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FDA Urges a New Diet Coke Label

Posted on December 25, 2008 by | Leave a comment

FDA Urges a New Diet Coke Label
By BETSY MCKAY

The Food and Drug Administration called on Coca-Cola Co. to revise the label on a version of its Diet Coke brand containing vitamins and minerals, warning the beverage giant that it makes inappropriate nutritional claims, according to a warning later posted on the agency’s Web site Tuesday.

The FDA said the soft drink, Diet Coke Plus, doesn’t contain enough nutrients to qualify for use of the word “plus.” Foods may use that name only if they contain at least 10% more of the reference daily intake or daily reference value of a nutrient than a similar product. The FDA also invoked a longstanding rule under which it “does not consider it appropriate” to fortify snack foods such as carbonated beverages.
[Regulators say Diet Coke Plus lacks enough nutrients to justify the word plus.] The Coca-Cola Company

Regulators say Diet Coke Plus lacks enough nutrients to justify the word “plus.”

The warning letter, sent to Coke Dec. 10, comes as a growing number of nutrient-enhanced beverages, from energy drinks to enhanced waters, have appeared on store shelves, putting pressure on the FDA to police more aggressively the claims many of the products make about the benefits they can deliver.

Coke isn’t the only company to add nutrients to a soft drink. Cadbury PLC marketed a fortified version of 7UP with calcium, fruit juice and Vitamin C four years ago, and PepsiCo Inc. currently sells Diet Pepsi Max, a diet soda with ginseng.

The FDA called on Coke to “take prompt action to correct these violations” and asked the company to respond within 15 days of receipt of the letter.

A Coke spokesman, Scott Williamson, said the company will respond to the FDA in early January, but that it has no plans to change the label.

“We take seriously the issues raised by the FDA in its letter,” he said. “This does not involve any health or safety issues, and we believe the label on Diet Coke Plus complies with FDA’s policies and regulations.”

Coke launched Diet Coke Plus in March 2007 as a calorie-free soft drink and “a good source of vitamins B3, B6, and B12, and the minerals zinc and magnesium,” according to a press release. The drink hasn’t been a huge hit, however, selling the equivalent of 10.2 million 8-ounce cases in 2007, compared with 990 million 8-ounce cases of Diet Coke that year, according to Beverage Digest, an industry publication and data service.

Write to Betsy McKay at betsy.mckay@wsj.com

http://online.wsj.com/article/SB123008190500032001.html?mod=googlenews_wsj

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FDA Unveils List of 20 Drugs In Side-Effect Probes

Posted on September 5, 2008 by | 3 Comments

FDA Unveils List of 20 Drugs
In Side-Effect Probes-

Goal Is to Provide  Signs of Possibility  Of Adverse Effects
By JARED A. FAVOLE
September 5, 2008

WASHINGTON — The Food and Drug Administration on Friday unveiled a report listing 20 drugs that the agency is investigating for potential side effects, as part of a new policy to warn patients and health-care professionals as early as possible.

The list includes a wide array of drugs, from Eli Lilly & Co.’s antidepressant Cymbalta to Purdue Pharma LP’s painkiller Oxycontin. It also addresses a range of adverse reactions, including cardiac arrest, cancer and Purple Glove Syndrome, which can result in patients having their arms amputated. (See the FDA’s list of drugs that are under investigation.)

The FDA has already sent out warnings about a handful of the drugs on the list. The report lists TNF blockers — such as Johnson & Johnson‘s Remicade — as being potentially associated with cancer in children. In June, the FDA said it was investigating the possible link. TNF blockers target a compound known as tumor necrosis factor, which is overproduced in many patients with inflammatory diseases like arthritis and Crohn’s.

But there appear to be new ones, too. The report lists Biogen Idec Inc. and Elan Corp.’s multiple-sclerosis treatment Tysabri as potentially being associated with skin cancer. Medical journals have reported cases of melanoma in patients taking Tysabri, but the FDA hasn’t previously said it was investigating the drug for this side effect…..read more here.

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FDA Warns Companies to Stop Selling Fake Cancer Cures

Posted on June 17, 2008 by | 2 Comments

FDA Warns Companies to Stop Selling Fake Cancer Cures
Fraudulent products present a safety hazard to the public, agency says

Posted June 17, 2008

 
By Steven Reinberg
HealthDay Reporter

TUESDAY, June 17 (HealthDay News) — The U.S. Food and Drug Administration has sent letters warning more than two dozen companies to stop selling fraudulent products that claim to prevent or cure cancer.

The agency is also cautioning consumers not to buy or use these products, which include tablets, teas, tonics, black salves, and creams, and are sold under various names on the Internet.

“Health fraud has been around for years, and it is a cruel form of greed,” David Elder, director of FDA’s Office of Enforcement in the Office of Regulatory Affairs, said during a morning teleconference Tuesday. “Fraud involving cancer treatments can be especially heartbreaking.”

The warning letters, sent to 23 U.S. companies and one Canadian and one Australian company, cover 125 unapproved products with labeling claims to cure, treat or prevent cancer. “These claims are unproven, unreliable, and they are unkind to the patient who is seeking help,” Elder said.

Elder said the FDA is concerned that some of the products present a safety hazard to consumers. “Others can interfere with medicines that a patient has already taken. And they could be used to forgo medically acceptable treatment plans,” he said.

