6 Keys to Effective Dietary Supplement Labeling
Dietary supplements occupy a vaguely defined space somewhere between food and drugs, making it easy to run afoul of regulators when it comes to supplement labeling. Manufacturers must choose a label based on intent, and unlike alcohol and drugs, there’s no pre-approval process. Get something wrong in your label statements, and you could face hefty fines or a product recall. These tips will help you get your label right the first time, and avoid punitive action by the FDA.
Is My Product a Supplement?
Most problems stem from using the wrong product label category. There are four qualifications a product must meet to be considered a supplement by the FDA:
1. It’s something you eat or drink.
While you may be able to absorb dietary ingredients from some topical creams, they fall under cosmetic or drug labeling regulations.
2. It’s not a primary, conventional food.
This definition is mostly determined by net quantity of contents users will consume. You can snack on a bag of gummies, so they’re food. You’re only going to take one or two vitamin gummies, so they’re supplements. Likewise, powdered drink mixes that are primarily intended to deliver supplements are fine, but if they’re made to flavor beverages, they’re food.
Energy drinks are an edge case, which we covered in detail with our blog Important Requirements for Energy Drink Labels. To avoid Federal legislation, the members of the American Beverage Association (ABA) came together to create a series of guidelines for energy drinks. Since then, the industry has largely split the segment into two categories. Drinks are categorized as food and follow FDA regulations for beverage and food safety, adding information about supplement ingredients, including caffeine. Energy shots are too small to be considered beverages, so they follow dietary supplement guidelines.
3. It doesn’t treat or affect an illness.
If the product does either of these things, it’s a drug. Some products can fall under either category, depending on the intended use. The difference comes down to choosing the correct wording and format for the structure/function claims.
4. It contains vitamins, minerals, botanical ingredients, amino acids, enzymes or other proprietary blends of dietary substances.
There is some gray area to interpreting this rule. However, you can be sure a product is a supplement and not a food if it contains ingredients not included in the FDA’s list of approved food additives.
Am I Making the Right Health Claims?
Use the wrong wording for health claims, and your supplement could be classified as a drug. For example, Vitamin C is a required nutrient, and it can treat diseases, like scurvy. However, it’s also sold as a supplement. What’s the difference? The Vitamin C tablets sold as supplements don’t make treatment claims.
If your product makes health claims, you must include a disclaimer that begins with “This statement” or “These statements” followed by “has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.”
Of course, if an ingredient is recognized primarily as a drug, it falls under drug labeling rules. For example, a vitamin drink powder is a supplement as long as it doesn’t make healthcare treatment claims. A severe cold tea usually contains pain relievers and cough suppressants, so it falls under drug rules.
Choosing the Right Wording for Supplement Facts Values
For the most part, the Supplement Facts panel is identical to the Nutrition Facts panel on food. That means you need to list calories, macronutrients and micronutrients as they apply to your product. If the FDA has an established value for the supplement, it must be included. For example, 1,000 mg is a common dosage size for Vitamin C supplements. The Supplement Facts label on this supplement must state it contains 1,667 percent daily value as determined by the FDA. For anything without an established value, like Omega 3 fatty acids, the notice “Daily value not established” must be included on the nutritional labeling panel.
Stating Net Quantity By Weight or By Piece
While most labeling of dietary supplement guidelines are similar to food guidelines, there is an exception for product volume. With most products, the net quantity must be stated in both customary and metric units for the full package. However, with dietary supplements label information, you have a choice of using weight, measure or numerical count, as well as a combination of these measurable amounts when it comes to the net quantity of contents statement. For example, on a bottle of tablets, you can use “100 tablets,” “200g (7 oz,)” or both measurements.
If it’s on Food Labels, it’s on Supplement Labels
Aside from health claims and a few minor wording changes, if it’s required information on a food label, it’s also on a supplement label. The principal display panel must include the product name as a heading, a statement of identity, and net quantity.
The information panel requires a Supplement Facts section featuring an ingredient statement. This includes an ingredient list, serving size, total servings per container, total calories, total saturated fat, total sugars, cholesterol, potassium, calcium, and any other nutrient content claims. It also includes the contact information for the supplement manufacturer, packer or distributor of the product. Like food packaging, the information panel on supplements must be to the right of the principal display panel.
Often, brand names for dietary supplement products clearly explain what’s inside the container when they have just one or two active ingredients. There’s not much to misinterpret when the bottle says “Fish Oil 1,000 mg” or “D Vitamin 1000 I.U.” However, you still need to include a separate statement of identity on the principal display panel. This can be the general name for the product, whether it’s a tablet, capsule, gummy or drink mix powder, or it can simply be called a “dietary supplement.”
Let the FDA Know About Your Mistakes As Soon As Possible
Did you accidentally violate good manufacturing practices or a label requirement? Error reporting is mandatory, but if you correct the error and inform the FDA about your changes as soon as possible, you may be able to avoid legal action that can lead to fines and product seizures. When you submit your report, be sure to include a timeline for the correction. You can get up-to-date information on error reporting on the FDA’s website.
Get the Equipment You Need to Label Your Supplements
Getting the right label design for supplements is hard, but getting labels on your products is easy. All you need to do is contact CTM Labeling Systems. Our local distributors will work with you to create a labeling solution that fits your production environment while delivering the consistent application you need for your containers. We offer several configurations of standard and print-and-apply systems for a wide range of container shapes and sizes.
