What Does FDA Approved Really Mean?
Product testing is important for consumers because it helps to protect them from harmful or dangerous products that could cause injuries, illnesses, and death. Some products require a higher level of testing, such as food and health products. Examples are products that fall under the Class III category designated by the Food and Drug Administration (FDA).
Class III products are medical devices that support or sustain human life. It also includes medical devices that prevent the impairment of human health or pose an unreasonable potential for injury or illness.
FDA premarket approval (PMA) of Class III devices is required before the product can be marketed. To obtain FDA premarket approval of a Class III device, the FDA requires that the applicant provide valid scientific evidence that the device is effective and safe to use for its intended use. The FDA premarket approval helps reduce the risk of death or injury for individuals who use the medical device.
What is FDA Approved?
The FDA is responsible for regulating a wide variety of consumer products. While the FDA is best known for approving food, drugs, and medical devices, other products also require FDA approval.
What is the FDA responsible for regulating? The FDA regulates most food products, veterinary drugs, human drugs, medical devices for human use, vaccines, radiation-emitting electronic products, tobacco products, dietary supplements, and cosmetics.
However, regulating and FDA approved are two different things. The FDA may regulate some products, but they are not FDA approved.
FDA approved means that the products underwent the premarket approval process. The FDA reviewed the product for effectiveness and safety. When the FDA approves a product, it means that the agency has determined that the product’s benefits outweigh any known risks for the intended use of the product.
However, the FDA does not test products. It reviews and analyzes the data provided by the manufacturer for the product’s effectiveness and safety. Not all products regulated by the FDA require FDA premarket approval.
Items that do require FDA approval include:
Human Foods and Drugs
The FDA does not require PMA for food. However, it does have the authority to approve certain food additives. Companies must submit data and information for FDA approval before adding new food additives to human food.
Drugs do require FDA approval before they can be marketed to consumers.
Drugs are defined as articles used for treatment, cure, mitigation, diagnosis, or prevention of disease. Also included are any articles intended to impact the structure or any function of the body. The FDA also reviews drug labeling to ensure that all requirements are met, such as warnings, risks, side effects, and ingredients.
Vaccines and Biological Products
Biological products and vaccines must also receive FDA approval before being marketed. Biologics include blood products, cellular therapies, therapeutic proteins, blood, and vaccines.
In addition to reviewing the scientific data, testing, and other information to ensure that the biologics are safe and effective, the FDA also requires manufacturers to prove that they can make the product according to federal quality standards.
The FDA approves medical devices in the Class III category, as described above. However, medical devices that fall in the Class II category of moderate-risk devices generally receive FDA “clearance” instead of approval.
When the FDA clears a Class II medical device, it determines that the device is significantly like a legally marketed device that does not require premarket approval. Class I medical devices have a low risk of harm and are only subject to general controls. Class I medical devices are exempt from the premarket approval process.
Radiation-Emitting Electronic Products
A radiation-emitting electronic product may be medical or non-medical. It is any product that emits any form of radiation. Examples include MRIs, mammography devices, LEDs, laser toys, and LCDs.
The FDA regulates these products. It verifies and enforces the regulations for radiation-emitting electronic products. They verify that these products meet the standards and requirements under the Electronic Code of Federal Regulations and the Electronic Product Radiation Control provisions of the FD&C Act.
Animal Feed and Veterinary Medicines
The FDA’s Center for Veterinary Medicine is responsible for regulating animal food, animal drugs, and veterinary products.
The FDA approves animal drugs, but it does not approve animal food. However, it does approve food additives used in animal food. Animal medical devices are not required to have premarket approval, but are subject to the general provisions for the FD&C Act.
The FDA does not approve tobacco products because there are no tobacco products considered safe for human use. However, the FDA regulates these products based on a public health standard.
A manufacturer must obtain a marketing order before putting a tobacco product on the market. The marketing order merely means that the manufacturer has met the legal requirements to market the product.
What Isn’t FDA Approved?
There are several products that the FDA does not review for approval. Those items include:
The FDA does not approve health care laboratories, facilities, or manufacturers. It is responsible for inspecting the facilities to ensure compliance with regulations. Most facilities are required to register with the FDA, even though the companies do not require FDA approval.
Compounded drugs are substances created when a doctor or pharmacist combines ingredients to create a medication for a specific use. The FDA may approve the ingredients, but it does not regulate nor approve compound drugs. Therefore, compound drugs are not reviewed to determine their safety or effectiveness.
Dietary supplements do not require FDA approval. They are not reviewed for their safety or effectiveness. However, if safety issues arise after a dietary supplement is on the market, the FDA evaluates the product’s safety through adverse event monitoring and research.
Cosmetics are not approved by the FDA, such as moisturizers, perfumes, hair dyes, makeup, and body cleansers. Labels nor ingredients require FDA approval before marketing. However, color additives other than coal-tar hair dyes do require FDA approval.
Medical foods do not require FDA premarket approval. It is assumed that medical foods are used under the supervision of a physician. Medical foods do not include foods or products to manage a disease or dietary foods. It is important to note that medical foods do not require nutrition information on the labels, but claims on labels should be truthful and not misleading.
Risks of Using Unapproved Products
The risks of using unapproved products vary depending on the type of product. The FDA approval process decreases some of the risks of using certain products because the data and information about the benefits and risks of the product have been carefully evaluated.
Using products not approved by the FDA can result in:
Increased Risk of Diseases
Unapproved products may not treat the disease they claim to treat. The product could make a disease worse because of individual ingredients in the product. A person who is harmed by an unapproved product could file a personal injury lawsuit against the product’s manufacturers.
The timeline for how long a personal injury lawsuit could take to complete depends on numerous factors. Cases involving unapproved drugs could take several years to complete because of the nature of the lawsuit.
Proving that a product caused your injury requires substantial research and discovery. Experts may be hired to assist in proving the product was dangerous. Working with an experienced defective product lawyer can help ensure the case moves as quickly as possible.
In the worst-case scenario, unapproved products can cause wrongful deaths because the company is not required to provide ingredient information or adhere to labeling requirements or other regulations. The ingredients or manufacturing process used to create the product could be defective or contain hazardous substances.
Unapproved products may cause allergic reactions that can be deadly. Because the products are not approved or regulated, they could contain ingredients that are not on the label. The ingredients could cause an allergic reaction or an adverse reaction when combined with other products.
When a product causes an injury or death, the parties harmed can file suit against the company that sold the unapproved products. Other parties may also be liable for damages, such as the product’s manufacturer and distributor.
Knowing when to hire a personal lawyer is important. If you suspect that an unapproved product caused your injury or the death of a family member, it is best to contact a personal injury lawyer immediately.
Cases involving dangerous or defective products are complicated. You need someone with the experience, skills, and resources necessary to investigate the matter to uncover the evidence you can use to prove the product caused you harm.
Also, there are deadlines for filing claims related to injuries and deaths caused by unapproved products. Contacting a lawyer as soon as possible is in your best interest. Missing a deadline could result in the loss of legal rights.