Food and drug administration to Reexamine Rules on Why is a Food ‘Healthy’

 

Introduction to Regulatory Science at the FDA

Video taken from the channel: Stanford


 

About FDA’s Regulatory Science Program

Video taken from the channel: U.S. Food and Drug Administration


 

Food and Drug Administration (FDA) Urges Stricter Regulation

Video taken from the channel: The Health Law Firm


 

U.S. FDA Regulations for Dietary Supplements

Video taken from the channel: Registrar Corp


 

Morning Rounds: FDA reevaluates regulations about “healthy” labels

Video taken from the channel: CBS This Morning


 

FDA To Redefine What Makes A Food Healthy

Video taken from the channel: Wochit News


 

How Does the FDA Approve a Drug?

Video taken from the channel: Healthcare Triage


FDA to Reexamine Regulations on What Makes a Food ‘Healthy’ Going by current and perhaps outdated U.S. food-labeling regulations, it’s impossible to know, food makers and legislators contend. Among food makers urging a reevaluation of “healthy” is Kind LLC, a producer of granola bars, which was warned by the FDA last year to stop labeling its bars as “healthy”. FDA to Re-examine What Makes a Food ‘Healthy’ Agency acknowledges changing standards, concerns U.S. food-labeling regulations, it’s impossible to know, food makers and. But that’s about to change under a U.S.

Food and Drug Administration plan to redefine the definition of “healthy” foods. “We believe now is an opportune time to reevaluate regulations concerning nutrient content claims, generally, including the term ‘healthy,'” the FDA said in a statement to the Wall Street Journal. The FDA has since allowed Kind to keep using the phrase “healthy and tasty” on its bars, the Journal reported. The guidelines that the FDA currently uses for “healthy” include total. FDA to re-examine what makes a food ‘healthy’ WBOC-TV 16, Delmarvas News Leader, FOX 21 U.S. food-labeling regulations, it’s impossible to know, food makers and. FDA to Re-examine What Makes a Food ‘Healthy’ 1. Health and diseaseHealth and disease 2. ” The soundness of body and mind isThe soundness of body and mind is called Healthcalled Health. A healthy.

The purpose of this guidance is to advise manufacturers who wish to use the implied nutrient content claim “healthy” to label their food products as provided by our regulations. FDA has started a public process to redefine the “healthy” nutrient content claim for food labeling. Redefining “healthy” is part of an overall plan to provide consumers with information and tools. But that’s about to change under a U.S.

Food and Drug Administration plan to redefine the definition of “healthy” foods. “We believe now is an opportune time to reevaluate regulations concerning nutrient content claims, generally, including the term ‘healthy,’” the FDA.

List of related literature:

One especially interesting feature of the food-labeling rules involved a loophole: the regulations allowed food companies to use the word “healthy” with few restrictions.

“Food Politics: How the Food Industry Influences Nutrition and Health” by Marion Nestle
from Food Politics: How the Food Industry Influences Nutrition and Health
by Marion Nestle
University of California Press, 2013

According to John Vanderveen, Ph.D., director of FDA’s Office of Plant and Dairy Foods and Beverages, the law makes the United States the first country in the world to have mandatory nutrition labeling and to allow health claims on food labels.

“Food Regulation: Law, Science, Policy, and Practice” by Neal D. Fortin
from Food Regulation: Law, Science, Policy, and Practice
by Neal D. Fortin
Wiley, 2016

This change ultimately culminated in the passage of the Nutrition Labeling and Education Act of 1990, which reaffirmed and defined the FDA’s authority to regulate the health claims made on food labels.

“Ingredients in Meat Products: Properties, Functionality and Applications” by Rodrigo Tarté
from Ingredients in Meat Products: Properties, Functionality and Applications
by Rodrigo Tarté
Springer New York, 2009

Restaurants and manufacturers could be required to disclose nutritional content and health warnings so that consumers may make more informed decisions.

