The House passed H.R. 1256, the Family Smoking Prevention and Tobacco Control Act
a few days ago
. The bill would put regulation of tobacco under the jurisdiction of the F.D.A.
of this bill, pointing out that Philip Morris is behind it. But the bill does contain many positive elements
. Manufacturers would be required to disclose product ingredients to the F.D.A. and marketing to children would be further restricted. [more inside]
The US Food and Drug Administration
started regulating the labeling of food, beverages, and medicines after the passage of the 1906 Pure Food and Drug Act
, and added food coloring and cosmetics with the 1938 Food, Drug, and Cosmetic Act
. They have just released a new website, the FDA Notices of Judgment Collection, 1906-1963
, containing data from thousands of cases of mislabeled or misadvertised products and drugs, available in multiple forms (text, PDF, metadata XML, .TIF image, etc.), with searchable archives. Poking around in the data will yield information on cases ranging from misbranding methamphetamine tablets
, to quack "Film-O-Sonic" devices
, to bacteria-laden unproven abortifacients sold over the counter
, to purported "4-way" cures for baldness
, to hunks of radium sold for putting in your drinking water
to "stimulate the sex organs" (judged against for stating an unproven use, not for actual danger of product). Organized by the FDA's history office
, the new database is a fascinating resource for historians, public safety advocates, researchers, and librarians.
FDA says your company's medical device isn't safe to market? No problem. Just hire a lobbyist
. Afraid of being sued? Don't worry. The Supreme Court says you are immune
Foodies, gourmands, and gluttons! Courtesy of those muckrakers at the New York Times, consider this recent op-ed piece
. For those still pissed about the Times cheerleading us into Iraq, skip it and just dig this handbook from your federal watchdogs
to determine just how much rat shit may have been in those beanie-weenies you enjoyed cold from the can last night at 1:34a.m. Handy alphabetization makes finding your favorite processed foods easy as pie.
Maybe outsourcing is
the answer. Canadian importers detected the salmonella tainted peanut products, and, prior to eight Americans dying from it, informed the US FDA.
"The FDA failing to follow up after this incident, does that mean that products that are not good enough for a foreign country are still good enough for the USA? That's a double standard that has deadly consequences for our citizens." [more inside]
Towards responsible use of cognitive-enhancing drugs by the healthy
- a commentary in Nature that says, "we call for a presumption that mentally competent adults should be able to engage in cognitive enhancement using drugs
". Farkesque debate here
. [more inside]
The single-shot Palm Pistol...
The U.S. Food and Drug Administration has accepted a conceptual, ergonomic 9mm handgun — designed for people crippled by arthritis, muscular dystrophy, or similar conditions that render them too weak to operate normal handguns — as a Class 1 Medical Device.... doctors could eventually write prescriptions for it and then be reimbursed by Medicare.
. Canada is banning it in baby bottles
, while the California State Senate recently passed a bill
to ban it in child care products. Even the US Senate
is getting in on the action. Bill Moyers thought it was interesting enough to run this Expose story
. In addition to the previously discussed cancer risk, it may also cause obesity
. Is this pointless overreaction
, or is it an example of government's failure to act
[PDF] in the face of industry pressure?
The FDA, was, after all, tasked with screening such endocrine disruptors over ten years ago
Previously on the blue
The blood substitute PolyHeme
has been previously discussed on MetaFilter
, but new evidence shows that PolyHeme actually raises the chances of death by nearly 30%
. PolyHeme was notable mostly for the reaction to its clinical trials
, which, controversially, did not require patient consent
Our Decrepit Food Factories.
Michael Pollan on what sustainability is really about. [Via Gristmill.]
A nation of outlaws.
A century and a half ago, another fast-growing nation had a reputation for sacrificing standards to its pursuit of profit, and it was the United States.
