On March 15, during a presentation at the Conference of Western Attorneys General (CWAG) 2017 Chair’s Initiative in Honolulu, a panel of experts reviewed a case involving OxyElite Pro, the dietary supplement manufactured by USPlabs LLC and linked to a 2013 outbreak of hepatitis in Hawaii.
“The USPlabs story is an unfortunate story about criminals and the criminal activity that resulted in … harm to consumers," said Duffy MacKay, senior vice president of scientific and regulatory affairs with the Council for Responsible Nutrition (CRN), the Washington-based trade association representing the dietary supplement industry. “It’s also a story about how federal and state authorities collaborated to catch those criminals."
“We share in your legitimate concerns about companies and individuals who deliberately adulterate products and get them into our marketplace," said Jen Johansen, vice president of quality and regulatory affairs with Cyanotech Corp., a publicly held company that produces BioAstin Natural Astaxanthin and Hawaiian Spirulina Pacifica.
“OxyElite Pro is not a dietary supplement," Johansen told the audience of state attorneys general. “They were a deliberately adulterated product."
Anthony Lakavage, senior vice president of global external affairs with the United States Pharmacopeial Convention (USP), began his presentation by stating USPlabs, the supplement manufacturer, is not affiliated with his employer.
USP is a nonprofit scientific organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients and dietary supplements.
“It has nothing to do with the US Pharmacopoeia," Lakavage said, referencing USPlabs.
Lakavage described a number of supplement manufacturers as being “very, very responsible," while he characterized others as “criminals."
The USPlabs case study, he said, is an example of the latter.
USPlabs and its officers are defending themselves against allegations of fraud in a criminal case being prosecuted by the U.S. Department of Justice. The company denied any wrongdoing, but the allegations alone—and the 2013 outbreak of liver injuries tied to OxyElite Pro—have sullied its reputation.
“Regarding the government's allegations, the company and the owners vehemently deny that the company ever attempted to defraud any of its retail customers or consumers, sold any unsafe products, or engaged in any wrongdoing," USPlabs stated on its website. “They expect to be fully vindicated and look forward to their day in court."
Joseph McMullen, an attorney representing USPlabs, did not respond to a request for comment on the CWAG conference.
Amid the hepatitis outbreak in Hawaii, USPlabs advised FDA in a letter (that USA Today posted online) that the company destroyed its inventory of supplements containing aegeline. While the supplement manufacturer said it was unaware of any safety concerns with OxyElite Pro or aegeline, USPlabs disclosed it had “made the business decision, in light of the adverse publicity, to reformulate the product and to discontinue the use of aegeline in the United States."
FDA previously declared in a letter to the company that aegeline was not proven to be safe and constituted an "adulterated" substance. In the Oct. 11, 2013 letter, FDA suggested "a causal connection" between reported illnesses and OxyElite Pro.
During the CWAG supplements presentation, the outbreak of liver injuries tied to OxyElite Pro was held out as an example of effective collaboration between state and federal agencies in removing a potentially unsafe product from the market.
“This case is an important illustration of the concerted teamwork to identify potentially … bad products and remove them from the marketplace," said Indiana Attorney General Curtis Hill, who moderated the presentation.
The Hawaii Department of Health began investigating an outbreak of hepatitis possibly tied to OxyElite Pro in the wake of a number of liver injuries at The Queen’s Medical Center in Honolulu. FDA and the Centers for Disease Control and Prevention (CDC) also investigated the cases of liver injuries.
In describing various outbreaks in Hawaii in recent years, including the OxyElite Pro crisis, state Rep. Della Au Belatti (D-House) echoed Hill’s observations.
“Clearly, the collaboration with CDC and the FDA was stellar in the instance of OxyElite Pro, in the instance of dengue fever, in the instance of Zika [virus], where public health departments across the country had been mobilized," she said. “That collaboration continues today…—here in Hawaii—as an outgrowth of the OxyElite Pro [case]."
Standards, Verification Programs
During the same presentation, industry representatives schooled state attorneys general on the federal regulations governing dietary supplements, investments in quality and compliance, voluntary programs such as third-party certifications, and the potential hazards of regulatory overreach.
“More companies are utilizing transparent standards and verification programs, which is a great sign," said Lakavage, who noted 700 million bottles carry the USP Verified Mark.
While he said the above figure only represents less than 1 percent of dietary supplements, Lakavage cited increasing consumer awareness regarding supplements and quality over the last few years.
“And that’s partially because of the work of state [attorneys general] across the country, the Department of Justice, and what FDA has been able to do with their relatively limited resources," he said.
Commenting on the regulatory framework governing supplements, MacKay of CRN said, “The regulatory paradigm is appropriate and intentionally strikes a balance between quality, safety and consumer access."
“It is true that supplements are regulated different than drugs," he acknowledged, “but this is intentional because things like vitamins, fish oil, fiber, whey protein are very different than antibiotics, chemotherapy, antipsychotics and other products."
Hill, Indiana’s attorney general, asked the panelists, “How do we do a better job of making sure that the consumer knows what they’re buying is safe?"
Johansen of Cyanotech, which specializes in microalgae technology, cited the relationship between costs and quality.
“How much does it cost?" she asked. “Quality costs. If you’re buying a supplement that’s $6.99 off the website, the person who made it probably didn’t pay very much for their dietary ingredients."
Hill wondered about the dangers of targeting good companies—and imposing undue burdens on them—in the quest to zero in on scoundrels.
“I think the danger there is that you are going to reduce consumer access," MacKay responded. “You’re not going to be able to scoop up companies like Jen’s company [Cyanotech] because she’s not doing anything wrong. So you can make the accusation. You can go inspect the facility, but then they’ll be OK."
However, MacKay cited another risk.
“Some people say, ‘The [supplement] regulations need to be rewritten. We need to start over,’" he observed. “And if that’s not done well, we have the potential to really increase the costs of these products."