The agency is deciding what to do about “old” supplements—tell them what you think! Action Alert!
Last year, we told you about the FDA’s massive attack on supplements that came in the form of a guidance document. That guidance is meant to provide clarity to supplement companies regarding “new supplements”—referred to as new dietary ingredients, or NDIs.
Federal law requires companies to submit a notification to the FDA before an NDI is sold in the US. Federal law also defines a NDI as an ingredient that was not marketed in the US before 1994—meaning that supplements marketed before 1994 are “old dietary ingredients,” or ODIs, for which no notification is required.
This leaves the question: how will companies know which supplements are considered NDIs and which are considered ODIs?
The FDA is asking for feedback from the public on whether or not to develop an official list of ODI ingredients.
While the creation of an official list may sound like a good thing, we think it’s possible that the FDA would use such a list to target supplements. FDA inspectors could simply go to a vitamin store with their ODI list, and anything that is either not on the list or doesn’t have an approved NDI notification would be wiped off the shelves.
ANH-USA has prepared comments to submit to the FDA that make the following points:
- As FDA staff have themselves pointed out, no law requires the creation of an ODI list; therefore, no ODI list should be created;
- If the FDA does decide to create a list, the omission of a supplement from the list should be “neutral”—meaning the exclusion of an ingredient from the list does not automatically make it an NDI;
- The list should never be closed, accepting new ODIs on a rolling basis;
- The FDA should broadly interpret the term “marketed” when creating an ODI list. The FDA has maintained that, for a supplement to be an ODI, it needed to be marketed in or as a dietary supplement before 1994. This excludes many nutrients that were in the food supply but not listed on the bottle of a supplement. Instead, the FDA should consider ODIs to be dietary ingredients that were sold, in any form, before 1994.
The FDA’s proposed NDI notification process remains one of the largest threats to the supplement industry ever. A win here would be a significant step toward fixing the mess that the FDA created.
Action Alert! Write your own message to the FDA, urging them to follow the course outlined above. Please send your message immediately.
No surprise; the government supports the pharmaceutical industry that hates safer options. I have been expected dead already four times. Currently I am reducing prostate cancer with herbs after refusing surgery and drugs. We have a right to make our own choice regardless of the consequences.
Make sure you get full body sun – use full spectrum sun lamps if it’s too cold or stormy outside.
while u r at it ,Marvin , look into the cures of cancers with cannabis oil . Check out , Rick Simpson,s , ” Run from the cure ” . You will find this very very beneficial to you . Gd luck …..
Also check out PuErh tea. This is dandelion root and has shown scientifically to kill up to 98% of all cancer cells. It’s available at almost any grocery or health food store.
actually, puerh tea is black tea that has been fermented in its processing, making it even more healthful than just black tea itself. Dandelion root is good for the liver, thus helping it to detoxify the body and strengthen it to fight off diseases.
I am with Marvin. I have an infection, pre-sacral abscess, which has been surgically removed twice. It came right back-now with fistulae. I am using herbal tinctures & looking into phage therapy in Tbilisi, Georgia, to overcome this. Another open surgery would kill me outright. All MDs tell me,”Get surgery now” or die. I’d rather not die from doctors & have my insurance pay for my death to be inflicted on me. I got C. Diff from the first surgery. I was very lucky to make it through that. Our medical system is horrid! A nightmare!
I got C. Dill after surgery and cured it with “zeolites”. The meds that big pharma uses on C. Diff causes Cancer and they don’t work all that well either.
The FDA IS THE TERROR FORCING POISONOUS DRUGS AND HELLISH “TREATMENTS” ON NAIVE, AND VERY IGNORANT, HELPLESS PEOPLE..You must be an innocent young kid, or just an old moron to volunteer to be another FDA health-system trapped lab-animal.. LEARN FROM MILLIONS WHO SAVED THEIR LIFE WITH HELP OF MOTHER-NATURE !! EAT ORGANIC ONLY, non-GMO food, do not expose your kids and pets to Geoengineered deadly poisonous “clouds” in the sky!! Get well.
