HEALTH

N.Y. health commissioner petitions FDA on behalf of nicotine-replacement therapies

BY Michael Johnsen

ALBANY, N.Y. The New York State health commissioner Richard Daines is currently pursuing a citizen’s petition with the Food and Drug Administration to sell nicotine-replacement therapies in single-dose convenient packs in an effort to make NRT products more competitive with cigarettes.

“We challenge the FDA to rethink its policies regarding nicotine replacement therapy,” Daines stated. “Under the current system, a smoker generally cannot buy safe nicotine in the same store where cigarettes are sold, and, even though most smokers buy cigarettes one day at a time, those who purchase safe nicotine must buy a one- or two-week supply costing $20 to $40. New York’s petition sets in motion a process requiring the FDA to critically examine how these products are now sold to smokers and how we can make them more readily available.”

“Many smokers are confused about the safety of nicotine patches, gum and lozenges, mistakenly believing that nicotine causes cancer or that patches are more likely than cigarettes to cause a heart attack,” noted Gary Giovino, professor of Health Behavior at the University of Buffalo. “By educating consumers and making these products more widely available, smokers will begin to see them as real alternatives to cigarettes and a product they can use to quit smoking altogether.”

Specifically, New York is petitioning the FDA to allow the sale of over-the-counter NRT products in all retail locations where cigarettes are sold, including convenience stores, gas stations, tobacco specialty stores, grocery stores, and other retail businesses that sell tobacco; to allow OTC NRT to be sold in “daily” units (containing an amount of NRT that would typically be consumed in a 24-hour period) at prices competitive with one 20-count pack of cigarettes and allow OTC NRT to be advantageously positioned near cigarettes and other tobacco products to promote the sale of OTC NRT products; and to modify labeling requirements to fully disclose to smokers the benefits of OTC NRT use relative to continued cigarette use, with risks associated with OTC NRT compared to risks associated with continued cigarette use.

The FDA has until the end of July to respond.

Anti-smoking products generated $495.4 million, down 1.8 percent across food, drug and mass (minus Wal-Mart) channels, according to the Nielsen Group for the 52 weeks ending Feb. 23. New convenience-oriented NRT products would arguably help bolsters sales for the category, especially, as the New York Commissioner predicts, that the new convenience offering would attract new users to the category.

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AMO introduces blink Tears eye drops

BY Michael Johnsen

SANTA ANA, Calif. Advanced Medical Optics on Monday announced the U.S. introduction of blink Tears, a new line of over-the-counter lubricating eye drops for the estimated 40 percent of Americans who suffer from occasional or chronic dry eye symptoms.

“The introduction of blink Tears lubricating eye drops is our first entree into the dry eye category and marks an important expansion of AMO’s complete refractive solution of eye care products,” stated AMO chairman and chief executive officer Jim Mazzo.

 “I believe that blink Tears will be a significant improvement to our treatment regimen for managing the symptoms of dry eye,” stated Eric Donnenfeld, who is in private practice with Ophthalmic Consultants of Long Island and is a trustee of Dartmouth Medical School. “The unique formulation of blink Tears distinguishes it from other currently available artificial tears because it can provide both a long duration of effect as well as superior visual clarity.”

AMO developed a formula for blink Tears lubricating eye drops that includes a blend of ingredients naturally found in the eye. Product benefits include: long-lasting relief with less blurring of vision; up to 60-minute moisture retention time; restored tear film with each blink; improved tear film stability; and adapts to an individual’s dry eye needs by thickening when the eye is open, and thinning when the eye blinks.

Dry eye syndrome is a common disorder of the tear film, afflicting especially those aged 40 years and older. Symptoms of dry eye may include redness, burning, itching, light sensitivity, excessive tearing, a gritty “foreign-body” feeling and dryness.

It is estimated that women are twice as likely as men to suffer from dry eye, especially as they grow older. Dry eye syndrome also can be associated with other illnesses or conditions. For example, people with diabetes or auto-immune diseases, such as rheumatoid arthritis or lupus, may be more susceptible to dry eye. Certain environmental factors can also aggravate dry eye, such as living in an arid climate. The dry air on planes can also make flying uncomfortable for those with dry eye.

One of the most common causes of dry eye syndrome is a dysfunction of the meibomian gland, which produces an oil that coats the eye. It is this oil, mixed with tears, which creates a healthy tear film that keeps one’s eyes properly lubricated. Without this oil, the eye compensates by producing more tears. But even with excessive tearing, a person’s eye is still left feeling dry, itchy, uncomfortable and even painful because the tear film’s moisture is out of balance.

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FDA issues consumer advisory for Total Body dietary supplement products

BY Michael Johnsen

ROCKVILLE, Md. The Food and Drug Administration on Friday advised consumers not to purchase or consume Total Body Formula in the flavors of Tropical Orange and Peach Nectar, or Total Body Mega Formula in the Orange/Tangerine flavor. The liquid dietary supplement products may cause severe adverse reactions, including significant hair loss, muscle cramps, diarrhea, joint pain and fatigue, the agency stated.

The Total Body Formula products are sold in eight-ounce and 32-ounce plastic bottles. The Total Body Mega Formula is sold in 32-ounce plastic bottles. Both products are distributed by Total Body Essential Nutrition of Atlanta. The company is the sole distributor of the products and has voluntarily recalled Total Body Formula in the flavors of Tropical Orange and Peach Nectar and Total Body Mega Formula in Orange/Tangerine flavor.

The Florida Department of Health recently provided reports to the FDA on 23 individuals who experienced serious reactions to these products seven to 10 days after ingestion. In all cases, the reactions included significant hair loss, muscle cramps, diarrhea, joint pain and fatigue. The FDA subsequently learned and is investigating a report that some individuals in Tennessee using the same products have experienced similar reactions.

FDA laboratories are analyzing samples of the products to identify the cause of the reactions, including the possibility that the products contain excessive amounts of selenium, which is known to cause symptoms such as those described in the adverse events reported to the agency. Selenium, a trace mineral, is needed only in small amounts for good health.

The products have been distributed in Alabama, California, Florida, Georgia, Kentucky, Louisiana, Michigan, Missouri, New Jersey, North Carolina, Ohio, Pennsylvania, Tennessee, Texas and Virginia.

The FDA is advising consumers in all states to avoid using the products immediately and to discard the products by placing them in a trash receptacle outside of the home.

Consumers who have been taking the products and have experienced adverse reactions should consult their health care professional.

The FDA is working with the Florida Department of Health in its investigation.

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