Entries in Food and Drug Administration (3)


FDA May Regulate Premium Cigars

iStockphoto/Thinkstock(WASHINGTON) -- Are big, fat, $10-a-piece cigars catnip to children?  That's one question the Food and Drug Administration is mulling as it considers whether or not -- or how -- to regulate the sale of premium cigars.

Makers and sellers of such cigars, understandably nervous, are pushing preemptive legislation in Congress that would force the FDA to butt out.

Arthur Zaretsky, who runs The Famous Smoke Shop in Forks Township, Pa., says that while the feds have yet to specify what regulations might be imposed, "the whole industry is quaking in its boots."

Zaretsky and other tobacconists fear two possibilities:

First, to ensure that no cigars are sold to minors, the FDA might prohibit all cigar sales except those made face-to-face.  Sales via mail order or the Internet would be forbidden.  That change alone, Zaretsky says, would snuff out 99 percent of his business.

Second, the FDA might mandate that cigars be sold the same way prescription drugs are sold in pharmacies: The customer, instead of strolling into a warm and fragrant humidor, where he could smell and handle a profusion of cigars, would be handed an antiseptic list, from which he would place his order.  This already is the way cigars are sold by some tobacconists in Canada and Europe, says Brian Telford, owner of Telford's Pipe & Cigar in Mill Valley, Calif.

What would be the reason for such a rule?  Telford speculates it might be to protect the impressionable youth from the blandishments of colorful or seductive packaging -- in the same way that cigarette manufacturers now are forbidden from using kid-friendly cartoon characters to market cigarettes.

But are kids really attracted to pungent, pricey, all-tobacco, hand-made, premium cigars?  Stogie-defenders say no.

They acknowledge there has been an uptick in sales to younger smokers of small, cheap, machine-made cigars flavored with additives like licorice or vanilla.  But the customer for "real" cigars, they say, is older.

Merchants who sell premium cigars want to distance themselves, for regulatory purposes, from purveyors of cheaper, more kid-friendly stuff.

To protect themselves, makers and sellers of premium cigars have sponsored -- though a group called Cigar Rights of America -- two bills in Congress, S. 1461 and H.R. 1639, that would stop the FDA from regulating what the legislation calls "traditional large and premium cigars," as distinct from "little cigars."  Sponsors include Sens. Marco Rubio, R-Fla., and Bill Nelson, D-Fla.

The FDA, for its part, says on its website that it is "developing a strategy to regulate additional categories of tobacco products" beyond those it already does, which include cigarettes and smokeless tobacco (e.g., snuff and chewing tobacco).  The site says the agency is moving "as expeditiously as possible" to release for public comment a new rule applicable to additional forms of tobacco, which, presumably, would include cigars.

Asked by ABC News if any date has been set for that release, an FDA spokesperson said no.

Zaretsky says a meeting has been scheduled between the FDA and Cigar Rights of America for Aug. 23.

Copyright 2012 ABC News Radio


Feds: GlaxoSmithKline to Pay $3B for Illegally Marketing Drugs

GLAXOSMITHKLINE/AFP/Getty Images(WASHINGTON) -- Heathcare giant GlaxoSmithKline has agreed to an unprecedented $3 billion settlement with the U.S. government over allegations that the company advertised drugs for uses not approved by the Food and Drug Administration and then used lavish gifts to convince doctors to prescribe the drugs.

In one instance, a drug was widely promoted to help treat depression even though the FDA had never tested it for such a use, according to the Department of Justice.  The multi-billion dollar settlement is the largest in U.S. history for alleged healthcare fraud, government officials said.

GlaxoSmithKline, or GSK, is a major manufacturer of prescription medication, vaccines and consumer healthcare products.  On its website, the company boasts, "every minute more than 1,100 prescriptions are written for GSK products."

In a 2011 Corporate Responsbility Report, GSK addressed the government's allegations broadly, saying, "Some people are concerned that marketing by pharmaceutical companies may exert undue influence on doctors, that sales representatives may not always give doctors full information about the products they are promoting, or that there may be promotion of medicines for unapproved uses."

