FDA Releases Guidance for Food Allergen Labeling Exemptions

The Food and Drug Administration (FDA) issued final guidance for industry on June 19 titled “Food Allergen Labeling Exemption Petitions and Notifications.” This guidance was preceded by draft guidance by the same name. The FDA received comments on the draft guidance and considered them when making revisions to the final guidance. The final guidance explains the FDA’s thinking on the submission of petitions and notifications for obtaining exemptions from labeling requirements for major food allergens under the Food, Drug, and Cosmetic Act (FD&C Act).

In 2004, the Food Allergen Labeling and Consumer Protect Act (FALCPA) created a new food misbranding charge regarding the labeling of major food allergens. FALCPA amended the FD&C Act to state that foods that failed to declare the presence of a major food allergen on the product label would be considered misbranded. The FD&C Act defines a major food allergen as “milk, egg, fish (e.g., bass, flounder, or cod), Crustacean shellfish (e.g., crab, lobster, or shrimp), tree nuts (e.g., almonds, pecans, or walnuts), wheat, peanuts, and soybeans.” Section 321(qq) also defines a major food allergen as a food ingredient that contains protein derived from the listed foods. However, FALCPA provided two pathways for certain ingredients derived from major food allergens to be exempt from allergen labeling requirements. Section 403 allows a person to petition the Secretary of the Department of Health and Human Services to exempt a major food allergen ingredient. Section 403 also states that a person need not file a petition if he or she files a notification with the Secretary.

Certain ingredients derived from major food allergens are modified to such an extent that they lack the offending allergenic protein. Additionally, it is possible for a major food allergen to be used as an ingredient such that the level of the allergenic protein in the finished food product does not cause an allergic response. The two FALCPA exemption pathways allow these types of ingredients to avoid major food allergen labeling requirements. Both pathways require a showing that the ingredient “does not cause an allergic response that poses a risk to human health.” First, an ingredient may become exempt through a petition process under which a petitioner has the burden of proof to present scientific evidence, including (in some cases) clinical studies of oral food challenges or skin prick testing to prove that the ingredient will not provoke an allergic response that poses a risk to human health. Second, an ingredient may become exempt through submission of a notification that contains scientific evidence that the ingredient “does not contain allergenic protein” or that there has been a previous determination through a premarket approval process under section 409 of the FD&C Act.

Both types of submissions will require an ingredient description, the method or procedure used to prepare or manufacture the ingredient, an ingredient protein characterization, a description of the intended use in the final food product, and methods used to obtain the scientific evidence. Petitions should contain information on the expected consumer exposure during a single consumption of the finished food product and clinical studies or risk modeling, using data on consumer exposure. Notifications should contain protein characterization, with a preference for clinical data, and any relevant animal or in vitro studies. The FDA will evaluate the scientific evidence for the specific ingredient and for the specific use of the ingredient as stated in the submission. According to the FDA, the submitter should determine whether a petition or notification is most appropriate for the ingredient and its specific uses. Finally, the FD&C Act requires all petitions and notifications as well as the FDA’s response to be posted publicly. The inventory of petitions received since 2004 can be found here, and the inventory of notifications can be found here. To date, eight notifications and three petitions have been filed. One petition has been approved (soy), and one notification has been approved (fish). The final guidance will provide direction to entities interested in having an ingredient exempted from major food allergen labeling requirements.

Original Source: http://www.natlawreview.com/article/fda-releases-guidance-food-allergen-labeling-exemptions

Data Points: Fast Facts on the Digital Label & Packaging Market

Digital Press Installations on the Rise

Run lengths are decreasing by an average of 7 to 9 percent each year, and as digital technology quickly evolves, digitally printed jobs are becoming more economically viable. Digital inkjet color presses capable of producing high densities, finer dots and faster speeds are propelling the digital printing growth.


North American Press Installations In 2013 & 2018 Conventional vs. Digital

The North American tag and label industry is considered one of the most innovative of the print segments. Digital technology has transformed the way labels are designed, specified, sourced and delivered.  In 2013 an estimated 9 to 10 percent of its work was produced on digital printing presses.

Digital production volumes are projected to grow at 17 to 18 percent CAGR over the next five years. As a result, the percent of digital press installations will exceed those of conventional presses by 2018.

Source:  PRIMIR 2014 study “Tag and Label Printing Trends” by LPC and AWA.

Why do Labels Matter?

