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TN Attorney General Calling for FDA to Regulate E-Cigarettes

Press release from the Office of Tennessee Attorney General Bob Cooper; September 24, 2013:

Tennessee Attorney General Bob Cooper has joined 39 other attorneys general asking the FDA to place restrictions on advertising and sales to minors and ingredients contained in electronic cigarettes (e-cigarettes), which are growing increasingly popular as alternatives to traditional tobacco products.

The Attorneys General expressed their concerns in a bipartisan letter co-sponsored by the Massachusetts and Ohio Attorneys General asking the FDA to take all available measures to regulate e-cigarettes as “tobacco products” under the Tobacco Control Act. E-cigarettes, an increasingly widespread product that is growing rapidly among both youth and adults, are battery-operated products that heat liquid nicotine, derived from tobacco plants, into a vapor that is inhaled by the user.

State Attorneys General have fought for years to protect people from the dangers of tobacco products. In 1998, the attorneys general of 52 states and territories signed a landmark agreement with the four largest tobacco companies in the United States to recover billions of dollars in costs associated with smoking-related illnesses, and restrict cigarette advertising to prevent youth smoking.

Unlike traditional tobacco products, there are no federal age restrictions that would prevent children from obtaining e-cigarettes. Noting the growing use of e-cigarettes, and the growing prevalence of advertising, the letter highlights the need to protect youth from becoming addicted to nicotine through these new products.

“We are always concerned when a potentially dangerous product is being sold to the public without regulation,” Attorney General Cooper said. “This is especially alarming when companies attract youth to addictive products through advertising.”

The letter to the FDA notes that e-cigarettes manufacturers have used cartoon characters (banned by tobacco manufacturers for years) and fruit and candy flavors that are often attractive to young people. In addition, the e-cigarettes and refills of liquid nicotine solution can be obtained over the Internet without age verification.

A survey conducted by the Center for Disease Control and Prevention shows that from 2011 to 2012, the percentages of youth who have tried or currently use e-cigarettes both roughly doubled. The survey estimates that nearly 1.8 million middle and high school students have tried e-cigarettes in 2012.

According to the U.S. Surgeon General, nicotine is highly addictive and has immediate bio-chemical effects on the brain and body at any dosage, and is toxic in high doses. The lack of regulation of e-cigarettes puts youth at risk of developing a lifelong addiction to a potentially dangerous product that could also act as a gateway to using other tobacco products.

E-cigarette manufacturers are using marketing tactics similar to those big tobacco used in the last 50 to 100 years to attract new smokers. Celebrity endorsements, television advertising, cartoons, fruit flavors, attractive packaging and cheap prices all serve to encourage youth consumption of these dangerous products.

Additionally, some marketing claims lead consumers to believe these products do not contain the same level of toxins and carcinogens found in traditional cigarettes, cigars, and other tobacco products. Additionally, some marking claims imply that e-cigarettes are a safe alternative to smoking, when in fact nicotine is highly addictive, the health effects of e-cigarettes have not been adequately studied, and the ingredients are not regulated and may still contain carcinogens. The lack of regulation puts the public at risk because users of e-cigarettes are inhaling unknown chemicals with unknown effects.

The letter to the FDA can be found here: http://www.tn.gov/attorneygeneral/cases/ecigarettes/ecigaretteletter.pdf.

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TN Settles Claim Against Major Cosmetics Company Over Eyelash Products

Press release from the Office of Tennessee Attorney General Robert Cooper; August 14, 2013:

State officials are cautioning consumers to carefully read labels before purchasing cosmetics such as mascara whose marketers claim their products will grow “longer, thicker” eyelashes.

The precautions come as a result of two recent legal agreements with cosmetic companies who were allegedly using ingredients unapproved by the FDA in their products. Davidson County Circuit Court Judge Joe P. Binkley, Jr. has approved an agreement between the State of Tennessee and Peter Thomas Roth, LLC. The agreement resolves a lawsuit filed by the Attorney General’s Office and Tennessee Division of Consumer Affairs regarding allegations against cosmetic manufacturer Peter Thomas Roth, LLC over its marketing of the eyelash products “Lashes to Die For”, “Brows to Die For” and “Lashes to Die For Platinum.”

The eyelash products were marketed and sold in Tennessee as products that were allegedly designed to grow longer, thicker eyelashes. These products were sold at Sephora stores, or via the internet through Amazon.com. The State alleged that the products’ ability to grow eyelashes arises because they may contain an analog or derivative of the drug compound prostaglandin. If the products contain this drug compound, the State alleged that Peter Thomas Roth should have obtained FDA approval prior to marketing and selling the products in Tennessee, and should have made certain disclosures to consumers.

As part of the agreement, Peter Thomas Roth has voluntarily agreed to stop selling these and similar products in Tennessee without first obtaining approval from the FDA. Peter Thomas Roth denied wrongdoing.

“Although there were no complaints from Tennesseans,” Attorney General Cooper said, “we are satisfied the company agreed to stop sales and comply with the law before anyone could be harmed.”

Gary Cordell added, “We are pleased this matter has been resolved and that the State’s investigation commenced quickly so that Peter Thomas Roth’s sales to Tennessee consumers of the eyelash growth products were minimal.”

This is the second settlement the Attorney General and Division have entered into regarding eyelash products. The State also entered into a settlement with Nutra-luxe, LLC in February of 2013 involving their eyelash products called “Beautylash”. That settlement was approved by Judge Hamilton Gayden and a bankruptcy judge. In that case, the company also ceased selling the products. Their products were sold to Tennessee consumers via Amazon.com. Nutraluxe denied wrongdoing in the settlement documents. You can view the filings relating to the Peter Thomas Roth, LLC by going to: http://www.tn.gov/attorneygeneral/cases/roth/roth.html and the Nutraluxe filings by going to http://www.tn.gov/attorneygeneral/cases/nutraluxe/nutraluxe.html.

