FDA Has Made Changes in Response to the New Serious Adverse Event Reporting Requirements and Has Received an Increased Number of Reports

FDA has made several changes in response to the new serious adverse  event reporting requirements established by law in 2006 and has  subsequently received an increased number of reports. FDA has also issued draft guidance and conducted outreach to industry  regarding the new reporting requirements. FDA Has Received an Increased Number of Adverse Event Reports Since Mandatory Reporting Went into Effect

Since mandatory reporting requirements went into effect, the agency has  seen a threefold increase in the number of all adverse events reported  compared with the previous year. For example, from January through  October 2008, FDA received 948 adverse event reports, compared with 298  received over the same time period in 2007. Although FDA Has Taken Some Steps to Identify and Act on Concerns about the Safety of Dietary Supplements, Several Factors Limit Its Oversight

FDA has taken some steps—such as analyzing adverse event reports and  detaining certain potentially unsafe imported products—to identify and  act upon safety concerns related to dietary supplements. However, several  factors limit the agency’s ability to detect concerns and efficiently and  effectively remove products from the market. For example, FDA has  limited information on the number and location of dietary supplement  firms, the identity and ingredients of products currently available in the  marketplace, and mild and moderate adverse events reported to industry. Additionally, FDA dedicates relatively few resources to dietary  supplement oversight activities compared with other FDA-regulated  products. FDA’s Lack of Authority Limits Its Ability to Remove Products from the Market

Once FDA has identified a safety concern, the agency’s ability to efficiently  and effectively remove a product from the market is hindered by a lack of  mandatory recall authority. While FDA Has Taken Some Actions When Foods Contain Unsafe Dietary Ingredients, Certain Factors May Allow Unsafe Products to Reach Consumers

Although FDA has taken some actions, such as issuing warnings, when  foods contain unsafe dietary ingredients, certain factors may allow unsafe  products to reach consumers. FDA may not know when a company has  made an unsupported or incorrect GRAS determination about an added  dietary ingredient in a product until after the product becomes available to  consumers because companies are not required to notify FDA of their self- determinations. In addition, the boundary between dietary supplements  and foods containing added dietary ingredients is not always clear, and  some food products could be marketed as dietary supplements to  circumvent the safety standard required for food additives. FDA Has Taken Limited Steps to Educate Consumers about Dietary Supplements, and Consumers Remain Largely Uninformed

While FDA has conducted some consumer outreach, these initiatives have  reached a relatively small proportion of consumers using dietary  supplements. Additionally, surveys and experts indicate that consumers  are not well-informed about the safety and efficacy of dietary supplements  and have difficulty interpreting labels on these products. Without a clear  understanding of the safety, efficacy, and labeling of dietary supplements,  consumers may be exposed to greater health risks associated with the  uninformed use of these products. Specifically, we were asked to examine FDA’s (1) actions to  respond to the new serious adverse event reporting requirements; (2)  ability to identify and act on concerns about the safety of dietary  supplements; (3) ability to identify and act on concerns about the safety of  foods with added dietary ingredients; and (4) actions to educate  consumers about the safety, efficacy, and labeling of dietary supplements.
Why GAO Did This Study

Dietary supplements and foods with added dietary ingredients, such as vitamins and herbs, constitute multibillion dollar industries. Past reports on the Food and Drug Administration's (FDA) regulation of these products raised concerns about product safety and the availability of reliable information. Since then, FDA published draft guidance on requirements for reporting adverse events--which are harmful effects or illnesses--and Current Good Manufacturing Practice regulations for dietary supplements. GAO was asked to examine FDA's (1) actions to respond to the new serious adverse event reporting requirements, (2) ability to identify and act on concerns about the safety of dietary supplements, (3) ability to identify and act on concerns about the safety of foods with added dietary ingredients, and (4) actions to ensure that consumers have useful information about the safety and efficacy of supplements.

What GAO Found

FDA has made several changes in response to the new serious adverse event reporting requirements and has subsequently received an increased number of reports. For example, FDA has modified its data system, issued draft guidance, and conducted outreach to industry. Since mandatory reporting went into effect on December 22, 2007, FDA has seen a threefold increase in the number of all adverse event reports received by the agency compared with the previous year. For example, from January through October 2008, FDA received 948 adverse event reports--596 of which were mandatory reports submitted by industry--compared with 298 received over the same time period in 2007. Although FDA has received a greater number of reports since the requirements went into effect, underreporting remains a concern, and the agency has further actions planned to facilitate adverse event reporting. FDA has taken some steps to identify and act upon safety concerns related to dietary supplements; however, several factors limit the agency's ability to detect concerns and remove products from the market. For example, FDA has limited information on the number and location of dietary supplement firms, the types of products currently available in the marketplace, and information about moderate and mild adverse events reported to industry. Additionally, FDA dedicates relatively few resources to oversight activities, such as providing guidance to industry regarding notification requirements for products containing new dietary ingredients. Also, once FDA has identified a safety concern, the agency's ability to remove a product from the market is hindered by a lack of mandatory recall authority and the difficult process of demonstrating significant or unreasonable risk for specific ingredients. Although FDA has taken some actions when foods contain unsafe dietary ingredients, certain factors may allow potentially unsafe products to reach consumers. FDA may not know when a company has made an unsupported or incorrect determination about whether an added dietary ingredient in a product is generally recognized as safe until after the product becomes available to consumers because companies are not required to notify FDA of their self-determinations. In addition, the boundary between dietary supplements and conventional foods containing dietary ingredients is not always clear, and some food products could be marketed as dietary supplements to circumvent the safety standard required for food additives. FDA has taken limited steps to educate consumers about dietary supplements, and studies and experts indicate that consumer understanding is lacking. While FDA has conducted some outreach, these initiatives have reached a relatively small proportion of dietary supplement consumers. Additionally, surveys and experts indicate that consumers are not well-informed about the safety and efficacy of dietary supplements and have difficulty interpreting labels on these products. Without a clear understanding of the safety, efficacy, and labeling of dietary supplements, consumers may be exposed to greater health risks associated with the uninformed use of these products.