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



Published: Fri, 18 Aug 2017 00:00:00 -0400

Last Build Date: Fri, 18 Aug 2017 04:47:11 -0400

 



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.[...]



Most Drug Expiration Dates Are Bogus, and the FDA Knows It

Mon, 14 Aug 2017 12:35:00 -0400

(image) Hospitals in the U.S. throw away $800 million worth of unused medicine every year, and pharmacies and consumers trash uncounted millions more, all because they didn't use or sell those medicines prior to the date printed on the bottle.

But according to a new report from ProPublica, most of those drugs are safe and effective for years after the expiration date. And the Food and Drug Administration (FDA) knows it.

"It turns out that the FDA, the agency that helps set the dates, has long known the shelf life of some drugs can be extended, sometimes by years," writes ProPublica's Marshall Allen. "In fact, the federal government has saved a fortune by doing this."

Allen explains:

For decades, the federal government has stockpiled massive stashes of medication, antidotes and vaccines in secure locations throughout the country. The drugs are worth tens of billions of dollars and would provide a first line of defense in case of a large-scale emergency.

Each year, drugs from the stockpiles are selected based on their value and pending expiration and analyzed in batches to determine whether their end dates could be safely extended. For several decades, the program has found that the actual shelf life of many drugs is well beyond the original expiration dates.

A 2006 study of 122 drugs tested by the program showed that two-thirds of the expired medications were stable every time a lot was tested. Each of them had their expiration dates extended, on average, by more than four years, according to research published in the Journal of Pharmaceutical Sciences.

An official with the Department of Defense, which maintains about $13.6 billion worth of drugs in its stockpile, says that in 2016 it cost $3.1 million to run the extension program, but it saved the department from replacing $2.1 billion in expired drugs. To put the magnitude of that return on investment into everyday terms: It's like spending a dollar to save $677.

I suggest reading ProPublica's entire report, which provides one stunning example after another of bureaucratic cautiousness fueling rational but egregiously wasteful behavior. Hospitals don't dispense perfectly safe but expired drugs because that may expose them to regulatory penalties or lawsuits. Pharmaceutical companies don't push back against the FDA "because regulations make it expensive and time-consuming for manufacturers to extend expiration date." And the FDA won't do anything, because...well, ProPublica doesn't really provide a good explanation. The simplest explanation is that regulatory structures are like weeds: They don't uproot themselves.

There is no top-down fix in sight. The American Medical Association has apparently been drawing attention to this issue for over a decade now, but the FDA has made exceptions only in the case of medicine shortages. But that doesn't mean consumers have to comply.




Crazy Pet Anti-Vaxxers Provoke My Canine Lyme Disease Vaccine Envy

Fri, 04 Aug 2017 13:30:00 -0400

(image) Admittedly it sounds like a spoof or a plot from the TV comedy Portlandia, but the the Brooklyn Paper is reporting that local veterinarians have noticed anti-vax madness has taken hold among Brooklynite hipsters who are refusing to get their dogs and cats inoculated. From the article:

Some Brooklynites are refusing to vaccinate their pets against virulent and potentially deadly illnesses — some of which could spread to humans — thanks to a growing movement against the life-saving inoculations, according to borough veterinarians.

"We do see a higher number of clients who don't want to vaccinate their animals," said Dr. Amy Ford of the Veterinarian Wellness Center of Boerum Hill. "This may be stemming from the anti-vaccine movement, which people are applying to their pets." ...

A Clinton Hill–based veterinarian said she has heard clients suggest the inoculations could give their pups autism, however, echoing the argument of those who oppose vaccinating kids. But even if pooches were susceptible to the condition, their owners probably wouldn't notice, according to the doctor.

Let's say it one more time: Numerous studies have debunked the claim that autism is linked to vaccinations.

Brooklyn anti-vaxxers should be wary of allowing their pets to romp across the fields and dunes in the Hamptons since the number of Lyme disease carrying ticks has exploded on Long Island this summer. The ticks that latch onto dogs can move along to their owners.

The Brooklyn Paper story, however, reminded me pooches do have access to effective vaccinations against Lyme disease while people do not. The one time I was infected from a tick-bite acquired while mowing the grass at my Blue Ridge cabin, I noticed the disease's characteristic bull's-eye rash and immediately got dosed with antibiotics. Looking back, I should have been inoculated with the human version when it was available between 1998 and 2002.

Although there were complaints of adverse reactions, follow-on research found that they were no more frequent or dangerous than those associated with other vaccines. Of course, I didn't know then its manufacturer would decide to withdraw the vaccine in the face of a class action lawsuit motivated by anti-vaccine fearmongering. The suit settled in 2003 and the plaintiffs got no compensation. Since the vaccine was withdrawn, the Centers for Disease Control estimates that 300,000 Americans are diagnosed with the disease every year. Thanks a lot, anti-vaxxers!

