FDA proposes to ramp up regulation of tanning beds

by Brian Wolfman

Yesterday, the Food and Drug Administration issued this proposed order regarding tanning beds. The FDA is proposing to reclassify these ultra violet devices to require more warnings -- including that minors not use them at all -- because they are a cancer hazard. The proposal would also require the products to meet certain perfomance standards. Basically, the problem is that hanging out in tanning beds causes melanoma, an often fatal form of skin cancer. Tanning devices can also cause skin burns.

One ramification of the FDA's order (if finalized) is that manufacturers would be required to submit their tanning devices for pre-market review. The FDA would then review the product to determine whether it meets the warning requirements and various performance specifications outlined in the proposed order. (Under current law, tanning devices are exempt from any pre-market scrutiny.)

Here is an excerpt from the FDA's press release:

[T]he U.S. Food and Drug Administration issued a proposed order that, if finalized, would reclassify sunlamp products and require labeling to include a recommendation designed to warn young people not to use these devices. According to the American Academy of Dermatology, there is a 75 percent increase in the risk of melanoma, the deadliest type of skin cancer, in those who have been exposed to ultraviolet radiation from indoor tanning, and the risk increases with each use. The proposed order does not prohibit the use of sunlamp products by those under the age of 18, but it provides a warning on the consequences. The order would reclassify sunlamp products from a low risk device (class I) to a moderate risk device (class II). “Using indoor tanning beds can damage your skin and increase your risk of developing skin cancer,” said FDA Commissioner Margaret A. Hamburg, M.D. “The FDA’s proposed changes will help address some of the risks associated with sunlamp products and provide consumers with clear and consistent information.” If the order is finalized, manufacturers would have to submit a pre-market notification (510(k)) to the FDA for these devices, which are currently exempt from any pre-market review. Manufacturers would have to show that their products have met certain performance testing requirements, address certain product design characteristics and provide comprehensive labeling that presents consumers with clear information on the risks of use. The order proposes to include a contraindication against use on people under 18 years old, and the labeling would have to include a warning that frequent users of sunlamp products should be regularly screened for skin cancer. The FDA will take comments on the proposed order for 90 days.

Brady Dennis has written this Washington Post story on the FDA proposal.

"Broken Circuit: Obstructionism in the Environment’s Most Important Court"

That's the name of this article by Si Lazarus and Doug Kendall of the Constitutional Accountability Center. "Broken circuit" is Lazarus and Kendall's characterization of the U.S. Court of Appeals for the D.C. Circuit. They point to "[a] new breed of activism on the .. the D.C. Circuit — for environmental cases second in importance only to the Supreme Court and the central venue for high-profile lawsuits — [that] threatens decades of progress."

Study Finds Payday Loans Cost Economy $774 Million in 2011

Here.  The report is by the Insight Center for Community Economic Development. It estimates the loans cost more than 14,000 jobs.

Ben-Shahar Reviews Boilerplate

Omri Ben-Shahar of Chicago has written Regulation Through Boilerplate: An Apologia, forthcoming in the Michigan Law Review. Here's the abstract:

 

This essay reviews Margaret Jane Radin’s Boilerplate: The Fine Print, Vanishing Rights, And The Rule Of Law (Princeton Press, 2013). It responds to two of the book’s principal complaints against boilerplate consumer contracts: that they modify people’s rights without true agreement to, or even minimal knowledge of, their terms; and that the provisions they unilaterally enact are substantively intolerable. I argue, counter-intuitively, that contracts with long fine prints are no more complex and baffling to consumers than any alternative boilerplate-free templates of contracting. Therefore, there is no alternative universe in which consumers enter simpler contracts better informed of the legal terms. In addition, I argue that any policy that mandates consumer-friendlier arrangements (such as ones that eliminate boilerplate arbitration clauses, warranty disclaimers, or data collection) would hurt consumers in an unintended but potentially costly way.

