"Food and Drug Administration"

Circuit Split Over Graphic Label Requirement for Tobacco Products



By: Joe Schuler, Staff Member

In a recent 2-1 decision, the U.S. Court of Appeals for the D.C. Circuit vacated regulations of the Food and Drug Administration that would require graphic warning labels on tobacco products.[1] The FDA implemented the warnings in compliance with the Family Smoking Prevention and Tobacco Control Act.[2] The warnings adopted by the FDA are viewable on the agency’s website.[3]

The court concluded that the warnings violate the First Amendment. [4] The court reasoned that the graphic warnings went beyond the traditional textual warnings because they are not “purely factual, accurate, or uncontroversial information to consumers."[5] Rather, the court said, the warnings are “unabashed attempts to evoke emotion (and perhaps embarrassment) and browbeat consumers into quitting."[6]

The ruling creates a circuit split because a panel of the Sixth Circuit upheld the regulations in March, in another 2-1 decision.[7] That means the six circuit judges who have considered the issue are evenly split. Given this, it seems that the matter of the Supreme Court’s involvement is a question of when- not if - it will take up the issue. The justices certainly could choose to let other circuits weigh in before it settles the matter, but the fact that it involves regulations of a federal agency mandated by Congress may serve to expedite the Court’s review.

Tobacco growers will be watching the development of this issue closely. Naturally, growers will have a keen interest in anything that could impact the market. Given that the aim here is to motivate smokers to quit and discourage others from picking up the habit, success would obviously mean a reduced demand for tobacco.

So what is the likelihood of success? Studies suggest that the graphic warnings are more effective than plain text, at least when it comes to communicating the anti-smoking message.[8] The graphic nature of the label seems to increase a viewer’s recall of the message.[9] In other words, more people are likely to notice, and remember, the content of the warning when it is accompanied by the attention-grabbing images.

How that translates to the desired behavior behind the policy- to quit or never begin smoking - is less certain. Ironically, if the Supreme Court adopts the reasoning of the D.C. Circuit, it could prove to be the Achilles’ of the statute and regulations. According to the panel, in order to prevail, the government must show that its asserted interest is substantial and that the regulation directly advances its asserted interest.[10] The panel stated that the FDA did not provide a “shred of evidence” that the warnings would lead to a reduction in the number of American smokers.[11] Although many countries have adopted similar warnings, the court found that the FDA had offered no evidence to show that the warnings actually resulted in decreased smoking rates in those countries.[12]

Thus, although the concern of tobacco growers and manufacturers is seemingly that the warnings will decrease demand for their products, they may ultimately prevail because the government cannot prove that very thing.


[1] R.J. Reynolds Tobacco Co. v. Food and Drug Admin., No. 11-5332 Consolidated with No. 12-50632012 U.S. App. LEXIS 12925 (D.C. Cir. Aug. 24, 2012). 
[2] Id. at *4.
[4] Reynolds, 2012 U.S. App. LEXIS 17925, at *45.
[5] Id. at *30.
[6] Id.
[7] Disc.Tobacco City & Lottery, Inc. v. United States, 674 F.3d 509, 537 (6th Cir. Ky. 2012).
[8] See e.g. Ryan Jaslow, Study: Graphic Warning Labels More Effective at Delivering Anti-smoking Message, CBS News, (June 15, 2012) http://www.cbsnews.com/8301-504763_162-57454112-10391704/study-graphic-tobacco-warning-labels-more-effective-at-delivering-anti-smoking-message/.
[9] Id.
[10] Reynolds, 2012 U.S. App. LEXIS 17925, at *32.
[11] Id. at *36.
[12] Id.

The Food Safety and Modernization Act meets Opposition from Local Governments




By: Colby Khoshreza, Staff Member

A growing movement towards food safety, which was kicked into high gear last year with the passage of the Food Safety and Modernization Act, has been met with some resistance by several local governments who have recently passed food sovereignty ordinances.  The ordinances raise a challenge to state and federal regulations, which mandate inspection and licensing requirements as tools to promote food safety. 

Over the past year, over eight towns in Maine have passed local food and community self governance ordinances that give more control over how small farms and local food producers sell their crops to the general public.[1]  In opposition to federal and state laws, which often require at least some level of regulation, the ordinances permit growers and food producers to sell their products without licenses, permits or inspections.[2]  The local ordinances essentially give farmers approval to bypass state and federal regulatory requirements when their products are sold directly to consumers.[3] 

Currently, three states have towns and cities that have passed similar ordinances.[4]  Towns in Vermont, California and Maine have all passed similar ordinances in the past year.[5]  The ordinances lessen standards on the local farmers thus allowing them to avoid making expensive upgrades and investments necessary to meet state and federal food safety requirements.  Upgrades such as new cooling systems, septic systems and other equipment, commonly cost tens of thousands of dollars, a huge burden on small producers who only sell their produce to a limited number of consumers.[6]

These enactments bring into question the validity of the ordinances in light of state and federal laws, including the recently enacted Food Safety and Modernization Act, which require inspection, licensing and regulation of food production and sale.  State agriculture officials in Maine have deemed the ordinances ineffective as state and federal law supersede them.[7]  However, warnings from state officials about the invalidity of the food sovereignty laws have not necessarily deterred towns and their residents from passing further ordinances; two were just enacted last month.[8]  

This movement by local towns, many of which are heavily based in small farming, is likely a reaction to increased regulatory efforts enacted by both the Food and Drug Administration and U.S. Department of Agriculture in the last couple of years.  Much of the new regulation requires additional upgrades, which means increased costs for food producers both domestically and abroad.  While some of the regulations are tedious and expensive, they are often not as onerous as some farmers make them out to be.  The ultimate goal of promoting consumer health and safety lends strong support to stringent regulatory standards and local ordinances such as these will likely fail when they do not meet state mandates in the areas of food safety.  



[1] More towns pass food sovereignty ordinances, MAINE BUSINESS NEWS SOURCE (June 22, 2012), http://www.mainebiz.biz/apps/pbcs.dll/article?AID=/20120622/NEWS0101/120629976
[2] Id. 
[3] Clarke Canfield, Some towns try to loosen reins on food producers, BUSINESS WEEK (June 22, 2012), http://www.businessweek.com/ap/2012-06-22/some-towns-try-to-loosen-reins-on-food-producers
[4] Id. 
[5] Id. 
[6] Id. 
[7] Some towns looking to ordinances to make local farms exempt from state regulations, THE WASHINGTON POST (June 22, 2012) http://www.washingtonpost.com/lifestyle/food/some-towns-looking-to-ordinances-to-make-local-farms-exempt-from-state-regulations/2012/06/22/gJQANxnOuV_story.html
[8] Id.