The “21st Century Cures Act” Draft Legislation Includes Welcome Support for First Amendment Rights

FDAThe House Energy and Commerce Committee released a 400-page “discussion draft” of its proposed “21st Century Cures Act” late last month. The bill includes a broad range of reforms governing the regulation of drugs and medical devices, most of which have been warmly received by broad segments of those industries. The bill is particularly welcome to supporters of commercial speech rights; it includes several provisions designed to ensure that government regulators do not prevent manufacturers from speaking truthfully about their medical products.

Social Media

One particular area of concern has been Food and Drug Administration (FDA) restrictions on manufacturer use of social media. Subtitle I of Title I of the bill would overturn those restrictions. One characteristic of social media is that it places a premium on brevity. For example, Twitter limits messages to 140 characters or less. In a Draft Guidance issued on June 18, 2014, FDA concluded that drug/device manufacturers should rarely, if ever, attempt to use social media platforms with character space limitations because those limitations deprives manufacturers of sufficient space to include all the risk and benefit information that the agency asserts is a necessary part of any such communications. It is not sufficient, FDA concluded, for a Twitter message to include the name of the drug and its intended uses, and then provide a hyperlink where detailed risk and benefit information is available. But as Washington Legal Foundation (WLF) pointed out in comments urging withdrawal of the Draft Guidance, a de facto prohibition on use of social media platforms raises serious First Amendment concerns. The First Amendment does not allow the government to prohibit an entire method of communication simply because other methods of communications are available to the speaker, at least not where the government’s goals can be achieved through more narrowly tailored means. Continue reading

The D.C. Circuit’s “POM Wonderful” Decision: Not So Wonderful for FTC’s Randomized Clinical Trial Push

FTC_Man_Controlling_TradeThe U.S. Court of Appeals for the D.C. Circuit last Friday largely upheld the Federal Trade Commission’s (“FTC”) ruling that POM Wonderful, Inc. violated the Federal Trade Commission Act by making unwarranted disease-prevention claims for its pomegranate juice products. But the ruling is far from the sweeping endorsement of FTC advertising-control measures that the Commission might have been hoping for. In particular, the ruling provides little, if any, support for the FTC’s recent assertions that food and dietary supplement manufacturers are largely barred from including health-related claims on product labels unless their claims are supported by randomized and controlled human clinical trials (“RCTs”). To the contrary, the appeals court made clear medical studies that do not meet RCT standards may nonetheless have considerable value, and that the FTC’s regulation of advertising is subject to strict First Amendment limitations. The decision suggests that courts may be very reluctant to uphold the FTC’s application of RCT standards to claims that a product promotes general health and nutrition, as distinct from claims that a product is effective in preventing or curing specific diseases.

POM’s ads were an easy target for the FTC. The ads touted POM’s products as effective in preventing a variety of diseases/conditions, including cardiovascular disease, prostate cancer, and erectile dysfunction (“ED”). Yet they failed to mention numerous shortcomings in the medical studies on which the disease-prevention claims were based—including that the studies’ findings were directly contradicted by other, larger clinical studies. Indeed, the D.C. Circuit held that it would have concluded that the ads were deceptive even had it chosen to apply a de novo standard of review to the FTC’s findings. (Because the case was on appeal from an FTC administrative proceeding, the D.C. Circuit reviewed those findings under a far more deferential “substantial evidence” standard.) Continue reading

Nutrition Nannies Win Only 1 of 4 High-Profile Ballot Initiatives

election2014The 2014 election featured four high-profile attempts by the national food nanny movement to impose its agenda through municipal and state ballot initiatives. Voters in Oregon and Colorado rejected mandatory “genetically-modified organism” (GMO) food-labeling measures, while voters in two California cities split on sin taxes for “sugary” drinks.

