February 14, 2017

February 14, 2017

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February 13, 2017

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FDA Increases Transparency of Adverse Event Data for Cosmetics and Foods

On December 6th, FDA announced that it is publicly releasing data received by the Agency’s Center for Food Safety and Applied Nutrition (CFSAN) about adverse events related to cosmetics and foods, including both conventional foods and dietary supplements.  Adverse events can be any negative reaction to a product, such as a serious illness or allergic reactions, or other complaints like packaging problems, that are received through FDA’s voluntary adverse event reporting systems for these classes of regulated products (except for in the case of dietary supplement manufacturers, who have mandatory reporting obligations).

The CFSAN Adverse Event Reporting System, called “CAERS,” includes data from reports submitted by consumers, medical professionals, and industry. The initial data file made public by the Agency contains CAERS data from January 2004 through September 2016. Subsequent data files will contain raw data extracted on a quarterly basis and will be posted here when available. Notably, CAERS data only reflect the information as it was reported – so the inclusion of a report in the system does notrepresent any determination by FDA that a product is causally linked to the reported adverse event.  It is also worth noting that although these data previously could be obtained from the Agency through a Freedom of Information Act request (often resulting in a lengthy and painful wait), the Agency is “hoping that this increased transparency will result in more detailed and complete reports that will help us to more rapidly identify red flags about a possible safety issue with products we regulate,” as articulated in a FDA blog post published by two CFSAN leaders the same day of the announcement.

The timing of this FDA announcement is interesting considering the start of the 115th Congress in January and the pending nature of the Personal Care Products Safety Act (S.1014), which we posted about most recently in October 2016. Under the proposed Personal Care Products Safety Act, among other changes to the law, cosmetic manufacturers would be required to report adverse events to the Agency, and FDA would gain mandatory recall authority over cosmetics. Cosponsors of that cosmetics reform bill, Senators Dianne Feinstein (D-CA) and Susan Collins (R-ME), have not made any formal remarks about FDA’s decision to release CAERS data, but supporters of the proposed legislation believe the development is a step forward.

Further, fallout from the ongoing WEN hair products investigation shouldn’t be overlooked as a potential contributing factor to FDA’s decision to make CAERS data easily available to the public. Dr. Linda Katz, director of the FDA’s Office of Cosmetics and Colors, recently explained that “the most frequently reported adverse events for cosmetic products go into the general categories of hair care (including shampoos, conditioners, hair smoothing products, and hair dyes) and skin care products.” Because FDA doesn’t have authority to require mandatory reporting of adverse events related to cosmetics, she added, the Agency is “just seeing the tip of the iceberg in CAERS.” Yet, reporting of adverse events associated with this category of products has increased since 2014, when only 445 reports were submitted – by comparison, in 2016 FDA received 3,576 adverse event reports for cosmetic products.

This new increased transparency from CAERS will help the Agency and other public health experts monitor and further examine trends in adverse event reports that could signal a true safety problem with a product – but the data will almost certainly also be mined by other interested parties who could use isolated reports to file lawsuits against manufacturers or retailers of certain products. So it may be wise for companies in this space to take their own actions to review the data sets in order to determine whether complaints about their products are being sent to FDA at a greater frequency or with different reactions than what might be typically reported directly to the company.  As people say, the best offense is a good defense!

Fatema Ghasletwala co-authored this post.

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About this Author

Joanna Hawana, Mintz Levin, FDA Lawyer, Consumer Protection Attorney, Washington
Of Counsel

Joanne advises clients around the world in the food, drug, and biotechnology industries on issues ranging from prescription drug advertising to state licensing requirements for wholesale distribution. In particular, Joanne counsels clients on the business impact of new US federal and state actions that affect regulated products, such as drugs, foods, and medical devices.

Joanne is experienced in US federal drug regulations, including pre-market and post-market requirements, and restrictions on advertising and sampling. Joanne also has counseled...

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