Federal officials raise alarm on dietary pill use

Professional body builder and physical trainer Cathy Lefrancois displayed nutritional supplements during a convention in California in 2007.HECTOR MATA/AFP/Getty Images

This story was produced by Stat, a national publication from Boston Globe Media Partners that will launch online this fall with coverage of health, medicine, and life sciences. Learn more and sign up for Stat's morning newsletter at Statnews.com.

Federal officials, in a scientific journal set for release Monday, raise an alarm about the huge popularity of unregulated — and in some cases, unsafe — dietary supplements among military personnel and young athletes.

The concerns about supplement use, and recommended policy shifts, could affect people such as soldiers in combat zones, high school football players, and consumers purchasing weight-loss pills, multivitamins, botanical remedies, and other supplements.

The journal included articles written by officials at the Pentagon and the US Anti-Doping Agency, who joined medical researchers and public health watchdogs in producing a special edition of the journal Drug Testing and Analysis.

Dietary supplement products don’t require a doctor’s prescription for purchase. And under a 1994 law, the Food and Drug Administration cannot review dietary supplements for safety or efficacy before they go to market. The agency is able to intervene only when adverse events tied to a particular supplement are reported.

Among the most striking statistics in the new studies: Three-quarters of all military personnel use dietary supplements each month. Health supplement stores such as GNC operate on almost every base in the United States and in many military zones abroad, said Harris Lieberman of the Military Nutrition Division at the US Army Research Institute of Environmental Medicine in Natick.

At least 23,000 emergency room visits in the United States each year can be traced to supplements, according to a report last month by researchers from the Centers for Disease Control and Prevention. The most common symptoms included heart palpitations, chest pains, allergic reactions, and choking.

Attorneys general in several states have also alleged that many supplements are mislabeled or contaminated. And many contain high doses of caffeine and other stimulants.

Military personnel under high stress already could be especially susceptible to dangerous side effects, Lieberman said.

Supplements “could potentially put military personnel at risk while doing their jobs. They’re exposed to a lot more stressors than people just going to the gym and working out,” Lieberman said. “The Department of Defense is trying to figure out ways — within the boundaries of the law — to keep unsafe supplements out of the hands of military personnel.”

In some cases, the Pentagon has proactively pulled supplements from store shelves on base when officials hear reports of adverse events tied to a particular product, issuing a notice to military personnel before the FDA takes action.

The Council for Responsible Nutrition, a trade group, said the industry is safety conscious and dismissed reports about adverse reactions as overblown.

“The margin of safety for these products in enormous,” said Steven Mister, president and chief executive of the council.

Authors from the US Anti-Doping Agency wrote their own study for the special journal edition, saying they’re concerned about young athletes ingesting copious amounts of caffeine, which experts say can be easy to miss on many supplement labels.

Young athletes commonly use supplements to drop weight, gain muscle, or boost their performance in competitions.

“The stakes are high for all of us to protect the health of young athletes and to protect clean sport,” the authors wrote.

One area the agency is particularly worried about: misleading supplement ads in fitness magazines, which can have high teen readerships.

A pending bill would make Massachusetts the first state to ban the sale of weight-loss and muscle-building supplements to people under 18.

The special journal edition also highlights a concerning case study from Hawaii. In 2013, the state’s only liver transplant center saw a spike in cases of acute hepatitis in relatively young healthy people. The common thread among all of them: a weight-loss product. Two of the nearly 40 hepatitis patients who had taken the product required liver transplants, and another patient deemed ineligible for a transplant died.

“People take these things as if they’re medicine,” said Dr. Sarah Park, the state epidemiologist at the Hawaii Department of Health. “They’re often marketed as ‘natural’ or ‘herbal’ or other buzzwords that people immediately consider as being not harmful.”

Dr. Joshua Sharfstein, a public health expert at Johns Hopkins University, authored a paper urging the medical community, consumer advocates, and the supplement industry to work together to develop a premarket approval process for supplements.

“It’s absolutely impossible for the FDA to police this market without knowing what’s on it,” Sharfstein said. “The smart thing for us to do is to get together and take some very practical and appropriate steps.”

But the dietary supplement industry wields considerable political clout in Congress, and Mister — of the Council for Responsible Nutrition — says pre-market approval isn’t a compromise the industry sees as a viable solution. Dr. Pieter Cohen, an internist with the Cambridge Health Alliance who organized the series of papers, said others in supplement sales may not be willing to play ball.

Cohen pointed out that the industry dismissed the recent report about emergency room visits tied to supplements by saying the numbers were small relative to the number of people taking the products.

“It’s like if car manufacturers were making cars that were hospitalizing people,” Cohen said, “and they said ‘2,000 people got injured, but think of how many people got home safely.’ ”