FDA Advises Against Consumption of American Lobster (Maine Lobster) Tomalley

The U.S. Food and Drug Administration today warned consumers to avoid eating tomalley in American Lobster (Maine Lobster), regardless of where the lobster was harvested, because of potential contamination with dangerous levels of the toxins that cause Paralytic Shellfish Poisoning (PSP).

American lobster, also known as Maine lobster, are harvested from the waters of the Atlantic Ocean from Northeastern Canada to South Carolina, inclusive.

The FDA advisory applies only to tomalley, the soft, green substance found in the body cavity of the lobster that functions as the liver and pancreas. Cooking does not eliminate the PSP toxins. However, studies have shown that, even when high levels of PSP toxins are present in lobster tomalley, lobster meat itself is typically unaffected.

Symptoms of PSP include tingling and/or numbness of the mouth, face or neck; muscle weakness; headache; and nausea. In extreme cases, when large amounts of the toxin are consumed, these symptoms can lead to respiratory failure and death. Symptoms usually occur within two hours of exposure to the toxin. Anyone experiencing these symptoms should seek medical attention.

PSP toxins normally occur from time to time in clams and other shellfish and are carefully monitored by state regulatory authorities. The FDA learned of this problem after routine sampling conducted by regulatory authorities in Maine and New Hampshire found dangerous levels of the toxins in lobster tomalley. Some shellfish beds have been closed in recent months due to elevated levels of PSP toxins.

Lobster tomalley normally does not contain dangerous levels of PSP toxins. The current high levels of PSP toxins likely are associated with an ongoing red tide episode in northern New England and eastern Canada. Authorities in Maine, Massachusetts and New Hampshire, as well as in Canada, have issued advisories cautioning against eating tomalley.

U.S. Grown Jalapeño and Serrano Peppers Not Connected to Salmonella Saintpaul Outbreak

The U.S. Food and Drug Administration is advising consumers that jalapeño and Serrano peppers grown in the United States are not connected with the current Salmonella Saintpaul outbreak.

However, the FDA continues to advise consumers to avoid raw jalapeño peppers--and the food that contains them--if they have been grown, harvested or packed in Mexico.

In addition to domestically grown raw jalapeño peppers, commercially canned, pickled and cooked jalapeño peppers from any and all geographic locations also are not connected with the current Salmonella Saintpaul outbreak.

The FDA is working with state regulatory agencies and food industry groups that represent restaurants, grocery stores and wholesalers to ensure everyone clearly understands this new, more narrow, advisory. The FDA will continue to refine its consumer guidance as the agency’s investigation continues.

The more narrow advisory the FDA is issuing today (July 25, 2008) is based on evidence gathered during a multi-week, intensive investigation conducted in partnership with the U.S. Centers for Disease Control and Prevention and public health authorities in several U.S. states to find the source of the contamination that led to the outbreak. The collective review of the current traceback investigation and harvesting dates, matched with the dates that people became ill, have combined to indicate that the contaminated jalapeño pepper originated in Mexico.

Additional traceback and traceforward information obtained last week has led to the determination that the Agricola Zarigoza produce-distribution center in McAllen, Texas--from where FDA took the positive jalapeño pepper sample--was not the original source of the contamination.

The FDA is continuing to advise that people in high-risk populations, such as elderly persons, infants and people with impaired immune systems, avoid eating raw Serrano peppers from Mexico or food made from raw Serrano peppers from Mexico until further notice.

Class Action Charges Botox Killed, Injured Consume

TT Note: We've always wondered about potential dangers with the popular use of botox injections. This story really made the hair on our heads stand up. We knew you'd want to read it as well.

Botox users and their families have filed a class action lawsuit against Allergan, claiming the company failed to adequately warn users of the drug's dangers....

Read the story.

HHS Announces New International Programs to Enhance Drug and Food Safety Joint Inspections with European Union and Australian Regulators

HHS Announces New International Programs to Enhance Drug and Food Safety Joint Inspections with European Union and Australian Regulators; Third-Party Certification Program Are Latest Steps toward Implementing New Import Strategy

U.S. Health and Human Services (HHS) Secretary Mike Leavitt today announced two groundbreaking programs designed to enhance the safety of food and medical products exported to the United States.

"These programs will significantly increase our collaboration with international and private sector partners to enhance the safety of imported food and medical products," Secretary Leavitt said. "Working together, we intend to offer expedited access to those products shown to
meet our standards and to focus more of our resources on those products that present higher risks."

Secretary Leavitt made the announcement in a speech to hundreds of industry leaders at an Import Safety Summit in Washington. He described the twin initiatives as the latest steps in a fundamental, government-wide shift to implement the Interagency Import Safety Action Plan finalized in November 2007. Historically, U.S. authorities have primarily relied on intervening at the border to intercept unsafe goods.

The new strategy calls for actively working with trading partners to help ensure they build quality into every step of a product's life cycle, targeting critical points where risk is greatest, and focusing attention and resources on these areas.

The first initiative is a pilot project the HHS Food and Drug Administration (FDA) is undertaking with its counterparts in the European Union and Australia to jointly plan, allocate for and conduct inspections of drug-manufacturing facilities. The project will initially focus on makers of active pharmaceutical ingredients. If successful, this program could expand to include other types of manufacturing facilities. The novel collaboration will allow HHS/FDA to
more fully take advantage of information gathered by trusted inspection and regulatory systems in other countries.

