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When were cigarettes approved by the FDA?

2009.

I'm surprised they didn't regulate them sooner than that. I thought nicotine was a drug.

FDA smoke screen on e-cigarettes
by Dr. Elizabeth Whelan

Dr. Elizabeth Whelan is president of the American Council on Science and Health.

http://www.washingtontimes.com/news/2009/aug/06/fda-smoke-screen-on-e-cigarettes/

"The Food and Drug Administration (FDA) held a press conference late last month to scare Americans about the so-called "e-cigarette" -- claiming it was loaded with harmful "toxins" and "carcinogens." The agency was implicitly saying: Stay away from these newfangled, untested cigarette substitutes -- better to stick with the real ones, the ones that we are more familiar with, the ones that cause over 450,000 deaths annually in the U.S.

In making its distorted, incomplete and misleading statement, FDA was violating its long-cherished tradition of sticking to sound science as the basis for its policies. And in doing so, it is putting the lives and health of millions of Americans at risk."

The FDA has shown E-Cigarettes to be less likely to cause cancer than even nicotine gum based on nitrosamine content.

FDA report on nitrosamine content of cigarettes, Nicotine replacements and E-Cigs
http://www.fda.gov/downloads/Drugs/ScienceResearch/UCM173250.pdf

Canadian report on nitrosamine levels in commercial cigarettes
http://smoke-vs-vapor.webs.com/Canadian%20Cigarette%20Data%202004.ods

Website that has compiled data and presented a table of the data for quick viewing
http://smoke-vs-vapor.webs.com/nitrosaminelevels.htm

Could you please elaborate when where and how was thimerosal removed? Why is it illogical to think that after so many years (at least a few decades? idk) of using this preservative, the vaccine makers wouldn't continue using it anyway? Has there been a government mandate, with tough enforcement preventing them from doing so? Were people able to sue them if they found it in the vaccines?

I'm not the person that you're replying to, but just thought I'd share this link:

Thimerosal in Vaccines. If you look at the table of contents, there is a table there that shows a list of vaccines and the amounts of Thimerosal in them. The majority of them are free of it. It also shows the date as to when the non-Thimerosal version was approved by the FDA.

The section "Recent and Future FDA Action" also discusses what the FDA has done to remove or limit the amounts of Thimerosal in vaccines.

I'm not going to copy and paste from the article, because I think the article should be read in its entirety. My take on it is that the FDA has not found any strong links between Thimerosal and neurological disorders, but there still needs to be research done into it, so they erred on the side of caution and asked manufacturers to remove it completely, or limit it to trace amounts.

That seems to apply to just "single serving" portions, hardly applicable to the tub of crisco I just bought:
http://www.fda.gov/Food/LabelingNutrition/FoodLabelingGuidanceRegulatoryInformation/InspectionCompliance/WarningOtherLetters/ucm110234.htm

There is even an article just last month admitting that they [FDA] are still evaluating the "serving size" issue:
http://www.nytimes.com/2010/02/06/business/06portion.html

The FDA has known about this for quite a while... http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ComplianceActivities/Enforcement/UntitledLetters/ucm091991.htm And yes, there is a Mr. FDA Man. The Office of Criminal Investigations. http://www.fda.gov/ICECI/CriminalInvestigations/default.htm They tend to prioritize based on danger to the public, so at least they have not lumped him in with the adulterated-drug people. Yet.

The FDA has known about this for quite a while... http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ComplianceActivities/Enforcement/UntitledLetters/ucm091991.htm And yes, there is a Mr. FDA Man. The Office of Criminal Investigations. http://www.fda.gov/ICECI/CriminalInvestigations/default.htm They tend to prioritize based on danger to the public, so at least they have not lumped him in with the adulterated-drug people. Yet.

Or maybe someday Canada? :-)
http://www.biophagepharma.net/

But thanks for the insight on the regulatory aspect. I had not known that.

Related:
"Choosing to let patients with superbug infections die rather than phage them?"
http://www.democraticunderground.com/discuss/duboard.php?az=view_all&address=103x338050
http://www.opednews.com/articles/life_a_pkdkso_080212_choosing_to_let_pati.htm
"""
In Canada the official body counters tell us that "an estimated 220,000 patients who walk through the doors of hospitals each year suffer the unintended and often devastating consequences of an infection" and they also estimate that 8,000 to 12,000 Canadian patients die annually from such infections and I have read claims that a similar number of limb amputations are done to cure such infections. That means as many as 30 Canadians become victims of superbug infections each day.
In the USA the Centers for Disease Control and Prevention reports that methicillin-resistant Staphylococcus aureus seriously sickened more than 94,000 Americans in 2005 and almost 19,000 died, more than the 17,000 Americans who died of AIDS-related causes.
Yet the French-Canadian microbiologist, Felix d'Herelle, while working at the Institute Pasteur in Paris in 1917 discovered phage therapy which uses highly specific viruses, bacteriophages, which have been observed to be harmless for humans, to treat bacterial infections, including infections caused by superbugs. While there is considerable expertise on phage therapy in Canada and the USA at the research level medical phage therapy is not currently approved or practised in Canada; however, according to a letter signed by the former federal health minister phage therapy can be made available legally to Canadian patients under the Special Access Program of our Food & Drugs Act! Additionally, there are moral and ethical reasons for making phage therapy available in countries that are members of The World Medical Association which states: "In the treatment of a patient, where proven prophylactic, diagnostic and therapeutic methods do not exist or have been ineffective, the physician, with informed consent from the patient, must be free to use unproven or new prophylactic, diagnostic and therapeutic measures, if in the physician's judgement it offers hope of saving life." ...
Further, the phage therapy file has dramatically changed because the US Food and Drug Administration (FDA) has amended the US food additive regulations to provide for the safe use of a bacteriophage preparation on ready-to-eat meat and poultry products as an antimicrobial agent against Listeria monocytogenes (see http://www.fda.gov/OHRMS/DOCKETS/98fr/02f-0316-nfr0001.pdf ). An enlightening FDA questions-and-answers document can be found at http://www.cfsan.fda.gov/~dms/opabacqa.html . Listeria causes an estimated 2,500 cases of mainly food borne infections in the USA annually and as many as 500 deaths; however, they ideas that ready-to-eat meat can be treated if contaminated with Listeria bacteria while a doctor could not get a pharmaceutical grade phage therapy product when faced with a patient suffering listeriosis strikes this author as absurd. Superbugs are everybody's business because sooner or later everybody will be faced with an infection or know a relative or friend who will be suffering or dying with one. Withholding such treatment from patients when antibiotics are failing ought to be a crime; however, those who have the money, knowledge and time to travel when faced with an infection where antibiotics are failing may b

Or maybe someday Canada? :-)
http://www.biophagepharma.net/

But thanks for the insight on the regulatory aspect. I had not known that.

