FDA Issues New Dietary Supplement Safety Rules

(HealthDay News) -- After years of pressure from consumer advocates to do so, the U.S. Food and Drug Administration announced Friday that it was tightening up its oversight of dietary supplements.

Firms that make vitamins, herbals and other supplements must now test their products to ensure they aren't contaminated and must include the ingredients listed on the label, FDA officials said.

"This is a critical component of FDA's implementation of the Dietary Supplement Health and Education (DSHEA) act that was passed by congress in 1994," Robert E. Brackett, director of the FDA's Center for Food Safety and Applied Nutrition, said during a late morning teleconference.

Under the act, manufacturers are responsible for making sure that their claims about their products are substantiated by adequate evidence, Brackett said. "This is to show the claims are truthful and not misleading," he added.

The move comes on the heels of recent scandals centered on adulterated supplements. Last year, the FDA discovered that some supplements contained undeclared active ingredients found in prescription Erectile dysfunction drugs, according to the Associated Press. In other cases, supplements were found to have lower levels of vitamins A or C than what was claimed on the label.

In the past, critics have slammed the FDA's approach to supplements as woefully ineffective. Since dietary supplements are considered food supplements and not drugs, they do not fall under the stricter FDA guidelines for drug safety and efficacy -- even though many people use them like drugs, or instead of drugs, to stave off or treat illness, with sometimes deadly consequences.

Consumer groups described the FDA's new efforts to rein in the $22 billion supplements industry as too little, too late.

Friday's move "not only is 13 years late but will not do anything to ensure that dietary supplements are safe or effective -- a critical necessity," Dr. Sidney M. Wolfe, director of the Public Citizen Health Research Group, said in a statement. Wolfe noted that, under the new rule, large manufacturers have a year to comply, and smaller firms have been given a three-year window.

And another advocacy group, Consumers Union, which publishes Consumer Reports, was similarly unimpressed. "This new rule requires dietary supplement makers follow procedures to ensure that their products contain the type and amount of ingredients on the label. However, consumers still have no idea if a given product works, or whether it is dangerous," the group's senior counsel, Janell Mayo Duncan, said in a statement.

The FDA's Brackett said that since the 1994 rule, supplement makers have been required to meet FDA standards set for food manufacturers. However, these new regulations are designed specifically for the supplement industry, he said.

"These rules also apply to supplements made outside the United States," Vasilios Frankos, the FDA's division director of the Office of Dietary Supplements, added during the teleconference.
"Under the rule, manufacturers of dietary supplements are required to evaluate the identity, purity, strength, and composition of their products," Frankos said. Should supplements contain contaminants or not contain the ingredients they say they contain, the FDA would consider these products to be "adulterated or misbranded," he said.

The purpose of the rule is to prevent manufacturers from including wrong ingredients or too much or too little of a dietary ingredient, Frankos noted. In addition, the rule puts the burden on manufacturers to be sure that their products are not contaminated by toxins, bacteria, pesticides, glass, lead and other heavy metals, or improperly packaged or labeled, he said.

In addition, the rule includes requirements for quality control procedures, designing and constructing manufacturing plants, and testing ingredients and finished products. It also includes requirements for record-keeping and handling of consumer complaints.

The FDA is also issuing an interim final rule that outlines a petition process for manufacturers to request an exemption to the good manufacturing practices requirement for 100 percent testing of specific dietary ingredients used in the processing of dietary supplements.

Under the proposed rule, manufacturers may be exempted from the dietary ingredient testing if there is documentation that reducing the frequency of testing still ensures the identity of the dietary ingredient.

The final good manufacturing practices and the interim final rule go into effect Aug. 24, with a three-year phase-in period. Companies with more than 500 employees have until June 2008 to comply; companies with fewer than 500 employees have until June 2009 to comply; and companies with fewer than 20 employees have until June 2010 to comply, Frankos explained.

One group representing industry, the Council for Responsible Nutrition, is cautiously optimistic about the new FDA rule.

"We are optimistic that these new dietary supplement good manufacturing practices will enhance consumer confidence in these popular products by raising the bar on production standards, helping ensure quality, and leveling the playing field for all dietary supplement companies," Steve Mister, the groups president and CEO, said in a prepared statement.

"I'm sure we won't agree with everything in the rule, but we are pleased that the new good manufacturing practices are here, as it's a step forward for our industry," he added.

More information
For more information on dietary supplements, visit the U.S. Food and Drug Administration.

Health Tip: Feeding Picky Eaters

(HealthDay News) -- Many children are finicky about what they'll eat. If you're attempting to coax a picky eater to try more foods, follow these suggestions from the University of California, San Francisco:

Give your child a variety of foods to choose from, including a fruit, vegetable, protein and starch. Don't only offer foods you know your child will eat.

