Are Probiotics Considered Nutritional Supplements?

According to the National Center for Complementary and Integrative Health, probiotics are live microorganisms that, when administered in adequate amounts, confer a health benefit on the host. Due to their classification under different regulatory frameworks, whether probiotics are considered nutritional supplements depends heavily on their intended use, form, and jurisdiction.

Quick Summary

This article explores the classification of probiotics within the regulatory landscape of the United States and Europe. It details the difference between dietary supplements and functional foods and explains the complexities of health claims and approval processes.

Key Points

• US Regulation: In the U.S., most encapsulated probiotics are regulated by the FDA as dietary supplements under DSHEA, not as drugs.

• EU Regulation: The EU's EFSA has historically been stricter, treating the term 'probiotic' as a health claim and largely rejecting them, though national guidelines now vary.

• Dietary vs. Functional: Probiotics are delivered either as concentrated dietary supplements (pills, powders) or as functional foods (yogurt, kefir).

• Claim Limitations: As supplements, probiotics can make 'structure/function' claims (e.g., supports digestive health) but cannot claim to treat, cure, or prevent a disease without drug approval.

• Manufacturer Responsibility: The safety and efficacy of dietary supplements are primarily the responsibility of the manufacturer, not pre-approved by the FDA.

• Informed Choice: Consumers should research specific strains and consult healthcare professionals, as quality and viability vary significantly between products.

What Defines a Nutritional Supplement?

Under the Dietary Supplement Health and Education Act (DSHEA) of 1994, the U.S. Food and Drug Administration (FDA) defines a dietary supplement as a product intended for ingestion that contains a "dietary ingredient" meant to add nutritional value to the diet. This category includes vitamins, minerals, herbs, amino acids, and also live microbials, which are commonly referred to as probiotics. This classification allows for probiotics to be sold without the rigorous pre-market approval required for pharmaceutical drugs. The manufacturers, not the FDA, are responsible for ensuring their products are safe and that any 'structure/function' claims are truthful and not misleading. However, dietary supplements cannot claim to diagnose, cure, mitigate, treat, or prevent a disease.

The Role of Regulation in the U.S. and E.U.

The regulatory environment for probiotics is not uniform across all regions. The primary difference lies in how products are defined and the types of claims that are permitted.

United States (FDA)

• Dietary Supplements: Most probiotics are sold under this category in capsules, tablets, or powders. Manufacturers are responsible for safety and quality control.
• Foods/Functional Foods: Probiotics are also added to conventional foods like yogurt and kefir. These fall under general food regulations and can make claims about improving lactose digestion, but specific health claims are restricted.
• Live Biotherapeutic Products (LBPs): If a probiotic is marketed to treat a specific disease, it is regulated as a drug or biological product and must undergo strict FDA clinical trials and approval.

Europe (EFSA)

• Health Claims: Regulation (EC) No 1924/2006 governs nutritional and health claims. The European Food Safety Authority (EFSA) must authorize all health claims. Historically, EFSA has been very strict, considering the term 'probiotic' itself a health claim, which is a major hurdle for manufacturers.
• National Guidelines: Due to a lack of harmonized EU-wide rules, some member states, like Italy and Denmark, have implemented national guidelines that allow the use of the term 'probiotic' on food supplements under specific conditions.
• Market Impact: This regulatory uncertainty has impacted innovation and consumer choice within the EU, contrasting with the more flexible, albeit less strictly controlled, US market for dietary supplements.

Probiotics as Food vs. Supplements

While both probiotic foods and supplements deliver beneficial microorganisms, they serve different purposes and offer different characteristics. Foods like yogurt provide a more diverse microbial ecosystem and may contain prebiotics, while supplements offer a more concentrated and standardized dose.

