Fda

  • Posted: July 26th, 2010 - 11:33am by Doug Powell

    Thanks to Tom Karst of The Packer for taking the time to read submissions to the U.S. Food and Drug Administration as the agency contemplates preventative controls for fresh produce.

    Christine Bushway, Executive Director of the Organic Trade Association (OTA) says “organic agriculture is the most highly regulated system of agricultural production in the U.S., and the USDA-accredited verification system, especially its recordkeeping and inspection requirements, should be recognized and considered by FDA when drafting rules requiring similar features.”

    Lots of record-keeping does not mean lots of food safety.

    Bushway also says, “the organic system offers an integrated process approach to preventive food safety practices that could stand as a national model for both farming and manufacturing operations. The organic process already contains many steps that contribute to food safety processes and it can be easily integrated into a more elaborate food safety system – especially in processing.”

    That’s true, and we said as much back in 2004 (see below). But why is it up to everyone else; why don’t organic processes expand so they can be considered a more rigorous or even certifiable food safety program?

    The potential for microbial contamination along the food production chain exists for both conventional and organic food products. Water quality, soil amendments such as composted manure and general sanitation need to be monitored and verified in any food production system. Organic certification is not a food safety certification.

    Microbial food safety considerations for organic produce production: an analysis of Canadian Organic Production Standards compared with U.S. FDA guidelines for microbial food safety,” by K.A. Blaine and D.A. Powell. Food Protection Trends 24, no. 4 (2004): pp. 246-252.

    Increased attention has been focused on fresh fruits and vegetables, especially raw or minimally processed, as a significant source of foodborne illness. Outbreaks have been linked to both conventionally and organically grown produce. This paper outlines the risks associated with fresh produce, common pathways of contamination, and current trends in organic agriculture. The primary objective was to determine whether the Canadian General Standards Board (CGSB) organic standard is consistent with the production of microbiologically safe produce and to examine the potential for the CGSB organic standard to include considerations for microbial food safety. This objective was achieved by examining information gaps between the US Food and Drug Administration on-farm food safety guidelines and the organic standard developed by the CGSB. This examination showed a significant degree of commonality and, in some cases, it was demonstrated that microbial food safety standards are achieved indirectly under organic production. The main difference between the U.S. guidelines and the CGSB standard is the focus on the process rather than the safety of the final product,and the lack of discussion of microbial considerations in the CGSB standard. Specific omissions include worker hygiene and recommendations for safe use of processing and irrigation water. The production of safe food is the responsibility of everyone in the farm-to-fork chain. With established relationships between growers and regulatory infrastructure, the CGSB organic standard would be an ideal vehicle for providing organic growers with information and guidelines on identifying and controlling microbial hazards on their produce.
     

    Your rating: None (2 votes)
    Bookmark and Share
  • Posted: July 10th, 2010 - 5:48pm by Doug Powell

    Who buys a hand sanitizer named Bee-Shield; is it also an insect repellant?

    The U.S. Food and Drug Administration said Friday that $230,000 worth of hand sanitizing gel made by Puerto Rico Beverage Inc. of Maunabo and distributed by Lord Pharmaceutical, LLC, doing business as Bee International Distributors was seized the day before.

    The hand sanitizer is distributed only in Puerto Rico.

    The product Bee-Shield Hand Sanitizer with Aloe Vera (10 fl. oz. or 1 gallon bottles) is an unapproved new drug and in violation of federal law

    The gel was marketed as a product that could kill 99.99 percent of viruses, bacteria, and fungi. However, its safety and effectiveness have not been established. Additionally, the active ingredient, benzalkonium chloride, is not recognized as safe and effective for over-the-counter (OTC) antifungal use, making it noncompliant with FDA’s final monograph for OTC topical antifungal drug products.

    The product also represents that it prevents the disease caused by the H1N1 influenza virus, that it is effective against viruses and provides extended antimicrobial efficacy. The FDA is unaware of any scientific evidence to support these claims.

    On March 3, 2010, the FDA warned consumers not to use this product because it contained high levels of a bacterium, Burkholderia cepacia, that can cause serious infections in humans.
     

    Your rating: None (1 vote)
    Bookmark and Share
  • Posted: July 1st, 2010 - 10:31am by Doug Powell

    The prison warden told Paul Newman’s Cool Hand Luke in the 1967 film that “what we have here is a failure to communicate.”

    It’s based on an authoritarian model and is the oldest excuse out there; all kinds of problems could be solved if everyone just communicated better, especially scientists and others.

    Nope.

    The anti-authoritarian heros of great American movies like One Flew Over the Cuckoo’s Nest, The Blues Brothers and Stripes all found different ways to communicate, in unconventional ways.

