Diet Supplement Marketers Target Kids; Largely Untested Products Alarm Health Experts

By Guy Gugliotta
Washington Post Staff Writer

Dietary supplement companies have begun aggressively targeting children and parents as consumers of their products, among them powerful chemicals designed to help kids gain strength, lose weight or treat illnesses ranging from colds and flu to depression and even attention deficit disorder.

As a result, increasing numbers of children are swallowing supplements, often with the knowledge, urging and even insistence of parents in search of "natural" remedies or "healthy" alternatives for youngsters who eat too many cupcakes or drink too much soda. One survey recently found that almost 20 percent of parents were giving their children supplements.

In Vancouver, Wash., Nutrition Now Inc., for example, created a cuddly rhinoceros cartoon character to promote its line of dietary supplements for children, including Rhino Pops containing the herb echinacea, a cold treatment. "100% natural, Moms love the soothing support, kids love the all-natural taste, vegetarian approved," reads the legend on the box.

From Saco, Maine, Fresh Samantha Inc. ships to supermarket shelves nationwide "body zoomer" fruit smoothies that carry cartoon pictures of children to catch the eye. A 16-ounce bottle of "Oh, Happy Day" contains 100 milligrams of the herb St. John's wort "to lift the spirits." Many adults in search of an alternative to antidepressants such as Prozac take a 300-milligram tablet of St. John's wort three times a day.

Although some products may be helpful, the surge in supplement use by children and adolescents is causing rising alarm among pediatricians, children's health advocates and federal and state medical officials. At the least, many of the products may be useless. At the worst, some may be dangerous, they say. Supplements are largely untested and unregulated. The full short- and long-term impact of these substances on young bodies is virtually unknown. And in some cases, there's evidence they may be harmful.

"Physicians use medications that have been tried and tested, with known side effects," said Rossanne Philen, chief of environmental hazard epidemiology at the Centers for Disease Control and Prevention in Atlanta. "When children are given herbal preparations, they are at the mercy of the adult who is experimenting on them."

Companies offer discounts and rebates in some states to high school coaches who supply creatine, a powerful body-building nutrient, to their athletes. In Fairfax County, coaches are forbidden to promote creatine, but that doesn't stop it from being popular.

"I did a report on creatine in journalism class when I was a freshman, and I did some research on different Web sites," said Sean Curry, 16, a running back on the Chantilly High School football team who noted that he has told his parents he is using creatine. "I started taking it last year, and I'm taking it now." Curry said he has gained 31 pounds over two years. "It's definitely been valuable."

Some products even include the stimulant ephedra, which is still recommended for children by some supplement salespeople for attention deficit disorder even though it has been linked to serious illness and even death by the Food and Drug Administration. Much of the industry warns youngsters under 18 away from it.

Because there's no central source of information about adverse reactions to supplements, it is difficult to get an accurate accounting of whether they are causing widespread problems. But almost all supplements can produce some unpleasant side effects, and their overall safety remains far from clear.

The reason for this is that dietary supplements, as defined by the 1994 Dietary Supplement Health and Education Act, may be sold without pre-market clearance by the FDA or a detailed scientific evaluation of their safety and effectiveness. Also, unlike prescription drugs, the FDA must prove a supplement is dangerous before removing it from the market. As a result, thousands of products are sold over the counter to anyone who wants them--including children--with far less scrutiny than prescription drugs.

Mark Blumenthal, executive director of the American Botanical Council, an herb advocacy group, acknowledged that no one has done a "formal risk-benefit review" of dietary supplements, including those designed specifically for children. But he noted that many herbal remedies have been used for hundreds or even thousands of years and are well known outside the United States.

"With only a few exceptions, most of these herbs are some of the best-researched in the world," Blumenthal said. "In Europe, where they are sold in pharmacies, they have a stellar record of safety."

Unreported Toll

Unlike pharmaceutical firms, supplement companies are not required by law to report serious product problems to the government. Agencies rely on sporadic voluntary reports that frequently come from inexpert sources.

