Have you tried a new product or prescription drug?
If you have, you might want to consider reporting your findings to the U.S. Food and Drug Administration (FDA).
Sharing new products with the FDA can help you avoid any harm or bad side effects. It can also help other consumers make well-informed decisions about the products they use on themselves and their families.
The FDA wants to hear from anyone who has had an adverse reaction to a product or drug, whether it was purchased over the counter, by prescription, imported, or purchased online.
The FDA also wants to hear about any side effects that were not listed in the instructions for a particular product or drug. For example, if you’re using a prescription drug that is supposed to cure your headache but instead makes you feel nauseous, you should report this side effect to the FDA. If no one reports these types of adverse reactions, then the manufacturer might not be aware of them. This means they might not follow up on these issues and improve their products.
According to a recent article on the ocregister.com website, you can help in sharing information about new products with the FDA. The story was written by Kevin Smith.
The public is encouraged to report any health problems or bad side effects from products such as foods, dietary supplements, over-the-counter drugs, prescription drugs, cosmetics and medical devices. If you see news or advertising regarding a new product that has recently been introduced, it would be helpful to share that information with the FDA.
If you do not report such matters it can be hard for the FDA to know if there are any safety concerns regarding new products.
To report possible safety concerns with a product directly to the FDA visit www.fda.gov/safety/medwatch/howtoreport/. To file an online complaint about a cosmetic product visit www.fda.gov/Cosmetics/ComplianceEnforcement/ComplaintForms/. To report a problem with an over-the-counter drug visit www.fda.gov/Safety/MedWatch/HowToReport/. For more information on reporting possible safety concerns with food visit www.foodsafety.gov/reportproblem/.
If you’ve ever tried a new product, you know it can be challenging. But have you ever tried a new product and experienced serious side effects? If so, the FDA wants to hear about it.
A new product is a complicated process that requires thorough testing. That’s why the FDA has rules about how new products are introduced to the public. Even though new products are tested for safety and effectiveness, there’s always the risk that something unexpected could happen when it hits the market.
That’s why it’s important to report any problems or adverse events to the FDA. Not only does this help ensure that other people aren’t harmed, but it also helps the FDA keep track of problems with medications and medical devices so they can take action if necessary. Reporting your story can help save lives!
“My daughter started using a new hair product, and after a few days she said her head was itchy and burning,” says Cara Welch. Welch is a senior advisor in the Office of New Drugs at the U.S. Food and Drug Administration. “A few days later, she had a large bald spot on her head.”
It was an extreme reaction to a new hair product that went unreported to the FDA. And Welch says it’s not uncommon for people to have bad reactions to products or medicines that aren’t reported to the agency.
“If you’re using these products and you’re having side effects or problems, something has gone wrong,” Welch says. “That’s not how they are intended to work.”
The reason not everyone reports their reactions is because they don’t know they can, she says. So the FDA decided to change that with some new ads on TV and radio, on social media and online that encourage people to report any problems with drugs or other products regulated by the FDA directly to them at fda.gov/reportit or by calling 1-800-FDA-1088.
Have you tried a new food or product that has made you sick? Or maybe you’ve heard about someone getting sick from a new product. It’s important to let the U.S. Food and Drug Administration (FDA) know so they can keep our food and products safe.
You can report any adverse event you’ve experienced, or witnessed, related to FDA-regulated products by calling 1-800-FDA-1088 or visiting MedWatch Online.
The FDA regulates more than $1 trillion worth of consumer goods, including $350 billion in foods; more than $200 billion in human and animal drugs; $105 billion in medical devices; and more than $400 billion in cosmetics, dietary supplements and other products.
Adverse events can occur with FDA-regulated products, but it is rare. When an adverse event occurs, it’s critical that we hear about it so we can act quickly to protect the public health.
Understanding and Abiding by the Rules of the Game: Consumers need to understand that the FDA cannot review new products for safety and effectiveness before they reach the public.
FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to maintain and improve their health.
The FDA performs its mission by constantly evaluating safety information about marketed products, educating consumers about safe use of these products, working with manufacturers to improve product quality, taking enforcement actions when necessary. The following are examples of various FDA actions:
Safety Alerts Safety alerts are used to inform consumers of potential risks associated with consuming certain foods or taking certain medications. While not all adverse events are reported to FDA (only those resulting in serious harm or death), this information has helped FDA identify problem areas in food production that would result in recalls or warnings (see previous section on Food Safety). In addition, safety alerts help educate consumers on the
The U.S. Food and Drug Administration (FDA) is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed[1] and veterinary products.
The FDA was empowered by the United States Congress to enforce the Federal Food, Drug, and Cosmetic Act, which serves as the primary focus for the Agency; the FDA also enforces other laws, notably Section 361 of the Public Health Service Act and associated regulations, many of which are not directly related to food or drugs. These include regulating lasers, cellular phones, condoms and control of disease on products ranging from certain household pets to sperm donation for assisted reproduction.
The FDA is led by the Commissioner of Food and Drugs, appointed by the President with the advice and consent of the Senate. The Commissioner reports to the Secretary of Health and Human Services. Scott Gottlieb is the current commissioner.