efficacy of product from patients for research purposes.

We need to think and reinvent how we can extend the abilities of packaging to adapt to future requirements as we see a rise in cases of poor compliance to medication and an ageing population in the developing world. Smart intelligent packaging can bring healthcare professionals and patients closer, promote safer consumption of medicines and improve the overall quality of healthcare and clinical trials.

Combating Counterfeits

The primary reason for the introduction of the mandatory regulation for product serialisation by the EU has been to counter threats to drug integrity due to the vast number of falsified medicines floating in the market. Counterfeit medicines pose a serious public health risk as even a small amount of substandard ingredient in a product can harm or potentially kill a patient. According to the new EU regulation, the unique identifiers should comprise of a product code, a serial number based on a randomised algorithm, a reimbursement number according to the countries which the medicine is marketed in, a batch number and expiry date. These numbers should be encoded into a 2-dimensional barcode within a machine readable data matrix which can be easily and accurately deciphered using simple scanning equipment.  

Similar to this process, a unique identity in the form of a digital twin for each product can also be maintained on the internet. The digital twin stores information pertaining to its authenticity throughout the supply chain, being scanned and verified by each participant, from manufacturer to distributors.

Serialisation and digital twins ensure that each saleable package of medicine is accounted for by all possible participants within a supply chain, allowing stores selling them as well as consumers to verify the authenticity of each individual product.

Infact, tracking data at serial item and batch level can help combat counterfeit products. Smart packaging with expanded abilities can allow consumers to scan and then report counterfeit products, allowing brands to keep an eye on locations and sources for them.

The new regulations for product serialisation and technological advancements together provide an opportunity for brands and manufacturers to upgrade packaging into more than a covering with basic product information for its contents. Apart from adherence to regulations for accountability of individual packs of medication as well as optimized logistics, they open up a wide array of possibilities to deliver delightful and intelligent interactions to consumers. Smart packaging holds the potential to bridge the gap between healthcare professionals and patients. It is the key to making supply chain events more transparent and much more easy to track and trace at all points of action. Extended actions of smart packaging combined with serialisation such as these need not be restricted to just pharmaceutical products. We’re already seeing significant efforts to serialise everyday consumer products such as foods, groceries, cigarettes, cosmetics and more.

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