The bogus cures include ingredients such as bloodroot, shark cartilage, coral calcium, cesium, ellagic acid, Cat’s Claw, an herbal tea called Essiac, and mushrooms such as Agaricus Blazeii, Shitake, Maitake, and Reishi, the FDA said.

“These products pose either a direct health risk to consumers because the products themselves can cause harm, or a serious indirect health risk because the products are marketed for a serious disease, in this case cancer,” Michael Levy, director of FDA’s Division of New Drugs and Labeling Compliance in the Office of Compliance, said during the teleconference.

For example, so-called black salve products, touted to treat skin cancer, can be particularly hazardous, Levy said. “Black salve products essentially burn off layers of the skin and are supposed to also burn away skin cancer,” he said. “But what we have seen is that it actually burns away healthy skin. There is documented evidence of black salve products destroying large parts of people’s skin and the underlying tissue.”

Levy also said the FDA is concerned that consumers will purchase these products instead of products that are proven to be safe and effective.

Elder said: “As a result of these warning letters, FDA expects prompt and complete corrective action. Firms that don’t heed the warnings we have delivered, and other firms marketing similar unapproved products, may face further regulatory action from the agency.”

According to the FDA, the fraudulent claims found on the products include:

  • “Treats all forms of cancer.”
  • “Causes cancer cells to commit suicide!”
  • “80% more effective than the world’s number one cancer drug.”
  • “Skin cancers disappear.”
  • “Target cancer cells while leaving healthy cells alone.”
  • “Shrinks malignant tumors.”
  • “Avoid painful surgery, radiotherapy, chemotherapy, or other conventional treatments.”

Companies that don’t stop these violations can have their products seized or injunctions placed upon them and also are liable for criminal charges, according to the agency.

More information

For more on fake cancer cures, visit the U.S. Food and Drug Administration.

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Posted in Alternative, Diseases, Drugs, Health & Fitness, Herbal Medicine, Longevitiy, Medicine, Politics and Medicine, Survival, Vitamins, Wellness, Women's Health

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Consumers Union Weighs In On Drug Ads

Posted on June 1, 2008 by | 1 Comment

Wants ads to include 800 number to report side effects

TV ads for prescription drugs are already required to list potential side effects, but Consumers Union says that mandate doesn’t go quite far enough. It wants the ads to also include a toll-free number and a website address where consumers can report serious side effects.

CU says it’s not an unreasonable request. By law, print ads for drugs are required to include a toll-free number and website address for Medwatch, the FDA’s database that tracks incidents of adverse effects of prescription medications. The same requirement, the group argues, should apply to drug ads on TV.

The FDA has two years to study and issue a recommendation on the appropriateness of including such information in direct-to-consumer television spots.

“Two years is too long to study whether the FDA should expand to television what is already required for print ads,” said Elizabeth Foley, policy advocate for Consumers Union. “We urge the FDA to complete this study as soon as possible and extend the requirement to TV ads.”

Expanding the reporting notice to TV would inform a wider audience, according to CU, allowing the FDA to get a more comprehensive picture of the possible risks of medications and better monitor drug safety.

In February, a Consumers Union poll found that among consumers who had taken a prescription drug, one in six (16 percent) had experienced a serious drug side effect, and only 35 percent were aware that serious side effects could be reported to the FDA.

Eight in 10 (81 percent) said they had seen or heard an ad for prescription drugs within the past 30 days, but virtually all — 98 percent — had viewed an ad on television. Respondents felt overwhelmingly — 87 percent — that TV ads should include information to report adverse reactions to the FDA.

“Considering the risks that may emerge after a drug is approved and comes on the market, we believe it is critical that consumers have a simple and understandable way to report serious side effects they experience,” said Foley.

“We urge the FDA to require this information be included in television ads as soon as possible. The more information that is available about potentially harmful drug side effects, the better the FDA will be able to evaluate risks and inform health care professionals and consumers so they, in turn, can make better informed healthcare decisions.”

Spending on direct-to-consumer advertising has soared since the FDA relaxed rules on drugs ads in 1997. In 2006 and 2007 alone, spending on prescription advertising topped $10 billion.

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Cold Medicines Risky for Babies and Toddlers

Posted on January 22, 2008 by | Leave a comment

WASHINGTON — Parents shouldn’t give babies and toddlers over-the-counter cough and cold medicines because they are too risky for children so small, the government will declare today.

The Food and Drug Administration still hasn’t decided if the remedies are appropriate for older children to continue using, officials told the Associated Press.

Expect a decision on that by spring, the deadline necessary to notify manufacturers before they begin production for next fall’s cold season.

The FDA is issuing a public health advisory today to warn parents to avoid these drugs for children under age 2 “because serious and potentially life-threatening side effects can occur.”

It isn’t the first warning about cold remedies and tots: Drug companies last October quit selling dozens of versions targeted to babies and toddlers. That same month, the FDA’s own scientific advisers voted that the drugs don’t work in small children and shouldn’t be used in anyone under age 6.

Today’s advisory marks the government’s first official ruling on the issue: Don’t give the drugs to children under 2. And it comes now because the FDA is worried that parents haven’t gotten that message despite the publicity last fall.

They may still have infant-targeted drugs at home, or they may buy drugs meant for older children to give to tots instead, said Charles Ganley, the FDA’s nonprescription drugs chief.

Dr. Ganley said he is concerned by recent surveys that suggest many parents don’t believe over-the-counter cold remedies could pose a problem, especially if they have used them with an older child who seemed to get better.

Copyright © 2008 Associated Press

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