The U.S. Food and Drug Administration is currently developing specific rules to implement that part of the law. A previously released draft of the regulations did include language suggesting that the final rules may not cover grocery stores, but companies in the sector don't want to wait to find out.

According to Bloomberg News, the Food Marketing Institute, an industry group, is advocating for the passage of additional legislation that would limit the effect of the new labeling regulation to "stores that get more than half of their total revenue from restaurant-style food prepared on site."

Erik Lieberman, the organization's regulatory counsel, told Bloomberg's Stephanie Armour that there are also other "options to minimize costs and to quantify the burden on industry." Specifically, Lieberman asserted that officials at the White House Office of Management and Budget are "charged with reviewing these regulations."

"They can put a check on the FDA, and the president should make sure they do that," Lieberman said.

In an interview with the Washington Post, Brendon Cull, director of government affairs at the Kroger Company, made the case that grocery stores are simply different from the fast food restaurants that the rule was designed to target.

"These regulations make sense for a restaurant, but that's not the case for a bakery in a grocery store," Cull said. "We might have thousands of SKUs for birthday cakes and thousands of types of prepared pizza. The problem is it forces us to label all of that, down to the olive bars and salad bars."

Cull added that if Kroger was forced to comply with the calorie-labeling regulations, it would cost the company as much as $20 million. According to Lieberman, the total cost to the grocery industry would exceed $1 billion during the first year alone.

FDA Commissioner Margaret Hamburg told lawmakers at an April hearing that the final regulations are scheduled to be completed by the end of the current year. However, with many of the other regulations linked to the healthcare reform act running far behind schedule, we could be well into 2014 before stakeholders are certain about whether new label compliance requirements will be applied to them.

Now, the global standards organization is partnering with Open Mobile Alliance (OMA) to develop a specification that will facilitate the scanning of barcodes by mobile devices. The goal of this project is to provide consumers with a secure link to trusted digital content provided by brand owners, who also own the rights to the GS1 barcodes on their products.

In a press release announcing the partnership, Bryan Sullivan, vice chairman of OMA's board of directors, emphasized the fact that barcode scanning is emerging as a "key driver for consumers to access data and media owners to engage users."

"Today, the industry is working with a barcodes ecosystem that is fragmented by non-standard solutions," Sullivan explained. "This specification will enable application developer innovation for the mCommerce and mobile advertising industry, allowing companies to develop interoperable and scalable applications."

The release indicated that the partners are planning to leverage existing GS1 and OMA standards to facilitate development of the new specification, with the goal of launching it in 2014. However, they are encouraging interested stakeholders to take part in the development process. Fujitsu, NEC and AT&T have reportedly signed on to participate already.

GS1's standardized barcodes are already used in the execution of more than 6 billion transactions across 150 countries every day. With the creation of this new specification for barcode scanning, the importance of having a GS1-compliant labeling solution in place will be greater than ever.

Consider the 2012 Olympics, when media commentators and members of the public expressed outrage upon discovering that the athletes representing the country were wearing uniforms made in foreign factories.

A 2012 AutoTrader survey showed that Americans also apply this commitment to their own shopping habits. More than 40 percent of prospective car buyers said that they believe it is important to purchase a vehicle that was manufactured in the United States. In fact, respondents indicated that they place a higher value on whether the car carried a "made in America" label than whether it was designed by a U.S. or foreign company.

A number of major companies have recently announced their intention to make more products in the United States. Late last year, Apple CEO Tim Cook told the press that his company would soon begin contracting with U.S. manufacturers to handle the production of some of its Mac computers. A spokesperson later confirmed to CNN that as much as $100 million was slated to be spent on the transition.

Although the production of Apple's more popular products such as the iPhone and iPad will continue to depend on the flexibility and sheer scale of existing industrial complexes in Asia, even these items already contain some items sourced from the United States. For instance, the processors that power the devices and the durable "Gorilla" Glass that protects their screens are made in America.

