Written by Gouri Sasidharan
Content Specialist, Esko
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.
Disclaimer: This blog post derives information from the U.S. Food and Drug Administration (FDA) website and is updated as of September 1st, 2025. Do refer to the FDA website for final and updated information regarding regulations. WebCenter is a software designed to streamline compliance for brands, not a service providing legal or regulatory advice.
What are Nutraceuticals?
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.
- 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.
- 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.
- 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.
| Feature | Nutraceuticals | Dietary Supplements | Pharmaceuticals |
|---|---|---|---|
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.
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 key differentiators. 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.
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.
Five Commonly Required Label Statements
The FDA states the following statements on every nutraceutical labeling.
- Name of the supplement: The label must clearly state the product’s name, ensuring it speaks to the product’s contents and function.
- Amount of supplement: This includes the net quantity weight or volume of the nutraceutical product, depending on its form.
- Nutrition labeling: This section provides information about the serving size, amount per serving, and daily percent value for various nutrients.
- Ingredient list: All ingredients must be listed in descending order by weight. Any potential allergens should be highlighted according to local regulations.
- 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).
