Nutraceutical product label.

Nutraceutical Product Label Guidelines

Nutraceuticals are poised for massive growth in the next decade. They’re also easy to pivot to if you’re already in food or supplement production. However, meeting regulatory requirements for these fortified food products is confusing. Are they foods, health foods, or supplements? How do you explain their benefits without crossing the line into drug regulations? Here’s what you need to know to make labels that will keep your clients and the government happy.

→ [Free Download] Don’t get stuck in a regulatory jam that could cost you time and money—get your product labels right from the start with our guide on Labeling Requirements.

What Exactly Are Nutraceutical Products — and How Are They Different From Drugs, Food, and Supplements?

There are no specific nutraceutical label guidelines. According to FDA regulations, nutraceuticals and dietary supplements are similar. Like supplements, a nutraceutical can’t claim to treat an illness. If it does, it falls under drug regulations.

Here’s where it gets confusing. “Nutraceutical” is a portmanteau of “nutrition” and “pharmaceutical.” Products in the nutraceutical market provide a medicinal benefit, but they’re also foods. As far as the FDA is concerned, most nutraceuticals are considered foods. A nutraceutical becomes a supplement if it meets one of two requirements:

  1. It contains anything that isn’t a food additive.

The FDA maintains a list of approved food additives with qualifiers for some ingredients. For example, a protein powder that is just protein is usually a food. However, creatine, an amino acid that may promote muscle growth, isn’t an approved additive. If a protein powder contains this ingredient, it’s a supplement. Other popular ingredients (like taurine and L-Glutamine) may fall under the supplement category, depending on how they’re used.

2. The product isn’t a sole food item.

There is a lot of overlap between nutraceuticals and supplements, with the main difference coming down to portion size. If you are only supposed to eat one or two vitamin gummies, they’re supplements. If you can safely eat a whole package of vitamin-fortified gummies, it’s a food. Unfortunately, there’s no rule on specific portion sizes, so use your best judgment. The energy drink industry has navigated around this by creating best practices that separate drinks from shots. You can learn more about this in our blog article about energy drink labels.

Labeling in Practice: Fueling Endurance Athletes

How does this work in practice? Let’s say you’re an endurance athlete going on a long run or bike ride. One of the worst things that can happen is “bonking,” the near depletion of glycogen in your muscles. Once glycogen supplies get too low, your brain limits its use to prevent permanent damage. This makes it difficult to keep moving, foiling your efforts. At the same time, refueling muscles leads to exercise-induced hypoglycemia. This leads to headaches, nausea, shaking, dizziness, and a general loss of well-being. The body may turn to alternative sources of fuel, including protein from muscles. Being in this state also suppresses the immune system for up to 72 hours – and your health may end up paying the price.

While it’s possible to manage glycogen stores with sugar-heavy snacks, nutraceuticals are an ideal solution. Energy gels, sports drinks, and snacks are designed specifically to combat bonking by including a range of simple and complex carbohydrates. Since the body processes these carbohydrates at different speeds, consuming these products keeps muscles supplied with glycogen over long periods. They’re also energy dense, packing a ton of calories into something that only weighs a few grams, whether it’s consumed directly or added to water.

These products are the perfect examples of nutraceuticals. They address a clear health issue and promote “wellness,” but they don’t claim to treat an illness. These are food products, and common additives, including amino acids, caffeine, and vitamins, are all approved food additives.

While you may not be preparing for an ultramarathon, most of us regularly consume at least one form of nutraceutical. Probiotic yogurt, fortified cereals, and foods with added Omega-3 fatty acids all fall under this category.

What Do I Need On the Principal Display Panel of My Nutraceutical Labels?

For the most part, supplement labels and food labels follow the same regulations. Like all products, you need a statement of identity. This is the brand name and common name for the product.

The net quantity is the total weight or volume of the product. Due to their portion sizes, nutraceuticals are required to use this format and not the number of doses, as used on most other dietary supplements. If you’re selling a supplement with just one supplement ingredient, the amount per serving must be on the principal display panel. For example, a package of vitamin C gummies may state “750 mg vitamin C.”

Health benefit claims can be made as part of the label design — as long as they’re paired with a statement that they haven’t been evaluated by the FDA.

Formatting the Information Panel: Differences Between Food and Supplement Labels

Like the principal display panel, the information panel is largely identical between food and supplements. However, a supplement facts panel does have some formatting differences compared to the nutrition facts label.

Serving size: This is the recommended serving size for foods defined by the FDA. For supplements, this is the amount the user needs to consume to get the recommended dosage.

Calories: This is in large print directly below the serving size on food labels. On supplement labels, this category is part of the daily values columns.

Daily values: This is the nutrition label that lists macro- and micro-nutrients in the product, as well as added sugar.

Supplement values: This is the amount of supplement ingredients in a serving size. This section must include the statement, “Daily Value (DV) not established.”

Dietary ingredients for foods are listed from the greatest percentage of content to the least. Ingredients for supplements use two listings. The active ingredients list includes all of the supplements. The inactive ingredients include everything else listed from the greatest percentage of content to the least.

There are two ways to notify consumers about allergens. Ingredients containing major allergens can be listed with said allergen. For example, “lecithin (soy)” can be used for lecithin, a soy-based thickening agent. Alternatively, an allergen statement can be added at the bottom of the list. For example, “contains soy.”

A “recommended use” section can be added to the information panel. This statement can be used for the suggested use of the product. For example, you could list the best times to use functional foods, like workout recovery drinks.

“Best by” dates are optional for both types of products. “Use by” dates also aren’t required, but they should be used if the active ingredients degrade over time. You can add this information to your pre-printed custom labels using our print and apply labeling machines.

We Have What You Need to Label Your Products

CTM Labeling systems builds a wide range of labeling equipment that can handle labeling requirements on everything from bags to bottles. Ready to upgrade your system? Contact us, and we’ll get you in touch with one of our distributors. They can help you design a high-quality label solution that fits your production and labeling needs.

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