Don't give your child too many high-calorie drinks, which could fill her up and keep her from wanting to eat.

Stick to a meal schedule, so that your child will be hungry at mealtime.

Keep meals pleasant, in an environment free of TV, argument or stressful conversation.

If your child won't eat, don't prepare a different meal just to satisfy her. She'll have another opportunity to eat at her next meal in a few hours.

Continue offering your child foods that she has once refused. Her eating habits may change.

Girls Who Like Dad Favor Partners Who Look Like Him

(HealthDay News) -- Women who had a good childhood relationship with their father are more likely to choose partners who resemble their father, new research suggests.

The study, published in the July issue of the journal Evolution and Human Behavior by British and Polish psychologists, also found that women who had a negative/less positive childhood relationship with their father weren't attracted to men who looked like their father.

The researchers had 49 Polish women (eldest daughters) look at pictures of 15 faces and choose the one they found most attractive. Their selections were compared to their fathers' faces. The women were also asked to rate their childhood relationship with their father.

The findings offer new insight into how people select partners and the effect that parents have on the process, the researchers said. Until recently, it was believed that this parental influence was a passive process. But this study adds to growing evidence that it's actually an active process.

The results of this study "show for certain that the quality of a daughter's relationship with her father has an impact on whom she finds attractive. It shows our human brains don't simply build prototypes of the ideal face based on those we see around us, rather they build them based on those to whom we have a strongly positive relationship. We can now say that daughters who have very positive childhood relationships with their fathers choose men with similar facial characteristics to their fathers," study author Dr. Lynda Boothroyd of Durham University said in a prepared statement.

More information
There's more on the mental health of children and adults at The National Institute of Mental Health.

Hollywood Headaches Are Flights of Fancy

(HealthDay News) -- Headaches don't kill. But you'd never know it if you relied on Hollywood for your medical information, researchers contend in a new report.

From a gracefully dying Bette Davis in the classic tearjerker "Dark Victory" to a doomed Nicole Kidman as Virginia Woolf in "The Hours," films have portrayed headaches as much worse than they are in real life, the researchers said. And this could leave an unsuspecting public with a distorted sense of headaches and their threat.

"A lot of people with headaches in the movies end up dead," said study co-author Dr. Katherine Henry, an associate professor of neurology at New York University School of Medicine. "That sends a frightening message to moviegoers."

Researchers have devoted significant time in recent years to analyzing how movies portray medical conditions such as comas and epilepsy. Not surprisingly, they are rarely benign.

In the new study, researchers searched the Internet Movie Database for movies that mentioned headaches in their descriptions. They found just 23 films made between 1931 and 2005.

Some of the movies are classics (including the Joanne Woodward multiple-personality drama "The Three Faces of Eve" and the James Cagney gangster flick "White Heat") or recent semi-hits ("Garden State" and "Dark Water"). Others are obscure, including a 1990 movie called "Dark Romances Vol. 1" that the researchers were only able to find by special order.

The researchers watched the movies to see if they accurately portrayed headaches. About half of the characters with headaches suffered melodramatic deaths, many of which were violent.
The Cagney character in 1949's "White Heat," for example, died in a fiery explosion at a chemical plant, yelling the famous line "Made it, Ma! Top of the world!" Kidman's Virginia Woolf character in 2002's "The Hours" committed suicide. Demons and spirits also killed headache sufferers.

The study authors also found that Hollywood headaches are often a symptom of a greater illness like cancer or an aneurysm -- or a remote control device implanted in a hapless person's head.
In real life, headaches usually aren't caused by other conditions, the researchers noted.

In another divergence from reality, most of the 26 headache sufferers in the 23 movies were men, while women are actually more likely to suffer from headaches.

The study authors acknowledged that they don't know what effect movies have on perceptions about headaches. The research also didn't look at the many TV shows focused on medicine that attract tens of millions more viewers than a few dozen movies.

Still, the authors assume the films have influence. "There's an assumption that everybody will go to the movies and realize it's all fantasy," said study co-author Dr. Bert Vargas, a neurology resident at New York University School of Medicine. "But we realize there's (some) reality, and it's hard for a moviegoer to pick up what's accurately portrayed and what's inaccurately portrayed."

But what about the inherent dramatic nature of films, which don't rake in big bucks if they tell routine, boring stories about people with routine, boring illnesses? "There's a lot of interesting things you can do with a character, but directors are killing them off because of a headache," complained Henry.

As a result, "patients worry a lot about what their headaches are from," she said. "It lends a little bit of anxiety when they start thinking about their headaches -- is there really something bad going on?"

The researchers were to present their findings Thursday at the American Headache Society's annual meeting, in Chicago.

More information
To learn more about headaches, visit the National Headache Foundation.