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FDA

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

Food roundup

by Walter Olson on May 8, 2014

  • “Particularly relevant …is the uncontested fact that Defendants – as manufacturers of [high-fructose corn syrup] – do not control how much HFCS is used in the finished products that Plaintiff consumed.” [New York federal court dismissing case, h/t Nicki Neily]
  • New frontier of public health disapproval: Girl Scout cookies [NPR]
  • “Former Kellogg Co. CEO Carlos Gutierrez says food industry is under attack by FDA” [MLive]
  • Whole milk, least processed of widely available milk varieties, would be banned in Connecticut childcares if pending bill passes [Elizabeth Nolan Brown]
  • House-passed expansion of Jones Act domestic-flag rules for food aid would harm hungry recipients and US farmers alike [Coyote]
  • “Archaic distribution laws” hamper craft-beer sector [Steve Hindy, NY Times, related Nick Gillespie (Florida)]
  • Facing mounting fiasco in school lunch program, feds double down [Baylen Linnekin, Reason]

The Food and Drug Administration is signaling that it may rethink a much-criticized rule that would severely restrict the reuse as livestock feed of “spent” grain used in the making of beer and other fermented beverages. [WLF "Legal Pulse"] That’s good news as far as it goes, but it’s a form of exception-making that would seem to be driven at least in part by the high visibility of this one particular recycling-and-sustainability constituency (microbrewery beer is a hot leisure activity, and and craft/organic animal husbandry is a popular consumer enthusiasm these days in educated urban circles as well). The implementation of the Food Safety Modernization Act (FSMA) of 2011 is endangering a wide range of other local, non-industrial, and traditional farming and foodmaking techniques, “such as using house-made fertilizers and irrigating from creeks,” that might not enjoy the broad constituency of microbrewing. Will anyone in Washington stick up for them?

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Jacob Grier has an analysis, and predicts a regulatory snarl for e-cigarettes based on a poorly written statute, cartel profits for major cigarette makers, bad news for cigar and pipe smokers, and wider black markets.

Mark Steyn revisits the subject of Kinder Surprise eggs, the chocolate-wrapped toys popular in much of the rest of the world but forbidden under a distinctive U.S. law which bans the “embedding of non-nutritive items” in confectionery. According to the Department of Homeland Security, border agents confiscated more than 25,000 of the prohibited treats in more than 2,000 seizures during one recent year. Earlier here (Steyn: “The real choking hazard is the vise-like grip of government”), here, etc.

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Medical roundup

by Walter Olson on April 17, 2014

  • Academics have underestimated sensitivity of medical system to liability pressures [Michael Frakes, SSRN via TortsProf]
  • “Nobody has gone out and bought a new home” — Mark Lanier talks down his verdict knocking $9 billion out of Takeda and Lilly after two hours of deliberation by a Lafayette, La. jury [Reuters] Japanese drugmaker says it had won three previous trials [ABA Journal]
  • Nursing home in living-up-to-its-name town of West Babylon sued over hiring male strippers to entertain residents [NYP, more (wife of complainant attended display), ABA Journal]
  • “Reining in FDA regulation of mobile health apps” [Nita Farahany, Volokh/WaPo]
  • Another setback for plaintiffs as Arkansas tosses $1.2 billion Risperdal marketing case against Johnson & Johnson [AP/Scottsbluff Star-Herald, Eric Alexander/Drug and Device Law, earlier here and here]
  • “Spacecraft collision injuring occupant”: docs scratch their heads at new revamp to billing codes [Steven Syre, Boston Globe via Future of Capitalism]
  • FDA preclearance, drug litigation: “Most [patients] never know they were harmed, because we never know what we might have had.” [John Stossel]

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At Reason, Baylen Linnekin asks me and several other people what key story we’re watching in the world of food policy. My answer:

The big, ominous, and still underpublicized story this year has been the Food and Drug Administration’s development of regulations to implement Congress’ panic-driven, ill-thought-out Food Safety Modernization Act of 2010. “Local growers are discovering that proposed FDA regulations would curtail many common techniques, such as using house-made fertilizers and irrigating from creeks,” reported the L.A. Times in February. Another batch of new rules will curtail the age-old practice of feeding livestock on spent beer grains, to the dismay of many small brewers and farmers. … Too bad for small, local, distinctive, traditional variety in food and farming….

Read the whole thing — including my semi-defense of the FDA on the legalities of the matter — here.

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Medical roundup

by Walter Olson on March 31, 2014

  • Latest don’t-blame-the-regulators shortage of a generic medical supply is nitroglycerin for acute cardiac care [New York Times, ACSH]
  • “Does Medical Malpractice Law Improve Health Care Quality?” Maybe not so much [Michael Frakes and Anupam Jena, SSRN via Tyler Cowen]
  • “Affordable Care Act opening doors to IT security attacks” [Ponemon via Fierce CIO] “States Barred from Requiring Obamacare Navigators Carry Error and Omission Insurance” [Craig Gottwals, Benefit Revolution] On suspension of statutory dates, Rule of Law has scanty constituency [Ramesh Ponnuru]
  • “Video Debate: Richard Epstein and Ryan Abbott on FDA, Off-Label Drug Use” [Bill of Health]
  • “Trial lawyers helped FDA with rule opening generic drug firms to lawsuits” [Paul Bedard, Washington Examiner]
  • Everyone including the agency itself discontented with FDA’s handling of new sunscreen ingredients [WaPo via Alex Tabarrok]
  • Does writing up a more careful patient chart help keep a doctor from getting sued? [White Coat]

So long, small-and-sustainable: critics say new Food and Drug Administration regulations implementing the Food Safety Modernization Act could render uneconomic the immemorial practice of using spent beer grains to feed livestock. Both farmers and brewers are upset. [Bangor Daily News/Lewiston, Me., Sun-Journal; proposed rule] More: Glenn Lammi, WLF.

Medical roundup

by Walter Olson on March 14, 2014

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