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Published: Mon, 23 Jan 2017 00:00:00 -0500

Last Build Date: Mon, 23 Jan 2017 20:26:11 -0500


Senator Pushes a Ridiculous "Milk" Law That Treats Consumers Like Idiots

Wed, 18 Jan 2017 14:55:00 -0500

For decades, Americans have managed to accept the existence of "soy milk" without melting down into existential confusion over the meaning of dairy. And yet—never content to leave to common sense what could be legislated—some federal lawmakers seek to clamp down on the use of the term milk to refer to non-dairy beverages. Introduced by a Democrat from the great dairy state of Wisconsin, Sen. Tammy Baldwin's "Defending Against Imitations and Replacements of Yogurt, Milk, and Cheese to Promote Regular Intake of Dairy Everyday (DAIRY PRIDE) Act" would prevent almond milk, coconut milk, cashew milk, and all other lactose-lacking products—along with goat's milk, sheep's milk, and all milk from animals other than cows—from being labeled with terms like milk, yogurt, and cheese. "Imitation products have gotten away with using dairy's good name for their own benefit," said Baldwin in a press release. "The DAIRY PRIDE Act would require the FDA to issue guidance for nationwide enforcement of mislabeled imitation dairy products within 90 days and require the FDA to report to Congress two years after enactment to hold the agency accountable for this update in their enforcement obligations." The statement also quotes Ellsworth Cooperative Creamery's Jerry Croes, who said it's "about time someone stands up for the American Dairy farmer. ... It's not fair that the name milk should be used by non-dairy drinks to further erode what little profit we have." But plenty of information on non-dairy milk labels indicates that they are not actually dairy—in fact, that's generally the selling point. If dairy milk sales are down, it's not because U.S. consumers are, en masse, too stupid to realize that soy milk and such aren't animal products, but because the past decade has seen a proliferation of plant-based alternatives to traditional cow's milk come on to the market, and consumers are—for a host of reasons, including lactose intolerance, nutritional benefits, animal-welfare concerns, and taste preferences—flocking to them. Mislabeling of plant-based products as 'milk' hurts our #GrownInWI dairy farmers. Taking a stand for #WIAg economy. — Sen. Tammy Baldwin (@SenatorBaldwin) January 12, 2017 As Baylen Linnekin noted here recently, "Americans are drinking many types of milk they've long consumed—cow, goat, camel, etc.—and newer types as well, including almond, coconut, hemp, rice, and soy," making "rules that reserve use of the term 'milk' for dairy-cow milk alone" more misleading from a consumer perspective. "Perhaps rules should be established that force dairy-cow makers to modify their use of the term 'milk' with the word 'cow,' in a way that would be consistent with every other use of the term ('goat milk,' 'almond milk,' etc.)," Linnekin suggested. Linnekin's melting-pot-of-milks column came in response to another recent move by federal lawmakers to limit the term milk to stuff that comes from cows. In December, more than 30 members of Congress petitioned the U.S. Food and Drug Administration, which defines milk as "the lacteal secretion . . . obtained by the complete milking of one or more healthy cows," to enforce this definition by going after non-dairy "milk" beverages. But without any evidence that consumers are harmed by non-dairy beverages being described as milk, the whole thing smacks of simple dairy-industry protectionism. In the end, forcing producers of cow-milk alternatives to ditch the term milk won't increase consumer clarity or safety but simply bring unnecessary costs to these companies (and all American taxpayers) while further muddying the milk marketplace.[...]

FDA Says Explaining the Main Advantages of E-Cigarettes Would Confuse Consumers

Wed, 11 Jan 2017 09:15:00 -0500

In a "clarification" published this week in the Federal Register, the Food and Drug Administration indicates that e-cigarettes cannot legally be sold as tools to quit smoking unless their manufacturers go through the prohibitively expensive process of getting them approved as new pharmaceutical products. The FDA also says e-cigarettes cannot legally be sold as a less hazardous alternative to the conventional kind unless their manufacturers go through the prohibitively expensive process of getting them approved as "modified risk tobacco products." The upshot is that e-cigarette companies are forbidden to be honest about the main benefits offered by their products, a form of censorship that is bound to retard the shift from smoking to vaping, thereby endangering lives that could have been saved by switching to a much less dangerous nicotine habit. The FDA's new rule is supposed to clarify when "a product made or derived from tobacco that is intended for human consumption will be subject to regulation as a drug, device, or a combination product." That can happen in two ways, one of which is "if the product is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease." The FDA regulates nicotine products such as gum and patches as medical products, based on the dubious premise that nicotine addiction is a disease, the treatment for which is nicotine in a different form. The label on Nicorette gum, for instance, identifies it as a "stop smoking aid" that "reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking." As far as the FDA is concerned, selling e-cigarettes as a competing form of nicotine replacement for smokers trying to quit (which is what they are) puts them in the same regulatory category as Nicorette: Claims related to smoking cessation have long been recognized as evidence of intended use conferring drug or device jurisdiction. Smoking cessation claims have also long been associated with intended uses of curing or treating nicotine addiction and its symptoms....Against this backdrop, smoking cessation claims on any product generally create a strong suggestion of intended therapeutic benefit to the user that generally will be difficult to overcome absent clear context indicating that the product is not intended for use to cure or treat nicotine addiction or its symptoms, or for another therapeutic purpose. The FDA does not explicitly rule out any reference or allusion to smoking cessation in the marketing of e-cigarettes. The agency even allows that "evidence may be developed showing that, in some situations, 'smoking cessation' is understood in context as referring to ending the use of traditional cigarettes and switching to a non-combustible product made or derived from tobacco." It's a mystery why new evidence would be required to prove that point, since that surely is the way that millions of people who have used e-cigarettes to quit smoking understand the concept. In any case, the FDA promises to "closely scrutinize 'smoking cessation' claims," creating a strong presumption that will encourage manufacturers to steer clear of the subject. The FDA says "the rule's treatment of smoking cessation claims as generally suggestive of a therapeutic purpose means that products marketed with such claims would generally be regulated as medical products." It adds that disclaimers of therapeutic intent generally will not be sufficient to keep e-cigarettes out of that category. Boston University public health professor Michael Siegel, an advocate of vaping as a harm-reducing alternative to smoking, questions the FDA's legal reasoning, arguing that smoking (unlike nicotine addiction), is a "health-related behavior," not a disease. Hence "a claim that e-cigarettes are intended to help someone quit smoking is not necessarily a claim that the product is intended to treat a disease." Rather, "The intention is to help alter a health-related behavior." The FDA pretends to address this argument but[...]