Related:
"Choosing to let patients with superbug infections die rather than phage them?"
http://www.democraticunderground.com/discuss/duboard.php?az=view_all&address=103x338050
http://www.opednews.com/articles/life_a_pkdkso_080212_choosing_to_let_pati.htm
"""
In Canada the official body counters tell us that "an estimated 220,000 patients who walk through the doors of hospitals each year suffer the unintended and often devastating consequences of an infection" and they also estimate that 8,000 to 12,000 Canadian patients die annually from such infections and I have read claims that a similar number of limb amputations are done to cure such infections. That means as many as 30 Canadians become victims of superbug infections each day.
In the USA the Centers for Disease Control and Prevention reports that methicillin-resistant Staphylococcus aureus seriously sickened more than 94,000 Americans in 2005 and almost 19,000 died, more than the 17,000 Americans who died of AIDS-related causes.
Yet the French-Canadian microbiologist, Felix d'Herelle, while working at the Institute Pasteur in Paris in 1917 discovered phage therapy which uses highly specific viruses, bacteriophages, which have been observed to be harmless for humans, to treat bacterial infections, including infections caused by superbugs. While there is considerable expertise on phage therapy in Canada and the USA at the research level medical phage therapy is not currently approved or practised in Canada; however, according to a letter signed by the former federal health minister phage therapy can be made available legally to Canadian patients under the Special Access Program of our Food & Drugs Act! Additionally, there are moral and ethical reasons for making phage therapy available in countries that are members of The World Medical Association which states: "In the treatment of a patient, where proven prophylactic, diagnostic and therapeutic methods do not exist or have been ineffective, the physician, with informed consent from the patient, must be free to use unproven or new prophylactic, diagnostic and therapeutic measures, if in the physician's judgement it offers hope of saving life." ...
Further, the phage therapy file has dramatically changed because the US Food and Drug Administration (FDA) has amended the US food additive regulations to provide for the safe use of a bacteriophage preparation on ready-to-eat meat and poultry products as an antimicrobial agent against Listeria monocytogenes (see http://www.fda.gov/OHRMS/DOCKETS/98fr/02f-0316-nfr0001.pdf ). An enlightening FDA questions-and-answers document can be found at http://www.cfsan.fda.gov/~dms/opabacqa.html . Listeria causes an estimated 2,500 cases of mainly food borne infections in the USA annually and as many as 500 deaths; however, they ideas that ready-to-eat meat can be treated if contaminated with Listeria bacteria while a doctor could not get a pharmaceutical grade phage therapy product when faced with a patient suffering listeriosis strikes this author as absurd. Superbugs are everybody's business because sooner or later everybody will be faced with an infection or know a relative or friend who will be suffering or dying with one. Withholding such treatment from patients when antibiotics are failing ought to be a crime; however, those who have the money, knowledge and time to travel when faced with an infection where antibiotics are failing may b

It certainly raises a red flag for me when you consider that a single vaccine can give a child an exposure 5-10x the OSHA limit for mercury poisoning.

Really? From childhood.com: "An infant who is exclusively breast-fed will ingest more than twice the quantity of mercury that was ever contained in vaccines and fifteen times the quantity of mercury contained in the influenza vaccine."

And: "Thimerosal — a preservative still used in the influenza vaccine — contains a different form of mercury called ethylmercury. Studies comparing ethylmercury and methylmercury suggest that they are processed differently in the human body. Ethylmercury is broken down and excreted much more rapidly than methylmercury. Therefore, ethylmercury (the type of mercury in the influenza vaccine) is much less likely than methylmercury (the type of mercury in the environment) to accumulate in the body and cause harm."

Are you going to argue that we should stop breastfeeding our children, since through breastfeeding children ingest a larger quantity of a more harmful form of mercury than was ever contained in vaccines?

And where are you getting the OSHA limit from? All I can find on their website is a limit on the air concentration of mercury, which is an entirely different issue.

All true, although the comparison of a single exposure to a lifelong exposure is a bit of a stretch. Particularly, since as you pointed out, since ethyl mercury is expelled from the body pretty quickly compared to methyl mercury which tends to accumulate.

What do you mean by "large"? According to this chart, the vaccine with the most mercury (Influenza-A) contains only .025mg of mercury, and is a one-time dose; this is much lower than OSHA's air-exposure limit of 0.1mg/m^3 per work week, if you somehow managed to ingest all of that mercury vapor.

And, as noted, most vaccines now contain zero mercury.

So much for your point ;)

The OHSA limit is 0.01mg/m^3 for long term occupational air exposure. The EPA daily intake limit is 0.1 micrograms/kg/day. Prior to 2000, the average round of vaccines for a 6-month infant contained 187.5 micrograms of thimerasol, almost three times the calculated exposure limit of 65 micrograms, based on this EPA guideline. (ref AAP, 1999, interim report; United States schedule, Tables 1 and 2). It's even worse for a small, underweight child.

Even the FDA cites isolated cases where far lower exposure has caused neurological problems http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/ucm096228.htm#guid.

As you pointed out, the FDA placed restrictions on the use of thimerasol in child vaccines. A large portion of vaccines like the flu shot still do. It's not uncommon to see pneumonia and flu vaccinnes administered to kids outside of the official guidelines from the drug maker. In some cases, thimerasol-free child versions of some vaccines simply are not available.

I'm not saying I agree that thimerasol is causing autism. In fact, I'm a bit skeptical. I'm saying that there is no concrete data proving it's absolutely safe for 100% of the population. Given the doubts and some conflicting data, it's safer to be conservative.

As another interesting point of data. I recall reading that 5% of contact lens wearers are sensitive to thimerasol containing saline solutions. I'm not how this compares to internal injection though.

Another huge cost is Good manufacturing practice, I looked into making medical devices in my dental lab and the effort involved in just the paperwork was 3 times the effort to actually make the device. Everything has to be documented, every lot number, every expiration date for the materials used and which went into which device, who did what and how, what their training was and the documentation had to be maintained for 2 years or the expected life of the device. This is a killer for small facilities.

