When Congress created the Reportable Food Registry (RFR) in Section 1005 of the U.S. Food and Drug Administration (FDA) Amendments Act of 2007, FDA was given the opportunity to develop a useful addition to its armamentarium of tools and techniques to prevent foodborne illness. In the law, which became Section 417 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), Congress directed that FDA establish an electronic portal to which industry must, and public health officials may, report when there is a reasonable probability that an article of human food or animal food/feed (including pet food) will cause serious adverse health consequences or death to humans or animals.
Companies of all sizes are being inspected.
To become compliant with GMP guidelines, passed in 2007, dietary supplement companies need to perform analytical testing of their products. Analytical laboratory analysis falls under the category of “manufacture” as defined by FDA CFR. Therefore, if testing is not performed, the dietary supplement company will be considered non-compliant regardless of the reason for not testing.
This new challenge for production will require substantial new testing in order to maintain compliance. Some dietary supplement companies have already found that outsourcing the testing, though thousands of dollars per year, is a more sensible business strategy than investing millions developing and maintaining their own compliant laboratories. When outsourcing analytical testing to laboratories, the FDA requires the outside lab to be cGMP compliant and FDA inspected.
Nitrofurans are a class of drugs that have the ability to kill micro-organisms. The group consists of four drugs. Since 1989, nitrofurazone has been discontinued from being classified as a drug by the US Food and Drug Administration. It has been reported that most nitrofurans are mutagenic and carcinogenic. [Read more…]
In September 2008, China found that milk powder, milk, yogurt and infant formula had been adulterated (contaminated) with melamine. Nearly 53,000 illnesses, over 12,800 hospitalizations and several infant deaths caused by kidney stones and renal failure have been reported.
Melamine was added to milk products to fool government quality tests. [Read more…]
ADPEN provides analysis results at a faster rate for Fluoroquinolones.
Fluoroquinolones are a subgroup of the quinolone antibiotics that were discovered within the last decades. These are employed against almost all bacterial infections, particularly against urinary tract infections and acute respiratory diseases. Both for human and veterinary medicine, fluoroquinolones play a decisive role. [Read more…]