Government Must Stop Protecting Cow Milk Producers from Competition

Sat, 07 Jan 2017 08:00:00 -0500

Last month more than 30 Members of Congress wrote a letter to the FDA asking the agency to require makers of non-dairy milks—including almond, rice, and soy—to stop using the term "milk" to describe their milk. The congressional letter is ridiculous, and reeks of a mix of unconstitutional protectionism and unconstitutional restrictions on free speech. Rep. Peter Welch (D-Vermont), who's spearheading the misguided effort, says he's pushing the FDA to act in order "to protect Vermont's dairy farmers." Such action is neither part of the FDA's mission nor job. Neither is it within the agency's power. Thankfully, others agree—and are pushing back. "Terms such as 'soymilk' and 'almond milk' clearly and accurately describe these plant-based beverages," says Nicole Negowetti, policy director with the Good Food Institute, which works to promote and defend plant-based foods, in an email to me this week. "This letter from lawmakers is a thinly veiled attempt to appease the dairy industry, discount consumer choice, and undermine competition by restricting free speech." The dairy industry has been making a living out of seeking government protection against its competitors since, perhaps, the dawn of time. And the federal government (along with state governments) has a long and sordid history of obliging the industry. Examples are this are so legion, and provide such foul evidence of ways the government wrongly protects one segment of the food industry, that I typically devote a whole week of the Food Law & Policy classes I teach to issues of dairy protectionism. Dairy prices too low? No worries. The USDA will buy up your surplus cheese, or pay Domino's to develop a cheesier pizza. Don't like non-dairy coffee creamers competing with your cow-milk creamer? The state will force your competitor to call its products by a bizarre, made-up name—"melloream"—that no one would ever buy. Problem solved. No lesser an authority than the U.S. Supreme Court has weighed in on government protection of dairy producers. In the late 1890s, the Court got it right, overturning a trio of mind-numbingly awful states' laws restricting the production and sale of margarine. In the 1930s, in a case many scholars argue forms much of the basis of modern law—take that for exactly what it's worth—the Court ruled Congress had the power to ban the sale of a dairy-milk substitute, Milnut. More recently, powerful dairy groups like the National Milk Producers Federation have attempted to use their considerable clout, as I note in my book, Biting the Hands that Feed Us: How Fewer, Smarter Laws Would Make Our Food System More Sustainable, to compel the FDA "to bar foods such as almond milk, soy milk, and other plant-based drinks from using the term 'milk' to describe their non-dairy milk." Enter Rep. Welch and his colleagues, to the rescue. I have an alternate proposal: If the FDA is going to take a hard look at use of the term "milk," it should probably look past soy milk and almond milk and look instead at the carve-out that exists for the unmodified use of the term by dairy cow makers alone. "Milk" today means cow's milk and cow's milk alone. It shouldn't. Americans are drinking many types of milk they've long consumed—cow, goat, camel, etc.—and newer types as well, including almond, coconut, hemp, rice, and soy. Rules that reserve use of the term "milk" for dairy-cow milk alone, at a time when Americans drink so many different types of milks, may be misleading. Perhaps rules should be established that force dairy-cow makers to modify their use of the term "milk" with the word "cow," in a way that would be consistent with every other use of the term ("goat milk," "almond milk," etc.). Perhaps not, too. While I'm confident my argument in favor of such rules is stronger than that of those like Rep. Welch who have set their sights on soy milk, we don't need more dumb rules. We need fewer. That said, from this day forward, without being compelled by government, I think I'll use the term "cow milk" in[...]

