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FDA



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



Published: Wed, 22 Nov 2017 00:00:00 -0500

Last Build Date: Wed, 22 Nov 2017 15:43:58 -0500

 



Permissionless Biotech Crop and Livestock Innovation

Thu, 16 Nov 2017 17:46:00 -0500

Obama administration minions issued drafts of biotech crop and livestock regulations just two days before they left office last January. They were apparently motivated by their worry that genetically improved crops and livestock created using precise new genome-editing techniques like CRISPR would escape government oversight. There is good news. The USDA has now withdrawn these proposed regulations. The FDA should immediately follow suit and withdraw the scientifically indefensible regulatory proposals submitted by the Obama Administration. As I reported earlier: 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 proposed USDA regulations were designed to change the way the agency approves genetically engineered plants and the draft FDA rules would subject genetically improved livestock to the same onerous process required to get the agency's permission to market new animal drugs. On the face of it, the precision of new genome-editing techniques would seem to call for less, rather than more regulation. The Obama administration proposed that breeders of gene-edited plants submit their new varieties to the USDA for pre-approval. Waiting on agency decisions would very likely slow down the process of developing new biotech crops even more. Under the Obama administration's proposed rules, the FDA would have required pre-approval of genetically improved livestock like Holstein dairy cows engineered to contain the same gene for hornlessness found naturally in Angus beef cattle. Since that gene in Angus cows harms no one, it wouldn't hurt anyone if it were in Holstein cows. So why should breeders have to beg FDA permission to sell hornless Holsteins? Why should breeders have to get regulatory permission at all to sell genetically engineered crop varieties or livestock? Breeders have for nearly 100 years been inducing genetic changes in plants by bathing them in caustic chemicals or blasting them with gamma rays to create hundreds of new crop varieties. The Mutant Variety Database run jointly by the Food and Agriculture Organization and the International Atomic Energy Agency lists more than 3,000 commercially available crop varieties created using mutagenesis. None of these mutated crop varieties required regulatory approval before their developers could introduce them into the marketplace. Why should crops created using vastly more precise biotech genome-editing need regulation? Animal welfare issues might arise in the cases of gene-edited livestock, but otherwise there is no scientific justification for regulating them as "new animal drugs." The FDA should speedily follow the USDA's salutary lead and withdraw the draft biotech regulations that the Obama administration left behind at that agency. Both agencies should step back and adopt the principle of permissionless innovation with respect to modern biotechnology. Mercatus Institute fellow Adam Thierer defines this as "the notion that experimentation with new technologies and business models should generally be permitted by default." He adds, "Unless a compelling case can be made that a new invention will bring serious harm to society, innovation should be allowed to continue unabated and problems, if they develop at all, can be addressed later." Since there is no such compelling case against advanced biotechnology, both agencies should radically reduce the amount of regulation that they currently impose on the development and deployment of modern biotech crops and livestock.[...]



Ronald Bailey Talks Designer Kids, Paris Climate Agreement, and More on Federalist Radio

Fri, 10 Nov 2017 15:45:00 -0500

(image) At a new Federalist Radio podcast, host Ben Domenech and I discuss Trump's science policies, the ethics of designer babies, alcohol regulations, and more.

Does Trump withdrawing from the Paris Climate Accord have any tangible effects? "With regard to greenhouse gases in the United States, it was practically irrelevant," I claim. "The clean power plan is not what destroyed the coal industry. What destroyed the coal industry is fracking."

I point out that however onerous Obama's clean power plan would have been (its provisions had not yet been implemented, due to a Supreme Court injunction), the real enemy of coal is cheap fracked natural gas. No matter how much the president loves miners, most of those jobs are gone forever.

The U.S. power sector is likely to cut its carbon dioxide emissions by about 32 percent even without the clean power plan, given the price trends for natural gas and renewable energy technologies, as I reported last week. A new analysis from the Rhodium Group consultancy bolsters those earlier conclusions: "Our current projections put power sector CO2 emissions 27% to 35% below 2005 levels."

I also argue that the folks who want to ban the gene-editing kids are calling for something akin to state-imposed eugenics. Progressive Era eugenicists used government power, via nonconsensual sterilizations, to forcibly prevent parents from passing on traits deemed deleterious. Now, 21st century eugenicists want the government to require people to risk passing along genes that the parents think are deleterious. In both cases, the state is empowered to decide what sorts of people may be born.

Go here to listen to the discussion.




The FDA Will Finally Let You See Your Genetic Information

Tue, 07 Nov 2017 08:45:00 -0500

(image) Food and Drug Administration (FDA) head Scott Gottlieb is reeling in his agency's outrageous four-year ban on direct-to-consumer genetic testing.

Under the Obama administration, the FDA sent a letter to the genetic testing company 23andMe warning that the company was "marketing the 23andMe Saliva Collection Kit and Personal Genome Service...without marketing clearance or approval in violation of the Federal Food, Drug and Cosmetic Act." The letter noted that the company's tests had been providing "health reports on 254 diseases and conditions," including categories such as "carrier status," "health risks," and "drug response." But not anymore: The folks at 23andMe had little choice but to knuckle under to the agency's demands and stop testing new customers.

The company was eventually permitted to offer genetic test information on customers' ancestry and on genes associated with traits like the length of their toes. In early 2015, the agency allowed the company to provide users with results from a trait carrier test for Bloom Syndrome. Prior to the FDA's ban, the company's $99 genomic screening test package had included results from 53 trait carrier tests.