Since when did taking what someone said on the internet, especially a vague broad sweeping statement (eg what you said) and asking for a reference to back it up become ignorance?

Wait, I'm confused. Someone else dressed me down for taking "citation needed" as an attack. But you are saying that demanding a reference as a response to a sweeping statement one doesn't believe is a rhetorical ploy.

I feel so vindicated by my post. Even those responding to me agree with my feelings on this:

"Citation needed" is an ambiguous rhetorical ploy that is at best, a rude request for more information, and at worst a feigned ignorance in order to start an attack that requires the person being attacked do more research and waste time before the true intentions of the attacker are known.

Either way, I'm safe in assuming that anyone using "citation needed" is ignorant, lazy, mean, and not worth a serious reply.

snopes.com has a bunch of articles on the 'bits of people in food' subject... but they don't exactly back up your opinions. On the face of it, I think you've been listening to one too many urban legends.

And, like the "citation needed" reply, you don't include your own statements, you don't define what you are replying to, and I'm left to do your work for you and guess. I took a look at http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Sanitation/ucm056174.htm and found that the FDA determines allowed rat feces and such is allowed in certain foods. That greatly substantiates the point so far. Was there something else specific you are objecting to? You didn't say. You just said that I needed a citation, and I provided one. Thus, I've fulfilled the request 100%. That it didn't answer all the questions you have is *your* fault, because "citation needed" didn't specify what part, if any, the poster was wanting more info on, and you didn't say either, only that you think it fake.

Does that make it a little more clear why "citation needed" is counter productive? I've been asked once for a citation, and provided it. It is to the official government site, and answers the majority of the original topic. If that's not the answer you are looking for, then you obviously asked the wrong way, because you (and no one else responding to me or the GP who was the one that had someone respond "citation needed") never asked for anything specific.

"Citation needed" is the cool Internet way of saying "bullshit" and when someone treats it like they said "bullshit" then they get all offended and claim they were nicely asking for references. That, my friend, *is* bullshit.

The "These claims have not been evaluated by the FDA" and its close friend "This product is not intended to diagnose, treat, cure, or prevent any disease." are generally a signal that the product is sold as a "dietary supplement" or "nutritional supplement".

Thanks to DSHEA, the FDA legally can't do jack about it unless they have direct evidence of a given product causing serious harm(and their budget for going on epidemiological expeditions for that sort of thing isn't much to write home about).

Whether you consider this a shining beacon of freedom, or an ignoble nest of quacks, it seems likely to remain so for the foreseeable future.

Not according to the FDA or the ACSH or MIT, among others. On the other hand, überquack Mercola and the holistic nutters agree. Basically, the aspartame thing is just like the vaccine thing: scientists with evidence versus quacks who try to dress their bias up as information. Sure, aspartame tastes like dog shit, but (unless you have a certain rare genetic disorder), it isn't dangerous.

Funny how every one of those things you listed with the exception of the military can be done cheaper and more effectively by the private sector.

DOT = employees getting paid above market wages to hold up "stop/slow" signs.

City water utility = Meter readers getting paid above market wages to drive a car and punch numbers into a PDA

FDA = Yeah, that's worked out real well. I trust the UL much more than I trust the FDA. I've yet to have a UL approved appliance burn my house down. I have had FDA approved food put me in the hospital.

The internet, yeah it was partially developed by DOD and then properly turned over to the private sector when the commercial uses become apparent. You think we would have seen the rush of online innovation if the government was still in charge?

Yes, because history has taught us time and again that when left to their own accords, the private industry can police itself.

Funny how every one of those things you listed with the exception of the military can be done cheaper and more effectively by the private sector.

DOT = employees getting paid above market wages to hold up "stop/slow" signs.

City water utility = Meter readers getting paid above market wages to drive a car and punch numbers into a PDA

FDA = Yeah, that's worked out real well. I trust the UL much more than I trust the FDA. I've yet to have a UL approved appliance burn my house down. I have had FDA approved food put me in the hospital.

The internet, yeah it was partially developed by DOD and then properly turned over to the private sector when the commercial uses become apparent. You think we would have seen the rush of online innovation if the government was still in charge?

http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/SpeedingAccesstoImportantNewTherapies/ucm128291.htm

FDA's explanation of Accelerated Approval, Priority Review and Fast Track for getting drugs to the market faster. It's a little sad that (in the FDA's own words) "drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists" are still talking an average of 50% as much time to get FDA approval as "a drug that offers at most, only minor improvement over existing marketed therapies". You can thank the drug company lobbying that pushed the FDA (via 2002's amendments to PDUFA) to focus more of their resources on those minor-improvement drugs so that PHRMA can keep extending the patents on their money makers.

The reason for this situation is that science funding by the federal government has been more or less flat for about a decade

I was going to give a 'you are full of it' reply, but realized you might actually believe this.
So here is some info on the Federal science funding:
NSF funding history
NIH funding trends
Defence funding (PDF file)

I know it's tough, but we must have competition! Unfortunately, that also means that many (most?) people will have to re-tool... Best of luck with your career though.

The FDA has had a table of valid genetic biomarkers for medications for several years now. While many of these are cancer drugs looking at specific metatabolic or receptor issues, our old friend warfarin (a "blood thinner" with a narrow therapeutic index, a reputation for causing a lot of trouble and a genomic profile that accounts for about half of the known variation in the drug) and the pain drug codeine are on that list as well. There's even a research website devoted to genetic calculation of warfarin dosing.

Carbamazepine (Tegretol) can cause a rare life-threatening reaction called Stevens-Johnson Syndrome (Toxic Epidermal Necrolysis), but it's mostly limited to individuals with a specific Human Leukocyte Antigen (HLA-B*1502). Again, known for quite a while and a part of the basic biology of the drug.

It's a fairly well-written article, but it's kind of breathless about stuff that I was really excited about back in the '90's when my medical school teachers were really excited about it too. The best news is that the FDA has really stepped up in the past few years to make this actionable data that a practicing clinician can use.

Even a cursory reading of the linked articles would show that this has almost nothing to do with patent protection, which lasts for 20 years from the date of filing regardless of the subject matter. This is all about regulatory exclusivity from the FDA. An example of regulatory exclusivity is new drug product exclusivity, which generally lasts for 5 years for completely new drugs and 3 years for new formulations of existing drugs. Another kind is the 180 day generic exclusivity for the first generic to market, which encourages generics to be made by giving them a small window of high profitability.

