F.D.A. Cracks Down on Nestlé and Others Over Health Claims on Labels

The Food and Drug Administration on Wednesday released 17 warning letters to food manufacturers, making good on a vow to crack down on misleading labels on food packages.

The agency accused the companies of pumping up the nutritional claims of their products or masking contents like unhealthy fats. The letters went out to the makers of a broad array of products, including Gerber baby food, Juicy Juice, Dreyer’s ice cream, POM pomegranate juice and Gorton’s fish fillets.

“The F.D.A. is not merely firing a shot across the bow; it is declaring war on misleading food labeling,” said Bruce A. Silverglade, director of legal affairs of the Center for Science in the Public Interest, an advocacy group that had pushed for stricter rules.

The warning letters followed commitments last fall by the F.D.A. commissioner, Margaret A. Hamburg, who has made a priority of improving information for consumers on food packages.

Asked about the warning letters, Scott Faber, vice president for federal affairs at the Grocery Manufacturers Association, pointed to an open letter from Dr. Hamburg to the industry that was also released on Wednesday. In that letter, she pledged cooperation with food manufacturers in improving labeling.

“What’s significant today is that Commissioner Hamburg took the extra step of reinforcing her commitment to work with industry to develop a clear, science-based labeling system that is effective with consumers,” Mr. Faber said. The letters, sent last month but just made public, addressed a range of violations.

Several products were singled out for labels that boasted prominently that they contained no trans fat, even though they had high levels of saturated fat. The products included Gorton’s Fish Fillets, Spectrum Organic All Vegetable Shortening and two products from Dreyer’s, the Dibs bite-size ice cream snacks and the vanilla-fudge Drumsticks.

According to Dreyer’s, the Dibs contain 17 grams of saturated fat per serving. Federal guidelines recommend that a person not consume more than 20 grams in a day.

In the case of POM pomegranate juice, the agency said that the company’s Web site, which is listed on its bottles, carried misleading claims that the juice could prevent or cure diseases like hypertension, diabetes and cancer.

Such claims are not allowed on food products and would require that the juice be treated, in regulatory terms, as a drug, according to the letter sent to the company.

POM said that “all statements made in connection with POM products are true” and supported by scientific research.

It added, “We are currently reviewing the F.D.A.’s concerns and, as strong advocates of honest labeling and fair advertising, we are looking forward to working with the agency to resolve this matter.”

The letters also singled out some baby foods made by Gerber and Beech-Nut. The letters say that those foods make numerous health claims that are not allowed because appropriate dietary levels for the nutrients cited have not been established for children under 2 years old.

The F.D.A. said that the labels of some Nestlé Juicy Juice products implied they were primarily made of a single juice, like orange or tangerine, rather than a flavored blend of juices.

Nestlé, which owns Juicy Juice, said that it believed its labels complied with regulations but that it was working with the F.D.A. Dreyer’s and Gerber, which are also owned by Nestlé, said they were cooperating with the F.D.A. and would not comment beyond that.

Efforts to reach several companies were not successful.

Source: nytimes

2 million faulty needles recalled by FDA

Needles can push bits of silicone from injection ports into patients' bodies

WASHINGTON - Federal health officials announced the recall of 2 million medical needles Tuesday because of a risk they can push bits of silicone into patients' bodies.

The Food and Drug Administration said Japanese manufacturer Nipro Medical Corp. has voluntarily recalled its Exel/Exelint Huber needles manufactured between January 2007 and August 2009.

The needles are used to access injection ports, which are devices implanted beneath the skin of patients who require frequent injections. The ports connect to a vein and allow easy delivery of chemotherapy, antibiotics and other injectable drugs.

Huber needles are designed to be non-coring, or to penetrate an injected material without retaining any of it.

However, a monthslong FDA investigation found that the needles can dislodge bits of silicone from the ports, potentially pushing them into the patient's bloodstream. The problem can also damage the ports themselves, resulting in problems delivering drug therapy.

60 to 72 percent had design flaw
An inspection at Nipro's manufacturing plant in Japan found that 60 to 72 percent of the company's needles had the design problem, according to the FDA.

"The agency's laboratory work helped determine the coring problem, and we will continue to work with manufacturers to address coring issues as quickly and thoroughly as possible," said Dr. Jeffrey Shuren, FDA's director of medical devices.

Huber needles have been approved in the U.S. since 1984, according to the FDA.

FDA officials told reporters Tuesday they are working with 19 other manufacturers to determine if their needles have the same problem. The agency estimates 6 million Huber needles are sold in the U.S. each year.

According to FDA regulatory specialist Mary Brooks, there have been no reports of silicone shards in patients, though it may be difficult for doctors to identify the problem.

Tuesday's announcement was the second mass recall from Nipro Medical in less than a week. On Thursday the company recalled 15 lots of GlucoPro Insulin Syringes because of a defect that can cause the needles to detach.

FDA advised hospitals and doctors to stop using the Huber needles and return them to Los Angeles-based Exel International, which distributed the products in the U.S. The company can be reached at 1-800-940-3935.

A spokesman for Exel said the company hopes to wrap up the recall within 30 days.

The FDA made several recommendations to physicians when using other Huber needles, including: watching for signs of tissue or nerve damage in patients, which could be a sign of damage to an injection port. The agency also suggested throwing out the first syringe injected into a port, in an effort to discard any bits of silicone.