Dying for Lifesaving Drugs
: Will desperate patients destroy the pharmaceutical system that produces tomorrow's treatments?Reason Magazine
In January 2006, small amounts of genetically engineered rice turned up
in a shipment that was tested ... by a French customer of Riceland Foods, a big rice mill based in Stuttgart, Ark. Testing revealed that the genetically modified rice contained a strain of Liberty Link that had not been approved for human consumption. What's more, trace amounts of the Liberty Link had mysteriously made their way into the commercial rice supply in all five of the Southern states where long-grain rice is grown. Aventis Crop Science had contracted with a handful of farmers to grow the rice, which was known as Liberty Link because its genes had been altered to resist a weed killer called Liberty, also made by Aventis. Then, the French pharmaceutical giant that owned Aventis Crop Science decided to sell the U.S. biotech unit and abandon the very emotional business of reengineering the foods we eat. "We didn't want to take any chances," says a former Aventis executive. "We burned and buried enough rice to feed 20 million people." Last November, the USDA retroactively approved the Liberty Link rice for human consumption.
First hundreds of pets were killed by the poisonous food additive
, from China. Then it turns out that this poison got into the human food chain leading to humans
. Then there was the flap about cough syrup killing thousands
of people. Then, there was that warning
a couple days ago about imported monkfish actually being deadly puffer
fish. And now
the FDA has issued warnings
that toothpaste imported from China has ethylene glycol in it. Yes, the same ethylene glycol that keeps your engine running in the winter. China responds to the warnings by saying "Hey, we printed the ingredients on most
of the labels, it's not our fault
if antifreeze kills you."
Melamine found in almost half of all Chinese food imports now on the banned list.
The Food and Drug Administration is enforcing a new import alert that greatly expands its curtailment of some food ingredients imported from China, authorizing border inspectors to detain ingredients used in everything from noodles to breakfast bars. The FDA has also announced that melamine laced products
have found their way into the human consumption cycle via poultry
. Interesting to note that the budget for FDA inspections is at it's lowest level ever, and that only 1% of all imports actually get inspected
Europeans love to bash American chocolate - especially Hershey's - almost as much as the like to bash, erm, America in general (apparently, it tastes like doggie treats
). Recently, Big Chocolate
have asked the FDA if they can stop using real cocoa butter in the chocolate-making process, which can only make it taste even worse. I often wonder how many so-called chocoholics know that most of the chocolate they eat was probably picked by slave labour in West Africa. Child slaves, even.
Meh, they probably don't care: research indicates that chocolate is 'four times better than kissing'. Never trust a junkie.
TSA Alert: US Bans Vegemite.
Is it because this yeast extract tastes
bad? Do the Marmite^
people have some sinister influence? Has Australia offended
our government somehow? How is it that a product that has been around for 80 years
suddenly becomes forbidden? Who would ban a product that can help prevent neural tube defects
(e.g., spina bifida)? Blame
the FDA, whose has ruled that folate (folic acid
) "should be kept under 1 mg per day ... because higher intake may complicate the diagnosis of pernicious anemia
, one form of vitamin B12 deficiency, which especially affects older people." Of course pernicious anemia is rare (less than 10-20 cases/100,000 people per year in the US), as is the Vegemite market. But when has logic ever dictated policy. The international fallout has
"I am never going to America", vows Xochiquetal, while a commenter at Geelong blogger Bernie Slattery’s site foresees US regulators going even further down the road to absurdity, "Americans don’t know what they’re missing … they’ll be banning Tim Tams next."
If the government wanted to ban something Australian, the least they could have done is started here
Feeling sick and thinking of buying over-the-counter cold medicine like Sudafed or Claritin-D? Be prepared to wait in line at the pharmacy counter, show a photo ID, and sign a log book. The nationwide restriction
of medication containing pseudoephedrine or ephedrine begins this weekend. Why? Those 2 ingredients are used to make meth
.. (NPR audio piece
[NewsFilter] A partial victory for public health over politics.
Amazingly, the FDA has finally, after 3 years of wrangling, approved over-the-counter sale of Plan B, an emergency contraceptive pill. The victory is partial because you need to be 18 or older to purchase it without a doctor's note. If you're under 18, you need to still have documentation from your physician (or nurse practitioner). The politics behind the approval process were laid bare in this (sincerely) fascinating GAO report
[note: links to .pdf file]. I also hope that OTC approval will avoid this
Plan B previously discussed on MeFi here.
"In 2006, the Union of Concerned Scientists (UCS) and Public Employees for Environmental Responsibility (PEER) distributed
a 38-question survey to 5,918 FDA scientists to examine the state of science at the FDA. The results
paint a picture of a troubled agency: hundreds of scientists reported significant interference with the FDA’s scientific work, compromising the agency’s ability to fulfill its mission of protecting public health and safety."