The issue here is whether biologic drugs should be given a longer than usual regulatory exclusivity period given that (so the argument goes) they are a new, experimental technology that is harder to develop than traditional small molecule drugs.

You might ask "if a drug is patented, then why is a (shorter) period of exclusivity even necessary?" Here's an example: inventor discovers a new compound that might be a useful drug. A patent is filed in 2000. Then 10 years go by while the inventor struggles to find the optimal dose and delivery mechanism. Now in 2010 the inventor's startup starts looking for a partner to bring it through trials and into production. 5 years later, human trials start. 3 years later the drug is approved by the FDA for sale. Now it's 2018 and the patent only has two years left. If the manufacturer has to recoup all of its costs in just 2 years, the price will have to be extremely high, which will limit the drug's availability. So the regulatory exclusivity period gives drug makers a guaranteed 5 years in which to recoup their costs.

So that's the argument for having an exclusivity period. There are also arguments against it, of course, but the main point is that all of this is only tangentially related to patent protection and has nothing whatever to do with a special patent rule for biologics.

Even a cursory reading of the linked articles would show that this has almost nothing to do with patent protection, which lasts for 20 years from the date of filing regardless of the subject matter. This is all about regulatory exclusivity from the FDA. An example of regulatory exclusivity is new drug product exclusivity, which generally lasts for 5 years for completely new drugs and 3 years for new formulations of existing drugs. Another kind is the 180 day generic exclusivity for the first generic to market, which encourages generics to be made by giving them a small window of high profitability.

The issue here is whether biologic drugs should be given a longer than usual regulatory exclusivity period given that (so the argument goes) they are a new, experimental technology that is harder to develop than traditional small molecule drugs.

You might ask "if a drug is patented, then why is a (shorter) period of exclusivity even necessary?" Here's an example: inventor discovers a new compound that might be a useful drug. A patent is filed in 2000. Then 10 years go by while the inventor struggles to find the optimal dose and delivery mechanism. Now in 2010 the inventor's startup starts looking for a partner to bring it through trials and into production. 5 years later, human trials start. 3 years later the drug is approved by the FDA for sale. Now it's 2018 and the patent only has two years left. If the manufacturer has to recoup all of its costs in just 2 years, the price will have to be extremely high, which will limit the drug's availability. So the regulatory exclusivity period gives drug makers a guaranteed 5 years in which to recoup their costs.

So that's the argument for having an exclusivity period. There are also arguments against it, of course, but the main point is that all of this is only tangentially related to patent protection and has nothing whatever to do with a special patent rule for biologics.

Brand-name drugs are generally given patent protection for 20 years from the date of submission of the patent. This provides protection for the innovator who laid out the initial costs (including research, development, and marketing expenses) to develop the new drug. However, when the patent expires, other drug companies can introduce competitive generic versions, but only after they have been thoroughly tested by the manufacturer and approved by the FDA.

Traditional pharmaceutical patents last for 20 years.

For the regular FluMist:
http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm123743.pdf
"FluMist® recipients should avoid close contact with immunocompromised individuals for at least 21 days."

For the new H1N1 mist, here is the insert:
http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM182406.pdf

The odds of transmitting the virus after receiving the nasal spray are about 2.5 percent.

I totally agree that if you're planning to get vaccinated that waiting a week or two for the shot is a better option. From what I've read most hospitals are having their staff vaccinated against the seasonal flu now, and they have a few more weeks to get the H1N1 vax, so most if not all should be able to wait and avoid the mist.

For the regular FluMist:
http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm123743.pdf
"FluMist® recipients should avoid close contact with immunocompromised individuals for at least 21 days."

For the new H1N1 mist, here is the insert:
http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM182406.pdf

The odds of transmitting the virus after receiving the nasal spray are about 2.5 percent.

I totally agree that if you're planning to get vaccinated that waiting a week or two for the shot is a better option. From what I've read most hospitals are having their staff vaccinated against the seasonal flu now, and they have a few more weeks to get the H1N1 vax, so most if not all should be able to wait and avoid the mist.

The expected dose for their treatment was 50 rads, and they received 300-400. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm185898.htm. Trying to downplay their dose by comparing it to the therac-25 is a little bit like comparing virtue among whores. They were burned by their dose.

Maybe have a look at this: FDA Food Defect Levels Handbook. For instance, strawberries are allowed to be up to 45% moldy. Wheat flour is A-OK as long as it averages less than 75 insect fragments per 50 grams. Cocoa beans can contain 10mg of mammal feces per pound. The point is, perfection is not possible. The existence of some sexist comments among billions of internet postings doesn't justify condemning the entire community. I'll fully support you in condemning individuals for their own behaviors. However, I think most of us have realized that arguing with internet trolls is futile. So if some jackass statement in a forum isn't followed up with righteous indignation, don't assume everyone else agrees with them.

Like the idiotic dog crap brownies story, you're making an irrational, emotional argument. Your only cleverness is being emotionally manipulative to try and convince people to stop rationally thinking and agree with you blindly.

There are human beings who suck. They're racist, sexist, classist, ablist, and a host of other ists. We can work over generations to change people's minds so that people appreciate that sexism is wrong on a gut level. But we're not going to entirely wipe it out in our lifetimes. There is going to be background sexism. The goal is to get that background level low enough that we can, by and large, cope and move on. Perhaps 0.1% isn't low enough, but the point is reasonable: there is an acceptable level. There has to be, because the other option is to spend all of our resources uselessly pursuing the impossible.

Me, I'm open to about 0.0002% of my cake being feces. It's a common FDA standard for "excreta" in a variety of foodstuffs.

I am curious about the equivalence of women developers and strawberries. I certainly wouldn't want a cake that was 50% strawberries as at some point it stops being cake. Should I infer that we want to keep women to maybe 5-10% of the development community?

Nice try, but squalene and other adjuvants are forbidden in U.S. vaccines by the FDA.

Yes, but they are not in Europe. It is still a concern.

Given that the article was about a U.S. hospital, and the bulk of the concerns in the comments were about U.S. vaccination policy, the fact that adjuvants are allowed in Europe really didn't warrant comment. Those vaccines aren't coming here unless the pandemic worsens significantly and there is no way to manufacture additional adjuvant-free vaccine.

With regards to the mercury, if it's that big of a concern to you, I hope you are on a tuna-free diet because there is more mercury in a tuna sandwich than in the thiomersal of any vaccine available in the U.S..

