U.S. Food and Drug Administration (FDA)
What the FDA Does and Does NOT Approve
Is It Really "FDA Approved"? Maybe you’ve seen these words on a company’s website or in a commercial promoting a product or treatment. Here are some facts about products that are, and aren’t, FDA approved.
Fact #1: Generic medicines work the same as brand-name medicines.
FDA-approved generic medicines provide the same clinical benefit and risks as their brand-name counterparts. A generic medicine is required to be the same as a brand-name medicine in dosage, safety, effectiveness, strength, stability, quality, and administration.Fact #2: Vitamins, minerals, herbs, and other dietary supplements are NOT FDA-approved to treat or prevent disease.
If a supplement promises a cure or quick fix for a health problem, it may be too good to be true.Fact #3: The FDA doesn’t approve compounded drugs.
Compounding is often regarded as a process in which a pharmacist or a physician combines, mixes, or alters ingredients to create medications that meet the needs of individual patients. FDA has observed that some compounders have made false and misleading statements.Fact #4: The FDA hasn’t approved an e-cigarette as an aid to quit smoking.
While certain e-cigarettes may help adults who smoke to transition completely away from, or significantly reduce their use of more harmful cigarettes, no e-cigarette product has been approved by the FDA as a method to help quit smoking.Fact #5: The FDA doesn’t approve facilities.
Like medical product companies, or health care providers, including physician offices, or laboratories.Fact #6: There’s no such thing as waterproof sunscreen.
Even those labeled “water resistant,” eventually wash off. Water resistance claims, for 40 or 80 minutes, tell you how much time you can expect to get protection while moving in and out of the water. And remember, sunscreen should not be put on infants under six months old, just keep them out of the sun.Fact #7: The FDA does not approve cosmetics.
The ingredients (except certain colors) and labeling of cosmetics, such as many perfumes, makeup, moisturizers, shampoos, hair dyes, face and body cleansers, and shaving preparations do not require FDA approval. However, under the law, cosmetics must not be "adulterated" or "misbranded.”Fact #8: FDA-approved vaccines have undergone a rigorous evaluation by the FDA to ensure their safety and effectiveness.
Making sure all vaccines meet standards for safety and effectiveness is one of FDA’s highest priorities. The FDA's assessment of vaccines encompasses their entire “lifecycle” of development and use. This includes studies conducted before testing in people occurs, studies conducted during development and continuous assessment after a vaccine is approved and made available in the U.S.Bonus fact: There is no link between vaccines and autism.
The scientific evidence does not support a link between vaccines and autism. The initial concerns that vaccines may cause autism were related to the measles, mumps, and rubella vaccine and thimerosal-containing vaccines. Dozens of reputable, peer- reviewed, scientific studies from the U.S. and other countries around the world have supported the safety of thimerosal-containing vaccines
Fact #9: Using CBD raises safety concerns, and some CBD products are being sold with unproven claims saying they can treat or prevent diseases or conditions.
Studies have shown the potential for CBD to harm the liver, male reproductive system, and interact with medications.The FDA has approved only one CBD product, a prescription drug product to treat children’s seizures associated with certain syndromes and disease.
CBD products with unproven claims may delay consumers from getting important medical care, such as proper diagnosis, treatment, and supportive care. Talk to a health care professional before using any CBD products.
Fact #10: The FDA is responsible for protecting the public health.
The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary food and drugs, biological and tobacco products, medical devices, cosmetics, and products that emit radiation. Advancing the public health means helping to speed medical innovations and informing the public with accurate, science-based information.
The FDA is here to provide the facts and you can help by sharing this information with your community and loved ones.
Fact #11: The FDA regulates dermal fillers as medical devices.
Dermal fillers are gel-like substances injected under the skin to create a smoother or fuller appearance in the lips, face, or back of hands. The FDA advises you work with a licensed health care professional who is experienced in injecting dermal fillers, knowledgeable about fillers, anatomy, managing complications, and most importantly, tells you about the risks and benefits before receiving this medical procedure.
Be Careful: The FDA has not approved injectable silicone or any injectable fillers for body contouring orenhancement.
Fact #12: There are no FDA-approved homeopathic products, including homeopathic cough and cold products.
Homeopathic products are generally labeled with the word “Homeopathic” and include ingredients listed in terms of dilution, e.g., 1X, 6X, 2C. Since homeopathic products have not been approved by the FDA for any use, they have not been demonstrated to meet the FDA’s standards for safety, effectiveness, and quality.
Fact #13: The FDA encourages diverse participation in clinical trials.
Participants in clinical trials should represent the patients who will use the medical products. Women, people from racial and ethnic minorities, older adults, and other diverse groups are often underrepresented in clinical research. If you think a clinical trial may be right for you, talk to your health care professional.
Fact #14: The FDA requires that manufacturers provide helpful nutrition information on food labels to make healthy eating easier.
The FDA required updates to the nutrition facts label by 2021. These included listing servings in larger bolder type, updating serving sizes, putting calories in larger type, updating daily values, creating an “Added Sugars” line, and making some additional changes in the nutrients required.
We’re also exploring other ways to ensure consumers have more information on food packages, such as requiring certain information on the front of the package and updating when a food product may claim that it is “healthy.”
Fact #15: The FDA doesn’t license pharmacies, including online pharmacies.
Some pharmacy websites operate legally, but others sell unapproved, counterfeit or otherwise unsafe medicines outside the safeguards followed by state-licensed pharmacies.
You can protect yourself and your family by being cautious when buying medicine online. Visit www.fda.gov/besaferx for more info.
Fact #16: The FDA regulates foods and drugs for animals.
Did you know the FDA regulates food for animals, including pet food and livestock feed, as well as the medicines that help keep these animals healthy?
Fact #17: More than 12,000 highly qualified scientists work at the FDA.
FDA scientists’ research, scientific activities, and inventions have a profound impact on the lives of all Americans. To protect the integrity of the FDA’s programs and operations, FDA employees are subject to a robust set of ethics requirements to ensure they have no conflicts of interests with their work assignments. The FDA’s decisions are guided by science and are focused on protecting and promoting the public health.
Fact #18: The FDA regulates the collection of blood and blood components.
This includes blood and blood components for transfusion and plasma used for the manufacture of products, such as immunoglobulins and clotting factors. The FDA establishes regulations, provides recommendations to blood establishments, and reviews their applications to help ensure blood safety and to protect the health of blood and plasma donors.
The FDA also regulates devices used in the collection of blood and blood components and transfusion medicine, including blood collection systems, transfusion-transmitted infectious disease screening tests, pathogen reduction technology and blood typing and compatibility tests.
Fact #19: mRNA vaccines were developed based on decades of scientific study at NIH before they were authorized and approved by the FDA.
Decades of medical research led to the development of mRNA vaccines. In 1961, scientists discovered, and began studying mRNA. In the early 2000’s, a laboratory breakthrough showed that modified mRNA can safely deliver instructions to cells. And in 2016, scientists began to collaborate on a general vaccine design that uses viral mRNA. This design was studied for protecting people from emerging viruses such as Nipah virus and the Middle East respiratory syndrome (MERS) coronavirus. In January 2020, scientists quickly pivoted from studies of other viral vaccines to focus on a vaccine candidate for COVID-19.
Fact #20: If you have a complaint about a product regulated by the FDA, the agency wants to hear about it.
The FDA offers several ways to report a complaint. Two of the main reporting systems available to consumers are the Consumer Complaint Reporting system and MedWatch.
Please visit www.safetyreporting.hhs.gov.
The FDA is here to provide the facts and you can help by sharing this information with your community and loved ones. Visit FDA.gov/RumorControl for more information.