Safer Alternative to Smoking Can’t Call Itself a Safer Alternative to Smoking

Tue, 20 Dec 2016 10:47:00 -0500

Snus, a nicotine-laced-tobacco product, has been credited with helping to reduce smoking-related deaths in Sweden, where it was invented and is widely used. In the United States, the Food and Drug Administration requires snus to carry the exact same warning labels as cigarettes, cigars, and chewing tobacco. It's been more than a year since Swedish Match, the maker of snus, asked to identify its product to Americans as what it is—as safer alternative to cigarettes—but last week the FDA said it won't be allowing that to happen anytime soon. In a ruling issued on December 14, the FDA told Swedish Match that the company's products—snus consists of a small packet, similar to a tea bag, filled with tobacco powder and placed in the upper lip, in a manner similar to chewing tobacco but without the need for chewing or spitting—would have to continue carrying a warning about the potential for tooth loss and gum disease. The federal agency deferred a decision on whether snus could be advertised as less dangerous than cigarettes, but indicated that it would continue working with Swedish Match to advance its application. "We took a major step towards our vision 'a world without cigarettes' by having the first [Modified Risk Tobacco Product] application ever accepted by the FDA in history and we believe it's a sign that we're moving in the right direction," said Swedish Match in a statement to Medpage Today, a trade journal. The so-called MRTP designation was created by a 2009 law allowing the FDA to evaluate tobacco products that could be less harmful than smoking cigarettes. In the application filed with the FDA in August 2014, Swedish Match proposed a label that says "no tobacco product is safe, but this product presents substantially lower risks to health than cigarettes." Snus submitted an MRTP application in August 2014 and, if approved, could be the first product to gain that designation. That would be a significant marketing victory for the Swedish Match, which is still trying to break into the American market. Still, this is about more than just marketing. Several studies have shown that snus is indeed a safer alternative to cigarettes and an effective pathway to getting smokers to quit. A peer-reviewed study published in Tobacco Control found that snus delivers high levels of nicotine with lower concentrations of other chemicals found in cigarettes and "does not appear to cause cancer or respiratory diseases." A study conducted in Norway and published in Nicotine and Tobacco Research found that using snus was much more effective at getting smokers to quit using cigarettes than nicotine replacement products like patches and gum. Snus-ers were three times as likely to quit smoking as smokers using nicotine gum, the researchers found. They believed snus was so effective because it delivered a nose of nicotine that was almost the same as cigarettes and provided a "sensory effect that medicinal nicotine products perhaps lack" because snus smells and tastes like tobacco. Brad Rodu and Philip Cole, researchers at the University of Alabama at Birmingham, reported in 2007 that 200,000 smoking-related deaths per year could be prevented if tobacco uses across the whole of the European Union adopted snus at the same level as Swedes. (Snus is banned in most of Europe, even though cigarettes are legal, an arrangement that Reason's Jacob Sullum has described as "banning bows and arrows as an intolerable threat to public safety while allowing a free trade in machine guns.") As I wrote last month in questioning why the FDA hadn't yet made a decision about snus' MRTP application: Approving Swedish Match's application to pitch snus as a safer alternative to smoking would probably save American lives, but it would create more competition for Nicorette gum and other pharmaceutical stop-smoking products like Chantix. It's worth noting that Mitch Zeller, director of the FDA's Center for Tobacco Products, is a former lobbyist for GlaxoSmithKline, a major pharm[...]

The FDA Keeps Us Guessing About the Scope of Its E-Cigarette Regulations

Fri, 16 Dec 2016 09:15:00 -0500

Next Generation Labs, which makes synthetic nicotine for e-cigar­ettes, argues that a recent statement by the Food and Drug Administration shows the agency does not plan to regulate e-liquids as tobacco products unless they contain ingredients derived from tobacco. I don't think the statement shows anything of the kind, but I can't be sure. Like the FDA's other pronouncements on the subject of what is covered by its potentially ruinous e-cigarette regulations, the statement cheered by Next Generation Labs is hard to decipher. Here is what the FDA said last month in response to Nicopure v. FDA, a lawsuit by a company that sells e-liquids and vaporizers: Not all nicotine-free e-liquids (NFLs) are subject to the deeming rule. Assuming an NFL is not made or derived from tobacco, it is subject to the rule only if it meets the definition of a "component or part"—that is, if it is "intended or reasonably expected" either "(1) To alter or affect [a] tobacco product's performance, composition, constituents, or characteristics; or (2) To be used with or for the human consumption of a tobacco product; and is not an accessory."...An NFL that is intended or reasonably expected to be mixed with liquid nicotine would qualify as a "component or part." The FDA is quoting from its own interpretation of the Family Smoking Prevention and Tobacco Control Act, the 2009 law that gave it authority over tobacco products. Since that law says a tobacco product must be "made or derived from tobacco," you might think it's obvious that an e-liquid is not a tobacco product if none of its ingredients is derived from tobacco. But the FDA says that e-liquid still might be a tobacco product because someone—a distributor, a retailer, or a consumer—could add nicotine to it later. Even if the e-liquid never contains nicotine, it would seem to qualify as a "component or part" of a tobacco product if it is consumed in a vaporizer that also can be used to inhale nicotine. By the FDA's reasoning, that vaporizer is a component of a tobacco product, meaning it is itself a tobacco product. Hence any e-liquid used with that vaporizer, whether or not it contains nicotine or any other tobacco derivative, is also component of a tobacco product. As far as I know, the FDA has neither endorsed nor rejected this understanding of the law, despite many opportunities to do so. But the interpretation is consistent with the agency's broad view of its authority under the Tobacco Control Act. Assuming the FDA reads the law this way, an e-liquid could escape regulation as a tobacco product only if it was part of a closed system that was incompatible with e-liquids containing nicotine. If a company specializing in nicotine-free liquids packaged them in cartridges that could be used only in that company's e-cigarette, the liquids presumably could not be considered components of a tobacco product. That approach would also avoid the possibility that nicotine added to the e-liquids by someone other than the manufacturer would retroactively transform them into tobacco products, as suggested by the FDA in its Nicopure brief. What does all this mean for e-liquids that contain synthetic nicotine? The possibility that someone would add tobacco-derived nicotine to them seems remote, so Next Generation Labs needn't worry about that (I think). But e-liquids containing its TFN-brand nicotine could still be deemed tobacco products if they work with multipurpose vaporizers. The company is therefore collaborating with Vapeix to develop a "cloud-connected smart vaporizer platform" that works only with e-liquids containing TFN nicotine. Next Generation cofounder Ron Tully says the alliance aims to "create a vape market which is unequivocally disassociated from traditional vaping devices that are intended to be used with tobacco-derived nicotine." Legally, it seems like that strategy could work. But I can't see how the FDA statement cited by Tully's company, which addresses (or avoid[...]