Food Labeling. Exactly 2/3 of Colorado voters said “no” to the Colorado Right to Know Act. The vote on Oregon’s Measure 92 was considerably closer, with the “no’s” outnumbering the “yes’s” 50.7% to 49.3%. Each initiative trumpeted the superficial appeal of  consumers’ “right-to-know,” and both made the oft-repeated misleading or false claims in their legislative “findings” sections that GMOs in food are unregulated, unsafe, and unhealthy. Much like California’s unsuccessful Proposition 37 initiative, the Oregon and Colorado proposals were riddled with labeling exemptions, including food served at restaurants and alcoholic beverages. Oregon’s proposal would have also unleashed the plaintiffs’ bar on food processors through a “private attorney general” enforcement provision.

Thin Taxes? Two California municipalities, San Francisco and Berkeley, held votes on soda excise taxes. The Berkeley measure, which passed by a large margin, imposes a one-cent-per-fluid-ounce tax on all soda, energy drinks, coffee syrups, sweetened tea, and other packaged “sugary” drinks, while exempting milk and diet soda. The failed San Francisco initiative would have imposed a two-cent-per-fluid-ounce tax on sodas and other sugar-sweetened drinks, including some juices, coffees and flavored waters. It garnered 55% at the polls, but fell short of the 66% “yes” votes needed for measures whose revenues are aimed at a specific purpose. The initiative would have funded children’s nutrition and physical education programs. The revenues from Berkeley’s tax measure will go into the city’s general fund.

The Bigger Picture. Mandatory GMO-labeling proponents have now lost each of their four initiative campaigns. And they have failed in states where one might think voters would overwhelmingly support such progressive measures: California, Washington, Oregon, and Colorado. With 2015 being a slow year for elections, activists will likely turn their attention now to state legislatures. The negative opinions of hundreds of thousands of voters in the aforementioned states should speak volumes to politicians in other states about mandatory GMO labeling. In addition, as several WLF publications have explained (i.e. here and here)—and a suit against Vermont’s labeling mandate argues—such mandates infringe on federal authority to regulate food labels and tread on food producers’ constitutional rights. Policy makers should bear these points in mind, and keep a watchful eye on the legal challenge to Vermont’s law, when they are urged to embrace mandated labeling.

Nutrition nannies such as former New York City Mayor Michael Bloomberg have trumpeted the Berkeley vote as a watershed moment. Given the Berkeley electorate’s historical affinity for fringe movements and big government, the outcome is more likely an aberration than a harbinger. The result also should be considered counterproductive for the fight against obesity. It advances the entirely baseless notion that regressive taxes on soda and other disfavored beverages will benefit taxpayers’ health. Reliance on such taxes also detracts attention and energy from actual solutions to America’s expanding waistline. But considering the financial largesse of benefactors like Mr. Bloomberg and the zeal of his activist allies, the fight over manipulative sin taxes is likely to continue.

Also published by Forbes.com on WLF’s contributor page

First Circuit Permits Challenge to Massachusetts Prior Restraint on Billboards

billboardIn recognition of Free Speech Week, the WLF Legal Pulse celebrates what may be the First Amendment’s greatest virtue: it protects speech that may be unpopular due to the nature of the speaker or the medium within which it is spoken. We do so by applauding an October 20 U.S. Court of Appeals for the First Circuit ruling that addressed a prior restraint on a method of communication that some disfavor—billboards—and that predominantly carries messages some consider unworthy of full constitutional protection—advertisements.

Unbridled regulatory authority. Section 302 of the Massachusetts Code of Regulations requires all outdoor advertisers to obtain both an operating license and a permit for each specific sign. The regulation vests the Director of the Office of Outdoor Advertising (“Director”) with broad discretion to grant, withhold, or revoke licenses and permits for billboards. Section 302 enumerates several factors that the Director “may” consider, including “health, safety, and general welfare” and “not [being] in harmony with the surrounding area.” The regulation, however, states the listed factors are non-exclusive and that the Director’s authority is “[w]ithout limitation.”

