Products Considered Supplements in the United States

The Dietary Supplement Health and Education Act (DSHEA) of 1994 established a specific regulatory framework in the United States, defining what a dietary supplement is and classifying it separately from conventional foods and drugs. This framework includes a broad range of products intended to be ingested and to supplement the diet.

Quick Summary

This guide details the various product categories and ingredients, including vitamins, minerals, botanicals, and amino acids, that are legally defined as dietary supplements under US law and FDA oversight.

Key Points

• Broad Definition: The DSHEA of 1994 defines dietary supplements broadly, including vitamins, minerals, botanicals, amino acids, and other ingestible substances intended to supplement the diet.

• No Pre-market FDA Approval: Unlike drugs, the FDA does not approve dietary supplements for safety or effectiveness before they are sold. Manufacturers are responsible for ensuring product safety and accurate labeling.

• Variety of Forms: Supplements are available in multiple forms like tablets, capsules, powders, and liquids, with the choice often depending on dosage needs and personal preference.

• Consider Third-Party Verification: For added assurance regarding product quality and purity, consumers can look for third-party certifications from organizations like NSF International or USP.

• Informed Consumer Approach: Due to limited FDA oversight, it is crucial for consumers to research brands, read labels, and consult a healthcare professional to ensure safe and appropriate use.

• Supplement vs. Diet: Dietary supplements are not a replacement for a balanced, nutrient-rich diet but rather an addition to help meet specific nutritional goals.

Defining Dietary Supplements in the US

In the United States, a product is considered a dietary supplement if it meets specific criteria outlined by the Dietary Supplement Health and Education Act of 1994 (DSHEA). To qualify, a product must be intended to supplement the diet and contain one or more of the following "dietary ingredients": a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance used to supplement the diet, or a concentrate, metabolite, constituent, or extract of any of these. This broad definition encompasses a vast array of products, from common multivitamins to specialized herbal preparations. Unlike prescription drugs, the FDA does not approve dietary supplements for safety and effectiveness before they are marketed. It is the manufacturer’s responsibility to ensure their products are safe and accurately labeled.

Major Product Categories Recognized as Supplements

Dietary supplements can be broadly categorized by their primary active ingredients. Here is an overview of the main groups:

Vitamins

These are organic compounds that an organism requires in limited amounts as a micronutrient. Supplements containing vitamins are extremely common. They can come as single-nutrient products, such as Vitamin C or Vitamin D supplements, or as part of a multivitamin formula. Key examples include:

• Vitamin D: Often used to support bone health.
• B-vitamins: Such as B12 and B6, which are crucial for energy metabolism and neurological function.
• Vitamin C: An essential antioxidant that supports the immune system.
• Folic Acid (Vitamin B9): Recommended for women who are or may become pregnant.

Minerals

Minerals are inorganic elements required for the body's normal function. These are another core component of the supplement market. Prominent mineral supplements include:

• Calcium: Fundamental for building strong bones and teeth.
• Magnesium: Involved in numerous bodily processes, including muscle and nerve function, blood sugar control, and blood pressure regulation.
• Iron: Necessary for red blood cell production.
• Zinc: An essential mineral that plays a role in immune function and metabolism.

Botanicals (Herbs)

These supplements are derived from plants or plant parts and are often used for their perceived medicinal or therapeutic properties. Many are part of traditional and complementary medicine. Examples of common botanical supplements in the US include:

• Echinacea: Frequently used to support immune health, especially during the cold and flu season.
• Ginger: Known for its anti-inflammatory and digestive benefits.
• Turmeric: Contains curcumin, a compound with potent anti-inflammatory effects.
• Ginseng: Often marketed for its adaptogenic and energy-boosting properties.

Amino Acids

Amino acids are the building blocks of protein and are essential for many physiological functions, such as muscle growth and repair. Popular amino acid supplements include:

• Branched-Chain Amino Acids (BCAAs): Comprising leucine, isoleucine, and valine, these are popular among athletes for muscle support.
• Creatine: A combination of three amino acids (arginine, methionine, and glycine) used to enhance athletic performance.
• Glutamine: A conditionally essential amino acid that can be beneficial during periods of stress or intense exercise.

Other Dietary Ingredients

The DSHEA's definition also includes other substances, such as enzymes, probiotics, and concentrates of other dietary ingredients.

• Probiotics: Live microbials that are beneficial for gut health.
• Omega-3 Fatty Acids: Often found in fish oil supplements, which support heart and brain health.
• Coenzyme Q10 (CoQ10): A substance found naturally in the body that supports energy production.

Comparison of Supplement Forms

Supplements are available in a variety of forms, each with its own advantages and considerations. Choosing the right form can depend on personal preference, convenience, and specific dietary needs.