In April of this year, the FDA finally allowed the company to supply customers with genetic health risk information for 10 different conditions, including late-onset Alzheimer's disease, Parkinson's disease, celiac disease, and hereditary thrombophilia (harmful blood clots). Before the ban, the company had been providing its users with some genetic insights with regard to all of those health risks and about 140 others.

Gottlieb's statement dramatically loosens his bureaucracy's stranglehold on direct-to-consumer genetic testing. After genetic health risk test manufacturers have passed through a one-time FDA review ensuring that they meet the agency's requirements for accuracy, reliability, and clinical relevance, any subsequent additional health risk tests will not need to undergo further review. "The floodgates for direct-to-consumer genetic tests are swinging wide open," declares the STAT science new service. Let's hope so.

For more background, see my 2011 Reason article on my own genetic testing experience here. Go to SNPedia here for even more information on my genetic flaws.




Seeing Through the FDA's Soy Ploy

Sat, 04 Nov 2017 07:20:00 -0400

Earlier this week, the Food and Drug Administration (FDA) said it would move to revoke a longstanding agency-authorized claim that soy-based foods can protect heart health. If an FDA rulemaking on the matter succeeds, the reversal on soy would be the first such revocation by the agency. In proposing the change, the FDA says there simply isn't enough evidence to support an agency-authorized claim. "We are proposing a rule to revoke a health claim for soy protein and heart disease," said the FDA's Susan Mayne, in a statement announcing the move this week. "For the first time, we have considered it necessary to propose a rule to revoke a health claim because numerous studies published since the claim was authorized in 1999 have presented inconsistent findings on the relationship between soy protein and heart disease." The soy food industry is unhappy with the FDA's plans. "The Soyfoods Association of North America is concerned that the FDA is proposing to modify the claim from unqualified to qualified," the group, which represents makers of soy foods, said in a statement this week. The group also says it will fight the proposed change. I have no opinions about whether or not soy proteins (or any other foods) are good for you. Eat what you like, I say, or what you think you should eat. Or don't. But I do have opinions about both the FDA's move this week and, more generally, the agency's dominion over food-related health claims. The agency's authority over these (and other) claims dates to 1990, after Congress passed the Nutrition Labeling and Education Act (NLEA). The law established "procedures whereby FDA is to regulate health claims on food labels[.]" FDA regulations soon followed. Since passage of the NLEA, the FDA has approved a dozen health claims, including, for example, a claim that some fruits and vegetables can lower a person's risk of developing cancer, along with the claim that soy proteins can help lessen the risk of heart disease. The FDA first proposed the soy health claim in 1998, and adopted the final rule the next year. While the FDA's skepticism about soy might be new, others have long questioned health claims related to soy foods, notably even at least as far back as the proposed FDA soy rule. "In September 1998, the Center for Science in the Public Interest [discussed] 'the overblown—and under-substantiated—world of soy claims,'" writes Marion Nestle, in her book Food Politics. "This skepticism was soon justified by independent studies suggesting that substituting soy for other proteins in the diet might have little effect on the coronary risk of North Americans." Though this is the first time the FDA has ever reversed course on its approval of a health claim, this is hardly the first time the agency has reversed its position on a food or food ingredient. In the 1970s, the agency attempted to ban the legal sweetener saccharin. The agency banned interstate sales of raw milk in the 1980s, after a federal court forced the agency's hand. Most recently, the agency banned oils that contain partially hydrogenated trans fats. Even if it's successful, the FDA's proposal to revoke soy's existing health claim won't mean the end of food labels touting the connection. Among other avenues, the agency says it'll permit makers of soy foods to continue to tout the connection through the use of another NLEA tool, the "qualified health claim, which requires a lower scientific standard of evidence than an authorized health claim[.]" "Regardless of the outcome for this particular claim, the law already allows food companies to make scientifically-valid claims, and whatever FDA does won't change that," says Michele Simon, executive director of the Plant Based Foods Association, in an email to me this week. "It also indicates the challenges for FDA in keeping up with all the latest science, which points to the need for more flexibility for companies, again as along as their claims are backed up by good science." I agree with Simon that the FD[...]



