In the United States, consumers often assume that every product on the market—especially food, medications, supplements, and medical devices—has been rigorously tested and approved by the U.S. Food and Drug Administration (FDA). This assumption, while understandable, isn’t always accurate. The FDA does not approve everything you can legally buy. In fact, many products are sold daily without FDA approval. But how is that possible? And more importantly, is it safe?
This article delves into the complexity of FDA regulations, clarifies misconceptions about product approval, and answers the critical question: Can a product be sold if not FDA approved? Whether you’re a consumer concerned about safety, an entrepreneur launching a new product, or simply curious about regulatory oversight, this guide will equip you with a thorough understanding of what FDA approval means, where it applies, and under what circumstances unapproved products can still reach the market.
Understanding FDA Approval: What Does It Mean?
The FDA is a federal agency responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, the nation’s food supply, cosmetics, and products that emit radiation. However, FDA approval is not a universal requirement and varies significantly by product category.
Products That Typically Require FDA Approval
- Prescription and over-the-counter (OTC) drugs: These must undergo rigorous clinical testing and be approved by the FDA before hitting the market.
- Biological products (e.g., vaccines, blood products, gene therapies): Subject to a Biologics License Application (BLA) process.
- Baby formula: Must meet specific nutrient requirements and undergo a pre-market notification process.
- New food additives: Require pre-approval if they are not generally recognized as safe (GRAS).
- Most medical devices (especially Class II and III devices like pacemakers or surgical implants): Require premarket approval (PMA) or clearance through the 510(k) pathway.
For these products, FDA approval is not just recommended—it’s mandatory. Selling them without approval can lead to severe legal consequences, including recalls, fines, and criminal charges.
Products That Don’t Require FDA Approval
However, several product categories enter the marketplace without formal FDA approval, either due to exemptions, grandfathered status, or alternative regulatory frameworks.
Dietary Supplements
One of the most misunderstood areas involves dietary supplements. Under the Dietary Supplement Health and Education Act (DSHEA) of 1994, supplement manufacturers do not need FDA approval before selling their products. Instead, companies are responsible for ensuring their products are safe and properly labeled.
The FDA only intervenes if a product is found to be adulterated, misbranded, or poses a significant health risk. For instance, if a supplement contains undeclared pharmaceutical ingredients or causes a serious adverse event, the FDA may issue a warning or force a recall.
Conventional Foods
Most foods, including packaged snacks, beverages, and frozen meals, do not go through an FDA approval process. The agency does not certify foods before sale, but it does regulate food safety through inspections, labeling requirements, and enforcement actions.
Exceptions include novel ingredients, such as artificial sweeteners or bioengineered substances, which may require premarket review. But in general, food producers can introduce new products without waiting for FDA clearance.
Cosmetics
Cosmetic products like lotions, makeup, perfumes, and shampoos do not require premarket FDA approval—except for color additives. Manufacturers are legally responsible for ensuring the safety of their cosmetic formulations. However, the FDA can take action against products that are unsafe or falsely advertised.
Devices Exempt from Approval
Certain low-risk medical devices (Class I) are exempt from premarket approval. Examples include elastic bandages, tongue depressors, and manual stethoscopes. These devices are subject to general controls (labeling, registration, good manufacturing practices) but don’t require individual FDA review.
Legal Pathways to Sell Unapproved Products
Just because a product isn’t FDA-approved doesn’t mean its sale is automatically illegal. Several regulatory mechanisms allow products to legally enter the U.S. market without formal approval.
Generic Drugs and ANDAs
Generic drugs are a prime example. While not “approved” under a new New Drug Application (NDA), they are allowed to be sold if they demonstrate bioequivalence to an FDA-approved brand-name drug through an Abbreviated New Drug Application (ANDA). This is FDA authorization—just not a full approval process.
This streamlined pathway helps keep medication costs lower while still maintaining safety and effectiveness standards.
Enforcement Discretion and the “Gray Market”
The FDA sometimes uses “enforcement discretion,” meaning it chooses not to take action against certain unapproved products under specific circumstances. This often applies to compounded pharmaceuticals, which are customized medications prepared by pharmacists for individual patients.
While mass-produced equivalents require approval, compounded drugs—especially for niche or allergy-sensitive patients—can be legally dispensed under certain conditions without formal FDA approval. However, this comes with strict limitations to prevent abuse.
Grandfather Clause Exceptions
Some products currently on the market were never formally approved because they were already available before current FDA laws were enacted. These are considered “grandfathered” and may continue to be sold under specific conditions.
For example, certain OTC medications introduced before 1938 (under the Federal Food, Drug, and Cosmetic Act) or before subsequent regulatory updates are permitted to remain on shelves as long as they comply with modern labeling and safety standards.
