Dec 9, 2013, Vol. 19, No. 13 • By THE SCRAPBOOK
It’s difficult to think of a company doing anything as gee-whiz neat as 23andMe. The Mountain View, Calif., firm, which opened its doors to the public in 2007, provides comprehensive genetic tests to anybody with $99 to spend. Customers send in a saliva sample and about six weeks later get access to a detailed website explaining their unique genetic code along with an opportunity to connect with (usually distant) relatives who have also done business with 23andMe. For those who use it, the results are endlessly fascinating; for scientists, the company’s trove of genetic data is hugely valuable. And that’s why it’s outrageous that the Food and Drug Administration has ordered 23andMe to stop selling its kits.
The FDA’s letter demanding the company to stop doing business is a model of bureaucratic overreach. It claims that the 23andMe test tube kit is a “medical device,” because it provides information about the “diagnosis of disease” but isn’t proven to be as accurate as the bureaucratic mandarins wish it were. As an example, the FDA speculates that false positive markers for breast cancer could lead women to “undergo prophylactic surgery, chemoprevention, intensive screening.”
This sounds pretty scary. Until one realizes that no doctor wanting to keep his or her license would ever perform any of these procedures without a battery of other tests and evaluations. Or that genetic sequences in apparently healthy adults are almost never—in themselves—the cause of disease but, rather, simply indicate risk of disease. Or, for that matter, that 23and-Me’s genetic testing, whatever its imperfections, provides vastly better medical advice than a huge number of self-help books and websites that the FDA (thankfully) has no ability to regulate.
In the end, 23andMe provides nothing more than information—useful, fascinating, potentially life-saving information. Banning the company’s products and services won’t save a single life, but it does reflect an overbearing, paternalistic mindset on the part of the FDA’s staff. There are certain things, even about individuals’ own genetic codes, that the FDA just doesn’t think Americans should have the opportunity to find out.
The irrational hostility to e-cigarettes.Aug 5, 2013, Vol. 18, No. 44 • By ETHAN EPSTEIN
Smokeless, odorless, and, indeed, tobacco-less, electronic cigarettes, or “e-cigarettes,” in common parlance, are projected to become a $1 billion industry this year. Yes, that’s “electronic” cigarettes: battery-powered gadgets that convert liquid nicotine into vapor, which the user inhales. The act is known—unfortunately, if accurately—as “vaping.” (It’s important to note that one doesn’t smoke an e-cigarette.) Some e-cigs are made to closely resemble actual cigarettes—they have the same shape and color and even an LED light at the end, designed to simulate a lit butt.
2:35 PM, Jun 20, 2013 • By JERYL BIER
The Food and Drug Administration's Office of Criminal Investigations is soliciting bids for "Data Mining and Targeting Software" to help in its efforts to combat illegal trafficking in cigarettes and other tobacco products.
9:56 AM, Apr 2, 2013 • By DANIEL HALPER
The federal government will now allow companies that sell "nicotine replacement therapy (NRT) products," such as Nicorette, not to put warning labels on their merchandise, the Food and Drug Administration announced. The change, the FDA now admits, is because the warnings, which were mandated for the last 30 years, were misguided from the very beginning.
12:55 PM, Dec 13, 2012 • By ALEXANDER KAZAM
The FDA is raising hackles over the equivalent of an espresso shot in a bottle: the popular 5-Hour Energy drink that has billions of dollars in sales over the past decade.
1:19 PM, Jul 3, 2012 • By DANIEL HALPER
"The U.S. Food and Drug Administration today approved the OraQuick In-Home HIV Test, the first over-the-counter, self-administered HIV test kit to detect the presence of antibodies to human immunodeficiency virus type 1 (HIV-1) and type 2 (HIV-2). HIV is the virus that causes acquired immune deficiency syndrome (AIDS)," a press release from the FDA states.
The Obama administration targets food marketed to children.Aug 8, 2011, Vol. 16, No. 44 • By KATE HAVARD
The Obama administration is after your Lucky Charms, or at least your children’s. The public comment period closed on July 14 for a set of “voluntary” guidelines for the marketing of food to children. If adopted, these rules will transform the advertising of breakfast cereals.
A recipe for indifference.12:50 PM, Apr 6, 2011 • By DAVID GRATZER
What if you passed a regulation, and nobody cared? Obesity is quickly emerging as a major policy issue, with related health costs consuming 10 cents on every health dollar – and rising. Policymakers, then, are eager for ideas. Top of the list: regulations to force chain restaurants to post calorie counts on their menus.
1:10 PM, Nov 29, 2010 • By JIM PREVOR
Today, the Senate is likely to vote on the Food Safety Modernization Act of 2010 (S510). But the bill is little more than an enormous grant of money and power to the Food and Drug Administration and a lot of reporting burdens imposed on the private sector. Those who favor a smaller, leaner government should oppose it.
4:00 PM, May 7, 2010 • By MARY KATHARINE HAM
Anthony Bourdain, celebrity chef and host of the Travel Channel's very popular "No Reservations" does not mince words about the possibility future overbearing salt regulation.
In this otherwise depressing Time piece that, among other creepy sentiments, asserts that "we can be trained" to get by with less sodium and calls salt a dietary "cocaine," Bourdain's delightfully politically incorrect sentiment is, well, the salt and the light.
Taking the decision with a grain of salt. 11:40 AM, Apr 23, 2010 • By STANLEY GOLDFARB
The FDA, acting on a recommendation to be made by a task force of the Institute of Medicine of the National Academy of Sciences, is about to take the unprecedented step of regulating the salt content of processed foods. There actually is a scientific rationale for this. Numerous studies have shown that high sodium chloride (salt) intake is associated with an increased likelihood of hypertension leading to strokes, heart attacks, and congestive heart failure. Of course tobacco isn’t good for you either, but the FDA, which now regulates cigarettes, isn’t talking about reducing the nicotine levels in every pack of cigarettes sold in the United States. The question is, why salt? How dangerous is it?
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