Feature	Tablets & Pills	Capsules & Softgels	Powders	Liquids & Gummies
Convenience	Easy to carry and store.	Easy to swallow and have no taste.	Versatile for mixing into drinks.	Enjoyable taste, good for those with swallowing difficulties.
Dosage Control	Fixed, pre-measured dose.	Fixed, pre-measured dose.	Adjustable dosage based on need.	Easy to adjust liquid dose.
Absorption Rate	Can be slow due to compression.	Often faster than tablets, especially softgels.	Can be very fast as they are predigested.	Fast absorption, can contain added sugars.
Shelf Life	Generally long, very stable.	Good, but can degrade if exposed to heat/light.	Good, but can clump if exposed to moisture.	Shorter than dry forms, can be less stable.
Ingredients	Can contain binders and fillers.	Fewer excipients than tablets, softgels often contain oil-based ingredients.	Often fewer added ingredients.	Can contain additives, sugars, and artificial flavors.
Suitability	Best for standard, fixed doses.	Good for nutrients in oil form or sensitive ingredients.	Ideal for high doses or customizable amounts.	Suited for children or individuals who dislike swallowing pills.

Navigating the US Supplement Market

Given the vast array of products considered supplements, it is crucial for consumers to be well-informed. Because the FDA does not evaluate supplements for safety and efficacy before they are sold, consumers bear the responsibility of vetting products and brands. Looking for third-party certifications, such as those from NSF International or USP, can help ensure products meet quality and purity standards. Always consult a healthcare professional before starting any new supplement regimen, as some supplements can interact with medications or have negative side effects.

Conclusion

The landscape of dietary supplements in the United States is broad, encompassing a diverse range of products from basic vitamins and minerals to complex botanical extracts and amino acid blends. Defined by the DSHEA, these products are intended to complement the diet rather than treat, cure, or prevent disease. Consumers can find these items in many forms, each with its own benefits. While they can be a helpful addition to a healthy lifestyle, an informed approach—consulting healthcare providers and seeking out third-party verified products—is essential for safe and effective use.

Learn more about the FDA's regulation of dietary supplements.

Understanding the Product and Regulation

What are dietary ingredients in the US?

Dietary ingredients, as defined by DSHEA, include vitamins, minerals, herbs or other botanicals, amino acids, and other dietary substances that supplement the diet.

What forms can a supplement take?

Supplements can be sold in various forms, including tablets, capsules, softgels, gelcaps, liquids, powders, and gummies.

What is the primary function of a dietary supplement?

The purpose of a dietary supplement is to add to, or supplement, the diet, helping individuals meet their daily requirements of essential nutrients.

How to Choose and Use Supplements Safely

Is the FDA responsible for approving supplements before they are sold?

No, the FDA does not approve dietary supplements for safety or effectiveness prior to them being marketed. This responsibility lies with the manufacturer.

When should I consult a healthcare professional about supplements?

It is always advisable to talk to a healthcare professional before taking a new supplement, especially if you have an underlying medical condition, are pregnant, or are taking medications.

Can supplements be taken as a replacement for a healthy diet?

Supplements are not a substitute for a balanced diet and should not replace a healthy and varied food intake.

What are some examples of supplements that are not vitamins or minerals?

Examples include botanical supplements like echinacea, amino acid supplements like creatine, and other substances like probiotics and fish oil.

Frequently Asked Questions

What is the legal definition of a dietary supplement in the US?

A dietary supplement is a product intended to supplement the diet that contains one or more dietary ingredients, such as vitamins, minerals, herbs, botanicals, or amino acids, as defined by the DSHEA of 1994.

Are all products in a health food store considered supplements?

No, not all products are supplements. While many are, conventional foods or products marketed as the sole item of a meal or diet do not fall under the dietary supplement category.

Does the FDA inspect supplement manufacturers?

Yes, the FDA has a role in regulating dietary supplements after they are marketed, including inspecting manufacturing facilities and taking action against unsafe products or false claims.

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

The main difference is in the product's intended use and labeling. Supplements are meant to 'supplement' the diet and must be labeled as such, whereas conventional foods are consumed as part of a meal.

Are probiotics considered supplements?

Yes, live microbials, commonly referred to as probiotics, can be considered dietary supplements if they are marketed for the purpose of supplementing the diet.

Can a product with a new dietary ingredient be sold without FDA approval?

A manufacturer intending to market a supplement with a 'new dietary ingredient' must notify the FDA before it is sold. However, this is not an approval process, and the FDA does not verify safety beforehand.

What should I look for on a supplement label?

A dietary supplement label is required to include a 'Supplement Facts' panel, a list of other ingredients, the product name, and the name and place of business of the manufacturer or distributor.