Showing posts with label Food and Drug Administration. Show all posts
Showing posts with label Food and Drug Administration. Show all posts

Thursday, September 13, 2018

FDA's good deed: protecting kids from e-cigs -- Sept. 13, 2018 column


By MARSHA MERCER

Remember Joe Camel? In the 1980s and 1990s, anti-smoking advocates blamed the cartoon figure for encouraging kids to smoke.

R.J. Reynolds insisted it was not marketing to children but in 1997 pulled ads for Camel cigarettes that portrayed the “Smooth character.” The White House praised the company’s decision.  

“We must put tobacco ads like Joe Camel out of our children’s reach forever,” President Bill Clinton said.

Twenty-one years later, President Donald Trump’s administration blames flavored e-cigarettes for encouraging kids to vape.

“We cannot allow a whole new generation to become addicted to nicotine,” Dr. Scott Gottlieb, commissioner of the Food and Drug Administration, declared Wednesday.

Those were welcome words from an administration that’s been busier rolling back regulations than proposing new ones to protect health.

In some ways, foes of tobacco have won. After decades of anti-smoking messages that cigarettes are dirty and smelly, only about 16 percent of American adults smoke.

But e-cigarettes present a new health danger in part because they look nothing like conventional cigarettes. Some sleek nicotine-delivery systems resemble a flash drive and can be charged in a computer’s USB port.

“Experience freedom from ash and odor. No mess. No fuss,” Juul Labs, the dominate e-cigarette maker with 72 percent of the market, says on its website.

E-cigarettes do not have the harmful chemicals of regular cigarettes, but some provide as much addictive nicotine as a pack of cigarettes.

“The developing adolescent brain is particularly vulnerable to addiction,” FDA said in a statement. 

That makes e-cigs “an almost ubiquitous – and dangerous – trend among teens,” Gottlieb said. “The disturbing and accelerating trajectory of use we’re seeing in youth, and the resulting path to addiction, must end. It’s simply not tolerable.”

More than two million middle and high school students used e-cigarettes last year, he said, as he announced a series of measures aimed at stopping the “epidemic” of teen vaping.

The FDA sent more than 1,100 warning letters to stores for the illegal sale of e-cigarettes to young people under 18 and issued 131 fines to stores that continued selling to minors.

The agency also gave Juul and four other manufacturers 60 days to prove they can keep the devices out of kids’ hands. If they don’t, the FDA threatened to pull flavored products off the market.

Trump’s FDA last year extended an Obama-era deadline for review of most e-cigarette products from August of last year to 2022. Public health and anti-smoking groups are fighting the extension in court. If e-cigarette companies fail to improve their products voluntarily, Gottlieb said, he may reconsider the longer deadline.

E-cigarette makers insist they are not marketing to children. But that’s what tobacco companies argued – both in company statements and at congressional hearings – before Joe Camel was put out to pasture.

The Vapor Technology Association, the industry’s trade group, says the products are designed for adults who want to quit smoking, and companies want to keep e-cigarettes away from minors. Vaping is safer than conventional cigarettes, the industry contends, and FDA’s actions could make public health worse by sending millions of ex-smokers back to conventional cigarettes.

The potential for helping adults quit smoking makes this war on nicotine more complicated than simply killing a cartoon character.

The administration is “committed to advancing policies that promote the potential of e-cigarettes to help adult smokers move away from combustible cigarettes,” Gottlieb said, but “that work can’t come at the expense of kids.”

Critics of FDA’s campaign called the agency’s measures a gift to the tobacco industry, which has found e-cigarettes a tough competitor. Tobacco stocks surged on the FDA news.

Health and anti-smoking groups praised the FDA’s plan, but said more needs to be done sooner rather than later. Campaign for Tobacco-Free Kids wants an immediate ban on all flavored e-cigarettes.

A generation ago, a tobacco company recognized Joe Camel was a public relations nightmare and needed to take a hike.  

E-cigarette companies need to recognize their own p.r. disaster. To prove their products are only for adults, they should ditch sweet flavors like mango, fruit medley and cool cucumber. That would be kid friendly.

