Analyzing data regarding reported health problems from dietary supplements, the U.S. Government Accountability Office (GAO) found that from 2008 through 2011, FDA received 6,307 reports of health problems—adverse event reports (AER)—for dietary supplements.
Seventy one percent of these reports came from industry as serious adverse events as required by law, and most of these AERs were linked with supplements containing a combination of ingredients, such as vitamins and minerals or were otherwise not classified within FDA’s product categories, the report noted.
However, according to the GAO report, FDA may not be receiving information on all adverse events, as consumers and others may not be voluntarily reporting these events to FDA, although they may be contacting poison centers about some of these events.
From 2008 to 2010, these centers received more than 1,000 more reports of adverse events linked to dietary supplements than did FDA for the same period. FDA officials said they are interested in determining whether the poison center data could be useful for their analysis and have held discussions with American Association of Poison Control Centers representatives, but cost is a factor.
GAO recommended that FDA explore options to obtain poison center data, if determined to be useful; collect information on how it uses AERs; provide more information to the public about AERs; and establish a time frame to finalize guidance related to GAO’s 2009 recommendations. FDA generally concurred with each of GAO’s recommendations.
Responding to the report, Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), Washington, D.C., said, his organization believes the recommendations in 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.”
CRN was instrumental in helping to pass the current adverse event reporting law, and remains 100% committed to making the law work to protect consumers, he added.
“Our association has engaged in industry education since the law was passed, and most recently, CRN—along with the American Herbal Products Association, the Consumer Healthcare Products Association, the Natural Products Association and the United Natural Products Alliance—partnered on an educational webinar for the supplement industry with participation from FDA, to further advise the industry on complying with serious adverse event reporting. This GAO report indicated that 71% of serious adverse events reported to FDA came from the industry itself—and CRN will continue to urge the supplement industry to comply and support FDA in taking enforcement action against those companies that do not.”
CRN supports transparency with respect to AER reporting, Mr. Mister noted, “to the extent that consumers will benefit from that transparency and that industry will not be made the victim of frivolous lawsuits because of it. However, along with transparency, there must be context and education, so that consumers are not misled and clearly understand that just because a consumer may have taken a product at the same time they experience an adverse symptom, it may not translate into a causal relationship between a product and the adverse event itself.
“Finally, we commend the GAO for urging FDA to finalize its draft guidance on 1) New Dietary Ingredients and 2) distinguishing liquid dietary supplements from conventional foods,” he continued. “In their final form, these guidance documents will provide much needed clarity to companies manufacturing and marketing dietary supplements.”
Seventy one percent of these reports came from industry as serious adverse events as required by law, and most of these AERs were linked with supplements containing a combination of ingredients, such as vitamins and minerals or were otherwise not classified within FDA’s product categories, the report noted.
However, according to the GAO report, FDA may not be receiving information on all adverse events, as consumers and others may not be voluntarily reporting these events to FDA, although they may be contacting poison centers about some of these events.
From 2008 to 2010, these centers received more than 1,000 more reports of adverse events linked to dietary supplements than did FDA for the same period. FDA officials said they are interested in determining whether the poison center data could be useful for their analysis and have held discussions with American Association of Poison Control Centers representatives, but cost is a factor.
GAO recommended that FDA explore options to obtain poison center data, if determined to be useful; collect information on how it uses AERs; provide more information to the public about AERs; and establish a time frame to finalize guidance related to GAO’s 2009 recommendations. FDA generally concurred with each of GAO’s recommendations.
Responding to the report, Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), Washington, D.C., said, his organization believes the recommendations in 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.”
CRN was instrumental in helping to pass the current adverse event reporting law, and remains 100% committed to making the law work to protect consumers, he added.
“Our association has engaged in industry education since the law was passed, and most recently, CRN—along with the American Herbal Products Association, the Consumer Healthcare Products Association, the Natural Products Association and the United Natural Products Alliance—partnered on an educational webinar for the supplement industry with participation from FDA, to further advise the industry on complying with serious adverse event reporting. This GAO report indicated that 71% of serious adverse events reported to FDA came from the industry itself—and CRN will continue to urge the supplement industry to comply and support FDA in taking enforcement action against those companies that do not.”
CRN supports transparency with respect to AER reporting, Mr. Mister noted, “to the extent that consumers will benefit from that transparency and that industry will not be made the victim of frivolous lawsuits because of it. However, along with transparency, there must be context and education, so that consumers are not misled and clearly understand that just because a consumer may have taken a product at the same time they experience an adverse symptom, it may not translate into a causal relationship between a product and the adverse event itself.
“Finally, we commend the GAO for urging FDA to finalize its draft guidance on 1) New Dietary Ingredients and 2) distinguishing liquid dietary supplements from conventional foods,” he continued. “In their final form, these guidance documents will provide much needed clarity to companies manufacturing and marketing dietary supplements.”
