The dietary supplement industry's experience could offer a preview of the cosmetics industry's future under legislation to require manufacturers to report serious adverse events to FDA within 15 business days of receiving the information.

The Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006 made serious adverse-event reporting mandatory for supplement makers, and monograph OTC drugs, and AERs linked to supplement products more than tripled in 2008, the first year the reports were required.

AERs continued to climb from the roughly 350 voluntary notifications FDA received in 2007 to nearly 3,300 mandatory reports in 2013, according to reports. Reportedly, 2014 was the first time that AERs declined versus the prior year.

Meanwhile, FDA has expressed concerns about underreporting in the industry. The agency issued guidance in July 2009 to clarify what qualifies as a serious adverse event and published a how-to guide in 2011 to promote industry compliance Also see "FDA Says Supplement Adverse Event Under-Reporting Should Feed Growth" - Pink Sheet, 22 August, 2011..

FDA warning letters citing supplement firms for failures to submit serious AERs have been on the rise as well Also see "Supplement GMP Inspections Reveal Adverse Event Reports, Prompting Warning Letters" - Pink Sheet, 21 July, 2014..

Notable enforcements linked to AERs not submitted to FDA include the agency's requests in 2009 for recalls of [Iovate Health Sciences Inc.]'s Hydroxycut weight loss supplement and [Matrixx Initiatives Inc.]'s homeopathic intranasal cold remedy Zicam Also see "FDA Says Supplement AERs Will Be Subject To Lower Threshold Before Action" - Pink Sheet, 11 January, 2010..

Industry has emphasized its challenges in investigating reports and separating the serious from non-serious, while suggesting FDA underestimates the costs and time burden on companies Also see "Supplement AER Compliance Costs Exceed FDA Estimates – Industry" - Pink Sheet, 4 June, 2012..

The proposed Personal Care Products Safety Act, S. 1014, would require cosmetics manufacturers to report serious adverse events to FDA within 15 business days of receiving the information. The timeline and the bill's definition of a serious adverse event are consistent with terms in the supplement and nonprescription drug law.

The Cosmetic Modernization Amendments of 2015, H.R. 4075, also proposes mandatory serious adverse event reporting, with some modifications Also see "FDA's Cosmetic AE Data Begs Question: What If Reporting Were Mandatory?" - HBW Insight, 10 March, 2016..

S. 1014 sponsor Sen. Dianne Feinstein, D-CA, is hopeful that the Senate Health, Education, Labor and Pensions Committee will hold a hearing on the draft bill this spring. The legislation is backed by the Personal Care Products Council, leading industry players and prominent trade, research and advocacy groups Also see "Feinstein, EWG Gunning For Spring Senate Hearing On Cosmetics Bill" - HBW Insight, 1 March, 2016..

In addition to mandating AERs, S. 1014 would require companies to register their facilities with FDA and submit product/ingredient statements. FDA would be authorized to order product recalls and would be responsible for reviewing the safety of five cosmetic ingredients or non-functional constituents annually.

The agency also would be expected to draft a regulation establishing good manufacturing practices for cosmetics, another potential compliance challenge the dietary supplement industry has had to navigate in recent years Also see "Supplement Industry Offers Cautionary Tale For Mandatory Cosmetic GMPs" - HBW Insight, 14 April, 2015..

Supplements' Mandatory Adverse Event Reporting Portends Cosmetics' Potential Future

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