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Cosmetics Supply Chain Challenges in 2022

In our last two blog posts of 2021, we talked about the global problem of counterfeit cosmetics and who investigates them when they’re discovered. For our first article of 2022, we’re talking about cosmetics supply chain challenges the industry should consider as we make our way through what will likely be another trying year for the global supply chain.

Please note that this isn’t a ranked list or a “countdown” to the No. 1 cosmetics supply chain challenge. That said, let’s get started.

Cosmetics supply chain challenges in 2022

Counterfeits and fakes

Yes, we’ve been talking about counterfeits a lot lately. But they’re one of the cosmetics supply chain challenges that bears repeating and re-emphasizing. Cosmetics and perfumery products are consistently among the Top 5 products “targeted by counterfeiters,” with fakes accounting for just under 10 percent of all customs seizures in 2019.

There are two main reasons why counterfeits are a challenge. First, they are a public health threat because they can contain hazardous materials. Second, they are a major threat to companies’ brand security. Traceability in a digital supply chain, including serialization and real-time environmental monitoring solutions, is your best defense. Read more in our brand protection blog series.

Sustainability

Sustainability is top of mind for all supply chain stakeholders. Consumers are one of the main drivers here, as they’re demanding accountability from the brands they buy. And if they don’t get it, they’re happy to take their business elsewhere. More and more regulatory bodies are also calling for sustainability.

Traceability, visibility, and transparency are how you can prove to consumers and regulators that you’re operating a sustainable supply chain with environmentally friendly/conscious processes and products. We wrote a good summary about “The Trifecta” of traceability, visibility, and transparency in our “Top Supply Chain Trends of 2021” post. Read that for more details about this important trend.

Refrigeration/Climate control

Some cosmetics must be shipped at specific temperatures. If the temperature dips or rises beyond that specified point — an event known as an excursion — products can be damaged, resulting in loss of revenue and, possibly, a knock to your brand reputation. This is a risk that’s simply not worth taking.

Climate control should be part of a larger real-time environmental monitoring solution. We call ours Integrated Monitoring. It’s an Internet of Things (IoT)-enabled solution that seamlessly integrates with your supply chain to monitor more than a dozen conditions, including temperature, on land, sea, and air.

Ethical considerations

One of the first cosmetics supply chain challenges is sourcing high-quality ingredients. (Indeed, this is a challenge in most industries; the concerns here should be on everyone’s radar.) In addition to the ethics involved in creating and maintaining a sustainable, environmentally friendly supply chain, cosmetics companies must contend with the issues of child labor and trafficked workers —even slavery.

To illustrate: mica and palm oil. The former is a sparkling mineral used in eye shadow, lipsticks, and highlighter; the latter is used for moisturizing or texture effects.

A 2016 report from the Amsterdam-based nonprofit Centre for Research on Multinational Corporations (SOMO) found that more than 20,000 children are forced to work in mica mines while their families live in severe poverty. Similarly, palm oil, the global market for which is expected to reach a global value of $57.2 billion by 2026, is plagued by human rights problems.

Companies must be vigilant. A digital supply chain with end-to-end traceability, visibility, and transparency is crucial.

Market changes

The cosmetics industry must continue to address changes in three areas: technology, regulations, and consumer sentiment. Of course, these changes are happening within the context of the pandemic, which arguably makes them more challenging.

In “The Global Cosmetics Market”, a white paper we published at the end of 2021, we get into the details of these challenges. Here are the broad strokes:

    • Technology is changing how consumers buy products and even how they interact with them. To adapt, companies can employ tools such digitalization and IoT devices to expand their supply chains without compromising efficiency.
    • Regulations are an ongoing concern in every industry. For example, in the United States, the Personal Care Products Act, if passed, would amend the Federal Food, Drug, and Cosmetic Act and give the Food and Drug Administration more oversight of production and authority over cosmetics products, including the power to demand recalls.
    • Everchanging consumer sentiment means cosmetics companies must pay attention to what people want, expect, and demand. This makes supply chain traceability, visibility, and transparency vital to success.

Final thoughts

We ended our “Top Supply Chain Trends of 2021” blog post with a questionnaire. These questions absolutely pertain to cosmetics supply chain challenges:

    • Are you keeping up with the trends we talked about today?
    • Are there gaps and blind spots in your supply chain?
    • Are counterfeits a problem in your industry?
    • Are you doing everything you can to protect your brand?
    • Are you actively reaching out to your customers to bring them closer to your brand?
    • Are there compliance deadlines on the horizon?
    • Are you certain your current supply chain solutions are truly optimal?
    • Are you using your supply chain as a strategic asset?

We encourage you to contact us to discuss why your supply chain is the key to keeping up with challenges. Our digital supply chain experts can share a short demo of our award-winning Traceability System that will clearly show why it’s the best solution for cosmetics companies.

We also encourage you look through our blog. To learn more about how transparency works, for example, read our “Transparency Trilogy,” which unpacks transparency in the global seafood supply chain. You can also subscribe to our quarterly newsletter, which tracks the latest news and trends in traceability, regulations, and other industry news. Find the subscription form at the bottom of any page on our website.

Who Investigates Counterfeit Cosmetics Products?

In our last blog post, we talked about the global problem of counterfeit cosmetics. Today, we’re talking about who investigates counterfeit cosmetics products, starting with how cosmetics are regulated in the United States and the EU.

Regulation of cosmetics products varies greatly from country to country, so our discussion today should not be taken as an overview of what to expect everywhere cosmetics are sold. Enforcement of laws and the actions authorities take to target counterfeits also vary.

What is universal, however, is that the cosmetics industry faces unique challenges with consumer safety, increased consumer demand for transparency, and being targeted by counterfeiters. It’s good to know who investigates counterfeit cosmetics products and what measures you can take to be part of the solution.

Who investigates counterfeit cosmetics products: USA and EU

Counterfeit cosmetics are dangerous because the criminals who make them don’t follow regulations or standards for production. Fakes are often contaminated with “stuff” you really don’t want to think about, let alone put on your face, such as bacteria, animal and human feces, arsenic, and mercury. So, regulators keep an eye on cosmetics.

