FDA allows food from cloned animals to enter the US food supply.
Jan 15th, 2008 | By Michael L. Saile, Jr., Esq. | Category: Blogs, Dangerous ProductsAfter years of detailed study and analysis, the Food and Drug Administration has concluded that meat and milk from clones of cattle, swine, and goats, and the offspring of clones from any species traditionally consumed as food, are as safe to eat as food from conventionally bred animals. There was insufficient information for the agency to reach a conclusion on the safety of food from clones of other animal species, such as sheep.
An animal clone is a genetic copy of a donor animal, similar to an identical twin, but born at a different time. Cloning is not the same as genetic engineering, which involves altering, adding or deleting DNA; cloning does not change the gene sequence. Due to their cost and rarity, clones are intended to be used as elite breeding animals to introduce desirable traits into herds more rapidly than would be possible using conventional breeding.
In 2001, U.S. producers agreed to refrain from introducing meat or milk from clones or their progeny into the food supply until FDA could further evaluate the issue.
The agency is not requiring labeling or any other additional measures for food from cattle, swine, and goat clones, or their offspring because food derived from these sources is no different from food derived from conventionally bred animals. Should a producer express a desire for voluntary labeling (e.g., “this product is clone-free”), it will be considered on a case-by-case basis to ensure compliance with statutory requirements that labeling be truthful and not misleading.
Because clones would be used for breeding, they would not be expected to enter the food supply in any significant number. Instead, their sexually reproduced offspring would be used for producing meat and milk for the marketplace. At this time, the agency continues to recommend that food from clones of species other than cattle, swine and goat (e.g., sheep) not be introduced into the food supply.
What do you think about eating food from cloned animals? Do you think the food from cloned animals is safe? Do you think that the FDA should require labels on food from cloned animals?
The author of this Blog, Philadelphia car accident lawyer, Michael L. Saile, Jr., Esq. of Saile & Saile LLP, Attorneys-at-Law focuses his practice on fighting for plaintiffs’ personal injury and car accident victim’s rights in both Pennsylvania and New Jersey. We handle all serious injury cases including, car accidents (both limited and full tort), wrongful death, slip & fall downs, construction accidents, Septa, NJ Transit, and other cases other cases. We are located just outside of Philadelphia in lower Bucks County. We also handle Philadelphia plaintiffs’ personal injury and car accident cases. Please visit our personal injury only website at www.pa-nj-injurylawyer.com for more injury information.
If the FDA says that medicaly nothing is wrong with the food, I would hav e to go along with that.
However, it does touch a nerve in me on a larger issue. Who are we, why are we here on earth, and why do we have to clone animals for a food source. What is our purpose and what is our future, what are our goals?
Where are we going as a people.
I saw on 60 minutes Sunday that Tuna is a commodity to where several hundreds tons of tuna are ran through Japan everyday, frozen, and shipped all around the world.
This kind of tuna, i think they called it bluefin tuna, is now becoming an endangered species.
Should be be creating huge huge hatchery /fisheries, where we clone bluefin tuna/
How far will be have to go to supply an ever growing human population with food, and what detriment is there to gene-pools in nature when we grow our cloning to mega proportions, and what effect will it have on humanity, society, culture, as well as human evolution physiologicaly?
Are we heading toward “a brave new world”?
So Jim do you think the FDA is god? Are they always right?
No individual is perfect or aleways right, and no organization is perfect or always right.
The fda is a well respected government agency with thousands and thousands of very smart, well respected , highly educated people working in it.
Are they going to be right 100 percent of the time, of course not. Haowever I would think that for every m illion things thewy check and say are ok, mabye 1 is not, for every million things they say is not good, maybe one is.
In this case, a food source that really, for all extensive purpurses feeds 95 percent of our population, there is no way, in my humble opinion, that the FDA wouldn’t say this food causes health problems above and beyond what we already know about fats, ect.., if there were problems.
We are talkking about poisoning 95 percent of out population. There is no way the FDA DIOD NOT CROSS ALL THE T’S AND DOT ALL THE I’S ON THIS ONE.
Mr. Saile, you are talking about the FDA here, an organization thaT FREAKS OUT if a chemist does not have the right time and date, in the proper format in A NOTBOOK OR ON A PRINTOUT, AND NOT ONOLY ON NEW DRUG APPLICATIONS, BUT FOR ROUTINE ANALYSIS OF A SUPPLEMENT, OPR ANYTHING MUNDANE.