“Sports Nutrition for Health Professionals” by Natalie Digate Muth, Michelle Murphy Zive
from Sports Nutrition for Health Professionals
by Natalie Digate Muth, Michelle Murphy Zive
F.A. Davis Company, 2019

Healthy: To use the word healthy, companies must meet certain FDA regulations per serving size.

“Mom Energy” by Ashley Koff, R.D., Kathy Kaehler
from Mom Energy
by Ashley Koff, R.D., Kathy Kaehler
Hay House, 2011

Food manufacturers complained to Congress that the new labeling requirement forced them to disclose what was wrong with their products (too much saturated fat, salt, sugars), and that they should be allowed to say what was good in them.

“Feed Your Pet Right: The Authoritative Guide to Feeding Your Dog and Cat” by Marion Nestle, Malden Nesheim
from Feed Your Pet Right: The Authoritative Guide to Feeding Your Dog and Cat
by Marion Nestle, Malden Nesheim
Atria Books, 2010

The FDA needs to change its current approach to the regulation of medical and functional foods to ensure safety and truthful labeling.

“Readings in the Philosophy of Technology” by David M. Kaplan
from Readings in the Philosophy of Technology
by David M. Kaplan
Rowman & Littlefield Publishers, 2009

Manufacturers may propose the addition of new food ingredients in the U.S. by either filing a food additive petition with the FDA to request a formal pre-market review or making a “generally recognized as safe” (GRAS) determination.

“Single Cell Oils: Microbial and Algal Oils” by Zvi Cohen, Colin Ratledge
from Single Cell Oils: Microbial and Algal Oils
by Zvi Cohen, Colin Ratledge
Elsevier Science, 2015

In an effort to deal with the obesity epidemic plaguing the country, the US Food and Drug Administration (FDA) has implemented a new rule that requires restaurants and sellers of prepared food items to include nutrition information on their menus or on the packaging of the food items.

“Conflict Management for Managers: Resolving Workplace, Client, and Policy Disputes” by Susan S. Raines
from Conflict Management for Managers: Resolving Workplace, Client, and Policy Disputes
by Susan S. Raines
Wiley, 2012

The suit, filed in U.S. Federal District Court, alleges that current FDA policy, which permits such altered foods to be marketed without any testing and without labels, violates the agency’s statutory mandate to protect the public health and provide consumers with relevant information about the foods they eat.

“Best of Growing Edge: Popular Hydroponics and Gardening for Small Commercial Growers” by Tom Alexander, Amy Knutson, Matt Harrington
from Best of Growing Edge: Popular Hydroponics and Gardening for Small Commercial Growers
by Tom Alexander, Amy Knutson, Matt Harrington
New Moon Pub, 2000

Oktay Kutluk

Kutluk Oktay, MD, FACOG is one of the world's foremost experts in fertility preservation as well as ovarian stimulation and in vitro fertilization for infertility treatments. He developed and performed the world's first ovarian transplantation procedures as well as pioneered new ovarian stimulation protocols for embryo and oocyte freezing for breast and endometrial cancer patients.

Mail: [email protected]
Telephone: +1 (877) 492-3666

Biography: https://medicine.yale.edu/profile/kutluk_oktay/
Bibliography: oktay_bibliography