The FDA's Unauthorized War on Pipes and Cigars

Tue, 13 Dec 2016 15:00:00 -0500

George Washington was a tobacco farmer and John Adams a pipe smoker, and every town in America has had a cigar store or pipe tobacconist since the nation's founding. But the Food and Drug Administration is determined to end all that. There are more than 2,000 cigar and pipe stores currently operating in this country, employing 35,000 Americans, and the FDA has put them all on notice that they need to stop doing business as usual and start filling their inventory with non-tobacco products. The situation is so bad that the three small trade groups representing cigars and pipes have been forced to file a lawsuit in federal court in Washington, D.C. The FDA wants for anyone hand-rolling cigars to register with the government; same with artisan pipe makers. Tobacconists would no longer be able to offer their store's unique blends without special permission, and no cigar or pipe tobacco introduced after 2007 would have much of a chance of being allowed into the marketplace. When representatives of the cigar and pipe industries pointed out to the FDA that these regulations would effectively put hundreds of stores out of business, their reply was frightening. As quoted in the lawsuit filed against the government, the "FDA's response to these small businesses is that they 'would be able to shift shelf space and other activities to non-tobacco products.'" This all started in 2009 when Congress passed the Tobacco Control Act, which gave the FDA authority to prevent the use of tobacco by young people. This was a time when the House of Representatives was controlled by Nancy Pelosi (D-Calif.) and the Senate by Harry Reid (D-Nev.), with President Barack Obama in the White House. The sweeping new regulatory powers granted to the FDA are typical of the government expansion that has occurred in recent years. Without question, this was a contributing factor to the backlash vote we saw last month when Donald Trump and the Republicans, vowing to get rid of needless regulations, were swept into office. This is not intended to be a politically partisan essay, but I mention the election because now is an ideal time for the cigar and pipe industries to find legislators who will propose a bill to exempt cigars and pipes and pipe tobacco from FDA control. If such a bill were passed, that would be that. But if not, there is the federal lawsuit filed by the Cigar Association of America, the International Premium Cigar and Pipe Retailers Association, and the Cigar Rights of America. If you want a case study in how bureaucracies can become tyrannical, there is no better example than the FDA's control over cigars and pipes and pipe tobacco. They were never included in the original Tobacco Control Act because everyone knew that kids were not running out and buying premium cigars or Dunhill pipes and expensive 965 pipe tobacco. Congress granted the FDA authority over four very specific tobacco products: cigarettes, cigarette tobacco, roll-your-own and smokeless. Well, you might ask, how does the FDA justify their regulations if pipes and cigars were not named in the original legislation? Picture the Salem witch trials, where certain people in authority would "deem" a woman to be a witch and then call for her to be burned at the stake. That is precisely what happened with the Tobacco Control Act. The FDA was given the right to "deem" newly created tobacco products to be under their control. The Act was not intended to be used as a weapon for the prohibition of the oldest forms of tobacco enjoyment; namely, pipes and cigars. Yet, that is how the FDA is interpreting the law. Whenever a federal agency wants to impose sweeping new regulations over an industry, there are several requirements they must satisfy before they are allowed to proceed. One is to ask in advance for feedback from the industry and the public. Well, the FDA did that. However, they completely ignored all of the comments. In fact, they doubled down and ma[...]

