Announces Modernization of Food Good Manufacturing Practices
agency plans to hold three public meetings this summer to receive data, information,
and other input on food GMP modernization from stakeholders. The meetings will
be held in College Park, MD., and Chicago, ILL., with a third one yet to be determined
and will include outreach to small businesses. FDA will announce the meetings
shortly in the Federal Register (FR). To help focus the public meeting comments,
the FR notice will include a list of specific questions about food GMP modernization
that FDA would like participants to address. The FDA will evaluate the data and
information received to determine how to revise the food GMP regulations. FDA
plans to publish a white paper with a summary of its findings in September. FDA
will then proceed through (notice-and-comment) rulemaking, as appropriate. FDA
is developing a final rule to establish GMPs for dietary supplements. The agency
will continue to coordinate any possible future revisions to the food GMPs with
dietary supplement GMPs.
virus may spread via sweat, food, sewage, touch: study
will continue safety campaign, says official
to see compliance with the science, and while enforcement is one aspect of this,
industry can certainly take their own actions to ensure this is achieved,¡± said
David Elder, director of the office of enforcement in the Food and Drug Administration¡¯s
office of regulatory affairs.
In a speech to supplement and ingredient manufacturer executives, Elder listed agency actions taken over recent years, including the recent ban on ephedra, the first outright ban of a dietary supplement since 1994¡¯s Dietary Supplement Health and Education Act (DSHEA) was passed.
FDA has also recently backed a crackdown on products containing androstenedione, which acts like a steroid but is generally marketed as a dietary supplement, as well as a number of supplements making claims that cannot be supported by available science, such as SeaSilver, which was subject to a seizure of $5 million worth of products.
Earlier this year previous commissioner of FDA Mark McClellan cited herbals such as bitter orange as products that would come under investigation in the future.
But Elder told NutraIngredientsUSA.com that while ¡®stimulant products¡¯ were particularly likely to be watched by the regulators, ¡°we are nowhere near the ephedra stage with these. There simply isn¡¯t enough science yet.¡±
He added that FDA may look at the regulation on ¡®new dietary ingredients¡¯ as an area of enforcement ¡°that we could do much more with¡±. This would involve checking for ingredients that had been refused approval under the rule - part of DSHEA that requires pre-market notification of an ingredient not previously found in foods or supplements - but are still on the market.
However the agency¡¯s action on ephedra, much criticised by industry for taking several years to come about, is unlikely to make similar enforcement quicker in the future.
¡°It was the first time we had taken an action like this and we were learning. But every decision we take has to be based on strong science, so we can¡¯t guarantee that it will be faster next time round. It will take as long as it takes to evaluate the science,¡± Elder told the audience.
He also said that the ¡°Administration is not looking for any changes to DSHEA, or to reopen¡± the legislation. Food manufacturers may be able to use more powerful health claims in the near future as the US Food and Drug Administration reconsiders legislation first tabled more than ten years ago. The agency yesterday reopened the comment period on a number of aspects of health claims regulation that have been subject to intense debate among trade industry and trade associations since the law was first proposed. These include the area of disqualifying levels of nutrients such as fat and ¡¦.According to Regina Hildwine of the NFPA, the proposed rule in 1995 ¡®accomodated about half of our requests¡¯. But in comments put forward last fall, FDA revealed that it was reevaluating the role of qualifiers in previously authorised health claims, those with significant scientific agreement to support them. The introduction of qualified health claims last year already demonstrated some consideration of the First Amendment obligations for free speech for food marketers, the backbone of industry¡¯s contention with restriction on health claims. But the new proposal for claims with numerous qualifiers has underlined the level of ¡®qualifying¡¯ in authorised claims too. ¡°In our view, FDA has done it the wrong way round,¡± said Regina Hildwine, of the National Food Processors Assocation. But she added that FDA is now asking questions about the language used in previously approved claims, showing that industry comments filed with agency may have had some impact. ¡°We claims using more forceful terms,¡± said Hildwine. ¡°This gives us an opportunity to reiterate our arguments as well as offer a new perspective on claims which have been made in recent years,¡±
