81_FR_88479 81 FR 88244 - Posting Adverse Event Report Data Associated With Conventional Foods, Dietary Supplements, and Cosmetics on the Internet; Availability

81 FR 88244 - Posting Adverse Event Report Data Associated With Conventional Foods, Dietary Supplements, and Cosmetics on the Internet; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 235 (December 7, 2016)

Page Range88244-88244
FR Document2016-29277

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.

Federal Register, Volume 81 Issue 235 (Wednesday, December 7, 2016) 
[Federal Register Volume 81, Number 235 (Wednesday, December 7, 2016)]
[Notices]
[Page 88244]
From the Federal Register Online  [www.thefederalregister.org]
[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

88244 Federal Register / Vol. 81, No. 235 / Wednesday, December 7, 2016 / Notices (B) The Flores Settlement Agreement, 2004 to the present. We will make these CAERS with new information, the Case No. CV85–4544RJK (C. D. Cal. data files available on a quarterly basis number of reports for a given product 1996), as well as the William on the FDA Web site at http:// and the content of individual reports Wilberforce Trafficking Victims www.fda.gov/Food/ may change over time. Furthermore, Protection Reauthorization Act of 2008 ComplianceEnforcement/ even with respect to dietary (Pub. L. 110–457), which authorizes ucm494015.htm. Each posting will supplements, for which reporting of post release services under certain consist of adverse event report serious adverse events is mandatory, conditions to eligible children. All information entered in CAERS for the adverse events associated with any programs must comply with the Flores previous 3 months with a roughly one product may be underreported. On the Settlement Agreement, Case No. CV85– month delay. The data files are provided other hand, in some instances there may 4544–RJK (C.D. Cal. 1996), pertinent in ASCII format and include be duplicate reports in CAERS for the regulations and ORR policies and information on the following topics (if same adverse event because multiple procedures. provided): people (such as an injured consumer • Demographic (e.g., age, gender) and and a health care provider who treated Christopher Beach, administrative information regarding him or her) may have submitted reports. Senior Grants Policy Specialist, Division of the adverse event; Questions and answers (Q&As) Grants Policy, Office of Administration, • Date of event; Administration for Children and Families. accompanying the data at our Web site • Product role (suspect or explain the data limitations, as well as [FR Doc. 2016–29326 Filed 12–6–16; 8:45 am] concomitant); the reasons why we need complete BILLING CODE 4184–45–P • Reported brand/product name; reporting. • Industry code/name; • Reported symptom(s); and Why is CFSAN posting these data on the DEPARTMENT OF HEALTH AND • Outcome information. FDA Web site? HUMAN SERVICES What is CAERS? • We are making this information Food and Drug Administration The CAERS database collects reports available for the purpose of improving submitted by consumers, health transparency by providing the public, [Docket No. FDA–2016–N–3274] professionals, industry, and others including researchers and health care Posting Adverse Event Report Data about adverse health events and product professionals, with online access to Associated With Conventional Foods, complaints related to CFSAN-regulated information from adverse event reports Dietary Supplements, and Cosmetics products. It includes voluntary reports about CFSAN-regulated products. This on the Internet; Availability involving conventional foods, including information has previously been food additives and color additives, and available only through the process of AGENCY: Food and Drug Administration, cosmetics, and both mandatory and specific requests under the Freedom of HHS. voluntary reports with respect to Information Act, 5 U.S.C. 552. In ACTION: Notice. adverse events involving dietary addition, we believe that posting these supplements. Reports are mandatory for data may increase the number and SUMMARY: The Food and Drug dietary supplements used in the United completeness of the adverse event Administration (FDA or we) is States in the case of a serious adverse reports we receive. For the most part, announcing the availability of data event that has resulted in death, a life- FDA does not have pre-market authority extracted from adverse event reports threatening experience, inpatient over foods and cosmetics. As a result, from January 2004 to the present hospitalization, a persistent or identifying through post-market involving food (including food significant disability or incapacity, a surveillance possible risks associated additives, color additives, and dietary congenital anomaly or birth defect, or with these products is critical. supplements) and cosmetics regulated that requires, based on reasonable by our Center for Food Safety and Where and when will data be posted? medical judgment, a medical or surgical Applied Nutrition (CFSAN). The data intervention to prevent one of those • We will post CAERS data on a files are being made publicly available outcomes (see 21 U.S.C. 379aa–1). In quarterly basis on the FDA Web site at on FDA’s Web site to improve such cases, dietary supplement http://www.fda.gov/Food/ transparency about adverse event manufacturers, packers, and distributors ComplianceEnforcement/ reports involving CFSAN-regulated must notify FDA if they receive reports ucm494015.htm. Each posting will products and increase awareness about about serious adverse events associated include adverse event reports entered in reporting these adverse events to FDA. with the use of the dietary supplement. CAERS for the previous 3 month period, FOR FURTHER INFORMATION CONTACT: Lyle The goal of CAERS is to improve with a roughly one month delay. So for Canida, Center for Food Safety and consumer protection by providing FDA example, if we post data files on the Applied Nutrition (HFS–014), Food and with information from which we may be CAERS Web page in February, the Drug Administration, 5001 Campus Dr., able to quickly identify situations in information would consist of adverse College Park, MD 20740, 240–402–1817. which the data provide a signal that a event reports entered (or revised) in SUPPLEMENTARY INFORMATION: particular product may be harmful and CAERS during the previous October should be investigated further. thru December time period. Data files I. Background However, we note that adverse event asabaliauskas on DSK3SPTVN1PROD with NOTICES from the January thru March time We are announcing the availability of reports about a particular product and period would be posted in the following data extracted from the CFSAN Adverse the total number of adverse event May, and so on. Event Reporting System (CAERS) from reports for a product in the CAERS Dated: December 1, 2016. adverse event reports involving food database only reflect information (including food additives, color reported and do not represent any Leslie Kux, additives, and dietary supplements) and conclusion by FDA about whether the Associate Commissioner for Policy. cosmetics regulated by CFSAN that product actually caused the adverse [FR Doc. 2016–29277 Filed 12–6–16; 8:45 am] were submitted to FDA from January event(s). Because we constantly update BILLING CODE 4164–01–P VerDate Sep<11>2014 17:54 Dec 06, 2016 Jkt 241001 PO 00000 Frm 00048 Fmt 4703 Sfmt 9990 E:\FR\FM\07DEN1.SGM 07DEN1


Document Created: 2016-12-07 05:31:59
Document Modified: 2016-12-07 05:31:59
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
ContactLyle Canida, Center for Food Safety and Applied Nutrition (HFS-014), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1817.
FR Citation81 FR 88244 
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