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July 14 — Risky dietary supplements are a moving target for the FDA, and purveyors of questionable cures exploit weaknesses in the agency's ability to police the $39 billion supplement industry, lawyers and academics tell Bloomberg BNA.
Significant legal and public health questions turn on whether the 1994 Dietary Supplement Health and Education Act adequately protects consumers from dangerous ingredients.
The federal law serves as the foundation of the Food and Drug Administration's authority over dietary supplements.
But DSHEA doesn't require the pre-market approval required for drugs, and that's the rub for those who criticize the law.
“They have to wait for evidence that something is harmful,” Michael Jacobson, executive director of the Center for Science in the Public Interest in Washington, D.C., told Bloomberg BNA. “So, the FDA just cannot be an effective watchdog as things are now.”
Consumer safety advocates cite as a prime example the manufacture and sale of various formulations of OxyElite by Texas-based USPLabs LLC. The weight-loss supplement allegedly caused two deaths in 2012 (see sidebar) and nearly 100 cases of liver failure under a different formulation.
But other observers aligned with industry say FDA's enforcement tools are sufficient to deal with supplements that prove harmful to human health.
“FDA’s done a very nice job of bringing heightened consciousness to the Department of Justice, but also to the industry,” attorney Scott Bass, of Sidley Austin's New York office, recently told Bloomberg BNA.Suits Follow Injuries
USP Labs LLC is facing civil and criminal litigation over a weight loss product it sold in 2012 and 2013.
The original version of OxyElite contained DMAA (1,3-Dimethylamylamine), a substance similar to the banned substance ephedrine.
The company recalled that version in 2012 after the deaths of two military personnel, but re-marketed it with aegeline, a synthetic ingredient linked to liver failure, the FDA said.
Nearly 100 liver failure cases, 47 hospitalizations, three liver transplants and one death followed, according to the CDC.
Bass represents businesses, including supplement makers, in FDA-related enforcement and regulatory matters.
State and federal prosecutions of violators, increased product screening by the supplement industry, and FDA's addition of 17 inspectors in China are having an impact, Bass said.
“FDA has the necessary enforcement tools,” Bass said. “Of course, FDA’s enforcement budget could be made larger by Congress and that would help a lot. That’s been a concern.”
A 2014 study by the Centers for Disease Control and Prevention estimated that more than 23,000 emergency room visits are attributable to dietary supplements each year. Of that number, more than 2,100 resulted in hospitalization, the study found.
Weight-loss and energy products accounted for more than half of supplement-related visits for patients between the ages of 20 and 34 years, according to the study.
Those public warnings—at least 124 since 2013—often concern products that purport to aid weight loss and athletic training, and typically include the words “contains hidden drug ingredient.”
One recent example is “Exhilarate,” a weight loss supplement sold in stores and on the Internet. It was found by FDA in June of this year to contain sibutramine, a controlled substance removed from the market in 2010 because of its cardiovascular risks, according to the warning.
Exhilarate also contains phenolphtalein, a chemical found in some studies to increase cancer risks, according to the FDA.
A different kind of danger is posed by powdered caffeine products, some of which pack a 28-coffee-cup punch in a quarter teaspoon, according to CSPI.
In 2014, the center filed a citizen petition with FDA urging a ban on the products, noting the deaths of two young men who ingested them that year. FDA sent warning letters to five companies that sold the products, but CSPI followed-up in April to advise the agency that sales persist elsewhere.
“In sum, FDA's five letters appear to have ceased the sale of powdered caffeine at only the companies to which the agency addressed its letters,” CSPI wrote.
“With caffeine, hopefully FDA will take action,” said Jacobson. “If it doesn’t, at some point we will file a lawsuit to try to get the FDA to respond to our petition.”
One of the problems, safety advocates say, is DSHEA doesn't require FDA clearance for ingredients sold prior to October 15, 1994. For new ingredients sold after that date, manufacturers must only notify the agency and provide evidence of how it determined the ingredient is safe for human consumption.
That gives some manufacturers leeway to market products based on questionable research.
