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FDA

Update: while the resulting regulatory costs could sink kitchen-table-based producers, the regulations don’t appear to be new [Reddit, Medical Daily; links and description updated] “Why aren’t underpants a medical device?” [Reddit commenter]

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Another hidden gift inside the Affordable Care Act: mandatory calorie labeling for many restaurant menus. Walter Olson comments on the complications and potential unintended consequences of such a mandate.

My new Cato podcast: the new FDA calorie labeling rules apply to not-so-big chains (20 +) of grocery stores and amusement facilities as well as restaurants, and make it less likely that servers and local managers will manage to vary from rigidly standardized recipes, menu listings and portion sizes based on knowledge of their local customers, temporary availability of attractive ingredients, and so forth. That won’t matter much for food servers who already design their offerings in a lab, but spells trouble for those whose offerings are more localized or unpredictable (earlier). Coverage by Ed Morrissey of what the scheme would mean for a 21-unit pizza chain is linked here.

In January, David Boaz commented on the parallel vending machine calorie label mandate:

In my experience, vending machines shuffle their offerings fairly frequently. If the machine operators have to change the calorie information displayed every time they swap potato chips for corn chips, then $2,200 [per operator per year] seems like a conservative estimate of costs. But then, as Hillary Clinton said when it was suggested that her own health care plan would bankrupt small businesses, “I can’t be responsible for every undercapitalized small business in America.”

Happy Thanksgiving!

More: Baylen Linnekin. And Julie Gunlock recalls her own days working in a supermarket deli. Goodbye, making up prepared salads in single-serving containers from whatever produce happened to be in overstock at the time. Hello, food waste!

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The panel is packed with big names and many of them offer suggestions with a law or regulation angle, including Philip K. Howard (“Radically Simplify Law”), Derek Khanna (rethink patent and copyright law; related, Ramesh Ponnuru), Morris Kleiner (reform occupational licensure; related, Steven Teles), Arnold Kling (“Sidestep the FCC and the FDA”), Robert Litan (admit more high-skill immigrants and reform employment of teachers; similarly on immigration, Alex Nowrasteh), Adam Thierer (emphasize “permissionless innovation”), and Peter Van Doren (relax zoning so to ease movement of workers to high-wage cities).

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Many libertarians have expressed interest in statutes, enacted in five states, which seek to give incurably ill patients access to “investigational” drugs which have passed the first stage in the FDA’s approval process but not reached final approval. Nice goal, but according to James Beck at Drug & Device Law:

…we don’t think these statutes are going to accomplish much, let alone achieve their purpose of making investigational drugs generally available to terminally ill patients having no other choices.

One obstacle is the supremacy of the FDA:

States can pass all the laws they want, but unless the FDA gives its okay to programs more expansive than its compassionate use (“expanded access”) program, nothing’s going to happen. It’s called “preemption.”

A second is liability. While the new crop of statutes are an improvement on earlier proposals which sought to conscript pharmaceutical companies’ participation, they still give drugmakers no strong protection from resulting lawsuits, and sometimes include language hinting at the reverse. Even though plaintiff’s lawyers would face their own challenges of proving causation and damages, there would still be unknowable legal downside with relatively scant upside, making for poor incentives to participate in the program by making investigational drugs available.

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Food roundup

by Walter Olson on October 24, 2014

Food roundup

by Walter Olson on September 25, 2014

  • Our posts on the closure of California’s Westover Winery following punitive fines for letting customers volunteer continue to draw interesting comments, including one from a reader identifying himself as William Smyth, owner of the winery;
  • FDA comes out with revised proposed FSMA rules, a preliminary look [AP] Agency only partially backs off restrictions on use of spent brewing grains as animal feed [Elizabeth Brown/Reason, WLF, earlier]
  • “Cottage food” law success: “Texans Created Over A Thousand Local Businesses After Texas Eased Restrictions On Selling Food” [Nick Sibilla, IJ/Forbes]
  • Artisanal salami maker eventually managed to persuade FDA that it should be permitted to ferment product at 72 degrees as the Italians do [WaPo] Craft sausage startup in Detroit “sort of operated under ‘do-things-until-you-get-caught” [Metro Times]
  • Does drinking diet soda make you fat? [Daniel Engber, Slate]
  • Kalona, Iowa maker of squeaky cheese curds cites mounting regulatory costs in decision to close (via Julie Gunlock) [Cedar Rapids Gazette]
  • Bee colonies getting sick: indictment of modern humanity’s interaction with nature? [Timothy Taylor, Conversable Economist]

