Subscribe: FDA
http://reason.com/topics/topic/232.xml
Added By: Feedage Forager Feedage Grade B rated
Language: English
Tags:
agency  cigarettes  dairy  drug  drugs  fda  federal  milk  new  nicotine  product  products  smoking  tobacco  vaping 
Rate this Feed
Rate this feedRate this feedRate this feedRate this feedRate this feed
Rate this feed 1 starRate this feed 2 starRate this feed 3 starRate this feed 4 starRate this feed 5 star

Comments (0)

Feed Details and Statistics Feed Statistics
Preview: FDA

FDA



All Reason.com articles with the "FDA" tag.



Published: Mon, 27 Feb 2017 00:00:00 -0500

Last Build Date: Mon, 27 Feb 2017 23:12:21 -0500

 



Smearing Team Trump

Wed, 08 Feb 2017 00:01:00 -0500

Oh, no! I did it again. It was a foolish mistake. But I slipped. I read The New York Times. This is bad for my health, because I get so mad at the smug socialist spin, but how can I not read it? It's my hometown paper. My wife wakes me up with indignant questions like, "How can you say government is too big? The Times says ..." Aargh! Nearly every day brings a new Times outrage. Saturday, a front-page story smeared Labor Secretary nominee Andy Puzder. The story begins, "Decades before President Trump nominated him ... Puzder went to battle with federal labor regulators ..." Wait a second. "Decades before"? They went back decades to criticize him? Actually, three decades—to 1983, when as a young lawyer, Puzder represented a client whom the Labor Department accused of squandering union money. The Times went on to say: "He has repeatedly argued that economic regulations stifle economic growth." Puzder "argued" that? Regulations obviously stifle growth. That's their purpose—to protect workers by putting limits on businesses' pursuit of profit. Regulation is a big reason this post-recession recovery has been so weak. In just the last 10 years, the Department of Labor added regulations that require another 70 million hours of paperwork. Monday: "Trump's FDA Pick Could Undo Decades of Drug Safeguards." Oh, no! Trump will poison America with unsafe drugs! President Trump hasn't actually made his Food and Drug Administration pick yet, but the Times worries "his push for deregulation might put consumers at risk." The reporter cites thalidomide, which, 60 years ago, "caused severe birth defects in babies whose mothers had taken the drug in pregnancy. Since then, the FDA has come to be viewed as the world's leading watchdog for protecting the safety of food and drugs, a gold standard..." Fool's gold. The FDA protected American babies from thalidomide not by being smart, but by being so slow. By the time thalidomide neared approval, its bad effects were visible in Europe. The Times eagerly reports damage done by drugs: "Drug safety watchdogs point to examples like the painkiller Vioxx, which was withdrawn from the market ... " But "invoking Vioxx as the icon for such looseness is itself ignorant looseness," says my medical researcher brother, Tom. "FDA approvals are tradeoffs between benefits and risks. The FDA knew about Vioxx's risks. It was the company, not the FDA, that withdrew the painkiller. Many doctors now say it was an ill-advised move that deprives patients of a good alternative. Vioxx's risks are no greater than painkillers like Motrin sold over the counter. The Times avoids detailing just how onerous today's regulation is. The reporter says, "The agency sets a 10-month goal for approving standard drugs." Gee, goals are nice, but does the agency honor them? The Times doesn't say. It also doesn't mention that the 10-month goal only applies to the final step of regulation—after all trials are done. The entire process takes an average 16 years and $2.6 billion. Americans want protection from bad drugs, but how many of us suffer needless pain, or die, while waiting those 16 years? How many die because a drug's developers cannot raise $2.6 billion? One more smear: "President Trump's pick to lead the Federal Communications Commission, Ajit Pai, has aggressively moved to roll back consumer protection regulations." Consumer protection? No. Socialist idiocy. The Times says Pai "stopped nine companies from providing discounted high-speed internet service to low-income individuals." No, he stopped a $9.25/month government subsidy for high-speed internet. "He withdrew an effort to keep prison phone rates down," says the Times. No, he stopped FCC lawyers from fighting about in-state phone calls because the FCC has no constitutional authority there. Utterly reasonable. But The Times quotes an advocacy group saying, "Chairman Pai is showing his true stripes ... (doing) favors for the powerful corporations." Please. Someone. Tell The New York Times that socialism was tried. It doesn't work. COPYRIGHT 2017 BY JFS PRODUCTIONS INC.[...]