Unless you have seen the FDA in action, up close, i guess maybe it is hard for you to understand what i amn trying to say.
The FDA IS BEYONMD BEING STICKLERS AND PERFECTIONISTS, THEY are the PERFECTIONIST’S PERFECTIONIST.
I do not know how else to describe what they do.
My experience with the FDA is in person experience as well as hands on experience feeding them documents for review, as well as face to face conversations in audits.
I have been through several face to face FDA audits of the factories and laboratories I have worked in, in several companies.
I have also worked on testing to be used for drug applications, which the FDA ALWAYS COMES TO REVIEW,… one being liquid prozac for a south jersey pharma.
I have worked in the business for 20 years and have a lot og first hand knowledge on how the FDA works in relation to many many aspects of manufacturing, testing, instrumentation, and validation.
I also have a lot of 2nd hand knowledge from chemists and manufacturing managers in other companies that i have met and talk to over the years over the course through my carreer.
I can tell you, to a man, without any doubt, the FDA ARE PERFECTIONISTS AND DEMAND PERFECTION IN EVERYTHING THEY DO AND EVERYTHINFG WE DO.
on a side note, this is why i want the FDA involved in breath testing, they would leave no stone unturned in haveing a relkiable breath testing device that no one could say was not reliable, of course, short of perfection in testing and validation and documentation which they mandate.
Even with all my knowledge and experience, it is very little compared to thousands of other people in NJ.
All you have to do is talk to analytical and manufacturing directors at Merck, J and J , ect.. to understand what i am talking about.
Or go to instrument manufacturers of HPLC’s such as Agilent to understand what the FDA wants.
here is a story for you.,,,
Agilent came in to validate one of our HPLC’s which I had under my direction. Now they had been in every year to do it, ,.. and they put the validation sticker on the side of the instrument ( not to mewntion the 2 notebooks of data accumulated in the validation and must be presentable to the FDA). Well… this validation engineer from Agilent told me that the FDA was upset to see a new sticker covering over an old sticker on an instrument in another company, and cited them for it in a report.
Well, my instrument was the same way, because Agilent puts the stickers on and over stickered previous stickers from other years. To a regular person this may seem like nothing, because , of course, we have all the instrument validation noteboks going back 7 years for wach instrument, as mandated by the CFR/FDA regs. But to the FDA this was an issue and they wrote up the company.
This is just one of countleess trillions of trilliuons of things the FDA looks at in audits.
If there is a word beyond perfectionist, tell me what it is, because that would descibe the FDA
It is no secret in the industry the enormous power the FDA has to demand and expect perfection, or the ability of the FDA to reconize quality or non quality work.
No one wants a form 483 from the FDA, it is a bad thing and a negative reflection on our work
I have tried to covey the perfection and amount of work the FDA mandates and expects. But I am not sure i have done that yet.
The general public really has no idea what goes into pharma manufacturing or OTC manufacturing.
When i use the term cleaning valkidation, you and the general pubvlic have no idea what it means.
It is an enormous amount of testing for each kettle and each packaging line, for trace residue analysis as well as microbiology. inmclude a photograph of each unit, and a validation package, for first 3 batches of each new formula, annually, used on each piece of manufacturing and packageing equpiment.
cleaninbg validation in a factory is a enormous undertaking, and yet only a droip in the bucket of what we need to do for the FDA.
anything not right can lead to the doors being padslocked by the FDA, a branch of the US Navy, and hundreds or thousands of people out of a job.
Perfection is the name of the game when it comes to the FDA.
sO, THE ANSWER YOYR FIRST QUESTION, YES, THE FDA IS AS CLOSE TO A GOD AS WE ARE GOING TO GET IN THE PHARMA INDUSTRY AND FOR A GOVERNMENT AGENCY
You can probably tell from my vast posts i belive in the law. in regards to the FDA , it what they mandate not only in the CODE OF FEDERAL REGISTER, BUT AS FAR AN POLICY AND AUDITS AND ADMINISTRATIVCE DECISIONS.
now, am i saying companies do not make mistakes, even try to hide things , no, im not saying that, … am i saying chemists do not make honest mistakes,.. no, of course not,,, am i say fda auditors do not miss things,.. no i am not saying that.
I am saying the risk, the consequences of any mistake, no matter how small, is great!