The good news is that the Food and Drug Administration is apparently fast-tracking a new human Lyme disease vaccine from the European biotech company Valneva. It could be approved as early as next year. This time, I won't dilly-dally about getting inoculated.




Will All Seriously Ill Americans Be Granted the ‘Right to Try’ Experimental Meds?

Fri, 04 Aug 2017 13:01:00 -0400

(image) A state-level movement to allow Americans who are seriously and potentially terminally ill to access medication earlier in the approval process may successfully be going national.

The U.S. Senate has approved—by unanimous consent—Senate Bill 204, sponsored by Sen. Ron Johnson (R-Wisconsin) and pushed by the libertarian Arizona-based Goldwater Institute. It mimics legislation in 37 states that allows for people with life-threatening illnesses earlier access to medication being evaluated through the very lengthy Food and Drug Administration (FDA) approval process.

To be clear, this "right to try" legislation does not create a free-for-all when it comes to access to experimental medicine. The bill requires that a person have a life-threatening illness or disease and that the drug in question has already completed the first phase of clinical trials for the FDA.

Furthermore it does not require drug manufacturers or dispensers to provide access if they don't want to, and they cannot be held liable if they refuse (and they can't be held liable if the drug causes harm except in cases of misconduct or negligence). And as a compromise for critics worried about the ethics of letting people access drugs early, drug manufactures who do provide medicine as part of this process will need to report to the government any adverse effects.

The bill now heads to the House of Representatives, where two Republican congressmen have already introduced companion legislation. In a release praising the passage of Johnson's bill, the Goldwater Institute notes how state-level right-to-try laws actually help:

Right to Try is saving lives already. In Texas alone, Dr. Ebrahim Delpassand has helped nearly 100 patients under his state law, providing a treatment that has completed clinical trials but is not yet fully approved for advanced stage neuroendocrine cancer. Many of these patients were told they had only months to live but are still alive a year later, thanks to Right to Try.

Reason has been covering the "Right to Try" movement for years now. Below, watch a ReasonTV explanation video from 2015 about the efforts:

src="https://www.youtube.com/embed/nerWf9Vydn4" allowfullscreen="allowfullscreen" width="560" height="340" frameborder="0">




A Cap on Nicotine in Cigarettes Would Be Hazardous to Health

Wed, 02 Aug 2017 15:20:00 -0400

Robert Proctor, the historian of science who wrote the fascinating 1999 book The Nazi War on Cancer, loves the Food and Drug Administration's idea of "reducing the nicotine in cigarettes to a nonaddictive level." Writing in The New York Times, Proctor, now a professor at Stanford, calls the FDA's proposal "exceptionally good news for tobacco control, and for human health." In fact, he says, "a legal cap on the nicotine in cigarettes could be one of the most important interventions in human health history." I don't think this intervention would work out the way Proctor imagines. His op-ed piece is an excellent example of expecting good intentions to ensure good outcomes, even when experience tells us the policy is bound to backfire. "Cigarettes with nonaddictive nicotine levels would be radically different from what used to be known as 'low tar' or 'light' cigarettes, marketing gimmicks now barred by law," Proctor assures us. "Those cigarettes were advertised as delivering less nicotine and tar into the lungs, even though there was no actual reduction." Although it is by no means clear that "there was no actual reduction," it's true that "light" cigarettes were at best only slightly less harmful than regular cigarettes. But the reason for that casts doubt on the logic of the proposal Proctor is championing. It turned out that smokers who switched to "light" cigarettes tended to engage in "compensatory behavior" that boosted nicotine delivery and moved them closer to their usual dose. They smoked more cigarettes, took more puffs from each one, took bigger puffs, or held the smoke deeper and longer. They even subconsciously covered the tiny filter holes that helped reduce a cigarette's machine-measured tar and nicotine yields. The upshot is that "light" cigarettes did not offer anything like the health advantage implied by those official, government-certified numbers. The problem was that tobacco companies reduced nicotine along with tar, when what they should have done was reduce tar while keeping nicotine the same. E-cigarettes embody the latter approach taken to its logical conclusion: They deliver nicotine with no tar at all, since they do not contain tobacco and do not rely on combustion. To its credit, the FDA has finally begun to recognize the huge potential health benefit of reducing the toxins and carcinogens that smokers absorb along with nicotine. In the case of conventional cigarettes, however, the agency is considering the opposite approach: forcing smokers to absorb more toxins and carcinogens for any given dose of nicotine. The aim, as Proctor says, is to "make addiction virtually impossible," so that "kids might start smoking, but they wouldn't have trouble quitting." But what about the 30 million or so Americans who already smoke cigarettes? Deliberately increasing their exposure to the dangerous compounds generated by burning tobacco is neither ethical nor sensible, even (or especially) from a "public health" perspective. There are other problems with the FDA's proposal, aside from its health-damaging paternalism. Proctor notes that "sales were disappointing" when Philip Morris introduced three brands of nicotine-free cigarettes in the 1980s, "in part because high-nicotine cigarettes remained on the market." But forcing cigarette manufacturers to dramatically reduce nicotine levels would stimulate a black market supplied by smuggled imports and illicitly manufactured smokes. Smokers could dodge the cap on nicotine by turning to the black market, spiking their cigarettes with liquid nicotine, or rolling their own using full-strength tobacco. As longtime British anti-smoking activist Clive Bates notes, it is not even clear that the FDA has the authority to mandate the nearly complete removal of nicotine from cigarettes. The Family Smoking Prevention and Tobacco Control Act bars the agency from "banning all cigarettes" or "requiring the reduction of nicotine yields of a tobacco product to zero." A rul[...]



