FDA Denies Lycopene Supplement Health Claims

The U.S. Food and Drug Administration has determined that the antioxidant lycopene is not likely to reduce the risk of cancer.

Supplement maker American Longevity had sought FDA approval to make cancer-fighting claims for its lycopene supplements. But the agency concluded that "there is no credible evidence to support qualified health claims for lycopene, as a food ingredient, component of food, or as a dietary supplement, and reduced risk of any of the cancers in the petition."

The malignancies that are supposedly inhibited by lycopene -- an antioxidant found in red fruits such as tomatoes and watermelon -- include prostate, gastric, ovarian and pancreatic cancer. However, for each of these cancers, the FDA said a review of studies found there was "uncertain" or "little scientific evidence" that lycopene conferred any benefits.

Several years ago, the H.J. Heinz Co. took out full-page ads proclaiming the health benefits of lycopene, and ketchup sales rose 4 percent. The FDA ordered the company to stop the ads because such claims required the agency's approval, according to the Boston Globe.

The FDA's ability to regulate dietary supplements is limited. The agency can take action against any unsafe dietary supplement after it reaches the market. Manufacturers do not need to register their products with the FDA, or get FDA approval before producing or selling dietary supplements. However, manufacturers must make sure that product labels are "truthful and not misleading."

The FDA announced its decision on lycopene in a Nov. 8 letter to American Longevity.

In response, the San Diego-based company said it would sue the agency within 30 days. "It's a violation of the First Amendment. We have all the evidence to back up our claim, and we should be able to tell the public," said American Longevity spokeswoman Brooke Holve.

American Longevity fought a similar battle over the cancer-prevention claims made for the mineral selenium. The company's effort got the FDA to change its position in 2003, and it is hoping that the lawsuit will do the same for lycopene, Holve said.

Holve said the FDA now allows selenium supplements to say on the label that they "may reduce the risk of certain cancers. Some scientific evidence suggests that consumption of selenium may reduce certain forms of cancer." The label must also say: "The FDA has determined that this evidence is limited and not conclusive."

Dr. Michael Thun, vice president for epidemiology and surveillance research at the American Cancer Society, thinks that the position taken by the FDA on lycopene is well reasoned.

"The FDA is beset by companies hoping to make health claims," Thun said. "The FDA's reasoning for the decision was clearly laid out."

Thun said he also wonders whether the health claims made for lycopene truly come from lycopene. "Foods are complex mixtures, and it is a leap of faith to say that one substance in isolation is the reason for the benefit. In addition, things that come in the context of a complex food are different from things that come in isolation at a different dose," he said.

The FDA must ensure that health claims, either direct or implied, are adequately supported by evidence, Thun said. "The FDA clearly put a lot of work into this review," he said.

More information

The National Cancer Institute can tell you more about antioxidants and cancer.

Uncanny Canines Sense Oncoming Seizures

Four o'clock in the morning a little more than two weeks ago, Cheryl Huey of Monroe, La., felt herself being roused from sleep.

Chelsea, the new 2-year-old female golden retriever that Huey and her teenage son Taylor had just brought home the day before had run from his bedroom to hers and was now agitatedly pawing at her arm.

"I got up and went to Taylor's bedroom and said, 'Hey, looks like we got to take her outside, she needs to go to the bathroom,'" Huey recalled.

However, "About 10 minutes later we were out in the parking lot, and Taylor starts having a seizure," Huey said. Taylor, 16, has epilepsy and experiences a temporarily debilitating attack about once a month.

Because the onset of a seizure is unpredictable and injury is possible if her son falls or is otherwise hurt during an attack, Cheryl Huey decided to adopt Chelsea -- a dog specifically trained to alert epileptics to seizures before they occur -- to help protect Taylor and give him an independence he hadn't had before.

Witnessing Chelsea's ability to sense the onset of an attack even as Taylor lay sleeping was extraordinary, Huey said. "At the time, I just couldn't believe it," she said.