Why We Don't Need a Department of Technology Policy

Tue, 07 Feb 2017 08:30:00 -0500

There seem to be embarrassing new "Internet of Things" failures every week now. Sometimes, they are on the humorous side, like when a "smart toilet" was hacked to randomly flush at startled bathroom-goers. Other times, they can be disturbing, as in case of critical vulnerabilities in St. Jude's implantable cardiac devices that could put users' lives in the hands of hackers. But in all cases, these failures tend to grab headlines and inflame calls for government regulation. It's not hard to see why. When faced with some kind of public dilemma, many people immediately assume that the government alone can solve the problem. And when you throw in futuristic fears about losing control of everyday things around us, the prospect of a savior from above seems all the more necessary. But we must take care that such "solutions" don't create more problems than they supposedly solve. Such would almost certainly be the case with one recent proposal: a "Department of Technology Policy." A 'World-Size Robot' Recently, Bruce Schneier, a veteran in information-security studies and leading voice in technology policy, penned a long article for the New Yorker in which he argues for the creation of a new federal agency—the "Department of Technology Policy"—that would consolidate control of technological regulations into a single body. Schneier explains how the incredible rate of "smart"-device adoption has created some new and unprecedented security challenges. Few people realize just how quickly IOT devices have saturated the world around them. This will only accelerate—Schneier likens the rise of IOT technologies to building a "world-size robot," with all of the sensors, commands, and computations to match. And with an expanded connected reality comes an expanded digital threat set. Computer bugs and software vulnerabilities no longer merely endanger personal data and hardware, they can potentially shut down connected home devices or hijack moving cars and even cause us physical harm. Indeed, there have been considerable security problems with connected devices. Often, the issues are theoretical: Security researchers warn the public at conferences and in journals of major vulnerabilities they discover in popular consumer routers or printers or security cameras—vulnerabilities which may or may not end up getting patched. But sometimes these vulnerabilities are actually exploited. Last October, some of the Internet's most popular websites—Twitter, Amazon, GitHub, Reddit—were knocked offline thanks to insecure IOT devices. Some malicious actor was able to infect an army of DVRs, cameras, baby monitors, and printers with a malware called Mirai, directing these devices to launch a distributed-denial-of-service (DDOS) attack on those websites' hosting provider, Dyn. While the attack was short, and the fallout was mostly limited to inconvenience and loss of sales, it was a major warning signal for security researchers who envisioned how such an attack could have been much more devastating. The main problem, as Schneier sees it, is that many companies developing and selling connected devices do not have the right security chops to make sure that they are safe before people buy them. Technology companies like Google and Apple have large dedicated teams to locate and patch software vulnerabilities as soon as possible—and even this process is imperfect. Now, companies who have no such software experience may put IOT products out to market without the necessary testing, which could create major unexpected problems down the road. And the home consumers who buy such devices are seldom equipped to evaluate the security settings on their own. Whose Failure? While Schneier's essay does an excellent job of describing the new security challenges that smart devices create, it falls short on solutions. "The market can't fix this," Schneier suggests, "because neither the buyer nor the seller cares … There is no market solution, because the insecurity is what economists call an externality: It's an effect of the purchas[...]