Republicans Should Snuff Out Deadly Tobacco Rules

Sun, 11 Dec 2016 10:00:00 -0500

Republican U.S. House leaders last month sent a pointed letter to federal agency heads warning them against finalizing "midnight regulations"—last-minute rules approved during a lame-duck session, without full oversight and hearings. Hastily approved regulations, they wrote, could have "unintended consequences" that "will harm consumers and businesses." That's a sensible warning, and a precursor to President-elect Donald Trump's promise to roll back counterproductive federal rules. But if the new president and Congress want a good specific place to start, they need not focus on the shady stuff rammed through by federal bureaucrats before the presidential transition. They can begin with a set of Food and Drug Administration (FDA) tobacco rules that have been moving ahead glacially and in full daylight, but which are so fraught with unintended consequences and so harmful to consumers and businesses that it's hard to understand how they got this far. We're referring to the "deeming" rules the FDA approved last summer and which—barring an act of congressional or Trumpian intervention—will go into effect August 2018. The final regulation deems some non-tobacco products as tobacco, thus giving the federal government broad authority to regulate and ban them. Those products include e-cigarettes, electronic devices that heat a flavored liquid and allow people to inhale the resulting vapor. The liquids are not made from tobacco, but usually contain nicotine. "Vaping" is proving to be one of the most effective means to break smokers of their dangerous habit, which explains why these rules are so dangerous. That looming August 2018 date is crucial. E-cigarette companies must have their vaping devices and liquids tested and approved by the FDA by then to be legally allowed to sell them. As harm-reduction expert Christopher Russell argued in an op-ed in The Hill: "Experts have estimated that undertaking this research package to a good standard could cost a manufacturer at least $3 million per product it wishes to keep on the market." Each combination of liquid flavor, device and nicotine strength would require a separate test, and there's no guarantee of approval, he added. Anti-smoking forces depict the vaping industry as a front for Big Tobacco, but the industry currently is dominated by small companies. These testing costs will put most of them out of business. So, Unintended Consequence number one: Federal rules designed to combat major tobacco companies will end up empowering them, given they are the only players with the kind of cash available to navigate the Rube-Goldberg-like FDA approval process. The real danger, however, comes from Unintended Consequence number two: As Russell noted, studies show that a large percentage of "vapers" will return to cigarette smoking. Public Health England, the main British health agency, has been out front on this one. Vaping, it argues, is 95 percent safer than smoking combustible cigarettes. Policymakers should promote vaping as a means for "harm reduction." Vaping isn't entirely safe, but sensible public-health policy should focus on promoting safer alternatives rather than myopic abstinence. Unintended Consequence number three: Devoted e-cigarette users will buy their products from overseas companies, and will deal with products manufactured according to heaven-knows-what standard. This will create black markets and an overall less safe situation. The FDA's summary of its rulemaking includes this line: "FDA is taking this action to reduce the death and disease from tobacco products." The agency isn't the only group that uses that explanation to justify its attack on vaping products. California Gov. Jerry Brown (D) and the state legislature last session increased the tobacco smoking age to 21, which is designed to make it harder for teens—whose brains are more easily prone to addiction than adults—to get hooked on coffi[...]

Tomato Growers Lose Millions Thanks to False FDA Warning, Courts' Failure to Act

Sat, 10 Dec 2016 08:00:00 -0500

Last week the Fourth Circuit Court of Appeals ruled that the federal government could not be held financially responsible for issuing erroneous warnings about the source of an outbreak of foodborne illness that caused the loss of millions of dollars of tomatoes. The warnings, issued by the FDA in 2008, turned out to be wildly inaccurate and deeply damaging. The first, issued on June 3, warned consumers in New Mexico and Texas not to consume several types of raw tomatoes because they may be tainted with salmonella, a bacteria that can sicken and kill those who consume it. A few days later, on June 8, the FDA expanded the warning to include similar types of tomatoes across the country. Soon after, on June 13, the FDA held a press conference that strongly inferred Florida tomatoes might be to blame. ("I'm not wanting to put the focus on Florida specifically, but...") But on July 17, the agency reversed course. "After a lengthy investigation, the FDA has determined that fresh tomatoes now available in the domestic market are not associated with the current outbreak," reads an agency press release, which concluded instead that consumers "should avoid eating raw jalapeño and raw serrano peppers." At the time of the first warning, on June 3, the FDA documented several dozen cases of foodborne illness it wrongly claimed were caused from eating tomatoes. By the time the agency admitted its error on July 17, the FDA acknowledged more than 1,200 such cases had occurred. By that time, the salmonella cases had mushroomed into "the largest foodborne outbreak in the United States in more than a decade." Clearly, the FDA warning hadn't helped consumers, who continued to buy and be sickened by contaminated hot peppers. And it didn't help consumers who stopped buying perfectly good tomatoes at the agency's urging, or who threw away tomatoes they'd already purchased. But if the FDA's misplaced warning was unhelpful at best and harmful at worst to consumers, it was downright devastating to tomato growers and handlers. The agency's warnings had spread like wildfire. For example, the New Mexico Restaurant warned its members against using tomatoes. Newspapers around the country warned consumers to avoid eating tomatoes. Demand for tomatoes plummeted by up to 40 percent in the wake of the warning, and prices fell by half. The industry lost hundreds of millions of dollars. Congress held hearings in the wake of the FDA's retraction of its tomato warning. "Shipments ground to a halt," Anthony DiMare, whose family's company suffered enormous losses, told Congress. "Tomatoes were left in the fields, in the packinghouses and on trucks that were turned away by our customers." DiMare criticized the FDA and CDC for acting without "knowledge they clearly lacked" and urged the agencies to work with industry so that they wouldn't repeat their mistakes. A group of tomato growers and handlers, including DiMare, sued the FDA in federal claims court in 2013, arguing that the incorrect warnings had served effectively as a regulatory taking under the Fifth Amendment. They argued, as a judge wrote in a 2014 order in the case, "all or almost all of the value of plaintiffs' perishable tomatoes was destroyed by the collapse in the market for tomatoes triggered by the FDA's warnings." Nevertheless, the judge rejected the claims of the tomato growers and handlers. "A regulatory takings claim is not plausible and cannot proceed when the government action at issue has no legal effect on the plaintiff's property interest," the judge ruled. "Advisory pronouncements, even those with significant financial impact on the marketplace, are not enough to effect a taking of property under the Fifth Amendment." I wrote an amicus brief in support of the plaintiffs in the case. "The FDA's improper warning cost the tomato producers millions of dollars and turned tons of good tomatoes into tons [...]

Is Your State Part of the War on Vaping?