But those who represent supplement makers say a recent law, the FDA Food Safety Modernization Act, Pub. L. No. 111-353, 124 Stat. 3885 (2011), is helping to stem the tide of suspect supplements.
“That will put a lot more pressure on suppliers to validate their products,” Bass said of FSMA, enacted in 2011. “It’s not going to clean up the problem completely—there are too many players who don’t follow the rules—but it will have a major impact in cutting down on the number of spiked products.”
FDA spokeswoman Lyndsay Meyer in Washington, D.C. told Bloomberg BNA the new rules allow for product recalls and the detention of potentially harmful inventories of adulterated or misbranded supplements.
Recalls may be ordered when there is a “reasonable probability that an article of food, including dietary supplements, is adulterated or misbranded” and the product will cause “serious adverse health consequences or death to people or animals,” Meyer said in an e-mail.
FDA detained inventories of OxyElite in 2013 after USPLabs said it intended to sell some of its remaining stock. The agency invoked its authority under FSMA to embargo the stock, which USPLabs ultimately agreed to destroy.
Further, DSHEA mandates that manufacturers report adverse events to FDA, and a Safety Reporting Portal facilitates adverse event reports by industry, clinicians and consumers.
The crux of the debate is whether these tools, and FDA's use of them, are sufficient.
“We have some authority,” but “the difference is we have to chase after any bad actor,” former FDA commissioner David Kessler recently said of the agency's regulation of dietary supplements.
Kessler's comments came at a June 25 Aspen Institute panel discussion that included six former FDA commissioners.
“And you have to go into court and the burden is on the FDA,” Kessler said.
He referred to the requirement that FDA show a product is adulterated or misbranded before it is allowed to remove the product from the market.
“It makes tobacco looks easy,” Kessler, who led FDA from 1990 to 1997, said.
Margaret Hamburg, FDA commissioner from 2009 to 2015, concurred with Kessler's overall assessment.
“The way the law currently exists, companies are required to report severe adverse side effects to the FDA, but it's very hard to even know what's going on because there isn't an opportunity to really track experiences,” Hamburg said.
Rend Al-Mondhiry, associate general counsel for the Council for Responsible Nutrition, recently told Bloomberg BNA the council disagrees with the commissioners' take on FDA's regulatory powers.
“It’s unfortunate the commissioners view it that way,” Al-Mondhiry said.
CRN, based in Washington, D.C., is a trade association for dietary supplement and food manufacturers.
“When FDA does engage in enforcement actions, we think it sends a strong message to the bad actors in the industry that they need to get their act together,” Al-Mondhiry said, noting the availability of criminal and civil penalties for the worst violators.
“The law works when it’s implemented,” Al-Mondhiry said. “It’s really up to FDA to use all those enforcement tools that are there.”
The supplement industry also has taken steps “to help separate the good industry from the bad,” she said.
A recent CRN survey found that 68 percent of Americans take supplements—including beneficial vitamins, minerals and herbal teas—and that 84 percent of respondents had overall confidence in their safety.
But Pieter Cohen, an assistant professor at Harvard Medical School in Cambridge, Mass., told Bloomberg BNA a complete overhaul of DSHEA is needed.
At a minimum, proposals that would require registration of all dietary supplements, standardized laboratory tests and clearer FDA authority should be considered, said Cohen, a frequent critic of FDA's regulation of the dietary supplement industry.
Peddlers of dubious or dangerous supplements are driven by the promise of profit, Cohen said in an e-mail.
“As long as companies can make millions selling these products, it's going to encourage others to jump in,” Cohen said. “Unless there are profound changes to the law, there will be no way to ensure the safety of supplements in the U.S.”
Sarah Sorscher, a consumer lawyer with Public Citizen, a consumer advocacy group in Washington, D.C., agreed.
FDA enforcement efforts aren't enough to deter some manufacturers, Sorscher told Bloomberg BNA.
“Even when the FDA does manage to build a strong case, as it did with USPLabs, penalties levied against a few businesses and individuals may not be strong enough to deter bad behavior across the industry,” said Sorscher, who focuses on health and safety issues.
“Without better regulation, better funding, or both, tainted products will continue to slip past federal regulators,” Sorscher said.
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