The Missouri Department of Health and Senior Services received the following recall regarding the expansion of Healthy People Co. dietary supplements to include all lot numbers sold on or before October 25, 2011. The original recall was initiated on Feb. 2, 2012.
FDA lab analysis confirmed the presence of Sibutramine and Tadalafil in the products identified herein, making the following products unapproved new drugs:
MINCE BELLE (Dietary Supplement, 30 Capsules
LOT: HPCMB/10-026, HPCMB/10-027, HPCMB/10-029, HPCMB/10-020, HPCMB/10-021, HPCMB/10-016; UPC7503013203305
EVERLAX (Dietary Supplement, 30 Capsules
LOT: HPCEX/074, HPCEX/076, HPCEX/072, HPCEX/032; UPC7503013203046
EVER SLIM (Dietary Supplement, 30 Capsules
LOT: HPCES-079, HPCES-070, HPCES-071, HPCES/038; UPC7503013203053
EVER SLIM Shake Mix (Dietary Supplement Strawberry Contents17.6 oz.
LOT: HPESSF/168: UPC7503013203084
EVER SLIM Shake Mix (Dietary Supplement Chocolate Contents17.6 oz.
LOT: HPESSC/061: UPC7503013203077
ACAI-MAN MANGOSTEEN Herbal Drink (Dietary Supplement Contents 16.6 oz.
LOT: HPJAC/004: UPC7503013203015
PERFECT MEN (Dietary Supplement, 10 Capsules
LOT: HPCPM/002; UPC7503013203190
Sibutramine is an FDA-approved drug for appetite suppressant for the treatment of obesity, making dietary supplements: Mince Belle, Everlax, Ever Slim, Ever Slim Shake Mix Dietary Supplement Strawberry, and Ever Slim Shake Mix Dietary Supplement Chocolate unapproved drugs. It is a Schedule IV controlled substance and because of the risks associated with its use, it should be taken only under the direct supervision of a qualified health care professional. Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk to patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. Sibutramine has been withdrawn from the U.S. marketplace. The active drug ingredient is not listed on the label for the products listed above.
Tadalafil is an FDA-approved drug for the treatment of male Erectile Dysfunction (ED , making Perfect Men Dietary Supplement and Acai-man Mangosteen Herbal Drink Dietary Supplement unapproved drugs. FDA advises that this poses a threat to consumers because Tadalafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.
These products were distributed nationwide.
The full recall announcement can be found at:
http://www.fda.gov/Safety/Recalls/ucm292796.htm?source=govdelivery.
interim final rule on record-keeping by food firms to make current regulation consistent with FDA's expanded access to records, which was granted by the FDA Food Safety Modernization Act in January 2011.
According to FDA, the new interim rule makes "the reference to records access in the food-firm record-keeping requirements under FSMA consistent with the current statutory language in the Federal Food, Drug, and Cosmetic Act." The agency's records access authority and the record-keeping requirements were first established by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.
"This new interim final rule is FDA's latest step in implementing the FSMA. The expanded records-access authority is expected to improve FDA's ability to respond to and contain safety problems with the human and animal food supply," said the agency Thursday.
A
new draft guidance, "Draft Guidance for Industry: FDA Records Access Authority under Sections 414 and 704 of the Federal Food, Drug, & Cosmetic Act," was published to provide more detailed information on the updated record-availability requirement.
FDA also published an update to its Guidance for Industry: Questions and Answers Regarding Establishment and Maintenance of Records (Edition 4 , to ensure the guidance is consistent with the new FSMA requirements. See
Guidance for Industry: Questions and Answers Regarding Establishment and Maintenance of Records By Persons Who Manufacture, Process, Pack, Transport, Distribute, Receive, Hold, or Import Food (Edition 5 .
The new interim final rule is effective March 1, 2012.
Public comments on the interim final rule may be submitted electronically to the docket through
http://www.regulations.gov. In addition, public comments to the guidance mentioned above may also be submitted electronically to
http://www.regulations.gov.
Comments may be submitted by mail to:
Division of Dockets Management (HFA-305 ?Food and Drug Administration
?5630 Fishers Lane, Rm. 1061?
