If you don’t get easy-to-understand information from your prescription drug label, don’t expect the lengthier instructions in the pack-insert to clarify matters much.
It is up to the brand owner to decide whether the artwork file to be shared to the printer will contain live text (open file) or not (curved/closed file).
Fonts are important in three aspects.
Font related issues are the most common reason for workflow interruptions.
All fonts should be embedded in the artwork PDF file. This is done to ensure that incorrect fonts aren’t used, which could potentially lead to the text becoming illegible. In some cases, text might disappear too. There are various fonts available (like True Type, Type 1, Type 3, etc.) and when a certain font is not available during PDF creation, it typically gets replaced by the courier font.
The pre-flight system should check and warn the designer if the artwork contains ‘courier’ font and confirm if it was intentional or a replacement for a missing font. Designers who wish to use courier intentionally, can use variants like ‘courier new’, which are not flagged during preflight.
Special fonts used in brand names and logos are typically not available in public domain. These are created specifically by the design team for the brand. While new print vendors are added to the supply chain, not all of them will have access to this special font. Embedding the font in the PDF is a good practice to make sure all vendors have access to the right font. Pre-flight tools can examine the PDF file and detect which fonts are embedded and which aren’t.
As per EU regulations, readability is determined by the combination of font size, letter spacing, spacing between lines, stroke width, type color, typeface, width-height ratio of the letters, the surface of the material and significant contrast between the print and the background.
Similar to the fonts, the text size is a factor in the regulatory guidelines. Regulations mention the minimum font sizes required (as per packaging size, packaging type, component type (like medication guides). Some regulatory agencies mention the requirement in mm, some in x-height. European Union’s FIC Regulation 1169/2011 requires that the minimum x-height of the font be 1.2 mm with the exception of containers where the largest surface area is less than 80 cm2, in which case the x-height of the font size shall be equal or greater than 0.9 mm.
Following examples are displayed in EU’s documents on food labeling:
Design over text Fonts are tiny
Very low contrast of font against packaging
FDA regulates the required labeling on an OTC drug product through regulations referred to as monographs. The monographs list the labeling requirements, active ingredients and testing requirements per OTC drug product category.
FDA regulations specify the font size, thickness of lines and whether type-set must be bold or regular font. Below is a sample Drug Facts panel showing the font sizes and the formatting that is required. This is a starting point for any graphic artist that is designing an OTC label.
For food on the other hand, the FDA published final rules on the new Nutrition Facts label for packaged foods to reflect new scientific information, including the link between diet and chronic diseases such as obesity and heart disease. Some of the updated formats are reflected below:
Standard Vertical 21 CFR 101.9(d)(12)
Tabular Format 21 CFR 101.9(d)(11)(iii)
Dual Column Display 21 CFR 101.9(e)(6)(i)
There are technical limitations on using smaller font sizes for some substrates and printing methods.
Depending on the component type, printing method & regulations, the pre-flight check should be able to suggest if there is any text in the artwork below the recommended size.
Letting mistakes and bad files get through to print is obviously expensive and leads to issues of who pays – customer or (sadly often) the printer who doesn’t want to lose further business by kicking up a fuss.
Printers know, at least in theory, that powerful preflight checking software will increase production efficiency in the workflow. With a pre-flight check done early in the design cycle, errors at a later stage can be avoided saving both time and money.
Image Credits: FDA.