FDA SAYS 99% OF MILK SAMPLES "FREE OF DRUG RESIDUES THAT ARE OF CONCERN"

FROM:  U.S. FOOD AND DRUG ADMINISTRATION
FDA’s Survey of Milk Finds Few Drug Residues
March 5, 2015

The U.S. Food and Drug Administration today announced results from its milk sampling survey, involving the testing of nearly 2,000 dairy farms for drug residues in milk. More than 99 percent of the samples are free of drug residues of concern-- underscoring the safety of the US milk supply. These findings provide evidence that the nation’s milk safety system is effective in helping to prevent drug residues of concern in milk, even in those limited instances when medications are needed to maintain the health of dairy cattle.

The agency initiated the study to determine whether dairy farms with previous drug residue violations in tissue derived from dairy cows were more likely to have violative drug residues in milk than other dairy farms. The FDA tested samples from two groups: a “targeted” list of farms with known previous tissue residue violations and a control group of farms. Results show that the occurrence of drug residues in milk is very low, even in the targeted group. However, the limited number of residues detected involved drugs that are not included in routine testing under the current milk safety program.

Despite the finding of a small number of drug residues in samples collected, the FDA intends to take steps to maintain the strongest possible system to ensure milk safety. The FDA will work closely with state regulators to consider modifying testing to include collecting samples as necessary from milk tanks on farms when investigating illegal drug residues in tissues involving culled dairy cows. The agency is also working with its milk regulatory partners to update the existing milk safety program, as necessary, to include testing for a greater diversity of drugs and to educate dairy producers on best practices to avoid drug residues in both tissues and milk.

ADDING THE ORION HEAT SHIELD

FROM:  NASA 

At the Operations and Checkout Building at NASA's Kennedy Space Center, the Orion crew module and heat shield are being moved into position for the mating operation. The heat shield will be tested on Orion's first flight in December, Exploration Flight Test-1 (EFT-1), an uncrewed flight that will put to the test the spacecraft that will send astronauts to an asteroid and eventually Mars on future missions. EFT-1 will launch an uncrewed Orion capsule 3,600 miles into space for a four-hour mission to test several of its most critical systems. After making two orbits, Orion will return to Earth at almost 20,000 miles per hour and endure temperatures near 4,000 degrees Fahrenheit, before its parachutes slow it down for a landing in the Pacific Ocean. Image Credit: NASA.

FDA QUESTIONS SAFETY, EFFECTIVENESS OF ANTIBACTERIAL SOAPS

FROM:  U.S. FOOD AND DRUG ADMINISTRATION 
FDA NEWS RELEASE
FDA issues proposed rule to determine safety and effectiveness of antibacterial soaps
The U.S. Food and Drug Administration today issued a proposed rule to require manufacturers of antibacterial hand soaps and body washes to demonstrate that their products are safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections. Under the proposal, if companies do not demonstrate such safety and effectiveness, these products would need to be reformulated or relabeled to remain on the market.

Today’s action is part of a larger, ongoing review of antibacterial active ingredients by the FDA to ensure these ingredients are proven to be safe and effective. This proposed rule does not affect hand sanitizers, wipes, or antibacterial products used in health care settings.

Millions of Americans use antibacterial hand soap and body wash products. Although consumers generally view these products as effective tools to help prevent the spread of germs, there is currently no evidence that they are any more effective at preventing illness than washing with plain soap and water. Further, some data suggest that long-term exposure to certain active ingredients used in antibacterial products—for example, triclosan (liquid soaps) and triclocarban (bar soaps)—could pose health risks, such as bacterial resistance or hormonal effects.

“Antibacterial soaps and body washes are used widely and frequently by consumers in everyday home, work, school, and public settings, where the risk of infection is relatively low,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER). “Due to consumers’ extensive exposure to the ingredients in antibacterial soaps, we believe there should be a clearly demonstrated benefit from using antibacterial soap to balance any potential risk.”

The widespread consumer use of antibacterial products, the accumulated scientific information and concerns raised by health care and consumer groups have prompted the FDA to reevaluate what data are needed to classify the active ingredients in consumer antibacterial products as “generally recognized as safe and effective” or GRASE.  Under the proposed rule, manufacturers who want to continue marketing antibacterial products will be required to provide the agency with additional data on the products’ safety and effectiveness, including data from clinical studies to demonstrate that these products are superior to non-antibacterial soaps in preventing human illness or reducing infection.

“While the FDA continues to collect additional information on antibacterial hand soaps and body washes, we encourage consumers to make an educated choice about what products they choose to use,” said Sandra Kweder, M.D., deputy director, Office of New Drugs at CDER. “Washing with plain soap and running water is one of the most important steps consumers can take to avoid getting sick and to prevent spreading germs to others.”

Consumers should continue to be diligent about washing their hands. If soap and water are not available, an alcohol-based hand sanitizer that contains at least 60 percent alcohol should be used.  More information on appropriate hand washing from the CDC may be found here.

Almost all soaps labeled “antibacterial” or “antimicrobial” contain at least one of the antibacterial ingredients addressed in the proposed rule. The most common active ingredients in antibacterial soaps are triclosan and triclocarban. Some soaps labeled “deodorant” may also contain these ingredients.

The proposed rule does not require the antibacterial soap products to be removed from the market at this time. When the proposed rule is finalized, as previously stated, either companies will have provided data to support an antibacterial claim, or if not, they will have to reformulate (remove antibacterial active ingredients) or relabel (remove the antibacterial claim from the product's labeling) these products in order to continue marketing. The proposed rule is available for public comment for 180 days, with a concurrent one year period for companies to submit new data and information, followed by a 60-day rebuttal comment period.