The FDA Warms to Vaping

Wed, 02 Aug 2017 00:01:00 -0400

On the face of it, the decision that the Food and Drug Administration (FDA) announced on Friday, extending by four years a crucial deadline for e-cigarette manufacturers to seek approval of their products, was no more than a stay of execution. But the FDA also signaled a new receptiveness to vaping as a harm-reducing alternative to smoking, which suggests this reprieve could turn into a commutation. That would be good news for smokers who want to quit and for anyone sincerely interested in helping them. For too long American public health officials have been unreasonably hostile to e-cigarettes, which are far less hazardous than the conventional kind and offer a closer simulation of the real thing than nicotine gum or patches do. Scott Gottlieb, the new FDA commissioner, seems to appreciate the public health potential of this innovation. "The overwhelming amount of death and disease attributable to tobacco is caused by addiction to cigarettes," he says. "Envisioning a world where cigarettes would no longer create or sustain addiction, and where adults who still need or want nicotine could get it from alternative and less harmful sources, needs to be the cornerstone of our efforts—and we believe it's vital that we pursue this common ground." Gottlieb's vision of nonaddictive cigarettes involves mandating a gradual reduction in nicotine content, which would increase the risks that smokers face by forcing them to absorb more toxins and carcinogens for the same dose of nicotine. But his interest in less dangerous alternatives to cigarettes is encouraging. The FDA says "a key piece" of its new approach is "demonstrating a greater awareness that nicotine—while highly addictive—is delivered through products that represent a continuum of risk and is most harmful when delivered through smoke particles in combustible cigarettes." The agency wants to strike "an appropriate balance between regulation and encouraging development of innovative tobacco products that may be less dangerous than cigarettes." Toward that end, the FDA is giving e-cigarette companies until August 8, 2022, to apply for permission to keep their products on the market under regulations published last year, rather than the original deadline of November 8, 2018. The agency says it will use the extra time to seek additional public comment and develop clearer guidance for the industry. The 2016 regulations require manufacturers of vaping equipment and e-liquids to demonstrate that approval of their products "would be appropriate for the protection of the public health." It is not clear what that means in practice, but the FDA projected that applications would cost hundreds of thousands of dollars per product, and many observers thought that was an underestimate. To give you a sense of how expensive and burdensome the process was expected to be, the FDA anticipated that it would receive applications for just a tiny percentage of existing products. The implication was that the regulations would drive the vast majority of companies out of business. If the FDA is serious about making "less harmful sources" of nicotine "the cornerstone of our efforts," it will develop transparent, straightforward, and practical criteria for approval of current and new vaping products. Standing between smokers and products that can save their lives is surely not "appropriate for the protection of the public health." Nor is making those products less appealing by arbitrarily restricting flavors. Since supposedly "kid-friendly" e-liquids are very popular among adults who switch from smoking to vaping, it's a bit worrisome that the FDA plans to solicit public comment on regulation of flavors, which it acknowledges may be "helping some smokers switch to potentially less harmful forms of nicotine delivery." A recent BMJ study suggests that e-cigarettes have accelerated the downward trend in smoking and may account for the first increase in the cessatio[...]