Rockville, MD 20852
On Wednesday, Pallone held a press conference at a preschool in New Brunswick, NJ to drum up support for his bill, "Arsenic Prevention and Protection from Lead Exposure in Juice Act of 2012'' otherwise known as the "APPLE Juice Act of 2012." The legislation, which DeLauro has cosponsored, would require that FDA establish lead and arsenic standards for fruit juices within two years.
Both arsenic and lead are known to affect brain development in children. Both toxins are pervasive in the environment -- both naturally occurring and the result of pesticide use, emissions and other industrial and agricultural chemicals. In both cases, the federal government has set a safety threshold for drinking water but not for juice.
Both lawmakers sent a letter to FDA this week to "strongly urge" the implementation of enforceable standards for heavily metals, including arsenic, in FDA-regulated products.
"There are no regulations for this toxin in other food products, including juices or infant formula, though China has a standard for arsenic in food," read the letter to FDA Commissioner Margaret Hamburg.
Pallone and DeLauro pointed to a
recent study published in Environmental Health Perspectives which found that food products sampled in the study "may introduce significant concentrations of [inorganic arsenic] to an individual's diet," which included infant milk formula and cereal bars." They also cited a January Consumer Reports investigation which found concerning levels of arsenic and other heavy metals in juice products from Connecticut, New Jersey, and New York.
Consumer Reports tested 88 samples of apple juice and grape juice purchased in three states and found that 10 percent had total arsenic levels exceeding the federal standards of 10 parts per billion (ppb for arsenic in drinking water, and that most of the arsenic "was the type called inorganic, which is a human carcinogen." The tests also found that 25 percent of the juice tested had lead levels higher than the 5 ppb limit for bottled water.
The FDA says its "level of concern" for heavy metals in juices is anything above 23 ppb. The agency maintains that there is no threat to public health but testing has been stepped up.
"Young children are the most vulnerable to the harmful health effects of chronic arsenic exposure, such as brain damage, so the high levels of arsenic and lead found in fruit juices and infant formula are absolutely unacceptable," said Pallone at the press event. "That is why I intend to put significant pressure on the FDA, starting today with a letter to the Commissioner, to act now and go even further beyond the specifications in my bill. FDA has a public health duty to protect babies and children from arsenic exposure - whether its fruit juice or baby formula."
In their letter, Pallone and DeLauro tout their bill, which targets apple juice, and ask FDA to move on a wider variety of FDA-regulated products: "Given that bill and the recent research on the threat that arsenic in fruit juices and food products pose, we urge you to implement maximum standards for all food products, including juices and infant formula, in a timely manner."
While the testing program may be inexpensive, it's critical because no other federal mechanism currently exists to conduct regular testing of fresh produce. (The Food and Drug Administration--which technically has jurisdiction over produce safety--conducts only limited inspections.
To date, the MDP has
tested high-risk produce such as alfalfa sprouts, cilantro, green onions, peppers, tomatoes, spinach, and other leafy greens. Every one of these vegetables has caused a food-borne illness outbreak or recall over the years, some of them lethal thanks in part to an industrialized food system that transports bugs nationwide. You might recall, a shocking
34 people (and counting died from a listeria outbreak last year in cantaloupe in 26 states (yes, melon - also on USDA's tested produce list . That tragedy alone should cause the Obama Administration to rethink this thoughtless budget cut.
It's not like this is some wasteful government program. It's a relatively cheap way to help save lives, so what's going on? Here is how food safety attorney Bill Marler
explains who just might be behind the idea:
The produce industry hates this program as it has found pathogens in domestic and imported samples and FDA has responded to the information and recalled products. The produce industry--via the fruit and vegetable advisory committee--recommended to USDA and Congress that the program be terminated.
The produce industry hates the program? Now we're getting somewhere.
According to this AP
story, lobbyists with the United Fresh Produce Association and other major trade associations "have repeatedly pushed the government in recent years to get rid of the comprehensive testing program, saying it has cost growers millions in produce recalls." (Isn't that the idea--to get tainted food off the market? Instead, industry suggests more private sector testing.