GSK goes on in that document to say that the company has "fundamentally changed our procedures for compliance, marketing and selling in the USA to ensure that we operate with high standards of integrity and that we conduct our business openly and transparently."

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Copyright 2012 ABC News Radio


McDonald's Dumps McMuffin Egg Factory over Health Concerns

Tim Boyle/Getty Images(NEW YORK) -- McDonald's will be looking for a new source of eggs for many of its hugely popular Egg McMuffins.

The fast food company says it "will no longer accept" eggs from one of the country's biggest egg companies, Sparboe Farms.  The egg producer is the subject of an ABC News investigation to be broadcast Friday on 20/20 and World News with Diane Sawyer, and was cited Thursday by the Food and Drug Administration for "significant…and serious violations" in the production of eggs.

In one of the most forceful enforcement actions since last year's salmonella egg outbreak, the FDA issued a company-wide warning letter to Sparboe Farms, the country's fifth-largest egg producer.  Citing "serious" and "significant violations" at five different locations, the FDA noted at least 13 violations of the recently-enacted federal egg rule meant to prevent dangerous salmonella outbreaks.

"This is a warning that there is a systemic problem, not just at one barn or one location," said former FDA food safety chief David Acheson, now an industry consultant.

The ABC News broadcast will include undercover video taken over the summer inside Sparboe facilities in three states by an animal rights group, Mercy for Animals.  The footage appears to show unsanitary conditions and repeated acts of animal cruelty.

Until Friday, the Sparboe facility in Vincent, Iowa had produced all eggs used by McDonald's restaurants west of the Mississippi River.  In its statement, McDonald's said its decision to discontinue its relationship with Sparboe was based on concerns about "the management of Sparboe facilities."

"McDonald's expects all of our suppliers to meet our stringent requirements for delivering high quality food prepared in a humane and responsible manner," the company said in a statement released overnight to ABC News.

The Mercy for Animals activist who went undercover to record the video inside Sparboe told ABC News chief investigative correspondent Brian Ross, "I saw workers do horrendous things to birds, they were thrown, grabbed by the neck, they're slammed in and out of cages."

Nathan Runkle, the executive director of Mercy for Animals, said the video shows how health hazards can be linked to large-scale, low-cost egg producers, so-called "factory farms."

"They're the model of efficiency but they place an emphasis on profit over animal welfare," said Runkle, who says he and his members eat no animal products because of the animal cruelty they have seen.

Sparboe executives told Ross the employees seen on the tape abusing the chickens were all fired.

"We have a zero tolerance policy," said Ken Klippen, Sparboe's director of government relations.  "People who violate that policy, we take that very seriously."

On a one-hour guided tour of the Sparboe facility in Vincent, Iowa, the source of all McDonald's eggs for restaurants west of the Mississippi, Klippen told Ross the Sparboe's facilities are "state of the art.

Sparboe has never had a single egg or chicken detected with salmonella, said Klippen, who added "there was no cause for any enforcement action."

A 2010 salmonella outbreak in the U.S. affected more than 1,900 people and was traced to a different Iowa egg producer, Wright County Eggs.  More than a half-billion eggs had to be destroyed, and the episode produced a nationwide health scare over the safety of eggs.

Salmonella in eggs is easily killed when both the white and the yolk are cooked until they are hard.  Many of those sickened last year ate custard at a California catering hall that used eggs from Wright County Eggs.

Since that outbreak, federal authorities promised stepped-up inspections and enforcement, and FDA officials said this week's action against Sparboe Farms was part of that effort.

McDonald's says its customers should have no health concerns because all of it eggs are thoroughly cooked before being sold.

"This is not a food safety issue for our menu items," McDonald's said in its statement.  "We can assure our customers that eggs in our entire supply chain meet McDonald's high standards for quality and safety."

As to the allegations of animal cruelty, a spokesperson said the behavior seen on videos provided by 20/20 was "disturbing and completely unacceptable."

Copyright 2011 ABC News Radio

ABC News Radio