Medical roundup

by Walter Olson on September 23, 2014

  • Down comes the pediatrician’s wall of baby pictures, another HIPAA casualty [Anemona Hartocollis/NY Times, resulting letters to the editor, earlier, NPR with somewhat different slant]
  • Had the Washington Post stayed on story of Maryland health exchange fiasco, it might have held power to account [my Free State Notes]
  • FDA rules requiring that certain drugs be kept out of hands of anyone but patients may inadvertently establish monopoly for some off-patent compounds [Derek Lowe via Alex Tabarrok]
  • Richard Epstein argues Hobby Lobby right result, wrong reasoning [new Cato Supreme Court Review, more]
  • Defensive medicine: so much easier to go ahead and order the ultrasound [White Coat]
  • Fate of melanoma-scanning device and the FDA [Alex Tabarrok via Elizabeth Nolan Brown] Can agency learn from European private certification? [more]
  • Seredipitous offshoot of study on rats helped premature infants; but would this have been quite as likely to appear in HuffPo if framed as “what we owe lab-animal research” rather than “what we owe federal research”? [Sam Stein; related, first volunteer given new trial Ebola vaccine, and a hat tip to lab-animal research on that too [Wellcome, U.K.]

It’s happening just as warned. Janet Fletcher at the Los Angeles Times:

…cheese counters could soon be a lot less aromatic, with several popular cheeses falling victim to a more zealous U.S. Food and Drug Administration. Roquefort — France’s top-selling blue — is in the agency’s cross hairs along with raw-milk versions of Morbier, St. Nectaire and Tomme de Savoie. …

Of course, French creameries haven’t changed their recipes for any of these classic cheeses. But their wheels are flunking now because the FDA has drastically cut allowances for a typically harmless bacterium by a factor of 10.

The new rules have resulted in holds even on super-safe Parmigiano Reggiano, and the risk of losing a costly shipment of a perishable commodity is likely to be enough to drive many European producers out of the market for export to America entirely. Highly praised artisanal cheese makers in the United States are facing shutdown as well. [Michael Gebert, Chicago Reader] Earlier on the FDA and cheese regulation here and, from Cato, here (2010 predictions, before FSMA passed), here, here, etc.

They told us this administration was going to be run by wine and cheese faculty liberals. Now where are they when they could actually do us some good?

Related, note that the regulatory pressure is coming from both sides of the Atlantic: “Newsweek: French cheesemakers crippled by EU health measures” [Cheese Notes, with discussion of role of giant manufacturers whose processed cheese operations can comply with the rules] (& welcome The Week, Reason readers; cross-posted at Cato at Liberty)

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Food roundup

by Walter Olson on August 26, 2014

  • “New York Times Hosts Panel on Farming, Forgets to Invite Farmers” [Julie Gunlock, IWF]
  • Historical perspectives on the current attack on food freedom [Baylen Linnekin and Michael Bachmann for the Institute for Justice; report, PDF, and summary; Reason and more Linnekin on the FDA's odd campaign against added ingredients which also occur naturally]
  • Food Safety Modernization Act of 2011 will increase costs and reduce variety in food intended for animals as well as for humans [Jerry Ellig and Richard Williams, Cato Regulation]
  • Elyria pink cookie, pride of the Ohio town’s school system, is casualty of federal food rules [Chronicle-Telegram, WEWS] NYC may launch another attack on toys in McDonald’s Happy Meals [Jeff Quinton, earlier]
  • UC Berkeley project assists effort to step up labor union presence in food area [Bill McMorris on Food Labor Research Center]
  • Lungs are better in the open air: Scotland has at least one haggis food truck [Baylen Linnekin, Vice mag]
  • “Eat great on food stamp budget” cookbook is hit, even if fans may not always have thought through its political valence [Maryn McKenna, National Geographic "The Plate"] Push to make food stamp program data public [Slate, USDA comments]

