[Federal Register Volume 81, Number 235 (Wednesday, December 7, 2016)]
[Notices]
[Page 88244]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-29277]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-3274]


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.

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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.

    Dated: December 1, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-29277 Filed 12-6-16; 8:45 am]
 BILLING CODE 4164-01-P