Is Beta Glucan FDA Approved for Dietary Use?

December 6, 2025 •

3 min read

Beta glucan, a soluble fiber found in sources like oats and barley, has been linked to numerous health benefits, with some studies showing it can reduce cholesterol levels by up to 15%. While many consumers are familiar with its health properties, there is often confusion regarding its official approval status from the U.S. Food and Drug Administration (FDA). Understanding the specific regulatory pathways is crucial for consumers looking to make informed choices about functional foods and dietary supplements.

Quick Summary

Beta glucan is not approved by the FDA as a drug, but the agency has authorized a specific health claim for it concerning heart disease risk reduction. This is based on its status as a food component and Generally Recognized as Safe (GRAS). Supplements themselves do not undergo FDA approval before marketing.

Key Points

No Drug Approval: Beta glucan is not approved as a drug by the FDA, as this process is reserved for pharmaceuticals requiring extensive clinical trials.
Authorized Health Claim: The FDA has authorized a health claim for beta glucan, allowing food products containing specific amounts from sources like oats and barley to state they can reduce heart disease risk.
GRAS Status: Many beta glucan sources have Generally Recognized as Safe (GRAS) status, meaning experts agree on their safety for use as food ingredients.
Post-Market Regulation: The FDA regulates dietary supplements and food ingredients, including beta glucan, primarily after they enter the market, enforcing safety and labeling standards.
Important Distinction: There is a significant regulatory difference between an FDA-authorized health claim for a food ingredient and full FDA approval for a drug.
Manufacturer's Responsibility: It is the manufacturer's responsibility to ensure that their beta glucan products are safe and that all health-related claims are truthful and substantiated.
Qualified Claims: Any claims made about beta glucan's health effects must be carefully worded and supported by scientific evidence, as the FDA does not permit claims to treat or cure diseases.

What is the distinction between FDA approval and a health claim?

It is critical to distinguish between the FDA's approval of a drug and its authorization of a health claim for a food ingredient. The FDA approves new pharmaceutical drugs after rigorous testing for safety and efficacy. Dietary supplements and food ingredients are not approved in the same way before being sold; they are regulated post-market.

A health claim, like the one for beta glucan, is a statement allowed on food labels that describes a relationship between a food substance and reduced risk of a disease. The FDA authorizes these claims based on scientific evidence, but it is not drug approval. Manufacturers are responsible for the truthfulness of these claims.

The FDA's health claim for beta glucan and heart disease

The FDA authorized a heart-healthy claim for oat beta-glucan in 1997, later including barley in 2005. This allows foods with a specific amount of beta-glucan to claim they help reduce coronary heart disease risk as part of a healthy diet. To use this claim, a food must contain at least 0.75 grams of beta-glucan soluble fiber per serving from qualifying sources like whole oats or barley. The FDA has determined that a daily intake of 3 grams can help lower cholesterol.

Beta glucan's regulatory status as Generally Recognized as Safe (GRAS)

Many beta glucan sources have Generally Recognized as Safe (GRAS) status, an exception to pre-market approval for food additives. GRAS status can be achieved through scientific procedures or common use before 1958.

Self-Affirmed GRAS: An independent panel deems an ingredient safe.
FDA-Notified GRAS: A company submits its GRAS data to the FDA, which may issue a 'no questions' letter.

Sources like oats, barley, and yeast beta glucan have achieved GRAS status, confirming their safety as ingredients but not drug-like efficacy.

Comparing FDA regulation of drugs vs. supplements and food ingredients


Feature	FDA-Approved Drug	FDA-Regulated Supplement/Food Ingredient
Approval Process	Mandatory pre-market approval with extensive trials.	No pre-market 'approval'; manufacturer ensures safety and labeling.
Burden of Proof	Manufacturer must prove effectiveness and safety before market.	Manufacturer must have evidence for claims, but doesn't need prior FDA submission unless it's a 'new dietary ingredient'.
Regulatory Approach	Pre-market control.	Post-market oversight for unsafe or misbranded products.
Health Claims	Tied to approved medical use.	Authorized for food substances; cannot claim to treat, diagnose, or cure.

The future of beta glucan and FDA oversight

As research into beta glucan's benefits grows, new regulatory questions may arise. The current health claim is heart-focused; new claims would need additional evidence and review. The form and source of beta glucan also matter. Manufacturers must continue to ensure safety and compliance through GRAS or other means as they develop new products. Consumers can look for products with GRAS status and FDA-authorized health claims for assurance of safety and accurate labeling.

Conclusion

Beta glucan is not 'FDA approved' as a drug but is regulated as a food ingredient or supplement. The FDA has authorized a health claim for beta glucan from certain oats and barley, linking it to cholesterol reduction and reduced heart disease risk. Many forms also have GRAS status, confirming their safety. This framework requires manufacturers to substantiate claims and ensures product safety without drug-like pre-market approval.

Note: This article is for informational purposes only and is not medical advice. Consult with a healthcare professional before starting any new dietary supplement regimen.

Frequently Asked Questions

The FDA has authorized a health claim linking beta glucan from certain whole oats and barley sources to a reduced risk of coronary heart disease. This is based on its ability to help lower blood cholesterol levels.

No, dietary supplements do not require FDA approval before they are marketed. The manufacturer is responsible for ensuring their products are safe and accurately labeled, and the FDA regulates them post-market.

GRAS (Generally Recognized as Safe) status means that qualified experts agree an ingredient is safe for its intended use in food. It is not an 'approval' by the FDA, but it exempts the ingredient from the more stringent food additive approval process.

No. The FDA requires that dietary supplements, including those containing beta glucan, do not claim to treat, cure, or prevent any disease. Such claims are considered misleading and would lead to FDA enforcement.

To qualify for the FDA's heart health claim, a food product must contain at least 0.75 grams of beta glucan soluble fiber from eligible whole oat or barley sources per customary serving. The daily intake associated with cholesterol-lowering effects is about 3 grams.

This distinction is important because it clarifies the level of government oversight. An FDA-approved drug has undergone extensive testing for effectiveness, while a food with a health claim is based on a scientific relationship, and the product itself has not been pre-approved.

No, the authorized health claim applies specifically to beta glucan soluble fiber from certain whole oat and barley sources. Other forms, such as those derived from yeast or fungi, are not covered by this particular claim.

The FDA recognizes beta glucan from whole oats, oat bran, whole oat flour, oatrim, whole grain barley, and dry milled barley products as eligible sources for the heart health claim.