Comparison Table: Probiotic Foods vs. Supplements

Feature	Probiotic Foods (e.g., yogurt, kefir)	Probiotic Supplements (e.g., capsules, powders)
Regulation	Regulated as a general food product; includes functional foods.	Regulated as a dietary supplement under DSHEA in the US; subject to food regulations in Europe.
Viability	Viability can fluctuate based on processing, storage, and shelf life; label may say "live and active cultures".	Formulated for stability and a guaranteed viable count at the end of shelf life.
Dosage	Varies widely by product and manufacturer; often less concentrated.	Provides a high, standardized dose (often in CFU) of specific, targeted strains.
Strain Specificity	Often contains a mix of bacteria, with specific strain information potentially limited.	Labels typically specify the exact bacterial species and strain, linking to specific clinical studies.
Absorption/Delivery	The food matrix (e.g., dairy fat in yogurt) can provide protection for the probiotics passing through the digestive tract.	Encapsulation or other delivery systems are designed to protect the microorganisms from stomach acid.
Health Focus	Broad gut health and overall wellness, often with lower doses.	Targeted health goals, such as specific digestive issues or immune support.

Making an Informed Decision

Ultimately, whether a probiotic is considered a nutritional supplement is not a simple 'yes' or 'no' question but rather depends on the product's regulatory classification, format, and intended use. For the majority of over-the-counter capsules and powders, the answer is yes, they are treated as dietary supplements in the U.S. and increasingly as food supplements in Europe, despite regional differences in labeling. For food products, they are considered functional foods. The core takeaway is that consumers should not equate a product's classification as a supplement with a guarantee of its effectiveness or quality. The responsibility falls on manufacturers to produce high-quality products and provide accurate information, and on consumers to consult healthcare professionals, especially for targeted health concerns. The ongoing evolution of regulatory frameworks in both the U.S. and E.U. shows a growing recognition of probiotics as a distinct product category, deserving of clearer standards for quality and claim substantiation. For specific information on a probiotic's effectiveness, consumers can research strain-specific data, like studies available on databases such as PubMed.

Conclusion

In conclusion, probiotics are indeed considered nutritional supplements in their pill, powder, and liquid forms within the regulatory framework of the United States and certain European nations. This is a classification that distinguishes them from pharmaceuticals, which require extensive clinical trials for approval for treating diseases. However, the presence of probiotics in fermented foods classifies them differently as 'functional foods,' which offer benefits within a complex food matrix. The key for consumers is to understand the differences in regulation and product delivery methods. While dietary supplements offer a concentrated, targeted dose of specific strains, functional foods provide broader benefits alongside other nutrients. Making an informed choice requires a critical look at product labeling, strain specificity, and consulting with a healthcare provider to ensure the product aligns with individual health goals. The regulatory landscape continues to evolve, pushing for greater clarity and quality standards in a market with diverse and sometimes confusing offerings.

Frequently Asked Questions

Does the FDA approve probiotic supplements?

No, the FDA does not approve probiotic dietary supplements for safety or effectiveness before they are marketed. Manufacturers are responsible for ensuring their products are safe and that claims are truthful and not misleading.

What is the difference between a probiotic supplement and a probiotic food?

A probiotic supplement is a concentrated, standardized dose of microorganisms in a pill, capsule, or powder format. A probiotic food, like yogurt, contains probiotics within its food matrix, and the viability and dosage can vary.

Can I get enough probiotics from food alone?

Yes, it is possible to get a variety of probiotics from fermented foods like yogurt, kefir, and kimchi. However, supplements can provide higher, more concentrated doses of specific, targeted strains, which may be needed for certain health goals.

What are the regulations for probiotics in the European Union?

In the EU, health claims for probiotics are highly restricted and must be authorized by EFSA. However, some member countries have created national guidelines that allow the use of the term 'probiotic' on food supplements under specific conditions.

How do I choose a high-quality probiotic?

Look for products that specify the exact strain (e.g., Lactobacillus acidophilus), the number of viable colony-forming units (CFUs) guaranteed through the expiration date, and store the product as recommended.

Are there risks associated with taking probiotics?

For most healthy individuals, probiotics are considered safe. However, people with compromised immune systems or other serious health conditions should consult a healthcare provider before taking them.

What is the difference between prebiotics and probiotics?

Probiotics are the live, beneficial microorganisms, while prebiotics are non-digestible food components (fibers) that act as food for these microorganisms, helping them to thrive.