I AM A HEAVY SUPPLEMENT USER. I HAVE BEEN FOR A GREAT MANY YEARS.
I AM 72 YRS. OLD AND PEOPLE DON’T BELIEVE ME. I CAN DO THINGS THAT A 50 YR OLD CAN’T DO. I AM QUITE SURE I OWE I ALL TO THE SUPPLEMENTS AND THE HEALTHY FOODS THAT I EAT. I HAVE ” NOT ” EATEN IN A RESTAURANT IN ABOUT 5 OR 6 YRS, NOW.
RESTAURANTS FOODS ARE SLOP AND BAD FOR THE SYSTEM, CHEAPLY MADE, ETC.
OH! I CAN AFFORED IT AND I AM NOT CHEAP EITHER. I GO ORGANIC FOODS, OR FOODS THAT IS GOOD FOR THE BODY’S HEALTH. NO, I DON’T HAVE A HEART CONDITION, OR ANY
THING LIKE THAT. SO, START TO DAY YOU WON’T REGRET IT. IT’S YOUR HEALTH IT’S
UP TO YOU. WHAT HAVE YOU GOT TO LOSE?
LETS TAKE ACTION AND SAVE THE SUPPLEMENT WORLD. IT IS A HEALTHY THING TO FIGHT FOR.
I am, right there with you. I have used herbs, oils, teas and acupuncture, for years. At 69, I am in “perfect” health and continue to work part-time. For Christmas, I bought myself a new chain saw. What does that tell you?
Good for you, Cheryl! I am 65, work full time, have taken supplements & herbs for years! Just bought a stand for my heavy bag to keep up my fitness & practice of taekwondo!! Have practiced martial arts since age 19!
Dear FDA, your agency is corrupt and a rotton group of MF’s who are on the take! Why don’t you stop Monsanto for poisoning our food source with GMO’s and poisoning our environment with round up and stay out of the business of people who want more, than to be controlled by MF’s on the take who have no right to do so. We are screwed in this country. We have big Pharm poisoning our children with aluminium, mercury, animal embreyo in vaccines, we have MD’s paid off by Pharm and Insurance companies to inject these poisons into our children. We have big pharm who are responsible for the opiod epidemic in this courtry and we have Monsanto paying their way into our government agencies. Instead of trying to interfere in our business, why don’t you take responsibility and clean up your horrible agency.
FDA: Keep your filthy hands away from our supplements.
Instead, go after the huge corporations poisoning the world.
I think the FDA and any others trying to continually take over all of our various supplements and herbal health foods should just leave Gods bounty alone and let those that are in the know about REAL health benefits continue to use their labs for sorting out ways and means toward healthy ways to help diseases, etc and leave them alone. If any are crooked and money hungry instead of caring about others, then those people do need to be looked into, as does some medical people, including the FDA.
Please leave our vitimins and supplements alone, this is suppose to be land of the free, yet your trying to force us into taking poisons, so Monsanto can profit and people will get sicker.
I am not the least bit surprised that the FDA is doing this all over again. They do not want the
American people to be able to make our own choices. No one will tell me what I can and cannot take whole food supplements to stay healthy. And how about all the toxic drugs out there on the market why aren’t they being taken off the shelves? I will tell you why..$$$$ it is all about the money trail. This is why there are so many more medical centers and hospitals being built because people refuse to take their health into there own hands; instead they listen to everything their doctors tell them to do and to take. My mother is on so many drugs she is 92 and a slave to the M.D’s. We must all fight this fight and speak out. We still have a voice then we got to use it.
You may need to grow your own herbs pretty soon.
Why do you think you have a right of access to dietary supplements? In a previous lawsuit against the FDA brought by the Farm-To-Consumer Legal Defense Fund, the FDA responded with these statements:
“There is no absolute right to consume or feed children any particular food.”
