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Rules & Regulations (11)

Dion Label Printing is a Part 11 and Annex 11 Compliant Printer

2017-03-20 14:28 by Amelia Stasky (comments: 0)

Press Release

Dion Label Printing is proud to be registered with the FDA and compliant with both FDA 21 CFR Part 11 and EU Annex 11.

Part 11 was established in 1997 by the Food and Drug Administration (FDA) to regulate security of electronic records. The law was established for pharmaceutical, medical, and similar FDA-regulated biotech companies. As a label printer for those industries, Dion Label Printing was required to complete the process to be a compliant printer and provide guaranteed secure printing. 

EU Annex 11 was established in 1992 through the European Union and details the steps needed to maintain Good Manufacturing Practices (GMP) in relation to electronic records and systems. GMP helps maintain quality control over items produced to confirm quality is maintained. The law ties directly into Part 11 as quality and compliance is especially necessary in pharmaceutical and medical companies. 

Dion Label Printing understands the importance of maintaining compliance as it is mandatory for some of our FDA-regulated customers. As a printer, Dion understands it is now our responsibility to maintain compliance with Part 11 and GMP to meet the needs of our customers as they grow into larger markets. 

Co-owner John Dion commented, "As the FDA ramps up enforcement under 21 CFR Part 11, our compliance (and also with EU Annex 11) will provide select customers greater confidence in computer software, system and records security at Dion Label as required under the rules. Although the process is initially time-consuming, maintenance of our status will have minimal effect on the cost of product manufactured accordingly."

Dion Label Printing is a digital and flexographic label printer located in Westfield, MA. Dion prints labels, shrink sleeves, pouches and specialty medical products for multiple industries. Dion Label Printing is a leader in the packaging industry with two HP Indigo presses, five flexographic presses, shrink sleeve equipment, sustainable practices and print options as well as finishing options including hot stamping, cold foil, embossing, and specialty coatings.  

For Immediate Release 

Editorial Contact: Ashley Obara 

Marketing Manager 

Dion Label Printing 800.583.6366   413.568.3713 x 137 

FDA Proposes New Changes for Nutrition Labels

2014-03-10 14:27 by Ashley (comments: 0)

New Nutrition Label Proposed

New Nutrition Label Proposed

Labels, especially when it comes to food products, provide ample information on the nutritional/ingredients of said product. But how many people are actually reading these labels prior to purchase or reading them correctly? Over the years, studies have shown misreading nutritional labels is highly common. According to CNN Health, the Food and Drug Administration (FDA) has proposed various changes to nutrition labels that will make them easier to read and comprehend. The photo above shows the current and future state for these labels. Notice that the new label proposed has various elements emphasized in bold, black text such as calories and number of servings. Part of the proposal is to make these items stand out to consumers along with added emphasis on vitamin counts. Other items such as “calories from fat” have been removed to put more emphasis on overall calories per serving. They are also asking that containers reflect accurate serving sizes. For example, many beverages sold in bottle form have more than one serving per container. However, the consumer will most likely drink the entire bottle when purchased. The proposed new policy would require each bottle/container to contain only one serving so as to accurately reflect the calorie count listed.


There is a three month debate/comment period for these proposed changes and we can expect to know the verdict by the end of the year. As the first large change in nutrition labels in over twenty years, the U.S. is hopeful that the proposition will pass. Once implemented, companies would have a period of two years to make changes to their products on retail shelves.


What are your thoughts on the proposed nutrition label changes? Leave us a comment today!

The New $100 Bill

2013-11-04 12:15 by Ashley (comments: 0)

Security features in printing

New $100 bill design

New $100 bill design

The U.S. Federal Reserve helped to design the newest look of the $100 bill. 3.5 billion pieces of the new design were released to the public on October 8th in an effort to protect the U.S. currency from counterfeiting. Above are photos of the new bill design (top) and the previous bill design (bottom). Notice that the new design has a blue broken ribbon running down the center of the bill that has microlenses. Microlenses create an optical illusion of images on the ribbon switching from “100’s” to Liberty Bells when the bill is tilted. To the right of our founding father, Benjamin Franklin, is a gold ink well with a faded quill graphic in the background. Within the ink well is a liberty bell printed in copper ink that changes colors depending on the angle. Microprinting, or printing too small to be visible to the naked eye, is utilized on Franklin’s jacket toting the phrase “The United States of America.” A photograph of Independence Hall remains of the back of the bill, but from the rear side of the building which is different from the previous design.