New York City Sued Over Unconstitutional Menu-Labeling Law

Sat, 29 Jul 2017 08:00:00 -0400

Earlier this month, several food-industry groups sued New York City in an effort to halt Mayor Bill de Blasio's plans to begin enforcing the city's mandatory menu-labeling law next month. The National Restaurant Association's Restaurant Law Center—along with the Food Marketing Institute, National Association of Convenience Stores, and New York Association of Convenience Stores—filed suit on July 14 in U.S. District Court in Manhattan. The suit argues the city's menu-labeling law—which I wrote about here in May, before the lawsuit—conflicts with a federal menu-labeling law, passed as part of the Affordable Care Act, even though enforcement of the pertinent portion of that federal law has yet to begin. The plaintiffs contend that under the U.S. Constitution's Supremacy Clause, New York City's "premature enforcement is preempted by federal law." That conflict is very real. The federal law and New York City law are similar but not identical, something the city admits freely. For example, the federal rules apply to restaurants with 20 or more locations nationwide, while the New York City rules apply to restaurants with 15 or more locations nationwide. And, as the lawsuit states, implementation of the federal rules has been delayed several times—most recently until May 2018—while New York City's rules are set to take effect next month. These differences matter. When Congress passed the menu-labeling law as part of Obamacare, notes this month's lawsuit, it "prohibit[ed] any state or locality from imposing any food labeling regulation 'that is not identical to'" the federal law. Nevertheless, Mayor de Blasio announced in May that the city would move ahead with enforcing its rules in part due to perceived federal foot-dragging. "We can no longer wait for federal action, and urge other cities to follow our lead," de Blasio said. The mayor's decision to "lead" means the staggering cost of doing business in New York City will rise even more for an estimated 3,000 restaurants there. Restaurateurs have argued the rules present them with "a legal quandary." Complying with menu-labeling laws is high—up to $1,000 for each menu item, according to the lawsuit. But so too are potential fines for noncompliance. In fact, the lawsuit was filed shortly after Mayor de Blasio announced the city would begin later this summer to issue fines of up to $600 for violations of the rules. Costs are very much at the heart of the debate over mandatory menu labeling. As I've explained before, the National Restaurant Association pushed for federal law as a way of avoiding the prohibitive costs of complying with potentially hundreds of local and state menu-labeling laws. In addition to these costs, the very basis of compulsory menu-labeling laws is flawed. While New York City is the scene of compulsory menu labeling's earliest triumph, it's also the site of many of its most public failures. In 2008, the city, under then-Mayor Michael Bloomberg, became the first in the nation to "to require chain restaurants to post calorie information on menus and menu boards." The purpose of the law was to help consumers choose lower-calorie options. But subsequent research on the menu-labeling law—see here, here, here, and here, for starters—has shown it to be ineffective at best, and counterproductive at worst. Rushing headlong to comply with a federal law that's inherently flawed, still in flux, and which may never take effect—a recent analysis suggests the FDA's delay in implementing the law has called "perhaps its core validity... into public question"—would be foolhardy. But in New York City, the costs of noncompliance with the looming local rules are now an immediate threat. "Plaintiffs' members should not be forced to alter their business models, or be marked as lawbreakers, because of New York City's ill-considered decision to jump ahead of the national regulatory regime," the lawsui[...]



Embracing Harm Reduction, FDA Gives E-Cigarette Industry a Regulatory Reprieve

Fri, 28 Jul 2017 13:15:00 -0400

Today the Food and Drug Administration (FDA) said it is giving manufacturers of electronic cigarettes until August 8, 2022, to apply for approval of their products under regulations announced last year, which were widely expected to drive most companies out of business. The original deadline was November 8, 2018, and the four-year extension is supposed to provide more time for public comment and industry guidance as part of a "comprehensive regulatory plan" that aims to strike "an appropriate balance between regulation and encouraging development of innovative tobacco products that may be less dangerous than cigarettes." The agency says "a key piece of the FDA's approach is demonstrating a greater awareness that nicotine—while highly addictive—is delivered through products that represent a continuum of risk and is most harmful when delivered through smoke particles in combustible cigarettes." That is music to the ears of harm-reduction advocates who see vaping as a life-saving alternative to smoking and viewed the original FDA rules as misguided, heavy-handed, and potentially deadly meddling that effectively gave conventional cigarettes an advantage over competing sources of nicotine that are much less dangerous. In addition to providing regulatory relief for the e-cigarette industry, the FDA will be investigating the possibility of mandating a gradual reduction in the nicotine levels of combustible cigarettes. The idea is to make cigarettes less addictive for new smokers, but the policy is apt to hurt current smokers by forcing them to absorb more toxins and carcinogens along with their usual dose of nicotine. The FDA "intends to issue an Advance Notice of Proposed Rulemaking (ANPRM) to seek input on the potential public health benefits and any possible adverse effects of lowering nicotine in cigarettes." The FDA's new commissioner, Scott Gottlieb, sees a nicotine-reduction mandate as complementing the agency's new receptivity to harm-reducing cigarette alternatives. "The overwhelming amount of death and disease attributable to tobacco is caused by addiction to cigarettes," Gottlieb says. "Envisioning a world where cigarettes would no longer create or sustain addiction, and where adults who still need or want nicotine could get it from alternative and less harmful sources, needs to be the cornerstone of our efforts—and we believe it's vital that we pursue this common ground." The FDA also seems to be contemplating flavor regulations that might favor e-cigarettes over the real thing. It says it will "seek public comment on the role that flavors (including menthol) in tobacco products play in attracting youth and may play in helping some smokers switch to potentially less harmful forms of nicotine delivery." The Family Smoking Prevention and Tobacco Control Act, the law that gave the FDA authority to regulate tobacco products, banned most "characterizing flavors" from cigarettes but made an exception for menthol, by far the most popular one (and, not coincidentally, a big moneymaker for Philip Morris, which supported the law). It sounds like the FDA might be reconsidering that exception, while at the same time recognizing that so-called kid-friendly e-cigarette flavors are in fact very popular with adults who switch from smoking to vaping. The FDA says it will use the reprieve it is giving e-cigarette companies to clarify what will be required to keep their products on the market. The agency also plans to develop product standards that address battery hazards and help keep e-cigarette liquids away from children. Over all, it looks like the FDA under Gottlieb will be taking a much more practical approach to e-cigarette regulation that recognizes the realities of the existing market and the relative hazards of different nicotine sources. Instead of wrecking an industry that seems to be accelerating the downward trend in smoking, [...]