More private sector testing? Like the
third-party "audit" that missed the deadly listeria in the cantaloupe at Jensen's Farms? According to a
Congressional report on the matter released in January, FDA called it "an inherent conflict of interest" for a private auditor to provide safe handling advice in exchange for payment. Moreover, such auditors don't have to adhere to scientific standards, are not regulated by the FDA, and cannot enforce FDA rules.
This is also the same United Fresh Produce Association that
claims to care about food safety but
does not want to pay the fees necessary to fully implement the Food Safety Modernization Act, the new law intended to improve inspection and oversight by the Food and Drug Administration.
According to the
Center for Responsive Politics, the United Fresh Produce Association has spent more than a million dollars a year on lobbying in each of the past three years. Of course only some of that money was spent lobbying on food safety but the trade group must expect a good return on its investment.
For its part, USDA claims the program doesn't belong there but is better suited to FDA, raising once again, the challenges caused by our currently fragmented oversight system and lack of a single, effective food safety agency.
The Food Safety Modernization Act may help fix some of these problems, but we still have to find the funding. Obama's budget also
seeks a 17 percent increase for FDA, but almost all of the new money would come from industry fees, which again, industry is dead set against. Moreover, it's not at all clear that FDA will pick up the slack from USDA's testing of fresh produce.
In sum, Obama is proposing to cut a nominal food safety program that's working fine, while suggesting new funds come from fees that industry will fight. Of course, testing won't solve all problems either. Not with an industrialized food system that consistently externalizes costs in favor of profits. Maybe if we examined how massive consolidation of produce growers, processors, and distributors contributes to these nasty outbreaks in the first place, and considered better prevention through smaller-scale production models, we wouldn't have to haggle over this testing program. But meantime, can't we find somewhere else to cut $5 million that doesn't make our problems even worse?
-----------------------------
Michele Simon, a public health lawyer, recently joined the Center for Food Safety as a Policy Consultant, where she will help CFS expand into issues related to food safety and nutrition. This commentary was first posted Feb. 22, 2012 on the
Center for Food Safety website.
Dr Andrew Farb, a medical officer at the U.S. Food and Drug Administration (FDA has advised clinicians on live case demonstrations of devices.
A study in the Journal of the American College of Cardiology: Cardiovascular Interventions suggests that broadcasting heart procedures live to doctors at medical meetings may not present a risk to the patient on the table. Doctors at Rambam Medical Center in Haifa, Israel reviewed 101 patients treated during live transmissions from a single center in 15 invasive-cardiology conferences between 1998 and 2010. The study found that procedural and 30-day clinical outcomes were similar to those found in daily practice and to those that have been reported in the contemporary published data, and concludes that these results suggest that broadcasting live case demonstrations in selected patients from selected centers may be safe.
Such demonstrations must first be approved by the FDA. In an interview with Reuters Health, Dr Andrew Farb, who co-wrote an editorial published with the findings said the main goal of these demonstrations is to increase awareness of a clinical trial, and possibly get more doctors to enroll patients in it. This, he stated, is part of the FDA's "mission" to help get clinical trials done in a timely manner and get effective treatments into practice.
Dr Farb also noted that the demonstrations must clearly state that the procedure involves an "investigational device," and the operators cannot try to commercially promote the device.
The full article from the Journal of the American College of Cardiology can be found
here.
Read the Reuters Health interview with Dr Andrew Farb
here.
Depending on who you ask, the U.S. Department of Agriculture's Microbiological Data Program (MDP , which randomly tests produce for dangerous pathogens, is either an unnecessary, slow-moving program housed in the wrong agency, or a critical public health initiative that fills a big, alarming gap in domestic produce testing.
The debate over MDP, which falls under the Agriculture Marketing Service, intensified last week with the news that the Obama administration's budget eliminates the $5 million program in Fiscal Year 2013.
