Military struggles to react to potentially dangerous supplements
By TRAVIS J. TRITTEN | STARS AND STRIPES Published: November 25, 2013
CAMP FOSTER, Okinawa — Craze was the first pre-workout fitness supplement Airman 1st Class Julio Sanchez ever took.
Sold as a performance booster, it added an unusual edge to his weightlifting sessions on Kadena Air Base over the summer. Often, he said, his chest seemed to pulse with his heartbeat.
“Immediately, I felt like I could lift the whole gym,” Sanchez said. “I thought all pre-workouts were like that.”
The 22-year-old airman did not know he was part of the military’s latest brush with a potentially dangerous fitness supplement. By late summer, public alarm bells were ringing — lab research found Craze contained a substance closely related to the street drug methamphetamine and major online retailers were no longer stocking it.
But the military did not pull the product from base stores until October, after more than a year of mounting evidence.
Meanwhile, thousands of troops may have been exposed to the untested substance in Craze, mirroring recalls of DMAA supplements in 2011 and a pre-workout supplement in October that was linked to an outbreak of liver disease.
As supplement health scares multiply, defense health officials are raising concerns over the military’s ability to balance $190 million per year in on-post dietary supplement sales with troop safety.
Some are calling for the Department of Defense to enact new restrictions on which supplements can be sold on base, warning that the current system of federal regulation is unable to protect hundreds of thousands of military consumers from a stream of potentially dangerous supplements sold on the open market.
Despite the recommendation, reform remains uncertain. One of the world’s largest supplement retailers says it opposes any new DOD regulations of its on-base sales, and the military’s own retailers have refused to make any public comments.
“Imagine endless energy,” the pre-workout supplement Craze boasted on its label.
Such claims are appealing to the many servicemembers who test their physical limits in the gym or just strive to meet fitness requirements. More than 1 million are estimated to be taking some type of supplement and about 25 percent of those consume products military health officials considered high-risk — pre-workout energy boosters, testosterone boosters and diet pills, according to Patty Deuster, a physician, professor at the Uniformed Services University and a DOD authority on supplements.
Craze’s performance-enhancing qualities caught the eye of the U.S. Anti-Doping Agency, an authority on drug use among Olympic athletes, about a year and a half ago.
The agency said it analyzed the supplement in spring 2012 and found it contained amphetamine, a powerful stimulant. The findings were backed this year by a national laboratory in Sweden, according to media reports.
By late summer, Craze was receiving national media attention and public scrutiny. Large online retailers had stopped stocking it and Driven Sports, the company that made Craze, had suspended manufacturing and distribution over public concerns.
The potential health risks of the supplement were ratcheted up again in August when South Korea’s National Forensic Service reported it found a methamphetamine-like substance in samples. Unlike amphetamine, meth has no medical use and is a highly addictive illegal street drug.
Sales continue on base
The public alarm did not end sales of Craze on military bases.
Military retail shops and gyms continued to stock the energy booster until October, when another research team reported an ingredient that looked similar to meth. A study published Oct. 14 in Drug Testing and Analysis said a “potentially dangerous designer drug” was measured in three separate samples of Craze. The research team included personnel from Harvard, an internationally accredited screening firm and a national institute in the Netherlands.
Pieter Cohen, a study co-author and assistant professor of medicine at Harvard, described the substance as a “cousin” of meth and said there has been almost no scientific research on its physical effects.
“We have no idea what qualities of methamphetamine it actually has on humans,” he wrote in an email. “Could it be addictive? Does it raise blood pressure? Does it increase the risk of strokes? We simply have no idea.”
The study finally spurred action by the DOD. Within days, military retailers said they ordered a stop to Craze sales at post stores and on-base outlets operated by supplement giant GNC.
But a week after the recall order — and nearly a year and a half after the USADA first raised amphetamine concerns — it was still for sale at the front desks of some Marine Corps gyms.
It was finally removed after the service was notified by Stars and Stripes on Oct. 22, according to Bryan Driver, a spokesman for Semper Fit and Exchange Services Division at Headquarters Marine Corps, which oversees retail sales for the service.
DOD urged to step in
It is unclear how many servicemembers might have been exposed to the untested substance in Craze — thousands if estimates of overall supplement use in the military are accurate.
The potential public health risks have worried military health officials. Last year, a DOD study looked at the problem and found that current federal regulations do not sufficiently protect troops from potentially dangerous supplements.
