As an elderberry entrepreneur, you may often find yourself grappling with the question: is elderberry a food or a dietary supplement? This conversation is quite controversial because the classification has significant implications for how you market, label, and regulate your products. Some makers push the limits but it’s important to be truthful and transparent for the integrity of the entire industry.

Understanding the nuances of this distinction can help you navigate the regulatory landscape more effectively and ensure compliance with relevant laws. In this comprehensive guide, we’ll explore the factors that influence whether elderberry is considered a food or a dietary supplement, and why this distinction matters.

The Dual Nature of Elderberry

Elderberry as a Whole Food

Elderberries are nutrient-rich berries that have been consumed for centuries. They are high in vitamins, antioxidants, and other bioactive compounds that can support overall health. As a whole food, elderberries can be used in a variety of culinary applications, such as jams, pancake syrups, pies and other baking preparations. When consumed in this manner, elderberries fit the traditional definition of food: something that can be eaten as part of a meal or used as a condiment.

Elderberry as a Dietary Supplement

Despite its status as a whole food, elderberry is widely used to support body systems and functions, much like a vitamin. Many people take elderberry products daily to boost their immune system or as a preventive measure during cold and flu season. This usage aligns more closely with the definition of a dietary supplement: a product taken by mouth that contains a dietary ingredient intended to supplement the diet. This dual nature complicates the classification of elderberry products.

Regulatory Definitions: Food vs. Dietary Supplement

Food Definition

Regulatory agencies, such as the U.S. Food and Drug Administration (FDA), define food as any substance consumed to provide nutritional support for the body. This includes traditional foods like fruits, vegetables, grains, and meat, as well as items used as condiments or components of meals. Food is generally intended for immediate consumption and is regulated primarily for safety and labeling.

Dietary Supplement Definition

The FDA defines dietary supplements as products taken by mouth that contain dietary ingredients intended to supplement the diet. These ingredients can include vitamins, minerals, herbs, amino acids, and enzymes. Dietary supplements are not considered conventional foods and are regulated differently, with specific requirements for labeling, manufacturing practices, and claims about health benefits.

Why Elderberry Makers Advocate for Food Classification

Easier Regulatory Compliance

One primary reason elderberry makers attempt to classify their products as food is the perceived ease of working with local regulators. Food products typically face less stringent regulatory scrutiny compared to dietary supplements. This can simplify the process of getting products to market, as well as reduce the costs associated with regulatory compliance.

Marketing and Consumer Perception

Classifying elderberry products as food can also make them more appealing to consumers who prefer natural and whole food options. The term “food” can evoke a sense of safety and wholesomeness that resonates with health-conscious buyers. Additionally, marketing elderberry as a food allows producers to emphasize its culinary versatility and traditional uses, broadening its appeal beyond the health supplement market.

Labeling and Health Claims

Foods are subject to different labeling requirements compared to dietary supplements. While dietary supplements must include specific disclaimers about health claims, foods cannot market health benefits at all. Alluding to health benefits automatically triggers a dietary supplement designation.

Cheaper Insurance
Food insurance companies like FLIP or NEXT are much more affordable than those like Lloyd’s of London who provide specialty dietary supplementation insurance. It’s important to choose the RIGHT insurance, despite the expense. Why? If you’ve convinced your local regulator that you’re a food and someone has an adverse reaction to your product, your FLIP policy will not cover you because you committed to them that you were, in fact, manufacturing a food (as defined above). The consumer; however, is making the claim that your product was marketed to them to be used in a dietary supplement way.

Challenges and Considerations

Regulatory Scrutiny

Despite the potential advantages, convincing regulatory bodies to classify elderberry products as food can be challenging. Agencies like the FDA have clear definitions and guidelines for what constitutes food versus a dietary supplement. They often rely on the intended use of the product to make this determination. If a product is marketed primarily for its health benefits and taken in a manner similar to a vitamin or supplement, it is likely to be classified as a dietary supplement. At that point, your local governing body will no longer entertain working with you and direct you to the FDA guidelines.

Manufacturing Practices

The manufacturing practices required for dietary supplements are more stringent than those for foods. Dietary supplement manufacturers must adhere to Good Manufacturing Practices (GMP) to ensure product safety, quality, and consistency. This includes rigorous testing for contaminants, accurate labeling, and proper documentation of the manufacturing process. For elderberry entrepreneurs, meeting these standards can be demanding but is essential for regulatory compliance and consumer safety.

Consumer Expectations

Consumers have different expectations for foods and dietary supplements. Those who purchase elderberry products as a supplement may expect higher potency and clearer health benefits compared to those who buy elderberry foods for their taste and culinary uses. Balancing these expectations while maintaining regulatory compliance can be challenging for elderberry makers.

Navigating the Regulatory Landscape

Consulting with Experts

Navigating the regulatory landscape requires expertise in food and dietary supplement regulations. Consulting with regulatory experts or legal counsel can help elderberry entrepreneurs understand the requirements for both categories and determine the best approach for their products.

Clear Product Labeling

Regardless of classification, clear and accurate labeling is crucial. For foods, this means listing all ingredients, nutritional information, and any potential allergens. For dietary supplements, this includes the Supplement Facts panel, ingredient list, suggested use, and any required disclaimers. Ensuring compliance with labeling regulations can help avoid legal issues and build consumer trust.

Documentation and Compliance

Maintaining thorough documentation of your manufacturing processes, ingredient sourcing, and quality control measures is essential. This documentation can support your classification claims and demonstrate compliance with regulatory standards. Regular audits and quality checks can help ensure that your products meet the required safety and quality standards.

Conclusion

The classification of elderberry products as food or dietary supplements has significant implications for elderberry entrepreneurs. While the flexibility and appeal of marketing elderberry as a food are attractive, the regulatory landscape often necessitates classification as a dietary supplement. Understanding the definitions, benefits, and challenges of each category can help you make informed decisions and navigate the complexities of regulatory compliance.

By staying informed and consulting with experts, you can ensure that your elderberry products meet all necessary regulations while appealing to your target market. Whether you choose to market elderberry as a food or a dietary supplement, prioritizing safety, quality, and transparency will help build a successful and trusted brand.

Start, Grow & ScaleYour Elderberry Business Alongside the Best!

Connect and collaborate with elderberry berry entrepreneurs across the world.

Success! In a few minutes, check your inbox!