Sure about that? First of it's a ridiculous argument, indeed the level of mercury in tuna are alarmingly high, it doesn't make it right. And regardless, you would have to eat a heck of a lot of tuna to equal even one flu shot.

The FDA lists the mean methylmercury content of canned albacore tuna to be .353ppm. That means 6 ounces (170g) of tuna contains approximately 59.5mcg of methylmercury, or slightly more than a 1mg dose of flu vaccine.

The point IS salient becuase despite that level, the FDA has indicated that tuna is safe for children to eat up to 6 ounces per week.

Let me demonstrate and I will give references. The Flu vaccine contains 25mcg of mercury (http://www.cdc.gov/flu/professionals/acip/dosage.htm) this is the seasonal flu link, the h1n1 contains the same amount. Oh sure , you can request the single dose without the mercury, but unless you do, your probably getting the multi-dose. The safe level of mercury is 0.1 mcg per kg body weight, (http://www.gotmercury.org/article.php?id=1169) So a 68kg (~150lb) person safe limit is 6.8mcg per day.

Kind of. What you're quoting is a reference dose, and it's a rate with a time component, not just a simple level. The RfD that you're quoting is the EPA's reference dose, and yes, it's .01mcg/kg body weight per day. So on one day, your 68kg person would ingest a higher than recommended amount, but if the person avoid tuna melts for the next week, his reference dose is back within the EPA's recommendation.

It's also worth noting that there are several reference doses issued by different agencies; the EPA's is the most conservative. The World Health Organization has the highest reference dose of 1.6mcg/kg/week of body weight.

So you just shot almost 4 times the safe limit for an average adult directly into your blood stream.

As a point of clarification, vaccines are injected into the muscle, not directly into the blood stream.

Worse the age group for fluzone is 6months or older... a large 6-7m infant might be 10kg as a high avg, that 1mcg safe limit... great you just shot up your infant with 25 times the safe levels.

Of course, that concern is why they also make the vaccine available in preservative-free doses. It's also why pediatricians will discuss the risks and benefits with parents.

This is on top most people already being near or above the safe daily limits taken in from water and foods. Looking at (http://www.csgnetwork.com/hgqtycalc.html) , eating a can of tuna for the same 150lb person a week is just slightly higher than what is considered safe levels. Don't forget children are to get 3 shots, 1 seasonal and 2 h1n1...

With the exception of broken lightbulbs, thermometers, and dental fillings, you've just outlined the major vectors f

The mechanisms for most CAM modalities (such as say, homeopathy) are usually highly implausible and often would require a complete reworking of the Standard Model.

Homeopathy would require something weird, but one can construct plausible theories about some effects of herbs, acupuncture and acupressure, chiropractic, massage, and osteopathy, as well as health cultivation practices such as yoga and qi gong, without stepping outside (or with only minor tweaks to) the "Standard Model". Even various "energy healing" modalities can be understood psychosomaticly. (And I guess homeopathy could be too, at that.)

Then throw in the fact that rarely is there even good scientific evidence that shows CAM modalities do anything at all and where are you left?

Rarely is there good scientific evidence that shows conventional modalities do anything. Very little medicine is evidence-based.

Moreover, there is a perfectly good reason why there is not nor will there be double-blind placebo controlled trials for vaccines.

Bullshit, as demonstrated by this controlled study of an HIV vaccine candidate: "The study had two (blinded) groups, one control group (receiving placebo injections) and one experimental group (receiving four 'prime' doses of ALVAC HIV and two boost doses of AIDSVAX gp120 B/E), with over 8,000 volunteers in each group, lasting from 2003 until now."

You are basically accusing most physicians of being corporate shills.

Have you been in a fscking doctor's office lately? Notice all the freebies with the names of drugs on them that pharmaceutical sales reps give out to doctors? Are you aware of the way that big pharma spends over $20 billion a year to essentially bribe doctors to use their products? Did you not hear about that recent fraud case against Pfizer?

Many doctors are corporate shills, yes. Many others have simply declined to engage their critical thinking skills, and believed whatever bullshit Big Pharma spoon-fed them as they were plied with gifts. (I dread the day my physician -- honest, hardworking, intelligent, compentent, and kind -- retires,

The fact that things like herbal supplements are more or less highly unregulated.

In point of fact, the FDA has basically the same regulatory power over supplements it has over food. It has the power to make supplement manufactures provide a complete list of ingredients, and to remove supplements from the marketplace if a danger is found. This is certainly a preferable state of affairs to the days of federal paramilitary law enforcement raids on people selling herbs and vitamins, don't you think?

Over the decades, yes, it has been taking longer to go from discovery to clinical implementation. Back before 1906, there were no regulations on the sale of drugs from a safety standpoint. A number of medication safety events led to the complex framework fo regulations currently in place. Concern about shady salesmen selling snake oil without safety or effectiveness, the thalidomide tragedy, the Vioxx debacle, and other events formed the public support for regulating drugs and biologicals. Right now there are 4 phases of human trials that drugs have to go through for approval (in the USA, anyway) -- on healthy volunteers, on a small sample of "sick" people, on a large sample of "sick" people, then follow-up from post-clinical studies. And that has to be preceded by specific animal studies with approval of an IND. There are a number of work-arounds for expediating cancer drugs, and the FDA is always finding ways to streamline and expediate the approval process without hindering the safety evaluation they are charged with. For further info:
On clinical trials
History of FDA oversight
On the Current act
Again, I apologize for the US-centric linkage. Also, I do not work for the FDA :)

And if you look at the labels on most American goods, you'll find that they include the metric size (weight, volume) of the contents, along with the Imperial size.

On foods and medicines, yes. That's dictated by the Metric Conversion Act of 1975, with the intent that we would eventually phase out the imperial units.

Take a look around and tell me what besides food are marked with both.

Around here, speed limits are posted in miles per hour. Cars themselves have speedometers in miles per hour, with tiny little numbers for kmph. Gasoline is measured in Gallons. Scales at the deli, despite being food, show the weight of something in decimal pounds (rather than pounds and ounces, since those aren't base 10).

Now, a few industries settled on metric units so that they could sell things internationally, but besides those are food/drugs, everything else here is in imperial.

Further, I'd wager the real reason stuff in the US has both metric and imperial units is so companies can use the same packaging in multiple countries, ie Canada, Mexico, Britain. They already have spanish on most of them, and french is starting to become more and more common >: In fact, they often list two phone numbers for customer relations. Canadian and American.