  • A Pressure Sensitive Focus

The part of the label market directly addressed by digital production presses is the pressure-sensitive sector, which accounts for about 33 percent of all labels. It also represents the fastest-growing and highest value sector of the overall market with retail prices for finished labels totaling $50 billion in worldwide annual sales.

  • Digital Labels are Strategic to Analog Converters

Digital presses have been successful at integrating themselves into the physical workflow of PS label manufacturing and have reduced process costs for short run levels. This has increased the value of labels that are customized or that can be made available on very short notice.

Users of analog pressure-sensitive labels have accepted and adopted digital presses running alongside flexo UV technology. Although the surface area printed by digital presses represents less than 1.5 percent of analog printed PS labels, the value of those digital labels, as a share of analog value is closer to 3 percent.

  • HP’s Activities Help All Players

Demand for digital labels has been stimulated by HP’s integrated marketing from the back of the value chain (manufacturing) to the front (brand owners) through the education and nurturing of all the players. This is an activity that lifts all boats on the tide and was among the most interesting and important activities in the market during 2013 and into 2014. It is a signpost for the future of other markets for digital packaging.

  • Electrophotographic (EP) Leads UV Inkjet

EP technology continues to dominate the digital label press market with HP Indigo the leader with ElectroInk technology. The rest of the market is mostly taken by UV inkjet presses from more than 10 suppliers with EFI-Jetrion as the leading supplier to date.

Source: IT Strategies

Value of Print for Folding Cartons

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Forecasted Compound Annual Growth rate, 2013-2018: 58.3%

This InfoTrends chart shows global gross billings for folding carton printing from companies that use color digital presses such as HP Indigo, Xeikon, Xerox, Screen, etc. for folding carton printing.

This type of printing has been a side application for narrow web label presses for several years, and Xerox has been placing its sheet-fed, narrow format iGen press in this segment since 2010. This mix of web and small, sheet-fed type printing of folding cartons will continue, although it will be dwarfed over the next few years as B2-size sheet-fed presses for folding cartons (such as the HP Indigo 30000) reach the market.

Source:  InfoTrends

Original Source: http://www.packageprinting.com/article/data-points-fast-facts-digital-label-packaging-market/all/

Increase Your ROI On Industrial Equipment With Maintenance

Product label options are just one area in marketing your product that offers a great deal of consideration.  The exterior of your product adds appeal and allure to what’s inside.  The label is what gets your product noticed amongst the competitors.  That is why it is so important to think about what label is best suited for your company’s product.  Product manufactures can choose from shrink sleeves, cut and stack, pressure sensitive and roll-fed labeling options to increase brand awareness.  Packaging labels come in a variety of shapes, sizes and materials.  They are each manufactured using their own unique method.  For commercial products, one of the most popular options is cut and stack labels.

Cut and stack labels are able to be printed in large quantities.  Once the labels have all been printed they are cut into individual labels and stacked to allow for easy shipping.  The printing process of cut and stack labels starts out with a large roll of paper that are roll fed into a printing press.  From there the labels are cut into the desired size and shape, most often rectangular.  Once cut and stacked the labels can be applied to the product.  Most often this process is done by overlapping the two ends of label and gluing them together.

There are many benefits to each type of product label manufactured today.  Cut and stack labels have many benefits over other options.  The first and often most recognizable to product manufacturers is the fact that they remain one of the most cost effectively custom designed product label on the market.  This makes them affordable to print even in the largest of quantities.  The label is also incredibly durable which allows them to be shipped without damage and can be made from a variety of materials.

Cut and stack labels can be used on a variety of products that consumers use every day.  Some product you may be familiar with that use this type of label are aluminum juice containers, canned good, aerosol cans as well as other food and beverage needs.  They are an extremely versatile option used in custom product labeling.

The benefits of cut and stack labels are overwhelming, they are not only inexpensive but also simple to customize.  The labels are good to use on most any size or shape package.  The label design and print influence consumer’s decisions to purchase.  It should consider highly when putting together a unique marketing plan for your product.  Cut and stack labels are a solid option to consider in product labeling.

At Anchor Printing, we take pride in offering our clients cut & stack labeling, pressure sensitive labels, roll-fed labeling, shrink sleeves as well as flexible packaging options. Contact us today at http://anchorprinting.com for all of your product label design, printing and packaging needs.

The Benefits Found With Stand Up Pouches and Flexible Packaging

An abundance of food and beverage products have begun to saturate the marketplace.  With so many products available the challenge for many manufactures is how they are to make their products stand out from the rest.  How do manufacturers differentiate their products from the sea of similar products?  In an effort to improve upon their existing marketing plan which consists heavily of research and advertising, manufacturers are looking into creative ways to package their products including new and innovative options like flexible packaging.