Maine Food Sovereignty Bends but Doesn’t Break After USDA Threats

Sat, 28 Oct 2017 08:00:00 -0400

This past June, Maine legislators passed a law, An Act to Recognize Local Control Regarding Food Systems, which allows cities and towns in the state to adopt laws permitting farmers and other food producers within their borders to engage in a host of direct-to-consumer food sales. The law, intended to bolster local food economies in the state, allows Maine municipalities to "regulate by ordinance local food systems," and requires the state, in turn, to "recognize such ordinances." While the act was intended to protect people like the "one-cow farmer who feeds the people in his community the food they want to eat," its protections had limits. "The law does not cover sales outside a given city or town that has a food sovereignty ordinance in place," I wrote in a column shortly after the law passed. "Neither does the law pre-empt federal law." And it's that latter area that got Maine into hot water with the federal government, before the law ever took effect. "Maine's Department of Agriculture is concerned that the law would keep it from inspecting any meat slaughtered and processed in a town that is food sovereign, negating an agreement it has with the USDA to meet federal standards," the Portland Press Herald reported last week. Indeed, threats made by the U.S. Department of Agriculture (USDA) against the state forced Maine lawmakers this week to amend its food-sovereignty law. In a July 6 letter from USDA to Maine's agriculture department, the federal agency threatened to pull its approval of slaughterhouses in the state, which could have temporarily shuttered five facilities in Maine and left Maine livestock farmers scrambling to find available out-of-state slaughter options. The letter, written by the USDA's Alfred Almanza, says the agency is "concerned that the Food Sovereignty Act, if implemented as currently written, would contravene Federal food safety laws and regulations." The USDA also threatened Maine—one of 27 states to run its own meat inspection system—with federalization of its slaughter regime. At an emergency legislative session this week, Maine lawmakers amended the law to require cities and towns that adopt new ordinances under the Food Sovereignty Act to "comply with state and federal laws when developing local ordinances for meat and poultry production and sales." That followed a committee vote to amend the law last week. While the Press Herald contends "[t]he cause of the problem is [Maine's] food sovereignty bill," that's not really the case. The causes (plural) of the problem reside in Washington. These causes are the USDA, Congress, and the Supreme Court. Maine's food sovereignty movement arose earlier this decade as a response to a state law requiring even the smallest poultry farmers to invest tens of thousands of dollars on needless processing costs. "Show me a farmer who spends $30,000 to sell $1,000 worth of food and I'll show you a farmer who's out of business," I write in my recent book, Biting the Hands that Feed Us: How Fewer, Smarter Laws Would Make Our Food System More Sustainable. "Food sovereignty ordinances sought to address the absurdities of laws like these." The idea that local farmers might butcher and process their own meat for commercial sale—or use a local abattoir to do the same—rubbed the USDA all wrong. That's because of a 1967 federal law that granted the USDA ultimate oversight of all beef, poultry, and pork processing for commercial sale. While the USDA does carve out a few exceptions—for farmers who don't intend to sell their meat to a grocer or restaurant or other commercial outlet and instead sell to, for example, bulk meat to an individual buyer—few can use a custom, non-USDA slaughterhouse. If it sounds bizarre to you that the USDA will fight for its power to regulate the sale of a single steak in some rural Maine town, that's not the half of it. The fact a law even exists that makes the USDA even believe the agency has such power is one part of [...]



FDA Commissioner Scott Gottlieb Goes to Bat For Evidence-Based Opioid Policies

Fri, 27 Oct 2017 16:05:00 -0400

Food and Drug Administration Commissioner Scott Gottlieb is now the highest-ranking member of the Trump administration to say in plain language that America can't address the opioid crisis by relying on outdated prevention campaigns or forcing dependent and addicted users to quit cold turkey. "[G]iven the scale of the epidemic, with millions of Americans already affected, prevention is not enough," Gottlieb said in a statement to the House Committee on Energy and Commerce this week. He also pledged his agency would do everything in its power to "break the stigma associated with medications used for addiction treatment." A physician and former resident fellow at the American Enterprise Institute, Gottlieb's testimony provided a dramatic and welcome contrast to the blunt and shallow statements of other Trump administration officials. Whereas former Health and Human Services Secretary Tom Price said that methadone and buprenorphine therapy—which can reduce opioid-related mortality by 50 percent—amount to "just substituting one opioid for another," Gottlieb acknowledged this week that some people with opioid use disorders will need "a lifetime of treatment." His agency, he added, is "revising the labels of these medical products to reflect this fact." He has also instructed Food and Drug Administration staff to develop more extensive guidelines for "non-abstinence-based" products that "address a fuller range of the symptoms of addiction such as craving." Lastly, Gottlieb delivered a rousing rebuttal to the idea that addiction and dependence are no different: Because of the biology of the human body, everyone who uses opioids for any length of time develops a physical dependence—meaning there are withdrawal symptoms after the use stops. Even a cancer patient requiring long-term treatment for the adequate treatment of metastatic pain develops a physical dependence to the opioid medication. That's very different than being addicted. Addiction requires the continued use of opioids despite harmful consequences. Addiction involves a psychological craving above and beyond a physical dependence. Someone who neglects his family, has trouble holding a job, or commits crimes to obtain opioids has an addiction. But someone who is physically dependent on opioids as a result of the treatment of pain but who is not craving more or harming themselves or others is not addicted. The same principle applies to medications used to treat opioid addiction. Someone who requires long-term treatment for opioid addiction with medications—including those that cause a physical dependence—is not addicted to those medications. Here's the bottom line: We should not consider people who hold jobs, re-engage with their families, and regain control over their lives through treatment that uses medications to be addicted. Rather, we should consider them to be role models in the fight against the opioid epidemic. Others have drawn this distinction before, so I hesitate to applaud Gottlieb for acknowledging what his peers have said for years. But this is Washington, a place where drug policy experts are often drowned out by quacks, drug cops, and prosecutors. Gottlieb is not the most progressive reformer in this debate—he may end up calling for the removal of still more opioids from the market, which will hurt legitimate pain patients and likely drive non-medical users to the black market—but his perspective on using opioid therapy to treat opioid addiction puts him head and shoulders above the D.C. status quo.[...]