The legacy of the Supreme Court's Concepcion decision

Read this post by Paul Bland, which contains a example of how the Supreme Court's decision in AT&T v. Concepcion is keeping consumers out of court and without any remedy. Here's Paul's synopsis:

In Betts v. McKenzie Check Cashing, after a two-day evidentiary hearing that was essentially a trial of the payday lender’s arbitration clause, the trial court found as a matter of proof that McKenzie’s class action ban would prevent consumers from holding the lender accountable under the state’s consumer protection laws. Notwithstanding the obvious injustice, after the U.S. Supreme Court’s decision in Concepcion, the Florida Supreme Court held that it had no choice but to overturn the lower courts and enforce the arbitration clause.  The Florida Supreme Court held that federal law requires the enforcement of class action bans even when they are proven to gut state consumer protection laws. 

The FDA is looking into caffeine regulation because it's not just coffee and coke anymore

by Brian Wolfman

As you may have read, the FDA is beginning to look into possible regulation of caffeine when used as an additive to foods and drinks, including foods and drinks marketed to kids. How about some caffeine with your marshmellows or nuts? Yes, indeed, these foods sometimes have caffeine thrown in. Read this interview with FDA Deputy Commissioner Michael Taylor about the FDA's first steps in this area. Here's an excerpt from a couple of Taylor's answers:

The [Wrigley's] gum [with a half a cup of coffee's worth of caffeine in each stick] is just one more unfortunate example of the trend to add caffeine to food. Our concern is about caffeine appearing in a range of new products, including ones that may be attractive and readily available to children and adolescents, without careful consideration of their cumulative impact. One pack of this gum is like having four cups of coffee in your pocket. Caffeine is even being added to jelly beans, marshmallows, sunflower seeds and other snacks for its stimulant effect. ... We have to address the fundamental question of the potential consequences of all these caffeinated products in the food supply to children and to some adults who may be at risk from excess caffeine consumption. We need to better understand caffeine consumption and use patterns and determine what is a safe level for total consumption of caffeine. Importantly, we need to address the types of products that are appropriate for the addition of caffeine, especially considering the potential for consumption by young children and adolescents.

Surprise--A study finds the Supreme Court is friendly to business.

Sunday's New York Times has a nice article discussing a recent study prepared by Lee Epstein, who teaches law and political science at the University of Southern California; William M. Landes, an economist at the University of Chicago; and Judge Richard A. Posner, of the federal appeals court in Chicago, who teaches law at the University of Chicago. Published in the Minnesota Law Review, the study finds that the Robert's Court is far friendlier to business than those of any court since at least World War II. I don't think this will come as a surprise to many consumer lawyers or professors.

 

American Banker: Payday Lenders Lash Out at CFPB

Brian posted in April on the CFPB's White Paper on payday lending. Payday lenders have fired back, as the American Banker reports here.

Pat McCoy on Barriers to Foreclosure Prevention

Patricia A. McCoy of Connecticut has written Barriers to Foreclosure Prevention During the Financial Crisis, forthcoming in 55 Arizona Law Review. Here's the abstract:

The number of modifications to distressed residential loans has been subpar to date compared to the number of foreclosures. This raises concerns about the presence of artificial barriers to loan modifications in situations where foreclosure should be avoidable. Numerous theories have been advanced for the relatively low level of modifications, including restrictions on loan modifications in private-label servicing agreements, threats of lawsuits by private-label investors, servicer compensation arrangements, the high cost of loss mitigation, accounting rules, junior liens, and tax considerations. This Article concludes that servicer compensation coupled with the costly nature of loan workouts, accounting standards and junior liens form the biggest impediments to an efficient level of loan modifications. These factors also distort the mix of loan modifications that are made toward types of modifications with higher redefault rates. Other explanations, such as servicing agreement restrictions, tax consequences, and the threat of lawsuits, either are not at play or are of second order importance.

Norm Silber and Joseph Sanderson in HuffPo Argue That Guns Should be Regulated as Consumer Products

Here.