How to Create an FDA Approved Supplement Facts Label

Supplement facts label

Dietary supplement labeling requirements are complex. Since nutritional supplements are regulated by the Food and Drug Administration, producers must comply with a set of strict governmental regulations designed to keep consumers knowledgeable about what they’re putting into their bodies. 

In addition to producing more informed consumers, creating an FDA-compliant supplement label protects your business from an FDA-enforcement action that can be costly to remedy and will tarnish your business’ reputation. In this dietary supplements labeling guide, we’ll take a detailed look at FDA supplement labeling regulations, options for formatting, and next steps to take as you consider creating your own dietary supplement labels

What Qualifies As A Dietary Supplement? 

First, let’s start by defining exactly what the FDA considers to be a dietary supplement. According to the regulatory definition, a dietary supplement is at least one of the following: 

“A vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for use by man to supplement the diet by increasing the total dietary intake, or a concentrate, metabolite, constituent, extract, or a combination of any ingredient mentioned above.” 

If your product fits into one or more of those categories, it must carry an FDA compliant supplement label.

FDA Supplement Labeling Regulations

Supplement labeling typically happens in two locations on product packaging: the front label panel and the informational panel. The front label panel is what’s displayed on the shelf, the side consumers are most likely to see as they browse the store. The information panel most often appears directly to the right of the front panel and houses all of the more technical information such as supplement facts, ingredients, and name and address of the manufacturer.  The FDA requires that five pieces of information be listed on a supplement label. 

  • Statement of Identity — This is the official name of the supplement. This information is typically found front and center on the front label panel. 
  • Net Quantity of Contents Statement — This information communicates exactly how much of the product is in the container. It’s usually listed on the front panel somewhere underneath the statement of identity. 
  • Nutrition Labeling — This is the real meat of the supplement label. It’s often referred to as the supplements facts section. (The nutrition labeling is so critical that we’ve set aside a section dedicated to it below.)
  • Ingredient List — The list of all the ingredients used to manufacture the supplement appears immediately below the supplement facts.
  • Name and Place of Business of the Manufacturer, Packer, or Distributor — This section is simply a listing of the name, city, state, and zip code of whoever manufactured, packed, or distributed the dietary supplement. This part typically finds its home right below the ingredient list.

Supplement Facts Label Requirements

The supplement facts component of a dietary supplement label has the most important and complex requirements. For all dietary supplement labels, the following information must be included in this section.

  • Serving Size Information — How much of the product constitutes one serving, and how many servings are there in the container?
  • Total Calories — List the number of calories per serving.
  • Name and Quantity of Every Ingredient — Each ingredient in the supplement gets listed here. Quantity measurements should be listed in IU’s (International Units).
  • Calories from and Types of Fat — Calories from fat, total fat, saturated fat, and cholesterol must be listed here. If your supplement contains any measurable amount of trans fat, that information must be placed directly underneath the listing for saturated fat.
  • Critical Components — The FDA requires that you list the quantities and percent daily value for the following nine ingredients: sodium, total carbohydrate, dietary fiber, sugars, protein, vitamin A, vitamin C, calcium, and iron. Listing this information for other substances is voluntary.
  • Percent Daily Value (DV) on Dietary Ingredients  — On all dietary ingredients, the percent daily value must be declared. 
  • Common Names Only for Ingredients with No Daily Value — If a daily value hasn’t been established by the FDA for an ingredient, its common name must be used.

We’ve just covered the core requirements above. It’s a good idea to refer to the FDA’s extensive, multi-chapter Dietary Labeling Supplement Guide that details exactly what they expect from supplement manufacturers when it comes to labeling.

Supplement Facts Labeling Formats

The FDA allows for a variety of different supplement facts formatting. Formats vary based on a variety of factors, including the type of supplement, ingredients used, and how often the supplement is designed to be taken. The FDA has a set of extensive examples of compliant supplement facts labels as part of their Frequently Asked Questions for Industry resource. You can use these as models for designing your own supplement facts label templates.

No matter how large of a batch of supplements you plan to run, you will need an FDA-approved label on your product. Failing to follow the governmental requirements for dietary supplement labeling can result in corrective action being taken by the FDA or complaints from consumers or consumer rights organizations. Especially for small dietary supplement brands, this type of scrutiny can be expensive to remedy and severely diminish the attractiveness of your products to consumers.

Dietary Supplement Label Design

Supplement labels must be tough enough to withstand the rigors of everyday use. We recommend choosing white vinyl, or white, clear, metallic, or holographic plastic to print your supplement fact label. These types of materials are designed to stand up well to normal use, such as being carried around in a gym bag or purse.

When it’s time to print your supplement product labels, Frontier Label can help. We offer a broad selection of durable label materials ideal for supplement label packaging. If you’re unsure what materials to choose or what features you need, get in touch — we’re happy to offer experienced advice.

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