"Then, out in the parking lot after he had stopped the seizure, I told her 'Stay, Chelsea,' and she crawled across his body and lay on top of him as I ran inside to get help. When I came out again, she was still across his body -- part of her training is to just protect and stay with him."

Jennifer Arnold, founder and operator of nonprofit Canine Assistants, where Chelsea was born and trained, said seizure-alert dogs can also be taught to push a button to dial 911, tug open doors to run and get help, and even use their mouths to bring their human a cordless phone or any medication they might need.

"Seeing Chelsea's reaction that first time, the response she had, I now have confidence that in the event of a seizure she's going to be in charge," Huey said.

Taylor Huey's new companion is giving him new freedom and peace of mind, too. "She's going to make me more confident and independent, help me do more stuff by myself," he said.

That's not always easy for people with epilepsy, which is still a very poorly understood disorder.

"It's a chronic condition and [an attack] is literally an electric storm in the brain that can change behaviors," explained Dr. Blanca Vasquez, director of clinical research at New York University's Comprehensive Epilepsy Center. While seizures can vary greatly in their intensity and outward manifestations, many are preceded by sensations known as an aura, she said.

Even from far across a room, seizure-alert dogs seem to be able to pick up on extremely subtle physiological changes -- minute alterations in odor or movement -- that may begin anywhere from 45 to five or 10 minutes before an actual attack. "More research needs to be done," Arnold said. "We don't exactly know right now what the dogs are responding to."

But their ability to sense these changes for their owners can be invaluable, since early warning of a seizure's onset helps people with epilepsy find a safe environment or take precautionary measures.

The Labradors and retrievers trained by the experts at Alpharetta, Ga.-based Canine Assistants begin their 18 months of instruction at just 2 days of age, learning over 90 standard commands. More mysteriously, some protective measures seem to come to the dogs by instinct, Arnold said. For example, when sensing an oncoming seizure, "they tend to want their person to lie on the ground," she said.

As any person with epilepsy will tell you, that's about the most sensible action an individual can take before a seizure, since falling is the leading cause of serious injury during an attack.

"It's fascinating -- dogs who have never seen anyone have a seizure will tug at their person's sleeve, they want you on the ground," Arnold said. "How do they have that instinct that lying on the ground is safer? We have no idea."

Arnold's investment in Canine Assistants is a very personal one. Stricken with multiple sclerosis at 16, she was confined for a time to a wheelchair. Seeking to help his daughter, Arnold's father, now deceased, discovered that people were training dogs to help partially immobilized patients navigate the tasks of daily living.

Fortunately for Arnold, her MS has improved so she can walk again. But her experience, combined with a love of dogs, compelled her and her mother to start Canine Assistants in 1991. The company matches dogs with owners in need, charging no fees.

Right now, the seizure-alert arm of Canine Assistants is funded by pharmaceutical company UCB Pharma, Inc. Arnold's team also trains dogs to help individuals with other disorders such as Parkinson's disease, multiple sclerosis, muscular dystrophy and amyotrophic lateral sclerosis (ALS, or Lou Gehrig's disease).

And the ability of these canines to sense other, hidden health dangers is emerging, too.

"There are already dogs that have been anecdotally reported to be able to pick up on dangerously low blood sugar, including one of our own seizure-alert dogs," Arnold said. "And a service dog a few years ago alerted his owner in the middle of the night that he was having a heart attack in his sleep -- and then did it again for a stranger in a mall."

For people with epilepsy, having a four-legged, early warning system that can be taken everywhere gives them a sense of security and independence many haven't had before.

Taylor Huey said he hasn't yet decided whether he'll start taking Chelsea to school, but he certainly feels comfortable bringing her to daily outings such as church or shopping.

And Chelsea's arrival means Cheryl Huey can finally let her teenager go off on his own without worry.

"Sunday we went to the mall, and he went with me," she said. "I went to get my nails done and, as usual, I said 'Come on, Taylor.' He looked at me and said, 'No, it's OK, I've got Chelsea.' And I thought, 'Yeah, you do.' "

More information

Learn more about Canine Assistants.