    So when the American Academy of Arts and Sciences' issued a ponderous report on Improving the Scientific Community's Understanding of Public Concerns about Science and Technology, which examined the ways in which scientists engage with the public, and how their mutual understanding could be improved, I thought, who writes this crap, in a release about communications?

    The report concluded (in a somber tone),

    Scientists and the public both share a responsibility for the divide. Scientists and technical experts sometimes take for granted that their work will be viewed as ultimately serving the public good. Members of the public can react viscerally and along ideological lines, but they can also raise important issues that deserve consideration.

    Scientific issues require an ‘anticipatory approach.’ A diverse group of stakeholders — research scientists, social scientists, public engagement experts, and skilled communicators — should collaborate early to identify potential scientific controversies and the best method to address resulting public concerns.

    That sounds like BS. I’ve sat in meetings for years where well-meaning people have gone on-and-on about how the public or the media gets it wrong, how the public needs to be better educated, and how communications is some sort of road to salvation.

    And none of these reports recommend what people should do day-to-day.

    What we’ve found from our food safety infosheet research is that elements of effective communication involve:

    • storytelling focused on specific outbreaks and individual incidents of foodborne illness;

    • information that gets people talking;

    • surprise or shock using humorous or graphical images, and data; and,

    • information that has meaning to an individual.

    Another report issued last month concluded the FDA must communicate more clearly with health care professionals and consumers during foodborne illness outbreaks and food safety recalls.

    "Despite awareness of recent food recalls, an illusion of invulnerability and a lack of knowledge about the food recall process appear to be widespread among American consumers. These findings signify the need for a clear, coordinated and centralized communication strategy for food recalls."

    Nope. More panels and reports and Dr. Phil-style interventions are a waste: for food safety, say what you do, do what you say, prove it.
     

    Your rating: None (1 vote)
    Bookmark and Share
  • Posted: June 20th, 2010 - 1:40pm by Doug Powell

    The demographic appeal of specific television channels is sorta easy to figure out.

    Weather channel, CBS Sunday Morning, U.S. Open Golf, there’s a lot of commercials for sexual enhancement aids and overactive bladders.

    But there are multiple tiers of companies flogging similar wares on the Internet (or so I've been told).

    The U.S. Food and Drug Administration is warning consumers that Magic Power Coffee, an instant coffee product marketed as a dietary supplement for sexual enhancement, contains an active drug ingredient that can dangerously lower blood pressure.

    Consumers who have Magic Power Coffee should stop using it immediately.


    Sexual enhancement products that claim to work as well as prescription products are likely to expose consumers to unpredictable risks and the potential for injury or even death.

    In the case of Magic Power Coffee, the FDA collected and analyzed the product and determined that the product contains hydroxythiohomosildenafil. This is a chemical similar to sildenafil, the active ingredient in Viagra.

    Hydroxythiohomosildenafil, like sildenafil, may interact with prescription drugs known as nitrates, including nitroglycerin, and cause dangerously low blood pressure. Consumers and health care professionals should be aware of this problem and the health hazard it presents.

    When blood pressure drops suddenly, the brain is deprived of an adequate blood supply, which can lead to dizziness or lightheadedness.
     

    Your rating: None (2 votes)
    Bookmark and Share
  • Posted: June 9th, 2010 - 10:09am by Doug Powell

    Really, didn’t the U.S. National Academy of Sciences say the Food and Drug Administration and Department of Agriculture and others should do this 30 years ago?

    To more proactively tackle food safety problems, FDA should implement a risk-based approach in which data and expertise are marshaled to pinpoint where along the production, distribution, and handling chains there is the greatest potential for contamination and other problems, the report says. The agency would then be able to direct appropriate amounts of its resources and attention to those high-risk areas and increase the chances of catching problems before they turn into widespread outbreaks, said the committee that wrote the report.

    A risk-based approach would give FDA's food safety officials the strategic vision needed to evaluate and plan for food safety concerns rather than tackling problems on a case-by-case basis, the report says. Without good information, agency officials cannot identify where its resources are needed most or determine which policy interventions are most effective. FDA has insufficient analytical expertise and infrastructure to gather, manage, and use data effectively. The agency should identify its data needs and review its policies for sharing data with other agencies and organizations.

    Uh huh. How many people got sick while this report was being put together? Did the report prevent anyone from barfing?

    Your rating: None (4 votes)
    Bookmark and Share
  • Posted: May 13th, 2010 - 4:18pm by Doug Powell

    I had chopped hazelnuts on my bagged salad of romaine lettuce left over from a TV interview for lunch today (right, not exactly as shown). It was yummy, but after reading Oregon’s Capital Press, I wondered, why do all these food groups wait until a problem is discovered to become born-again about food safety?