Actually, for food items, they're required by law to have the metric units on there.

Then there's the flip side of that coin. I'm sure someone will remember the movie but the point stands as a reasonable example.

The trials have to have a baseline or control group usually and that means a placebo or no treatement for those unlucky ones in the trial.

So you have a group that is suffering from an ailment and they get into a trial and then don't get treated anyway. So while the drug was being delevoped and during the testing and all the way up until it is released to market, the person doesn't get treatment. This can take decades for some companies although 12 years is common. During that time people will have died. If the drug is worth anything and would have saved lives, a percentage of that number are those that drug testing didn't save during the trials.

I'm not saying that the trials are completely heartless or wrong, but that there are multiple sides and perspectives that have to be addressed in this issue.

Read up on it:
http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm143534.htm

No its not a myth. Citing a small sample test performed by Food Detective who is hardly an authoritative or unbiased source, is quite laughable. I doubt you even realized that study was funded by an MSG trade association. I'll bet you watch Fox news or CNN and believe all their crap too, eh?

The studies sponsored by the FDA show that MSG is generally regarded as safe, but they do cite that many people have sensitivity to high portions of MSG. For the summary of FDA recommendation as put out in 1995, please see http://vm.cfsan.fda.gov/~lrd/msg.html. For the lazy people, here is a key passage - "Among the report's key findings: An unknown percentage of the population may react to MSG and develop MSG symptom complex, a condition characterized by one or more of the following symptoms:"

If you're not too lazy, this Mayo clinic article sums it pretty well.
http://www.mayoclinic.com/health/monosodium-glutamate/AN01251

McDonalds claims their burgers are made with 100% Beef Products, which is not the same things as only contains 100% beef products. FDA considers that term to include a whole list of cow parts that you won't find in the supermarket. They pressure wash the remains off the bones and add that gruel to the low grade ground cowparts that comprise low grade beef (that's why it looks so grey). Intact chicken is usually okay, but stuff like mcnuggets that use "processed" chicken isn't exactly all white meat.

Are aware that the FDA guidelines allow manufacturers to consider some ingredients as incidental (usually under a certain percentage or considered inert) and not include them in the labeling? Common ingredients would be things like the solvent for some of the flavoring and spices. For a grosser example, consider that up to a certain ppm of rat turds are allowed in the food, but not required to be listed on the label. MSG can be in the food but not be apparent on the label, as it can be included in other ingredients (soy sauces for example) or be described under one of several other chemical names?

I really wish the FDA would include MSG in their list allergens, which would force the manufacturers to be more open about the MSG content of their products. FDA won't because its not a potentially life-threatening sensitivity, but a significant amount of the population has ill effects from large doses (usually headaches).

I have had plenty of chem classes, and can pronounce the names quite well. The phrase "unpronounceable chemicals" is just a phrase - don't take it literally. I take exception that I need to use google to determine what those chemicals are, why they might be used, and what health risks they entail.

Technically, they shouldn't list dihydrogen monoxide as the FDA guidelines require plain language names where possible. For example sugar instead of sucrose, but you see HFCS listed instead of sugar quite often.
http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabelingNutrition/FoodLabelingGuide/ucm064880.htm

The beauty of leaded gasoline is that even your children's children's children will know about it.

The FDA and EPA are aware of the problem of powerful drugs entering the water supply, see http://www.epa.gov/ppcp/ and http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm101653.htm. Aside from certain classes and types of drugs, the FDA recommends that most drugs be mixed with regular solid waste for disposal, not flushed down the toilet (the mixing with solid waste is to prevent children and pets from accidently ingesting the drugs by rendering them unpalatable). The FDA had list of classes of drugs that should be flushed (I can't find it now). Most of them were either opiates that represented a theft and abuse problem (think junkies going through your trash for a fix), or were powerful antiviral or anticancer drugs that you probably don't want sitting around in your trash.

A number of communities and private companies have set up drug takeback programs, either through pharmacies, hospitals, or household hazardous waste programs. They collect the drugs and recycle them or dispose of them properly. See http://www.takebacknetwork.com/monthly_feature_06_09.html for some basic links to drug takeback sites, or you can Google for them.

No, but it certainly seems like a lot of the loudest conservatives (note: not all conservatives are Republicans and vice versa, but people rarely make the distinction, same with liberals / Democrats) are always shouting about limited government, free capitalism, let the free market solve all our problems, and so on.

If you tune to some of the loudest leftists (note: not all leftists are Democrats and vice versa) you will hear them shouting things that would have made Karl Marx cringe. The rich only got rich on the back of the poor, Wall Street is responsible for every single thing that goes wrong in this country, "General betray us", etc, etc, etc.

When your exposure to conservative ideals comes from these guys

Do you judge liberalism by the likes of Michael Moore? No? Then why judge conservatism by the likes of Sean Hannity and Rush Limbaugh?

It's usually accompanied by lines like "Do you really think the government can do anything right?"

Can it though? In my area we have a mixture of private garbage collection and municipal. Some communities have municipal service and some have private service. Follow the two trucks around for a few minutes one day to see the difference between the private sector and the public sector. The private guys haul ass -- the municipal guys prod along and are lucky to cover half the ground that the private guys do. You know what makes it even more pathetic? The muni guys are paid nearly three times as much.

but the people asking are usually happy to be protected by a government-run police, fire, and military force, drink from the municpial water supply, drive on state-constructed roads, use cellphones and GPS and other things made possible by NASA, eat food and take medicine knowing it's been inspected by the FDA and they don't need to personally inspect the farm / pharmacy, live and work in buildings that won't collapse because they've been built to government-approved codes, and so forth. Seems a strange position to take, if you ask me.

I don't think it's strange at all. Some of what you just listed could be accomplished more efficiently by the private sector (municipal water). NASA didn't set out to deploy GPS -- it set out to keep us competitive with the Russians. It's great that we got some civilian applications out of that investment but don't kid yourself into thinking that's why we spent the money.

As far as the FDA goes, I don't trust them at all and many people would argue that they've done more harm than good. They've turned the process for approving new drugs into a bureaucratic nightmare and have denied dying people the right to take experimental medicines even though they are fully aware of the risks of doing so. Given the events of the last few years I think I'd trust an organization like the Underwriters Laboratories more than Uncle Sam. My UL approved outlet and appliances have yet to burn my house down. My FDA approved peanut butter and drugs on the other hand....