Helix Launches Online Personal Genomics Testing Marketplace

Tue, 25 Jul 2017 15:05:00 -0400

Helix wants you to become a lifelong repeat customer in its newly launched genomics testing marketplace. For $80 the company will use your saliva sample to sequence all 22,000 protein-coding genes in your exome, along with some additional genetic sequences that its scientists find relevant to human health. The exome (the protein-coding region of the human genome) represents less than 2 percent of the genome but contains about 85 percent of known disease-related genetic variants. The company says it will keep your genetic information securely on file. Customers can now purchase various genetic testing "apps" from about a dozen vendors in Helix's genomics marketplace. Helix will share the relevant sections of your exome with the vendors, who then provide the results of their readouts directly to you. The current options include an ancestry testing app from National Geographic ($69.95); a family planning test from Sema4 ($199) that tells you if you are a carrier of any of 67 different genetic variants that might affect the health of your prospective children; a fitness app from Exploragen ($24.99) that identifies genes that may affect your sleep pattern; a health app from Admera ($124.99) that tests for a genetic predisposition to having high levels of bad cholesterol; and a nutritional app from Everlywell ($249) that tests for food senstivities that may be related to your genetic makeup. There is even a wine explorer entertainment app by Vinome ($29.99), which claims to match your genes to your vintage tastes. Now that Helix has created a genomics marketplace, the company plans to add new validated tests from additional app vendors over time. Once they become available, Helix customers can purchase them and then simply have their online genetic information sent along for analysis. Prior to getting the results from the health apps in the marketplace, customer's health histories are evaluated by physicians from an independent third party network. That part—the evaluation of health app results by independent physicians—is clearly aimed at getting around the Food and Drug Administration's outrageous ban on direct-to-consumer genetic testing. The ban essentially began in 2013, when the agency shut down the personal genomics start-up 23andMe. In April of this year, the agency finally relented somewhat and allowed 23andMe to offer tests to identify genetic variants that contribute to 10 different conditions, including Parkinson's disease, late-onset Alzheimer's disease, and a blood-clotting disorder. But tight restrictions are still in place. When I was an early customer, the company provided me with genetic insights not just about those 10 health risks, but also about 140 others. We will never know how much further along companies, customers, and medical practitioners would be now had the government not hamfistedly stymied the development of direct-to-consumer genetic testing for four years. The good news is that the Helix marketplace model seems designed to work around such regulatory excesses and enable Americans to gain access to their genetic information.[...]



