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Showing posts with label fda. Show all posts
Showing posts with label fda. Show all posts

Tuesday, August 17, 2010

Independent Toxicologists Issue Warning: Urgent Concerns Regarding FDA Recommendations to Open Offshore Shrimp Fisheries

/PRNewswire/ -- Attorney Stuart H. Smith, representing the United Commercial Fishermen's Association, the Louisiana Environmental Action Network, public and private entities, and citizens harmed by the BP oil catastrophe, today issued this statement:

"Independent water and seafood testing and analyses by Gulf Oil Disaster Recovery experts reveal that highly toxic chemicals remain in the water and food chain. These toxins pose a significant risk to marine reproduction and human consumption of Gulf seafood.

"The greatest concern is the presence of chemicals known as PAHs (or polynuclear aromatic hydrocarbons), which have carcinogenic properties. Our studies have shown that PAHs are present in shrimp from the impacted Gulf areas of the spill at 10 times the levels found in shrimp from inland, low-impacted areas.

"Further, BP's use of dispersants at 5000 feet below the sea surface caused PAHs and other toxic substances to remain in the seawater. This means biodegradation of the toxins in crude oil is greatly reduced. It could be at least 8 months before the toxic soup we are seeing in the Gulf experiences significant biodegradation, due to low temperatures, lack of sunlight, and other factors.

"Moreover, we have major concerns about FDA disclosures regarding seafood safety. The decisions to re-open commercial fishing in selected off-shore areas affects thousands of seafood consumers of shrimp in Louisiana and Mississippi. However, these decisions were based upon as few as a single shrimp sample from Louisiana offshore waters, and two shrimp samples from Mississippi offshore waters (rendered as composites from 12 shrimp), with detectable PAH levels present in all shrimp samples.

"We vigorously refute FDA claims that they have performed sufficient sampling to declare shrimp from this area safe for consumption. The result may have been for state authorities to issue premature shrimp harvesting area re-openings, based on flawed FDA recommendations. Given the potential public health issues at stake, this is a major cause for concern.

"Therefore, I am releasing several statements by toxicologist Dr. William Sawyer, as well as supporting material, which address these issues in greater detail. Official documents from FDA confirm that the recommendations to re-open selected areas for commercial harvesting were based on insufficient samples for state authorities to render responsible decisions. A thorough review of all available FDA test results to date further confirm our findings."

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Tuesday, September 22, 2009

Candy and Fruit Flavored Cigarettes Now Illegal in United States; Step is First Under New Tobacco Law

The U.S. Food and Drug Administration announced today a ban on cigarettes with flavors characterizing fruit, candy, or clove. The ban, authorized by the new Family Smoking Prevention and Tobacco Control Act, is part of a national effort by the FDA to reduce smoking in America. Smoking is the leading preventable cause of death in America.

The FDA's ban on candy and fruit-flavored cigarettes, effective today, highlights the importance of reducing the number of children who start to smoke, and who become addicted to dangerous tobacco products. The FDA is also examining options for regulating both menthol cigarettes and flavored tobacco products other than cigarettes.

"Almost 90 percent of adult smokers start smoking as teenagers. These flavored cigarettes are a gateway for many children and young adults to become regular smokers," said FDA Commissioner Margaret A. Hamburg, M.D. "The FDA will utilize regulatory authority to reduce the burden of illness and death caused by tobacco products to enhance our Nation's public health."

Flavors make cigarettes and other tobacco products more appealing to youth. Studies have shown that 17 year old smokers are three times as likely to use flavored cigarettes as smokers over the age of 25.1

"Flavored cigarettes attract and allure kids into lifetime addiction," said U.S. Department of Health and Human Services Assistant Secretary for Health Howard K. Koh, M.D., M.P.H. "FDA's ban on these cigarettes will break that cycle for the more than 3,600 young people who start smoking daily."

The FDA is taking several steps to enforce the ban. A letter recently sent to the tobacco industry provided information about the law, and explained that any company who continues to make, ship or sell such products may be subject to FDA enforcement actions.

The FDA has also made available today an advisory to parents on the risks associated with flavored tobacco products.

"Youth are twice as likely to report seeing advertising for these flavored products as adults are," said Dr. Joshua Sharfstein, a pediatrician and the FDA Principal Deputy Commissioner. "Marketing campaigns for products with sweet candy and fruit flavors can mislead young people into thinking that these products are less addictive and less harmful."

The FDA encourages consumers to report continuing sales of flavored cigarettes through a special tobacco hotline (1-877-CTP-1373) and Web site (www.fda.gov/flavoredtobacco).

Parents and consumers can learn more about the risks of flavored tobacco products at www.fda.gov/ .


Footnote:

1 Klein SM, Giovino GA, Barker DC, Tworek C, Cummings KM, O'Connor RJ. Use of flavored cigarettes among older adolescent and adult smokers: United States, 2004-2005. Nicotine Tob Res. 2008;10(7):1209-14.

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