Even as the FDA prepares ambitious new rules pressuring food makers to reduce the amount of salt in their wares — recipe regulation, as we’ve called it — a new study questions whether most people in Western countries really need to cut salt after all. The study, led by Dr. Salim Yusuf of McMaster University, finds evidence consistent with sodium being a health risk for person with hypertension and those with the highest salt intake, but also suggests that most of the population is in the optimal zone for salt intake and that adding potassium-rich fruits and vegetables to the diet may be a superior way for many to fend off bad effects from sodium. The study ran jointly in the New England Journal of Medicine with a second which lays more emphasis on hazards of salt intake. [Yahoo News] More: Just One Minute, ACSH.

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We’ve warned many times that the Food Safety Modernization Act of 2011 is sure to drive up food prices, make life hard for small farmers, and encourage the substitution of industrial farm methods for the traditional and local. Now the FDA is rumbling that wooden onion crates may need to give way to plastic, although defenders say wooden crates have a good safety record in actual use. “Replacing a million wooden crates would cost about $200 million. … plastic crates can only hold about half the weight of wooden ones and they cost nearly three times as much.” [Economics 21]

In June, after an outcry, the FDA backed off hints that it would end the age-old practice of aging cheese on wooden boards.

P.S. Interesting discussion in comments on whether the cited cost figures are plausible. One thing I like about Overlawyered readers is that they know so much about onion crates.

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Medical roundup

by Walter Olson on August 1, 2014

  • Doctor criticized on Science-Based Medicine blog proceeds to sue [Steve Novella, Orac]
  • “Can you imagine Google becoming a health company?” Sergey Brin: doubt it, field’s “just so heavily regulated” [Michael Cannon/Cato, David Shaywitz]
  • “One Box of Sudafed Over the Line: Florida Woman Arrested for Trying to Relieve Allergy Symptoms” [Jacob Sullum]
  • MICRA battle: survey finds OB-GYNs in Los Angeles County pay average $49,804 a year for coverage, in Long Island where there’s unlimited liability it’s $196,111 [Legal NewsLine]
  • Medical liability claims fall in Wisconsin [Althouse] And Pennsylvania [TortsProf]
  • FDA wants to look over drugmakers’ shoulders when they communicate with consumers, not an easy formula for social media [Elizabeth Nolan Brown]
  • “The reason that we are being required to measure BMI isn’t because a patient’s BMI has any meaningful clinical use … it’s that the BMI can be measured.” [White Coat]

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Food roundup

by Walter Olson on July 24, 2014

Pharmaceutical roundup

by Walter Olson on June 30, 2014

  • “Report: Government warnings about antidepressants may have led to more suicide attempts” [Washington Post]
  • Celebrity doc known for touting diet-health snake oil told off by Senators known for touting socio-economic snake oil [NBC, Business Week]
  • Physicians’ prescription of drugs off-label may “seem odd to the uninitiated, but it is called the practice of medicine, and there is absolutely nothing wrong with [it].” [Steven Boranian/D&DLaw, Sidley, Steve McConnell/D&DLaw (False Claims Act angle, with much background on that law generally)]
  • “23andMe Closer to FDA Approval” [Matthew Feeney/Cato, earlier]
  • FDA guidance could foreclose most use of tweets, Google ads and other character-limited vehicles in pharmaceutical promotion [Jeffrey Wasserstein/FDA Law Blog, Elizabeth N. Brown/Reason]
  • Average wholesale price (AWP) litigation: “Pennsylvania High Court Joins Judicial Stampede That’s Trampling State Attorneys-General/Plaintiffs’ Bar Alliances” [WLF, Beck, earlier]
  • California infant’s death opens window on lucrative (for some prescribers) intersection of workers’ comp and compounded pharmaceuticals [Southern California Public Radio]

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A year ago the Cato Institute interviewed Jill Erber, of Northern Virginia cheese shop Cheesetique, after the FDA decided to ban the traditional French cheese Mimolette. More on the FDA and cheese here, here, here, etc.