Medical Foods and Special Dietary Uses
Medical foods are formulated for patients with specific diseases or conditions under medical supervision. Although they are regulated by the FDA, they don’t go through the same approval process as drugs. Instead, they fall under a special category and must meet nutritional requirements for the target population.
Examples include formulas for people with phenylketonuria (PKU) or malabsorption disorders. These products can be sold without FDA approval but are not available over the counter like regular supplements.
Risks and Consumer Implications of Unapproved Products
Selling non-FDA-approved products isn’t inherently dangerous—many are safe and effective. However, the absence of premarket review increases risks, especially when companies cut corners or make unsupported health claims.
Misleading Claims and False Advertising
A major consumer concern involves products marketed with unverified health claims. For example, a dietary supplement may claim to cure cancer, boost immunity, or promote rapid weight loss without clinical proof. While the company may not require FDA approval, such claims can still trigger enforcement actions.
The FDA and Federal Trade Commission (FTC) monitor advertising closely and have taken action against companies making false or misleading statements.
Case Study: Weight Loss Supplements
In 2022, the FDA issued warnings against several weight-loss supplements found to contain undeclared ingredients like sibutramine (a banned drug linked to heart problems). These products were never approved, yet were sold openly online and in stores—putting consumers at risk.
Contamination and Quality Control Issues
Without premarket approval, some manufacturers may lack rigorous quality control. Contaminants such as heavy metals, bacteria, or pharmaceutical agents can slip into products—especially in supplements manufactured in poorly regulated facilities.
Third-party testing organizations (like USP or NSF) offer certification programs to help consumers identify higher-quality products, but these are voluntary and not mandatory.
Delayed or Limited FDA Oversight
Because the FDA often acts only after a problem arises, some harmful products remain on the market until enough complaints are reported. The post-market surveillance system relies heavily on consumer and healthcare professional reports, meaning risks can go unnoticed for extended periods.
Products That Cannot Be Sold Without FDA Approval
Despite the exceptions, some products absolutely require FDA approval—and selling them without it is illegal.
New Prescription Drugs
No new prescription drug can be legally marketed without an approved New Drug Application (NDA). This process includes preclinical testing, clinical trials (Phases I–III), and a comprehensive review by the FDA to ensure safety and efficacy.
Selling unapproved prescription drugs—as seen in cases involving online pharmacies marketing unauthorized cancer or opioid treatments—can lead to criminal penalties and public health crises.
High-Risk Medical Devices
Class III medical devices, which support or sustain human life or prevent impairment, require Premarket Approval (PMA). Examples include implantable defibrillators, heart valves, and certain surgical lasers. Selling such devices without PMA is a serious federal violation.
Biologics and Vaccines
All biologics used in the U.S., including vaccines, insulin, and monoclonal antibodies, require a Biologics License. The FDA carefully evaluates manufacturing processes, purity, potency, and sterility. Unauthorized biologics pose significant risks, including infection or immune reactions.
Global Perspectives and Imported Unapproved Products
The question becomes even more complex when considering imported goods. Products legal in other countries may not meet U.S. standards or may not be approved by the FDA.
Importing Prescription Drugs
It is generally illegal to import unapproved prescription drugs into the U.S., even if they are approved in other countries. However, the FDA exercises enforcement discretion in limited cases, such as when:
- The product is for personal use
- The quantity is for fewer than 90 days’ supply
- The drug is not for resale
- The drug represents a significant unmet medical need
Despite these allowances, large-scale importation of unapproved drugs (e.g., Canadian insulin or European Alzheimer’s treatments) remains prohibited.
Dietary Supplements from Abroad
Supplements imported from outside the U.S. are subject to the same DSHEA rules. However, enforcement can be challenging, and counterfeit or tainted products occasionally enter the market through online retailers. The FDA monitors imports at ports of entry and may detain or refuse shipments found to be unsafe.
What Businesses Need to Know
If you’re considering selling a product in the U.S., understanding FDA requirements is essential to avoid legal pitfalls.
Know Your Product Category
Classifying your product correctly determines whether FDA approval is needed. Is it a drug? A supplement? A cosmetic? Each category has distinct rules.
For example:
– If you market a pill to treat high blood pressure, it’s a drug and requires approval.
– If you sell the same pill as a “natural wellness booster,” it may be considered a supplement—but making disease treatment claims could reclassify it as an unapproved drug.
Labeling and Marketing Compliance
Even for unapproved products, labeling must be truthful and not misleading. Claims like “clinically proven” or “fights diabetes” require evidence and may attract FDA scrutiny. Structure/function claims (e.g., “supports healthy joints”) are allowed for supplements, but disease claims are not.
Adverse Event Reporting
Manufacturers of dietary supplements and medical devices are required to report serious adverse events to the FDA. Failure to do so—even for unapproved products—can result in penalties.