I have ibntegrity, most people in my field have integrity. The FDA expects integrity anbd perfect application and documantation of their madates, .. the penalty for infractions go beyond a 483, they go to criminal prosecutrion.
as close to 100 percent as we can get to conformity to FDA mandates, we get to, only very rarely do companies not conform.
Able labs was one in nj a few years ago that had their doors padlocked the the FDA.
TAHIS IS WHY THE fda needs to be involved in the alcotest, alcohol is a drug, and there is no governmen t agency better to put fear in , this case the States, to have a program that is not approachable by defense attorneys.
this is what i want…. this is what we as a people should want, however, this is not whaty defense attorneys want…. defense attorneys want a unit in place that is questionabvle, so occassionaly they can get a defandant off of charges, … but to me this is totally the wrong approach and a philosophical difference between me and resig/levow.
the last thing reisig or levow wants is a breath testing unit that is unjappraoachable as to its accuracy or reliability,.
IF WE AS A PEOIPLE WANT A GOOD INSTRUMENT THAT CAN BE REKLIABLE AND VIRTUALLY UNCONTESTED IN ITS RESULTS, WE NEED THE FDA INVOLVED IN THE ENTIRE PROGRAM ON A NATIONAL BASIS
THIS IS WHY THE ENTIRE CHUN CASE IS A DEBACTLE AND AN EXRCISE IN NOTHING MORE THAN ARGUMENT.
as i have said before , we have a trillion or more dollars to fight in iraq over the course of a decade, we shopuld hav e the money , easily, to have a fda regulated breath testing program, it is a no brainer.
You can understand that from the perspective of someone like me has, and there are 10,000 plus of us in NJ, that not only is it possible to have an unapproachable breath testing device mandated and overseen by the FDA on a scientific basis, BUT THAT WE SHOULD HAVE IT, AND that that becauase of our knowledge of analytical instruments and what the FDA mandates, that we are frustrated by what the State and Drager are willing to call reliable.
You certainly can questiuon the FDA on major political-economic decisions as mandated by presidential administrations, ,,… however you can not question the expertise or demands of the FDA on us, as an industry, to supply the highest quality of work possible known to mankind.
you can, but it would be unwarranted,
the FDA is unapproachable in its management and unrelentless approach and enforcement of perfection!!!!!!!!!!!!!!!!
Can you at the very least, acknowledge, that someone with my expericence in the pharma industry, with the fda, after all i have tried to explain in the above posts, is upset and highly agitated about an unvalidated anal,ytical intrument that is going to be able to put someone behind bars?
Mr. Saile, i want to ask you a question… and this question have nothing to do with any case of any kind….
I JUST WANT AN ANSWER
What do you think happens when a generic pharama company in NJ manufactures a batch of acteominophen tablets?
Do you belive that testing is done with VALIDATED methods on validated instruments, and that the results of the tests are reliable and correct in its results, and the batch is properly released for distribvution to pharmacies and supermarkets abnd convience stores?
and that the fda mandates perfection in this manufacturing and testing from every possible angle of review?
if you do not belive this, my arguments are really a lost cause….
but if you do belive this, and say yes, then it is not a far jump to say the FDA could have a validated breath testing device in place nationbally that could rarely be challanged.
Jim:
I do not know anything about the how the FDA monitors this process. Does the FDA monitor wine, liquor, and beer production in the US? I think the FDA would get involved if people were eating breath testing machines…
NHSTA is a federal organization that monitors transportation. What do they do to validate and monitor breath test machines?
Well, are you saying you do not belive me, and do not know from what i say, that the FDA monitors to the extent of perfection?
Transportation has nothingb to do with analytical instruments.
I do know that the fda is the worls foremost authority on analytical instrumentation.
Are you willing to take the time and investigate my assertions on this?
are you willing to contact heads of analytical depratments at pharama companies to obtain knowledge?
i’m a nobody and i know the FDA is the worlds formost authority on analytical validation.
do we not want a incotravertaible breath testing device?
this goes to the core of my arguments as they pertain to the statutes allowing scientific evidence into courts!
if one wants to argue analytical sciebtific result should be allowed as evidence in a court of law, then onbe must show it is accepted by the scientific community, in the case of analytical istrumenhts produving results, this IS THE FDA’S REALM OF FORMOST EXPERTISE!!!!
IF YOU WANT TO KNOW THE TRUTH, YOUY CAN DO ONE OF 2 THINGS, EITHER TAKE MY WORD FOR IT, OR START COMMUNICATION WITH ANALYLYTICAL HEADS AT TOP PHRAMA COMPANIES.