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47 comments

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  • The FDA IS A PAID OFF AGENCY FOR THE PROMOTION OF OF OF PHARMACEUTICAL COMPANIES. WHO DOES THE FDA OR WHAT GUVES THEM THE RIGHT TO PROTECT PHARMA. FUCK THE DEA & PHARMA COMPANIES. TIME TO REMOVE THE PHARMACEUTICAL INDUSTRY. WE GET 10’S OF THOUSANDS OF AMERICAN CITIZENS TO MARCH INTO EVERY PHARMACEUTICAL COMPANY & REMOVE EVERY SINGLE FAMILY INVOLVED WITH POISONING THE AMERICAN CITIZENS.
    THEY RUN CONGRESS, SENATE, GOVERNORS, EVERY SINGLE DEA FRAUD. DEA IS THE PHARMACEUTICAL INDUSTRY OF THE SS COSTOPO. SHUTTING DOWN OR MAKING UP FAKE CHARGES TO CONTROL WE THE PEOPLE. NO MORE TIME TO OUT EVERY PERSON WHO WORKS FOR THE PHARMACEUTICAL COMPANIES, THE DEA, & THE MEDICAL PROFESSION, DOCTORS DON’T CARE ABOUT THE PEOPLE, JUST THEIR DRUG BONUSES AT THE END OF THE YEAR. EVERY FRAUD WHO SAYS WEAR A MASK, STAY 6′ APART NEEDS TO GO. THEY ARE WITH BILL THE MURDERER GATES, DON’T BELIEVE ME, ASK OR PULL UP WHAT GATES VACCINE KILLER DID TO AFRICAN CHILDREN. THAT’S WHY AFRICA WANTS GATES CHARGED & PUT TO DEATH. VACCINE COMES OUT WILL BE TO LATE, BUT WE THE PEOPLE ORGANIZE & SHOW UP WHEN THE GATES SS COSTOPO SHOW UP AT A AMERICAN CITIZEN HOMES TO INJECT THEIR POISON, WE SHOW UP IN BY THE TENS OF THOUSANDS, ARMED & READY TO FIGHT FOR OUR HUMAN RIGHTS.
    REMEMBER YOUR EITHER WITH US, OR AGAINST US. BE CAREFUL WHAT YOU WISH FOR. WWG1WGA.

  • As usual, great video. Love that you actually used “fancy shmancy”. I feel like we’re not using enough Yiddish slang anymore these days, and hearing you say it was refreshing. Keep up the good work!

  • The important thing Americans should realize about the FDA approval process of a drug is; 1. The FDA does none of the testing, in many cases they review testing (either done directly or funded by ) the pharmaceutical company seeking the drugs approval…much of the information in these test results has been proven to be manufactured!!!!! 2. A medical patent isn’t awarded unless a drug is a chemical compound (as opposed to natural organic materials) that is unique. 3. It can cost a pharmaceutical company a billion dollars to get a particular drug approved (wonder why we are paying so much for health care?!?!) 4. The FDA is never held accountable for their mistakes in letting unsafe drugs (or food for that matter) become approved. WHAT’S WRONG WITH THIS PROCESS?!?!?

  • Hello healthcaretriage! Thanks for the informative video. I’m wondering if you could do a video about FDA approval of medical devices?

  • Vaccines (like flu) are reformulated every year, so it cannot go this approval process. Which medications are exempt from this multiyear process?

  • The FDA does far greater harm by withholding good drugs and procedures than it prevents by withholding bad ones. We should NOT trust the government to make our health decisions!

  • I wish you had discussed the conflicts of interest inherent in the process. I also think it would have been good to mention that safe and effective does not necessarily mean safer and more effective than the existing drugs.

  • Thanks for the Video! Excuse me for chiming in, I am interested in your opinion. Have you thought about Millawdon Physique Power Trick (search on google)? It is an awesome one of a kind guide for saying goodbye to diabetes minus the hard work. Ive heard some decent things about it and my buddy finally got astronomical success with it.

  • I wouldn’t say hard, but it’s certainly slow. People die while they wait too. So many change.org petitions about the FDA slowness. People should be able to volunteer for trials at any stage.