Survey shows significant interest in 're-shoring'

A new survey conducted by the Institute for Supply Management (ISM) shows that more companies are realizing the value of "re-shoring" and thinking about moving their manufacturing operations back to the United States. More than 500 supply chain professionals attending ISM's annual conference in Dallas responded to the survey, which asked whether their organizations were planning to begin sourcing more material from the United States over the course of the next year.

Almost 30 percent of respondents indicated that their companies are "likely" or "very likely" to re-shore some of their production activities.

In a press release discussing the results of the organization's survey, ISM CEO Thomas Derry asserted that there had long been several factors pushing corporations to re-shore their manufacturing. However, the executive asserted that the recent surge in the number of companies actively planning to put more American links in their supply chains "is largely resulting from the risks that companies were exposed to in Thailand and Japan from natural disasters."

"Combine this with increasing freight rates and increased levels of inventory, companies are re-evaluating the approach," Derry said. "Many want to have inventory close to the point of manufacture – even if it means duplicating resources to do it."

The survey results support Derry's conclusions. Almost 40 percent of respondents said their greatest concern about sourcing from abroad is high levels of instability and rapidly changing economies in low-cost countries. Meanwhile, 36 percent pointed to the disadvantages associated with "long distances and lead times."

Re-building a domestic manufacturing base will help companies address these concerns, while putting the "made in America" label back on their products may aid them in increasing their market share.

After all, if a company can't certify that shipments contain what they are supposed to, how will the right ingredients – and proper labeling – be applied to finished products? Furthermore, serialized labeling is essential for planning and conducting fast, effective recalls.

Last week, this lesson was on display when Whole Foods Market was forced to put out an apologetic press release after discovering that it had accidentally distributed two salads whose labels had been mixed up during the packaging process.

The items in question include a curried chicken salad and a meat-free version of the same product, which contained a vegan alternative referred to as "chick'n." The mislabeled salads were sold in only 15 of Whole Foods' approximately 300 U.S.-based stores, but the incident doubtlessly undermined the company's reputation in the minds of some consumers nonetheless. The recall affects retail locations sited throughout New York, New Jersey, Massachusetts, Maine and Connecticut.

A complete list of affected stores is available online through the website of the U.S. Food and Drug Administration. The agency also noted that that labeling swap led to the presence of undeclared allergens in each of the products. The vegan salad contains soy, while the chicken salad contains egg. Fortunately, no illnesses linked to the mislabeled salads have been reported at this time.

Whole Foods has reportedly posted signs in its stores to notify customers of the recall and is offering a full refund for those affected by the labeling mix up. However, if the company is truly interested in making amends and restoring consumer confidence, it will need to tighten up its labeling processes to ensure that this type of incident does not happen again.

COOL was first mandated by Congress in 2002, expanded to include new products in 2008 and put into effect in 2009. However, the process of implementing the law has been plagued by a number of different obstacles, including an international legal drama that could reach a climactic moment later this month.

The labeling regulations have long been under fire from Mexican and Canadian cattle farmers, who claim that the U.S. law discourages American meat processors from purchasing foreign animals, thus constituting a technical trade barrier, barred by agreements the United States made with its neighbors under the auspices of the World Trade Organization (WTO).

Those countries' representatives filed a formal complaint with the international regulatory body, which resulted in the convening of a dispute settlement board (DSB). In 2012, the DSB ruled that although the U.S. was legally allowed to require COOL, the way the law was being implemented placed a disproportionate burden on foreign producers.

The board specifically asserted that the record-keeping and verification requirements associated with the U.S. COOL program ran afoul of the country's international obligations. The U.S. government was given until May 23, 2013 to bring its labeling regulations into compliance with WTO rules.

Canadians claim updated rules fail to address problems

On March 8, the U.S. Department of Agriculture (USDA) released a proposal to modify the existing COOL system by requiring products to be labeled with information about where each step of the production process – from birth to slaughter – took place.

"USDA expects that these changes will improve the overall operation of the program and also bring the current mandatory COOL requirements into compliance with U.S. international trade obligations," U.S. Secretary of Agriculture Tom Vilsack said in a press release announcing the new regulations.