food law and regulations symposium
poisoned as students sabotage soup in school dinner row
Gloves engage in germ warfare
Regulated by the U.S. Food and Drug Administration as medical "devices," gloves are available in mind-boggling variety. There are sterile and nonsterile gloves. There are gloves made of latex, vinyl, nitrile and a range of other synthetics. Some are coated inside with cornstarch powder, while others are hypoallergenic or powder-free. And they're no longer just clear or opaque white: Doctors and nurses who want to make a fashion statement can glove up in fluorescent orange, purple or even hot pink.A French rubber goods company has devised a surgical glove that contains a virus-killing liquid sandwiched between layers of the fabric. The idea is to reduce the potential infection of health care workers whose gloves are punctured by a needle.A company in Los Angeles has developed a double-layered surgical glove with a single cuff at the wrist so that surgeons won't have to don two separate pairs, as they do now to provide extra protection.Some surgeons use a glove that moisturizes their skin while they work. It's coated inside with a dried form of aloe vera, which is activated by the heat of the wearer's hands."We've got a zillion different kinds," says Dr. Thomas M. Scalea, physician in chief at the Maryland Shock Trauma Center. "Me, I just wear whatever."One recent day, Scalea went through about 15 pairs of sterile gloves during five separate surgeries as well as "countless" nonsterile pairs while outside the operating room. He says the advent of AIDS revolutionized the way hospitals treat infection control.
"Old men like me that trained before we knew what HIV disease was, we never wore gloves when I put IVs in as a resident," Scalea says. "It never would have occurred to me to put on gloves."Last year, hospitals spent about $529 on gloves for every licensed bed, according to a survey by Hospital Materials Management, an industry newsletter. That was up 34 percent, compared with $396 for each bed in 2002. Many hospitals have abandoned powdered latex gloves because of allergies and are using higher-priced alternatives, accounting for some of the increase.Sir William Halsted, a founding physician at Johns Hopkins Hospital, was among the first to introduce rubber gloves to the OR. The move wasn't, it turns out, for the most scientific of reasons.According to an account in the Journal of the Royal Society for the Promotion of Health, Halsted commissioned the Goodyear Rubber Company of New York to make a pair of gloves for his scrub nurse in 1890. The nurse, Caroline Hampton, had been complaining of skin irritation from constantly washing her hands in a harsh antibacterial solution.
The journal noted that Halsted might have been "especially attentive" to the woman's concerns. She later became his wife.While some of his colleagues adopted gloves, the master surgeon didn't start wearing them himself until his protege, Dr. Joseph Bloodgood, used them during hernia operations and reported a near 100 percent drop in infections.Studies have shown, perhaps surprisingly, that hospital staff today wash their hands about half as often as they should. Lack of proper hand washing undoubtedly contributes to some of the 2 million infections acquired in U.S. hospitals every year.Medical gloves, of course, have helped reduce the number of such infections. But Barza, the Boston doctor, thinks the new antimicrobial gloves -- which were developed by Bernard Technologies Inc. -- have the potential to reduce cross-contamination even more."There are lots of holes in the system with respect to transmission (of germs) by hands," says Barza, who sits on the company's board. "We think we are adding an extra layer of defense beyond the simple barrier effect."
Barza said the gloves emit the gaseous form of chlorine dioxide, which has been shown to kill bacteria, viruses, fungi, parasites and spores, which have protective coats.The chemical, which is registered by the Environmental Protection Agency, commonly is used to disinfect drinking water, meat, seafood and produce packaging. It kills microbes by disrupting the flow of nutrients across the cell wall.To test their antimicrobial effectiveness, Barza seeded the gloves with four types of bacteria. He reported his results in March in the journal Clinical Infectious Diseases.After one minute of exposure to light, the number of S. aureus bacteria -- a common cause of hospital infections -- was reduced by 99 percent on the gloves' surface. After 10 minutes, the bacteria virtually were gone. The bacteria count on the wearers' hands -- inside the gloves -- significantly was reduced.