Good Manufacturing Practices (GMPs)
While not requiring premarket approval, supplement and food manufacturers must follow Current Good Manufacturing Practice (CGMP) regulations. These ensure products are consistently produced and controlled according to quality standards.
What Consumers Should Do
Consumers play a vital role in navigating the landscape of FDA-approved versus unapproved products.
Read Labels Critically
Look for:
- Supplement Facts panels
- Manufacturer contact information
- Avoidance of miracle cure claims
- Third-party certification seals (e.g., USP, NSF)
No label should claim a supplement can treat, cure, or prevent disease unless it’s an FDA-approved drug.
Research Before You Buy
Use reliable sources like the NIH Office of Dietary Supplements, FDA warning letters database, or consumer review platforms that verify product authenticity.
Be especially cautious with products marketed via social media influencers, pop-up websites, or unverified online marketplaces.
Report Suspicious Products
If you believe a product is unsafe or falsely advertised, report it to the FDA through the Safety Reporting Portal or by calling 1-888-INFO-FDA. Your report could prevent harm to others.
Emerging Challenges and Future Outlook
The current regulatory framework faces new challenges in the digital age. E-commerce, influencer marketing, and direct-to-consumer supplement startups have made it easier than ever to sell unapproved products globally.
FDA Modernization Efforts
In recent years, the FDA has increased its focus on dietary supplement oversight. In 2023, the agency proposed new rules to strengthen the dietary ingredient notification process, enhance inspection capabilities, and improve transparency about product safety.
Legislative proposals like the DSHEA Modernization Act aim to close loopholes that allow potentially harmful supplements to stay on the market unchallenged.
Increased Use of Artificial Intelligence
The FDA is now leveraging AI and data analytics to monitor websites, social media, and adverse event reports in real time. This helps identify risky products faster and target enforcement actions more effectively.
CBD and Hemp-Derived Products
The legal status of cannabidiol (CBD) exemplifies the challenges of evolving regulations. While the FDA approved one CBD-based drug (Epidiolex) for seizures, it has not approved CBD for general use in foods, supplements, or cosmetics. Yet thousands of CBD products are sold without approval—leading to regulatory uncertainty.
Conclusion: Yes, But with Important Caveats
To answer the original question directly: Yes, a product can be sold in the United States without FDA approval—but only under specific conditions and within defined regulatory boundaries. The absence of approval does not always equate to illegality or danger, but it does mean reduced oversight and increased consumer responsibility.
Understanding the difference between FDA-approved drugs, regulated-but-not-approved supplements, and fully exempt categories like cosmetics is crucial. Both businesses and consumers must be vigilant—manufacturers to comply with labeling and safety standards, and buyers to critically assess claims and product quality.
The FDA’s role is not to approve every item sold, but to ensure that the regulatory system protects public health while allowing innovation and access. As the marketplace evolves, so too must consumer awareness and regulatory enforcement.
Ultimately, while non-approved products are legally permitted in many cases, their availability underscores the importance of informed decision-making. The more you know about FDA regulations, the safer and smarter your choices—whether you’re buying a bottle of vitamins or launching the next health innovation—will be.
Can a product be legally sold in the United States without FDA approval?
Yes, certain products can be legally sold in the United States without FDA approval, depending on the product category and its intended use. The FDA’s regulatory authority primarily covers food, drugs, medical devices, biologics, cosmetics, and tobacco products. However, not all items under these categories require premarket approval. For example, dietary supplements do not need FDA approval before they hit the market, though manufacturers are responsible for ensuring their safety and truthful labeling. Similarly, cosmetics (except for color additives) are not subject to premarket approval, placing the burden on companies to self-regulate safety and compliance.
Other products, such as software classified as low-risk medical devices or general wellness products, may fall under FDA enforcement discretion, meaning the agency chooses not to regulate them strictly. Additionally, products sold under specific exemptions—such as those used in clinical investigations or under the “compassionate use” provision—can be distributed without formal approval. However, selling products that clearly fall under regulated categories—like prescription drugs or high-risk medical devices—without approval is illegal and can result in enforcement actions, including seizures, injunctions, or criminal charges.
What are common legal loopholes allowing unapproved products to be sold?
One common legal loophole is the “grandfather clause,” which allows products on the market before certain regulatory requirements were enacted to continue being sold without new approval. For instance, some drugs introduced before 1938 were allowed to remain available if they had been marketed continuously and safely. Another loophole involves the use of “cosmetic” claims instead of “drug” claims. A product labeled and marketed only for beautification (e.g., “reduces the appearance of wrinkles”) may avoid FDA drug regulations, even if it contains bioactive ingredients.
The compounding pharmacy exemption also permits certain custom-prepared medications made by licensed pharmacists for individual patients without standard FDA approval, provided they follow state and federal guidelines and do not mass-produce drugs. Additionally, the FDA sometimes exercises enforcement discretion for low-risk products, allowing them to remain on the market while prioritizing more dangerous items. These pathways, while legal, can be exploited if not strictly adhered to, leading to regulatory scrutiny or changes in policy to close perceived gaps.
