4265 San Felipe # 1000
Houston, TX 77027


What Does FDA Approval Mean?

fda seal of approval drug injuries

Table of Contents

When many people hear “FDA-approved” or “FDA seal of approval,” they often think of a perfectly safe, well-tested product. Unfortunately, this is not always the case. We expect both prescription and over-the-counter products to keep us healthy and safe, but some products produce dangerous side effects due to poor labeling or unforeseen defects. Taking defective drugs or using defective medical devices causes a large number of people every year to suffer unfortunate injuries. 

At Reich & Binstock, our Houston pharmaceutical litigation attorneys work day in and day out on behalf of our clients. Whether you were hurt because of inadequate labeling, misleading information, or some other mishap, we’re here to represent you against big pharma companies. If you or someone you love suffered injuries as a result of using defective drugs or medical devices, you need the attorneys at Reich & Binstock in Houston. For your free, no-obligation consultation, please call 713-622-7271.

Does FDA Approval Mean Anything?

Yes. The Food and Drug Administration regulates a wide variety of products that we see here in the United States. These products include prescription drugs, over-the-counter drugs, biologics, dietary supplements, medical devices, surgical implants, food additives, cosmetics, tobacco products, and infant formula.

Generally, we believe that anything with an “FDA-approved” received rigorous testing. However, this is not always the case. The technical meaning behind FDA approval is that the product in question, let’s say a diet pill, has benefits which outweigh the risks. Therefore, if a product has 51% beneficial qualities and 49% potentially harmful qualities, it could still receive FDA approval.

Essentially, the FDA approval process is flawed, and until there’s a push to revamp how the Food and Drug Administration selects the products that make their way to market, we will continue to have unsafe food, drugs, and medical devices, especially drugs.

What Does FDA Approval Mean?

Let’s be clear: the labeling system is not yet perfect. Oftentimes, companies that initially gain FDA approval end up recalling their product due to a safety hazard or product defect. In many cases, these hazards or defects result in many consumers sustaining injuries. Then, the victims of these unsafe products will pursue class-action lawsuits.

This happens because “FDA-approved” does not always equal “safe.”

In fact, many people over the years have suffered permanent bodily harm or even death after using an FDA-approved product. Notably, the FDA itself does not develop the products that it evaluates.

FDA Approval Process for Testing

Additionally, it does not even conduct its own testing. Rather, the FDA reviews independent clinical testing in order to determine the safety of products.

This leaves the door open for companies to engage in less than honest or ideal practices, to say the least. Since huge conglomerates, such as pharmaceutical companies, can pay to have their products reviewed at any third party testing facility that they please. Testing facilities that are hired by these companies obviously have an incentive for the product to hit the market.

In layman’s terms: the FDA approval process for testing comes with an abundance of bias towards products that may or may not be safe.

What is the Difference Between FDA Cleared and FDA Approval?

As we stated above, “FDA approved” just means that the benefits of a product’s intended use outweigh its known risks. In order to achieve this status, manufacturers must submit a premarket approval (PMA) application, as well as the results of clinical testing to the FDA. FDA clearance, however, is a little different. Class II and Class I medical devices usually receive clearance. FDA clearance means that the manufacturer of the product demonstrated that the product is “substantially equivalent to another (similar) legally marketed device” that already obtained FDA clearance or approval. Before the clearance process begins, the manufacturer must submit a “premarket notification submission”, or 510(k) to the FDA. Products that receive either approval or clearance from the FDA may be marketed or sold in the United States.

If a Medication Doesn’t Have FDA Approval, Is It Safe?

As we demonstrated before, even those products that have the FDA seal of approval are not always safe. Therefore, products that do not have FDA approval are not always unsafe. FDA approval applies to products for their intended use. This means that, if the manufacturer intended for the product to be used for a specific purpose or for a specific age group, the FDA approves its use for those purposes. Doctors, however, can usually decide whether or not certain medications are appropriate for “off-label” use. This just means that the use for which the doctor prescribed the medication is not on the product’s label. It is a fairly common practice, and the FDA generally does not waste time or money approving one product for multiple uses. Further research generally guides a doctor’s decision to recommend a medicine for off-label use. 

However, if a product does not have FDA approval or clearance at all, we simply do not know enough about it. Using drugs that have not gained the FDA seal of approval at all have the potential to be very dangerous, as we do not know who can safely use those products. Products such as vitamins or supplements, however, do not require approval. This is because they are not actually “drugs.” Before deciding to use any product for health or wellness reasons, we recommend speaking with your trusted general practitioner.

Should Drug Manufacturers Be Strictly Liable for All of Their Medicines?

There are actually a number of different ways in which we can hold drug manufacturers accountable for defective drug injuries. Below, we outline the most common ways in which we at Reich & Binstock tackle this issue:

Strict Liability

Product liability laws in Texas involve strict liability. Basically, this means that manufacturers of any product, including drug companies, could be held liable for injuries caused by their product. This strict liability applies even if the manufacturer did not know about the defect. However, almost all drugs carry some sort of risk. Generally, a drug’s risk of dangerous side effects must be higher than its potential benefits to be considered defective.


Manufacturers of drugs also have a certain duty of care to produce safe products. If the manufacturer employed careless testing or production, they are liable for negligence. In order to prove negligence, the injured person and their legal team must show that the company knew or should have known about the potential danger.

Failure to Warn

Lastly, drug manufacturers have a duty to warn consumers about a product’s potential dangers. If they fail to provide proper warnings, their company is liable for injuries.

Did You Suffer Injuries from a Drug with the FDA Seal of Approval?

If you or a loved one suffered injuries or illness from a drug with the FDA seal of approval, contact Reich & Binstock for qualified representation. Experienced defective product attorneys provide the best chance for receiving the compensation you deserve for your injuries. We’ll stand up to drug manufacturers on your behalf, and fight for your rights. Don’t let drug companies walk all over you in an attempt to save their profits.

Contact Reich & Binstock today for an attorney who will work hard to get your life back on track. Call our Houston office at 713-622-7271, or visit our website.

Contact Us For a Free Legal Consultation

There is a never a fee unless we recover on your behalf.

*By clicking submit, you are providing express consent to be contacted by SMS, possibly using automated technology to the number you provided. If at any time you wish to opt-out of communication, please reply "STOP". Text "HELP" for help. Message frequency may vary. Message/data rates may apply. Submission of this form does not authorize the purchase of goods, services, or products. See the privacy policy/Terms and Conditions on the webpage.