DIY Biohackers Are Editing Genes in Garages and Kitchens

Wed, 18 Oct 2017 11:30:00 -0400

"A biohacker for me is somebody who is doing something clever or interesting in biology," says Josiah Zayner, a molecular biophysicist who runs The ODIN, a company that sells do-it-yourself genetic engineering kits. "They're usually these people that have been fucked by the system who are trying to unfuck themselves." Zayner is one of the leading figures in the biohacking movement and is the main organizer of the BioHack the Planet Conference, a yearly gathering of citizen scientists. This year, over 100 members of the biohacking community met in Oakland, California to discuss a wide array of issues from at-home genetic engineering to questions on bioethics. Biohackers have often been compared to computer hackers of the 1980s, but instead of breaking into and manipulating information technology systems, they're focused on hacking living organisms with the hopes of curing illnesses and in some cases obtaining superhuman powers. Their shared mission is to put this technology into the hands of as many people as possible. "People should be able to use all the technologies that science develops," says Zayner. "It shouldn't just be patented and given to companies or exclusively given to certain people." These do-it-yourself biologists say the democratization of science has given them the freedom to do work on projects that are often ignored by larger institutions. They're using gene editing technologies like CRISPR to create personalized treatments for those suffering from rare diseases or cancer, reverse engineering pharmaceuticals like Epi-Pens so people can make their own medicine at home, and even creating glow in the dark beer. "I think this is the most exciting time thus far in the history of the world to be alive with respect to what we can and will do with life forms," says Hank Greely, the director of the Center for Law and the Biosciences at Stanford University. But breakthroughs in the world of biohacking are drawing more scrutiny from federal regulators. Earlier this year, the Food and Drug Administration began placing restrictions on non-human genetic modifications and declared that genetically edited animals must be classified as drugs. This gives the agency broad authority over a number of do-it-yourself genetics tests and requires experiments involving animals to go through the same vetting process as a new drug. "I guess they couldn't call them cosmetics and they couldn't call them foods, so they're like dogs are drugs," states David Ishee, a Mississippi canine breeder who is working on editing out genetic diseases in dogs. "Everybody's worried about what someone could do with this technology and nobody seems to care about the damage that not doing it will cause because these animals are dying." Increasing regulation could undermine biohacking breakthroughs for humans as well. "I'm a huge fan of deregulation because I believe in the inherent goodness of capitalism," says Zayner. "Stuff doesn't progress unless people do useful things with it." Produced by Alexis Garcia and Justin Monticello. Camera by Garcia, Monticello, and Zach Weissmueller. Ascent by Jon Luc Hefferman is licensed under a Creative Commons Attribution license (https://creativecommons.org/licenses/by/4.0/) Source: http://freemusicarchive.org/music/Jon_Luc_Hefferman/Production_Music_1841/Ascent Artist: http://freemusicarchive.org/music/Jon_Luc_Hefferman/ Cut and Run - Electronic Hard by Kevin MacLeod is licensed under a Creative Commons Attribution license (https://creativecommons.org/licenses/by/4.0/) Source: http://incompetech.com/music/royalty-free/index.html?isrc=USUAN1100851 Artist: http://incompetech.com/ New Dawn by Bensound is licensed under a Creative Commons Attribution license (https://creativecommons.org/licenses/by/4.0/) Source: https://www.bensound.com/royalty-free-music/cinematic/2 Artist: https://www.bensound.com/ Sci-Fi by Bensound is licensed under a Creative Commons[...]



FDA Warning to Bakery: You Can't Say There's 'Love' in Your Granola

Tue, 03 Oct 2017 19:20:00 -0400

The Food and Drug Administration is responsible, its website reminds us, for "the safety and security of most our nation's food supply." And it takes that responsibility seriously. Very seriously. So seriously that so much as a little joke on the label of a granola bar can trigger a legal warning. The FDA just whacked Massachusetts-based Nashoba Brook Bakery for claiming that "love" was an ingredient in its granola. Seriously. "Your Nashoba Granola label lists ingredient 'Love'. Ingredients required to be declared on the label or labeling of food must be listed by their common or usual name," the FDA wrote in an official warning letter sent to the bakery Tuesday. "'Love' is not a common or usual name of an ingredient, and is considered to be intervening material because it is not part of the common or usual name of the ingredient." No shit. Without "prompt action to correct the violations" identified in a recent inspection—it also cited the bakery for not accurately labeling sub-ingredients in its sourdough bread, for an employee wearing a nose ring while kneading dough (presumably not with his or her nose), and damaged floor and ceiling tiles—the FDA threatened to take regulatory actions "without further notice, including, without limitation, seizure and injunction." The government taking away your bakery because you listed "love" as an ingredient in your granola isn't very lovable. John Gates, CEO of Nashoba Brook Bakery, told Bloomberg the FDA's letter "just felt so George Orwell." "I really like that we list 'love' in the granola," Gates said, according to Bloomberg. "Situations like that where the government is telling you you can't list 'love' as an ingredient, because it might be deceptive, just feels so silly." Maybe, but once you let one bakery put "love" in its granola, where does it end? Birthday cakes layered with happiness? Macarons stuffed with mirth? One wonders how the republic would survive without a government agency regulating the level of bliss in our biscuits or the passion in our pastries. Sadly, this is not the first time the FDA has gone after the labels on granola bars. In 2015, the administration filed a complaint against Kind LLC for using the word "healthy" on the packaging despite levels of saturated fat that were, under FDA rules, too high for such a description. The use of "love" on an ingredients list is the most ridiculous complaint filed against Nashoba Brook Bakery, but the rest of the letter identifies several other instances where products were "misbranded," according to the FDA. Reading it gives you some sense of the headache-inducing regulations facing American businesses that want to do nothing more dangerous than make some bread. 2. Your Nashoba Granola product is misbranded within the meaning of Section 403(q) of the Act [21 U.S. C. 343(q)] because it fails to bear a nutrition facts label in accordance with 21 CFR 101.9. In addition to wholesaling this product, you also sell this product at your retail café using the same wholesale label. 3. Your Whole Wheat Bread (retail) product is misbranded within the meaning of section 403(g)(1) of the Act [21 U.S.C. 343(g)(1)] because it is a food for which a definition and standard of identity has been prescribed by regulation, but it fails to conform to such definition and standard. The label states "whole wheat" and "slow rise breads from . . . ." Therefore, it is represented as whole wheat bread for which a standard of identity exists under 21 CFR 136.180. Under the standard, the dough must be made exclusively from whole wheat flour. This product contains wheat flour and corn meal. Therefore, it does not meet the standard of identity for whole wheat bread. It goes on like that for a while, but you get the point. Suffice to say, if the FDA were required to list its ingredients, "common sense" would not be among them.[...]



