WASHINGTONGovernment officials are aware of an increasing reported number of severe health illnesses and problems associated with dietary supplements.
But FDA often is unable to determine what caused an illness because these incident reports contain few details, and the search to discover how a product affects a person's health is complicated by "the growing number of complex supplements on the market", the U.S. Government Accountability Office (GAO) revealed in a 58-page report that was released earlier this month.
Most of the supplements identified in the "adverse event reports" (AERs) were either a combination of different types of dietary ingredients or supplements that FDA had not classified into one of its existing supplement categories, according to the report.
"These officials said that these supplements are challenging for FDA because of limited scientific knowledge on how different supplement ingredients interact and their effect on consumers' health," GAO stated.
On a brighter note, only a small fraction of the health problems FDA received in recent years potentially associate dietary supplements with deaths and life-threatening injuries, GAO said. Over a three-year period, just 2 percent or 92 AERs were connected to fatalities while 8 percent or 512 incidents reflected life-threatening conditions, the report disclosed. Roughly half (53 percent) of the reports relate to unspecified medical events. FDA has said it is investigating several deaths connected with energy drinks, which are variably classified as dietary supplements, as part of a broader probe into the safety of the caffeine-laden beverages.
FDA officials have emphasized the health reports don't prove that products classified as dietary supplements such as energy drinks and multivitamins caused, or even contributed to, the alleged injuries.
Underreporting of Health Problems?
Still, the GAO report indicates many health problems related to dietary supplements aren't being reported. Although there were an estimated 55,000 dietary supplements on the market as of 2009 and half of the American population is said to take these diet and nutrient boosters, FDA received a total of just 6,307 AERs from 2008 through 2011. By comparison, the food and drug agency received more than 1.8 million AERs that relate to prescription drugs from 2008 through 2010.
Given the size of the dietary supplement market (reportedly $30 billion in 2011 sales), FDA officials receive fewer adverse health incidents than they would expect. A government report released last year found that 26 out of 127 labels on dietary supplements didn't contain phone numbers or complete addresses, making it difficult for consumers to reach a company in an emergency. Dietary-supplement firms aren't entirely to blame. Consumers who associate these products with an illness often contact poison control centers rather than FDA, according to GAO's analysis.
FDA Often Unable to Determine Cause of Illnesses
Since December 2007, distributors, manufacturers and packers of dietary supplements have been required under federal law and regulations to report adverse events, including birth defects, deaths, hospitalizations and life-threatening injuries. But the data often omits crucial details such as whether a person has allergies, a preexisting medical condition or consumed other products in combination with a dietary supplement. FDA rarely is able to determine whether a product contributed to the reported health problem.
Of the 6,307 AERs FDA received, the agency only established a "certain" relationship between the product and the reported health problem in 3 percent of the cases, the GAO revealed. In 67 percent of the incidents, FDA was unable to determine whether the dietary supplement caused the reported health problem because the report contained inadequate information.
The U.S. Department of Health and Human Services (HHS) "acknowledges that the current AER system is inherently limited," HHS stated in comments on the GAO report. "The core limitation of this system and all post market passive surveillance systems for consumer products is the challenge in determining whether reports in the system reflect cause-and-effect relationships between specific products and specific harms."
According to FDA guidance, dietary-supplement firms aren't required to submit such details as allergies and preexisting medical conditions. The limited facts contained in the AERs may be undermining the government's ability to detect trends that compromise consumer safety. It can take several months or years for the agency to detect a trend that would lead to a government demand or request that a dietary-supplement firm withdraw a product from the market, according to the GAO's analysis.
"FDA officials said that most AERs do not initiate or support consumer protection actions because it is difficult to establish causality based on the limited information in an AER," the report stated.
FDA Cites Enforcement, Lawsuits as Reasons for Increase in AERs
Reports of health problems have increased threefold in recent years, which may indicate a growing commitment from supplement companies to follow the law. The number of mandatory AERs has risen from 689 in 2008 to 2,040 in 2011. During the same period, consumers and others voluntarily submitted, on average, 461 reports annually.
FDA attributes two factors to the increases in mandatory reports: stepped up enforcement activity and lawsuits that publicize the consequences of failing to report adverse events. In a 2011 case, Matrixx Initiatives, Inc. v. Siracusano, the U.S. Supreme Court held that a plaintiff could state a claim for securities fraud based on the pharmaceutical company's failure to disclose reports of adverse events even if the reports don't reveal a statistically significant number of adverse incidents. Also, several lawsuits were filed against firms that produced and distributed the weight-loss supplement Hydroxycut. According to the GAO, the complaints cited FDA's request for a recall based on AERs linking the product to liver damage.
Poison Control Centers Field Supplement Complaints
The number of AERs linked to dietary supplements is much higher if one includes incidents reported to poison control centers. According to annual reports by the American Association of Poison Control Centers (AAPCC), from 2008 through 2010, poison centers received around 145,000 calls from consumers or others related to dietary supplements. GAO calculated there were 4,863 adverse events reported during this same period.
Poison control centers don't automatically share this information with FDA. Officials with FDA's Center for Food Safety and Applied Nutrition have been in discussions with the AAPCC to obtain the data at a reduced price. But accessing four years of data was estimated to cost $800,000, roughly twice what FDA earmarked to process and perform surveillance of dietary supplement AERs in fiscal year 2011.
"Additional high-quality data could enhance FDA's ability to accurately estimate background rates of illnesses and injuries, establish temporal relationships where signals of a possible safety problem exist, and detect more subtle safety signals," HHS acknowledged.
Recommendations to Improve AERs
The GAO made a number of recommendations to FDA to expand the use of the health reports. It advised exploring possible options to obtain poison center data and collecting information on when AERs are used to support consumer protection actions.
Other recommendations included allowing companies to electronically report the adverse incidents (FDA said it anticipates this option will be available by mid-2014) and determining what additional information FDA can provide to the public about the health reports.
We believe that the recommendations from the GAO report are reasonable and open the door for further dialogue with FDA as to how industry and government can continue to work together to help ensure consumers are making wise decisions about incorporating dietary supplements into their health regimens," said Steve Mister, president and CEO of the Council for Responsible Nutrition.