United States

In the United States, the Food and Drug Administration (FDA) is the governing body for cosmetic regulations. Cosmetics products do not require FDA approval — but they are regulated. The Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA) explain the FDA’s requirements, restrictions, and disciplinary actions regarding cosmetics.

The FDA focuses on preventing adulteration and misbranding, mislabeling, and harmful ingredients or drugs. Adulteration refers to products or product ingredients that are not in line with FDA regulations or that have been contaminated. A misbranded product is “improperly labelled or deceptively packaged,” which could include counterfeit cosmetics products. The FDA prohibits 11 chemicals from being used in cosmetics products.

Additionally, the FDA reserves the authority to request recalls and work with the Department of Justice, Federal Bureau of Investigation (FBI), and Border Customs if any violations are found. It maintains a “Cosmetics Recalls & Alerts” page and has a searchable “Enforcement Report” database of recalled products.

The European Union

Cosmetics products manufactured in and imported to Europe are regulated under the EU Cosmetic Regulation. Like the FDA, the EU regulates ingredients and labeling; generally, however, the regulations are broader and more precisely defined.

For example, more than 1,300 substances (e.g., chemicals, colorants, and preservatives) are banned from cosmetic use, and hundreds more are permitted only under certain conditions. The regulations also mandate Good Manufacturing Practices (GMP), whereas the FDA only suggests GMP as “guidelines for effective self-inspection.”

Furthermore, the EU requires significant product documentation. Every cosmetics company must have a “responsible person” for every product they make. This person is responsible for ensuring products are safe and comply with regulations, and must submit a cosmetics product notification through an online portal before a product can be sold.

The responsible person must also create a product information file that includes the name, description, and nature of the product; description of the manufacturing methods; statement of compliance with regulations and GMP; a product safety report; and data about animal testing, if any. They must also assemble a product safety report that contains product safety information and a product safety assessment.

Do consumers have a role?

Yes, and it begins with vigilance with prices, packaging, and product quality:

      • Prices: If the price is too good to be true or just noticeably cheaper than the last time you bought it, there’s a good chance it’s a fake.
      • Packaging: The printing might look shoddy or the colors might seem off. There might not be a barcode. There might not be packaging at all, and the products might be offered in bulk.
      • Product: If the consistency or texture seem different, it’s likely a fake

In the United States, consumers can “report suspicions concerning the manufacture or sale of counterfeit or pirated goods” to the FBI. For suspected counterfeit cosmetics products seen online, consumers can contact the FBI Internet Fraud Complaint Center. The FBI has also partnered with the National Intellectual Property Rights Coordination Center to create a tip line where consumers can report products they suspect to be fake.

In the EU, consumers are encouraged to contact their local authorities about counterfeit cosmetics products. Depending on the nature of the situation, the authorities might investigate themselves or contact the appropriate investigative body, which could include Europol. The United Kingdom has Action Fraud, an online reporting tool for fraud and cybercrime.

Consumers should also be aware of what brands are doing to combat counterfeits and consumer engagement programs that encourage people to report suspicious products.

Final thoughts

If you really want to drill down into the U.S. and EU regulations, download our “Global Cosmetics Market” white paper today. It also has a section about regulations in Singapore, plus more information about counterfeit cosmetics products.

In “Top Supply Chain Trends of 2021,” we posed some important questions companies should ask themselves as we move toward what is likely to be another challenging year for supply chains. Many of those questions, listed below, fit perfectly with what we talked about today — regulations, counterfeits, brand protection, consumer engagement.

Your supply chain is where all of these concerns converge. Which is why you should schedule a short demo of our solutions. In about 15 minutes, we can show you the basics of our Traceability System and how it transforms your supply chain into a strategic asset that will improve and protect every facet of your business.

 

  • Are you keeping up with supply chain trends?
  • Are there gaps and blind spots in your supply chain?
  • Are counterfeits a problem in your industry?
  • Are you doing everything you can to protect your brand?
  • Are you actively reaching out to your customers to bring them closer to your brand?
  • Are there compliance deadlines on the horizon?
  • Are you certain your current supply chain solutions are truly optimal?
  • Are you using your supply chain as a strategic asset?

Why We Should Worry About Counterfeit Cosmetics

Counterfeit cosmetics have boomed during the pandemic. Not that they’ve ever not been in fashion among the criminal set. But recent research shows a renaissance, a proliferation of often dangerous fakes readily available to more people and through newer channels.

We just published a white paper about the global cosmetics market. It has a section about counterfeit cosmetics, and now we want to keep the conversation going with more information about this global problem. Here we go.

The statistics reveal “a worrying threat”

In “Global Trade in Fakes: A Worrying Threat” (June 2021), the Organisation for Economic Co-operation and Development (OECD) reported that the global value of counterfeits and pirated goods amounted to as much as $464 billion in 2019, or 2.5 percent of world trade.

Worldwide, there were “consistently” more than 130,000 customs seizures of counterfeit and pirated goods annually in 2017, 2018, and 2019. “Overall,” the report continues, “the unified database on customs seizures of IP-infringing goods includes almost half [a] million observations.”

In 2017 and 2018, counterfeit cosmetics and perfumery products accounted for about 4 percent of all customs seizures. That rose to just under 10 percent in 2019 — a considerable jump in a very short time. Furthermore, cosmetics and perfumery products were among the Top 5 products “targeted by counterfeiters” every year from 2011 to 2019. (The others were articles of leather, clothing, footwear, and watches.)

What toll do counterfeit cosmetics take on the industry’s fiscal health? One report shows that annual sales losses from counterfeiting in cosmetics and personal care products sector amounted to 4.7 billion euros, or about $5.3 billion.

Our brand protection series talks more about counterfeits. It’s a real problem that every industry, some more than others, must contend with.