FDA Pushing Forward with Terrible Menu-Labeling Rules

Sat, 02 Sep 2017 00:01:00 -0400

The Food and Drug Administration (FDA) has announced the agency will forge ahead with implementing the Obama administration's costly, misguided, pointless, reckless, and potentially unconstitutional menu-labeling rules. "As a doctor, father[,] and the head of the U.S. Food & Drug Administration, I believe that everyone is entitled to the information they need to make informed decisions about the food they eat," FDA Commissioner Scott Gottlieb said in a statement earlier this week. "We serve as the nation's expert on food labeling, which is why Congress entrusted us with the responsibility of crafting predictable, uniform federal standards that will benefit the health of families across America by ensuring access to essential calorie and nutrition information on food and menu labels." I will give Gottlieb that he's a doctor, father, and the head of the FDA. After that, the facts become murky. For example, if the FDA were indeed "the nation's expert on food labeling," as Gottlieb claims, one way the agency might demonstrate that expertise is by not forcing America's food manufacturers to change their food labels every couple years. Nevertheless, Gottlieb's rationale about Americans' nebulous entitlement to information is predictably familiar. It's been trumpeted in recent years by those who support mandatory labeling of genetically modified (GMO) foods, mandatory "added sugar" labeling, mandatory trans fat labeling, and pretty much every other potential food-labeling requirement under the sun. So what's wrong with mandatory menu labeling? For one, as Politico reported this week in a piece on the FDA's menu labeling plans, there's some debate over its effectiveness. "[E]vidence on whether it works is mixed," Politico notes. "Some studies have found that it helps certain individuals, especially women, eat slightly fewer calories, but others have found no effect." I wish Politico had also reported perhaps the most significant evidence around menu labeling: Its very basis is a ruse. Research has shown mandatory menu labeling doesn't help most people choose to eat fewer calories, and may in fact push people to eat more calories. "Who cares about calories?" asked a 2013 NBC News headline. "Restaurant menu labels don't work, study shows." "[A]t no time did the labels lead to a reduction in the calories of what diners ordered," the New York Times reported in 2015. "Even if people noticed the calorie counts, they did not change their behavior." Estimates of the escalating costs of complying with the FDA rules is another reason to hate the rules. A new study by the National Association of Convenience Stores (NACS), estimates the regulations will cost its members more than $84 million each year. "The way the FDA rule is written makes it virtually impossible for businesses to comply with the regulations even though they will spend billions over the next several years trying to do so," says economist David Zorn, who authored the NACS study. Compliance costs for the entire food industry are estimated to run somewhere north of $300 million per year. Even with all those costs, attempting to comply with the rules may prove futile. As I wrote earlier this summer, complying with these rules may be somewhere between difficult and impossible for many food sellers. Take, for example, pizza-delivery outfits like Domino's. "With 34 million ways to make a pizza, it makes no common sense to require this industry—which already discloses calories voluntarily, for the most part—to attempt to cram this information on menu boards in small storefronts," said Lynn Liddle, who chairs the American Pizza Community, a coalition representing much of the American pizza industry, in an email to me in 2013. If menu labeling is costly, impossible, and ineffective—something I've written time and again—then why doesn't the FDA just scrap the p[...]



Vaccines, Peter Thiel and the Fine Art of the Journalistic Hatchet Job

Fri, 01 Sep 2017 18:10:00 -0400

"Peter Thiel Funds 'Unethical' Offshore Herpes Vaccine Trial," blared a headline over at the DailyBeast. The single problem is that it's false. The story is illustrated with a photoshop of venture capitalist Peter Thiel holding a menacing syringe. Even more damning, the editors added, "The Trump adviser is part of a group of wealthy businessmen spending millions to test the vaccine on people—while evading Food and Drug Administration regulations." Which is also false. The DailyBeast article was published on August 27. The headline for the biotech news site genomeweb's summary of the story reads, "A Libertarian Vaccine?" The headline and the story appear to be an instance of never letting facts get in the way. Unwary readers encountering the artfully constructed article would likely be led to conclude that a cabal of greedy libertarian venture capitalists had experimented on desperate people without their consent. The problem that the startup in the story, Rational Vaccines, is taking on is huge. In the United States, more than 23 million people—about one in seven people ages 14 to 49 —have genital herpes. As many as three million suffer herpes outbreaks four to 24 times per year. Those who suffer frequent outbreaks experience open sores, considerable pain, frequent headaches, and the infection sometimes results in blindness and life-threatening bouts of meningitis. Chronic sufferers experience stigma and social isolation. The vaccine trial referred to in the story took place more than a year ago. Thiel Capital actually invested on August 23. So what gives? What actually happened is that in 2015 and 2016 Southern Illinois University viral immunologist William Halford set up a trial of his attenuated herpes simplex 2 (HSV-2) vaccine. He inoculated 20 volunteers from the U.S. and U.K. at a site on the Caribbean island country of Nevis and St. Kitts. Rational Vaccines reported in an October, 2016 press release participants had, on average, experienced a 3-fold reduction in their herpes symptom-days per month relative to their experience taking standard treatment antiviral drugs. Halford submitted his results to a peer-reviewed journal that initially rejected his paper and asked for further data. Halford had years earlier contracted a rare form of cancer and died in June at age 48. Halford had been researching herpes viruses for more than two decades. Eventually he came to question the medical consensus that vaccines should be developed using viral protein subunits. Previous virus vaccines including polio, measles, rubella, and chickenpox had been created using live-attenuated viruses. Such vaccines used weakened versions of viruses that could not cause disease to prime the immune system protect against natural strains. By the 1980s, many vaccine researchers concluded that using proteins derived from disease-causing viruses was safer. However, Halford's research convinced him an HSV subunit vaccine would be relatively ineffective because HSV genomes are much more complicated than simpler human papillomavirus and hepatitis B viruses. Attempts to develop HSV subunit vaccines have so far not borne fruit. In lab mice his live-attenuated vaccine elicited 10 to 100 times greater protection against genital herpes than a subunit vaccine did, Halford reported. To check its safety, Halford injected himself with his own vaccine. Rational Vaccines is developing both a therapeutic vaccine for people who are already infected and a prophylactic vaccine to protect the rest of from becoming infected. Halford and Augustin Fernandez III, CEO investor in Rational Vaccines approached Thiel Capital and other possible venture investors in April 2017, after the preliminary results of the initial trial were in. Fernandez says he never spoke with Thiel, but met with Jason Camm, chief medical officer of T[...]