However, Canadian officials were far from pleased with the USDA's decision.

"We do not believe that the proposed changes will bring the United States into compliance with its WTO obligations," Canadian Agriculture Minister Gerry Ritz said in a statement. "The proposed changes will increase the discrimination against exports of cattle and hogs from Canada and increase damages to Canadian industry."

Ritz said the Canadian government would "consider all options, including retaliatory measures, should the U.S. not achieve compliance by May 23, 2013, as mandated by the WTO."

Although he did not clarify exactly which measures Canadian officials would take, it seems as if the most likely outcome would be for the country to impose tariffs on American goods. To do this, Canada would first need to request authorization from the WTO.

U.S. officials claim retailers in near-universal compliance with COOL regulations

Despite the international controversy surrounding the subject, implementation of COOL seems to have run relatively smoothly.

Since the COOL regulations went into effect in March 2009, the USDA's Agricultural Marketing Service (AMS) has carefully scrutinized numerous products on the market to ensure that retailers are maintaining compliance with the law. During 2012, the agency conducted more than 3,800 compliance reviews at U.S. retailers. Based on what they observed, officials estimated that the compliance rate among retailers is approximately 98 percent.

Additional information about COOL can be obtained at the AMS website. And for ongoing updates regarding this case and other labeling issues that are important for today's enterprises, interested stakeholders should keep a close eye on this blog.

The so-called sequester is expected to result in significant delays – up to five days at major sea ports – to the processing of cargo shipments as a result of cuts to U.S. Customs and Border Protection (CBP).

After across-the-board spending cuts took effect on March 1, Deputy Commissioner David Aguilar issued a guidance document to stakeholders informing them of the steps that the agency was planning to take in order to meet budgetary targets. Specifically, the CBP announced that it would reduce overtime for all personnel immediately and begin employee furloughs by mid-April. A hiring freeze has also been put into effect.

According to estimates developed by the agency, it will need to reduce its work hours by the equivalent of more than 5,000 border patrol agents and 2,750 CBP officers. CBP has also noted that the roll out of some of its strategic initiatives, such as the Automated Commercial Environment (ACE) and the Centers for Excellence and Expertise (CEE), could be delayed due to a lack of funding.

Some types of shipments may be affected more by sequestration than others. For instance, CBP has said it will continue to regard the processing of perishable commodities as a "top cargo priority," which bodes well for the food and beverage industry. However, companies in that sector could still be affected by the delayed arrival of new equipment, replacement parts or other non-perishable items.

Meanwhile, businesses across a range of other industries will likely see their operations disrupted as a result of the cuts. However, there are actions companies can take to reduce the impact.

Ensuring key data is readily available to regulators speeds the inspection process

One of the most important things an organization can do to keep its supply chain running smoothly during the sequester is to ensure its labels are in full compliance with all applicable industry standards, U.S. laws and international trade agreements. This is especially critical for companies in highly regulated sectors such as healthcare, chemicals and electronics.

Last week, we discussed stakeholders' expectation that an international summit in Geneva will result in new controls on chemicals. With fewer customs officials available to handle growing volumes of cargo governed by increasingly complex webs of red tape, it is imperative for companies that depend on fast, consistent shipping to facilitate the process as much as possible by ensuring their labels are printed properly.

The sensitive nature of health issues makes it possible for seemingly innocuous decisions to result in calls for additional regulation or even bans of particular items. For example, in a previous post, we looked at how beverage makers' controversial decision to put caffeine in alcoholic drinks prompted the U.S. Food and Drug Administration (FDA) to initiate an investigation, warning more than two dozen companies that it was looking into the "safety and legality of their products."

Several states acted quickly to ban the beverages altogether, while companies such as Phusion Projects, which developed the popular "Four Loko" drink, were pressured to remove the caffeine from their products.

Now, it's caffeinated foods that have the federal food safety agency threatening to take action. In a press release, Michael Taylor – the FDA's Deputy Commissioner for Foods and Veterinary Medicine – said the agency is taking a "fresh look" at the impact that the addition of caffeine to common snack foods may have on human health.