Counterfeit cosmetics in a huge global market

According to a Fortune Business Insights report published in September, the cosmetics market was worth $277.67 billion in 2020. Despite an overall decline in sales during the pandemic, the market is projected to grow to $415.29 billion by 2028.

The market has responded to consumer demand for a wider variety of products, and online shopping has added an ease of access. Online shopping will drive the market and, according to industry watchers, could account for nearly 30 percent of global beauty sales by 2026.

However, the dramatic shift from in-person to online purchasing during the pandemic has emboldened criminals to churn out more and more counterfeit cosmetic products. As OECD put in its “Global Trade in Fakes” report, “Under confinement, consumers turn to online markets to [fulfill] their needs, driving significant growth in the online supply of a wide range of counterfeits.”

Research from the U.S. Department of Homeland Security supports this finding. Its “Combating Trafficking in Counterfeit and Pirated Goods” report (January 2020) noted that “Selling counterfeit and pirated goods through e-commerce platforms and related online third-party marketplaces is a highly profitable venture.”

The threat to businesses and consumers

Counterfeit cosmetic products are a real threat to manufacturers and consumers. The bogus goods mimic the original, undercutting company sales. They bypass quality control processes and regulatory oversight, which means they can contain harmful “ingredients.”

For example, in 2018 authorities in the United Kingdom recovered counterfeit cosmetics that were found to contain mercury and high levels of hydroquinone, a skin-whitening agent. UK Police have also warned consumers about fake products containing “rat droppings, human urine, and arsenic.” Police in Los Angeles found counterfeits with bacteria and animal waste.

With the surge in online orders, shipping has become important to the counterfeit industry. The OECD reported that between 2017 and 2019, 64 percent of global seizures were postal shipments and 13 percent involved express couriers. In the same period, 77 percent of all counterfeits seized by authorities were discovered during the shipping period.

Final thoughts

Counterfeit cosmetics — counterfeit anything — threaten consumer safety and brand reputations.

Your supply chain is your first line of defense. With the right solution for end-to-end traceability, like our rfxcel Traceability System, you can leverage data and lock down your supply chain guard to against counterfeits and help mitigate other risks.

You’ll also be able to meet consumer demand for transparency. You can tell them with certainty that your products are what you say they are. You’ll ensure product safety and protect your brand.

If you have questions, we can help. Take a look at our solutions for brand protection and download our white paper about the global cosmetics market. And contact us today to arrange a short demo of our Traceability System. In about 15 minutes, our supply chain experts can show how our solutions will turn your supply chain into your most valuable strategic asset.

Top Supply Chain Trends of 2021

The supply chain has been grabbing headlines since the pandemic began, but this year was especially newsworthy. From flotilla-like bottlenecks at major U.S. ports to warnings about counterfeit toys in Santa’s sleigh, it’s been a challenging time for supply chain stakeholders and consumers alike. So, as the year winds down, we thought we’d take a look at some of the top supply chain trends of 2021.

The Year’s Supply Chain Trends

Before we start, please note that this isn’t a ranked list or a “countdown” to the No. 1 supply chain trend of the year. It’s just a collection of trends that have occurred in different industries and that have made industry news as we’ve worked our way through the year. That said, without further ado, here are the top supply chain trends of 2021.

Automation

Automation includes robotics, machine learning, artificial intelligence, process mining, drones, and driverless delivery systems. This trend dates back to the first half of 2019, when companies in North America spent $869 million on more than 16,000 robots. This year, the World Robotics 2021 Industrial Robots report said there were 3 million industrial robots operating in factories globally, a record number and an increase of 10 percent. The report also said sales of new robots grew 0.5 percent, with 384,000 units shipped globally in 2020.

Blockchain

Blockchain has been a buzzword for years, and worldwide spending on the technology has been predicted to reach more than $11 billion by 2022. In regard to supply chain management, blockchain has great potential for traceability because it allows the provenance of any product to be easily demonstrated with and supported by immutable, tamper-proof data. It’s a big topic, so download our “Blockchain-Based Supply Chain Traceability” white paper to learn more.

Sustainability

There’s been a barrage of research about supply chain sustainability, particularly consumers’ expectations for transparency and environmentally friendly products and packaging. In one recent survey, 83 percent of respondents said it was “important or extremely important” for companies to design environmentally conscious products. Another found that 81 percent of shoppers say transparency is important or extremely important to them. In short, more companies are choosing to make their supply greener and more transparent.

Consumer engagement/customer experience

Consumer engagement and customer experience have always had a place in marketing and branding, but they’ve risen to a priority position over the last several years. (See a tidy summary of why here.) But what does your supply chain have to do with any of this?

The short answer: Your supply chain is a gold mine of information that can be leveraged for robust, innovative engagement/experience strategies. The basic building block is serialization. Read our two-part series to learn more. And definitely read our article about how supply chain traceability is building a “consumer kingdom.”

“The Trifecta”: Traceability, Visibility, Transparency

It should come as no surprise that we’re including these three “must-haves” on our list of the top supply chain trends in 2021. We’ve always maintained that visibility, transparency, and traceability are the key to a successful supply chain; however, the last two years have shown us that this trifecta is more important than ever and is the best way to optimize, safeguard, and leverage your supply chain for business value.

Visibility means using data to gain insight into how your supply chain is functioning and to take steps to make it run more efficiently. The goal is to see every ingredient/input, every product, every partner, every handoff … everything. Transparency means communicating supply chain knowledge internally and externally so all stakeholders, including consumers, can see how you operate. Traceability means you can follow a product to its point of origin and prove what it is and where it came from.

We have written extensively on these topics. Here’s a suggested reading list:

Internet of Things (IoT)

IoT is a network of physical objects that connects to the internet via sensors and software. It’s the basis of our Integrated Monitoring solution. It enables greater visibility and flexibility across your entire supply chain. For example, IoT-enabled sensors placed in a shipment of vaccines will send a real-time alert if a problem arises, such as a temperature excursion or route diversion. We’ve written about IoT in the food and beverage industry, and rfxcel CEO Glenn Abood wrote a great article about real-time monitoring in the pharma cold chain. We also have a great video about it.