Pizza Is Awesome and the FDA Sucks

Fri, 01 Sep 2017 07:02:00 -0400

Don't get me wrong: Food and Drug Administration (FDA) Commissioner Scott Gottlieb is my dude. He's is one of the best things about the Donald Trump administration. In his short time as the head of America's top regulator of stuff we put into our faces, he's been doing good work and saying good stuff on drug pricing, vaping (mostly), and health tech regs. Matt Welch gives him a high-five in Reason's June cover story about deregulation. And I understand that, pace Littlefinger, he can't be fighting every battle, everywhere, always. But Gottlieb whiffed on this one: On Friday last week, when you might have been distracted by a few other small news items, he declared himself "pleased to announce" that he's caving on long-delayed implementation of Obama era regulations (Section 4205 of the Affordable Care Act, "Nutritional Labeling of Standard Menu Items at Chain Restaurants") that require a huge swath of restaurants, cafes, and other vendors to slap calorie counts and other nutritional information all over their menu boards. The battle over menu labeling has been lengthy and arduous. As I wrote more than six years ago in "The Federal Government Wants You to Know That Your Pizza Contains Between 1,840 to 3,740 Calories. You're Welcome," these rules are ill-suited to the way the fast casual sector of the food industry functions. When restaurants have lots of options for customization and many different sizes, labeling each option becomes cumbersome quickly. Blessed are the pizzamakers for they have been on the front lines, since Domino's and co. feared they would suffer most as regs made getting a pie a little more expensive and a little more annoying for every single one of their customers. But as some provisions were gradually tweaked to accommodate folks with big lobbying shops, that opposition has dwindled. In fact, the restaurant industry has basically more or less given in on this, having already spent many of the hundreds millions of bucks compliance costs as the deadlines drew ever closer. And Gottlieb, bless his heart, retreated to the highest ground available to him: transparency. He's right that transparency is good. (He might want to mention that to his boss, incidentally.) As a doctor, father and the head of the U.S. Food & Drug Administration, I believe that everyone is entitled to the information they need to make informed decisions about the food they eat. But elaborate hyper-specific federal regulations are not the appropriate way to achieve that transparency, and they come with an epic list of unintended consequences. So here's my last cry into the darkness: They're now a fait accompli, but menu labeling mandates are still bad. They're expensive, as even the FDA itself acknowledges. They're ineffective tools to reduce obesity. They are redundant to existing regulations which already require restaurants to make nutrition information available online and in handouts, doubly so in a country where nearly everyone carries all of human knowledge in their pockets every day all day. The regulations lag change in private industry, where many restaurants were already responding voluntarily (and more intelligently) to demand for more information and healthier choices. The government's commitment to the labeling rules will almost certainly outlast the validity nutrition science they are based on. Plus they encourage bad graphic design.[...]