More: Baylen Linnekin at Reason on why the FDA hasn’t really backed off its latest on wooden shelving (“You dine at the pleasure of the FDA. Enjoy it while it lasts.”); also at Reason, Elizabeth Nolan Brown. And some of the reassurances we heard at the time about FSMA being no big deal are here and here.

Yes! Following an enormous outcry from cheese makers, commentators, and the general public, the agency beats a hasty retreat. Commentator/ Pepperdine lawprof Greg McNeil has the details at Forbes (and his earlier commentary on the legalities of the agency’s action is also informative). Earlier here.

In a classic bureaucratic move, the agency denied it had actually issued a new policy (technically true, if you accept the premise that a policy letter from its chief person in charge of cheese regulation is not the same as a formally adopted new policy) and left itself the discretion to adopt such a policy in future if it wishes (merely declaring itself open to persuasion that wood shelving might prove compatible with the FSMA).

McNeal:

This is also a lesson for people in other regulated industries. When government officials make pronouncements that don’t seem grounded in law or policy, and threaten your livelihood with an enforcement action, you must organize and fight back. While specialized industries may think that nobody cares, the fight over aged cheese proves that people’s voices can be heard…

There is a less optimistic version, however. It happens that a large number of editors, commentators, and others among the chattering classes are both personally interested in the availability of fine cheese and familiar enough with the process by which it is made to be un-cowed by claims of superior agency expertise. That might also be true of a few other issues here and there — cottage food sold at farmer’s markets, artisanal brewing practices — but it’s inevitably not going to be true of hundreds of other issues that arise under the new Food Safety Modernization Act. In a similar way, the outcry against CPSIA, the Consumer Product Safety Improvement Act, rose to a politically effective level only on a selected few issues (publishers and libraries got a fix so that older children’s books would not have to be trashed; youth motorsports eventually obtained an exemption, and so forth) but large numbers of smaller children’s products and specialties whose makers had less of a political voice simply disappeared.

More: Andrew Coulson, Cato, and on the trade aspects, K. William Watson; Chuck Ross, Daily Caller (quoting me at length for which thanks). On the FDA’s new statement: “Typical bureaucratic doublespeak that seems meant to maximize uncertainty for the regulated community” [Eric Bott of Wisconsin Manufacturers and Commerce] “This was the worst possible outcome. It reinforces elites’ view that regulators are reasonable and wise and will fix mistakes.” [@random_eddie] “Pay no attention to the Leviathan behind the cheesecloth” [Scott Lincicome, in an exchange after a writer at Slate observed that "Libertarians aren't the only ones" who might want to keep board-aged cheese legal] (Vox, Reason, Carly Ledbetter/HuffPo; & welcome Instapundit, Alexander Cohen/Atlas Society, Q and O readers)

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We warned at the time that the ill-conceived Food Safety Modernization Act (FSMA) of 2011 would tend to choke off many non-industrial food sources. Now the FDA, interpreting FSMA as part of its regulatory process, is moving to ban the aging of cheese on wooden boards, a process that dates back thousands of years and has been practiced safely by many of the world’s finest cheese makers. The agency apparently intends to apply the same standard to imported cheese as well, which means that in addition to devastating artisanal cheese producers in this country, the move would cut off Americans’ access to large numbers of classic European cheeses, many of which, like Comte and Reblochon, “are required to be aged on wood by their standard of identity.” [Jeanne Carpenter, Cheese Underground (Wisconsin); Matt Spiegler, Cheese Notes]

Our coverage of FSMA, including its many-sided impact on traditional and artisanal farm and food practice, is here.

More: “Old guy in the cell: What are you in for? New guy in the cell: I aged cheese on wooden boards.” [Scott Greenfield] Plus: William Watson, Cato; Greg McNeal, Forbes, on the legalities including an apparent shift in the FDA’s earlier stance approving wood board aging]

Update June 11: agency backs down.

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Medical roundup

by Walter Olson on June 9, 2014