Are dietary supplements required to be FDA approved before sale?
No, dietary supplements do not require FDA approval before they are sold to consumers. Under the Dietary Supplement Health and Education Act (DSHEA) of 1994, manufacturers and distributors are responsible for ensuring that their products are safe and properly labeled. The FDA does not evaluate the efficacy or safety of dietary supplements premarket, but it does monitor products after they are on the market. If a supplement is found to be unsafe or falsely advertised, the FDA can take action to remove it from shelves.
Manufacturers must notify the FDA if a supplement contains a new dietary ingredient, providing evidence that it is reasonably expected to be safe. Additionally, they must follow Good Manufacturing Practices (GMPs) to ensure quality and consistency. While structure/function claims (e.g., “supports joint health”) are allowed with a disclaimer, disease claims (e.g., “treats arthritis”) would classify the product as an unapproved drug. This regulatory framework allows dietary supplements to enter the market quickly but shifts the burden of safety and compliance onto the industry, with oversight occurring after potential risks emerge.
What risk do consumers face when buying non-FDA-approved products?
Consumers may face significant health risks when purchasing non-FDA-approved products, particularly those marketed with unsubstantiated medical claims. Without FDA evaluation, there is no guarantee that the product is safe, effective, or manufactured under sterile conditions. Contamination, incorrect labeling, or undisclosed ingredients—such as hidden pharmaceuticals in supplements—can lead to adverse reactions, interactions with medications, or delayed diagnosis and treatment of serious conditions.
In addition to safety concerns, consumers may waste money on products that do not deliver promised benefits. Misleading marketing can exploit vulnerable populations, such as those with chronic illnesses seeking alternative treatments. In extreme cases, unapproved drugs or devices have caused organ damage, hospitalization, or death. Therefore, individuals should carefully evaluate product claims, research ingredients, and consult healthcare providers before using any non-approved items, especially those advertised as alternatives to conventional medicine.
How does the FDA enforce regulations on unapproved products?
The FDA enforces regulations through inspections, product sampling, consumer complaints, and monitoring of advertising and labeling. When the agency identifies a product being sold illegally—such as an unapproved drug claiming to treat cancer—it can issue warning letters, request voluntary recalls, or take legal action. The FDA also works with U.S. Customs and Border Protection to intercept unapproved products entering the country, particularly from international online sellers.
In serious cases, the FDA can pursue seizures, injunctions, or criminal prosecution against companies or individuals. The agency prioritizes enforcement based on risk, focusing first on products that pose immediate dangers to public health. While the FDA cannot monitor every product on the market, it uses public notifications and safety alerts to inform consumers about potentially harmful unapproved items. This reactive enforcement model depends heavily on reports from the public, healthcare providers, and industry stakeholders to uncover violations.
Can a medical device be sold without FDA approval?
Yes, certain medical devices can be sold without full FDA approval through regulatory pathways like the 510(k) clearance, de minimis exemptions, or FDA enforcement discretion. Class I devices (e.g., tongue depressors or elastic bandages), which pose the lowest risk, are often exempt from premarket notification requirements. Some Class II devices can be marketed after demonstrating substantial equivalence to a legally marketed predicate device, a process known as 510(k) clearance, which is not the same as FDA approval.
However, high-risk devices (Class III), such as implantable pacemakers or prosthetic heart valves, generally require Premarket Approval (PMA), which involves rigorous scientific review. Devices that fail to meet regulatory requirements or are marketed with unapproved claims can be subject to FDA enforcement. Additionally, software as a medical device (SaMD) may have different pathways depending on its function, with some wellness apps allowed without formal oversight. Understanding device classification and regulatory expectations is crucial for legal marketing.
What steps can companies take to legally market a product before obtaining FDA approval?
Companies can legally market certain products before full FDA approval by carefully navigating regulatory pathways and complying with applicable exemptions. For example, drugs may be distributed under an Investigational New Drug (IND) application for clinical trials, allowing testing in humans without commercial approval. Medical devices can enter the market via the 510(k) process or be used under a Investigational Device Exemption (IDE) for research purposes. In emergencies, the FDA may issue Emergency Use Authorizations (EUAs) to allow unapproved products to address public health crises.
Additionally, companies can market products under cosmetic or dietary supplement regulations if they avoid making drug claims. Firms must ensure accurate labeling, refrain from false advertising, and follow Current Good Manufacturing Practices (cGMPs). Engaging with the FDA early through pre-submission meetings can clarify regulatory expectations and streamline the approval process. While these strategies allow for provisional market access, ongoing compliance is essential, as any misstep can trigger enforcement actions, reputational damage, or product recalls.