Fri, 09 Dec 2016 15:32:00 -0500

A new report from Surgeon General Vivek Murthy released this week called for the federal government to hit electronic cigarettes with high taxes, regulatory restrictions, limits on advertising for vaping products, and bans on the sale of some vaping products. The alarmist report could pave the way for the U.S. Department of Health and Human Services to take action to curb the growth of vaping, even though doing so would make it harder for smokers to switch to e-cigarettes, which are undeniably safer than traditional, combustible cigarettes. Some state and local governments are already way ahead of Murthy. Two states in particular—California and Massachusetts—account for more than 200 local-level restrictions on the sale or use of electronic cigarettes. A new report from Halo Cigs, a leading producer of e-cigarettes and other vaping products, takes a look at the wide range of regulations on vaping at the state and local levels. Massachusetts, despite its small size, has the most local restrictions on where e-cigarettes can be bought or used. The state is one of several that apply the same rules to vaping products as traditional cigarettes and other tobacco products—despite the fact that e-cigarettes contain no tobacco. That's a common fallacy surrounding the regulations of e-cigarettes, and one that Murphy used repeatedly in his new report, as Reason's Jacob Sullum pointed out yesterday. While the graphic above gives you some idea about which states are most and least welcoming to vaping, it doesn't tell the whole story. Local and state-level restrictions on the use of e-cigarettes are only one way that governments have wacked the vaping industry. In Pennsylvania, for example, there are few local rules prohibiting vaping (as the map above indicates), but a new tax 40 percent wholesale tax on vaping products passed by state lawmakers in June has forced some vape shops to close their doors. None of those local and state-level restrictions may matter much in the long run, since new rules from the FDA could drive the vast majority of e-cigarette products out of the market. Starting next year, manufacturers will have to pay up to $1 million per product to clear the FDA's new permitting process for vaping products. Shutting down vaping with onerous taxes or regulatory decrees makes it harder for nicotine-addicted smokers to kick the habit by taking up a safer alternatives. Many e-cigarettes contain nicotine extracted from tobacco, but considering them the equivalent of cigarettes is an affront to common sense and medical science. There's no combustion, no smoke and no tar in e-cigarettes, along with fewer cancer-causing chemicals. One study from the United Kingdom found that e-cigarettes are 95 percent safer than their combustible cousins. Government-led efforts to keep people from accessing or using e-cigarettes is not a victory for public health, but, like so many other things, the federal government should let states experiment with different policies to see what works. In 10 years, we might be able to tell whether Massachusetts and Calfornia's heavy-handed approach to vaping has prevented e-cigarettes from being widely used and what consequences that had on general smoking rates and smoking-related diseases. We could compare that to what will have happened in states that took a lighter touch on regulating vaping. If the FDA and the surgeon general get their way, though, the federal government will close that possibility in favor of restrictive policies that hurt small businesses and smokers trying to kick the habit. This post has been updated to correct the spelling of the surgeon general's name.[...]

Reactions to Trump FDA Chief Rumor: Unmitigated, and Unsupported, Fear of a Libertarian Planet

Thu, 08 Dec 2016 20:50:00 -0500

A rumor, not linked to any named source, is circulating (Bloomberg seems to have first reported it yesterday) that Donald Trump is likely to name Jim O'Neill to head the Food and Drug Administration (FDA). O'Neill is currently a managing director at Mithril Capital, an investment firm co-launched by Peter Thiel, who is on Trump's transition team. Gizmodo is hitting the panic button hard at this rumor, with its headline: "Trump is Considering an Insane Silicon Valley Libertarian to Head the FDA." The bill of indictment against this dangerous madman, who they find "pretty freaking terrifying"? he has advocated for the FDA to give up on vetting the efficacy of new drugs before they come to market. O'Neill, in other words, would like the FDA to stop performing one of its primary functions and let all of us act as lab mice. Such a move might allow drug makers to rake in tons of cash on untested medical treatments that might not ever work. "We should reform [the] FDA so there is approving drugs after their sponsors have demonstrated safety—and let people start using them, at their own risk," O'Neill said in a 2014 speech at the conference Rejuvenation Biotechnology. "Let's prove efficacy after they've been legalized." Those "insane" ideas that relate to the FDA may seem familiar to readers of Reason as they have been defended at length and intelligently here by our science correspondent Ronald Bailey, at most detail in this 2012 article. In it Bailey presents some facts and analysis Gizmodo might not be aware of, or maybe not care about. (Gizmodo does not make the slightest attempt to actually explain why O'Neill's ideas are allegedly insane or bad for America.) Bailey notes that "a 2010 study in the Journal of Clinical Oncology by researchers from the M.D. Anderson Cancer Center in Houston, Texas found ...that the delays caused by requirements for lengthier trials have instead resulted in the loss of 300,000 patient life-years while saving only 16 life-years." Bailey reports skyrocketing costs and time to get potentially lifesaving drugs through the FDA gantlet, and that it is Phase III trial on efficacy and potential side effects that are the largest cause of this time and money sink, "Between 1999 and 2005, clinical trials saw average increases in trial procedures by 65 percent, staff work by 67 percent, and length by 70 percent," Bailey writes. Writing about health policy analyst Avrik Roy's call, like O'Neill's, for allowing drugs that have passed Phase I and Phase II to be conditionally marketed, Bailey notes: Speeding up drug approvals saves lives. A 2005 National Bureau of Economic Research study found that, on balance, the faster FDA drug approvals made possible by new funding legislation passed in the 1990s saved far more lives than they endangered. In fact, new drugs saved up to 310,000 life-years compared to 55,000 life-years possibly lost to the side effects of drugs that were eventually withdrawn from the market. Conditional approval would accelerate access to more drugs, especially drugs that aim to treat the common diseases that afflict more of us. Not only would conditional approval get drugs faster to sick people willing to take a risk on a new treatment, sales of the drug would help fund the Phase III trials needed for full approval.... Roy is not alone in his advocacy for conditional approval. In a February 14 Wall Street Journal op-ed, former FDA Commissioner Andrew von Eschenbach argued that "after proof of concept and safety testing, the [new therapeutic] product could be approved for marketing with every eligible patient entered in a registry so the company and the FDA can establish efficacy through post-market studies."... Delaying access to new drugs kills people. As Competitive Enterprise Institute general counsel Sam Kazman has observed [PDF], "Whene[...]