Inspired by the security features of the new $100 bill, Dion decided to comment on some of the label printing security features that we offer. Label security features are critical to maintain the integrity of a product and limit counterfeiting. Void pattern films are one security printing feature Dion offers. When a label printed on a void pattern film is removed, it leaves behind a void pattern on the label and the item it was removed from. Other label materials are created to be self destructing and are impossible to remove without tearing. Clear fraud seals are available that can be hidden on any label without detection, and black light inks can be utilized on specific portions of a label for verification of authenticity. Tamper cuts and specialty perforations can be included in label construction to indicate if it was been compromised. Other features available include microtext, consecutive numbering, and hot/cold foil stamping.


Be sure to check out our previous blog, “Ski Ticket Security Features: How Safe are Your Tickets” or contact us for more information!

Locally Made Product Labels

2013-10-21 17:06 by Ashley (comments: 0)

California Leads the Way

Made in California labels

Made in California labels

As consumers are seeking transparency on the manufacturing of products, packaging that indicates locally grown or manufactured products are on the rise. An increased amount of packaging and labels are emerging on the market toting phrases such as “locally grown” or “buy local.” Many of the companies currently using this phrase are smaller “mom & pop” shops that want to promote local sales for job retention. However, larger corporations and even entire states are getting in on the “go local” craze such as the largest state in the U.S: California.


Providing residence for close to forty million residents, sourcing locally is critically for California merchants to maintain jobs and local businesses. According to the U.S. Department Bureau of Labor, “Total manufacturing jobs in the state have fallen 18 percent over the past 10 years.” In response, California’s Governor's Office of Business and Economic Development (GO-Biz) and Governor Jerry Brown founded the “Made in California” label initiative. The program would provide labels to California made businesses starting on January 1st, 2014. To tote a label, the product must be created from over fifty percent California made goods. GO-Biz hopes to utilize the well liked attitudes toward the state to aid in attracting customers with these labels. 


Check out our previous blog, “WindMade Product Label Introduction” about a sustainable energy product label implemented earlier this year.

New Supplement Label Regulations Coming Soon?

2013-08-28 15:12 by Ashley (comments: 0)

Supplement Label Laws

Supplement Label Laws

The market for supplements and nutraceutical products has grown rapidly over the past decade or so with new products hitting the market each day. Though the Food and Drug Administration (FDA) does regulate these supplement products, two U.S. Senators have proposed a new act that would require more detailed product information to be printed on all supplement labels. The legislation is called the Durbin-Blumenthal Dietary Supplement Labeling Act that would require companies to include more information on labels and give more control on the trafficking of these products to the FDA. The new labeling law would also provide the public with possible side effects of ingredients in certain supplements. Senator Dick Durbin commented, “Regulation of supplements can be improved to protect public health and it starts with making more information available to consumers and the FDA.”


Some of the new label requirements called out on the proposition would require warnings for ingredients that could pose possible health side effects for certain individuals (ie: women who are pregnant). Also, if an ingredient could react with a medication they must call out the possible reaction on the label along with the amount of that ingredient included in the supplement product. Batch numbers would be required on all supplement labels so they are available in case of a FDA recall. Finally, the act would require clear labeling to if the product is a food/beverage product or if it is a food/beverage product with additives.


For more information on nutraceutical labels, be sure to read our industry guide today!

WindMade Product Label Introduction

2013-08-12 14:49 by Ashley (comments: 0)

WindMade labels

WindMade labels

Sustainable energy has been around since prehistoric times but has been utilized in several specific forms in the past few decades. Among the most popular are solar, water and wind power that provide energy in a clean sustainable manner that will not impact the future of the planet. The first ever identifier label of clean wind energy was recently introduced by a global wind energy non-profit organization called WindMade. The company is based out of Belgium and their goal is to expand the use of wind power and inform the public on companies and products affiliated with sustainable wind power. CEO of WindMade Henrik Kuffner commented, “The WindMade product label provides consumers with the transparency they demand, and with a credible and intuitive tool to make informed purchasing decisions.”


The photo above is an example of the type of label found on products that are certified by the organization. Notice that each white label totes the WindMade blue circular logo meant to represent the spinning blades of a wind turbine. Products that receive the label and certification use a minimum of 75% renewable energy with wind power being the highest form. Coinciding with the introduction of the labels, the organization also launched a global campaign called “Show You Care” to spread the word about products created with clean and sustainable energy.


What other products on the market have you seen with labels relating to clean energy?

Is Your Product Made in the USA?