Digitization

If we were ranking the 2021′ supply chain trends, we’d make digitization No. 1. A supply chain that isn’t digitized cannot function efficiently. It cannot give consumers what they demand. It cannot comply with regulations. It cannot compete. It cannot make your business better.

Final Thoughts

As we move toward the New Year, it’s a good time to think about the future of your supply chain. Ask yourself some basic questions:

    • Are you keeping up with the trends we talked about today?
    • Are there gaps and blind spots in your supply chain?
    • Are counterfeits a problem in your industry?
    • Are you doing everything you can to protect your brand?
    • Are you actively reaching out to your customers to bring them closer to your brand?
    • Are there compliance deadlines on the horizon?
    • Are you certain your current supply chain solutions are truly optimal?
    • Are you using your supply chain as a strategic asset?

The next step is to contact us. Our digital supply chain experts can share a short demo of our award-winning Traceability System that will clearly show why it’s the best solution for any business, under any circumstances.

Understanding GS1 Barcodes in the Global Supply Chain

Where would we be without standards? One thing’s certain: Your supply chain would be a lot messier, if not chaotic, if you and your partners didn’t have a “common language” to process and exchange data. Standardized GS1 barcodes are one way we avoid this chaos.

GS1 barcodes keep everybody “on the same page.” They allow companies in virtually every industry to easily record, store, and transfer data. We’ve all seen them, and chances are your organization uses them — maybe even millions or billions of them. But let’s do a quick refresher course as another way to keep us all on the same page.

Why are GS1 barcodes important?

The short answer is, as we said above, standardized GS1 barcodes allow us to maintain order and avoid chaos. Work flows become quicker and more efficient. The GS1 barcodes keep supply chains running by enabling companies to sell, ship, track, reorder, and return products, in most cases by scanning with a handheld device or a camera-based system.

GS1 barcodes also expedite communication, traceability, visibility, and transparency. It’s really all about sharing information quickly in order to know the source of ingredients/components and products, where they’ve been and where they’re going, and when they reach their final destination.

These capabilities not only make supply chains more efficient — they also increase product safety and protect consumers. If there’s a recall, for example, a company can locate its products quickly, make sure shipments are stopped, remove items from stores, and share data with regulators and even consumers.

GS1 barcodes also save money. Administrative costs come down when everybody uses the same standards and has the same expectations. And because GS1 barcodes facilitate digital supply chains, they increase speed and reduce paperwork.

GSI Identification Keys

GS1 standards define a set of unique identification codes, known as identification keys. GS1 says its identification keys “refer unambiguously to a real-world entity,” such as a product, a logistics unit, a physical location, a document, a service relationship, or another entity.

In other words, the ID keys let you quickly and conveniently access information about items in your supply chain and share it with your partners. Only GS1 members can build ID keys, which must include a GS1 company prefix. There are 12 ID keys:

        1. Global Trade Item Number (GTIN): identifies products and services, such as food and clothing
        2. Global Location Number (GLN): identifies parties and locations, such as companies, warehouses, factories, and stores
        3. Serial Shipping Container Code (SSCC): identifies logistics units, such as parcels and palletized products
        4. Global Returnable Asset Identifier (GRAI): identifies returnable assets
        5. Global Individual Asset Identifier (GIAI): identifies assets, such as equipment used in manufacturing and transportation
        6. Global Service Relation Number (GSRN): identifies relationships between service providers and recipients, such as hospital staff and members of brand “loyalty” or rewards programs
        7. Global Document Type Identifier (GDTI): identifies documents, such as shipping paperwork
        8. Global Identification Number for Consignment (GINC): identifies consignments, such as logistics units being transported in a container on a ship or airplane
        9. Global Shipment Identification Number (GSIN): identifies shipments
        10. Global Coupon Number (GCN): identifies coupons
        11. Component/Part Identifier (CPID): identifies components and parts
        12. Global Model Number (GMN): identifies a product’s model number

The GS1 standards also encompass data capture, including definitions of barcode and radio-frequency identification (RFID) data carriers, that allow ID keys and other data to be affixed directly to an object. Data standards also address the hardware to read and produce barcodes (e.g., scanners and printers), and hardware and software to connect the barcodes and RFID tags to business applications.

The different types of GS1 barcodes

All GS1 barcodes are “containers” that can hold different amounts information, such as serial numbers, batch numbers, GTINs, and expiration dates. As the image below from GS1 shows, there are four types, or “families,” of barcodes: EAN/UPC, two-dimensional (2D), DataBar, and one-dimensional (1D).

GS1 barcodes

EAN/UPC family. GS1 says, rightly, that these “are printed on virtually every consumer product in the world.” They are characterized by a series of vertical lines and a horizontal row of numbers, and come in four types: UPC-A, EAN-13, UPC-E, and EAN-8.

These GS1 barcodes are designed to be used at the point of sale and can be read by omnidirectional scanners. None support attributes — they cannot contain product information such as an expiration date, a batch number, or item weight. UPC-A has 12 numbers and supports GTIN-12; EAN-13 has 13 numbers and supports GTIN-13; UPC-E has 12 numbers (the zeros are “suppressed) and supports GTIN-12; and EAN-8 has 8 numbers and supports GTIN-8.

2D barcodes. Like EAN/UPC barcodes, 2D barcodes are ubiquitous. They are incredibly robust, able to hold dense product information and remain legible at greatly reduced sizes or when they’re etched into a surface, such as a plastic bottle cap. There are two kinds of 2D barcodes:

      1. GS1 DataMatrix codes are omnidirectional and support attributes and all GS1 ID keys. They can hold 3,116 numeric or 2,335 alphanumeric characters.
      2. GS1 QR codes are also omnidirectional and support attributes and all GS1 ID keys. They can hold 7,089 numbers or 4,296 alphanumeric characters.

DataBar family. There are seven members in the DataBar family. Generally, they’re divided into two groups: those designed for use at the point of sale (i.e., can be read by omnidirectional scanners) and those that are not.

