Designing your Product Label

The pre-market checklist.

August 1, 2023

When it comes to labeling your food, beverage, or dietary supplement product, it's crucial to balance your marketing and product-positioning goals with regulatory compliance. Getting your labels right can be incredibly complex, but whether you're producing your labels yourself or working with an outside regulatory specialist, it’s critical to line up the right information before you start.

That’s why we put together this checklist of items to gather before diving into label production. Following this checklist will help you and your team avoid uncertainty, steer clear of unnecessary delays, and ensure an efficient label-production process and launch.

Product information

Composition and product attributes

  • Formulation. The final formula for the product, including the exact proportion of each ingredient used.
  • Confirmation that all ingredients are permitted. In the U.S., this can include details to support that the ingredients are generally recognized as safe (GRAS).
  • Confirmation that the product meets any applicable standards of identity. The FDA and USDA have established composition requirements for certain categories of foods like cheeses, peanut butter, and meat products.
  • List of all ingredients and source(s), including flavors: Detailed inventory of all elements included in the product, and their origin.
  • Allergen information from manufacturing facility: Information about potential allergens present in the facility where the product is manufactured and might contaminate the product.
  • Serving size: It is the standard amount of the food that people typically consume in one sitting.
  • Water loss: This refers to the reduction in the quantity of water in the product during the production process.

Specifications for each ingredient

  • Sub-ingredients. Components that constitute a main ingredient.
  • Allergens. Components that could trigger allergic reactions in some people.
  • Complete nutrition. Detailed information about the nutrient content of the product.
  • For liquid products: Density. The mass of the liquid per unit volume.
  • For products with protein claims: Protein Digestibility-Corrected Amino Acid Score (PDCAAS) information. PDCAAS is a measure of protein quality based on human amino acid requirements and digestibility.
  • For juices or concentrates. Composition and Brix levels. Brix levels measure the sugar content of an aqueous solution.
  • Bioengineered-food status. Whether the food was produced using techniques like genetic engineering.
  • Formulation or approximate ranges. The variation in the quantity of each ingredient.

Product positioning and claims

  • Intended classification (food or dietary supplement.) How the product is categorized for regulatory and marketing purposes.
  • Regulatory jurisdiction. Whether the product is regulated by FDA or USDA. If the product is regulated by USDA, determine whether the label requires USDA approval.
  • Desired claims and marketing language. The preferred wording and any graphical representations for promoting the product's features and benefits.
  • Where the product is manufactured and packaged. The geographical location of the production and packaging facilities.
  • Any third-party certifications (e.g., kosher, halal, USDA organic). Certifications that confirm compliance with specific standards.
  • Instructions for use. Guidance on how to properly consume or use the product.
  • Handling instructions. Information for storing the product for safety or quality.

Label and packaging details

  • Label artwork with dimensions: Visual elements and measurements of the product's label.
  • Package type and dimensions: The kind of packaging used and its size.

Other details for a successful project

  • What success looks like: a brief description of the objectives and expectations of the project.
  • Detailed description of how the product is processed.
  • Background on product portfolio, including information about the range of products that the company produces or plans to produce.
  • Any previous advice received, including feedback or recommendations previously given that might be relevant for the project.

Creating a compliant product label might seem overwhelming at first, but following a pre-market checklist can help you ensure that everything is in order before launching your product. By taking the time to understand the guidelines, identifying your target audience, reviewing your marketing claims, meeting packaging requirements, and designing a clear and eye-catching label, you can avoid potential regulatory issues and ensure a successful launch.

Feel confident in your brand, and leave the regulatory details to us. Get in touch to learn more about how we can help get your products to market.

Download this Checklist
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