What Makes Something a Supplement and How Are They Defined?

According to the Dietary Supplement Health and Education Act (DSHEA) of 1994, a dietary supplement is a product taken orally that contains one or more dietary ingredients intended to supplement the diet. However, the legal and scientific distinctions defining what makes something a supplement are more complex than this simple description.

Quick Summary

This guide outlines the critical criteria and regulatory framework that define a dietary supplement, differentiating it from conventional foods and pharmaceuticals. It covers the specific ingredients, intended use, and labeling requirements that classify a product as a supplement.

Key Points

• DSHEA Definition: A supplement is an orally ingested product containing dietary ingredients meant to supplement the diet, not replace meals.

• Intended Use: The product's intended use is critical; supplements cannot claim to treat, cure, or prevent disease, as that would classify them as a drug.

• Specific Ingredients: Supplements must contain a specific category of dietary ingredients, including vitamins, minerals, herbs, amino acids, and other extracts.

• Labeling Requirements: A mandatory "Supplement Facts" panel lists all dietary ingredients, differentiating it from a conventional food's "Nutrition Facts" label.

• Manufacturer Responsibility: Manufacturers are responsible for ensuring their supplements are safe and their claims are truthful, as the FDA does not approve products before they are marketed.

• No Disease Claims: Supplements are permitted to make "structure/function" claims (e.g., "supports bone health"), but not disease prevention or treatment claims.

• Not a Food Replacement: Supplements are intended to augment, not replace, a balanced and healthy diet of whole foods.

Understanding the Legal and Regulatory Framework

The most significant factor in defining what makes something a supplement is the legal and regulatory framework governing it. In the United States, this is primarily dictated by the Dietary Supplement Health and Education Act (DSHEA) of 1994, which is overseen by the Food and Drug Administration (FDA). DSHEA places dietary supplements in a special category under the general umbrella of “foods,” rather than treating them as drugs.

The DSHEA specifically defines a dietary supplement as a product (other than tobacco) intended to supplement the diet that contains one or more "dietary ingredients". These products are also explicitly not meant to be used as a conventional food or as the sole item of a meal or diet. The intended use is key; if a product is intended to treat, diagnose, cure, or prevent a disease, it is considered a drug, regardless of its label. This distinction significantly impacts the claims a manufacturer can legally make about their product.

DSHEA's Core Criteria for Supplements

• Form: A supplement must be in a form that can be ingested, such as a tablet, capsule, powder, softgel, gelcap, or liquid.
• Labeling: The product's label must clearly identify it as a "dietary supplement" or a similar descriptor, such as "iron supplement".
• Ingredient Inclusion: It must contain a "dietary ingredient," a specific category of substances defined by the DSHEA.
• Oral Administration: The product must be intended for oral consumption.

The Role of Ingredients in Supplement Classification

Beyond the regulatory definition, the type of ingredients a product contains is central to classifying it as a supplement. The DSHEA specifies several categories of "dietary ingredients" that can be included in supplements:

• Vitamins: Essential compounds like Vitamin C, D, and B vitamins.
• Minerals: Essential elements such as calcium, iron, and magnesium.
• Herbs and Botanicals: Plant-based substances like echinacea, ginger, and turmeric.
• Amino Acids: The building blocks of protein, such as tryptophan and glutamine.
• Concentrates, Metabolites, and Extracts: Substances derived from dietary ingredients, like caffeine from a botanical source.
• Probiotics: Live microorganisms that can provide health benefits.

New Dietary Ingredients

A "new dietary ingredient" is any dietary ingredient that was not marketed in the U.S. before October 15, 1994. The law requires manufacturers to notify the FDA and provide evidence of safety for any new dietary ingredient they plan to market. The FDA does not, however, approve dietary supplements for safety or effectiveness before they are sold to the public; it is the manufacturer's responsibility to ensure their products are safe.

Supplement vs. Conventional Food: Key Distinctions

Distinguishing a supplement from a conventional food product can be complex, especially with the rise of fortified foods and functional beverages. The key lies in the intended use, labeling, and form.