The first group has four types: omnidirectional, stacked omnidirectional, expanded, and expanded stacked.

      • Omnidirectional and stacked omnidirectional have 14 numbers. They support GTINs and Global Coupon Numbers (GCNs) but do not support attributes.
      • Expanded and expanded stacked have a maximum capacity of 74 numeric and 41 alphabetic characters. They support GTINs and GCNs, but do support attributes.

There are three types of barcodes in the second group: truncated, limited, and stacked. These have 14 numbers and support GTINs, but do not support attributes. They are not designed for use at the point of sale, so they cannot be read by omnidirectional scanners.

1D barcodes. The two types of 1D barcodes — GS1-128 and ITF-14 — are used in retail distribution, healthcare, and logistics. GS1-128 barcodes can carry any GS1 ID key and up to 48 alphanumeric characters, including serial numbers, expiration dates, and other information that helps track products through a supply chain. More than one GS1-128 barcode can be used on a single item. ITF-14 barcodes can hold only GTINs; GS1 says it is suitable for printing on corrugated materials.

Final thoughts

This year was the 50th anniversary of the GTIN. As GS1 said, “It is no exaggeration to say that the development of the GTIN set the stage for global, digitalized commerce.” Indeed, labeling standards and barcode technologies have evolved and advanced since 1971 to the great benefit of businesses and consumers alike.

We have been talking about the advantages of end-to-end traceability in a digital supply chain for a long time. When your products, labeled with powerful identifiers such as 2D DataMatrix codes, move through a digital supply chain powered by our award-winning Traceability System, you can leverage rich, unit-level data for much more than compliance and operational efficiency: You can create genuine, tangible business value. For example:

That’s really just the beginning of what a digital supply chain can do. To learn more, contact us today to see a short demo of our solutions. Our supply chain experts will show you how our Traceability System transforms your supply into your most valuable strategic asset.

What is the Drug Supply Chain Security Act?

Today’s question: What is the Drug Supply Chain Security Act?

We’ve written extensively about the legislation, which was passed on November 27, 2013. But with the deadline for full compliance quickly approaching, we thought a quick overview was in order. So let’s answer the question, What is the Drug Supply Chain Security Act?

What Is the Drug Supply Chain Security Act?

If you’re a pharmaceutical company — a manufacturer, wholesaler, dispenser, repackager, or third-party logistics provider — you must comply with the Drug Supply Chain Security Act (DSCSA) if you want to do business in the United States.

The U.S. Food and Drug Administration (FDA) says the goal of the DSCSA is “to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States.” The Act “will enhance [the] FDA’s ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful” and “improve detection and removal of potentially dangerous drugs from the drug supply chain to protect U.S. consumers.”

The law has been rolled out in phases since it was passed nearly 10 years ago. Implementation culminates on November, 27, 2023, at which time the U.S. pharmaceutical supply chain will be fully serialized.

Key requirements of the Drug Supply Chain Security Act

The FDA puts DSCSA requirements into the following categories:

1. Product identification/serialization

A unique product identifier (PI), such as a bar code, must be placed on certain prescription drug packages.

2. Product tracing

Stakeholders must provide information about a drug and who handled it each time it’s sold. This includes transaction information (TI), a transaction statement (TS), and a transaction history (TH), collectively known as “T3” information. Read our “Dispensers and DSCSA 2023” white paper for more about T3 information.

3. Product verification

Stakeholders must establish systems and processes to verify PIs for certain prescription drugs packages. The Verification Router Service (VRS) enables a rapid, secure exchange of data to do this. See more about VRS below.

4. Detection and response + notification

Stakeholders must quarantine and promptly investigate suspect or illegitimate drugs. They must also notify the FDA and other interested parties when they find such drugs.

5. Licensing

Wholesalers must report their licensing status and contact information to the FDA. Third-party logistics providers must obtain a state or federal license.

Looking forward

The FDA has delayed the rollout of the DSCSA two times, giving the industry extra time to prepare. However, an FDA official recently said there will be no more delays. November 27, 2023, is a done deal.

In terms of what’s next, take a look at our “DSCSA 2023: The Future of Pharmaceutical Traceability in the United States” blog post. This gets into the granular details of the transformation that’s going to happen in 2023, but here are the basics of what to expect:

Serialization

Serialization relies on product identifiers (the “PIs” we mentioned above), which include serial numbers and expiration dates. For 2023, all transaction information (the “TI” we mentioned above) must include the PI. TI includes the following:

  • The product name
  • The product’s strength and dosage form
  • The product’s National Drug Code
  • The container size and number of containers
  • The lot number
  • The transaction date
  • The shipment date
  • The name and address of the businesses from which and to which ownership is being transferred
Authorized trading partners

Put simply, the DSCSA says that if you’re not an authorized trading partner (ATP), your access to the U.S. pharma supply chain will be severely restricted or denied altogether. All manufacturers, wholesale distributors, repackagers, third-party logistics providers, and dispensers and their trading partners must be ATPs. We did a deep dive on ATPs earlier this year; read our two-part series here.

Verifying drugs

The DSCSA’s saleable returns verification requirement stipulates that wholesalers must verify all returned drugs before they can be reintroduced to the supply chain. This is done by verifying a drug’s PI. A wholesaler must initiate a verification request to the drug’s manufacturer, then the manufacturer must provide a verification response within 24 hours. The Verification Router Service — the VRS — is what enables the rapid, secure exchange of data between these parties. Like everything else in the DSCSA, we’ve written extensively about the VRS. Our “DSCSA Saleable Returns Verification Requirement: Just the Facts” article is a good place to start.

Final thoughts

What is the Drug Supply Chain Security Act? The DSCSA makes pharma stakeholders responsible for securing the U.S. supply chain. It doesn’t matter if you’re a manufacturer, wholesaler, repackager, third-party logistics provider, or a dispenser — the law affects how you conduct business. Your compliance depends on making sure you can meet your responsibilities.

That’s where rfxcel comes in.

