Who determines the safety of dietary supplements? A Guide to Regulation

December 25, 2025 •

4 min read

Despite the fact that over half of all Americans take dietary supplements, the approval process is very different from that of prescription drugs. This often-misunderstood framework begs the question: who determines the safety of dietary supplements, and what role do consumers, manufacturers, and regulators play in the process?

Quick Summary

The responsibility for dietary supplement safety falls primarily on the manufacturer, with the FDA providing regulatory oversight after products are on the market. Consumers must also take an active role by verifying claims and seeking third-party certification.

Key Points

Manufacturer's Primary Responsibility: The manufacturer is legally required to ensure their dietary supplement is safe and properly labeled before selling it.
FDA's Post-Market Role: The FDA does not approve dietary supplements for safety before they hit the market but enforces regulations on manufacturers post-market.
Good Manufacturing Practices (cGMPs): The FDA sets standards for how supplements are manufactured, but does not test every product.
Importance of Third-Party Verification: Independent organizations like USP or NSF offer voluntary certification to verify a product's content and quality, which consumers can look for.
Consumer Due Diligence: Consumers must play an active role by researching products, checking for third-party seals, and consulting healthcare professionals.
Limited FDA Resources: Due to the vast number of supplements, the FDA has limited resources and prioritizes enforcement based on reported adverse events and other violations.

The Core Regulatory Framework: DSHEA

To understand who determines the safety of dietary supplements, one must first grasp the foundational legislation: the Dietary Supplement Health and Education Act (DSHEA) of 1994. Under DSHEA, dietary supplements are classified as a category of food, not drugs. This distinction is critical because it fundamentally alters the regulatory burden. Unlike new drugs, which must undergo rigorous pre-market testing for safety and effectiveness and receive FDA approval, supplements do not require FDA approval before they are sold to the public.

The Manufacturer's Primary Role

The manufacturer and distributor of a dietary supplement have the primary legal responsibility for ensuring their product is safe and its labeling is truthful and not misleading. This pre-market responsibility means companies must possess evidence that their products meet safety standards. If a product contains a "new dietary ingredient"—one not sold in the U.S. before October 15, 1994—the manufacturer must notify the FDA at least 75 days before marketing and provide safety data. However, the vast majority of supplements are not required to provide this pre-market notification.

The FDA's Post-Market Authority

While the FDA does not approve supplements, it does have significant authority once products are on the market. The agency’s role is primarily to monitor and enforce regulations, not to perform pre-emptive testing.

FDA Enforcement Powers Include:

Good Manufacturing Practices (cGMPs): The FDA mandates that supplement manufacturers follow specific cGMPs to ensure products are consistently produced and controlled according to quality standards. This helps prevent contamination and ensures ingredients are properly identified and measured.
Adverse Event Reporting: Companies are required to report serious adverse events related to their products to the FDA. The FDA also collects reports from consumers and healthcare professionals, using this data to identify safety signals.
Label and Claim Monitoring: The FDA reviews supplement labels and other marketing materials, including websites, to ensure they comply with labeling rules and do not make illegal disease-cure claims. The Federal Trade Commission (FTC) also regulates advertising for supplements.
Product Removal: If a product is found to be unsafe, adulterated, or misbranded, the FDA can take action to remove it from the market or compel a voluntary recall. However, the FDA must bear the burden of proving the product is unsafe after it has already entered commerce.

The Rise of Third-Party Certifiers

Given the limitations of FDA pre-market review, independent third-party certification is a crucial tool for consumer confidence. Organizations like U.S. Pharmacopeia (USP), NSF International, and ConsumerLab offer voluntary programs that test products for quality.

Third-party seals typically indicate that a product:

Contains the ingredients listed on the label in the declared potency.
Does not contain harmful levels of specified contaminants, such as heavy metals or pesticides.
Has been made using cGMP-compliant processes.

