Entries in FDA (9)


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


Sour Lemons: Consumer Group Accuses 4 Brands of Watered-Down Juice

Top Photo Group/Thinkstock(NEW YORK) -- Bottled lemon juice is a $100 million business but the National Consumers League is asking the Food and Drug Administration to put the squeeze on four brands that the group says are passing off a watered-down product as 100 percent lemon juice.

The National Consumers League tested samples of four different products labeled 100 percent lemon juice.

After testing two bottles each of NaturaLemon 100 percent Lemon Juice from concentrate -- Natural Strength, Lira 100 percent Lemon Juice from concentrate, Lemon Time Lemon Juice from concentrate and Pampa -- the group’s lab found that NaturaLemon contained about 35 percent lemon juice; Lira, about 25 percent; Lemon Time, about 15 percent; and Pampa, just 10 percent.

“We wrote them [the FDA] in March,” said Sally Greenberg, the executive director of the National Consumers League. “We haven’t heard anything. When the FDA doesn’t respond and they have got everything together -- all the evidence there -- it sends a signal to the industry that you can cheat consumers and you can rip them off and nothing is going to happen.”

The FDA prohibits adding excessive water to juice.

Greenberg said these companies take the risk of cheating consumers to save money.

“Lemons are expensive,” she said. “Unscrupulous companies decide ‘Hey, we’re going to save ourselves a lot of money. We are going to mislabel the product and we’re going to rip consumers off. In the meantime, we are going to pocket the change.’”

ABC News found these four brands in discount stores and dollar stores.

“They are marketed to those kinds of stores, to people who don’t have a lot of money to spend and may not have enough information,” she said.

Castella Imports, the distributor of Lira, said that its product met the government definition of lemon juice.

“The product’s ingredients include lemon juice from concentrate, water, citric acid and lemon oil, along with preservatives and emulsifiers -- ingredients that are listed clearly on the label and all of which are included in the U.S. Food & Drug Administration’s Code of Federal Regulation for ingredients in lemon juice.

“Furthermore, our lab tests indicate that Lira contains appropriate concentrations of dissolved lemon solids to meet the FDA definition of lemon juice.  There is no intent to mislead consumers and in fact, we are currently seeking FDA approval of revised front-of-package labeling that we hope will clear up any questions consumers might have,” Castella said in a statement to ABC News.

NaturaLemon’s distributor said that it would investigate the NCL’s claims.

“We are very surprised at this result and we are investigating. We’ve been in business for over 30 years and we have a perfect reputation in the industry."

“Again, we are very surprised and investigating,” said Hope Iovine, the general manager of Sirob Imports.

Calls to the other products’ distributors and manufacturers were not returned.

Copyright 2012 ABC News Radio


British Pharma Company Seeks FDA Approval for Marijuana Drug

Brand X Pictures/Thinkstock(LONDON) -- A British pharmaceutical wants the F.D.A. to approve the world's first "prescription" drug developed from key ingredients of marijuana.

It would be a medical milestone that would give some legitimacy to a plant that's caused so much controversy in this country. GW Pharmaceuticals of Britain has developed a mouth spray called "Sativex", that contains marijuana's two best known psychoactive ingredients, Delta-9 T-H-C and cannabinoids. The drug has already been approved in Canada, New Zealand, and eight European countries for relieving muscle spasms in patients with multiple sclerosis.

The drug company is in advanced trials to get the spray approved in the U.S. as treatment for severe cancer pain.

Copyright 2012 ABC News Radio´╗┐


Coca-Cola Admits Its Orange Juice Contains Fungicide

Ramin Talaie/Bloomberg via Getty Images(ATLANTA) -- Coca-Cola has come out as the company that recently notified the Food and Drug Administration that some of the orange juice it imports from Brazil contains low levels of the fungicide carbendazim, which is used to control fungi or fungal spores.

The soft drink maker told on both itself and a competitor, fueling the FDA to conduct tests on all orange juice entering the U.S.

On Wednesday, the agency told ABC News preliminary results from three samples of imported O.J. turned up negative.  The FDA added that it currently has 30 additional samples pending, which include juice from Brazil, Mexico and Canada.

