Posting Adverse Event Report Data Associated With Conventional Foods, Dietary Supplements, and Cosmetics on the Internet; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA or we) is announcing the availability of data extracted from adverse event reports from January 2004 to the present involving food (including food additives, color additives, and dietary supplements) and cosmetics regulated by our Center for Food Safety and Applied Nutrition (CFSAN). The data files are being made publicly available on FDA's Web site to improve transparency about adverse event reports involving CFSAN-regulated products and increase awareness about reporting these adverse events to FDA.

FOR FURTHER INFORMATION CONTACT:

Lyle Canida, Center for Food Safety and Applied Nutrition (HFS-014), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1817.

SUPPLEMENTARY INFORMATION:

I. Background

We are announcing the availability of data extracted from the CFSAN Adverse Event Reporting System (CAERS) from adverse event reports involving food (including food additives, color additives, and dietary supplements) and cosmetics regulated by CFSAN that were submitted to FDA from January 2004 to the present. We will make these data files available on a quarterly basis on the FDA Web site at http://www.fda.gov/Food/ComplianceEnforcement/ucm494015.htm. Each posting will consist of adverse event report information entered in CAERS for the previous 3 months with a roughly one month delay. The data files are provided in ASCII format and include information on the following topics (if provided):

• Demographic (e.g., age, gender) and administrative information regarding the adverse event;
• Date of event;
• Product role (suspect or concomitant);
• Reported brand/product name;
• Industry code/name;
• Reported symptom(s); and
• Outcome information.

What is CAERS?

The CAERS database collects reports submitted by consumers, health professionals, industry, and others about adverse health events and product complaints related to CFSAN-regulated products. It includes voluntary reports involving conventional foods, including food additives and color additives, and cosmetics, and both mandatory and voluntary reports with respect to adverse events involving dietary supplements. Reports are mandatory for dietary supplements used in the United States in the case of a serious adverse event that has resulted in death, a life-threatening experience, inpatient hospitalization, a persistent or significant disability or incapacity, a congenital anomaly or birth defect, or that requires, based on reasonable medical judgment, a medical or surgical intervention to prevent one of those outcomes (see 21 U.S.C. 379aa-1). In such cases, dietary supplement manufacturers, packers, and distributors must notify FDA if they receive reports about serious adverse events associated with the use of the dietary supplement.

The goal of CAERS is to improve consumer protection by providing FDA with information from which we may be able to quickly identify situations in which the data provide a signal that a particular product may be harmful and should be investigated further.

However, we note that adverse event reports about a particular product and the total number of adverse event reports for a product in the CAERS database only reflect information reported and do not represent any conclusion by FDA about whether the product actually caused the adverse event(s). Because we constantly update CAERS with new information, the number of reports for a given product and the content of individual reports may change over time. Furthermore, even with respect to dietary supplements, for which reporting of serious adverse events is mandatory, adverse events associated with any product may be underreported. On the other hand, in some instances there may be duplicate reports in CAERS for the same adverse event because multiple people (such as an injured consumer and a health care provider who treated him or her) may have submitted reports. Questions and answers (Q&As) accompanying the data at our Web site explain the data limitations, as well as the reasons why we need complete reporting.

Why is CFSAN posting these data on the FDA Web site?

• We are making this information available for the purpose of improving transparency by providing the public, including researchers and health care professionals, with online access to information from adverse event reports about CFSAN-regulated products. This information has previously been available only through the process of specific requests under the Freedom of Information Act, 5 U.S.C. 552. In addition, we believe that posting these data may increase the number and completeness of the adverse event reports we receive. For the most part, FDA does not have pre-market authority over foods and cosmetics. As a result, identifying through post-market surveillance possible risks associated with these products is critical.

Where and when will data be posted?

• We will post CAERS data on a quarterly basis on the FDA Web site at http://www.fda.gov/Food/ComplianceEnforcement/ucm494015.htm. Each posting will include adverse event reports entered in CAERS for the previous 3 month period, with a roughly one month delay. So for example, if we post data files on the CAERS Web page in February, the information would consist of adverse event reports entered (or revised) in CAERS during the previous October thru December time period. Data files from the January thru March time period would be posted in the following May, and so on.