The U.S. Food and Drug Administration must prove a product is unsafe before it can restrict sales — often a difficult and time-consuming task, according to the study published in Military Medicine in December by a team that included Deuster as well as officials from the U.S. Army Medical Command, Headquarters Marine Corps, Joint Base San Antonio-Lackland and Evans Army Community Hospital at Fort Carson, Colo.
“The FDA cannot act swiftly to protect the public, and it may take years after a product is marketed and harm occurs before it is finally removed from the market,” according to the study.
The FDA has taken no action against Craze or its maker, agency spokeswoman Shelly Burgess said in late October.
The researchers proposed that new DOD-level rules should be enacted until new national standards are put in place.
Safety risks grow
Lax federal standards have coincided with a boom in the supplement industry — more than 85,000 products are now on the market, compared with 4,000 in 1994 when current federal regulations went into effect.
Health scares on military bases have also become more common.
In June, the DOD completed a safety review of DMAA, also known as dimethylamylamine, a previously obscure stimulant that was used in about 18 energy-boosting fitness supplements sold on U.S. military bases until 2011.
A team of health officials within the department found servicemembers who took DMAA supplements for 80 days or longer were about three times more likely than other users to die or suffer heat injury, irregular heartbeat, seizures, muscle breakdown, brain hemorrhage or kidney failure.
Most of the DMAA products had been pulled from the market in the U.S. before the study was released. Some were quickly reformulated and restocked on military store shelves.
The energy-booster OxyElite Pro was among those reformulated supplements. The Army and Air Force Exchange Service began selling it again in November 2012 — seven months before the DOD completed its DMAA safety study, according to AAFES spokesman Judd Anstey.
Last month, the FDA linked the supplement to an outbreak of nonviral hepatitis in Hawaii. The supplement that had once contained DMAA appeared to contain a new ingredient that was not safety tested for human consumption, the FDA reported. One of the hepatitis patients died; two more required liver transplants.
The military pulled OxyElite Pro from base store shelves for a second time following the FDA warning in October.
The contents and health effects of Craze and other supplements remain controversial. Makers have pointed to their own research and denied reported health risks.
“We have been working very hard to figure out why others have been concluding that Craze contains amphetamine-like substances,” Driven Sports said in an Oct. 15 statement.
The company says its supplement contains dendrobium, a substance found naturally in orchids and “related but very different” from the meth-like substance reported by various labs. It said four independent studies submitted for publication in peer-reviewed journals found no harmful effects on test subjects.
The maker of OxyElite Pro said the substance detected by the FDA was a tree extract that is safe, and called the hepatitis outbreak a “mystery.”
To cut through the controversy and shield troops, DOD public health officials have proposed that all supplements sold on military bases be analyzed and certified as safe by an independent body. More than 60 percent of the supplements used by servicemembers are bought on military bases, according to the Military Medicine study in December. Those bought online represent 13 percent or less of sales.
Third-party certification is already done voluntarily by some supplement manufacturers and is a way to filter out any potentially dangerous substances such as DMAA before they reach base shelves.
A handful of organizations now lead the third-party certification industry, including NSF International and U.S. Pharmacopeia, which are both nonprofits.
“Many in the military public health community believe that in the absence of further FDA regulations the primary way to ensure dietary supplements sold on military bases are safe is to require them to be third-party certified or verified by credentialed certifying organizations,” Deuster wrote in an email.
The requirement likely would reduce sales of supplements on bases initially, but the drop would be temporary as more companies opted to have products tested for quality and purity, she wrote.
Certification is facing resistance from at least one U.S. supplement retailer.
GNC bills itself as “the world’s largest company of its kind” and has developed a widespread presence with its vitamin and supplement outlets on military bases around the world.
Military retailers contacted GNC when they sent out the call to stop base sales of Craze and other questionable supplements.
“First, the certification process would do nothing to improve safety and would not cover products bought online or in stores off base by military personnel,” GNC spokesman Greg Miller wrote in an email to Stars and Stripes.
Miller said the regulation would also unnecessarily increase the cost of supplements for troops.
From GNC’s point of view, the United States and the military already have all the necessary regulatory powers.
“The law already requires … labeling on all dietary supplements be accurate and FDA has all the authority it needs to enforce and police the industry in this regard,” Miller wrote.
For now, it is unclear whether the military’s own retailers support the public health proposal.
When contacted by Stars and Stripes, AAFES, the Navy Exchange and Marine Corps Exchange said they would not discuss third-party certification of supplements.
“Until new guidance is provided, it would not be appropriate for us to comment on pre-decisional proposals,” Driver wrote in an email.