Are there any FDA approved probiotics?: Understanding Regulation and Safety

October 10, 2025 •

3 min read

According to the National Center for Complementary and Integrative Health (NCCIH), the use of probiotics by U.S. adults quadrupled between 2007 and 2012. While their popularity soars, the key question remains: are there any FDA approved probiotics? The answer involves a critical distinction in how the FDA regulates products based on their intended use, a fact often misunderstood by consumers.

Quick Summary

Most probiotic products sold as dietary supplements or food are not FDA approved as drugs. The agency regulates them differently based on intended use, with only specific Live Biotherapeutic Products (LBPs) receiving drug approval for certain medical conditions.

Key Points

No FDA-Approved Probiotic Supplements: The FDA does not approve probiotic products sold as dietary supplements or food for general use.
Regulation by Intended Use: A product's classification as a food, dietary supplement, or drug depends on its intended use and the health claims made by the manufacturer.
Live Biotherapeutic Products (LBPs) are Different: A few live microbial therapies, known as LBPs (e.g., REBYOTA, VOWST), have been FDA-approved as drugs for specific medical conditions like recurrent C. difficile infection.
GRAS Status for Food: Some probiotic strains have achieved Generally Recognized as Safe (GRAS) status, which applies to their use as ingredients in foods, not as therapeutic drugs.
FDA Warns Against Use in Vulnerable Groups: The FDA has issued warnings about the risks of using unapproved probiotics in vulnerable populations, such as premature infants.
Supplement Claims Are Limited: Probiotic dietary supplements can only make general structure/function claims; they cannot claim to treat, mitigate, or cure a disease.

The Regulatory Landscape of Probiotics

The notion that a probiotic supplement is approved by the U.S. Food and Drug Administration (FDA) is a common misconception. The reality is that the regulatory status of a probiotic product is determined by its intended use. The FDA does not recognize a single regulatory category for "probiotics." Instead, they are regulated under three main pathways: as foods or food ingredients, as dietary supplements, or as biological products (drugs).

Most commercial probiotics found on store shelves are categorized as either a food ingredient or a dietary supplement. These categories have significantly less stringent regulatory oversight than drugs. For instance, manufacturers of dietary supplements do not need to obtain FDA approval before marketing their products. They are, however, responsible for ensuring the product's safety and that the label is truthful and not misleading.

The Case of Live Biotherapeutic Products (LBPs)

In recent years, a new class of microbial therapies, known as Live Biotherapeutic Products (LBPs), has emerged. These are developed with the specific intention of treating, preventing, or curing a disease, and are therefore regulated as drugs. This means they must undergo the FDA's rigorous pre-market evaluation process, including comprehensive pre-clinical testing and multi-phase clinical trials, to prove both safety and efficacy.

REBYOTA™ and VOWST™: The FDA has approved microbial-based therapies like REBYOTA™ and VOWST™ for the prevention of recurrent Clostridioides difficile infection (CDI). These approvals are for specific, targeted treatments and are distinct from the general probiotic supplements found in stores.
Investigational New Drug (IND) Applications: For an LBP to be tested in clinical trials, a company must first submit an Investigational New Drug (IND) application to the FDA. This process is essential for ensuring patient safety during the testing phase.

Comparing Probiotic Regulation: Supplements vs. Drugs


Feature	Dietary Supplements (General Probiotics)	Live Biotherapeutic Products (LBPs)
Regulatory Oversight	Center for Food Safety and Applied Nutrition (CFSAN)	Center for Biologics Evaluation and Research (CBER)
Pre-Market Approval	Not required for general marketing; manufacturer is responsible for safety	Required. Must prove safety and efficacy through clinical trials before marketing
Intended Use	To supplement the diet; used for general wellness or 'structure/function' claims	To diagnose, cure, mitigate, treat, or prevent disease
Allowed Claims	General health statements about supporting a body function (e.g., "supports digestive health"). No disease claims	Specific disease-related claims based on clinical evidence (e.g., "approved for treating recurrent C. difficile")
Examples	Probiotic capsules, powders, and fortified foods like yogurt	REBYOTA™ and VOWST™ for recurrent C. difficile

Safety Concerns and FDA Warnings

While probiotics are generally considered safe for most healthy individuals, serious complications can occur, particularly in vulnerable populations. The FDA has voiced concerns and issued warnings regarding unapproved probiotic products, especially for use in hospitalized preterm infants. A significant risk is potential contamination during the manufacturing process, which can lead to severe infections in immunocompromised individuals. The FDA actively encourages the reporting of adverse events associated with probiotics.

Another key issue is product inconsistency. Since most probiotics are not subject to the same level of scrutiny as drugs, manufacturers' quality control can vary. Studies have revealed discrepancies between the microbial content listed on a label and the actual contents, including variations in the quantity and viability of strains.

The Future of Probiotics and FDA Regulation

As research into the human microbiome expands, the development of new, targeted microbial therapies will likely continue. This includes products that may eventually gain full FDA drug approval for specific health conditions, similar to REBYOTA™ and VOWST™. Advancements in manufacturing standards and scientific understanding of strain-specific effects may pave the way for more rigorously tested and regulated probiotic therapies.

Ultimately, consumers must understand the regulatory difference between dietary supplements and drugs. Consulting a healthcare professional before starting any probiotic regimen is crucial, especially for individuals with compromised immune systems, to ensure safety and suitability.

Conclusion

So, are there any FDA approved probiotics? The simple answer for the vast majority of consumer products, including yogurts and supplements, is no. These are regulated as foods or dietary supplements and do not undergo pre-market approval. However, in the narrow, but growing, field of medical therapies, specific Live Biotherapeutic Products (LBPs) have received FDA drug approval for treating distinct diseases. This distinction is paramount for consumer safety and informed healthcare decisions.

Frequently Asked Questions

No, the FDA's regulatory approach depends on the product's intended use. Probiotics are regulated as foods, dietary supplements, or drugs, each with different standards for safety, manufacturing, and claims.

A Live Biotherapeutic Product (LBP) is a product containing live microorganisms intended to prevent, treat, or cure a disease. Unlike most probiotics, LBPs are regulated as drugs by the FDA and require rigorous testing and approval.

For products intended to treat or prevent a disease, FDA approval ensures they have undergone thorough evaluation for safety and effectiveness through multi-phase clinical trials. This process is crucial for products targeting specific medical conditions, particularly in vulnerable patients.

No. Probiotic dietary supplements are not permitted to make health claims suggesting they can treat, mitigate, cure, or prevent a disease. They can only make general structure/function claims, such as "supports digestive health".

No. Generally Recognized as Safe (GRAS) status means that a probiotic strain is considered safe for use as a food ingredient under specific conditions. It is not a therapeutic approval and does not imply efficacy for treating disease.

Since supplements aren't FDA-approved, look for third-party certifications from organizations that verify product quality, purity, and potency. Consider products that clearly label the full name of the probiotic strain(s), not just the genus and species, and consult a healthcare provider.

Yes. While generally safe for most healthy people, probiotics can pose risks, especially for those with compromised immune systems or serious illness. There is also a risk of contamination during manufacturing. Always talk to a doctor before starting a new supplement.