0
Food and Drug Administration (FDA)
The Food and Drug Administration (FDA) is an agency run by the Executive Branch of the American government that makes sure that all food and medical supplies are safe to eat or use before going out to the general public. This was created by president Theodore Roosevelt after the novel by Upton Sinclair called ' The Jungle ' was released, which described the horrors in the meat industry. Questions in this category should include questions about the recall of certain foods and drugs, testing methods used by this agency, and the history of the FDA.
430 Questions
Did the fda shut down deep foods?
The FDA shut the a distributor by the name of Chetak Foods, Chicago because of hygiene issues. The facility has since been re-opened.
A statement has been made by Deep Foods Inc and can be read in the discussion page of this answer.
FDA recommended that wood pallets Not to be used in Connection where there is food preparation is?
Wood pallets are not easily cleaned and sanitized, so they could be a possible source of contamination in a food preparation area. That, along with the possibility of being a foreign object source (wood splinters or nails), is the reason FDA doesn't like wood pallets near exposed food.
What role does FDA play in regards to prescription medication?
To protect the public health by assuring prescription drug information is truthful, balanced and accurately communicated. This is accomplished through a comprehensive surveillance, enforcement and education program, and by fostering better communication of labeling and promotional information to both healthcare professionals and consumers."
The list is quite extensive, however most of the so-called "failures" were caught by using studies which examines the long-term use of a medication or treatment. You see, when a drug comes up for review, there is no way of knowing the long-term affects of a medication. The FDA can only react to these incidents after someone comes forward (usually a Dr. who has prescribed the drug to someone on a long term basis.) When they do find out the FDA is quick to react by requiring drug companies to insert warnings, or if the incident is very serious, they can take it off the market all together.
Does fda allow rat feces in cereal products?
There appears to be no publicly available FDA sponsored sanitation information relating directly to cereal. The FDA's Sanitation and Treatment Handbook does not list cereal directly. (opinion) this may be because the regulations apply to the manufacture of the Ingredients (like wheat, Flour, sugar, dyes, etc) which are all listed at source 1.
Cereal is listed at source 2 but that's nutritional portion information. so the FDA does acknowledge its existence as a Human staple food.
Is the grading of poultry mandatory by food and drug administration?
No. The United States Department of Agriculture (or the equivalent State agency if there's no interstate commerce) has jurisdiction over poultry.
What information does the FDA's Investigational New Drug IND application contain?
The IND Application form (Form FDA 1571) is 3 pages long and asks for much information, including: the sponsor, the drug itself, clinical trial protocols, contract research organizations. The form's instructions are 5 pages long. The application can also be filed online. You can find the form on FDA's website.
Zembrin is a patented version of Sceletium Toruosum, an indigenous plant from South Africa. Zembrin was developed by HGH Pharmaceuticals over a 10 year period and is supported by rigorous clinical data.
Zembrin is not approved by the FDA.
It pertains to a food or medical product or process that has applied for approval and received it from the Food & Drug Administration. Go to the FDA website for more precise information about it's mission and authority. FDA link: fda.gov
Fdg is a foundation degree; FdA is a foundation degree in arts
Did Obama send the FBI to raid the Mormon food canaries?
No. The situation regarding the food production system of the Church of Jesus Christ of Latter-day Saints (the "Mormon" church) has been blown way out of proportion. Under the old system, church farms and orchards were cared for and harvested by volunteers from local congregations, then processed and canned in church canneries, also by local volunteers. The food items were then distributed for free to the needy or purchased at cost by the public.
Recent changes in federal food production and distribution guidelines, as well as financial needs, have required the church to change their system. Anyone working or volunteering at the farms, orchards, and canneries must go through a more lengthy and intense training program, meaning that each location will likely have a small group of assigned workers, rather than accepting any willing volunteers. Additionally, while canneries will continue distributing church-produced foods, most will no longer be canning the items on-site.
The official statement from the Church published in June 2013 says: "Over the past several weeks, misinformation and unnecessary concern has been circulating on blogs, over social media channels and by email regarding changes in operations at the church's home storage centers, which are located in the U.S. and Canada. No home storage centers are being closed, but the church is making welcomed modifications in its operations at most of these centers that will help to better serve the needs of members of the church, as well as significantly improve efficiency.
"In all but 12 of the church's 101 home storage centers in the U.S. and Canada, patrons will no longer self-can products, but they may purchase these same items pre-canned or prepackaged at no additional cost. The church currently operates 101 home storage centers in the United States and Canada where food storage items such as beans, dry milk, wheat, rice and sugar may be purchased. These changes have been considered for some time as the church has looked at the best way to provide home storage goods to church members efficiently. Much of the discussion regarding this issue has suggested that this change is due to food safety regulation. While it has been a factor, the concern expressed regarding that issue has been overstated."
Kefauver-Harris Amendment.
To add to J. Baker's Expert Answer that ephedra was causing strokes and heart attacks, it was ephedra's use in over-the-counter Dietary Supplements (DS) that FDA banned. Those products presented an unreasonable risk of illness or injury under ordinary conditions of use. Consumers were attracted to the perceived benefits of weight control and boosting sports performance and energy, but did not believe or were unaware of the side effects. The process actually started in 1997 with FDA's requiring warnings be placed on labels. This culminated in the Final Rule of the ban in 2004.
What is the equivalent of the US FDA called in Japan?
The Japanese equivalent of the FDA is the Japanese Ministry of Health & Welfare.
The wages of the employees and the sanitation.
Who is responsible for ensuring that all medicines are safe and effective?
Part of U.S. FDA's stated mission is "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."
Notice that "all" is omitted. Perhaps it is assumed.
Who is required by the FDA to file a 510K?
http://www.fda.gov/CDRH/DEVADVICE/314.html
510K is a process to get FDA clearance to market a medical device.
Any medical device manufacturer (or importer / repackager / relabeler)
* introducing a new medical device * or significantly changing the technology or indication for use, safety or efficacy, to an existing 510K cleared device
must file.
However, the 510K is only for devices that provide the same functionality (substantial equivalence) as an already cleared device (called a predicate device).
Devices that are a new application (without a predicate device) must file a PMA, (not a 510K)-- which usually means clinical trials must be done.
Once a product receives the 510K, it is cleared to market.
However, the company still needs to have a working Quality System.
FDA will conduct periodic inspections to enforce compliance with Quality System Regulations.
I add this additional information because a lot of small manufacturers don't realize the importance of the Quality System regulation and will run into hassles if they don't comply after receiving 510K clearance and before marketing the device.
What can the FDA and FSIS do to prevent the spread of listeriosis?
The Food and Drug Administration (FDA) and the Food Safety and Inspection Service (FSIS) can legally prevent food from being shipped, or order food recalls, if they detect any Listeria bacteria.
The EPA stands for the Environmental Protection Agency. It is responsible for the wellbeing "of protecting human health and the environment by writing and enforcing regulations based on laws passed by Congress."
The FDA is the Food and Drug Administration. It is responsible for The FDA is responsible for" protecting and promoting public health through the regulation 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), veterinary products, and cosmetics.
What did US Food and Drug Administration annouce?
This week the FDA announced the approval of a new drug combination for weight loss - containing naltrexone and bupropion. (12/6/2010)