A fully serialized pharma supply chain is just two years away. It’s important to use this time to get your systems in place. We have almost 20 years of experience providing the pharmaceutical industry with leading regulatory and compliance software. So if you aren’t sure if you’re going to be ready for DSCSA 2023 and want to see a short demo of our solutions — or just want to know more about your responsibilities — contact us today. Our DSCSA experts will work directly with you to design a solution that meets your specific needs, no matter your role in the supply chain.

In the meantime, you can hear directly from our experts in our “Plan for DSCSA Readiness” webinar and our DSCSA 2023 webinar series. These are great resources to help you better understand the law.

Brand Protection Strategies and Your Supply Chain

Welcome to Part II of our brand protection series. In Part I, we talked about the top supply chain threats that brand protection strategies must address: counterfeits, diversion, theft, and insufficient traceability.

Today, we’re talking about the supply chain solutions that combat these threats — solutions that should be integral to your brand protection strategies.

A holistic supply chain approach to brand protection strategies

Your supply chain is the embodiment of your business. If it’s not healthy, your brand can’t be healthy. You need to be able to continuously scan it, diagnose it, and take immediate action should a threat arise.

Fine-tuned digital supply chain solutions are the answer. Working together from end to end, they create a “central nervous system” that monitors and senses every touch point in real time while collecting and sharing data to inform your next move.

Serialization, real-time monitoring, and end-to-end traceability are the key solutions that help mitigate supply chain threats and provide the intelligence for effective brand protection strategies. Let’s take a look.

Serialization

Serialization is the building block of a secure supply chain and effective brand protection strategies. By assigning a unique serial number to each product, you create what rfxcel calls a “digital asset” with a unique digital identity. Every product can be linked to virtually any information you want, such as its origin, when it was harvested or manufactured, its lot number, and its expiration date.

Serialization also enables you to track every individual unit through your entire supply chain, from production to retail distribution to the final consumer and beyond. It creates a barrier to fight counterfeits and fakes and contributes to end-to-end traceability that eliminates blind spots and locks down your supply chain.

Serialization also fuels brand protection strategies because you can leverage each digital asset for consumer engagement to build confidence and trust. As we said in Part I of our consumer engagement series, your customers are absolutely a part of brand protection, and serialization empowers them in three important ways.

First, it’s the basis of an indelible, demonstrable, shareable product provenance that proves that your product is what you say it is and gives consumers the information they demand.

Second, as we discussed in Part II of our consumer engagement series, your serialized product is a device for one-on-one communication with your customers. For example, with a quick smartphone scan of a 2D Data Matrix code, a person can access rich data about your product and exclusive content through which they’ll establish and build a relationship with your brand.

Third, serialization lets you “crowdsource” brand protection through your consumer engagement activities. For example, if a person scans a product and the scan doesn’t work or they’re taken to a suspect website or other suspicious content, you can incentivize them to contact you and report that something is wrong. This is actionable, granular data that will protect your brand.

Real-time monitoring

A blind spot in your supply chain creates opportunities for trouble. Common blind spots include deviations from prescribed routes and harmful environmental conditions. The solution is real-time monitoring.

rfxcel’s Integrated Monitoring solution paints a vibrant, detailed picture of where your products are and what is happening to them. It provides better data, continuity, visibility, and security to protect your products and consumers. With detailed, unit-level data coming in around the clock, you’ll understand and immediately act upon specific risks.

It works like this: Pallets, cases, or unit-level items are equipped with Internet of Things (IoT)-enabled sensors that send data over communication networks at regular intervals. The sensors provide real-time information about how long an item has been in transit, if the transport vehicle is sticking to its approved route, if the shipment stopped and for how long, and environmental conditions such as temperature, light, humidity, and shock. If something is not as it’s supposed to be, the sensors transmit an alert so you can halt shipments that may have been adulterated and redirect shipments to keep products safe. You’ll protect your customers and safeguard your brand.

Check out our short videos about our Integrated Monitoring solution for the pharmaceutical and food and beverage industries.

End-to-end traceability

End-to-end traceability in a digital supply chain means you can design end-to-end brand protection strategies.

With a suite of solutions acting in concert — like our Traceability System — you’ll create a full, traceable provenance for every product. You can add critical tracking events and key data elements at any point in your supply chain. For example, add a photo of a product as it leaves the factory or integrate a quality inspection to enrich the data associated with the product. Consumers can access this information and confirm that your product is what you say it is. This burnishes your reputation and builds trust with the people who buy your products or are thinking about buying your products.

rfxcel Traceability System

And there are numerous other benefits of end-to-end traceability. If you can see every part of your supply chain from one end to the other, you’ll be able to manage operations more efficiently, including dealing with recalls and other crisis situations. You’ll make it harder for counterfeits and fakes to reach consumers. You’ll consolidate data to improve processes, outcomes, and product quality. And you’ll be empowered to make better decisions based on that data.

Mobile traceability: an on-the-go solution for brand protection strategies

A discussion of brand protection strategies isn’t complete without mentioning mobile traceability. Why? Because if you don’t have access to your supply chain data 24/7, no matter where you are, you’re not shedding light on blind spots and not building a solid perimeter around your brand.

rfxcel’s MobileTraceability solution brings our industry-leading track and trace capabilities to virtually any location, including places that traditionally may not have had absolute visibility in your supply chain, such as remote fields, distribution centers, and warehouses. With unparalleled convenience and speed, it gives you everything you need to keep you supply chain running at optimal efficiency. To learn more, read about what our Mobile Traceability solution can do for the pharmaceutical and food and beverage supply chains.

Final thoughts

A supply chain problem is a brand protection problem. By giving all your products a unique digital identity through serialization, then following and controlling them in real time with integrated monitoring and traceability solutions, you can demonstrate to the world that your brand is strong and reliable. You can build a reputation for integrity and transparency with partners and consumers. You can use data to innovate your brand protection strategies, consumer engagement activities, and every part of your operations.