  • Our society has become so dependent on medicines and it seems as though there is always a new drug, either name brand or generic. So many people just go and buy over the counter drugs to help with symptoms or trust their doctors when they are being prescribed a drug. It seems as though no one ever questions where the drug came from, how it is made or even how safe it is. I myself have never asked these questions or thought twice before going and picking up a new medicine. I will say that after watching this video it is good to know that the FDA does extensive testing on new medicines before releasing them to a public. I never realized how many trials a drug had to go through before it could be deemed as ok for patients to take. It is great that these measures are being taken because if prescribed a wrong medicine a person can become serious harmed by it, whether it messes up their cognitive process or how they move physically. Not only is prescribing a problem but with new drug they have to be careful on what side effects are possible because the side effects cannot outweigh the good the medicine does. I do not like that cancer drugs are being tested on patients who are not responding to normal treatments. I get why it is being done but it just feels as if the weak the desperate are being exploited because they are desperate and willing to try anything. As I said before I understand why they are chosen and it is because they are desperate and are the perfect people to test it on as they already have the disease and nothing else is helping. I just do not like that people with such awful diseases are being used as guinea pigs. I found it very interesting as to how many times data on the studies has to be submitted, reviewed and approved before it can actually go out and be sold. I was quite shocked when he said that it takes fifteen years on average for a drug to be approved. But then again it is that such extensive measures are taken to be sure that drugs people will be buying are safe.

  • If we find ourselves in a crisis such as an epidemic or a pandemic and there is a promising substance which is claimed to be effective, are there any kind of fast procedures for the drug to be approved?

  • the FDA is made up of a bunch of lying hacks. i can not tell you just now much you are made a fool of by these fools.. when we lie and steal it comes back to you. as you grow older you realize this.. and you do not sleep well think about this and never you are always being watched!! again deep inside you know this to be true.. just pretend i do not know what i am talking about!! DO YOUR OWN RESEARCH AND not from FDA or ama or medical fake ou

  • I actually was familiar with this as I have a rare genetic disease that I had the opportunity to join both phase two and phase three trials for an experimental drug to treat it. Currently that drug is languishing in one of the later phases of approval by the FDA and it’s driving me CRAZY! It’s already approved in Europe and I know rare disease drugs are not on the top of the FDA’s radar, but cmon! It’s been almost four years since phase three trials. The community of people who have EPP (my disease) are all pretty close because it’s so rare (and we’re kind of hermits) and everyone who had the control verses the actual product KNEW it, to the point people were pretty excited if they got some mild nausea because they knew they weren’t in the control group. And it’s STILL languishing! There are actually members of the community who have purposefully made a short trip overseas just to get treatment in places like Switzerland. I know safety is super important…but ARG!

  • Is it too easy to get drugs approved?  Read Overdo$sed America to find out.
    Yes spending all of that time and money means research gets fudged to push drugs to market to recoup costs.

  • FDA SUCKS!!!!! Legalize all so we can fucking live and be free to choose. People are going to get there hands on stuff and you can’t stop them. Just Give up. Instead of banning everything just have more drug education.

  • MSB got me here (ASX stock), their shares went bust by 31%, as FDA questioned their data…..

    im here to consider if its a good investment, but first i need to understand how FDA approves drugs…. random hey… thanks for the knowledge!

  • How does the FDA approve a drug? That’s easy. They take as much in bribes as they can from every pharmaceutical company out there to promote their deadly drugs for them. Same way pharmaceutical companies bribe Doctors to over-prescribe their medicine. CDC is worse. They’re drug traffickers. Deadly Medicines and Organised Crime: How big pharma has corrupted healthcare by Peter Gotzsche. Or his Deadly Psychiatry and Organised Denial or just ask any psychiatric drug survivor.

  • I know one of the hot new promises in the future is that instead on one drug for everyone, we can do better targeting.  For example, perhaps a fancy cancer drug will work wonders for me, but the side effects might be lethal to you.  Rather than say I don’t get the drug, it’d be even better if there was some kind of screening-efficacy type test we could take to figure it out.  I’m sure countless drugs haven’t made it through trials when they really should have, if only we’d had a better way to predict who would get unmanageable side effects.

  • Hi!Thanks for ur great channel!You gotta do one on this shocking one, please:  http://www.buzzfeed.com/bengoldacre/deworming-trials

  • Dang i had no clue that it was that extensive to be able to get a new drug approved by the FDA. I will say that it does make me feel more safe that the FDA won’t approve anything before it goes through its 15years of trial and errors… but on the other side people who are suffering from a disease and they hear that theres a new drug that is being tested may not meet the criteria to be in the 1 of 4 clinical trials. If that person doesn’t happen to make it in there then they have no clue how long they would have to wait to receive the drug! thats if it even makes it to the market. Even if it makes it to the market that person who had the disease could have gotten worse or even worse they have passed away because they had to wait 15 years for a drug.