Launched under President Bush's 2001 Food Safety Initiative, MDP now tests about 15,000 samples of fruits and vegetables each year, far more than any other federal or state program. Public health officials pull samples of alfalfa sprouts, cantaloupe, cilantro, hot peppers, bagged lettuce and spinach and tomatoes to gather data on E. coli (STEC , E. coli O157:H7 and other pathogens that can contaminate these products.
Samples are collected from produce distribution centers in 11 states, which, according to MDP, represent about 50 percent of the United States population. Any isolated pathogens are then sent for pulsed field gel electrophoresis (PFGE testing and the resulting pattern is uploaded into the Centers for Disease Control PulseNet database so that it can be matched against human isolates or outbreak patterns.
In its budget request for FY 2013, the Obama administration justified cutting MDP, calling it a "lower-priority program because it is has a low impact and is not central to the core mission of AMS, which is to facilitate the competitive and efficient marketing of agricultural products."
On Monday, The New York Times ran an
editorial boosting the obscure program into the limelight. In "A Tiny Program That Matters," the editors call the proposed cut "an alarming setback in the fight to keep the food supply safe."
"Keeping food safe requires consistent monitoring by the federal government," read the editorial. "Ending this small program would harm those efforts."
The produce industry has long argued that MDP is ineffective and does nothing for food safety.
"By the time they detect something and notify FDA the product has already been eaten," said David Gombas, senior vice president for food safety and technology at United Fresh, in an interview with Food Safety News last summer, adding that it could be several weeks before a recall is initiated after a positive test. "They're not preventing anything. That produce is gone."
United Fresh, which represents the majority of the produce industry, has lobbied for eliminating the program, arguing that the MDP has strayed from its original mission, data collection, to regulatory and enforcement activities that are slow and unnecessary.
"Growers, processors are not notified at the time samples are taken. Most results are well past shelf-life," read the minutes of a United Fresh Food Safety & Technology Council meeting in January 2011. "Does a single sample positive make any sense to cause a recall without reported illnesses? We do not believe this program is adding to public safety. There must be other alternatives."
Tiny Program, Broad Impact
According a r
eport in the Chicago Tribune, which first flagged that the program was on the chopping block last summer, MDP tests have triggered at least 19 produce recalls in the past two years.
In the past couple of months, for example, MDP tests conducted by the Washington State Department of Agriculture sparked recalls of
bagged spinach and
jalapeno and serrano chili peppers, both for Salmonella.
Washington state's capacity for produce testing is a prime example of the impact MDP can have on the ground. In 2010, the WSDA's microbiology laboratory received $400,000 to implement produce testing for MDP, resources that state officials say also help boost local food safety oversight.
"It is unlikely that we would be able to continue the activity using existing state resources," said Kirk Robinson, Assistant Director at the Food Safety and Consumer Services Division, in July, adding that the lab would likely have to cut staff that are currently funded by the program. "This loss of staff could impact the timelines of work in response to foodborne illnesses outbreaks."
Robinson noted that the MDP funding helps WSDA improve testing infrastructure and laboratory equipment.
"Besides testing MDP samples, this equipment has been utilized for testing food and dairy products for regulatory purposes, and has successfully identified human pathogens in higher-risk foods on several occasions in the last few years," he said.
One state official estimated there is generally about a week of lag time between when a produce sample is collected from a distribution facility and when FDA might recall product that is confirmed positive.
According to an MDP document obtained by Food Safety News, between 2002 to 2011, MDP-participating laboratories analyzed approximately 121,000 fresh fruit and vegetable samples.
During this same time period, numerous pathogens were isolated from the produce samples tested by MDP: (128 Salmonella, (42 non-O157 ETEC, (97 non-O157 STEC, (2 E. coli O157:H7, and (4 Listeria monocytogenes, and throughout the decade of testing, MDP significantly improved the turnaround time on samples.
"Constantly refining procedures and adding technologies such as automated DNA extraction and real-time PCR has allowed MDP laboratories to reduce the time it takes from sample receipt to pathogen isolation from 14 days to as little as 5 days," according to the document, which outlined the program's accomplishments.
According to MDP, the program provides close to 90 percent of all available bacterial pathogen data for fruit and vegetables and is a "significant contributor" to CDC's PulseNet Database.