Chuck Schumer Thinks He Needs to Stop You from Shoving Chocolate Up Your Nose

Mon, 10 Jul 2017 12:30:00 -0400

Apparently some people are snorting raw chocolate powder like it's snuff. Rather than pointing out that chocolate is so much more fun to eat, meddlesome Sen. Chuck Schumer (D–N.Y.) wants the Food and Drug Administration (FDA) to regulate it. Meet Coko Loko, a snortable raw cacao concoction that also includes caffeine powder and other (perfectly legal) ingredients associated with energy drinks. Given the open and relatively cheap access to these products, it's not exactly clear why anybody would prefer an awkward snuff-influenced delivery system (it's faster, apparently), but that's a marketplace issue. If people want to buy chocolate and snort it up their nose, that's their business. That's not good enough for Schumer. Coco Loko got a recent burst of media publicity, which has prompted Schumer to send a letter to the FDA over the weekend to demand that they do something about people doing things he doesn't want them to. His complaint (via USA Today): "This suspect product has no clear health value," he said in a statement. "I can't think of a single parent who thinks it is a good idea for their children to be snorting over-the-counter stimulants up their noses." It may be a struggle for us to visualize a child who would rather shove chocolate up his or her nose rather than eat it, but we lack the capacity to see the citizenry as a collection of hapless Ralph Wiggums the way Schumer does. Coko Loko is sold online for about $20 per small container, each of which holds about 10 doses; it is also available in some shops. That price is a pretty clear indicator that kids aren't going to be getting their hands on it easily. They can get 15 Kit Kat bars for that! This is not unlike the absurd belief that kids are going to regularly get their hands on costly marijuana edibles that look like candy. But Schumer's "for the children" complaint is really about his regulatory war on powdered caffeine and the general panic about anything that is connected to energy-drink-like concoctions. Reason's Jacob Sullum has regularly taken note of the exaggerated fearmongering around energy drinks. Caffeine powder on its own can potentially be dangerous. But in the case of Coko Loko, we're dealing with much smaller amounts. Apparently the product's creator got the idea from Europe, where snortable cacao is apparently a thing and has been sold there for a while, according to a Denver Post report. The Post already turned to the FDA to see if it is going to meddle in the sales, even before Schumer started yelling about it. It's not yet clear whether the government is going to try to stop you from putting chocolate up your nose, but it is clear that it believes it has the power to do so if it so chooses. Schumer's miserable need to interfere in your consumption choices doesn't end with caffeine. He frequently uses his powerful position as a senator to call for bans on anything he finds troublesome, from laser pointers to violent video games to virtual currencies. Indeed, his inane insistence on the federal government's role in monitoring what people put into their bodies landed him on Reason's list of enemies of freedom. If you're actually curious about Coko Loko, here's a fellow trying it out on YouTube: src="https://www.youtube.com/embed/a08ybhnSt5k" allowfullscreen="allowfullscreen" width="560" height="340" frameborder="0">[...]



FDA's Vaping Regulations Will Hurt Smokers Trying to Quit

Mon, 03 Jul 2017 14:46:00 -0400

Electronic cigarettes are now the most popular technique used by Americans who want to quit smoking. But that pathway could close later this year, thanks to shortsighted federal regulations that effectively prevent innovation. When Congress passed the Tobacco Control Act in 2009, few electronic cigarettes were on the market. Under the terms of that law, the Food and Drug Administration (FDA) would have the authority to approve or deny any new tobacco products introduced after February 15, 2007, while products that had been on the market before that so-called "predicate date" would be free from the new level of scrutiny. That works out fine for cigarettes, cigars, chewing tobacco, and other items that have been around a long time, but it effectively froze the market. Any new products—including almost all vaping devices and the nicotine-laced liquids used in those devices—would have to go through an expensive and vague regulatory process before being offered to consumers. The deadline for filing those applications is November 8 of this year, unless Congress and the FDA act to change the rules and let e-cigarettes remain on the market. Greg Conley, president of the American Vaping Association, explains it like this. If you have not filed a retroactive application for any vapor product that has come to market since 2007—which is every single product on the market today—your product is banned. If you file an application before November 8, and the FDA doesn't like what you have included, you're banned. If you file an application on November 8, and the FDA hasn't ruled on that application by November 8, 2019, you are banned. "So you could spend millions and millions of dollars to try to comply with very vague requirements that have been put out by the FDA, and the FDA could still simply never review your application or just turn it down for an arbitrary reason," Conley said at a recent forum sponsored by the American Enterprise Institute. The FDA's own economic analysis of the regulation suggests that 98 percent of all e-cigarette products will not apply to stay on the market. That's bad news for vaping businesses, but it's also bad news for Americans hoping to stop smoking cigarettes. According to research from the Center for Disease Control, 35 percent of Americans who sought to quit smoking from 2014-2016 used electronic cigarettes as a substitute. Vaping allows would-be smokers to get a hit of nicotine and to maintain the same physical routine, while avoiding the dangerous chemicals and soot that come from burning tobacco and inhaling it into their lungs. Compared to other methods used to quit smoking, the CDC reports, e-cigarettes are the most popular, beating out nicotine gum, anti-smoking patches, and FDA-approved medications such as Zyban and Chantix: Killing the majority of vaping products currently available on the market while leaving cigarettes available is almost certain to drive some e-cigarette users back to combustible tobacco options. That means the FDA—the very government agency that claims it is "responsible for protecting the public health" and "for advancing the public health by helping to speed innovations"—will be banning innovative products that are helping Americans improve their health. They'll be doing that because Congress, a decade ago, made an arbitrary decision that tobacco products made after 2007 should have to face a different level of scrutiny than those that came earlier. Imagine how a similar rule would effect any other industry. What would computers look like today if Congress decided in 1999 to force any new microchip-using devices to jump through additional regulatory hurdles while leaving older models on the market? What car would you be driving today if any innovations to internal combustion engines were [...]