Barza says the germs don't have to touch the gloves to be destroyed. The gas forms what he called a "microenvironment" around them. "It's an atmosphere," he said.The gloves are used in hospitals in Asia, including China, Hong Kong and Singapore, according to the company, though they are not yet being sold with claims about their antimicrobial properties on the label."The gloves feel and look like totally normal gloves," says Barza, who hopes the germ-fighting technology can also be applied to catheters to help eliminate central line infections. "You can't tell them apart."
Food Safety Informaiton05/10.
More mad cow mischief
Furan: FDA probes potential carcinogen in foods
"The FDA will continue to thoroughly evaluate its preliminary data and conduct additional studies to better determine the potential risk. Until more is known, FDA does not advise consumers to alter their diet," said Dr. Lester M. Crawford, acting FDA commissioner. The FDA preliminary analysis - using a new gas chromatography/mass spectrometry method developed by FDA scientists - detected furan at levels as low as 2 parts per billion in coffee and some juices. Furan was found at varying higher levels in products including baby foods, spaghetti sauces, canned soups, creamed corn and baked beans. Keen to reassure industry and consumers the FDA said that the levels of furan - naturally occurring chemical found in a variety of substances, including foods and drinks - should not be viewed as an ‘indicator of furan exposure? or as the ‘risk?of eating certain foods. ?First, calculating exposure requires consideration of both furan levels, and the amounts of food that consumers eat. Second, estimates of furan exposure take into account not single food items, but the wide variety of foods found in a range of diets. Third, the scope of our data is too limited to properly consider potential sources of variation in measured furan levels, ?said the FDA.
US food industry reacted to the FDA statement by stressing that the findings ’were
not a warning to consumers, nor are they a finding of risk associated with any
particular foods or individual brands.?br>
The European Commission recently earmarked €166m in funding for a range of projects under the 'food quality and safety' priority of the Sixth Framework Programme (FP6). One particular project will focus on health risks associated with hazardous compounds in heat-treated carbohydrate-rich foods, where substantial amounts of acrylamide - another potential carcinogen recently found in carbohydrate-rich fried foods - and similar compounds can be formed. In order to assess the potential risks, the project is exploring cooking and processing methods in industry and households with the aim of controlling and minimising the formation of hazardous compounds such as furans.
Food Research Institute Annual Meeting to be held
safety experts will gather in Madison, Wis. on May 18 and 19 for the annual Food
Research Institute meeting at the Univ. of Wisconsin-Madison. The Institute has
a long history of achievement in identifying and addressing food safety issues.
This focus on food microbiology & toxicology has developed through academic
pursuits and partnerships with industry and government.
Celsis reveals new contracts
company's tests for contamination in milk, has been installed at Scottish Milk
Dairies, which produces 30 million litres of milk a year, a US specialist dairy
producer, Gehl's Guernsey Farms and German company Berchdesgadenerland dairy.
Last week the company announced its renewed contract with Milk Link, the UK's largest UT milk producer, and it said that now it is reestablishing itself in the sector.¡±The strategic implications of these placements across regions...underscore the continued success of our product group in securing the leadership position in the European dairy testing business, in addition to expanding our dairy markets around the world¡±,the group's executive, Jay LeCoque stated in a Reuters report.
Celsis has undergone some major restructuring and has centralised its research and development unit in Germany over the last four years, and this has allowed the group renew its focus in the sector.
Dairy products safety is an important issue in the market. Consumption of products such as UHT milk is increasing steadily according to industry reports. It is estimated that UHT milk will in the long-term outsell regular milk. Thus consumer trust is becoming increasingly important.
The rapid diagnostics firm also produces tests for the Pharmaceutical, cosmetics food and beverage industries. Its technology is used to detect microbe activity in finished products providing safety to consumers.