One popular design in flexible packaging is the stand up pouch bag.  These pouches are comprised of plastic, aluminum and other materials thus making this packaging strong enough to protect food and beverage products from both environmental and physical hazards that are often encountered while being transported and stored.  Another major benefit of using stand up pouches, as with other flexible packaging products other than the attractive design is the added features such as zip locks and spouts that allow the package to be reused and more convenient.

Advantages Of Flexible Packaging

Highly Customizable:  Flexible pouches are highly customizable.  Manufacturers can tailor the package to fit any size or shape needed to fit your product.  This gives manufacturers an edge over competitors using more traditional methods of packaging and label design.

Made From High-Grade Durable Materials:  Flexible pouches are created from highly durable materials.  Stand up pouches or bags are created from materials that are approved by the FDA for use with food and beverage products.  If manufacturers desire they can enhance the safety of package by adding additional ultraviolet protection.

Creative Display Options:  Creativity is a key consideration when it comes to choosing flexible packaging.  The manners in which you can display flexible pouches are fairly limitless considering you can hang in a peg display or stand on a shelf.

Reusable:  The reusable nature of flexible pouches makes them incredibly popular as well.  With additional features such as zip locks, spouts and the ability to re-seal themselves flexible packages are convenient making them just what manufactures desire to help drive sales upward.

Upgraded Design:  Rotogravure printing is a new printing technique that flexible packaging manufacturers are using to create a very vivid and clear logo.  Both techniques are fairly new to the product packaging industry and incredibly popular at creating a package that stands out amongst competitors.

Gusseted Bottom:  The design of a flexible package allows more of the product to fit without compromising space the package takes up overall.  A gusseted bottom design, one which expands, is found in flexible packaging and allows for this.

Environmentally Friendly:  The fact that the package is environmentally friendly as well.  It does not take a tremendous amount of resources to produce.  Adding this feature costs manufacturers not a penny more so that helps too!

These reasons make flexible packaging, in particular stand up pouches and supreme choice amongst other types of package and label options.

At Anchor Printing, we take pride in offering our clients cut & stack labeling, pressure sensitive labels, roll-fed labeling, shrink sleeves as well as flexible packaging options. Contact us today at http://anchorprinting.com for all of your product label design, printing and packaging needs.

Finding The Right Label For Your Product

Packaging labels in general are seen in the most simplistic manner as a way to distinguish between the vast array of product available in the marketplace.  In the most basic manner this is one of the roles the label plays however as a marketer the purpose of the products label goes much deeper.

Custom product labels are a significant tool used in marketing to help create brand awareness and loyalty amongst consumers.   A connection is created between the company’s product and the customer largely because of the visual presence of the products label.   Marketers use the label as a tool to help consumers gravitate towards visually familiar products and brands throughout the store.  The label itself is important as is the design and material used to create the label.  When it comes to selecting a label there are a wide variety of options to choose from.  Some of the most common choices available in packaging labels include:

Heat Shrink Sleeves:  Shrink sleeves also known as shrink wrap labels are made from a unique polymer plastic film that shrinks as heat is applied to it.  This particular label type is designed to take the shape of the container as it shrinks which makes it fit perfectly.  Another benefit to shrink sleeves is that it gives marketers a three hundred and sixty degree space to design.   With the extra space there is room to add important information and graphics.  Shrink sleeves are used a lot in beverages.

Pressure Sensitive Labels:   Pressure sensitive labels attach to the outside of a container once a slight pressure is applied.  The label is attached using a strong adhesive that allows it to stay securely in place as it travels from the manufacturer to the shelf.  One major benefit of pressure sensitive labels is that they are able to be cut into a variety of different shapes and sizes to ensure that it meets the constraints placed by the container.

When it comes to choosing a label for your product is important to understand what your marketing plan is.  Not every marketing plan or concept will match every label type.  It is essential that you consider all of your options when choosing a label type.  In order to best build brand awareness and loyalty for your product look at all of your options, consider all of the pros and cons of each type of label.  Choose the label material that is a best fit with your products marketing concept.

At Anchor Printing, we take pride in offering our clients cut & stack labeling, pressure sensitive labels, roll-fed labeling, shrink sleeves as well as flexible packaging options. Contact us today at http://anchorprinting.com for all of your product label design, printing and packaging needs.