Vilsack in the Hot Seat
Last Friday, the debate over zeroing out MDP came to a head at a four-hour agriculture appropriations hearing, during which U.S Rep. Rosa DeLauro (D-CT grilled Agriculture Secretary Tom Vilsack over the cut.
"I think it's a critical program, I've always believed that, I've always advocated for it," said DeLauro, who pressed Vilsack to defend USDA's decision.
"It's a question of where it's appropriately funded," said Vilsack. "We don't think it's consistent with the mission of [the Agricultural Marketing Service]. That's the question. As we take a look at our budget, we've got to take a look at our core competencies and what is directly linked to our mission."
Citing the "disgrace" of the proposed food safety budget for the U.S. Food and Drug Administration, DeLauro continued to press Vilsack on the issue during two rounds of questioning. She said she believes the administration's budget showed their focus on food safety was "questionable."
DeLauro pointed out that, in the scheme of things, the MDP's budget is "not a lot of money" -- it "winds up being budget dust." The congresswoman also lambasted the idea that state and local governments pick up the slack on produce testing.
"Talk about resources! Go to any state effort. There are no resources there," she said. "We're not talking billions of dollars - like the numbers that get thrown around this institution for things that don't have the same kind of ability to save lives. Is this a program that's going to fall through the cracks and no one is going to pick it up?"
"I wish we would figure out how to take programs that work and provide a real difference and say that that's worth saving."
Vilsack responded saying he'd like to see FDA's budget increase by $4 million to absorb the program, but the austere fiscal situation means making tough choices. DeLauro promised to give USDA some suggestions for alternative cuts because, she said: "I am telling you, it's not going to happen at FDA."
"I will work with you. I will go through your budget. I will find a place where we can get $4.3 million to potentially save lives," added DeLauro. "That's what this piece does."
announced a recall of ASSI branch frozen oysters from South Korea, which has been linked to an outbreak of norovirus in the Pacific Northwest.
Now the Centers for Disease Control and Prevention (CDC reveals the story behind that recall in the February 17 edition of its Morbidity and Mortality Weekly Report (MMWR . It's a cautionary tale about a batch of contaminated oysters that could have made many more people sick had public health officials not been able to crack the case quickly.
On Oct. 19, 2011, the CDC relates, a woman in Washington state contacted Public Health - Seattle & King County and said she began suffering from acute gastroenteritis after dining at a local restaurant.
Staff members interviewed the woman and her companions and learned that three of the seven in the dinner party had eaten a raw oyster dish, and from 18 to 36 hours later experienced aches, nausea and diarrhea. One of the three also reported vomiting.
The four diners who did not eat the raw oysters did not become ill.
A stool specimen from one of the ill diners, collected 17 days after onset of symptoms, tested positive for norovirus.
Health department investigators collected eight 3-lb. bags of frozen raw oysters in the restaurant's walk-in freezer and sent them off to the Food and Drug Administration's Gulf Coast Seafood Laboratory for testing. They were positive for norovirus.
The frozen oysters, which had been distributed in seven states, had a two-year shelf life and could have made many other people ill -- freezing does not kill norovirus -- had they not been removed from circulation.
"Such contamination has potential for exposing persons widely dispersed in space and time, making cases difficult to identify or link through traditional complaint-based surveillance," the CDC authors wrote in the MMWR.
The CDC noted that it has recently launched a national electronic norovirus outbreak surveillance network, called CaliciNet, and recommends the collection of stool specimens to confirm a diagnosis, characterize the norovirus strain and upload the sequence results into CaliciNet.
"Additionally, all suspected and confirmed norovirus outbreaks should be reported to CDC by state and local health departments through the National Outbreak Reporting System," the authors advise.
Noroviruses are the most common cause of epidemic gastroenteritis, responsible for at least half of all gastroenteritis outbreaks worldwide, and a major cause of foodborne illness. In the United States, norovirus is estimated to cause about 21 million illnesses each year.
