How to tell if a brand is FDA approved for medication, devices, and supplements

According to the FDA, fraudulent products can make unproven health claims, waste money, and pose serious risks. This makes it critically important for consumers to know how to tell if a brand is FDA approved before purchasing any medical product, including prescription medications, over-the-counter drugs, and medical devices.

Quick Summary

The process for verifying FDA approval depends on the product type, using official FDA databases like Drugs@FDA for medications or Devices@FDA for medical devices. Be aware that many supplements are not FDA-approved, and deceptive 'FDA Registered' claims are misleading.

Key Points

• Check Official FDA Databases: For medications, use Drugs@FDA and the Orange Book. For medical devices, use Devices@FDA.

• FDA Does Not Approve Supplements: Dietary supplements are not FDA-approved, so check for reputable third-party seals like USP.

• 'FDA Registered' is Not 'FDA Approved': Many companies falsely use "FDA Registered" to imply approval, particularly for medical devices, but this only means the company has registered their facility with the FDA.

• Be Skeptical of Exaggerated Claims: Be wary of products marketed with "miracle cure" claims, as these often indicate fraudulent, unapproved products.

• Understand Product Categories: The method for verifying FDA status differs for drugs, medical devices, and dietary supplements, so knowing the product type is the first step.

• Report Suspected Fraud: If you encounter a fraudulent or potentially harmful product, report it to the FDA via their MedWatch program.

Understanding the Different Levels of FDA Oversight

When it comes to the U.S. healthcare market, the term "FDA approved" is often misunderstood. The FDA regulates a wide range of products, but the type and level of regulatory oversight vary dramatically. A simple claim of being "FDA approved" is not enough. You must understand the specific product category and the corresponding regulatory process to perform a proper verification.

For example, prescription and over-the-counter (OTC) drugs undergo a rigorous pre-market review and receive a formal approval. Medical devices may be approved, cleared, or simply listed, depending on their risk level. Most dietary supplements, however, do not require FDA approval before being sold. Unscrupulous companies often use misleading claims like "FDA registered facility" to trick consumers into thinking their products are approved. This guide will walk you through the correct methods for verifying products using official, free, and publicly accessible FDA databases.

How to Verify FDA Approval for Medications

For prescription and most over-the-counter drugs, the FDA's Center for Drug Evaluation and Research (CDER) requires a New Drug Application (NDA) or an Abbreviated New Drug Application (ANDA). You can verify a drug's approval by using the following official databases.

Drugs@FDA Database

This comprehensive database is your primary resource for verifying the approval status of human drug products.

• How to use it: Visit the Drugs@FDA website.
• Search options: You can search by the drug's proprietary name (brand name), active ingredient, or the application number (NDA/ANDA).
• Reviewing results: The search results will provide information about the drug, its approval history, and the official FDA-approved label. A drug with an active NDA or ANDA number is a strong indicator of FDA approval.

The Orange Book

The "Orange Book," officially known as "Approved Drug Products with Therapeutic Equivalence Evaluations," is another critical tool, especially for generic drugs.

• How it works: The Orange Book lists most FDA-approved drug products and is searchable by proprietary name, active ingredient, and application number.
• What it indicates: Inclusion in the Orange Book means the drug has been approved for safety and effectiveness.

How to Verify FDA Status for Medical Devices

Unlike drugs, medical devices have different regulatory pathways, so it's vital to know the distinction between approval, clearance, and registration.

Devices@FDA Database

This is the official database for finding information on FDA-approved or cleared medical devices.

• How to use it: Navigate to the Devices@FDA Database website.
• Search options: Search by device name or company name.
• What to look for: Look for the Premarket Approval (PMA) status, which indicates approval for high-risk devices, or the 510(k) clearance status for lower-to-moderate risk devices.

The Crucial Difference: Supplements vs. Medications

One of the most dangerous myths is that dietary supplements are FDA approved. Under the Dietary Supplement Health and Education Act (DSHEA), the FDA does not approve dietary supplements for safety or effectiveness before they are marketed. The manufacturer is responsible for ensuring the product is safe and accurately labeled.