Trump Could, And Should, Save Vaping Industry From FDA’s Costly Regulations

Wed, 01 Feb 2017 09:30:00 -0500

If President Donald Trump is looking for an easy way to bring American jobs back—without imposing tariffs, building walls, or imposing other big government policies that will cost American consumers more in the long run—and ease regulations on American businesses, he could start by repealing new regulations for electronic cigarettes approved in August by the Food and Drug Administration. Those regulations for electronic cigarettes adopted by the FDA during the final year of the Obama administration could, if left on the books, effectively wipe out large swaths of the vaping industry. The Smoke-Free Alternatives Trade Association, an e-cigarette industry group, believes as much as 99 percent of all vaping products could be affected. That costs jobs, of course, but it also curtails the potential health benefits from getting Americans to switch from smoking to vaping. A new report released this week by the R Street Institute, a Washington, D.C.-based free market think tank, argues that the Trump administration should take immediate steps to overturn the FDA deeming rule and other federal impediments to the growth of vaping. "Perverse tobacco policy is failing the American public and will soon destroy thousands of small and medium-sized businesses that are part of the solution, not part of the problem," write Clive Bates, former director of the United Kingdom's Action on Smoking and Health; Eli Lehrer, president of the R Street Institute; and David Sweanor, a professor at the University of Ottawa's Center for Health Law, the three authors of the R Street report. Among the eight recommendations in the report, the most important is probably wiping away the 2016 reinterpretation of a 2009 law giving the FDA authority to regulate electronic cigarettes and e-liquid by the same standards as tobacco products like cigarettes—yes, even though there is no tobacco in e-cigarettes. As Reason's Jacob Sullum has written, this is essentially a slow-motion ban on many vaping products. The FDA's application process will cost as much as $1 million and a separate application will be required for each and every product. Smaller manufacturers unable to afford the costly application process will likely be driven out of the market, or will be bought up by larger businesses. Any product that has been introduced since 2009 is subject to the new rules and manufacturers have until later this year to either pull their products off shelves, or pay up and get approved. So far, there have been no signals from the Trump administration on whether it will continue with Obama-era policies on e-cigarettes or move in a new direction. It's unlikely that there will be any major policy announcements until Trump chooses a new FDA commissioner—something that he's unlikely to do until after his pick to run the U.S. Department of Health and Human Services, Congressman Tom Price (R-Georgia) is confirmed by the Senate. Jim O'Neill, a managing director at Mithril Capital, an investment firm co-launched by Peter Thiel, has been rumored to be on Trump's shortlist to run the FDA. Vaping businesses are hoping to see quick action from the new administration. "We believe something needs to be done to protect the thousands of businesses that are a crucial player in the global tobacco harm reduction strategy, and help those who are eager to quit smoking have easy access to vaping products," said Patricia Kovacevic, general counsel for Nicopure Labs, a Florida-based manufacturer of e-cigarette fluid that has launched a lawsuit challenging the FDA's deeming rule. Another major change recommended in the R Street report is allowing vaping products to be advertised as what they are: healthier than traditional cigarettes. The authors note that vaping isn't completely safe—few things are—but evidence shows that vaping is safer than combustion-based products like cigarettes and cigars. Guy Bentley, a research associate for the Reason Foundation (which publishes this blog), writes at the Washington Examiner that more tha[...]



Texas Sought Banned Death Penalty Drugs From Overseas Party Dealers

Fri, 27 Jan 2017 12:06:00 -0500

The state of Texas—hell bent on procuring banned drugs to be used in lethal injection executions—nearly completed a deal with five party drug dealers in India before the men were arrested. According to an absolutely bonkers report in Buzzfeed, Indian court documents reveal Provizer Pharma—the company equally owned by five Indian men in their twentires—was selling "psychotropic drugs and opioids illegally to people in the US and Europe," but also had a deal in principle with Texas' Department of Criminal Justice (TDCJ) to sell the agency sodium thiopental, a drug used in lethal injections. The TDCJ wrote in a statement, "The agency has not engaged in any transaction with this company," which would technically be true, because the five men from Provinzer Pharma were arrested by India's Narcotics Control Bureau while picking up returned packages loaded with illegal drugs at a FedEx store in Surat before Provinzer's sale of sodium thiopental to the state of Texas could be completed. But per a Drug Enforcement Agency (DEA) report obtained by Buzzfeed, the TDCJ tipped off the DEA of the planned purchase, and even named Provinzer Pharma as the vendor. Buzzfeed adds, "It's unclear how the Texas Department of Criminal Justice found this small company in India that made the rounds on Internet message boards for teens and 20-somethings looking to buy drugs without a prescription," but an American named Chris Harris ended up replacing Provinzer Pharma as Texas' drug supplier. Harris has made sales of death penalty drugs to four states—earning over $100,000—but each time the drugs have been detained by the Food and Drug Administration (FDA). As we've reported at Reason, death penalty states have had a hell of a time in recent years trying to get their hands on drugs used in executions, partially due to a European Union (EU) ban on the sale of such drugs to state governments that allow capital punishment, but also due to public backlash over the many executions which were botched because of drugs of questionable provenance and quality. The final status of the FDA-impounded shipments of sodium thiopental from India is still unsettled. The U.S.'s lone manufacturer of the drug stopped producing it because of its use in executions, and for a time, the Obama administration's FDA allowed states to import the drug, but the agency was eventually ordered by a federal court that it had "a mandatory obligation" to keep the "the misbranded and unapproved drug, thiopental" out of the U.S. That ruling came down in 2012, and has served as the FDA's go-to reasoning for refusing to release the detained shipments of drugs paid for by certain states' dollars. Earlier this month, the Texas Department of Criminal Justice filed suit against the FDA, demanding the release of the drugs. Ars Technica reports Texas Attorney General Ken Paxton accused the FDA of "gross incompetence or willful obstruction" in refusing to make a final decision on the fate of the impounded drugs. Paxton's main argument is that the state has a "responsibility to carry out its law enforcement duties"—which includes executions—and thus should be granted a "law enforcement exemption" and be permitted to import sodium thiopental. President Donald Trump might be the most enthusiastic proponent of capital punishment ever to inhabit the White House. It's one of the few policy positions on which he has never wavered, having taken a full-page ad in four major New York newspapers back in 1989 demanding "BRING BACK THE DEATH PENALTY", as well as writing in his 1997 book Trump: The Art of the Comeback, "I believe in an eye for an eye." In 2010, Trump said the punishment for WikiLeaks' publishing of classified documents provided by Chelsea Manning should be "the death penalty or something." When Trump gets around to appointing a new FDA commissioner, he could direct the agency to stand down on its opposition to importing the drugs, which could theoretically help states like Texas make the case that[...]