Go Ahead, Put Salt on Your Food

Sat, 01 Jul 2017 20:41:00 -0400

"Salt," an unknown wit once said, "is what makes things taste bad when it isn't in them." In that sense, government nutrition nannies have spent decades urging Americans to make their food taste bad.

In June 2016, the Food and Drug Administration (FDA) issued proposed guidelines to the food industry to reduce the amount of sodium in many prepared foods. The agency, noting that the average American eats about 3,400 mg of sodium daily, wants to cut that back to only 2,300 mg. That is basically the amount of sodium in one teaspoon of salt. The Centers for Disease Control and Prevention (CDC) similarly advises that "most Americans should consume less sodium" because "excess sodium can increase your blood pressure and your risk for a heart disease and stroke."

There's one problem: Evidence has been gathering for years that government salt consumption guidelines might well kill more people than they save.

The research does suggest that some subset of Americans may be especially sensitive to salt and would benefit from consuming less. Among those are folks with ancestors from Sub-Saharan Africa. But for most people, the risk lies elsewhere.

A 2014 meta-analysis of more than two dozen relevant studies, published in the American Journal of Hypertension, concluded that risk of death appeared to be lowest among individuals consuming between 2,565 mg and 4,796 mg of sodium per day, with higher rates of death above and below that consumption range. As noted above, the FDA itself reports that average daily consumption is 3,400 mg—right in the middle of the ideal range.

In April, a new study by researchers at the Boston University School of Medicine, who followed more than 2,600 people for 16 years, once again debunked the dire claims about salt. "We saw no evidence that a diet lower in sodium had any long-term beneficial effects on blood pressure," said lead researcher Lynn Moore. "Our findings add to growing evidence that current recommendations for sodium intake may be misguided."

In fact, the authors found that study participants who consumed less than 2,500 mg a day had higher blood pressure than those who consumed more. They also pointed out that other research has also found that people who consume very high or very low amounts are both at greater cardiovascular risk. "Those with the lowest risk," they noted, "had sodium intakes in the middle, which is the range consumed by most Americans."




FDA's Gottlieb Hints at a Huge Overhaul of Health Tech Regulations

Fri, 16 Jun 2017 13:50:00 -0400

When Apple CEO Tim Cook was asked in 2015 if the forthcoming Apple Watch would feature cutting edge health technology, the answer was a very clear no. Making the Apple Watch more than just a really pricey fitness tracker would require approval from the Food and Drug Administration, and that, in turn, would "hold [Apple] back from innovating." In a blog post published this week, recently approved FDA Commissioner Scott Gottlieb acknowledged that "ambiguity regarding how FDA will approach a new technology can lead innovators to invest their time and resources in other ventures." To that end, writes Gottlieb, FDA will provide guidance to clarify our position on products that contain multiple software functions, where some fall outside the scope of FDA regulation, but others do not. In addition, FDA will provide new guidance on other technologies that, although not addressed in the 21st Century Cures Act, present low enough risks that FDA does not intend to subject them to certain pre-market regulatory requirements. Greater certainty regarding what types of digital health technology is subject to regulation and regarding FDA's compliance policies will not only help foster innovation, but also will help the agency to devote more resources to higher risk priorities. We don't yet know what the FDA's new guidelines will look like, but the tech industry is likely to get more clarity. Gottlieb wants the new guidelines to be transparent enough that developers can "apply them on their own, without having to seek out, on a case-by-case basis, FDA's position on every individual technological change or iterative software development." The timing for these reforms couldn't be better. Apple has been hiring medical tech engineers since early last year, and it is allegedly working on a blood glucose monitor for diabetes patients that doesn't require piercing the skin. Verily, meanwhile, is working with Dexcom, which manufactures a continuous glucose monitor that does pierce the skin, to make the device even less obtrusive. (All of Verily's projects look great, actually—and all, I suspect, will require some interaction with the FDA.) At the cheaper end of the market, we may just get better fitness and health apps for mobile devices. This software generally doesn't require FDA approval, but even device makers aren't sure when they should talk to the agency. In 2015, when he was still at the American Enterprise Institute, Gottlieb told NPR that bringing these apps under the FDA's purview would "create so much uncertainty for product developers that it's going to discourage a lot of investment and it's going to discourage a lot of programmers from getting into this space." "Hopefully this is a signal that the FDA is waking up to the realities of the Information Age and are willing to let consumers take advantage of the many life-enriching—and potentially even life-saving—technologies that could be at their disposal if not for excessive bureaucratic red tape," says Adam Thierer, a senior fellow at the Mercatus Center's Technology Policy Program. As soon as this fall, writes Gottlieb, the "FDA will pilot an entirely new approach toward regulating this technology."[...]



The FDA Commissioner's Novel Plan for Cutting Drug Prices: Competition

Wed, 07 Jun 2017 15:45:00 -0400

(image) Scott Gottlieb, the nation's new head of the Food and Drug Administration, wants to tame drug prices the old-fashioned way: by letting more companies compete.

