FDA’s Latest Regulatory Salvo at “Added Sugars” Ignores Federal Laws, Due Process, Part II

FDAThis is the second part of a two-part commentary on FDA’s requirements that added sugars be listed on the food Nutrition Facts panel, and that a Daily Reference Value (DRV) be set for added sugars and included in the panel footnote. For part I, click here.

 FDA’s Reliance Solely on a DGAC Report to Establish a DRV is Unprecedented

When implementing the Nutrition Labeling and Education Act, FDA first set daily reference values in 1993 based on “sufficient scientific consensus,” a standard established by the agency under that law. FDA did not rely on a federal advisory committee’s report. Moreover, it relied only minimally on the Dietary Guidelines for Americans itself. Instead, FDA cited numerous consensus reports which, taken together, constituted “sufficient scientific consensus.” Continue reading

FDA’s Latest Regulatory Salvo at “Added Sugars” Ignores Federal Laws, Due Process, Part I

FDAAs we discussed in an August 11 post, a “supplementary proposed rule” from the Food and Drug Administration (FDA) has taken the federal government’s contrived campaign against “added sugars” to a new level. FDA not only cites a federal advisory committee’s report as retroactive justification for added-sugars disclosure on food labels, it also seeks to establish a Daily Reference Value (DRV) for added sugars. The DRV would be used to calculate a “%DV” that would appear in addition to the grams of added sugars on the Nutrition Facts label. Finally, FDA released results of a consumer survey, completed after its initial added-sugars labeling proposal in March 2014, in support of the Nutrition Facts mandate. The public comment period for these items ends on October 13.

In this two-part commentary, we discuss some of the federal statutory and administrative procedural problems with the supplementary proposed rule. These legal infirmities, which stakeholders will likely raise in their public comments, could expose the agency to court challenges. Continue reading

San Francisco’s Sweetened-Beverage Warning Mandate and Ad Ban Tread on First Amendment

GoldenGateIn past posts, we’ve characterized California as the “too much information” state. Under the everything-gives-you-cancer Proposition 65 law, even parking lots and coffee houses must post warning signs. San Francisco tried, and failed, to impose health warning signs at cellphone dealers. Undaunted, Berkeley passed its own cellphone warning ordinance this year, which faces a First Amendment challenge. And in the compelled speech spirit of those laws, Oakland has adopted an ordinance requiring builders to devote a certain square footage of new buildings to “public” art.

So it’s not surprising that San Francisco recently became the first city in America to require warnings on billboards and other media that promote “sweetened” beverages. Not content to simply compel speech, the Board of Supervisors also passed a sweeping ban on beverage advertising in certain city locales. The ordinances are so blatantly disrespectful of advertisers’ and consumers’ First Amendment rights, it’s not a question of whether a court will strike them down, but on which grounds it will do so. Continue reading

WLF Pens Guest Blog Post on 1st Amendment Victory for Craft Brewer

flying dogWashington Legal Foundation Chief Counsel for Legal Studies Glenn Lammi published a guest commentary on May 4 on the blog of the San Francisco law firm Hinman & Carmichael, Booze Rules. The post, Appellate Court Ruling Strikes Blow Against State’s Arbitrary Beer Label Ban, discusses the implications of a U.S. Court of Appeals for the Sixth Circuit ruling, Flying Dog Brewing v. Michigan Liquor Control Commission.  The court allowed a lawsuit against the Control Commission’s members individually to go forward.  Flying Dog is alleging that the commissioners violated its First Amendment rights by arbitrarily rejecting approval to the label of one of the brewery’s products.

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