Coke, which makes Simply Orange and Minute Maid, hasn’t said which of its brands contains the fungicide that’s not approved for use in the U.S.

While the Environmental Protection Agency says that the amount of carbendazim found in the drink is not harmful, future prices for orange juice sank on Wednesday because of perceived effects on demand.

Even though shipments of orange juice from overseas are being stopped at the border for inspection, there's been no move to pull cartons of O.J. from stores shelves in the U.S.

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


FDA Finds Unsanitary Conditions at Kellogg's Cookie Plant

Scott Olson/Getty Images(ATLANTA) -- FDA investigators discovered unsanitary conditions, flies and dangerous bacteria earlier this year at a factory that makes Keebler and Famous Amos cookies.
In a June 7 letter sent to Kellogg’s, the director of the FDA’s Atlanta office warned that foods made at the company’s cookie factory in Augusta, Ga., “have been prepared, packed, or held under unsanitary conditions whereby they may have become contaminated with filth.” More troubling, agency investigators also found Listeria monocytogenes throughout the facility.
Harmless to most people, Listeria can be a serious health risk for children, pregnant women and the elderly.

Kellogg's Company spokesman Kris Charles told ABC News in an email that the plant “produces a variety of Keebler and Famous Amos cookies.”

“While the FDA did not identify specific concerns with the food, we take this situation very seriously,” Charles wrote. "We have undertaken a number of aggressive actions to address their concerns including comprehensive cleaning and extensive testing. We have confidence in the safety of our food.”

The FDA said baking the cookies would be likely to kill the bacteria but went on to warn Kellogg’s, “the positive environmental swabs are indicators of insanitary conditions in your facility and demonstrate a failure of cleaning and sanitation operations that may allow for contamination of foods with filth or pathogens.”
This is not Kellogg’s first problem with Listeria in Georgia. In 2009, as reported by ABC News and others, Kellogg’s shut down and sanitized an Eggo frozen waffle plant in Atlanta after discovering Listeria monocytegenes.

Copyright 2011 ABC News Radio


Four Loko Manufacturer to Remove Caffeine from Products

Photo Courtesy - ABC News/WABC-TV New York(CHICAGO) -- Phusion Projects, the manufacturer of the caffeinated alcoholic drink Four Loko, announced Tuesday that it will reformulate its products, removing caffeine from its drinks.  The company's announcement comes just as the Food and Drug Administration is set to ban Four Loko.

Along with the removal of caffeine, Phusion Projects will also extract guarana and taurine from its products nationwide.

In a statement, the company's three co-founders said, "We are taking this step after trying – unsuccessfully – to navigate a difficult and politically-charged regulatory environment at both the state and federal levels."

The FDA's position on caffeinated alcoholic drinks could come as early as Wednesday.  Four states -- Washington, Michigan, Utah and Oklahoma -- have already banned Four Loko in response to several recent incidents in which college students were hospitalized after consuming the drink.´╗┐

Copyright 2010 ABC News Radio


GlaxoSmithKline to Pay $750 Million in Federal Health Care Fraud Settlement

Photo Courtesy - Getty Images(BOSTON) -- GlaxoSmithKline has agreed to plead guilty and pay a massive fine totaling $750 million to the federal government and the states to resolve allegations that the company caused false claims to be submitted to government health care programs for certain quantities of adulterated Kytril, Bactroban, Paxil CR and Avandamet. 

The federal government argues that "GSK sold certain batches, lots or portions of lots of drugs," that possessed a strength, purity or quality "which fell materially below" that which was specified in the drugs' FDA applications.  Consequently, the government says GSK "knowingly caused false and/or fraudulent claims to be submitted" to Medicaid and other federal health care programs.

"Adulterated drugs undermine the integrity of the FDA's approval process, can introduce substandard or ineffective drugs on to the market and, in the worst cases, can potentially put patients' health at risk," said Tony West, Civil Division Assistant Attorney General for the Department of Justice.

The Justice Department says this settlement is part of the government's ongoing effort to battle health care fraud under the False Claims Act.  The law has helped the government to recover $4.2 billion in cases related to federal health care fraud since January 2009.

Copyright 2010 ABC News Radio

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