The American Association of Poison Control Centers, which collects data from 65 locations in all but a few states, in 1998 listed 704 reports of bad experiences with dietary supplements involving youngsters ages 6 to 18.

The association's list of supplements does not include ephedra, used primarily by adults to boost energy or lose weight and the subject of a virulent controversy between the herbal industry and the federal and state agencies seeking to regulate it.

In a report earlier this year, the FDA documented 134 cases linking serious illness--including insomnia, nervousness, seizure, hypertension, stroke and death--to ephedra during a 33-month period ending in March 1999. Ten of the reports involved children younger than 18.

In one case, a 15-year-old girl was hospitalized with severe chest pain after taking six ephedra tablets and drinking a pair of "double-shot (coffee) lattes," the FDA report said. The labeled dosage was two tablets, three times daily to lose weight, but the 125-pound victim decided to take all six pills at once.

The FDA has also documented cases of adverse effects from other supplements. Echinacea and ginseng produce minor and infrequent problems. The same is true of St. John's wort.

A substance known as DMAE, included in products marketed as alternatives to Ritalin for the treatment of attention deficit disorder (ADD) and attention deficit hyperactivity disorder (ADHD), can cause side effects similar to Ritalin's: insomnia, hives, headache, drowsiness and involuntary muscle movement.

Creatine, taken to enhance the body's ability to deliver energy to muscles, also causes muscles to accumulate water, which can lead to weight gain, cramping, muscle strains, dehydration, diarrhea and gastrointestinal pain. The University of Tennessee recently banned creatine after 14 of its football players had cramping episodes during one game.

Many of creatine's bad effects can be avoided by cautious use, but this is not a talent generally ascribed to the young. "High school kids don't have a clue about how to take it," said sports nutritionist Ruth Carey, a registered dietitian in Portland, Ore. "I don't find a whole lot of awareness on the part of parents, either. They don't realize it's an unstudied drug."

At the same time, there has been little research on creatine's long-term effects, and virtually none regarding its effects on young bodies.

Finally, studies have shown that the potency of many herbal supplements--including St. John's wort, ginseng and ephedra--often does not match the potency advertised on the bottle. A survey of 20 ephedra products conducted by the University of Arkansas in May found that the potency of half of them was either much greater or much less than what was indicated by the dosage listed on the bottle.

"Support for this type of thing [supplements] is simply not there. We don't know proven effectiveness. We don't know contaminants, or the concentration bottle-for-bottle," said Susan S. Baker, chairman of the American Academy of Pediatrics' committee on nutrition. "It's pretty serious. It's like taking a vial of water and not knowing whether it comes through a filter or from the sewer--and then drinking it."

Aggressive Marketing

Despite these misgivings, supplement companies are actively marketing a range of products for children using a variety of techniques.

Some strategies are obvious. Considerable science has shown that creatine increases power in short bursts in sports that require it, such as weight lifting, football and sprints.

MLO Products Co. of Fairfield, Calif., has forged a relationship with football powerhouse Mater Dei High School of Santa Ana, Calif. "How Would You Like to Increase Lean Weight By 11 lbs. In 3 Months?" read a promotion on MLO's Web site. "The Mater Dei High School football team has been consistently ranked among the top 10 teams in the country."

The company originally provided creatine to Mater Dei in order to use its athletes in a study and then publish the results, said Ryan Snyder, a sales manager. "We've just continued sponsoring Mater Dei," Snyder said. "We just want to be associated with a high-quality football program."

In Irvine, Calif., Met-Rx Engineered Nutrition has gone a step further. It has 200 high school "Mentor" programs in "almost every state," according to marketing directing Charlie Wright. Met-Rx supplies creatine and other supplements to athletes at 60 percent of the retail cost and sends 10 percent of the purchase price to the school's athletic programs.

