What Exactly is a Dietary Supplement?
Increasing interest in weight loss, fitness and preventative medicine is driving massive growth in the supplement industry. In fact, industry studies estimate the worldwide market for supplements will double in size by 2030. This makes supplements a prime market to enter, especially if your company already produces foods or pharmaceuticals.
However, regulations can be confusing, especially when it comes to things like the net quantity of contents statement. Which products are considered dietary supplements? What required information do you need on your product labels to meet Food and Drug Administration (FDA) supplement labeling requirements and consumer expectations? How do you instruct buyers on use without being accused of making false claims?
Here’s how the FDA defines a dietary supplement:
- It contains a vitamin, mineral, botanical, amino acid, enzyme, dietary supplement or some combination of these things.
- The active ingredient isn’t a medicine. Medicines are used to treat an illness or an effect of an illness.
- The product is intended for ingestion.
- The product isn’t represented as a conventional food or a sole item of a meal or a diet.
This leaves some large gray areas, especially when it comes to food-based products and dietary ingredients. The way supplement labeling requirements are handled makes it even more confusing.
Unlike food and alcohol, the government doesn’t have much authority over supplements until they’re on the market. To avoid legal problems, manufacturers have to choose the correct label type based on intent. This is loosely defined, but you can expect legal trouble if the FDA decides your label statements give the impression that the product treats an illness. Be extremely wary of making health care claims pertaining to dietary supplements. Here are a few product examples and how they fit into this category.
Caffeine is a food additive, a supplement, or a drug, depending on how it’s used. This naturally-occurring substance is found in coffee, tea and chocolate. It’s also an approved food additive, which means that soda with added caffeine is a food.
If this chemical is added to a pill to be used as a stimulant, it’s a supplement. However, if you look at most migraine medications, caffeine is listed as an active ingredient. In this use case, caffeine is used to relax muscle contractions and increase blood flow, reducing pain from a migraine. Since it treats an illness, it’s a drug.
Vitamins are in a gray area, similar to caffeine. They are approved food additives and used in supplements. However, they become drugs when they’re used to treat a specific ailment. If trying to maintain that the vitamin is a supplement, claims on the label must be vague, so that the label’s intent isn’t to sell the product as a drug.
If it comes in a pill, gel cap or tablet, and it doesn’t contain drugs, it’s a dietary supplement. Skin creams and other cosmetics that allow measurable amounts of vitamins to absorb ingredients into your skin aren’t considered supplements.
Regular gummies are a food, since you can eat several of them as a snack, but vitamin gummies are supplements, since you only eat one or two as a delivery method.
A meal replacement shake or bar is a food, since it’s intended to be the sole item in a meal. However, if the food is just a delivery method, it’s a supplement. That means protein powder is a supplement, but a protein bar is a food. Likewise, energy gels are food, even if they’re mostly used to address glycogen depletion.
Energy drinks and shots have come close to getting their own FDA regulations. As it stands today, they can be marketed as either dietary supplements or food, with the choice being up to the producer. The de facto industry practice is to label energy drinks as food and shots as supplements.
Both types of drinks list the amount of caffeine they contain on their nutrition label, even though it’s only required on supplement labels. If you want to learn more about requirements and best practices for energy drink labels, read our blog on the subject here.
What Do I Need on the Front of My Dietary Supplement Labels?
Supplements are considered a subset of food, so many of the requirements carry over for the principal display panel.
Statement of Identity: This is the brand name (or usual name) for the product. If the supplement is a single ingredient, the amount per serving should be listed on the container. For example, the dosage of a vitamin should be listed in milligrams.
Net Quantity: For most products, this is the total weight or volume of the container, stated in both customary and metric measurements. For pills, this should be the number of pills in the container.
Health claims can be made on the principal display panel as long as they don’t make the product sound like a treatment for a disease. These claims must have a disclaimer on the information panel saying that they have not been evaluated by the FDA. This statement should include, “This product is not intended to diagnose, treat, cure or prevent any disease.”
Supplement Facts: The Connection Between Food and Drug Labels
The Supplement Facts label shares formatting with the Nutrition Facts label (used on food) and the Drug Facts label (used on medications). The layout and fonts for Supplement Facts labels are the same as a Nutrition Facts label. Below the “Supplement Facts” title, you need the following sections.
- Serving Size: This is how much must be taken to get the recommended dosage size, whether it’s a certain number of tablets, or a measurement of weight or volume.
- Servings Per Container: Servings per container is the number of recommended servings in the container.
- Active Ingredients: Active ingredients include the amount per serving and the daily value. For ingredients that don’t have an established DV, place an asterisk in this column. At the bottom of the label, add the note “* Daily Value (DV) not established.” Ingredients with no daily value must be listed by their common names.
- Other Ingredients: This section includes all ingredients not listed on the active ingredients list.
If the supplement is also a type of food, you need to include nutrient content information on the supplement facts panel, similar to food labeling requirements. This includes sections for the percent daily values of total calories, fat calories, fat, saturated fat, cholesterol, sodium, total carbohydrate, dietary fiber, sugars, protein, vitamin A, vitamin C, calcium and iron.
Other Label Information for Meeting Regulations and Informing Consumers
Additional information is included on the information panel.
You are required to include the name and contact information of the supplement manufacturer, packer or distributor. If there could be hazards caused by using the product, you also need to include a warning (this should state any possible allergic reactions or side effects). Regulations and required statements are constantly changing, so your best course of action is to search for ingredients on the FDA’s guidance documents website.
The following sections are optional for the labeling of dietary supplements:
- Recommended use: This is the suggested use for the product. For example, fat soluble vitamins absorb better when paired with fat, so you may suggest taking them with food.
- Notice: This space is used for other important information, like storage of the product.
- Expiration dates and lot numbers are allowed on supplement labels, but they are not required. If you’re looking for a way to add this information, check out our print and apply labelers.
Get the Consistency and Quality You Need for Your Dietary Supplement Labels
When you need a fast, accurate labeling solution for dietary supplement products that works with your production environment, talk to the experts at CTM Labeling Systems. We have local distributors that work directly with you to create a labeling solution that meets all of your requirements, including speed, durability and sanitation.
To learn more about all of the labeling solutions available through CTM, a trusted labeling system manufacturer for businesses worldwide, reach out today!