Consumers who have complaints about Peter Thomas Roth, LLC, or any individuals or businesses engaged in unfair or deceptive trade practices are encouraged to contact Consumer Affairs at either of the numbers listed above. Complaints also may be filed online at http://tn.gov/consumer/consCompFrm.shtml.

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FDA Admits Disseminating ‘Incorrect Data’ on Meningitis-Linked Facilities

Press release from the Tennessee Department of Health; October 23, 2012: 

NASHVILLE – The Food and Drug Administration has posted a message to its website citing some technical problems and incorrect data with a list of facilities earlier believed to have received suspect medication from the New England Compounding Center.

That list had been used by the Tennessee Department of Health and other state health departments to notify health care facilities they had received potentially unsafe injectable medications used in some eye and heart surgeries.

The FDA said it is working to correct the list and will repost it to the FDA website when staff members are sure it is accurate. The Tennessee Department of Health used the FDA-supplied information to identify 74 facilities in the state receiving suspect materials. TDH withdrew that information from its website today, and is now waiting to receive corrected information. If corrected information reveals facilities in Tennessee need to be notified, TDH will do so promptly. TDH believes the corrected list will identify significantly fewer Tennessee facilities affected by the recall.

The mission of the Tennessee Department of Health is to protect, promote and improve the health and prosperity of people in Tennessee. For more information about TDH services and programs, visit http://health.state.tn.us/.

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FDA: Possibility of Additional Problems with NECC Products

Press release from the Tennessee Department of Health; October 15, 2012: 

NASHVILLE – The Tennessee Department of Health and other state health departments across the United States today received information from the Food and Drug Administration that there is evidence indicating possible additional problems with products from the New England Compounding Center. To access the FDA announcement, please go to: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm323946.htm

As the FDA launches a national effort to notify clinicians about the possibility of additional materials from NECC which may pose a risk to patients, the Tennessee Department of Health will support this effort through outreach. TDH urges all Tennesseans to be alert to messages from their physician concerning possible exposure to products from NECC. FDA is advising a heightened awareness of any symptoms of infection in those persons who were exposed to NECC products.

The Tennessee Department of Health will use the Tennessee Health Alert Network and other avenues of communication to reach out to medical professionals statewide with this new information from FDA.

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Tennessee AG Pleased With FDA’s Assault on AEDs

Tennessee Attorney General Press Release, Nov. 17, 2010:

Robert Cooper Applauds FDA’s Warnings to Alcoholic Energy Drink Makers that Their Products are Unsafe

Attorney General Bob Cooper today joined several other Attorneys General and the City Attorney of San Francisco who expressed appreciation to the Food and Drug Administration’s (FDA) for warning the makers of alcoholic energy drinks (AEDs) that their products are unsafe.

The FDA announced today it has sent letters to the makers of four AED manufacturers, warning that adding caffeine to their alcoholic beverages makes them ‘unsafe.’ Such adulterated products are not approved by the FDA and are therefore unlawful, the FDA has warned the manufacturers.

AEDs are alcoholic beverages to which caffeine and other stimulants, such as guarana, have been added at the point of manufacture. Packaged in 23.5 ounce cans resembling energy drinks with fruit flavors like Fruit Punch, Lemonade and Watermelon, some AEDs such as the popular brands “Four Loko ” and “Joose” contain the alcohol equivalent of five or six beers and caffeine equaling four to five colas or up to two cups of coffee.

Last year, Attorney General Cooper joined other State Attorneys General and the San Francisco City Attorney in asking the FDA to determine that the use of caffeine in alcoholic beverages is not ‘Generally Recognized as Safe,’ or ‘GRAS,’ under FDA law. In support of that request, the Attorneys General submitted a report by experts in medicine, forensic toxicology, and public health documenting the dangers presented by these beverages, whose caffeine and other stimulant ingredients mask but do not offset alcohol intoxication.

In turn, the FDA informed AED manufacturers they had 30 days to submit data to dispute the experts’ findings, warning that if it determined that the use of caffeine in their alcoholic beverages is not GRAS, FDA would ensure that the products would be removed from the marketplace. Over the past year, medical and public health research has continued to confirm the dangers presented, particularly among young people with whom these beverages are most popular.

“This is a good first step to protect consumers and educate them to the dangers of combining alcohol and caffeine,” Attorney General Cooper said. “We appreciate the FDA’s actions and hope that consumers as well as manufacturers of these drinks heed the warnings.”

The Attorneys General have noted previously that young people appear to be targeted by the manufacturers and may mistakenly believe the caffeine will offset the effects of alcohol. The manufacturers have aggressively marketed their products on social network sites and college campuses that promote excessive drinking and enhanced abilities, the Attorneys General have said. The unfortunate consequences as cited by experts include reports of alcohol poisoning, serious injury including sexual assault, and hospitalizations.

Today’s actions follow a similar joint effort in 2008 when Attorneys General initiated investigations of the two leading manufacturers of AEDs at that time: MillerCoors Brewing and Anheuser-Busch. As a result, the companies agreed to stop making caffeinated alcoholic beverages altogether. However, smaller AED manufacturers introduced products packaged in larger containers (up to 23.5 ounces) and containing a higher percentage of alcohol (up to 12% alcohol by volume).

FDA’s warning letters require that the manufacturers take prompt action to correct their violations of federal law, and that failure to do so may result in enforcement action.

Anyone who has complaints with any business regarding unfair or deceptive conduct may contact the Tennessee Department of Commerce and Insurance, Division of Consumer Affairs at 1-800-342- 8385 or online at www.tn.gov/consumer/.