The U.S. Food and Drug Administration (FDA) is the government agency responsible for protecting public health by regulating human drugs and biologics, animal drugs, medical devices, tobacco products, food (including animal food), cosmetics, and electronic products that emit radiation. What may surprise you is that many of these products do not undergo an FDA approval process before they become available to consumers. Some products are put through the approval process after they are already for sale. But many of these common items are not nor will they ever be “FDA approved”.
The FDA does not approve companies. Health care facilities, laboratories, and manufacturers are regulated by the FDA and the FDA has been given regulatory authority by Congress to act and investigate companies when safety issues arise. Companies are required to comply with good manufacturing practices, but not required to undergo FDA approval.
While the FDA approves new drugs and biologics, they do not approve compound use of these drugs. Doctors often prescribe multiple medications to their patients to treat one or many ailments. The combination of these medicines is not approved by the FDA and never evaluated for safety, effectiveness, or quality.
Cosmetics are not FDA approved. Perfume, makeup, moisturizers, shampoos and conditioners, face wash, and shaving products do not require FDA approval before they go on the market. Medical foods, infant formula, and dietary supplements are not FDA approved. Their manufacturing facilities are subject to regulation by the FDA, but the ingredients used are not required to obtain approval before the products are labeled and marketed to consumers.
Food labels and Nutrition Facts are not approved by the FDA. Food companies are expected to make labels that are truthful and not misleading and include certain information such as serving size and nutrient content of each serving. But the labels themselves are not approved by the FDA before the items are sold.
The FDA uses a risk-based, tiered approach for regulating medical devices. Class III devices pose the highest risk to patients and Class I the lowest risk. Class II and Class I devices do not require premarket approval by the FDA, meaning they can be used on patients without ever being approved. The Stockert 3T heater-cooler system is a device commonly used during cardiothoracic surgeries to regulate a patient’s body temperature. Since 2010, an alarming amount of patients have developed mycobacterium chimaera, a dangerous infection with a 50 percent mortality rate.
Physiomesh is a surgical mesh commonly used in the treatment and repair of hernias. Physiomesh was not required to receive the approval of the FDA before being used in hernia surgery because the manufacturing company claimed it was similar to other types surgical mesh already being used. Many patients soon discovered that this claim was false and have suffered complications including major pain, hernia reoccurrence, and adhesions.
Product liability lawsuits are a way consumers can hold manufacturers accountable for their negligent actions. When the FDA does not require a manufacturer to get approval for their product, consumers run the risk of experiencing damaging side effects from product use. Filing a product liability lawsuit against a company forces manufacturers to accept responsibility for damages caused by the product and change their manufacturing process to protect future consumers.
If you or someone you love has experienced a damaging or deadly side effect after using a product, Tad Thomas, Louisville, KY product liability lawyer can help. The legal team at Thomas Law Offices is experienced in cases that hold manufacturers and businesses responsible consumer safety. Contact Thomas Law Offices today for a free, zero-obligation consultation of your case.