Coaches and parents must approve each athlete's participation, thus opening "a communications link" about nutrition, Wright said. "Here's a way for them to get information [on supplements], save some money and create some new revenues for strengthening athletic departments."

Other marketing strategies simply developed from consumer demand. At Gaia Herbs, based in Brevard, N.C., herbalist Mary Bove designed a set of 20 products for children to respond to "physicians all over the states...calling me about giving kids herbs."

Gaia's list, one of the country's most extensive, includes products ranging from "Skin Cream for Baby Bottoms" to "Melissa Supreme for Children," an herbal treatment recommended in company literature for ADD and "impulsiveness."

Melissa, also known as lemon balm, is a medicinal tea herb and mild tranquilizer used as a sleep aid or to calm an upset stomach. Gaia's literature suggests combining Melissa Supreme with a second supplement containing St. John's wort for "hyperactivity, mood swings and tantrums."

Concern about ADD and ADHD, combined with parental misgivings about Ritalin, the most popular pharmaceutical treatment for these conditions, has spawned a brisk competition among companies searching for alternatives.

"Attention Focus," made by Nature's Way of Springville, Utah, uses essential fatty acids to encourage "proper transmission of brain and nerve signals," the label says. Herbs Etc., a Santa Fe, N.M., company, sells a melissa product called "Kid-A-Lin."

The Scotts Valley, Calif., company Source Naturals hit pay dirt in 1999 with "Focus Child," developed by Cathleen Rapp to find "something to appeal to people who don't want to use Ritalin."

Focus Child's key ingredient, dimethylaminoethanol bitartrate or DMAE, was developed by Riker Laboratories in the 1950s and sold by prescription for nearly 30 years as "Deaner," a treatment for children's learning disabilities. But in 1983, the FDA forced DMAE's removal from the market after determining that it wasn't effective.

Nevertheless, there are several DMAE child supplements today, including chewable tablets and fruit and chocolate bars. Natural Organics of Long Island, N.Y., makes a DMAE product called "Pedi-Active A.D.D."--an "advanced diet delivery" system, according to the legend on the label.

At least one company, the Utah-based Enrich International, has promoted ephedra in the past as a substitute for Ritalin to treat ADD and ADHD among young children, and at least some of the company's affiliated salespeople still recommend it.

And Mary Lou Wilson, who buys Enrich products and resells them as an independent Enrich distributor based in Granbury, Tex., continues to recommend ephedra six years after she prescribed it for her grandson, Woody, then 10 and suffering from ADHD. "He used it for three months and never had to use it again," she said. "It makes such a difference."

Ephedra is a close cousin of methamphetamine, and in the past enjoyed a certain status among many young people as "legal speed" because of the kick it could give, especially when combined with other stimulants, such as caffeine.

Most large ephedra companies stopped promoting ephedra as a source of a natural high and in recent years have put labels on their products warning against the use of ephedra for any reason by anyone under 18.

But the companies' position remains ambiguous. The industry opposes a proposed New York ordinance to prohibit ephedra sales to youngsters under 18, believing "it would be more effective as a labeling issue," said Wes Siegner, counsel to the ephedra committee of the American Herbal Products Association. "You don't want to cause trouble for salesclerks."

And despite the warning labels, ephedra still enjoys considerable popularity among teenagers trying to lose weight.

Ephedra's checkered reputation makes some retailers nervous. "I won't sell the tablets to kids," said Damien Gray, branch manager for a General Nutrition Centers store a few blocks from Suitland High School in Prince George's County. "They'll take one, and it won't have any effect, so they'll take more. Who knows what's going to happen?" But the brightly colored energy-boosting ephedra drinks, many of which also carry warning labels, are a different story. "At least I know how much they're getting," he said.

Eager Consumers

Once a promotional strategy is in place, many companies are finding instant success with an eager public. The San Diego-based Nutrition Business Journal, which tracks the industry, reported 1999 sales of $120 million in herbal and nutritional supplements for children. In 1999, a study conducted by National Public Radio, the Kaiser Foundation and the Kennedy School of Government found that 18 percent of parents were giving their children dietary supplements that were not vitamins or minerals.

