Federal Food and Drug Administration

The attitude of the Federal Food and Drug Administration revolves basically upon two sections of the federal law Section 402(a), A food shall be deemed to be adulterated if it bears or contains any poisonous or deleterious substance... or if it bears or contains any added poisonous or added deleterious substance which is unsafe within the meaning of Section 406. The applicable portion of Section 406 is Any poisonous or deleterious substance added to any food, except where such substance is required in the production thereof or cannot be avoided by good manufacturing practice, shall be deemed to be unsafe for the purposes of the application of Clause 2 of Section 402(a) but when such substance is so required or cannot be so avoided, the administrator shall promulgate regulations.. .. ... 

B. Functions and Organization of the Federal Food and Drug Administration... 

The cautious approach to drug approval, as overseen by the federal Food and Drug Administration (FDA), has been described in detail elsewhere (Findlay, 1999). The risks and benefits of a new drug submitted for FDA approval are rigorously studied through randomized, controlled clinical trials. Despite the enormous effort put forth to study new drugs, and the huge financial investment required to support clinical trials, many questions are often left unanswered by the relatively small-scale preapproval studies that may fail to detect, or fully describe, low-incidence adverse effects. These adverse effects may become evident within the months or years immediately... 

These categories should be used as initial guidelines. The federal Food and Drug Administration desires that studies of a new chemical entity be compared with placebo in small groups of patients during phase II testing. 

And when all the studies have been completed, they will ask approval of the Federal Food and Drug Administration to market the product for the uses that have been proved out by research. 

Chemists have been searching for ways to reduce the caloric content of foods without decreasing their flavor. Many people who believe that no fat is synonymous with no flavor can understand this problem. The federal Food and Drug Administration (Section 30.13) approved the limited use of Olestra as a substitute for dietary fat in snack foods. Procter and Gamble spent 30 years and more than 2 billion to develop this compound. Its approval was based on the results of more than 150 studies. 

Because there are always potential risks associated with any implantable device, before any new biotextile product can be distributed, sold and implanted clinically in a human patient in the United States, its properties and performance are required by law to be carefully reviewed and evaluated by the federal Food and Drug Administration. Its role is to ensure the safety and efficacy of all implantable devices before they are made available for surgical use in the United States. Other countries and jurisdictions have similar regulatory bodies that require all biotextile products to comply with their regulatory process (Chapter 7). 

Given the published failure reports, a survey of the Federal Food and Drugs Administration (FDA) website at www.fda.gov showed a number of... 

The Federal Food and Drug Administration (FDA) regulates the use of food colors and food contact colors in the United States. Food colors must be approved in an extensive petition process with the FDA. There are two methods by which food contact colors can be used. First there is the traditional food additive petition for use of a food contact substance. If successful, this process leads to listing in the Code of Federal Regulations (CFR) as a new color available for various substrates. Restrictions may be applied to the use of listed colors. The CFR should be consulted and... 

The United States Federal Food and Drug Administration (FDA) regulations require the complete characterization of drug compounds. Since most pharmaceutical agents are organic compounds, much of this characterization involves various chromatography-based analytical techniques, as well as NMR, IR and various physical testing methods (such as DSC, TGA and XRD). The field of atomic spectroscopy has not traditionally played a major role in the characterization of pharmaceutical products, but on closer inspection it is clear that absorption and emission spectroscopic techniques can play a valuable role... 

In response to reports from England of the poisoning of people eating apples grown in the United States, the Federal Food and Drug Administration in 1927 banned any fruit involved in interstate commerce if it possessed more the 3.57 ppm equivalent of arsenic trioxide. This landmark legislation established the precedent for what is commonly known... 

Following a 1992 mandate by the Federal Food and Drug Administration, producers of pharmaceuticals are required to evaluate the effects of individual enantiomers and to verify the enantiomeric purity of chiral drugs that are... 

Two Federal Food and Drug Administration (FDA) approved grades of thermoplastic polyurethane elastomer (TPU) with different hardness values were employed in this study. One was a Shore A 85 ( D 29) and the second a Shore D 45. Both TPU materials were Texin grades from Bayer Corporation and had similar melt viscosities. A high... 

---