A Maui woman died, two people needed liver transplants and 41 others in Hawaii suffered acute liver failure last year after taking OxyELITE Pro, a weight-loss supplement.
Yet in late January, when Senate Bill 2067, which would regulate dietary supplements, was before the state Senate Health Committee, doctors from the Queen’s Medical Center’s Liver Center, who had first identified the public health emergency, were among the few to show up to testify in favor of the bill. There was much more public interest on a bill that would require the labeling of genetically modified foods, which have troubled some consumers but have not been shown to cause health problems.
The contrast at the hearing that day provides an interesting example of how the public evaluates health risks and a lesson in how some consumer issues can be written off as unfortunate anomalies while others turn into political causes.
Unlike the mobilization against GMOs, there has been no march to the state Capitol over dietary supplements, no demonizing the corporations behind OxyELITE Pro, and no warnings to lawmakers that they will be voted out of office if they fail to respond to dangerous weight-loss cures.
"It touched a nerve," said state Sen. Josh Green (D, Naalehu-Kailua-Kona), an emergency room doctor and the chairman of the Senate Health Committee, who supports greater regulation of dietary supplements and GMO labeling. "These are the kind of problems that will occur over and over again if as a society we don’t get smarter about regulation of nutrients and supplements."
Green said that while the two issues are different — GMO foods are more prevalent than dietary supplements — there is some overlap, particularly the growing consumer demand for transparency.
"At least having awareness. At least being able to know, OK, I’m making an informed consumer decision," he said.
The state Department of Health has told lawmakers that the U.S. Food and Drug Administration, not the state, regulates food.
The department respectfully opposed the bill, which would prohibit the sale of dietary supplements in Hawaii that do not conform to federal good manufacturing practices. The department explained that the manufacture of products outside of Hawaii are not subject to state law; they are subject to federal interstate commerce standards.
State legislation, the department said, would not have prevented the tragic consequences linked to the weight-loss supplement and would likely not improve the state’s ability to prevent future outbreaks.
The Department of Health does have the power, like it did with OxyELITE Pro in October, to take dietary supplements off the market in Hawaii when there is sufficient evidence that the product has been adulterated, misbranded or epidemiologically linked to illnesses.
Peter Oshiro, the department’s environmental health program manager, called some of the makers of weight-loss supplements "the modern day snake oil salesmen," but said the bill would not have the intended impact.
"It’s the responsibility of the federal government to pass rules and regulations that will ensure the safety of these dietary supplements," Oshiro said.
The Department of Health has also opposed GMO labeling. The department has told lawmakers that there is no practical way for the state to detect GMOs in food and no scientific evidence linking GMO foods to health problems.
THE WEIGHT LOSS market in the U.S. is valued at about $60 billion, according to Marketdata Enterprises, a Florida-based research firm, with retail diet pills and meal replacements accounting for about $2.7 billion.
OxyELITE Pro, which was made by USPLabs, a Texas-based company, was marketed for weight loss and bodybuilding.
Last year, a stockpile of the supplement was pulled from the market and destroyed under FDA order after an ingredient — DMAA, or dimethylamylamine, a geranium extract — was found to cause high-blood pressure that could trigger heart attacks and seizures.
USPLabs, according to the FDA, removed DMAA from OxyELITE Pro and swapped in aegeline, an alkaloid extract from bael tree leaves. The new formulation of OxyELITE Pro was linked to the liver damage in Hawaii and the product was eventually recalled by the company in November.
The FDA said the retail value of the weight-loss supplement taken off the market was about $22 million.
Sonnette Marras, a 48-year-old Makawao laborer and driver, died in October after taking OxyELITE Pro for weight loss after a pregnancy. Two others needed liver transplants.
The Department of Health is investigating 52 reports of people who have taken dietary supplements and developed acute hepatitis, including the 44 cases linked to OxyELITE Pro.
Under federal law, the manufacturers of dietary supplements generally do not have to register or obtain FDA approval before going to market. The products must contain truthful label information and follow federal good manufacturing practices.
Prescription drug makers, by contrast, generally have to show the FDA that drugs are safe and effective before commercial sale.
Dr. Naoky Tsai, medical director at the Queen’s Liver Center, said that it is unfortunate that dietary supplements do not have to follow the federal standards applied to drugs.
"They can put out a product without having to prove to any authority that they are effective or they are safe, as long as they can claim that their ingredients all come from a food source," he said. "So they are food. So if it is food you don’t have to prove anything."
As a first step, Tsai said, the state could require manufacturers to publicly report whether new dietary supplements — after three or six months on the market — have been linked to any health issues.
"Our point is that if the law doesn’t change, these things would happen again," he said.
BOTH THE DIETARY supplement and GMO labeling bills have moved out of the Senate Health Committee. Green, the committee’s chairman, even advanced a second GMO labeling bill to help increase the chances the issue will stay alive this session.
Anti-GMO activists have targeted Sen. Rosalyn Baker (D, West Maui-South Maui), the chairwoman of the Senate Commerce and Consumer Protection Committee, using social media and telephone appeals to try to persuade the senator to hear a GMO labeling bill. Some activists have been urged to remind Baker that she is facing a primary challenge from Terez Amato, a Kihei environmentalist who supports GMO labeling.
Babes Against Biotech, an anti-GMO group, had previously tagged Baker as "Monsanto’s hero" for blocking GMO labeling last session.
Baker and her staff report no equivalent public urgency behind the dietary supplement bill. The senator said on Friday that she has received no requests to hear the bill.