Did you know that the nutraceuticals industry is expected to hit USD 417.66 billion by 2026? 

In the last decade, the industry has boomed as more individuals prioritize their health and better understand the significance of consuming nutritious food and supplements. This proves how nutraceuticals play a vital role, especially among adults. 

However, behind the promises of improved health, better energy, and overall well-being, lies a world of complex regulations governing the labeling of these products. 

Here, along with understanding the important labeling aspects of nutraceuticals, let’s learn how they differ from your regular dietary supplements and whether they only come in the form of capsules.

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Disclaimer: This blog post derives information from the U.S. Food and Drug Administration (FDA) website and is updated as of September 1st, 2024. Do refer to the FDA website for final and updated information regarding regulations. Artwork Flow is a software designed to streamline compliance for brands, not a service providing legal or regulatory advice.

What are nutraceuticals?

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Nutraceuticals are a combined form of nutrition and pharmaceuticals. They are food or parts of food sources that have been scientifically shown to provide health benefits and prevent various diseases. Nutraceuticals are nutritionally rich whole foods that contain vitamins, minerals, probiotics, amino acids, and herbs. Some examples include soy protein, garlic, beetroot, and spinach. 

Nutraceuticals vs. dietary supplements vs. pharmaceuticals

People often get confused with the jargon they use at drug stores or pharmacies. While these terms are often used interchangeably, there are distinct differences between nutraceuticals, dietary supplements, and pharmaceuticals.

1. Nutraceuticals: As we have already defined what nutraceuticals are, they offer specific health benefits beyond the standard nutritional value of food, such as antioxidant properties, immune support, or disease prevention.

2. Dietary supplements: Dietary supplements are foods that complement your diet and contain one or more ingredients. It provides additional nutrients that may be lacking in a person’s diet. You can ingest them as liquids, capsules, tablets, powders, soft gels, or gel caps. 

3. Pharmaceuticals: These are the drugs that are intended to treat or prevent diseases and require a prescription from a health professional. Pharmaceuticals undergo extensive testing and approval processes to ensure safety and efficacy.

Importance of nutraceutical labeling

Along with the demand for nutraceutical products, there is an increase in the need for accurate and compliant labeling. Nutraceutical labeling is not merely a regulatory requirement—it plays a key role in ensuring consumer safety, building trust, and sustaining the industry's integrity. Manufacturers don’t need FDA approvals to distribute their nutraceutical products but they must ensure they aren’t spreading the wrong information. 

1. Ensuring regulatory compliance

One reason nutraceutical labeling is crucial is to ensure compliance with local and international regulations. Regulatory bodies such as the U.S. Food and Drug Administration (FDA), the European Food Safety Authority (EFSA), and other national agencies have stringent guidelines governing the labeling of nutraceutical products. Following these regulations helps manufacturers avoid legal troubles, including fines, product recalls, and worse, bans. Not only does compliance protect your brand’s reputation, but it also ensures that products can be legally marketed and sold in targeted regions.

Also read: Product Recall: How to Save Yourself from the Mess

2. Consumer protection and transparency

Labels provide essential information about a product’s ingredients, usage, and nutritional value. Accurate labeling helps consumers make informed decisions about the products they use, especially for those with dietary restrictions, allergies, or specific health concerns. By listing allergens or possible side effects, nutraceutical labels protect consumers from potential health risks.

3. Building trust and credibility

Transparent and informative labeling helps establish brand trust and credibility. Consumers are more likely to purchase from brands that clearly communicate what’s in their products and how they benefit their health. This confidence turns to brand loyalty, as consumers can make informed choices.

4. Differentiating products in a competitive market

In a saturated market, clear and effective labeling can serve as a key differentiator. A well-designed label that highlights unique selling points, such as organic ingredients, non-GMO certifications, or specific health benefits, can set a product apart from its competitors. Eye-catching and informative labels can attract attention on crowded shelves, making it easier for consumers to identify and choose your product over others.

Also read: A Guide to Visual Hierarchy in Label Design

Nutraceutical labeling requirements

To ensure consumer safety and provide accurate information, nutraceuticals must adhere to specific labeling requirements. These requirements vary slightly depending on the regulatory framework of different countries, but some elements are required in general.

Also read:

• Your Go-to Handbook of FDA’s Labeling Requirements For Dietary Supplements
• Pharmaceutical Labeling 101: FDA Drug Labelling Regulations Guide [2024 UPDATED]
• The 2024 Guide to FDA Labeling Requirements for Cosmetics Packaging
• Understanding the FDA Food Labeling Guide: A Comprehensive Overview

(The more the merrier!)

Five commonly required label statements

The FDA states the following statements on every nutraceutical labeling.

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1. Name of the supplement: The label must clearly state the product's name, ensuring it speaks to the product’s contents and function.

2. Amount of supplement: This includes the net quantity weight or volume of the nutraceutical product, depending on its form.

3. Nutrition labeling: This section provides information about the serving size, amount per serving, and daily percent value for various nutrients.

4. Ingredient list: All ingredients must be listed in descending order by weight. Any potential allergens should be highlighted according to local regulations.