"The only time that FDA explicitly approved the added use of caffeine in a food was for cola and that was in the 1950s," Taylor said. He added that as a result of the introduction of new caffeinated products, vulnerable populations such as children and adolescents "may be exposed to caffeine beyond those foods in which caffeine is naturally found and beyond anything FDA envisioned when it made the determination regarding caffeine in cola."

The range of items in this rapidly expanding group runs from Wrigley's Alert Energy Gum to Wired Waffles and more provocatively named products, such as an espresso bean candy called Crackheads.

Concerns could lead to new labeling regulations

Some may wonder why an item's caffeine content is not displayed on the Nutrition Facts Panels that products are required to display on their packaging.

"Caffeine is not a nutrient," the FDA explained in a primer on the subject. "It is a naturally occurring chemical [and if] caffeine is added to a food, it must be included in the listing of ingredients required on food product labels."

Although this level of disclosure is already mandatory, some food safety advocates have suggested that the agency should consider expanding the labeling requirements linked to caffeine.

Deputy Commissioner Taylor concluded his statement on the subject – released on the same day that the first pieces of caffeinated gum hit store shelves – by saying that if the FDA determines the wave of new products pose serious health risks, it "will take appropriate action."

Exactly what this means remains to be seen, but if new labeling rules are part of the regulatory response to the growth of the caffeinated products market, stakeholders will be able to find the information they need to ensure compliance right here, on the Enterprise Labeling blog.

The Basel, Rotterdam and Stockholm Conventions – all of which are based in Geneva, where the meeting is taking place – are reportedly considering placing new limits on certain substances. However, the primary impetus behind the decision to hold a single conference for all three organizations was that it would make it easier for stakeholders to identify new ways to improve human and environmental safety by bolstering compliance with existing regulations.

In a string of joint meetings, the parties will review the impact of arrangements that were put in place by national governments following a 2011 agreement, which was aimed at strengthening cooperation and generating new synergies between the three treaties. Delegates will also discuss whether it is necessary to make additional changes to the organization of the conventions' administrative offices – the secretariat – as well as the program and budget for joint activities to be conducted in 2014 and 2015.

In addition to the combined parts of the event, each of the conventions will also hold a number of separate sessions to deal with issues that are not immediately pertinent to the other treaties.

New regulations may be put in place on multiple chemicals

According to the Associated Press, after the two-week conference kicked off on Saturday, top officials asserted that they believe delegates will ultimately vote to approve the implementation of new internationally recognized controls on the transportation and use of a number of industrial compounds. The group is also expected to work on an agreement to resolve issues pertaining to instances of cross-border pollution.

Jim Willis, executive secretary for all three conventions, said he expects that delegates will agree to gradually phase-in a ban of hexabromocyclododecane, or HBCD, which is a flame retardant commonly used in building insulation, furniture, vehicles and electronic devices. Willis also told reporters that delegates will most likely agree to a stricter set of requirements for disclosing information about exports of several different substances, including an herbicide, an insecticide, a fabric protector and two additional flame retardants.

The construction material Chrysotile asbestos may also face new regulations. A previous effort on the subject was blocked by Canada – a major asbestos producer – and several other nations. Willis asserted that Canadian delegates appear to be more supportive of the proposal this year, although he expressed some concern that Russia – a relative newcomer to the treaty and possessor of large reserves of asbestos – may try to block the motion.

Although the three conventions make all of their decisions based on the consensus among nations' delegates, officials told the AP that it is uncommon and difficult for single countries to block action in the face of pressure from the majority of the others.

The climax of the event will come on May 9, when as many as 80 government ministers arrive for two days of high-level discussions. If any substantive changes to existing chemical regulations are approved, it will reinforce an ongoing trend that is seeing companies pressed to ensure key safety data about materials can be made accessible throughout the supply chain.

The industry has been supported by a number of positive trends recently. For instance, the number of new drugs approved by the U.S. Food and Drug Administration (FDA) hit a 16-year high of 39 during 2012. Meanwhile, venture capital outlays for life sciences companies surged by more than 20 percent.

