The FDA does not regulate the practice of drugs, medical services, the price or availability of medical products, or whether health insurance or Medicare reimburses them. The FDA does not regulate the transplantation of vascularized human organs, such as kidney, liver, heart, lung, or pancreas. The Health Resource Services Administration (HRSA) oversees vascularized human organ transplantation. The.
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The scope of the FDA's regulatory authority is very broad. The FDA's responsibilities are closely related to those of several other government agencies. It is often frustrating and confusing for consumers to determine the right regulatory agency to contact. The following is a list of traditionally recognized product categories that are under the regulatory jurisdiction of the FDA; however, this is not an exhaustive list.
The following contact information is for government agencies that have functions related to those of the FDA. Contact information is provided for the agency's headquarters, which are located in Washington, DC. Local offices, listed in the phone book in the US. UU.
The government may also be available to provide assistance. Consumers can write to TTB at 1310 G St. N, W. The Animal and Plant Health Inspection Service (APHIS) of the Department of Agriculture, of the Center for Veterinary Biology, regulates aspects of veterinary vaccines and other types of veterinary biological products.
Public inquiries about the APHIS Veterinary Biology Center should be mailed to the Veterinary Biology Center, 1920 Dayton Ave, P, O. Box 844, Ames, Iowa, 50010; phone (51) 337-6100 or see the APHIS contact page. The Environmental Protection Agency (EPA) regulates aspects of drinking water. The EPA develops national standards for drinking water from municipal water supplies (tap water) to limit impurity levels.
The FDA regulates these substances in foods, drugs, dietary supplements, cosmetics, and some devices. While makeup, lotions, perfumes, shampoos, hair dyes, and similar products are not regulated by the FDA, the color additives they contain must be approved before going to market. The FDA oversees other cosmetics once they are on sale. Ingredients must be properly labeled, and the FDA can enforce those laws if a product doesn't meet the standards.
When public health concerns arise about the safety of a dietary supplement or ingredient, the FDA has the authority to take steps to protect the public. Products such as multivitamins are regulated by the FDA, but they work a little differently than the way drugs and medical devices are administered. The FDA can inspect facilities that produce food and drugs and can take samples to ensure that manufacturers and facilities are complying with laws. However, FDA rules require that specific labeling elements, including nutritional information, appear on most foods, including dietary supplements.
If you experience an adverse event while taking a dietary supplement, stop using it immediately, seek medical attention or advice, and report the adverse event to the FDA. It's part of the Department of Health and Human Services, and the FDA also alerts the public when a product is unsafe. The FDA has the authority to inspect regulated facilities to verify that they comply with current applicable good manufacturing practices and other requirements, including a properly designed and controlled production process. Statements regarding the structure and function of dietary supplements include a disclaimer stating that the statement has not been evaluated by the FDA and that the product is not intended to diagnose, treat, cure, or prevent any disease.
There is no such thing as a safe tobacco product, so the FDA's safety and efficacy standard for evaluating medical products does not apply to tobacco products. If you have a general, non-serious complaint or concern about dietary supplements, contact your local FDA consumer complaint coordinator. The Federal Food, Drug, and Cosmetic Act (Act FD&C) was amended in 1994 by the Dietary Supplement Health and Education Act (often referred to as DSHEA), which defined the term “dietary supplement” and established FDA authority with respect to such products. The FDA can approve (or reject) new drugs and biological products, such as drugs, vaccines, and gene therapies, before they go to market.
In the case of dietary supplements, the FDA administers the final product; it does not approve them before they go on the market. Dietary supplement companies must report serious adverse events they receive about their dietary supplements to the FDA within 15 days. Although the FDA does not approve dietary supplements, the agency has functions to regulate them. .