“There is no ‘deeply rooted’ historical tradition of unfettered access to foods of all kinds.”
“Plaintiffs’ assertion of a ‘fundamental right to their own bodily and physical health, which includes what foods they do and do not choose to consume for themselves and their families’ is similarly unavailing because plaintiffs do not have a fundamental right to obtain any food they wish.”
If the FDA believes you have no right to choose what you want to eat, by that same logic they contend that you also have no right to choose what supplements (if any) you want to consume.
As the Life Extension Foundation aptly named their book – “FDA: Fraud Deception and Abuse.”
The FDA has no right to make any law they wish. God gave us the right to freely choose what to put into our bodies, what food to consume, and whether or not we wish to avail ourselves of their toxic “medical” care. To deny us the right to self medicate is to deny us life, liberty, and the pursuit of happiness. The FDA can go stick it where the sun don’t shine. We are NOT their slaves, we are their MASTERS!
There is a time of trouble coming soon. Get ready now and get outta the cities ASAP. Get a garden spot and raise your own food (and herbs). Time is short so move fast.
If the FDA does not want to honor fundamental human rights, then the “officials” who comprise it will find out that “we the people” don’t recognize any fundamental right for federal agencies to exist.
you are barking up the wrong tree. Get out of the cities now while you still can.
Many citizens are taking action creating Bills gaining victories within their State laws for farm to consumer sales and removing Federal and often times State’s regulations. As my state just passed food freedom but each constituent must actively approach each town they reside in to support and enact as well.
Get out now while you still can. Your running out of time, so get a move on.
LOL I live on over 100 acres of wilderness in the woods. Surrounded by organic farm community. Fortunately, Thanks though
Wake up folks, time is short.
Leave my supplements alone!
Years ago, many older people I knew told me that the reason for their good health: keeping out of doctor’s offices. It is amazing how many today totally trust the government and their minions, when 1 out 2 will get either heart disease or cancer; or both. When America spends more on medical care than any other country. When the 4th leading cause of disease…is legal drugs. It is incredible that supplements are being targeted. It shows the total stupidity of the FDA who is not aware of the poor agricultural tactics which leave our soil devoid of nutrients. They need to go after Monsanto’s Glyphosate, which is destroying organisms in the soil, which make nutrients in the plants. There is very little value in all that food sitting on grocery shelves all over America. The only place most Americans would be wise to shop…in produce sections…and hopefully buy as much organic as possible to avoid produce which has been sprayed with toxic poison, which doesn’t wash off. I have been guided to use supplements for years, but make sure they are manufactured by reputable manufacturers. It’s disturbing that vitamin supplements, are challenged, but known killers like toxic legal drugs, tobacco and alcohol are dispensed so freely.
The government will never save you. Get a small farm out in the country.
You are so right…However, I would love to have an orchard. Fruit is my favorite food. We are thinking about growing fruit trees in the near future.
The FDA sould be disbanded, and two new administrations created, one for food, and one for drugs. The two new admistrations should be independent of each other.
The USDA FDA and EPA are actively disbanding the NOSB with corporate patented ingredients.
I met people who survived leukemia, liver, pancreatic cancer because they actually lived on stabilized Aloe Vera, taking Bee Propolis, Bee pollen 20-30 pills a day. Doctors in USA don’t believe that it is possible, even their colleagues in Europe treat people with what helps to restore body’s functions.
The corruption between the CDC, FDA and big Pharma is such a horrible and disgusting Act of treason against the good people of our country. Using fraudulent science harassing their own scientists and whistleblowers to protect profits while knowingly harming the public.
Endless fraudulent claims and rigging the system so that there’s no recourse there’s no checks and balances there’s no accountability there’s no responsibility it just evil. Liars, thrives, murderers. The funeral directors of America.
In Jesus name I Pray for Good to Prevail over evil in all sectors of our country. Amen.