FDA Lies About Vaping While the CDC Inches Toward the Truth

Thu, 31 Aug 2017 14:15:00 -0400

Between 2011 and 2016, according to survey data from the U.S. Centers for Disease Control and Prevention, cigarette smoking by teenagers fell by half, cigar smoking fell by a third, pipe smoking fell by two-thirds, and smokeless tobacco use fell by a quarter. Yet according to the Food and Drug Administration, there were "no significant declines in overall high school tobacco use" during that period. How is that possible? Let me answer that riddle by posing another one. If you call an e-cigarette a tobacco product, and the incidence of past-month vaping among high school students more than sextupled from 2011 to 2016, how does that affect the trend in overall tobacco use? The answer is that it does not affect the trend in overall tobacco use at all, because calling an e-cigarette a tobacco product does not make it a tobacco product. Yet that is what FDA does, partly for regulatory reasons. E-cigarette fluid often contains nicotine derived from tobacco, which supposedly transforms a tobacco-free product into a tobacco product, giving the FDA authority to regulate it. The FDA maintains that pretense even when reporting what is happening in the real world. The result, as Boston University public health professor Michael Siegel notes on his tobacco policy blog, is an alternative reality where dramatic declines in adolescent tobacco consumption never happened. The CDC plays the same game, falsely claiming "current use of any tobacco product did not change significantly" among high school students from 2011 to 2016. This blatant misrepresentation magnifies a problem (underage tobacco use) that the FDA and the CDC are charged with addressing, making their work seem more urgent and more worthy of funding. It also conflates e-cigarettes, a noncombustible, tobacco-free alternative to conventional cigarettes, with products that are far more dangerous, obscuring the enormous harm-reducing potential of this innovation. By lumping e-cigarettes in with tobacco products, the FDA and CDC may hope to scare kids away from them. But the message to current smokers—that they might as well keep puffing away, since all these nicotine sources are essentially the same—is potentially deadly. A new CDC webpage about e-cigarettes gives some ground on that score, conceding that "e-cigarettes have the potential to benefit adult smokers who are not pregnant if used as a complete substitute for regular cigarettes and other smoked tobacco products." But by insisting that e-cigarettes be a "complete substitute," the CDC dismisses the health benefits of smoking less, even if the number of cigarettes per day does not fall to zero. "Dual use is not an effective way to safeguard your health," the CDC says. "Because smoking even a few cigarettes a day can be dangerous, quitting smoking completely is very important to protect your health." This slippery formulation deliberately obscures the fact that smoking a few cigarettes a day is less dangerous than smoking a pack or two a day. If e-cigarettes help smokers make that change, they are reducing tobacco-related harm. The CDC's discussion of how the health hazards of vaping compare to those of smoking is similarly misleading. "Are e-cigarettes less harmful than regular cigarettes?" it asks. "Yes—but that doesn't mean e-cigarettes are safe. E-cigarette aerosol generally contains fewer toxic chemicals than the deadly mix of 7,000 chemicals in smoke from regular cigarettes. However, e-cigarette aerosol is not harmless. It can contain harmful and potentially harmful substances, including nicotine, heavy metals like lead, volatile organic compounds, and cancer-causing agents." Sadly, it counts as an improvement that the CDC is willing to explicitly say e-cigarettes are less harmful than regular cigarettes instead of [...]



FDA Deems MDMA, Banned Since 1985, a 'Breakthrough Therapy'

Mon, 28 Aug 2017 12:30:00 -0400

Two decades after the Drug Enforcement Administration banned MDMA, classifying it as a dangerous intoxicant with no accepted medical use, the Food and Drug Administration has deemed the same substance a "breakthrough therapy." The designation should speed MDMA's approval as a prescription medicine, which could happen as soon as 2021. That remarkable turnaround is thanks to the hard work of a plucky and persistent organization known as the Multidisciplinary Association for Psychedelic Studies (MAPS), founded the year after the DEA banned MDMA. Last fall the FDA gave MAPS a green light for Phase III studies of MDMA as a treatment for posttraumatic stress disorder (PTSD), the last stage before approval of a new medicine. MAPS, which plans to start enrolling subjects for its first Phase III study this spring, announced on Saturday that MDMA had qualified as a breakthrough therapy. The designation, created by the Food and Drug Administration Safety and Innovation Act of 2012, means the FDA thinks MDMA "may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development." It is not hard to see why the FDA reached that conclusion, given the very promising results of the MAPS-sponsored Phase II studies conducted by Charleston, South Carolina, psychiatrist Michael Mithoefer and his wife, Annie, a psychiatric nurse. The subjects in the first study were crime victims, mainly women who had been raped or sexually abused. More than four-fifths of the subjects who received MDMA in conjunction with psychotherapy showed a clinical response, meaning they saw reductions greater than 30 percent in the severity of their PTSD, as measured by the Clinician-Administered PTSD Scale (CAPS). The mean CAPS score in this group fell from about 80 to less than 30. Ten of the 12 subjects, all of whom began with CAPS scores indicating severe PTSD, no longer qualified for the diagnosis. By comparison, 25 percent of the subjects who received placebos saw improvements of more than 30 percent. Seven of the eight subjects in the control group subsequently chose to take MDMA, and all of them showed a clinical response. That study, published by the Journal of Psychopharmacology in 2011, had a small sample, and blinding probably was less than fully effective, since subjects may have surmised they were getting the real thing based on the effects they perceived. But follow-up evaluations conducted 17 to 74 months after the last treatment found that the improvements experienced by the subjects who received MDMA generally persisted. While two of the 16 subjects who completed all of the evaluations relapsed, the average CAPS score was essentially unchanged. A subsequent MAPS-sponsored study involved 21 Iraq and Afghanistan veterans, plus three firefighters and one police officer. The results, which have been shared with the FDA but have not been published yet, were similarly impressive. Instead of using an inactive placebo, as the earlier study did, this one randomly assigned subjects to receive either 30 milligrams, 75 milligrams, or 125 milligrams of MDMA, followed by supplementary doses equal to half the original upon request. Summarizing the results at a MAPS conference last April, Mithoefer said there was "not much improvement" in the 30-milligram group but "quite a lot of improvement with the other doses." Mean CAPS scores, which ranged from 80 to 90 at the beginning, fell to between 70 and 80 in the low-dose group, less than 50 in the high-dose group, and less than 30 in the medium-dose group. In addition to the breakthrough-therapy designation, the FDA has reached an agreement with MAPS on the design for the Phase II[...]