5. Name and place of business of the manufacturer or distributor: Include the contact information of the responsible party. This information is essential for traceability and consumer inquiries.

The FDA requires that these statements be visible and placed in specific areas on the label. All statements must be located either on the front Principal Display Panel (PDP) or the Information Panel (IP).

Statement of identity

The statement of identity is the common name of the product and must be prominently displayed on the front label. It differs from the brand name. E.g., Super Omega-3 is the general name of food under the law that you have to display and not the company name.

It should accurately describe the nature of the product, helping consumers understand what they are purchasing.

Net quantity of contents

This statement displays the amount of product in your nutraceutical product container, typically expressed in the metric system and the US Customary system. You must specify the quantity in both metric and imperial terms if using volume or weight measurements. E.g., "Net Weight: 60 Capsules".

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It must always be placed on the bottom 30 percent of the front of the package and be easily visible to consumers. The net quantity of contents doesn't include the weight of the wrappers and other packing materials included with the supplement. 

Nutrition labeling

The supplement facts panel provides a detailed breakdown of the product's nutritional content. This includes information for:

1. Serving size: The maximum amount of the product one typically can consume in one sitting. If there's no recommended amount, the serving size is 1 unit (pill, teaspoon, etc.)

2. Calories: The total energy content.

3. Nutrients: The amount per serving of various nutrients, such as total fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrates, dietary fiber, sugars, protein, vitamin A, vitamin C, calcium, and iron.   

4. Daily percent value: Daily Values or DV is the amount of nutrients you must consume in a day. The percentage of Daily Values (% DV) is the percent of the recommended nutrient amount your supplement provides daily. You must list the% DV for all dietary ingredients that have DVs except protein. 

The layout and content of this panel must adhere to specific regulations set by authorities like the FDA.

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Do you want to add the correct serving size to your nutraceutical label? What if you notice the font size differs between the ingredients before the launch? Oh, and the nutritional values definitely can’t go wrong overall! 

Here’s where an AI-powered label compliance tool like ComplyAI figures. It helps you smoothly set up your regulatory framework online and check every label against it using automated proofing. 

Ingredient labeling

Ingredients must be listed in descending order by weight. This list helps consumers identify what is in the product and assess its suitability, particularly for those with dietary restrictions or allergies. Special attention should be paid to allergen labeling, as certain ingredients must be accurately identified to protect consumers with allergies.

From food allergens to fragrance allergens, there are allergen ingredients that you must declare on your label. But sometimes you might miss out on adding them or end up adding the wrong one. 

You can run information panel reviews with ease on ComplyAI by customizing rules for each of the key elements on your information panel. From heavy ingredient information to the name and place of business, ComplyAI scans every detail within seconds. 

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This reader needs to know more about ComplyAI!

Nutrient content claims

These are claims about the level of a nutrient in the product, such as "low fat," "high in fiber," or "sugar-free." Nutrient content claims must meet specific criteria defined by regulatory authorities. A good source claim may be made when your product contains between 10 and 19% DV of an ingredient. A high source claim can be made if the % DV exceeds 20%.

Other labeling requirements

Additional labeling elements may include, 

• Warnings or cautions: Any potential risks or side effects to the usage of the nutraceutical product.
• Suggested use: Recommended dosage and frequency of the nutraceutical supplements.
• Expiration date: The date by which your nutraceutical product is used.
• Storage instructions: Guidelines for proper storage, such as in a cool, dry place.
• Manufacturer/distributor information: Contact details for the company responsible for the product.

Nutraceutical labeling done right with ComplyAI

By sticking to the labeling requirements outlined above, you can build consumer trust, avoid regulatory ambushes, and contribute to the growing market of health-focused products. Proper labeling not only fulfills legal obligations but also encourages your customers to make informed decisions about the products they choose for their health and well-being.

If you are looking to simplify the labeling process for your nutraceutical brand, smart compliance software like ComplyAI can be the game changer. 

But how?

1. Build your customizable rulebook: If you have hundreds of label creatives lying around to review with different rules, you can feed them onto the AI label compliance software, and let it screen the creatives accurately for you. With ComplyAI, you can set the rules for the nutritional value including the font style and size along with allergens, warnings, disclaimers, and more.

2. Detect wrong barcodes: With our barcode scanner, review barcode information accurately on your nutraceutical packaging to verify product identity and ensure that the correct label is used.

3. Identify misclaims, missing allergens, and incorrect logos: With the specs you feed into the software, the AI engine flags the wrong or missing information allowing you to send out error-free and safe nutraceutical products. 

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Artwork Flow is an artwork management software that streamlines the entire label management process for top nutraceutical brands such as Enervit, Hammer Nutrition, Fit Foods, and more. With its robust features like flexible workflows, smart proofing, specification management, asset management, etc, Artwork Flow helps ensure every label meets regulatory standards, is free of errors, and aligns with your brand’s messaging. 

Want to achieve seamless label management, reduce time-to-market, and minimize the risk of costly mistakes? Connect with the Artwork Flow team!

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