The FDA needs to mind their own business, if we want to take supplements we should have that right. I’d like to know what you do with the money you get from Big Pharma, why do you get to own stock in the pharmaceutical co.s? Do you help Big Pharma kill the natural cure Dr.s? I already wrote President Trump about all of the natural cure Dr.s that have been murdered, and he had someone in the WH within 10 days.
“he had someone in the WH…?Who And what did they do? Have you received a reply?
I have read that he has let the FDA know that he is going to have them checked out. I didn’t get a reply on that but have on other issues. So many of the cases law enforcement claimed that they were suicides, when it didn’t even make sense. A Dr. in Col. was giving IV turmeric treatments for cancer and the FDA went in and closed him down, he even prepared his own turmeric.
Did you know that when Reagan did his “Take Down That Wall” speech in Germany that he went there to get treated for 3 kinds of cancer, by using Hyper-baric oxygen, it kills it at a cellular level and it doesn’t come back?
Thank you Camille for speaking for these threatened and deceased natural compassionate healers my heart don’t stop breaking …knowing.
I pray R Kennedy Jr will be appointed chair a new Scientific Integrity Committee.
As I often shop I always come across vitamin supplements on shelves. Sometimes I buy what only pertains to my healthcare needs. But on the other hand there is the label stating that many of them have not been approved by the FDA (Food and Drug Administration). So the question that always arises within me; is why are the manufacturers of these supplements allowed to sell their products if none of it has been approved by the FDA. The another question that arises in me; is why don’t the FDA find a way to remove these products from the shelves.
Are you serious? The FDA states that no natural food herb vitamin mineral etc is medicine. Medicine in USA is only by U.S. costly non-organic R&D patents
Anything not tested and approved by the FDA should not be trusted. Everyday it is being found out that allot of prescribed medications that were issued to patients has horrible side-effects. Even though approved through FDA, its was stilled prescribed, and they new in advance of the bad side-effects. It is good that through court settlements the FDA can be held accountable for their actions and these bad meds can be removed from pharmacy shelves and destroyed. I know by personal experience of previous meds prescribed to me by a private physician and through veterans affairs department that had very bad side-effects were removed from their treatment plan regarding me, and many others, are no longer being prescribed to other patients.
We probably would not be having such issues as these if we could actually hold the FDA accountable for their actions. They are supposed to be the people’s watchdog against dangerous practices in the food and drug industries. Maybe we should make them just watchdogs, remove all of their abilities to create policy and rules, and limit them to just investigation. They would then have to report their findings to a congressional committee that would determine what rules need added, removed, or changed. That should add accountability. Since the members of this committee would be elected officials, the people would be able to remove them if they mess up, whereas we cannot do this with the FDA.
I wonder if tweeting at Trump or the white house would be helpful. This administration is keen to lower regulatory burden on companies. Surely the fda is on their radar…
I suggest transmitting to the White House demands via facsimile, telephone, U.S.P.S. Mail and FedEx that this regulatory activity be suspended and the regulation itself be rescinded.
The White House
1600 Pennsylvania Avenue NW
Washington, DC 20500
PHONE NUMBERS
Comments: 202-456-1111
Switchboard: 202-456-1414
What about the 250,000+ plus deaths associated with the FDA’s two CASH COWS?
Doctors and the pharmaceutical industry??
Now they want to kill the health supplement industry and Osteopaths on OUR side. Do you see how useless and against you your OWN government has become??
Harassing with illegal and unconstitutional taxes and trying to do the same with gun ownership. How did they manage to TWIST the Constitution?
No, not they ignoring it. It was YOU. Read your Constitution and only FOLLOW what’s in it when they decide to go ROGUE.
This is what happens. You went ROGUE like they did.
The gig is up. It is almost past time to get out of the cities and get a small farm in the country. Raise your own food (and medicine) ASAP.
We have a right to choose.