The second initiative is a third-party certification pilot program involving aquacultured (farm-raised) shrimp. HHS/FDA is seeking the participation of certification bodies that currently certify foreign processors of aquacultured shrimp for compliance with the FDA's seafood regulations. The project is designed to help HHS/FDA learn how to evaluate third-party certification programs and implement them in the field -- a key part of leveraging the additional resources of the private sector and other regulators.

Americans Eating More Processed Sugar, Study Finds

Americans are getting more than 10 percent of their daily calories from fructose, used mainly in sugar-sweetened beverages and processed foods, a new study finds.

The study, analyzing the amount and sources of dietary fructose consumption among U.S. children and adults from 1988 to 1994, was published in the July 9, 2008 issue of The Medscape Journal of Medicine.

Fructose occurs naturally in fruits and vegetables, however, it is added to many processed foods as table sugar (sucrose) and high-fructose corn syrup.

"Measurement of fructose consumption is important because growing evidence suggests that it may play a role in health outcomes," says lead study author Miriam Vos, MD, MSPH, assistant professor of pediatrics, Emory University School of Medicine.

Vos and colleagues examined fructose consumption patterns by sex, age group, race/ethnicity, socioeconomic status and body mass index for 21,483 U.S. children and adults. They used a single 24-hour dietary recall administered in the third National Health and Examination Survey (NHANES), the only nationally representative survey in the past 20 years to include fructose content as a reported variable.

The study found that U.S. children and adults consumed 54.7 grams of fructose per day, an almost 50 percent increase from a national study sample conducted in 1977-1978, which estimated mean consumption of fructose at 37 grams per day.

Fructose consumption was highest among adolescents ages 12 to18 at 72.8 grams per day. Among racial and ethnic groups, non-Hispanic blacks consumed the most fructose at 57.7 grams per day, or 11 percent of total calories. Normal-weight participants (56.2 grams) consumed more fructose than obese persons (51.1 grams). And those in the highest-income category consumed less of their total calories from fructose than those in the lowest-income category.

The largest source of fructose was sugar-sweetened beverages (30.1 percent), followed by grains, which include processed foods such as cakes, pies and snacks, breads and cereals (21.5 percent), and fruit or fruit juices (19.4 percent).

"Short-term studies have shown that fructose can elevate plasma triglycerides," says Vos. "Further surveillance and research are needed to assess trends in fructose consumption and to develop a better understanding of the health impact of this common additive in the food supply."

India's Public and Private Sectors Should Unite to Address Diabetes Epidemic

Central and state governments as well as private industry and universities are among some of the groups that should unite to enact policy changes addressing India's growing diabetes epidemic, say leading U.S. and global diabetes researchers.

The researchers include Karen Siegel, MPH, a research associate at MATRIX Public Health Solutions, Inc., K. M. Venkat Narayan, MD, MSc, MBA, of Emory University's Rollins School of Public Health, and Sanjay Kinra of the London School of Hygiene and Tropical Medicine in the United Kingdom. Their recommendations for diabetes prevention and control policies in India are published in the July 8, 2008 issue of Health Affairs.

"Diabetes is part of a larger global epidemic of noncommunicable diseases," says Narayan. "Because these diseases share many risk factors, policies that encourage healthy eating and active living will prevent not only diabetes, but also obesity, cardiovascular disease, chronic respiratory illnesses and diet-related cancers. An integrated system can maximize disease prevention while avoiding the need to develop separate courses of action."

India is currently home to 35 million people with diabetes, a number that is expected to double by the year 2025. This places a large burden on India's health system, and threatens to cripple the country's rapidly growing economy. The World Health Organization estimates that India will lose $237 billion in national income due to diabetes, stroke and heart disease.

Siegel, lead author of the paper, adds, "Economic growth policies aimed at transforming India into a developed nation by 2030 are contributing to escalating diabetes rates that threaten to cripple the rapidly emerging economy. Research shows that diabetes is preventable through physical activity and healthy eating, but current conditions in India promote sedentary lifestyles and unhealthy eating.

"Updated policies and comprehensive action to address diabetes are needed to incorporate health as a national priority, and to encourage healthy lifestyles as well as economic growth," says Siegel.

Among the policy recommendations proposed by Siegel and Narayan are comprehensive, multisectoral national actions that address diabetes risk factors.

Players, they say, should include central/state governments, multilateral organizations, private sector, nongovernmental organizations, academics and researchers, public-private partnerships, health care sector and the media.

Siegel and Narayan also recommend "best buys" for diabetes prevention and treatment based on impact, cost and effectiveness, including:

• Working with the private sector to encourage investments in employee health Promoting physical activity, especially active transport
• Modifying agricultural policies and practices to encourage consumption of fruits and vegetables
• Creating research and development policies that focus on innovative ways to deliver affordable fruits and vegetables on a mass scale
• Spearheading national efforts to reduce salt, fat and sugar in processed foods
• Building capacity in public health schools, medical schools and other institutions

'Natural' On The Label Can Be Misleading

TT Note: Yet another reason not to believe everything you hear--

The government has some very precise rules about what food can be labeled "organic." But there are few real rules to govern the use of "natural," and the result, food producers warn, can lead to consumer confusion......

Read the story.