The laws are stated that I am not allowed to sell milk labeled that it came from cows not injected with BST. That's crazy. If some people want to pay twice as much for non-BST milk, why should gov't get in the way? They aren't lying in the labeling.

Here is a link explaining why the FDA will not let manufacturers sell milk with the claim that rBST was not used in its production. Part of the reason is due to market confusion, but there is also the point of verification. In short, there is no way to analyze two samples of milk and determine whether or not the BST in the milk is of Cow or Injection origin.

Substantiation of Labeling Claims

There is currently no way to differentiate analytically between naturally occurring bST and recombinant bST in milk, nor are there any measurable compositional differences between milk from cows that receive supplemental bST and milk from cows that do not. Therefore, to ensure that claims that milk comes from untreated cows are valid, States could require that firms that use such claims establish a plan and maintain records to substantiate the claims, and make those records available for inspection by regulatory officials. The producer of a product labeled with rbST claims should be able to demonstrate that all milk-derived ingredients in the product are from cows not treated with rbST. Failure to maintain records would make it difficult for a firm to defend itself in the face of circumstantial evidence that it is using rbST or selling milk from treated cows. In some situations (e.g., dairy cooperatives that only process milk from untreated cows), States may decide that affidavits from individual farmers and processors are adequate to document that milk or milk products received by the firm were from untreated cows.

States should consider requiring that firms that use statements indicating that their product is "certified" as not from cows treated with rbST be participants in a third party certification program to verify that the cows have not been injected with rbST. States could seek to ensure that certification programs contain the following elements: Participating dairy herds should consist of animals that have not been supplemented with rbST. The program should be able to track each cow in the herd over time. Milk from non-rbST herds should be kept separate from other milk by a physical segregation, verifiable by a valid paper trail, throughout the transportation and processing steps until the finished milk or dairy product is in final packaged form in a labeled container. The physical handling and recordkeeping provisions of such a program would be necessary not because of any safety concerns about milk from treated cows but to ensure that the labeling of the milk is not false or misleading.

Emphasis mine

IGF-I

The Canadian report indicates that milk from rbGH-treated cows contains significantly elevated levels of insulin-like growth factor I (IGF-I) in milk, and presents human health safety concerns. IGF-I is a protein normally found in all humans, and is not intrinsically harmful. IGF-I is necessary for normal growth, development, and health maintenance. Circulating plasma levels of the hormone increase from birth to late puberty and subsequently decline in adults to approximately 100 ng (10-9 grams)/ml (range = 42 - 308 ng/ml for men and women >23 yrs). IGF-1 is structurally similar to insulin and, like insulin, is not biological effective following oral administration.

The safety of IGF-I in milk was thoroughly considered by FDA in its review of the Posilac application. Some early studies suggested that treatment of dairy cows with rbGH produced a slight, but statistically significant, increase in the average milk IGF-I concentration. FDA determined that this modest increase in milk IGF-I concentration was not a human food safety concern because it was less than the natural variation in milk IGF-I levels observed during lactation and was less than the fluctuation observed in milk from treated and control cows prior to rbGH administration.

Since making that analysis, however, FDA has received and reviewed several more comprehensive studies designed to ascertain the effect of rbGH treatment on milk IGF-I levels. These studies have demonstrated that the levels of IGF-I found in milk from treated cows are within the range of those normally found in milk from untreated cows. In 1993, the JECFA Committee concluded, "the most definitive and comprehensive studies demonstrate that IGF-I concentrations [in milk] are not altered after rbGH treatment". The 1998 JECFA Committee report summarized a study showing no significant difference in commercially available milk labeled as coming from non-rbGH treated cows and milk from cows presumed to be treated with rbGH but not labeled as to treatment.

A recent study(7) has been published on the association between prostate cancer and IGF-I. This study showed a positive correlation between the level of IGF-I in plasma and the increased risk of prostate cancer. Although the mechanism responsible for induction of cancer has not been characterized fully, it is clear that IGF-I is not the causative agent.

FDA has examined the literature and finds no definitive evidence of any direct link between IGF-I and breast cancer. Some authors have hypothesized a link, whereas others have expressed that while IGF-I is one of several growth factors and hormones that can contribute to an increase in cell numbers of many cell types invitro, no one factor is responsible for changing normal cells into cancerous cells. Furthermore, FDA has been advised that there is no substantive evidence that IGF-I causes normal breast cells to become cancerous.(8)

In evaluating the potential for human health risk from a natural component of the body, one can examine the effect of an increased exposure to IGF-I by employing several assumptions (i.e., IGF-I levels in milk from rbGH-treated cows are increased from 4 ng/ml to 6 ng/ml, all of the IGF-I in milk is absorbed into the body, and absorbed IGF-I is confined to the vascular compartment). Assuming 5000 ml b

omg chemicals are teh evilz

I'm sure the overwhelming quantity of available information on the dangers of chemical additives and pesticides in food has been planted only recently by the organic food lobbyists to sway the opinion of us ignorant plebes (kind of like how God put fossils in the Earth to trick people into believing that the Earth was more than 5000 years old). So good of you to point this out.

The higher price of organic food must also be a direct result of the organic food lobby. It certainly couldn't have anything to do with the true cost of pesticide-free food grown sustainably (which is what the fuck "organic" is supposed to mean, fyi). There is no way food grown in this manner could simply cost more to produce than pesticide-laden food grown in a manner that is environmentally destructive. Thanks for speaking truth to power.

maybe we should instead focus the FDA on doing something about the "supplement" and "herbal remedy" market that is currently totally uncontrolled.

You're right that ephedrine containing products caused thousands of preventable deaths. However, you're not right to blame the FDA. Sure, the FDA has had numerous failures of science in the service of citizen protection in the past decade, but with regard to dietary supplements their hands are tied by actual legislation. The Dietary Supplement Health and Education Act of 1994 was among the dubious legislative achievements of the Newt Gingrich's Congress. Call on your congress persons to repeal the law that categorizes such supplements as food products. This effectively places the burden of proof on the FDA to prove that an ingredient is unsafe, rather than on the manufacturer to prove than an ingredient is safe.