We Love Pharma, courtesy of CDM Worldwide
The pharmaceutical industry gets a bad rap. To listen to the critics you’d think pharmaceutical companies are in the same sleazy category as oil, finance and tobacco companies. But pharmaceutical companies invent life-saving medications, not to mention countless other psychoactive products that many of us enjoy on a recreational basis. Pharmaceutical companies get blamed for fraud, kickbacks, and research deaths, but they never get the credit for oxycontin.
That is why I was thrilled to see that GlaxoSmithKline is sponsoring the prize for the
British Medical Journal
‘s annual
Research Paper of the Year. Sure, the pharma-bashers will whine like infants at the
BMJ’
s decision to brand a medical research prize with the name of multinational drug company, just as they’re whining about an American editor’s decision to re-locate a leading bioethics journal to the Texas headquarters of a
stem cell tourism clinic. These people just don’t get it. This is not about propaganda or corruption. It is about developing innovative medications for diseases that we didn’t even know existed.
In that spirit, my nomination for the GlaxoSmithKline (GSK Research Paper of the Year goes to a ground-breaking article about GSK’s very own antidepressant, Paxil, which was published in the
Journal of the American Academy of Child and Adolescent Psychiatry
. The title of the article is “Efficacy of Paroxetine in the Treatment of Adolescent Major Depression,” but seasoned pharma-watchers know it better as
Study 329. The data behind Study 329 showed that Paxil didn’t actually work in adolescents – that, in fact, it was
no better than a sugar pill. However, as any marketer understands, bad data cannot be allowed to interfere with a good paper. By the time Study 329 appeared in print, GSK had used the magic of biostatistics to transform the raw data into a gleaming advertisement for Paxil. As a result, when FDA eventually decided that Paxil had a few minor side-effects,
such as suicide, Study 329 had already done its work: getting a GSK product into the hands of troubled teenagers. And wait, here’s the beauty part: although the published version of Study 329 was “authored” by leading academic psychiatrists, it was actually
written by a GSK ghostwriter.
Of course, the pharma-bashers have been complaining about Study 329 for years. Some of them even want the journal to retract it. The lead “author” who signed the paper, Martin Keller of Brown University, has been
beaten up by the Senate Finance Committee,
harassed by the New York attorney general, and vilified in the press, all because he put his name on a ghosted article and forgot to report
half a million dollars in pharmaceutical income. To which I say: stand strong, GSK. Ignore the naysayers and the nitpickers. It’s about time you gave these good people some public recognition. Yes, it’s true that Study 329 is eleven years old, but you’re paying the BMJ over $47,000 to
sponsor this prize. Surely they can bend the rules, just this once.
Category: Health News
Created: 2/21/2012 2:05:00 PM
Last Editorial Review: 2/22/2012
 |
In an unusual turn of events, the U.S. Food and Drug Administration (FDA has actually decided to aggressively protect public health rather than shield corporate profits by denying a recent request made by the Juice Products Association (JPA , a juice industry trade... |
The Missouri Department of Health and Senior Services received the following recall regarding Phenylephrine HCl Injection, USP, Lot 0693 due to potential safety concerns.
The product recall includes:
- Phenylephrine HCl Injection, USP, 1% (10mg/mL , 5 mL Vial NDC # 0517-0405-25, Lot # 0693, Exp Date: October, 2012.
Potential adverse events after intravenous administration of solutions containing particulates may include disruption of blood flow within small blood vessels in the lung, localized inflammation (swelling and redness , and granuloma formation.
Phenylephrine HCl Injection, USP is intended for the maintenance of an adequate level of blood pressure during spinal and inhalation anesthesia and for the treatment of vascular failure in shock, shock like states, and drug-induced hypotension, or hypersensitivity. It is also employed to overcome paroxysmal supraventricular tachycardia, to prolong spinal anesthesia, and as a vasoconstrictor in regional analgesia.
The product was distributed to wholesalers and distributors nationwide.
Hospitals, emergency rooms, clinics, and other healthcare facilities and providers should not use this product for patient care and should immediately quarantine any product for return.
The full recall announcement can be found at:
www.fda.gov/Safety/Recalls/ucm292951.htm?source=govdelivery.
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