The Comparison: Supplements vs. Drugs

It is vital for consumers to understand the difference in the regulatory pathways for dietary supplements and prescription drugs. This comparison table highlights the core distinctions:


Feature	Dietary Supplements	Prescription Drugs
Pre-Market Approval	Not required (except for new ingredients)	Required, based on extensive clinical trials
Safety & Effectiveness	Manufacturer's responsibility to ensure safety; not required to prove effectiveness	Manufacturer must prove safety and effectiveness to the FDA
Labeling Claims	Can make structure/function claims (e.g., 'supports joint health') with a disclaimer	Can make disease-cure claims, backed by clinical evidence
FDA Oversight	Primarily post-market enforcement	Pre-market approval and ongoing post-market surveillance
Adverse Event Reporting	Mandatory reporting by manufacturers	Mandatory reporting by manufacturers and ongoing monitoring

Your Role as an Informed Consumer

Ultimately, consumers hold a significant part of the responsibility for their own safety when choosing dietary supplements. It is not wise to assume that a product is safe simply because it is available for purchase. Informed decisions are crucial. To be an informed consumer, you should:

Consult a Healthcare Professional: Always discuss any supplements you are considering with your doctor, pharmacist, or a registered dietitian. They can help assess your need and potential interactions with other medications.
Look for Third-Party Certification: Seek seals of quality assurance from reputable third-party organizations like USP or NSF. These seals provide a level of confidence in product quality, though they do not guarantee safety or effectiveness.
Report Adverse Events: If you suspect a supplement has caused a health problem, report it to both your healthcare provider and the FDA. This helps the FDA identify and investigate problematic products.
Read the Entire Label: Scrutinize the Supplement Facts panel and the ingredients list. Be wary of exaggerated claims and unfamiliar ingredients.
Be Skeptical of “Miracle” Claims: If a product promises unrealistic or miraculous results, it is likely too good to be true. Remember, supplements cannot legally claim to cure or treat diseases.

Conclusion: A Shared Responsibility

Who determines the safety of dietary supplements? The answer is not a single entity but a shared responsibility. The primary onus rests with the manufacturer to ensure their product is safe and their claims are truthful. The FDA provides critical post-market enforcement, ensuring cGMPs are followed and taking action against unsafe products. However, the system is not without limitations. This makes the consumer's role more important than ever. By being informed, seeking third-party verified products, and consulting healthcare professionals, consumers can navigate the supplement market with greater confidence and reduce their risk.

For more detailed information, consumers can visit the official FDA page on Dietary Supplements here.

Frequently Asked Questions

Yes, dietary supplements are regulated by the FDA, but under a different framework than prescription drugs. They are treated as a category of food, meaning the FDA's role is primarily post-market regulation and enforcement, not pre-market approval.

Under DSHEA, the manufacturer has the primary responsibility for ensuring their product is safe and that its label claims are truthful and not misleading. They are also required to follow Good Manufacturing Practices (cGMPs).

Since the FDA doesn't pre-approve supplements, look for seals from independent third-party organizations like U.S. Pharmacopeia (USP) or NSF International. These seals verify that the product contains the ingredients listed and is free from harmful contaminants.

No, manufacturers are not required to prove their products' effectiveness to the FDA. They only need to ensure their label claims are truthful and substantiated by scientific evidence, and they cannot claim to cure or treat a disease.

If a supplement is found to be unsafe, the FDA can take action to have it removed from the market. Manufacturers are also required to report serious adverse events to the FDA, and consumers can report issues directly to the agency.

Manufacturers are required to use this disclaimer when making 'structure/function claims' (e.g., 'supports heart health'). It clarifies that the claim has not been reviewed by the FDA and the product is not intended to treat, cure, or prevent any disease.

If a supplement contains a 'new dietary ingredient' (one not marketed before 1994), the manufacturer must provide the FDA with evidence of safety at least 75 days before marketing. This pre-market notification is one of the few exceptions to the general rule.