Lawsuit Shows Muddied Waters over What Counts as 'Spring Water'

Sat, 26 Aug 2017 08:00:00 -0400

Earlier this month, a group of plaintiffs filed a federal class-action lawsuit against food and beverage maker Nestlé. The 325-page suit, filed in U.S. District Court in New Jersey, argues Nestlé's Poland Spring Water is not actually spring water but is instead "common groundwater that doesn't meet the [FDA] definition of spring water." Consequently, the suit claims, Poland Spring Water's marketing amounts to "a colossal fraud perpetrated against American consumers." The suit seeks damages and injunctive relief for the alleged fraud under both federal law and the consumer-protection laws of several states. The lawsuit comes just as Poland Spring plans to open a new $50 million bottling facility in Maine, where it plans to add 80 new jobs. The company refutes the claims in this month's lawsuit. "[T]he claims made in this lawsuit are without merit and an obvious attempt to manipulate the legal system for personal gain," the company says in a statement. "We are highly confident in our legal position and will vigorously defend ourselves against the frivolous claims in this lawsuit." This isn't the first time Poland Spring has landed in hot water (so to speak) over its marketing claims. The company settled a 2003 class-action lawsuit, filed in state court in Connecticut, that claimed, the New York Times reported at the time, "Nestlé draws its water from a site 30 miles away from the original Poland Spring and often uses ground water and a spring that is near the site of a former garbage dump." Bottled water sales and marketing are tightly regulated. Though there are myriad rules that apply to bottled water, no rules require a bottled water maker to identify its source. For example, neither Aquafina (Pepsi) nor Dasani (Coca-Cola) claims to be a "spring water." Both source their water from municipal water supplies. They sell packaged tap water, in other words, and don't claim otherwise. Fiji, on the other hand, markets its spring water as "spring water." Its spring water comes from springs in Fiji. When a seller chooses to make claims about its source—such as Fiji and Poland Spring—then they open themselves up both to government scrutiny and lawsuits if those claims are of dubious validity. FDA rules, for one, state that water may be referred to as "spring water" only if the water is 1) collected at the spring or via "a bore hole tapping the underground formation feeding the spring" and 2) the location of the spring is identified. Poland Spring indicates online that its waters come from eight springs in Maine. The company admitted in 2013 that about one-third of its spring water came from Poland Spring. Today, Nestlé isn't exactly hiding the ball about its use (or lack thereof) of Poland Spring's eponymous spring. The company's website notes they "no longer use the original Poland Spring source" to bottle their water. So who's right here: Nestlé, or the people suing them? I don't really have an opinion. As I've written countless times, questions such as whether Nestlé's Poland Spring Water is or is not fraudulent are exactly the sort of matters that are best addressed by courts. This is part of my belief, firmly rooted in the First Amendment, that food labels should be open "to any and all statements that aren't demonstrably false," as I wrote in a 2012 column. Who should decide the question of falsity? Courts. That's the ideal outcome for any First Amendment question. But the FDA's involvement in crafting definitions for foods of many sorts—known as "standards of identity"—unfortunately serves to muddy the waters. Like every standard of identity, the FDA's standard of identity for spring water, which the plaintiffs in the present lawsuit cite in support of their cl[...]



Canadians Can Eat Genetically Enhanced Salmon; Americans Can't

Wed, 16 Aug 2017 10:25:00 -0400

Our neighors to the north can now enjoy salmon genetically enhanced to grow faster and eat less feed. Thanks to absurd overregulation, Americans can't. The Atlantic salmon are enhanced using a Chinook salmon gene that enables them to grow much faster using less feed. Nature News reports that AquaBounty Technologies, which developed the fish, has now sold nearly five tons of it to customers in Canada. The company applied to the Food and Drug Administration (FDA) to get approval for its genetically enhanced salmon back in 1995; it took the agency til 2015 to rule that AquAdvantage salmon, as the product is known, "is as safe to eat as any non-genetically engineered (GE) Atlantic salmon, and also as nutritious." Health Canada approved it for sale six months later. But you still can't buy it here in the U.S. The usual claque of anti-science activists are suing the FDA in an effort to block the company from marketing the fish. And Alaska Sen. Lisa Murkowski, aiming to protect her state's salmon fishers from competition, has inserted a rider in the agriculture spending bill that bans the sale of enhanced salmon until the the FDA publishes its final labeling guidelines. Murkowski claims that Americans must be warned that AquAdvantage salmon are "frankenfish." As a general regulatory principle, genetically enhanced foods do not have to be labeled unless they are nutritionally different than their conventional versions. Canada sensibly does not require special labels on AquAdvantage salmon. AquaBounty is currently raising its sterile triploid salmon in an onshore facility in Panama. In June the company announced that it will expand a Prince Edward Island production facility and has acquired a fish farm in Indiana, where it plans to begin raising its enhanced fish for the U.S. market. Aquabounty sold its fish at wholesale for $5.30 per pound in Canada. In comparison, Tradex Foods reports that the current price on fresh atlantic salmon (farmed) in Miami for trimmed fillets is $4.25-$4.30 per pound. In any case, Alaskan fishers should rest easy. The Aquabounty facility in Indiana would produce about 1,200 tons of Atlantic salmon annually. Americans annually consume about 180,000 tons of Atlantic salmon, of which 170,000 tons are imported. Only 2,000 tons of Atlantic salmon are wild-caught. Most of the 105,000 tons of Pacific salmon is wild and is caught in domestic waters. Congress has tied the FDA's hands with respect to the AquAdvantage salmon, but the agency could do a great deal of good by withdrawing the scientifically ridiculous draft regulations meant to govern genomically improved livestock, which the Obama administration issued on its way out of the door in January. Personally, I dislike the flavor of salmon. But I plan to eat an AquAdvantage fillet as soon as I can legally lay hands on one.[...]