Is It Really “FDA Approved”? Part 2. Here are 10 more facts about how the FDA works to protect public health.
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 or enhancement.
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.