How to Vet Dietary Supplements

Since there is no FDA approval to check, you must rely on other indicators of quality.

• Look for Third-Party Seals: Non-profit organizations like U.S. Pharmacopeial (USP) and NSF International offer voluntary testing and verification programs. A USP-verified mark means the product contains the listed ingredients at the labeled strength and is free from harmful contaminants.
• Be Cautious of Claims: Be wary of supplement companies making claims about treating or curing diseases, as these are unapproved drug claims and illegal.
• Report Concerns: If you experience an adverse reaction or suspect a fraudulent product, you can report it to the FDA's MedWatch program.

Comparison of FDA Regulatory Pathways

To summarize the different ways the FDA oversees various products, here is a comparison table.

Feature	Prescription Drugs	Medical Devices	Dietary Supplements
Pre-Market Review	Rigorous FDA approval required (NDA, ANDA)	Approval (PMA) or Clearance (510(k)) required, based on risk	No FDA approval required
Manufacturer Responsibility	Must prove safety and effectiveness to FDA	Must prove safety and effectiveness (PMA) or substantial equivalence (510(k))	Responsible for product safety and label accuracy
Database for Verification	Drugs@FDA, Orange Book	Devices@FDA	No FDA database for approval. Check for third-party seals.
Misleading Claim Example	Fake "FDA certified" letter	"FDA registered" not equal to "FDA approved"	"FDA approved facility" or miracle cures

The Dangers of Online Pharmacies and Fraud

Buying medication from unsafe online pharmacies is dangerous and potentially deadly. The FDA issues warning letters and maintains lists of websites engaged in illegal activity. Always ensure you are purchasing from a legitimate and verified source.

To protect yourself, remember to:

• Verify the product using the official FDA databases mentioned above.
• Be skeptical of claims that seem too good to be true, especially for supplements claiming to cure diseases.
• Look for third-party certifications for supplements, such as the USP Verified Mark.
• Use the FDA's website for official information and report suspicious activity through the MedWatch program.

Conclusion: Your Role in Ensuring Safety

Empowering yourself with the knowledge of how to properly verify FDA status is your best defense against medical product fraud. Relying solely on a brand's claims is risky. By using the official FDA databases for medications and medical devices and being vigilant about dietary supplement claims, you can make informed and safe decisions. The FDA's rigorous approval process exists to protect you, but you must take the initiative to use the resources they provide to ensure the products you consume are genuinely safe and effective.

For more detailed information on drug approvals and related resources, visit the official FDA drug approvals and databases page.

Frequently Asked Questions

Does the FDA approve all medical products before they are sold?

No, the FDA's level of oversight depends on the product type. While prescription drugs require rigorous pre-market approval, dietary supplements and certain low-risk medical devices do not require the same level of review.

What is the difference between FDA Approved, FDA Cleared, and FDA Registered?

FDA Approved is the highest standard, confirming a product's safety and effectiveness (e.g., high-risk drugs and devices). FDA Cleared (510(k)) means a device is substantially equivalent to a previously cleared product. FDA Registered simply means the manufacturing facility has registered with the FDA, and it does not imply product approval.

How can I verify if a prescription drug is FDA approved?

To verify a prescription drug, use the official Drugs@FDA database on the FDA website and search by the drug's brand name, active ingredient, or application number (NDA/ANDA).

Is there an official list of all FDA-approved products?

Yes, there are multiple official FDA databases. For drugs, you can use Drugs@FDA or the Orange Book. For medical devices, use the Devices@FDA database.

Do I need to worry about the FDA approval of dietary supplements?

You should be aware that the FDA does not approve dietary supplements for safety or effectiveness. The responsibility falls on the manufacturer. Look for independent third-party seals like the USP Verified Mark for quality assurance.

What should I do if a product label says "FDA Registered"?

Do not assume the product is FDA approved. "FDA Registered" only indicates the facility has registered with the agency, a standard requirement for some products. Always verify the product's actual status through the appropriate FDA database.

How can I report a potentially fraudulent product or false claim to the FDA?

You can report misleading or fraudulent products to the FDA through its online MedWatch program. This allows you to report adverse events or concerns about a product.