HealthLawProf Blog

Too Much Information? GM Food Labeling Mandates

As NPR reported yesterday, voters in Colorado and Oregon will decide next month whether foods with genetically-modified (GM) ingredients should be identified as such with labeling. And why not? More information usually is better, and many people care very much whether they are purchasing GM foods. Moreover, it is common for the government to protect consumers by requiring disclosures of information. Thus, sellers of securities must tell us relevant information about their companies, and sellers of food must tell us relevant information about the nutritional content of their products.

Nevertheless, there often are good reasons to reject state-mandated disclosures of information to consumers. Sometimes, the government requires the provision of inaccurate information, as when states require doctors to tell pregnant women that abortions result in a higher risk of breast cancer or suicide. At other times, the government mandates ideological speech, compelling individuals to promote the state’s viewpoint. Accordingly, the First Amendment should prevent government from requiring the disclosure of false or misleading information or of ideological messages. (For discussion of abortion and compelled speech, see this forthcoming article.)

What about GM labeling? Is this similar to requiring country-of-origin labeling for meat and produce, a policy upheld by the D.C. Circuit earlier this year? GM labeling likely will mislead more than inform. Many people harbor concerns about genetic modification that are not justified by reality. In particular, as the NPR report indicated, researchers have not found any risks to health from eating GM foods. Indeed, genetic modification can promote better health, as when crops are fortified with essential vitamins or other nutrients. For very good reasons, GM foods run throughout the food supply, whether from traditional forms of breeding or modern laboratory techniques. Thus, the American Association for the Advancement of Science has concluded that GM labeling “can only serve to mislead and falsely alarm consumers.”

[cross-posted at PrawfsBlawg and orentlicher.tumblr.com]

SCOTUS Embraces Regulatory Synergy in POM Wonderful

A great post by my colleague Diana Winters, cross-posted from Bill of Health

By Diana R.H. Winters

While today’s unanimous (sans Justice Breyer, who recused himself) decision by the Supreme Court in POM Wonderful LLC v. Coca-Cola Co. was certainly not a surprise, especially after the clear tenor of the oral argument, the case may have some implications for FDA law going forward. In this case, POM Wonderful sued Coca-Cola under the Lanham Act, alleging that the label on Coca-Cola’s pomegranate blueberry juice was false and misleading, and that this deception caused it to lose sales. Coca-Cola argued that because its label complied with the Food, Drug, and Cosmetic Act, POM’s Lanham Act claim should be precluded. The district court and the Ninth Circuit agreed.

Continue reading

FDA Regulation of E-Cigarettes—A Gateway to Teaching Administrative Law

 

It’s likely that most readers of this blog already know that the FDA just announced its intent to extend its regulatory powers to E-Cigarettes.   E-Cigarettes have proven to be a "high interest" topic in both my "Constitutional Issues in Health Law" and "Legal Issues in Human Subject Research Classes."  The struggle between the FDA and those it wishes to regulate raise questions about the powers of all three branches of Government.  It can serve as a proxy for all administrative agencies in an Admin Class or as a direct source of study in a public health, environmental or (of course) food & drug law class.

The FDA's current struggles include energy drinks, body building supplements and truth in calorie reporting (no more hiding calories by assuming unrealistic serving sizes).

But back to E-Cigarettes.  

Here is the text of the proposed rule.  And here is the Campaign for Tobacco-Free Kids’ list of reasons why the FDA is justified—and should—be able to do this.

The FDA’s relationship with regulating tobacco products has been a complicated one.  This book review by Margaret Gilhooley can bring you up to date on the history of FDA’s failed attempts to obtain jurisdiction.  It was not until June 22, 2009 that the FDA finally did get regulatory power when President Obama signed the Family Smoking Prevention and Tobacco Control Act (FSPTCA) that the FDA got any authority to regulate tobacco products—and that only through the filter (sorry) of protecting children.   And that still remains the outer limit—protecting children. 

So any regulation of E-Cigarettes has to be along the lines of making them less available to minors.  That’s why what sounds like a relatively weak reason—“even if they are harmless, they are a gateway for children to real cigarettes” is important because that is the statutory basis of the FDA’s power.  It’s not surprising that the FDA’s announcement has been met with immediate protest from Vapers.  New York’s ban (and remember, all the FDA’s done is to announce it intends to assert its authority to look into the product’s safety) has sparked considerable push-back based on issues of “personal liberty.” Apparently this anti-regulation movement is not restricted to the U.S.

   Vapers have had little success persuading cities to exempt e-cigarettes from public spaces, but they have been able to prevent outright bans and to allow the creation of “vaping lounges” –-the English majors among you know these better as modern day equivalent of a legal opium den—perhaps inhabited by today’s Keats, Shelleys and Coleridges.  We even have them in Lubbock.  

The FDA’s goal is to build on the actions of the cities that are equating e-cigarettes with “old style” tobacco to keep e-cigarettes as an “adults only” product.