Scientifically Absurd Proposed FDA Regulations on Genetically Improved Livestock Should Be Withdrawn Immediately

Wed, 25 Jan 2017 12:45:00 -0500

The Food and Drug Administration issued, just two days before the end of the Obama administration, draft guidance on how the agency proposes to regulate genomically altered food animals. The FDA claims authority to regulate livestock and their products developed using the fantastically precise and versatile new genome editing techniques like CRISPR. Ultimately, the FDA's guidance document is rife with scientific nonsense. First, the overreaching agency claims it has the authority to regulate genetically improved livestock as a "new animal drug." As the agency points out all new animal drugs are "deemed unsafe" unless it has approved a new animal drug application. Treating each version of new improved livestock as a drug is really bad news for developers and consumers, since it takes years for a new drug to get through the FDA process at an average cost of more than $1 billion. Consider that it took the agency 20 years to approve the Aquabounty salmon that was genetically engineered simply to grow faster. The new FDA proposal is also ridiculously bad science. In fact, the regulation of modern biotech crops has been based on bad science for nearly three decades. Researchers have pleaded for years that regulation, if needed, be based on whether the end product poses novel risks, not on the method by which it is created. Under the new idiotic FDA guidance, any intentional change to a single-nucleotide base pair would make the entire animal a regulated drug. Let's put this into perspective. DNA, the chemicals that make up genes, are safe to eat. Unless you are eating only things like processed pure sugars and some minerals (in which case you'd be dead by now), nearly everything you eat contains DNA. In fact, by one estimate you eat more than 100 trillion genes that are in your food every day. Eating the DNA that specifies the production of snake venom is no more dangerous than eating any other DNA (even eating snake venom isn't necessarily dangerous, but I personally wouldn't advise it). Genetically improved livestock like hornless Holstein dairy cows are now in the FDA regulators' crosshairs. Researchers at the University of California, Davis used precise genomic editing to change the horn gene in Holstein dairy cattle to match the hornless gene found in Angus beef cattle. Most dairy cattle are dehorned as a way to keep them from harming farmers. As someone who has dehorned both calves and cattle, I can tell you that the animals don't enjoy the experience. This gene editing actually advances animal welfare. Since it is safe to eat hornless Angus cows, it is also safe to eat and consume dairy products from now hornless Holstein cows. Yet, the proposed FDA guidance wants the developers to go through its whole new drug regulatory rigamarole before products from these genetically improved animals can be offered to the public. This is on top the the FDA regulations that have stymied biotech advances in crop agriculture for decades. As Alison van Eenennaam, one of the researchers who developed the hornless Holsteins tells Gizmodo: "If DNA is a drug, then all life on Earth is high." She adds, "We have equivalent products with the same risks. Human intention isn't where risk lies. Who would say a Holstein is a drug? It's a bull without horns. There's no normal person that would think that's a drug." The FDA guidance blandly observes: In general, FDA's guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word "should" in Agency guidances means that something is suggested or recommended, but not required. As the former head of the Obama administration's White House Office of Information and Regulatory Affairs Cass Sunstein notes today over at Bloomberg News: "In theory, people are free to ignore guidance document[...]



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. https://t.co/X9Ng4F5Dwe pic.twitter.com/tQ0HbTQzvP — 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 intende[...]



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 du[...]



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 w[...]



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." Le[...]



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[...]



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[...]



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 plain[...]



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.[...]