Guide To Making a Supplement Label – With FDA Compliance Tips

how_to_create_a_supplement_label_FDA

How to Create a Supplement Label

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When starting a supplement business, creating labels for supplement products is oftentimes overlooked, with many not considering the intricacies behind the regulations. In fact, the Food and Drug Administration (FDA) requires that certain information be displayed on the supplement label in a specific manner, and if any of the information is missing and/or goes against regulations it may result in a warning letter from the FDA or, even worse, your products being recalled. That said, this blog functions as a comprehensive guide on how to create a supplement label with all the legalities kept in mind.

Are Supplement Labels Regulated?

Yes, the FDA regulates supplements and their labels. All supplement labels must comply with FDA guidelines. These guidelines can be a bit challenging to follow, which is why we broke them down to assist in your journey of making your own supplement label.

FDA Guidelines for Making a Supplement Label

fda_supplement_label_guidelines

What can a supplement label claim?

Supplement labels can only make structure/function claims. There are a few different versions of these claims lets take a look at the three most common here:

  1. Describing the role an Ingredient is Intended to affect the normal structure or function of the human body. For example, a dietary supplement product that contains a high amount of calcium in it may declare, “Calcium builds strong bones”.
  2. Characterizing the means by which a nutrient or dietary ingredient acts to maintain such structure or function. For example, a product that is rich in antioxidants can say, “antioxidants maintain cell integrity.”
  3. General well-being claims. These describe general well-being from consumption of a nutrient or dietary ingredient. For example, a product having a statement claiming “supports relaxation.”

Click here to reference the entire FDA’s criteria for permissible structure/function claims.

What can supplement labeling not claim?

Supplement labels cannot claim that the supplement product:

  1. Treats any illness or disease
  2. Cures any illness or disease
  3. Prevents any illness or disease
  4. Has been approved by the FDA

For all Info on What is Not Allowed CLICK HERE

What is required on a supplement label?

There are not only certain things you can claim on a supplement label, but also certain places that information must be placed. Below is a sample label for reference.

sample_supplement_label_guideline

The Principal Display Panel (PDP):

This is the center part of the label and also the part that is most likely to be displayed, presented, shown, or examined under customary conditions of display for retail sale. This panel requires:

  1. A statement of identity (Product name and Brand)
  2. The term “Dietary Supplement” or “Herbal Supplement”
  3. A statement of net quantity of contents

The Information Panel:

This is generally the panel immediately to the right of the PDP. This tends to be the area that is the most challenging for companies to create. This panel requires:

  1. A supplement facts chart
  2. Quantity by weight (or by volume, for liquid ingredients) of each dietary ingredient or proprietary blend must be declared
  3. Ingredients: all botanical dietary ingredients need to be designated by their latin name or common name in decreasing order of predominance by weight
  4. Name and place of business of manufacturer, packer or distributor
  5. Major food allergens
  6. Other ingredients
    – These must be displayed outside of the supplement panel and must be preceded by the words “Other Ingredients”
Now, where companies experience the most complications is the supplement facts chart. Let’s take a look at these requirements.
supplement_facts_requirements

Supplement Facts Requirements:

1. The title “Supplement Facts”
2. The subheading “Serving Size”, with the serving size expressed using a term that is appropriate for the form of the supplement.
3. The subheading “Servings Per Container,” with the servings per container rounded to the nearest whole number.
4. The column heading “Amount Per Serving,” or a heading consistent with the serving size, e.g. “Amount Per Capsule”.
5. The column heading “% Daily Value” on the same line and to the right of the “Amount Per Serving” heading. Note: “Daily Value” can be abbreviated as “DV” if the acronym is explained in a footnote.
6. Information on dietary ingredients that have a Reference Daily Intake (RDI) or Daily Reference Value (DRV) established in §101.9(c). Whether information must be provided on each dietary ingredient depends on several factors, including the level at which it is present, whether a claim is made about the dietary ingredient, and whether the dietary ingredient is added for supplementation. The required information consists of:
a) The name of the (b)(2)-dietary ingredient
b) The quantitative amount per serving by weight
c) The %DV represented by the quantitative amount per serving
7. Information on dietary ingredients for which RDIs and DRVs have not been established. These ingredients are referred to in §101.36 as “other dietary ingredients”. The most common of these are herbs and herbal extracts. This can be seen in the chart on the right above.

Any Panel:

This information can be put on any part of the label

  1. Directions for use (optional, unless necessary for safe use)
  2. Warnings (optional, unless necessary for safe use)
  3. Country of origin (optional, unless product is foreign-sourced)
  4. DSHEA disclaimer (optional, unless structure/function claims are made)

What is the difference between a supplement label and nutrition label?

nutrition_vs_supplement_label

The FDA maintains a list of food ingredients tested and determined to be “generally regarded as safe”, or GRAS for short. Products that use only GRAS ingredients or FDA-approved food additives will have a nutrition facts label (considered food products), whereas ingestibles which contain ingredients not on this list will have a supplement facts label (considered supplement products). If you are unsure of whether or not your ingredients are considered supplements or not, you can check the FDA website here, or hire a consultant. Now let’s take a look at the difference between a supplement label vs nutrition label:

  1. Nutrition Facts panel lists only nutrients, vitamins, and minerals, whereas on a Supplement Facts Panel, all ingredients with nutritive value are listed.
  2. Dietary supplements must use percentage levels to refer to ingredients without daily value (DV)– reference amounts (expressed in grams, milligrams or micrograms) of nutrients to consume or not to exceed each day– whereas food products (nutrition facts) may not.
  3. With dietary supplement facts, the specific part of the plant must be listed to indicate how the dietary ingredient was derived. For example, a dietary supplement that contains chamomile as an ingredient would list “extract of chamomile flower” on the dietary supplement facts. On a nutrition label, however, it would just appear as “chamomile”.
  4. Dietary supplement facts allow the source of the dietary ingredient to be listed alongside of it, while nutrition facts cannot. For example, a supplement panel may list “collagen from grass-fed cows” as an ingredient, whereas a nutrition panel may only list “collagen”.

Designing a Supplement Label

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Once you’ve learned all of what must be included on your supplement label, you can focus on the fun part: designing it! While the FDA is pretty strict about what information goes where, as long as your text is easy to read and the background contrasts against the font color, you have free reign on how to design it! This ranges from color scheme and graphics to font style and size and whatever other creative touches you can think of!

While designing your own label is completely doable, it might be worthwhile to hire a graphic designer to get the job done right. Not only does a skilled and experienced graphic designer already have the skills and knowledge required to make a supplement label that can capture and hold a potential customer’s attention, but they also generally know all the legalities on what a supplement label should and should not entail (basically, everything we went over in this blog!). This can ultimately save you a lot of time and money in the long-run, while also creating a design that looks professional and unique to your brand.

Final Thoughts

Creating a supplement label for your supplement product doesn’t have to be a complicated process. Hopefully, with this guide as well as the FDA’s posted guidelines, you can turn what most would consider to be a headache into an exciting project. After all, a label creates the first impression of your supplement product like a cover is to a book: it gives potential customers important insight into your product, brand and company.

Resources & References:

American Public Health Association — For science. For action. For health. (apha.org)

Dietary Supplement Labeling Guide | FDA

eCFR :: 21 CFR Part 111 — Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements

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