©2018 Marsha Mercer. All rights reserved.
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Thursday, June 18, 2015

Freedom's not another word for trans fats -- June 18, 2015 column

By MARSHA MERCER
When the founding fathers talked about freedom, they never envisioned artery-clogging trans fats or the microwave popcorn, frozen pizzas and other processed foods that contain them.
But when the federal government started slow-walking toward a ban of artificial trans fats, critics invoked the freedom to eat whatever they please, regardless of the cost to their health, as if it were guaranteed by the Constitution.
The conservative Heritage Foundation warned about “Government Control of Your Diet: Threats to `Freedom to Eat,’” in a 2013 issue brief about the evils of nutrition information on menus and of food bans.
“There are some lines the government should never cross. This certainly includes seeking to control what people eat,” wrote Daren Bakst, research fellow in agricultural policy at Heritage.
Even if you agree, it’s hard to argue with the many medical studies since 1993 that have linked partially hydrogenated oils and heart disease. Trans fats raise LDL or “bad” cholesterol and lower the HDL or “good” cholesterol, increasing the risk of heart disease, the leading cause of death in the United States.  
The federal government estimates that eliminating trans fats could prevent 20,000 heart attacks and 7,000 heart-disease deaths a year in the United States.
Other countries -- Denmark, Austria, Hungary, Norway, Iceland and Switzerland – already have set limits on trans fats. In California, a 2008 law limits trans fats in restaurants. The cities of New York, Boston and Philadelphia have similar measures.
But our federal government moves with glacial speed. On Tuesday, the Food and Drug Administration finally ordered food manufacturers to stop using trans fats -- unless they get approval for the additive – by June 18, 2018.
Critics say the new rule is ridiculous and unnecessary. Since 2006, food manufacturers have been required to list trans fats on Nutrition Facts labels, and they voluntarily cut the amount. Heeding consumer demand, many large companies -- including Wal-Mart, Starbucks and McDonalds – have cut trans fats.
Trans fat consumption dropped nearly 80 percent between 2003 and 2012, but current intake is still a health concern as there’s no safe level of trans fats, FDA said.
Public health groups were joyful about FDA’s announcement, and manufacturers were relieved to have three more years to reformulate their products. The cost to manufacturers is estimated at $6.2 billion but the benefit in reduced medical costs is $140 billion over 20 years, FDA estimated.
The idea of adding hydrogen to oil to make a solid fat was a 20th century invention that brought us Crisco as an alternative to lard. Trans fat won the hearts of food manufacturers, bakeries and restaurants because it inexpensively extends shelf life, improves texture and enhances taste.
At first it was thought that trans fat would also be healthier than natural saturated fats, but over time medical studies showed otherwise.
To avoid trans fats, check a product’s ingredient list for partially hydrogenated oils. Even if the Nutrition Facts label lists “0 grams” of trans fats, the product can have half a gram per serving, and that can add up. Besides pizza and microwave popcorn, trans fats are found in frostings, packaged pies, stick margarines and coffee creamers.   
Conservatives view FDA’s rule as more overreach by the Obama administration, a shove down the slippery slope to give government more power over what we eat.
Critics argue that everything from nutrition labels and calorie counts at restaurants to capping the size of sugary drinks infringes on personal freedom, as former New York Mayor Michael Bloomberg learned when he tried to limit drink size. Ultimately, the state’s highest court said no.
Last November, voters in Berkeley, Calif., overwhelmingly passed a 1-cent per ounce tax on sugary drinks to be added to drink distributors’ business license fees.
In Texas, though, the new agriculture commissioner, Sid Miller, favors allowing school districts to bring back deep fat fryers and soft drinks. The state banned both in public schools a decade ago.
“It’s not about french fries; it’s about freedom,” Miller says.
Really? Even Crisco has modernized and greatly reduced its trans fat content. For most of us, freedom means good health.    
©2015 Marsha Mercer. All rights reserved.
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