With rfxcel, you can fortify your brand with data from a digital supply chain. You can combat the threats we’ve discussed no matter where you are and no matter where you supply chain goes. Contact us today to see how our solutions can work for better, stronger brand protection strategies.

Brand Protection Strategy and the Top Supply Chain Threats

We just did two articles about why your supply chain is vital to an effective consumer engagement strategy. Now we want to jump into brand protection strategy and your supply chain.

First, let’s define our terms. Although consumer engagement is a usually a dedicated effort to boost brand recognition and loyalty, it must always be considered part of your brand protection strategy. As we’ll see, getting your customers involved in fighting counterfeits and identifying disreputable sellers and other bad actors is critical. Let’s continue breaking this down.

Why do you need a brand protection strategy?

Do you want to protect your business? Your employees, your bottom line, your reputation, your supply chain, your intellectual property?

Of course you do. Your brand protection strategy is your firewall. It’s how you shield your business from things that can harm it. And many — if not most — of the factors that can harm your brand are directly related to your supply chain. These include counterfeits (also called fakes), diversion, theft, and insufficient traceability.

Top supply chain threats

Let’s take a closer look at the top supply threats your brand protection strategy should address.

Counterfeits and fakes

The joke is that the best way to fight counterfeits is to make products nobody wants to buy.

We know that’s not how it works, though, which is why counterfeits and fakes are the No. 1 brand protection concern. In fact, counterfeits and pirated products accounted for up to 3.3 percent of world trade in 2016.

That statistic comes from a 2019 report by the Organisation for Economic Co-operation and Development (OECD) entitled “Trends in Trade in Counterfeit and Pirated Goods.” The OECD also found that trade in counterfeit and pirated goods was rising steadily despite stagnation in overall trade volumes. Based on 2016 customs seizure data, the value of imported fake goods worldwide was $509 billion, up from $461 billion in 2013.

But there’s a lot more to be concerned about. Counterfeits are of inferior quality and often contain harmful, even deadly, materials/ingredients. The people who make them, including children, often work for long hours in sweatshop conditions. Some may have been trafficked or coerced. Furthermore, it has been established that counterfeits are inextricably linked to organized crime.

The pandemic provided many examples counterfeits making their way into the global supply chain — fake vaccines, fake COVID-19 testing kits, fake masks, fake nitrile gloves. But counterfeiting affects every industry, from food and footwear to cosmetics and computers.

Diversion and theft

When your goods are in transit along your supply chain, you want them to reach their final destination as quickly and safely as possible. This is why diversion is another key consideration for a brand protection strategy.

Diversion is actually a two-pronged problem. Let’s use pharmaceuticals to illustrate. Many drugs must be kept within a certain temperature range or maintained under certain lighting or humidity conditions. Even the slightest delay could spell disaster — ruined products, which means patients might not get medicines on time.

Diversion can also indicate theft. If a truck goes off its prescribed route, bad actors might be hijacking it and your product could end up on unauthorized e-commerce sites (rogue websites) and other grey markets or black markets. If the diversion has compromised the integrity of your product — a drug, for example — people’s lives may be jeopardized.

Insufficient traceability

As we’ve discussed before, supply chain traceability brings tangible value to just about every part of your business, including your brand protection strategy. If you’re not taking traceability seriously, you’re not just opening the door to assaults on your brand; you’re risking problems with regulators, alienating (and losing) customers, and weakening your supply chain.

A recall is among the most damaging events that can happen to a brand, so let’s use it as case study. If you can trace a recalled item, you can better collaborate with trading partners and authorities and help to get the product out of the supply chain and out of stores. With traceability, you’re protecting consumers from a health hazard and safeguarding your brand from bad publicity. And with a transparent approach to engaging with customers about your products, you create a strong brand image that conveys trust, credibility, and reliability.

Traceability also helps fight counterfeits, diversion, and theft. The ability to trace and authenticate every product in your supply chain in real time, 24/7, is foundational to an effective brand protection strategy. We’ll get into those details in Part II of our brand protection series.

Final thoughts

At the end of August, the Office of the United States Trade Representative published a request for comments “that identify online and physical markets to be considered for inclusion in the 2021 Review of Notorious Markets for Counterfeiting and Piracy (Notorious Markets List).”

Counterfeits have also been making headlines in recent weeks:

In this environment, a comprehensive brand protection strategy driven by granular supply chain data is your best defense against bad actors. rfxcel understands this. We can help you leverage your supply chain to combat counterfeits and the other concerns we addressed today. Our brand protection solutions will fortify your brand with data from a digital supply chain. Contact us today to learn more — and read Part II of our brand protection series.

Top Reasons Your Supply Chain Is the Key to an Effective Consumer Engagement Strategy

Welcome to Part II of our series about effective consumer engagement. In Part I, we talked about the benefits of consumer engagement. Today, we’re focusing on your supply chain — and how you can use it for a next-level consumer engagement strategy. Let’s jump right in.

It’s all about data from your supply chain

Your supply chain is a gold mine of information that you can leverage for a robust consumer engagement strategy. The basic building block is serialization, which turns each one of your products into what we call “digital assets.” Each digital asset has a unique digital identity that can be monitored from production all the way to the person who buys it.

With rich, traceable data about every item in your supply chain at your fingertips, you can establish and maintain connections with consumers before, during, and after the sale. (You can also do much, much more, but that’s beyond the scope of what we’re talking about today.)

Four ways supply chain data can supercharge your consumer engagement strategy

1. You’ll share the product information that consumers demand. Consumers demand information. Every product — every digital asset — in your supply chain can be “loaded” with data that consumers can access at the store, at home, at a restaurant, at a sporting event. Anywhere. For example, a quick scan of a 2D Data Matrix code or QR code with a smart phone will reveal every detail you want to share about your product: where and when it was grown or made, its ingredients, the route it took to get to the consumer. This demonstrable provenance using supply chain data builds consumer trust and confidence; it is foundational to consumer engagement.