Are E-Cigs the Market Solution that Can Save a Billion Lives?: New at Reason

Thu, 08 Dec 2016 13:50:00 -0500

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"This is a market solution to one of the biggest health crises we've ever seen in the history of the world," says Aaron Biebert, director of A Billion Lives, a documentary that makes the case that regulatory agencies and non-governmental organizations are engaged in a campaign of misinformation against e-cigarettes. "It's disturbing to me that something that's working is being demonized."

Biebert sat down with Reason TV's Zach Weissmueller to discuss the film and the state of the vaping industry in the wake of new Food and Drug Administration (FDA) guidelines that the American Vaping Association, a pro-vaping industry group, claims could wipe out 99 percent of existing e-cigarette manufacturers and retailers. The FDA, for its part, plans to "hire additional Office of Small Business Assistance staff to provide assistance to small tobacco product entities wherever possible." And just today, the Surgeon General issued a report claiming that e-cigarettes are "now a major public health concern."

But are e-cigarettes actually dangerous, or is this simply fear-mongering propaganda from public health agencies that are slow to adapt to innovation?

Watch the full interview above to hear more on that question.

Interview by Zach Weissmueller. Shot by Alex Manning and Lexy Garcia. Music by Chris Zabriskie.

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Are E-Cigs the Market Solution that Can Save a Billion Lives?

Thu, 08 Dec 2016 13:33:00 -0500

"This is a market solution to one of the biggest health crises we've ever seen in the history of the world," says Aaron Biebert, director of A Billion Lives, a documentary that makes the case that regulatory agencies and non-governmental organizations are engaged in a campaign of misinformation against e-cigarettes. "It's disturbing to me that something that's working is being demonized."

Biebert sat down with Reason TV's Zach Weissmueller to discuss the film and the state of the vaping industry in the wake of new Food and Drug Administration (FDA) guidelines that the American Vaping Association, a pro-vaping industry group, claims could wipe out 99 percent of existing e-cigarette manufacturers and retailers. The FDA, for its part, plans to "hire additional Office of Small Business Assistance staff to provide assistance to small tobacco product entities wherever possible." And just today, the Surgeon General issued a report claiming that e-cigarettes are "now a major public health concern."

But are e-cigarettes actually dangerous, or is this simply fear-mongering propaganda from public health agencies that are slow to adapt to innovation?

Watch the full interview above to hear more on that question. Click below to listen now via SoundCloud.

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Interview by Zach Weissmueller. Shot by Alex Manning and Lexy Garcia. Music by Chris Zabriskie.

Subscribe to our YouTube channel.

Like us on Facebook.

Follow us on Twitter.

Subscribe to our podcast at iTunes.

FDA Salt Guidance Could Kill More People Than It Saves

Fri, 02 Dec 2016 11:10:00 -0500

The Food and Drug Administration issued proposed guidance in June to the food industry aiming to reduce the amount of sodium in many prepared foods. In its draft guidance, the agency stated: Average sodium intake in the U.S. is approximately 3,400 mg/day. The draft short-term (two-year) and long-term (10-year) voluntary targets for industry are intended to help the American public gradually reduce sodium intake to 2,300 milligrams (mg) per day, a level recommended by leading experts and the overwhelming body of scientific evidence. The targets are also intended to complement many existing efforts by food manufacturers, restaurants, and food service operations to reduce sodium in foods. The FDA further asserted: CDC has compiled a number of key studies, which continue to support the benefits of sodium reduction in lowering blood pressure. In some of these studies, researchers have estimated lowering U.S. sodium intake by about 40 percent over the next decade could save 500,000 lives and nearly $100 billion in healthcare costs. So, the science of salt is settled, right? Actually, no. The FDA asked for public comments on its draft guidelines and it evidently received sufficient pushback that it extended the deadline for comments until December 2, 2016. As I reported earlier more and more studies are calling into question that idea that reducing salt consumption at the population level will actually result in net health benefits. For example, the New England Journal of Medicine published a study in August 2014 finding that people who consume less 1,500 milligrams of sodium (about 3/4ths of a teaspoon of salt) are more likely to die than people who eat between 3,000 to 6,000 milligrams of sodium per day (1.5 and 3 teaspoons of salt). The free-market think tank, the Competitive Enterprise Institute has submitted comments that show that the FDA's confident claim that reducing salt consumption by Americans will save lives is at best, a hope, and at worst, tragically wrong. The CEI comments to the FDA nicely summarizes the relevant scientific studies. Here is the nub of the issue: Reduced sodium consumption affects different individuals in different ways. Only an estimated 17 to 25 percent of the population is "salt sensitive"—they experience higher blood pressure with increased dietary sodium—while 75 percent are considered salt resistant and will experience no change in blood pressure with altered dietary sodium. However, an estimated 11 to 16 percent of the population are inverse salt sensitive, which means reduced dietary sodium can increase their blood pressure. With this heterogeneity in response to salt, trying to force a population-wide reduction in sodium availability in order to reduce incidences of hypertension would be ineffective at best and counterproductive at worst. Among other evidence, CEI cites a 2014 metanalysis in the American Journal of Hypertension of more than two dozen sodium studies which concluded that risk of death appeared to be lowest among individuals consuming between 2,565mg and 4,796 mg of sodium a day with higher rates of death in the upper and lower range. The FDA itself notes that average daily consumption - 3,400 mg - is right in the middle of that range. CEI correctly argues: For a minority of the population, reducing dietary sodium can be an effective means of lowering cardiovascular and hypertension risk. But identifying for whom sodium restriction may be beneficial and by how much is something that individuals and their doctors must determine. For the general population, sodium reduction is, by no means, a silver bullet to reducing hypertension and has the potential to increase risks for a large portion of the population. Treat people as individuals not j[...]