FDA re-opens probe into benzene contamination of soft drinks US food safety authorities have re-opened an investigation closed 15 years ago into soft drinks contaminated with cancer-causing chemical benzene, following evidence the industry has failed to sort out the problem.
This is not good news.
U.S. health officials have issued a warning about possible birth defects in infants born to women who take the antidepressant Paxil during the first trimester of pregnancy.
Your mother was right.
You can go blind from doing that. Federal health officials are examining rare reports of blindness among some men using the impotence drugs Viagra
and Cialis. Since it doesn't actually do anything, Enzyte
should still be safe.
FDA to ban sperm donations from homosexuals.
Claims the rate of HIV among gay men is statistically high enough
to warrant the exclusion. Gay community suggests discrimination
. See also: Gay blood ban
(in effect since 1985).
Singaporean scientists genetically modify zebra fish to detect water pollutants by turning fluorescent
. An American company realizes there's a consumer market for novelty glow-in-the-dark fish, and starts selling the US's first genetically modified pet
. While the FDA, which oversees GM animals, 'finds no reason to regulate'
, California's Fish and Game Commission bans sales in the state over ethical concenrns
, and a coalition of watchdog groups files suit to support a national ban
A year later, GloFish are still on sale, and California's reconsidering its sales block
. With the first GM pet quietly swimming into homes, and others (like hypo-allergenic cats
) close behind, are we ready for a designer pet invasion?
Your hair is drab. Dull. Needs more volume. Needs less frizz. It needs something. Maybe it needs cetyl alcohol
. Mixed with a dash of propylene glycol
, and how about a little butane
, or acrylamide
Once upon a time, people lathered, rinsed, never repeated, and went on their merry bad-hair days. Then, science and chemistry specialized the way folks condition and shine.
Companies began creating new compounds so they could design products for specific hair types. Now, some consumer groups worry about the mix of chemicals
: they point to incomplete labeling and little government oversight of the cosmetics and hair industry, accusations the Food and Drug Administration
does not deny.
"The FDA needs to define what is safe to put in these products, and come up with standards," says Tim Kropp, a senior scientist with the Environmental Working Group
, a nonprofit consumer organization in Washington that helped produce a study on problem ingredients in everyday products. "There are no safety standards in place
." (to access main link, a little help from BugMeNot).
Doctors put spotlight on Plan B pill
The American Medical Association voiced its support for over-the-counter sales of morning-after birth control, saying the Food and Drug Administration was wrong to reject such sales and urging doctors to write advance prescriptions.
"A single test can now reveal the presence
of meat from any of 32 different species in food samples, enabling a wide range of important questions to be answered. These include whether chicken has been bulked up with beef or pork extracts; whether expensive albacore tuna is really cheap skipjack tuna; whether rats, mice or even bits of people fell into the mincer when your burger was being made..."
The FDA has put the brakes on clinical trials of a promising form of stem cell therapy
which uses the body's own stem cells to heal dammage. The procedure was used earlier this year to heal the heart of a teenager who was shot in the heart by a nail gun
. Other research is being done with the body's own stem cells on the heart
and the spinal cord
, and new ways to produce large numbers of adult stem cells have been discovered by MIT
and the British company TriStem
. With the controversy over embryonic stem cells
, I'm glad that adult stem cell therapy is showing promise. [Some links via FuturePundit
, who is rather annoyed
with the FDA.]
Perpetuating a common misconcetion about the "Morning After" pill and RU-486 Avrum Bluming, determined that my mom should try an experimental treatment, mifepristone, a synthetic antiprogestin better known as RU-486, the "morning after" contraception drug.
In a little throw-away line, Scientific American columnist Michael Shermer perpetuates the idea that RU-486
and the "Morning After" pill
are the same thing. They are entirely different
. In fact, mifepristone is not a contraceptive at all. Regardless of anyone's opinion about these two products, shouldn't Scientific American know better than to mistake the purpose of an FDA-aproved prescription drug?
How much trans fat is in that Devil Dog?