  • Approve manageable amounts of marijuana and powder form of cocaine to be in CoCa Cola and traces of THC in burgers. Euphoria. TIP Harris, Troy, Dell, Sam, Reggie, Dion����������

  • I would love an episode of HCT about psychosomatic diseases and conditions: which ones are thought to be more psychosomatic than biological, what’s the breakdown between the psychological and biological contributors for psychosomatic diseases, and how to diagnose them on an individual basis and how to design RCTs to test for them.

  • The FDA won’t approve any drug or vaccine to cure any disease, because it won’t benefit them, they want us to be sick and depend on them.

  • If they did a video on natural remedies/supplements, it would be remarkably short:
    1) Find substance you’d like to sell and think up a snazzy name. (Inclusion of substance in actual product is optional.)
    2) Develop eye-catching packaging, being careful to NOT make any direct health claims on it (structure/function claims are strongly encouraged).
    3) Bring product to market and cross fingers that not too many people become ill or die from it, because then the FDA eventually will intervene.

  • The length of time it takes to make and test a drug before it goes on the market to patients is new to me. All of the testing and analyses makes me feel better about the drugs that do get approved. The only issue that some people may have a disease where there is that the drug seems to be working, but hasn’t gone through all the testing yet and is not available. Those people with that disease may lobby for early accelerated drug approval to have access to a drug that may work for them. This is a very controversial topic because the side effects and whether or not the drug actually will work is usually unknown. It depends on the situation and specifics of the drug and disease, but usually I lean towards allowing accelerated approval for drugs that are promising, especially if the disease is life threatening. The patients who would use the accelerated drug would be made aware that it may not work and could possibly harm them. For some people, this is their only option and they are at the point where they will try anything.

  • Great video. Very informative. Obviously the way it should go….although apparently it doesn’t always when we follow the next pharma scandal in the news. Still super cool vid!

  • The FDA would rather reject effective drugs than risk allowing an ineffective drug. There’s no bad press for rejecting or postponing a drug’s approval, even though this is deadly.

  • I’m curious how FDA approval compares to the Canadian system. I’ve heard that some of the testing is different, but don’t really know the details. Many drugs get cleared through both, but what does it mean when a drug company chooses to only go through FDA or Canada?

  • In what part of the process do they determine that “people with condition X should not take this drug?” Do they have to cross-check people with the disease with every other combination of conditions?

  • A drug my brother has been taking for crohn’s disease has been leeching calcium from his body and causing his teeth to break. But he’s been told by medical “experts” that medication is the only treatment for crohn’s. I smell a rat.

  • also that lawyer  stuff on tv about death of a drug is usually from  death of like 25 people out of 1000 that used that drug and how they used it and why so that’s another complex one

  • Just to play a little devil’s advocate here….
    1. Drug studies are now typically conducted by the pharmaceutical company looking to get the drug approved.  Conflict of interest?
    2. Politics
    3. The Tamiflu effect.  Though an FDA committee of experts declined to approve the drug citing that it had not been proven effective, FDA administrators overruled them and approved it anyhow citing observational studies.  Over a decade later we find that the scientific evidence presented then is still the same now it doesn’t work and has some nasty side effects.

    I believe the FDA is one of the most corrupt federal department we have.  They play politics, have been suspected (and sometimes directly accused of) accepting payoffs, have attempted a number of grabs towards controlling the vitamin and supplement market, and don’t even get me started with cannabis.

  • If a drug has been tested on animals in another country and the company would like to export it to the US, does the drug need to undergo another animal test in the US or the current test results are honored by FDA?

