Are there FDA-approved probiotics? Understanding the regulatory landscape

Over 4 million U.S. adults reported using probiotics or prebiotics within a 30-day period, according to a 2012 survey, yet many are unaware of the nuanced regulatory status of these products. The critical distinction is whether probiotics are marketed as dietary supplements or drugs, which determines if there are FDA-approved probiotics available to consumers.

Quick Summary

This article clarifies the complex regulatory environment surrounding probiotics by explaining the difference between dietary supplements and FDA-approved drugs. It details the pathways for FDA approval and addresses the fact that most products marketed as probiotics do not undergo the rigorous review required for drug status, with a few specific exceptions.

Key Points

• FDA Approval is Not Required: The FDA does not pre-approve the vast majority of probiotic products sold as dietary supplements or functional foods.

• Intended Use Determines Regulation: Whether a probiotic is regulated as a food, a dietary supplement, or a drug depends on the product's intended use and the claims made by the manufacturer.

• Dietary Supplements Have General Claims: Probiotics marketed as dietary supplements can make general "structure/function" claims, but cannot claim to treat, cure, or prevent a disease without FDA review.

• Specific Microbial-Based Therapies are Approved: The FDA has approved a new class of products called Live Biotherapeutic Products (LBPs) as drugs for specific medical conditions, like recurrent C. difficile infection.

• GRAS Status is Not FDA Approval: Many probiotic strains have GRAS (Generally Recognized As Safe) status for use in food, but this is not the same as FDA drug approval for therapeutic use.

• Consumer Caution is Advised: Due to less stringent regulations for dietary supplements, there can be inconsistencies in product quality and viability, making it important to research brands and consult a healthcare provider.

Navigating the regulatory confusion surrounding probiotics

When consumers see a variety of probiotic products on store shelves, from yogurts to pills, it's easy to assume they have all been vetted equally by the government. However, the regulatory landscape is significantly more complex. The U.S. Food and Drug Administration (FDA) does not review and approve every probiotic product before it is sold. Instead, the intended use of a product determines its regulatory pathway. Most probiotics are sold as dietary supplements or functional foods, which are not subject to the same strict pre-market approval process as drugs designed to treat or prevent a disease.

The crucial distinction: Dietary supplements vs. drugs

The central issue is the legal distinction between a dietary supplement and a drug. A dietary supplement is a product intended to supplement the diet and can make structure/function claims, such as "supports digestive health" or "promotes a healthy immune system". These claims must be truthful and not misleading, and the product must carry a disclaimer stating that it has not been evaluated by the FDA and is not intended to diagnose, treat, cure, or prevent any disease. Manufacturers are responsible for ensuring the safety and labeling of their products without needing pre-market FDA approval.

In stark contrast, a product is classified as a drug if it is intended to diagnose, cure, mitigate, treat, or prevent a disease. Before a drug can be marketed, it must undergo extensive and rigorous clinical trials to prove its safety and effectiveness for its specific intended use. This intensive pre-market review and approval process explains why it is exceptionally rare to find FDA-approved probiotics in the traditional sense.

The rise of Live Biotherapeutic Products (LBPs)

There is a new category of products that are changing the conversation: Live Biotherapeutic Products (LBPs). These are microbial-based therapies developed specifically with the intention of treating or preventing diseases, putting them in the drug classification. LBPs must go through the same stringent clinical trial and Biologics License Application (BLA) process as other biological products. In fact, the FDA has approved certain microbial-based therapies, such as REBYOTA™ and VOWST™, for specific medical conditions like recurrent Clostridioides difficile infection (CDI). These approvals, however, apply only to the specific formulation and medical indication and do not mean that over-the-counter probiotic supplements have FDA approval.

What about GRAS status?

Another term that adds to the confusion is "Generally Recognized As Safe" (GRAS). This is a designation for substances that have a history of safe use in food or are proven safe through scientific procedures. Many probiotic strains used in foods like yogurt or dietary supplements have achieved GRAS status, either affirmed by the FDA or determined independently by qualified experts. GRAS status confirms that an ingredient is safe for its intended use in food, but it does not equate to FDA approval for treating a medical condition. It's important to recognize that GRAS status is not a therapeutic claim and does not involve the same level of efficacy testing required for a drug.

A comparison of regulatory pathways

To clarify the differences, consider this comparison table.