The FDA has announced that starting in 2006 food manufacturers must list the number of grams of trans fatty acid -- very bad fat -- on food packages. This is supposed to be a big deal, meant to save lives and billions of bucks. Not so fast. I say, it is a useless addition to the already confusing line-up of numbers on the nutrition panel. Besides, the presence of trans fats is already revealed in ingredients lists on food boxes and wrappers -- look for hydrogenated and partially hydrogenated oils. But the stuff flies off shelves anyway. I say, if the FDA really wants to tell people how bad these foods are, they should come right out with it. It's time for warning labels on junk food. THIS PRODUCT CAUSES OBESITY. THIS PRODUCT WILL CLOG YOUR ARTERIES. THIS PRODUCT MAY LEAD TO HEART DISEASE AND DEATH.
FDA now officially useless?
Well, it's looking that way.. They are now about to allow unverified
health claims on food labels. They say this is a good thing. I wonder... What function does the FDA have now if it's not to protect the consumer from wild and potentially false claims on their food products?
are described as being "a secret killer"
, and "about as bad as bad gets"
. The US FDA
does not currently require trans fats to be listed on product labels, but that may soon be changing
Smoke 'em if you can get 'em?
Philip Morris' decision to support FDA regulation of cigarettes has smoke coming from between my ears trying to figure it out. Good, bad, victims of the cigarette tax money-grab?
FDA stops nicotine lollipop, lip balm sales
As a follow up to This Thread
, kiss your pops good bye...
CNN Says The Food and Drug Administration warned three pharmacies Wednesday to stop selling nicotine lollipops and nicotine lip balm on the Internet, calling the products "illegal." They said said the lollipops and lip balm are "unapproved drugs" that need, but do not have, FDA approval. And the pops are "candy-like products present a risk of accidental use by children."
FDA has ruled that implantable microchips dont need to be regulated.
It looks like, the Jacobs
family can now have their VeriChips
. Does anyone else think that some kind of regulations of these devices is called needed? (via GMSV
Next up on the list of products to help you quit smoking but not the addiction. NicoStop, NicoPop and Likatine are some of the brand names these laced suckers carry, but the interesting thing here is that it's not a giant pharmaceutical company making them -- it's your neighborhood pharmacy
, and they're doing it below the radar of the FDA. (more inside.)
Ecstasy approved by the FDA
Well not exactly but I thought it would grab people's attention a lot better than the original title of the article.
My only question is: Does seeing my fat, hairy, aunt naked qualify me as suffering from post-traumatic shock syndrome?
A few years back I remember seeing a news report asking whether adverse reactions to Anthrax vaccination during the Gulf War was responsible for Persian Gulf War Syndrome. How come no one is talking about this now?
If congress or the media start clambering for Anthrax Vaccinations, will anyone remember the adverse side effects suspected by many soldiers and scientists? Yes the FDA approved the Anthrax Vaccine, but there are still many questions about it's safety. The military is not unaware of the ongoing debate, but The FDA does not have an unblemished record.
This is all getting very X-Files... (scroll down to 1991)
The FDA burns books on herbal sweetner.
Starting with the 19th century's Comstock Act
the US has had the power to confiscate and destroy "obscene" materials. The FDA used this power to destroy the works of Wilhelm Reich
and now the herbal sweetner Stevia.
Why is everybody so happy?
This Thursday, U.S. regulators approved numerous copycat versions of Prozac. I wonder how long it will be until Bayer makes Flinstones Chewable Prozac for teens.
FDA approves camera pill
that takes pictures of your gastrointestinal system as it "glides through the small intestine." For anyone who has ever endured an endoscopy.
FDA sez "Frankenfoods don't need labeling".
Even though 86% of Americans want mandatory labels.
Warner-Lambert Withdraws Diabetes Pill Rezulin
Imagine how it feels hearing this news about six hours after my doctor told me "After looking at your latest liver test, you'd better stop taking the Rezulin, and come in for more tests." For the record, I was aware of the potential risks before I & my doc started it, and have been doing regular liver tests all along; before my last test, I had noted to doc that I was getting more symptoms of out-of-control diabetes, even though frequent monitoring showed the blood sugar numbers were always IN control, and I was ready to ask for a change to one of the newer drugs... when my latest refill runs out. I'd always assumed that by the time the FDA acts on it it'll be too late, and I am very interested in the official FDA non-position on the safety of the newer drugs...