FDA Approves Final Stage of MDMA Drug Trials

Wed, 30 Nov 2016 08:15:00 -0500

(image) More than three decades after the Drug Enforcement Administration banned MDMA, federal regulators have approved research that could make the compound legally available as a psychotherapeutic catalyst by 2021. The New York Times reports that researchers studying MDMA as a treatment for posttraumatic stress disorder (PTSD) yesterday received permission from the Food and Drug Administration for Phase 3 clinical trials, the final step before approval of a new medicine.

The Multidisciplinary Association for Psychedelic Studies (MAPS), which is sponsoring the research, funded six Phase 2 studies involving a total of 130 subjects. Hundreds of subjects will participate in the next phase.

In one Phase 2 study, scores on the Clinician-Administered PTSD Scale fell by almost two-thirds, on average, among 19 subjects who underwent MDMA-assisted psychotherapy. A follow-up study found that the improvements generally persisted an average of almost four years later.

"It changed my life," an Iraq and Afghanistan veteran who participated in one of the Phase 2 trials told the Times. "It allowed me to see my trauma without fear or hesitation and finally process things and move forward." Another subject, a firefighter traumatized by "years of responding to gory accidents," said MDMA-assisted psychotherapy "gave me my life back."

The psychotherapeutic potential of MDMA, which enhances empathy, reduces fear, and encourages openness, was apparent back in the late 1970s and early '80s, when the drug gained a following among psychiatrists. But once it was dubbed Ecstasy and became popular as a party drug, its fate was sealed. Like marijuana, LSD, and psilocybin, it has only recently re-emerged as a subject of legitimate medical research.

Reason TV covers the MAPS-sponsored MDMA research:

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What Trump's Win Means for Food and Agricultural Policy

Sat, 19 Nov 2016 08:00:00 -0500

The looming presidency of Donald Trump has left many (perhaps most) Americans uncertain of what the future might hold. On my beat—food and agricultural law—that future is no clearer. Eight years of food and agricultural policy under President Barack Obama was mostly chaff. First Lady Michelle Obama planted an organic garden on the White House grounds and sought to work with the food industry to reduce calories, reformulate foods, and promote exercise in an unsuccessful attempt to reduce obesity rates in this country. Obama's activist FDA banned trans fats, pushed for "added sugar" labeling on packaged foods, and adopted sweeping new food safety regulations under the Food Safety Modernization Act. The Affordable Care Act, Obama's signature legislation, contains requirements for nationwide calorie labeling on many restaurant menus. Farm subsidies administered by the USDA ballooned to unprecedented levels during the Obama administration. The USDA co-published controversial new dietary guidelines. And the First Lady championed changes to the USDA National School Lunch Program that mandated the serving of more whole grains, fruits, and vegetables. Save for the first lady's White House garden, I've been mostly critical of these actions. Given Trump's putative status as the anti-Obama, how might a Trump administration differ from his predecessor when it comes to food and agricultural policy? We've gotten an early glimpse. And so far, supporters of stricter regulations appear alarmed. A set of Trump food and agriculture talking points obtained by Politico suggests "a shift back to conventional agriculture, to promises for the Trump White House to be an 'active participant' in writing the next Farm Bill, to fighting the so-called good food movement and undoing Obama-era agricultural and environmental policies." As the Washington Examiner's Paul Bedard noted this week, a recent report by the American Action Forum suggests the Trump administration could cut a recent slew of regulations that would cost more than $40 billion under a law known as the Congressional Review Act. According to the AAF list, many recent food and agricultural rules—several billion dollars' worth—could be repealed as early as January. The Trump administration also appears likely to roll back Michelle Obama's school lunch reforms. That sounds promising. But, as I detail in my book, Biting the Hands that Feed Us, any reversal of course that simply returns the failing program to the flailing program it was five or ten years ago is untenable. Trump's stance on immigration—not just a human rights issue but also a key food and agricultural issue, as many of the people who grow, pick, cook, and buy our food are immigrants—is frighteningly bad. Ditto his position on (or, rather, against) free trade. Outside of specific laws and regulations the administration might embrace, some other indicators have emerged recently. For example, Quartz reports the Trump transition team is being headed by a veteran food lobbyist. And while the lists of potential cabinet heads of the USDA and HHS (which houses the FDA) are still reasonably long, they're not terribly inspiring. So food and agricultural policy will likely look very different under Trump than it's looked under Obama, who, in the words of one Associated Press writer this week, "made healthier, safer and better labeled food a priority[.]" That characterization is, in my view, quite a reach. The Obama administration made regulating food a priority. But many of its regulations don't appear to have made us healthier, or our food safer or better labeled. Even Obama supporters found his administration's stance on food to be "more symbolic t[...]