"A lot of parents are finding that natural herbal remedies are working very effectively on their kids, and it's taking a lot of pressure off of running to the doctor every time you get a runny nose," said Amy Zanger, manager of the Crossroads Health Hut in Glendale, Ariz., near Phoenix. "People are taking charge of their own health, and the pendulum is swinging natural."

Supplement-containing "body zoomers" are "one of our top selling categories," said Fresh Samantha public relations manager Kim Mayone, who acknowledged that "Oh, Happy Day" contains "a mood-enhancing herb," but not enough for it "to be a medicine."

In less than a year, Source Nutritionals' "Focus Child" became a top-10 bestseller for a company that sells more than 400 items. For health food store manager Zanger, it was a godsend. "We're not into drugging our kids," said Zanger, worried because her son, 8, couldn't concentrate in school. "So we decided to go natural." They chose Focus Child.

"I just got his progress report card, and I almost cried; it was so much better," she added. Zanger also gives Focus Child to her 2 1/2-year-old son "before we go out to eat or to the movies" to keep him quiet. "It seems to be fine for him."

Creatine, because it works, because it's legal and because it does not appear to have any unmanageable side effects, is in a class by itself as the most popular sports nutrient on the planet, with sales of $400 million worldwide.

In a 1999 Blue Cross-Blue Shield Association survey, 27 percent of children ages 12 to 18 said they knew someone who used performance-enhancing substances, and more than half of those knew someone who used creatine. A survey by New York's Mount Sinai Hospital Sports Medicine Center found that children of both sexes as young as 12 were using creatine and that usage rose to 44 percent among high school seniors.

"I took it for a month to get stronger for the football season. My bench press increased 30 pounds, and my curls and squats increased 50 pounds," said Tommy McDonald, a 190-pound senior offensive guard at Jesuit High School in Portland, Ore. "All of a sudden, everything shot up very quickly. I made all-league."

But sometimes, marketing strategies go awry. In 1998, the ESPN sports network apologized for running a General Nutrition Centers ad for creatine during the Little League World Series.

In May, Boston's Efamol Nutraceuticals Inc. ran afoul of the Federal Trade Commission and agreed to stop advertising its products Efalex and Efalex Focus as cures for the effects of ADD and ADHD in the absence of scientific proof. J&R Research Inc. of Massena, Iowa, entered into a similar agreement for its product Pycnogenol.

Efamol was using fatty acids as key supplement components, promoting them with a slogan that said "Long Term Side Effects May Include: Hugging your Mom." J&R Research's Pycnogenol is a substance dismissed in most scientific research as showing little evidence of either safety or effectiveness.

And sometimes the bloom simply starts to fade. In recent years, there have been signs that creatine is losing favor among those who used to be its strongest promoters--some coaches are starting to question its use. "Hell, it's not illegal, and if you want your son on it, that's your business," said Dick Adams, head football coach at Annandale High School in Fairfax County. "But I don't promote it. I tell them, 'It's a drug. Don't be frustrated with what God gave you.' "

Last year, the Texas legislature easily passed a law prohibiting public school employees from selling or promoting "performance-enhancing products" on school time after Ann Torrez complained that coaches at Hays High School outside Austin were offering to sell creatine to her son Lyndsey, then 15, to help him bulk up for the season.

"Where are they [coaches] going to be 15 or 20 years from now if this should turn out to have damaging effects?" Torrez asked at a Texas House of Representatives committee hearing. "Are they going to be there to pick up the pieces from our children? I don't think so."

That's the sentiment of Maryland health consultant Patricia Mann, the former team nutritionist for the Washington Capitals. "It's going to be years before we know what we've been doing to ourselves," Mann said. "We're not a toxic waste dump, and I don't know why people think they can put things in their body and not have bad events. You wouldn't treat your car that way."