2012-12-04 13:20 by Ashley (comments: 0)

Brand Certification Mark

Made in the USA logo

Made in USA Brand logo

Outsourcing and overseas production has become extremely popular especially for high volume production. But with the down economy and jobs being scarce, more and more Americans want to purchase products that were made in the USA created by American workers. From this idea, the Made in USA Brand certification was created for a unified symbol of American made products. To be considered for the certification all of your products must be made or grown in the USA (packaging may be outsourced). Over 900 companies currently have this certification from beauty companies to food and clothing providers.


Notice the design of the mark that was created in the USA’s red white and blue color scheme. The logo was created in the shape of an outstretched hand to play on the idea that the product was made with American hands. The color patterns, however, were designed after the American flag.


What products have you come across with the Made in USA Brand logo? Leave us a comment; we love to hear from our readers!

Sunscreen Packaging Must Meet FDA Rules

2012-05-04 15:57 by Ashley (comments: 0)

Featuring Coppertone

Coppertone Sport Lotion packaging

Coppertone Sport lotion packaging

Summer weather is rapidly approaching which means that the sun is out and sunscreen season is back! But remember when we blogged last year about the new FDA requirements for sunscreen labels? According to Happi Magazine, here is a quick recap of what sunscreen labels now require to be considered FDA approved:

  • For the label to say the product is “broad spectrum SPF” it must protect from both UVA/UVB light rays.
  • Only “broad spectrum” sunscreens with and SPF over 15 can “claim to reduce the risk of skin cancer” on the label
  • Terminology including “waterproof”, “sweatproof” and “sunblock” cannot be used unless FDA approved with testing data to back up the claim. The term “water resistant” is allowed but only if the text states the exact length of time is protects the skin for (ex: Water resistant (80 minutes).
  • “Drug Facts” are now required to be printed in the text on all labels.

 Coppertone Sport Twin Pack

Coppertone Sport Twin Pack

One brand that is highly recommended is Coppertone, as everything with an SPF of 15 or higher is FDA approved. I am a huge fan of their “sport series” collection as all of the products are FDA approved and they have some unique packaging. Notice that the sport lotion (left photo) comes in an inverted squeeze bottle with front and back labels. What I love about this product is that the bottle is actually shaped with a jagged edge for easy gripping during activities where you could perspire. In the photo on the right you will see a twin pack of their sport continuous spray sunscreens (manufactured in metal aerosol containers) that are packed together with none other than a shrink sleeve! Check out our past blog, Yet Another Use for Shrink Sleeves, where we talk about how companies utilize shrink to attach two products together as with the twin pack above.


What are your favorite sunscreen brands that also have some interesting packaging?

Announcing Dion’s New HP Digital Press!

2010-04-16 15:26 (comments: 0)

Dion HP WS 6000 Press

HP recently sent out a press release announcing our purchase of their latest press!

Check out the capabilities our HP WS6000 press purchased in March 2010. It is the newest press on the market from HP and will increase our capabilities, including endless possibilities of substrates for printing.

“Short run, multiple SKUs, repeatable high-quality printing and the ability for variable data has helped to maintain our steady growth,” said Randy Duhaime, General Manager, Dion Label. “ The purchase of the HP Indigo WS6000 will allow us to continue this trend with longer run lengths transitioning from our conventional flexographic printing department to our digital department. WS6000 enhancements, such as its large repeat length and its ability to print on substrates from 12 microns to 450 microns, will open additional opportunities.”

Dion highlighted in recent article!

2009-12-29 10:28 (comments: 0)

“Short Run Labels”- Label & Narrow Web

 Label & Narrow Web recently looked to industry experts for their article on short run labels and interviewed Dion Label Printing. The ability to affordably print short run orders has led to more opportunities for product manufacturers. Here is a brief excerpt from the article:

Stacy Santos, marketing manager for Dion Label Printing, Westfield, MA, USA, says the company takes into account the length of the run when deciding which printing process it’s going to use. In Dion’s case, short run jobs, among others, get moved to one of the company’s HP Indigo presses. "We decide whether a job will go digital or flexo based on the amount of footage we are going to run, the complexity of a customer’s label graphics and the number of SKUs in a particular run. About a third of our business is digital. We made the investment in digital in April 2005, and because our digital business grew so quickly, we invested in another HP Indigo digital press. And our digital operations have steadily grown over the years.

"Digital printing is perfect for multiple SKUs, low volume orders, promotional labels and prototyping," Santos says. "It’s a great way to offer high quality printing, complex graphics, and vibrant colors to customers that do not have large volume quantities. Our customers do not have to sacrifice label quality while keeping their inventories low."

Read the full article here!