Generic drugs are typically sold for far less than their chemically identical branded counterparts. Yet from 2010 to mid-2015, the prices of more than 300 of the 1,441 established generic drugs experienced at least one extraordinary price increase of 100 percent or more, according to a 2016 Government Accountability Office report. Lack of competition is one major reason why.

A stunning 2,640 generic drug applications are currently stuck in the FDA's approval process. (In 2006, by contrast, the agency's generic drug backlog stood at only 800 applications.) A 2016 article in the Journal of the American Medical Association pointedly noted that "none of the approximately 1500 generic drug submitted in fiscal year 2014 had been approved by the end of that year."

Lower-priced generic drugs saved the health care system an estimated $254 billion in 2014. An FDA study has found that as the number of competing manufacturers for a drug goes up, the price falls dramatically. When two companies compete, the price falls an average of just 6 percent; when there are nine competitors, the price drops by an average of 80 percent.

Gottlieb reportedly plans to prioritize the approval of additional generic competitors, and he hopes to eliminate the backlog of generic-drug applications within a year. It isn't surprising that he'd set such a goal: He wrote an op-ed last August arguing that excessive FDA regulation was stymieing the development and approval of generic drugs.

For example, the Obama administration abruptly imposed higher manufacturing standards on generic makers in 2009, forcing many to leave the market. Gottlieb's op-ed also noted that the average cost to file a generic drug application with the agency had risen from about $1 million in 2003 to $5 million in 2016—and that sometimes it was as high as $15 million. As a result, a company would have to expect to earn considerably more revenue from a generic product for it to be worth its while to consider competing against companies already in the market.

Last year Gottlieb called for changing that; this year he'll get a chance to try.




Mandating Menu Labeling is Foolish, Not 'Easy'

Sat, 27 May 2017 08:00:00 -0400

This week, New York City—the first place in America to require chain restaurants to post calorie information on their menus—expanded the reach of its menu-labeling law. The city is now "the first municipality to require grocery and convenience stores with more than 15 outlets nationwide to clearly display calorie counts for prepared foods and beverages and have additional nutritional information available upon request," reports New York's Fox 5. "The rules will apply to about 1,500 food retailers." This expansion is a microcosm of a larger, ongoing debate in Washington over the fate of federal menu-labeling rules. In a column last month, I correctly predicted the agency responsible for implementing the rules, the FDA, was likely to delay—once again—implementing enforcement of its menu-labeling rules. The agency delayed enforcing the rules—which were mandated by Congress under 2010's Affordable Care Act—for one year, just days before enforcement was set to begin. I oppose mandatory menu labeling for many reasons. For one: it's ineffective. Research has shown that posting mandatory calorie counts on restaurant menus doesn't help people make better choices. One key sticking point in Washington is whether the federal rules should apply (as they now do in New York City) to grocery and convenience stores, along with pizza chains. This week, the USA Today editorial board weighed in on the issue. Apparently, the USA Today editors have never seen a less intractable problem than devising and complying with menu-labeling rules. "It's not rocket science," the USA Today editors note. It's "so seemingly simple." Isn't it even a little bit difficult? Nope. "[H]ow hard can it be to post a small sign over each offering with a calorie count?" they ask. "Not very." The alleged simplicity of devising and complying with menu-labeling rules is a common argument in support of them. If it's so easy to provide calorie information, then certainly one place that must have figured it out is the Breaking News Café, located inside USA Today's Mclean, Va. headquarters. I called this week to ask. The woman who answered the switchboard at Gannett (USA Today's parent company) at noon on Thursday said she could not connect me with the cafe because she did not have their updated number. But she volunteered to me that she has not seen calorie information during the times she has been in the Breaking News Café. (She then connected me with catering, where the phone rang a few times before I was disconnected.) I did a bit more poking around. While many of the two-dozen or so photos of the cafe show food on sale, I did not see any calorie counts displayed. Maybe this is because the calorie information just isn't there. Or it could be because the information is present but goes unnoticed (which would track with research that most people don't even see calorie counts on menus, hence defeating their very purpose). Or maybe there's a long, sad trail of unanswered internal memos from USA Today's editors demanding calorie counts be displayed at the Breaking News Café. I don't know. (No one responded to my Thursday email to the editorial board.) One thing I do know, though, is that the USA Today editorial gets at least one key fact wrong about menu labeling when it argues the FDA rules place "no burdens on small business, as the law applies only to chains with 20 or more outlets." As I've written time and again, that's not how it actually works. Franchisees—small-businesspeople who own one or more restaurants that USA Today argues should be subject to the rules, such as your local Domino's franchisee—could be forced to comply with the rules. A small businesswoman who owns o[...]