Regulatory Update: Labels, Food & Budgets

This week, the FDA finds itself at the center of two more high-profile disputes over consumer labeling. On Tuesday, a coalition of 33 state attorneys-general sent a letter to the agency urging that warning labels and childproof packaging be required for liquid nicotine and related “e-liquid” substances that fuel increasingly popular electronic cigarettes, citing thousands of cases of child poisoning nationwide. On Wednesday, three of the biggest names in big tobacco (Reynolds, Altria, and Imperial) sued the FDA in a bid to kill a new labeling directive on branding changes that the companies allege constitute infringement on commercial speech rights.

State AG Campaign
http://www.reuters.com/article/2015/09/29/us-usa-ecigarettes-warnings-idUSKCN0RT2NZ20150929
State AG Letter
http://www.ag.ny.gov/pdfs/Final-Letter-AG-FDA-Comments-Nicotine-Exposure-Warnings.pdf
Corporate Lawsuits
http://www.reuters.com/article/2015/09/30/us-usa-tobacco-lawsuit-idUSKCN0RU2RK20150930

The tobacco fights are just the latest in the stream of FDA-related developments. The latest round of budget wrangling has shed light on FDA progress (or lack thereof) in implementing the sweeping 2011 Food Safety Modernization Act (FSMA). The law was originally enacted without mandatory funding, putting it at the whim of the (sequestered) yearly appropriations process for the necessary staff hiring, retraining, and stepped-up domestic and foreign inspections. Agency officials are requesting $64 million more than Congress is willing to provide for FY 2016.

FDA Funding
http://www.agri-pulse.com/Moran-willing-to-increase-FSMA-funding-09162015.asp

Underscoring the stakes on food safety, a federal judge sentenced the CEO of now-defunct Peanut Corporation of America to 28 years in prison in September, following his conviction last year on over 70 criminal charges stemming from willful neglect of food safety statues that lead to deadly Salmonella outbreak in 2008 and 2009. The case represents the most severe punishment ever for a food related crime.

Executive Sentencing
https://www.washingtonpost.com/national/health-science/former-peanut-executive-sentenced-to-28-years-in-prison-for-outbreak-that-killed-nine-people-sickened-hundreds/2015/09/21/aba7500e-60a7-11e5-8e9e-dce8a2a2a679_story.html?tid=pm_pop_b&wpmm=1&wpisrc=nl_daily202

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