2. You’ll create compelling customer experiences. Consumers also want experiences. With data from your supply chain and other brand resources (e.g., an app) you can curate experiences such as contests, loyalty programs, games, and unique online content. You can encourage storytelling about your brand. If you’re a winemaker, connect people to a virtual tour of your vineyard. If you sell organic foods, share video recipes online or invite people to see your sustainable operations. If you make cosmetics, link to virtual try-ons. Importantly, you can hyper-personalize and hyper-target every engagement, and even “broadcast” specific information to specific locations or events.

3. You’ll communicate directly with consumers. Your serialized product is a device for one-on-one communication with the person who bought it. When a customer accesses the information from your digital asset, you can connect them to your website, social media, an app, a survey, or other forums where they can start a conversation with your brand. They can ask questions and provide feedback — and you can give answers and reactions. Relationship-building is another cornerstone of an effective consumer engagement strategy, and the products people are literally holding in their hands are the first step of the conversation.

4. You’ll gain valuable insight into your customers. An effective consumer engagement strategy creates a world for your customers. And as they navigate and participate in that world, they share information. Where are they buying your products? What do they like? What don’t they like? What inspires them? What engagement activities resonated the most? This business intelligence can inform every part of your business, from how your supply chain works to creating better consumer engagement strategies.

Final thoughts

The purchase used to be the last part of your supply chain; now it’s the beginning of a new realm of possibilities. Every digital asset is an opportunity to connect your customers to your brand and put your products front and center in their lives.

rfxcel’s Traceability System is an end-to-end supply chain solution that creates the digital assets. It gives you in-depth, real-time insights all the way from production to your final customers. The data you connect to your products will fuel compelling consumer engagement activities that can reach people everywhere you do business.

And now, as part of Antares Vision Group, we can offer even more ways to engage with consumers. Contact us today to find out more.

 

BONUS CONTENT!

Last year, we did a piece called “Supply-Chain Traceability Is Building a New Kind of Consumer Kingdom.” Here’s an excerpt that ties into what we’ve said about an effective consumer engagement strategy:

In fact, consumers are not only thinking deeply about where the things they buy come from and what goes into making them, they are actually becoming a pivotal part of the supply chain itself. What’s more, they’re participating willingly and with gusto, demanding detailed information about the goods they purchase and even expecting to interact with products far beyond the point of sale. Just how far will they go to get what they want? More than 70% of customers say they’re willing to share their data in exchange for a more personalized experience, according to one recent survey.

Read the full article here.

Countdown to DSCSA 2023 Serialization: The Deadline Is Just Two Years Away

November 27, 2023 — the date the pharmaceutical industry has had its sights on since the U.S. Drug Supply Chain Security Act (DSCSA) was enacted eight years ago. With only two years until the deadline, we thought it was a good time to recap what’s in store for DSCSA 2023 serialization.

The DSCSA Timeline

As our timeline shows, November 27, 2023, will be the 10th anniversary of the DSCSA. Per Section 582(g)(1) of the DSCSA (Title II of the Drug Quality and Security Act), “On the date that is 10 years after the date of enactment of the Drug Supply Chain Security Act … interoperable, electronic tracing of product at the package level requirements shall go into effect.” In other words, DSCSA 2023 serialization.

DSCSA 2023 Serialization Timeline

DSCSA 2023 serialization: recent developments

No more delays. On August 9, 2021, the FDA signaled that the DSCSA 2023 deadline for interoperability would not change. Leigh Verbois, the director of the FDA’s Office of Drug Security, Integrity, and Response, made the comments during a webinar hosted by the Healthcare Distribution Alliance (HDA).

Draft and final guidance on product identifiers (PIs) and more. On June 3, 2021, the FDA published “new guidance to further enhance the security of prescription drugs in the U.S. supply chain.” Guidance was released for PIs, suspect and illegitimate products, and enhanced drug distribution security.

Full serialization

For DSCSA 2023 serialization, transaction information (TI) must include the PI, which includes serial numbers and expiration dates. The Electronic Product Code Information Services (EPCIS) appears to be the standard the industry will use to enable this exchange. Right now, TI and transaction statements (TS) are being electronically exchanged at the lot level, which is usually done with an advance ship notice (ASN). The transition from ASN to EPCIS is a cornerstone of DSCSA 2023 serialization.

Authorized trading partners

Under the DSCSA, authorized trading partners (ATPs) may engage in transactions only with other ATPs. In other words, all manufacturers, wholesale distributors, repackagers, 3PLs, and dispensers and their trading partners must be ATPs. If they’re not authorized, their access to the U.S. pharma supply chain will be severely restricted or denied altogether. Read our in-depth ATP blog series here.

Verification Router Service (VRS)

Under the DSCSA saleable returns verification requirement, wholesalers must verify saleable returns before they can be reintroduced to the supply chain. This is done by verifying the drug’s PI. A wholesaler must initiate a verification request (to a manufacturer) to verify the returned products, and the manufacturer must provide a verification response within 24 hours. The VRS enables the rapid, secure exchange of data between these parties. Get more details here.

Final thoughts

We have been talking about and reporting on the DSCSA Day 1. We’ve been active in industry initiatives, particularly the VRS and the Open Credentialing Initiative (OCI) to meet ATP requirements. We’re ensuring the Ohio Department of Veterans Affairs is DSCSA-compliant. And we’ll soon be announcing another exciting initiative in the move toward full serialization of the U.S. pharma supply chain. Keep an eye out for that.

This year, we hosted a “Plan for DSCSA Readiness” webinar in March and a DSCSA 2023 webinar series in June that covered ATPs, EPCIS, and the VRS. We also published a “Dispensers and DSCSA 2023” white paper in May.

We’ve also been helping pharma companies and public-sector organizations comply with the DSCSA and other pharma regulations around the world. From our Serialization Processing and Compliance Management solutions to the full-scale power of our Traceability System, we ensure compliance no matter your role in the supply chain.

Take another look at our DSCSA timeline. A lot has happened since 2013 — and the pace will only intensify over the next two years. Contact us today if you need to know more. Our supply chain and DSCSA experts are here to help and make sure you’re ready for 2023