FDA Registration – OTC Drugs
The Division of Compliance Risk Management and Surveillance oversees the FDA registration for over-the-counter drugs (OTC Drugs). FDA considers FDA registration for OTC drugs a key component of its FDA’s ability to monitor drug safety. As of June 1, 2009, FDA no longer accepts FDA registrations for OTC drugs specifically, drug establishment registration and drug [...]
Food Safety Modernization Act (FSMA) (FY 2012)
How does FDA identify a high-risk (HR) facility? The agency is utilizing a decision-making process based on the risk factors identified in section 421(a)(1) of the FD&C Act, which are: The known safety risks of the food manufactured, processed, packed, or held at the facility; The compliance history of a facility, including with regard to [...]
Marketing Food to Children
Children’s Food Marketing and Obesity Congress directed the Federal Trade Commission, together with the Food and Drug Administration, the Centers for Disease Control and Prevention, and the U.S. Department of Agriculture, to establish an Interagency Working Group of federal nutrition, health, and marketing experts to develop recommendations for the nutritional quality of food marketed to [...]
Cola Carcinogen Debate Bubbles Over – Food Safety News
As reported on of Food Safety News Cola Carcinogen Debate Bubbles Over Last week a consumer advocacy group reported that the leading brown sodas contain levels of 4-methylimidazole (4-MI) – an animal carcinogen – high enough to cause cancer in 7 out of 1 million Americans. Days later, soda companies, including Coca-Cola and Pepsi, [...]
USDA Creates New Food Safety Alert System on Twitter
If you’re careful about what you eat or feed your family, chances are pretty good you pay attention to food safety issues. The number of “tainted product” warnings in the last few years have seemingly been on the rise, with the most recent dangerous incident last summer’s listeria-contaminated cantaloupe incident that sickened a total of [...]
USFDA to decide BPA ban in food packaging by 31 March – Food Business Review
The US Food and Drug Administration will decide whether to ban the use of Bisphenol-A (BPA) in all food packaging by 31 March. BPA is an industrial chemical that causes reproductive and fetal development problems, prostate and several other cancers. According to Endocrine-Related Cancer Journal, BPA was found in the urine of 93% of Americans, [...]
Fruit Juices and Carbendazim
Fruit Juices and FDA Regulations FDA investigators are reviewing reports that carbendazim, a fungicide, is present at low levels in some orange juice products. The products in question are domestic orange juice that is being blended with imported orange juice from Brazil. The initial reports is that the levels of carbendazim seem to be the [...]
Ex-FDA chemist gets 5 years for insider trading | Reuters
A Food and Drug Administration chemist on Monday was sentenced to five years in federal prison after pleading guilty to insider trading by using confidential information about drug approvals. Cheng Yi Liang, 58, admitted buying and selling stock in more than two dozen companies with confidential FDA information to rack up just over $3.77 million [...]
Recordkeeping Under Food Safety Modernization Act
The Food Safety Modernization Act was signed a little over a year ago and FDA continues to make strides in implementing all the new FDA laws required under the Congressional mandate. The latest proposed FDA law issued February 2012 addresses establishment, maintenance, and availability of records: Amendment to Record Availability Requirements. Under the proposed FDA [...]
US regulators dispute finding of cancer-causing soda | Reuters
U.S. regulators said soft drinks from PepsiCo Inc and Coca-Cola Co posed no health risk, contrary to a U.S. watchdog group that reported several popular brands contain high levels of a chemical linked to cancer in animals. The Center for Science in the Public Interest (CSPI) said it found unsafe levels of a chemical used [...]