Feature	Dietary Supplement (Most Probiotics)	FDA-Approved Drug (e.g., LBPs)
Regulatory Pathway	Regulated by the FDA under the Dietary Supplement Health and Education Act (DSHEA).	Regulated by the FDA under the Federal Food, Drug, and Cosmetic Act.
Pre-market Approval	No FDA approval is required before marketing.	Mandatory pre-market approval by the FDA after rigorous testing.
Safety and Labeling	Manufacturer is responsible for ensuring safety and truthful labeling.	FDA evaluates safety and efficacy based on clinical trial data.
Permitted Claims	Can make general structure/function claims (e.g., "supports a healthy gut").	Can make specific health claims about treating, mitigating, or preventing a disease.
Examples	Probiotic capsules, yogurts, and fermented milks with general health claims.	REBYOTA™ and VOWST™ for recurrent C. difficile infection.
Disclaimer	Required to have a disclaimer: "This statement has not been evaluated by the FDA...".	No such disclaimer is required; claims are FDA-verified.

Making informed choices about probiotics

Given the varied regulations, how can a consumer make an informed decision? First, it is crucial to understand the purpose of the product you are considering. If you are looking for a general health-promoting food, products with GRAS status or those sold as dietary supplements may be sufficient. However, if you are seeking a therapeutic effect for a specific medical condition, you should look for a product that has undergone the FDA's drug approval process. Currently, most products traditionally labeled as "probiotics" do not fall into this category. It's always a good idea to consult with a healthcare professional to discuss your needs and ensure you choose an appropriate product.

Challenges in probiotic regulation

The current system is not without its challenges. Because most probiotics are sold as dietary supplements, there are concerns about quality control and potential inconsistencies between the label and the actual contents, such as variations in the number or viability of microorganisms. This lack of standardization can complicate research and make it difficult to gather consistent evidence of efficacy for specific strains. The FDA has acknowledged these issues, and efforts are ongoing to improve the regulatory framework, but consumers must remain vigilant.

Conclusion

In conclusion, the direct answer to "are there FDA-approved probiotics?" is no for the vast majority of products marketed as dietary supplements or functional foods. However, the regulatory landscape is evolving. While traditional probiotic products remain largely unregulated by the FDA, a new class of microbial-based drugs, known as Live Biotherapeutic Products (LBPs), is achieving FDA approval for specific medical conditions. For the average consumer, it is essential to distinguish between the general health claims on dietary supplements and the specific, verified therapeutic claims of FDA-approved drugs. As always, consulting a healthcare provider is the best way to determine the right course of action for your health needs.

References

Synapse Patsnap. (2025). How many FDA approved Probiotics are there? Retrieved from https://synapse.patsnap.com/article/how-many-fda-approved-probiotics-are-there National Center for Complementary and Integrative Health (NCCIH). (2019). Probiotics: Usefulness and Safety. Retrieved from https://www.nccih.nih.gov/health/probiotics-usefulness-and-safety

Frequently Asked Questions

Does the FDA approve probiotic supplements?

No, the FDA does not approve probiotic products that are sold as dietary supplements before they are marketed. The manufacturer is responsible for ensuring the product is safe and accurately labeled.

What is the difference between an FDA-approved drug and a probiotic supplement?

An FDA-approved drug has undergone extensive clinical trials to prove its safety and effectiveness for a specific disease. A probiotic dietary supplement only requires the manufacturer to verify its own safety and can only make general health claims, not therapeutic ones.

What are Live Biotherapeutic Products (LBPs)?

Live Biotherapeutic Products (LBPs) are a class of microbial-based therapies developed to treat or prevent diseases. Unlike dietary supplements, they are regulated as drugs and must undergo rigorous FDA approval.

Can a probiotic product with GRAS status be labeled as FDA-approved?

No, a probiotic with GRAS (Generally Recognized As Safe) status cannot be labeled as FDA-approved. GRAS status simply means that an ingredient is considered safe for its intended use in food, not that it is an FDA-approved drug for treating a health condition.

Why did the FDA recently raise concerns about probiotics for infants?

In 2023, the FDA issued a warning about unapproved probiotic products being used to treat or prevent diseases in preterm infants due to a lack of safety and effectiveness evaluation for this vulnerable population.

What does a disclaimer like 'This statement has not been evaluated by the FDA' mean?

This disclaimer indicates that the product is a dietary supplement and has not gone through the FDA's pre-market review process. It reinforces that the product is not intended to treat or cure any disease.

Are there any probiotics that are FDA-approved as drugs?

Yes, some microbial-based products have achieved FDA approval as drugs for specific medical purposes, such as REBYOTA™ and VOWST™ for recurrent C. difficile infection. However, these are not the same as typical probiotic supplements.