Comparison Table: Supplement vs. Conventional Food

Feature	Dietary Supplement	Conventional Food
Primary Purpose	To supplement the diet by providing nutrients or beneficial substances.	To be consumed for taste, aroma, or nutritive value as part of the overall diet.
Labeling	Features a “Supplement Facts” panel that details the dietary ingredients and their amounts per serving.	Displays a standard “Nutrition Facts” panel.
Form	Typically ingested in specific unit doses (pills, capsules, powders, liquids).	Consumed in traditional food forms (solids, liquids, semi-solids) without controlled dosing.
Regulatory Path (US)	Falls under DSHEA and is treated as a food, not a drug. No pre-market approval required.	Regulated differently and requires pre-market approval for new additives.
Health Claims	Can make "structure/function" claims (e.g., "supports joint health") but not disease claims.	Can make nutrient content claims but generally not specific health condition claims.
Consumer Perception	Often viewed as a targeted health aid.	Seen as a source of general nourishment.

Labeling and Claims: The Power of Language

For a product to be sold as a supplement, its label must comply with strict regulations concerning claims and nutritional information.

The Supplement Facts Panel

The "Supplement Facts" panel is a crucial feature that sets a supplement apart. It lists the serving size, servings per container, and all dietary ingredients, including their quantitative amounts. This panel is mandatory for almost all dietary supplements.

Structure/Function Claims vs. Disease Claims

Supplement manufacturers can make claims about how a product affects the structure or function of the body, provided there is scientific substantiation. For example, a company might claim that calcium "supports bone density." However, they are legally barred from making claims that the product can diagnose, treat, cure, or prevent any disease. A disclaimer must also be included on the label stating that the FDA has not evaluated the claim and that the product is not intended to treat or cure diseases.

Conclusion: Defining the Line Between Supplement and Food

What makes something a supplement is determined by a combination of its intended use, form, ingredients, and regulatory oversight. Supplements are products explicitly designed to augment the diet with concentrated ingredients, whereas conventional foods are consumed primarily for their nutritional or sensory qualities. While DSHEA has provided a clear legal framework, the line can sometimes blur, especially with the proliferation of functional and fortified products. For consumers, understanding these defining characteristics, particularly the distinction between a "Supplement Facts" panel and a "Nutrition Facts" panel, is vital for making informed health decisions. Ultimately, supplements are not a replacement for a healthy, balanced diet of whole foods, but rather a tool to help fill potential nutritional gaps.

Lists of Supplement Forms and Ingredients

Common forms of dietary supplements include:

• Tablets
• Capsules
• Soft gels and gel caps
• Liquids and drops
• Powders
• Gummies
• Bars (as long as they are not represented as a sole meal item)

Common dietary ingredients found in supplements include:

• Vitamins (e.g., Vitamin D, C, B12)
• Minerals (e.g., Iron, Calcium, Zinc)
• Herbs and botanicals (e.g., Echinacea, Ginkgo Biloba)
• Amino Acids (e.g., L-arginine)
• Fatty Acids (e.g., Fish oil, Flaxseed oil)
• Probiotics (live microbials)
• Coenzyme Q10
• Creatine

Visit the FDA website for more information on the regulation of dietary supplements.

Frequently Asked Questions

What is the key difference between a supplement and a conventional food?

The primary distinction lies in the intended use, form, and labeling. Supplements are meant to add nutrients to the diet and come in forms like pills or powders with a 'Supplement Facts' label, while conventional foods are consumed for general nourishment and have a 'Nutrition Facts' label.

Does the FDA approve dietary supplements before they are sold?

No, the FDA does not approve dietary supplements for safety or effectiveness before they are marketed. It is the manufacturer's responsibility to ensure their product is safe and their claims are truthful.

What kind of ingredients can be included in a supplement?

Supplements can contain a variety of dietary ingredients, including vitamins, minerals, herbs, amino acids, and other substances like enzymes or probiotics.

Can a supplement manufacturer claim their product prevents a disease?

No, it is against federal regulations for supplement manufacturers to claim their products prevent or treat any disease. They can only make structure/function claims, such as "supports healthy joints".

What is a 'new dietary ingredient'?

A 'new dietary ingredient' is one that was not marketed in the U.S. prior to October 15, 1994. Manufacturers must notify the FDA and provide evidence of safety before marketing a product with such an ingredient.

Is a protein bar a supplement or a food?

This depends on its intended use and labeling. While bars can be supplements, they are only classified as such if they are not represented as a conventional food or as the "sole item of a meal or the diet".

Are supplements intended to replace a healthy diet?

No, supplements are intended to augment or add to a healthy diet, not to replace the variety of foods that are important for overall health.