Best Practices for Transparency in Your Nutritional Supplement Label
Discerning customers are aware of what constitutes natural ingredients, and the FDA is always on the lookout for infringements. That’s why label errors can break your growing dietary supplement brand.
The consequences of mislabeling can range from mild to severe:
Product Spoilage: If the label’s “Use by” date is wrong, the product may be unknowingly ineffective.
Recall or Withdrawal: This is a costly, time-consuming process that involves a lot of paperwork and putting out fires.
Civil Suit: A company could be held liable for wrongdoing.
Brand Reputation: Your reputation could quickly become irreparably tarnished or ruined, making customers less willing to trust your products.
Dangerous Combination: The product may contain an ingredient that shouldn’t be combined with a different supplement or medication the consumer might be taking.
Adverse Side Effects: The product may contain an ingredient that can be dangerous for a person with a certain medical condition (such as diabetes).
Food Allergen: The product may contain an ingredient that causes illness or even death if consumed.
No business wants to cause or suffer from these significant ramifications of not meeting nutritional supplement label requirements, which is why we’re here to give you the information you need.
What Makes a Mislabel
The Department of Defense’s Operation Supplement Safety resource specifies that a dietary supplement is mislabeled if it’s:
Missing any required labeling
Misleading or contains false advertising
Not listing the name and quantity of each ingredient (excepting proprietary brands)
Failing to include the words “dietary supplement” (or equivalent)
Not identifying the part or parts of an herb from which an ingredient is derived
Failing to meet requirements of:
Identity
Strength
Quality
Purity
Compositional specifications
If your product has any of these errors, it’s likely it does not meet FDA nutritional label requirements.
Nutrition Labels vs. Nutritional Supplement Labels
Also called dietary supplement labels, nutritional supplement labels are not the same as nutrition labels placed on food products.
Nutrition labels are for products that are 75–99% food-based, like a granola bar with an added supplement.
On the other hand, nutritional supplement labels are for products that contain mainly raw nutrients, like a powder or tincture. These use a label that lists nutrition at the granular level of specific vitamins and minerals. They also list the specific source of the nutrients, such as “rose hip” (not just “rose”).
FDA Nutrition Label Requirements for Dietary Supplements
There are three circumstances in which dietary supplement products are exempt from the FDA nutrition labeling requirements. If a product’s label bears no claims or other nutrition information, a business is exempt if it meets any of the following stipulations:
Earns <$50,000 gross sales in food OR <$500,000 per year from total sales
Sells <100,000 units of product annually, has <100 full-time employees, AND files an annual notification with the FDA
Ships the product in bulk form, does not distribute the product in bulk form to consumers, AND supplies it for use in manufacturing other dietary supplements
Supplement Facts Labeling
The nutrition label for a dietary supplement is called a “Supplement Facts” panel. Any ingredient that does not have Reference Daily Intakes (RDIs) or Daily Reference Values (DRVs) must be listed in the supplement facts panel.
That means the daily values (% DV) for fat, cholesterol, carbohydrates, protein, etc., don’t need to be included on the label unless they are present in measurable amounts.
Other Supplement Facts regulations that must be included on labels are:
The “Serving Size” and “Servings Per Container”
The names and quantities of dietary ingredients
“Other dietary ingredients” specified and listed according to their quantitative amount by weight per serving
The part of the plant from which a dietary ingredient is derived (example: dandelion root)
See Chapter IV in the FDA's Dietary Supplement Labeling Guide for more information.
Ingredient Labeling
An “ingredient” is a compound (such as calcium carbonate), binder, coloring, filler, flavor, etc., contained in the supplement. However, you don’t need an ingredient label if the product only contains compounds and not any binders, fillers, etc.
Other ingredient labeling regulations include:
The word “Ingredients” must proceed the ingredient list.
The ingredient list needs to be placed immediately below or to the right of the nutrition label.
The ingredients (including water) must be listed in descending order of predominance by weight.
The lowercase type size cannot be smaller than 1/16th inch tall
See Chapter V in the FDA’s Dietary Supplement Labeling Guide for more information.
Common Errors of Nutritional Supplement Labeling
For full transparency into your products, Earth Lab Botanicals suggests you avoid the following common errors of labeling:
Having a lack of knowledge and training on proper labeling procedures
Not relabeling after changes to your:
Recipe
Ingredients
Supplier
Date code
Inadequately cleaning equipment and not using line clearance procedures
Foregoing proper packaging and release procedures
Considering packaging art more than true information
Fixing these errors provide full transparency and traceability of your supplement and diminishes the consequences of mislabeling.
Contact Us for Conscientious Labeling
We invite you to start a dialogue with our experts who can support your product formulations and adhere to all labeling requirements. As a quality supplier of natural, raw ingredients from sustainable resources, we are very knowledgeable and experienced in herbal extraction, contract manufacturing, and private label products.
Contact Earth Lab Botanicals today for more information about conscientious nutritional supplement labeling.