On the Market

Dietary supplements may be sold without detailed scientific evidence of their safety and effectiveness. Thus, short- and long-term risks and benefits have not always been assessed for supplements designed specifically for children. Here are some common supplements.

NAME	USES	SAFETY	EFFECTIVENESS
St. John's Wort	To treat depression and associated symptoms, including fatigue, appetite loss, insomnia, anxiety and nervous unrest.	Probably safe when for used short-term medicinal purposes. Can cause insomnia, restlessness, anxiety, irritability, fatigue, dry mouth, dizziness, headache and mania in depressed patients.	Probably effective in treating mild to moderate depression, and possibly effective when used for physical symptoms associated with mild depression or to treat anxiety.
Creatine	To increase exercise performance and muscle mass in athletes and older adults. Also used to treat heart failure.	Possibly safe when used appropriately, but there is insufficient infor-mation on safety of long-term use. Can cause nausea and diarrhea. Athletes report muscle cramping.	Possibly effective when used to enhance muscle performance during brief, high- intensity exercise. Likely ineffective when used for increasing endurance.
Echinacea	For treating or preventing colds and other upper respiratory infections. Also as an antiseptic, antiviral and immune stimulant, dilator of blood vessels and treatment for urinary infections.	Likely safe when daily use is limited. There is concern that long-term use might depress immunity. Can cause allergic reactions, including acute asthma and hives.	Possibly effective as therapy for influenza-like infections, or for shortening the duration of colds and as supportive treatment for respiratory infections.
DMAE or Dimethylaminoethanol	For treating attention deficit disorder, enhancing memory and mood, boosting cognitive function, increasing physical energy and improving athletic performance.	Possibly safe when used appropriately. Can cause constipation, hives, headache, drowsiness, insomnia, confusion, depression, elevated blood pressure and mania.	Possibly effective in combination with other supplements in improving exercise performance. Clinical studies of use in treating attention deficit disorder have been inconclusive.
Gingko Biloba	To treat cerebral conditions and to increase alertness. Also used to improve cognitive function and sleep in depressed patients.	Likely safe when used appropriately, unsafe when used intravenously. May cause gastrointestinal pain. Large doses may cause restlessness, diarrhea, nausea and vomiting.	Possibly effective when used to stabilize or improve cognitive function in patients with cerebral conditions, or when used to treat dizziness and headache.
Ephedra (also known as ma huang)	For asthma, bronchitis and allergic disorders, and as a stimulant and appetite suppressant. Used for weight loss in combination with other herbal products.	Possibly safe when used short-term. Likely unsafe in high doses or long-term. Can cause dependence. Adverse reactions include anxiety, insomnia, high blood pressure and heart failure.	Effective in short-term treatment of diseases of the respiratory tract. Likely ineffective when taken as a single agent for weight loss. Insufficient reliable information about other uses.
Valerian (also known as ma huang)	As a sedative and for mood disorders such as depression, infantile convulsions, epilepsy and attention deficit hyperactivity disorder.	Possibly unsafe when used long-term or in high doses. Can cause headache, excitability, uneasiness, cardiac disturbance and insomnia and, occasionally, morning drowsiness.	Possibly effective when used for improving sleep quality and for improving mood and concentration.
Melissa (lemon balm)	As a digestive, mild tranquilizer and for stimulating appetite. Traditionally used to promote sweating and to treat nervous problems, insomnia, cramps, headache and toothache.	Possibly safe when used on a short-term basis -- no more than 14 days. Hypersensitivity reactions have been reported.	Possibly effective when used for nervous sleeping disorders and gastrointestinal pain or as topical treatment of cold sores.

Source: Natural Medicines Comprehensive Database

More information about supplements is available at the following World Wide Web sites: Nutritionalsupplements.com, NutritionNewsFocus.com, Vicus.com, Vitacost.com.