  • general shepherd the Alex Jones show https://youtu.be/A9MniUKCiyw and nyc democrat says hcq saved his life https://youtu.be/OFJF0Q9FBEo from timcast

  • you need to mention PDUFA acceptance not just NDA acceptance in this process as that’s another 6-9 months AFTER nda acceptance before it’s cleared to even hit the market. NDA acceptance is less strenuous compared to PDUFA acceptance.

  • The FDA needs to look are the different peoples youtube post about Ciprofloxacin 500 mgs,antibiotics,, how they say it has destroyed their life………….many many people left with neuro problems,,,its is not safe to take anything,,,and they take our pain meds away,,,FDA<<

  • I was trying to figure out how to send a private message via the YouTube page or the Facebook page and on my phone was not able to find one.

    I have been a fan of this channel since it was suggested from Scishow (I think?)

    May I suggest the topic of Glaucoma as a subject for an up coming video?

    I have been battling this since 6 years old and would love to hear a healthcare providers view on this chronic disease.

    Thank you for your time
    Yours truly
    Angie

  • Decent summary, but it may be misleading. Yes, the drug approval process is-and should be-rigorous. This doesn’t mean concerns about corruption in and ineffectiveness of parts of the process are unwarranted or that costs in the US (relative to other developed nations’ drug development, manufacture, and distribution costs) are justifiable.

  • Remember this?  ““It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as an editor of The New England Journal of Medicine.”  Other studies have shown as few as 1/3 of results are reproducible.

  • it only gets approved if there are side effects worse than it’s purpose. so they can go ahead and make another drug to cure your side effects, and that’s how you end up with many various drugs you have to take for the rest of your life.
    But mainly the drug has to be expensive so they can make as much money from your health.
    (think about this) why would they cure you if they are making billions keeping you sick. open your eyes.
    the best cure is being healthy build up your immune system let your body heal itself.
    Most doctors are here on a quota they need to prescribe you this drugs. why aren’t doctors here to talk to you how to prevent from you getting sick. all they do is prescribe (MONEY) get it. they want your health to make money.
    last thing you heard this I’m sure, this dr has his own PRACTICE, he owns a PRACTICE. they are using you to PRACTICE on you all this Drugs keeping you sick keep bringing you to the Dr and making more money from your health.
    eat clean detox your body build your immune system up live long.

  • I think the system could dramatically be improved by having different “grades” of approval. Where the safest or most effective drugs get an “A” rating and drugs that are less effective and safe get lower (i.e. “B”, “C” etc) rating. Because some drugs that dont reach stat significance in efficacy do work for a good percent (20-30%) of people. And if you are refractory to all other meds, maybe taking a class B or C drug would be better than taking none at all

  • I was expecting you mention the crucial difference between a phase 2 study and a phase 3 clinical trial (methodological rigor, not only sample size). Many physicians, institutions and even countries (where regulations are not that strong) make clinical decisions based on phase 2 studies.

  • So you are reason long term patients are dying?Who is the doctor for chronic pain. It is better to cry than help me a person who has been perfect patient for 30 years and Paid all that money, your day is coming.

  • FDA steals cures and puts them in a grave.
    Such is the case against Dr Burzynski.
    Kessler is worst than Hitler and Stalin.
    FDA should approve holistic and homeopathic remedies. The way it was before the Rockefeller’s and Rothschilds. Damn them.
    They outlawed natural remedies.

  • Is there any concrete evidence of corruption in this process (bribery, corporate intimidation, expressive lobbying to get a drug approved/disproved, etc), or is that all just hot air from “big pharma” conspiracy theorists?

  • I’m currently taking Pharmacology and this was extremely informative. Thank you.
    also, Can you please tell me where you purchased the Skeleton Teddy Bear in the background? It’s ADORABLE!!!

  • Dr. Carroll, there is an interesting Opinion paper published by Nature Drug Discovery in 2012 talking about the costs in time and money to approve new drugs. It helps understanding why we have billions being spent on research these days, without having a significant number of newer drugs entering the market. This is the link:
    http://www.nature.com/nrd/journal/v11/n3/full/nrd3681.html