Your Guide to Label Regulations

By: Denise Webster

We at Bex are experts in packaging design, but none of it would be on shelf for long without the help of those who are experts in regulatory compliance. We rely on their advice to ensure our packaging adheres to the rules set by the FDA and/or USDA, to communicate what the product is, its benefits and how it differentiates from its competition. Denise Webster of Food Brand Protection, LLC is one of these experts.

Denise has worked with an extensive network of manufacturing, retailers, and industry partners for over 25 years and is an industry leader in food safety, regulatory and quality. She has a strategic focus on product commercialization and business processes improvement for brand protection and growth.

We have worked alongside Denise multiple times and felt her area of expertise would be valuable for our community here, so she’s been gracious to give us a brief overview on all things regulatory!


So where to begin to ensure your label is compliant?

There are many factors to consider when designing a label which includes: product name, placement of key regulatory information, marketing copy, claims, images, and all within the amount of space available. Depending on the product and claims being made, it will have to comply with FDA or USDA requirements including possible disclosures and food safety statements. As someone who does this every day, I’m going to try to provide my best elevator pitch on what you need to know and why it is important for achieving a successful launch of your next product!

Let’s hop on … 1st Floor — Principal Display Panel (PDP)

The side of the label that will face the consumer at the retail shelf is considered the PDP and requires at minimum, a Standard of Identity (SOI) and Net Weight. The SOI must clearly declare the product description (e.g. cereal, mix, crackers, meal), any characterizing flavors (e.g. natural or artificial), and any fanciful name that the brand would like to add. It must further declare the quantity in the lower 30% portion of the label, in both household (oz/fl oz) and metric units (g/kg). The net weight must meet minimum font size and not be crowded by other details or images.

2nd Floor — Claims and Images

Regulations specifically state that a label must not be misleading and/or detract from the prominence of the required information. The selection and placement of images need to be carefully considered, for example if you are selling a brownie mix but show a fully baked brownie with frosting — it could be considered misleading to the consumer unless ‘servings suggestion’ is declared. Claims can be either direct or implied and must be supported by validated evidence. Simply re-stating grams of protein anywhere on the label other than the Nutrition Facts Panel makes it a claim that requires %DV to be stated and possible disclaimers. There are a vast number of possibilities and equal the amount of ways to create risk to your brand or consumer unless an adequate evaluation and declaration is achieved — when in doubt consult!

3rd Floor — Nutrition Facts Panel (NFP)

Consumers’ growing interest in health and wellness starts with foods they are consuming and what products meet their specific dietary preference (e.g. keto, low in sodium) or offers added nutritional benefits (excellent source of vitamin/minerals), which influences buying decisions. The NFP is the main source, which is why it is required to be communicated in a consistent way for consumers to get the information they need to make informed choices. The NFP must be to the immediate right or back panel of the PDP. Its style and size is dictated by the size and layout of the packaging with a standard format that must be followed. Although there is flexibility, as the NFP can be any one color to align with the design, included additional voluntary vitamins/minerals, and serving size that is aligned with the new Dietary Guidelines.

4th Floor — Ingredients and Allergens

Immediately following the NFP, declaration of ingredients and then proceeded by allergens, if present must be included without any intervening information. The #1 reason products are recalled are due to mis-declared allergens and inadequate formula vetting or design. Understanding the ingredients and their sub-ingredients including processing aids and incidental additives are paramount in getting it right on the label and protecting consumers. A brand must ensure ingredients are declared in their common and usual name, in order of predominance, and any allergens are bolded or listed in a “Contains” statement that specifies the type/species (Contains: Tree Nuts (Almond, Walnut), Milk).

[Helpful Tip: Consider formulating with Clean Label ingredients that lack artificial flavors, colors, and preservatives, and simple ingredient lists with natural additives while still accurately declaring them on the label. Example: Natural color must be declared the specific type “Beet Juice Extract (for color)”.]

5th Floor — Marketing Copy & Social Media

Marketing is defined by the activity of promoting and selling products or services, which if done well can lead to great benefits to the company. Although with any story there is another side, the FDA partners with the FTC to evaluate marketing copy and claims that are made on labels to ensure that consumers are not being mislead or potentially harmed by products. They also have declared that any claim or statement on a company’s website and even acknowledgement on social media through liking a post is a direct extension to your label and can result in a warning letter if not truthful, misleading, or is an implied drug claim (e.g. cure, prevent or treat). Our regulatory world is expanding and having everyone knowledgeable about the importance of labels and statements can be all the difference.

We’re here to help!

Raising your label to the next level and communicating value to consumers while avoiding regulatory issues is all about ‘getting it right the first time’ and staying abreast of the latest regulatory changes. There are more complexities to labels than what we can cover here, but there are solutions and we are here to help not only design your label, but ensure compliance through creative risk-based solutions!

Get in Touch with Bex and learn more about our ability to provide additional regulatory label review services for your next label design.

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