At the same time, a number of challenging developments have created a feeling of widespread uncertainty within the sector.

Industry-wide changes putting pressure on all stakeholders

"We as a healthcare system are at a pivotal moment," David Meeker, CEO of Sanofi SA's Cambridge-based Genzyme division, told attendees at the BIO conference.

Meeker noted that sluggish economic growth in major markets such as the United States and Europe has put pressure on healthcare spending, which had been increasing rapidly for years when the financial crisis hit. Commercial health insurers and government-linked payers have started rolling out more stringent reimbursement standards that focus on results, rather than volume of care. The new trend toward cost containment and personalized medical is putting pressure on companies that have grown accustomed to operating in a high-growth environment.

Steven Burrill, chief executive of the healthcare-focused financial firm Burrill & Company, elaborated further on the changes that are sweeping through the industry.

"When you think about the healthcare system, it's going from a cost and procurement system to a value and outcomes system," Burrill explained. "So the companies today are going to have to sell outcomes and they're going to have to sell outcomes at lower costs."

One aspect of this trend is seeing the industry challenged by growing regulation of pharmaceutical products. The process of bringing experimental drugs to market has become longer and more complex as federal officials have started to demand that companies provide more patient-specific data about new medications before they are granted approval.

Improving collaboration seen as key to meeting emerging challenges

Companies are looking to overcome these obstacles by forming more partnerships.

Such arrangements are being facilitated through the use of "earnouts," a new financing mechanism that allows one company to pay less upfront to acquire or partner with another, with additional payments contingent upon new drugs' ability to hit key regulatory or sales milestones.

Public organizations are also playing a role in bringing firms together. At the BIO convention, officials representing five countries announced a new initiative that will encourage companies from areas that have vibrant life sciences sectors to partner with firms in Massachusetts.

The state's Life Sciences Center is planning to invest as much as $1 billion over the course of a decade to expand biotechnology research and development in the Bay State. Companies from the Australian state of Victoria, Belgium's Wallonia area, the Alsace region of France or Quebec, Canada could win up to $500,000 to support their projects.

Although the rise in collaboration between companies will help them meet some challenges, it will also create new ones. For instance, coordinating the movement of critical data within the supply chain can be much more complex for inter-organizational projects.

In order to succeed in the increasingly results-oriented sector, biopharma firms will need to make sure they have solutions in place that allow them to manage and track information about inputs and finished products. This is key for not only maintaining compliance with regulatory requirements, but improving customer outcomes as well.

Today, GS1 standards are used by more than 2 million companies operating in 150 countries and 25 distinct industries, from apparel manufacturers in Asia to healthcare providers in Europe and the defense industry in the United States. These standards are used to identify, capture and share information about products and services in real-time, facilitating the development and distribution of a wide range of items.

According to GS1, more than 5 billion of its barcodes are scanned every day in a variety of different settings. From the factory floor all the way through the supply chain to the retailer's checkout counter, barcode labels provide stakeholders with the data they need to conduct operations in an efficient manner.

"Trading partners use our standards to share many complex pieces of data globally in order to transact business, and they need to be able to automate these business processes to reduce cost, human error, or improve safety and interoperability of systems," Bob Carpenter, president and CEO of GS1 US, said in a press release analyzing the organization's progress over the years. "For example, manufacturers and distributors must communicate product information and company location, at minimum."

Carpenter added that a "common language and globally accepted standards are essential for trading partners to be able to understand each other, conduct business one way around the world and collaborate efficiently."

GS1 US will commemorate the 40th anniversary of its standards' adoption at its upcoming annual conference. GS1 Connect 2013 will be held June 10 to 13 at the JW Marriott in San Antonio, Texas. Supply chain experts from major companies such as Coca-Cola, Kellogg and Target will be at the event to share best practices for leveraging GS1 standards to tackle the toughest challenges facing companies in their industries.

With the importance of the topic continuing to increase, any companies that are behind the curve on standardization may want to learn more about how GS1 is – in Carpenter's words – "working with [its] members to shape the future."