    Last September, three months before the Food and Drug Administration found salmonella in an Oregon hazelnut processing plant, the hazelnut industry met to address food safety.

    Why wasn’t it 10 years ago?

    Polly Owen, manager of the Hazelnut Industry Office, said the discovery of salmonella in December at Willamette Shelling in Newberg, Ore., was a wake-up call.

    In a recent report to the Oregon Board of Agriculture, Owen said the industry is taking a two-pronged approach to ensuring hazelnuts are safe.

    The first involves developing good handling and management practices.

    The second involves educating growers and processors on safety measures.

    Who knows if any of this will be effective without follow-up, verification, and food safety assistance for growers and processors.

    Your rating: None (3 votes)
    Bookmark and Share
  • Posted: March 17th, 2010 - 12:37pm by Doug Powell

    The Department of Justice, in an action initiated by the U.S. Food and Drug Administration, is seeking a permanent injunction against A Chau Sprouting Co., a sprout grower in Gretna, La., company owner and manager Quang “Mike” Trinh, and Hue Nguyen, the company production manager.

    The complaint, filed on March 16, 2010, in the U.S. District Court for the Eastern District of Louisiana, charges the defendants with violating the Federal Food, Drug, and Cosmetic Act by preparing, packing, and holding sprouts under insanitary conditions, where they may have become contaminated with filth.

    “The agency has repeatedly warned the company over several years that corrective actions need to be taken in this facility,” said Michael Chappell, acting associate commissioner for regulatory affairs at the FDA. “While no illnesses have been reported to date, this action is necessary to ensure that it remains that way.”

    The ready-to-eat sprouts are distributed to wholesale suppliers, who in turn distribute them to customers located in Gulf Coast states, including Louisiana, Mississippi, Alabama, Florida, and Texas.

    Five FDA inspections over the past nine years, including an inspection conducted between August 2009 and September 2009, revealed that the defendants failed to implement basic food sanitation principles and practices for their sprout growing operation, according to the complaint.

    Your rating: None
    Bookmark and Share
  • Posted: March 4th, 2010 - 5:36pm by Doug Powell

    There’s this Joint Institute for Food Safety and Nutrition at the University of Maryland where U.S. Food and Drug Admin. types go to be trained in all matters related to food risk.

    A few years ago, I shook hands with one of the directors and said, sure, I’ll help you out on risk communication stuff, cause he said they sorta sucked at it.

    I never heard back, despite several e-mails.

    And they still suck at it.

    JIFSAN’s spring symposium is, Risk Communication - Communicating Science to the Public.

    Risk communication 101: talk with people, not to them. If any of you had kids you would know this.

    Your rating: None
    Bookmark and Share
  • Posted: January 9th, 2010 - 12:00am by Doug Powell

    Author: 
    Doug Powell

    Failure to document proper refrigeration, failure to keep fish species separate to avoid cross-contamination, failure to meet sanitation standards or keep records of compliance, and failure to verify that imported fish met FDA standards has led the U.S. Food and Drug Administration to shut down Congressional Seafood of Jessup, Md.

    Michael Chappell, acting associate commissioner for regulatory affairs at FDA, said,

    “On numerous occasions, FDA has warned the defendants, both orally and in writing, about their conduct and has emphasized the importance of their compliance with the (Federal Food, Drug, and Cosmetic) Act.”

    Under a consent decree filed Friday, to become compliant with food safety laws, Congressional Seafood must have its HACCP and sanitation plans submitted by an independent expert and approved by FDA.

    The FDA complaint accompanying the decree notes that the production of fresh, frozen and ready-to-eat seafood products without adequate HACCP plans poses a significant public health risk because these products are well-known sources Escherichia coli, Listeria monocytogenes, Clostridium botulinum, Salmonella spp., and other pathogenic microorganisms. Humans who consume food containing these bacteria can suffer serious health consequences.

    Your rating: None
    Bookmark and Share
  • Posted: December 11th, 2009 - 2:55am by Doug Powell

    Federal auditors found that nearly half the food manufacturers they surveyed that are supposed to register with the Food and Drug Administration failed to give the agency accurate contact information, according to a report to be released Friday by the U.S. Department of Health and Human Services inspector general's office.

    Companies that manufacture, process, pack or hold food that is eaten in the United States are required by federal law to provide their address and basic contact information to the FDA, so investigators can follow suspect foods through the supply chain.

    After interviewing managers at a sample of 130 such companies, however, government investigators found that 48 percent didn't give the agency accurate information. More than half were unaware companies had to register, and about a quarter provided no emergency contact information, because current rules don't require it.

    Your rating: None
    Bookmark and Share