I am not saying that I do not believe you because I know nothing about the issue, nor do I have time to research the issue.
My question is: what types of matters does the FDA get involved with? Certainly the FDA’s jurisdiction is not every machine that needs analytical validation…
i will say this, at some point in the future, i will invite you into an analytical laboratory and show you the instruments and testing and teach you about it, that way you would have first hand knowledge and experience in it.
i am a very good teacher.
i would not be suprised if the nhsta consulted at lewast on an informal basis with the fda in regards to breath testing.
mr saile, as a person, do you not want a breath testing device that in incontrivetible as to the results.
no, i do not know what the nhsta does, but i do know what they do not do, they do not require the instruments to be validated as the fda does, or we would not even be having this discission.
if the alcotest instruments were validated as according to fda regulattions, we would not be having this discussion.
the rsults from it would be beyond approach !
come into one of my labs in the furture and look at the vaildatuion that is done on a daily basis.
i know you do not have the time to look into such a huge economic-social-political issue…and be a grandstander, nor are you willing to to donate your life to do so, …
but do not discount my arguments because you have no knowledge of them
however, the State of NJ, Drager, and the Chun defense team has had not only the time to do it, but the mandate to do it!!!!!
drager has absolutley no excuse at all, as i have looked at their website and have found they are a huge copr. involved in amny many theings in analytical testing and sahould know better than to try to pull the wool over our eyes on the alcotest.
The State also has no excuse, as NJ pharma companies are the worlds leader in analytical testing!
defense lawyers, i give a little break, because they need to yet be educated.
As far as the Satute and case law goes, the NHsta is not the scientific community and had no standing in the area of analytical results
The foremeost authority on analytical results is the chemistry community, and the leader in this community is the FDA!!!! to a man, hands down!!!!
Yes, to answer your question, the FDA has the responsibilty to oversee the validation of every piece of analytical instrumentation that is use in the mNUFACTURE, DISTRIBUTION, PACKAGAING, AND TESTING OF DRUGS, AND OVER THE COURTER THE PRODUCTS SUCH AS VITAMINS, COSMEITCS WITH SUNSCREENS, FOOD, AND OTHEr PERSONAL CARE PRODUCXTS THAT CLIAM ANB ACTIVE INGREDIENT.
The FDA had the abilty and mandate to audit and revue , and they do this, even for instruments that test antiperspirent!
Yes, every signle gd instrument in the US testing these produxts is validated and overseen by the FDA, with the threat of prosecution if regs are not followed.
I am not kidding or making this up!
Every single piece, every instrument!!!
Billions of instruments in the US are under the watchful eye of the FDA for comlinace with the CFR/FDA regulations.
Every instrument in every comapny.
I am tellin you , for a fact, this is no joke as to what the FDA does and is responsible for.
all of thre big pharamas have office right in the facilities for the FDAS to work out of, the smaller companies get visits., and if anything is wrong, it is adressed.
I kid you not!!
the fda would never allow an instrument such as the alcotest to be used in the testing and release of pharmas, otc, food, or personal care products.
imstruments need to be validated, each and every indidvidual one, i kid you not!
and this validcation is not simply a calibration verification, is involves many things far beyond simple calibration.
i have touched on these issues over the summer in many posts.
just to take one aspect of the alcotest, …. even it it has a temperture sensor, as alabama uses, this sensor needs to be validated and calibrated.
lets take another aspect, the calculatuion, this needs to be verified for each instrument with a special program that imputs signals through a program to see if it comes up with the correct response..
lets take another aspect, … there is 100 percent absolutley no way, tHE fda would allow an analytical instrument with the ability to produce such a meaningful result using an ir scan, not to have to actual ir scan avaibable for review. to me this is a fundamental issue, as it is the crucial piece of evidence, to not have the ir scan is unbelivelable.
do you realize how many ir’s are in in use in nj that produce scans…. probably 100,000.
do you realize actually how many ir scans i have been personally responsible for in my 20 year carrer…. suffice it to say more than i can count in years time.
if these ir instruments are producing a scan crucial to the testing and realese or raw materials and finished goods, they are subject to the fda is the cfr!
i kid you not on this mr saile.
more to come out of my head on this….
I’d eat it as long as it was proven to be safe. I do also feel that the food from a cloned animal should state just that, as to give the consumer the choice and the heads up as to what they are eating themselves and also feeding their family.