Van Wagner Communications, which lobbied against the 2012 amendments to Section 302, filed a facial challenge to the regulation in federal court, arguing that it imposed an unconstitutional prior restraint on the company’s speech. The U.S. District Court for the District of Massachusetts held that because the Director had approved Van Wagner’s license and all 70 of its permit requests over two years, the company suffered no injury and thus lacked standing to sue. Continue reading

Update: World Trade Organization Rejects USDA Meat Rule on Country of Origin Labeling

WTOYesterday, a World Trade Organization (WTO) compliance panel publicly released its determination that the United States Department of Agriculture’s (USDA) country of origin labeling rule for certain cuts of muscle meat violated the international Technical Barriers to Trade agreement. Canada had sought such a determination, supported by other nations such as Argentina, Australia, and Japan.

News reports on this decision caught The WLF Legal Pulse‘s attention because U.S. meat producers had challenged the so-called COOL rule under the First Amendment in the U.S. Court of Appeals for the D.C. Circuit.  A number of posts (here and here) assessed the court’s July 29 en banc decision rejecting the producers’ challenge.

As we argued in the August 25 post, the majority improperly assisted the government by identifying the substantial government interests that the USDA rule advanced, including the protection of domestic farmers from foreign competition. Because of the pending proceedings at the WTO, the U.S. government had formally denied that protectionism was one of the goals of its COOL regulation.

The meat producers have asked the D.C. Circuit to reconsider its en banc holding, a motion on which the court has yet to rule. It is uncertain what impact the WTO determination will have on that request.

Not so “Grrr-eat”: The Response Nutrition Nannies Have Grown to Love

Half-full or half-empty?

Half-empty

Nice, but not good enough. That is the near-Pavlovian response professional activists routinely offer whenever their targets announce some voluntary action that, to the casual observer, seems to advance the activists’ agenda.

Consider, for instance, a September 23 Politico story, “Food, Beverage Firms to Dial Back Marketing to Kids.” The story reported on voluntary commitments International Food and Beverage Alliance member companies made to the World Health Organization regarding product marketing to children under 12. Those commitments include restrictions that nutrition activists have long sought from government regulators. Yet, there was the glass-half-empty response of Center for Science in the Public Interest’s (CSPI) nutrition policy director, Margo Wootan:

If they’re saying they’re covering all media, they’re not. They’re missing on-package marketing [and] in-store and on-display marketing.

Ms. Wootan’s comments confirm a theory WLF has been arguing for the past several years in the context of plain packaging initiatives for tobacco: activists have their sights on more than one category of consumer products. Continue reading

Second Circuit Overturns Law that Compelled Businesses to Advertise their Competitors’ Services

2nd CircuitOn September 4, with Safelite Group, Inc. v. Jepsen, the U.S. Court of Appeals for the Second Circuit made an important contribution to the jurisprudence of compelled speech (an area of growing disharmony in the federal courts, as we’ve noted recently). The court unanimously struck down a Connecticut law that permitted certain businesses to promote their auto-glass repair services only if they mentioned the similar services of their competitors.

The Law at Issue. The Petitioner, Safelite Group, is an insurance claims management company that owns and operates a Connecticut affiliate, Safelite Auto Glass. If auto insurance companies direct Connecticut drivers with auto-glass claims to Safelite, Safelite can recommend (but, under state law, cannot require) Safelite Auto Glass to do the repairs. When it does so, Safelite voluntarily discloses its ownership interest to the insureds. If insureds cannot or do not want to utilize a Safelite Auto Glass shop, Safelite recommends another shop that Safelite has pre-approved.

Unaffiliated Connecticut auto-glass shops took their complaints about Safelite’s “unfair” practices to the legislature, which in May 2013 adopted a law that in part prohibits insurance companies or their claims administrators from mentioning their affiliate repair shops unless they also reference a competitor.

First Amendment Challenge. Safelite sought a preliminary injunction against Connecticut’s enforcement of the law, arguing in federal district court that the compelled speech requirement abridged its First Amendment rights. The district court denied the injunction, holding that the mandate simply required disclosure of factual, uncontroversial information that does not offend the company’s First Amendment freedoms. Continue reading