Read here:
http://vm.cfsan.fda.gov/~dms/dietsupp.html ...
For decades, the Food and Drug Administration regulated dietary supplements as foods, in most circumstances, to ensure that they were safe and wholesome, and that their labeling was truthful and not misleading. An important facet of ensuring safety was FDA's evaluation of the safety of all new ingredients, including those used in dietary supplements, under the 1958 Food Additive Amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act). However, with passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA), Congress amended the FD&C Act to include several provisions that apply only to dietary supplements and dietary ingredients of dietary supplements. As a result of these provisions, dietary ingredients used in dietary supplements are no longer subject to the premarket safety evaluations required of other new food ingredients or for new uses of old food ingredients. They must, however, meet the requirements of other safety provisions. ...

If one does a little digging and actually reads the letter the FDA sent to the company, they said that the "FDA has concluded that these products MAY pose a serious risk to consumers who use them....". Whereas, the press release says "The U.S. Food and Drug Administration today advised consumers to stop using three products marketed over-the-counter as cold remedies because they ARE ASSOCIATED with the loss of sense of smell (anosmia)." The two differ a lot in meaning. The message to the company says that there could be a connection, whereas the news release just says there is a connection. Personally, I think that the FDA is being overly aggressive. The Obama admin. has encouraged a change from the (awful) years of Bush. Likewise, the FDA has taken a very aggressive stance toward companies. PS- I have used Zicam and it works, and I can still smell! Sources: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm167065.htm http://preview.tinyurl.com/lq68wd

According to the warning letter the solution contains "an active ingredient measured in homeopathic strength--Zincum Gluconicum 2X".
2X equals to 1:100 solution - which may be quite a significant dosage of the "active ingredient", depending on its nature.

Incidentally, this is not the first time this particular maker of this particular homeopathic drug has been a cause of this particular health concern.

While Zicam also makes zinc-containing oral cold remedies, these are not subject to this warning because the development of anosmia appears to be related to the intranasal application of zinc.

Don't these guys know ANYTHING about homeopathic medicines? The strongest ones don't have any of the 'active ingredient' in them at all, you just take sugar pills and think happy thoughts at them until the sun shines out your ass.

Let me list your extraordinary claims, and then you can provide the citations:

1) Safety devices have doubled the price of cars
2) Driver education is more effective at saving lives than seatbelts and airbags
3) The government never does it's job
4) Government is less transparent than a corporation
5) Government is somehow not accountable

For instance, the FDA issues rules on food safety for restaurants, available here. You know when you to go a restaurant, and they have those little papers that allow you to see how the restaurant is rated for food safety? Do you think any restaurant would ever post that information on it's own?

The real fact is that protecting profits are far more important than protecting consumers for any business. The only agency that can compel a powerful organization to be honest is a policing authority, which is typically provided by the government. If you have a better idea that isn't based entirely on your own hallucinations and imaginary data, please let me know.

Or Elixir Sulfanilamide.

I was unnecessarily harsh, I think.

The problem with having overly general laws is that it places more of a burden on the interpreter. The judgment becomes more "arbitrary"...we are basically talking rule of law vs. rule of man.

Right now there is an ad for Extenze on tv. We have truth in advertising laws. Yet they still run this ad that says:

(a) they have a pill (also a soda!) that will enlarge a penis...yeah, sure thing
(b) they will let you try it for free.

In reality, I'm sure it's a complete waste of time, and if you read the legal copy at the bottom, the free trial is an enrollment in a monthly shipping program. Like Columbia House, but for penis pills. Imagine what they could get away with if the only upfront restriction on them was "be honest". They clearly don't give a crap about honesty!

On the other hand, look at Nutrition Facts on food...the FDA has clear guidelines on what constitutes a claim like "fat free" or "excellent source of fiber". It's annoying because, as with legalese, words take on extra meanings that the layperson does not expect. Excellent might mean something like "16g or more". And it's limiting, because not everyone will agree that 16g is excellent. It also creates a barrier to entry, since there's also a good amount of research that you have to do before designing a Nutrition Facts label (as I often do in my work).

I posted a quote from A Man for All Seasons somewhere else on the page. More (in the play) basically says he would not cut a path through the law to get at the devil, because then there would be nowhere to hide when the devil turned round on him. Law doesn't just protect us from crooks, it protects us from vigilantes as well.

Despite all this, I do not doubt that there is a good chunk of legal procedure that exists just to give lawyers something to charge people for.

The FDA can't even tell the cosmetic industry to stop including toxic ingredients in their products (like lead, formaldehyde, 1,4-dioxane, etc)

How this intelligent gentlemen gets to this conclusion gets me a bit confused...

No the problem is they can't, these are often FDA approved medical devices and applying a patch is considered re-manufacturing the device and the organization making the modification then assume the manufacturer's liabilities. The documentation requirements for Good Manufacturing Practice / Quality Systems are quite intense.

Validation
Each changed device, accessory, labeling, packaging, and process should be thoroughly verified and/or validated by the appropriate department. Then the test results and all information related to the change should be reviewed by the change control board or other designated review group. This procedure is the same as needed for designing and introducing a new product or process into production and is detailed in section 820.30, Design Controls. Changes that only modify documents and do not change any design aspect of a device or process are performed according to 820.40 Document Controls. The change control procedure should state the details of the evaluation and review process or, as appropriate, refer to the company control procedures. The change control procedure should define the responsibilities of the various departments and members of the review board. DOCUMENT AND CHANGE CONTROL

I's love to go into Medical Devices like sleep-apnea/anti-snoring devices, but the FDA requirements means I'd have to spend twice as much time documenting and record keeping as I would actually making the things.

No the problem is they can't, these are often FDA approved medical devices and applying a patch is considered re-manufacturing the device and the organization making the modification then assume the manufacturer's liabilities. The documentation requirements for Good Manufacturing Practice / Quality Systems are quite intense.

Validation
Each changed device, accessory, labeling, packaging, and process should be thoroughly verified and/or validated by the appropriate department. Then the test results and all information related to the change should be reviewed by the change control board or other designated review group. This procedure is the same as needed for designing and introducing a new product or process into production and is detailed in section 820.30, Design Controls. Changes that only modify documents and do not change any design aspect of a device or process are performed according to 820.40 Document Controls. The change control procedure should state the details of the evaluation and review process or, as appropriate, refer to the company control procedures. The change control procedure should define the responsibilities of the various departments and members of the review board. DOCUMENT AND CHANGE CONTROL

I's love to go into Medical Devices like sleep-apnea/anti-snoring devices, but the FDA requirements means I'd have to spend twice as much time documenting and record keeping as I would actually making the things.