New FDA Food Detention Powers Could Endanger Your Access to Food and Supplements
November 29, 2011
They no longer need evidence that a product is harmful. Just a suspicion that there’s an error in the paperwork.
The Food Safety Modernization Act (FSMA) was signed into law on January 4 of this year. For the past several months we’ve been sharing our concern over one of the FSMA’s mandates that eventually developed into the disastrous NDI draft guidance. There are only a few days left to tell the FDA what you think about these new anti-supplement rules—FDA’s public comment period ends this Friday, December 2. Please take action today, if you haven’t done so already!
There is another rule mandated by the FSMA, which is currently being implemented, that we also want to highlight. It gives the FDA wider authority to detain food products, including supplements. Under the previous law, in order to administratively detain food, the FDA had to show “credible evidence” that a food presents “serious adverse health consequences or death to humans and animals.” The new rule gives the FDA enhanced authority to detain any food or supplement they have “reason to believe” may be “adulterated” or “misbranded.”
Using the vague terms “misbranded” and “adulterated” as a standard to detain food is extremely problematic. It gives the FDA too much discretionary power against small food companies and dietary supplements and potentially allows the agency to detain food and supplements on even minor violations. Under the “adulterated” or “misbranded” standard, a farmer’s paperwork error could be treated just as harshly as a multinational corporation that knowingly sells tainted food.
As we’ve reported previously, a food or supplement may be considered “adulterated” under the Federal Food, Drug, and Cosmetic Act if some vaguely written FDA rule is deemed to have not been followed. “Misbranded” can mean that the producer makes a completely true statement about the product but without FDA permission. A cherry producer who cites peer-reviewed scientific research from prestigious universities on the health benefits of cherries would, in FDA-speak, have engaged in “false” and actionable “misbranding” which suddenly turns the cherries into drugs. Producers, of course, have the right to take cherries through the vastly expensive new drug approval process!
“Administrative detention” means that the FDA can now act without judicial oversight. It doesn’t even have to be true, since the FDA merely needs “reason to believe” that the product is misbranded or adulterated. This makes it an extremely subjective process. By its own admission, the FDA estimates that up to 48% of food detained could prove not to have been adulterated.
The food or supplement can be held for up to twenty days, with a possible ten-day extension if FDA wishes to initiate legal action. Many food products are perishable in that amount of time, which would have a severe impact on business, especially small businesses that could not cope with the loss.
This new, broader FDA food detention authority opens the door for the FDA to abuse its power and hold any supplement they believe has not filed an NDI notification. If the proper notification paperwork has not been submitted and officially accepted by the FDA, the agency considers them “adulterated” supplements—even though FDA’s interpretation of what a New Dietary Ingredient actually is and what the NDI notification process is supposed to entail are clearly contrary to what Congress intended when they passed the law. It also flies in the face of common sense.
This makes it extremely important that the NDI guidance be revised. As it stands now, the rules ensure that most dietary supplements will be found in violation of the FDA’s ludicrous interpretation of the NDI notification process.
There are only a few days left to make your voice heard on this absurd NDI guidance. If you have not done so already, please send the FDA your comments today!
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Pre-market safety of food is not the FDA jurisdiction. I believe the FDA should be challenged on this legally. This is the USDA mandate. The FDA should not censor foods or dietary ingredients just because they are presented in different packages, quantities, or combinations. This is onerous.
The FDA approves drugs which cripple and murder millions around the world. This tax-payers supported institution wishes to protect the interests of Pharma, working, more or less behind our backs to turn supplements known to work into expensive drugs. The pharma has been heavily involved in pulling extracts out of herbs and foods and giving them different names. These products will be very expensive, and it will never be as good as the entire plant.
I am most concerned as I watch our rights being stripped from us that now nature itself is coming under “attack”. I have turned my health completely around by making my own personal decision to stop catering to the alopatchic approach of treating a symptom. I research everything thoroughly, use herbs and other holistic means of taking care of myself. No one talked me into it – it was MY OWN personal decision. This is supposed to be a country where you have the right to choose. Everyday more and more people are waking up and taking responsibility for their bodies and their health. We do not need anyone to do this for us.
I agree with all of the above. I also believe that the silly, stupid, rediculous, insane, unscrupulous, dumb, dam, idiotic law that states that only a drug can treat or cure a disease must be struck down. If a food is deemed a remedy or cure, it can then be classified as a “drug”. A food is a drug? That is senseless. But big pharma can take that food and tweak it and make it into a pharmaceutical medicine complete with nasty side affects and charge an outrageous price for it, in the the complete confidence that the puppet FDA will approve it. Not only that, just think of all the poor animals that suffer needlessly in the name of research.
Please leave our supplements alone.
Why don’t you (the Goverment) leave us alone, and let us buy what we want.
The FDA approves medication that can kill you, get you addicted and has terrible side affects… They don’t want people to know the truth about healthy alternatives because it would run the drug companies out of business.
Where has our rights as Americans gone? Is is sad that we are becoming less of a democracy and more of a dictatorship. Some of our elected officials are swayed by large companies with highly paid lobbyist and lawyers who not only dictate and mandate laws but make it criminal to do otherwise. This type of mandatory dictatorship first started with the small mom and pop farmers as oppose to the mega ranchers. Now the FDA and the large pharmaceutical companies are doing the same thing….WHY, because people who are informed, who take control of their lives and health are contagious. We share our knowledge. We seek out alternative methods to maintain our longevity and health. We don’t blindly believe all the hype that is printed in the media and advertised on TV regarding the latest ‘WONDER’ drug. We the informed consumer are hurting the pharmaceutical companies wallets, which is why they are in alliance with the FDA. If our concerned elected officials continue to allow the FDA to legislate, regulate and mandate the use of natural vitamins and supplements, while allowing unsafe medications flourish, healthcare will truly become a crisis EPIDEMIC.
God placed all we need in natural form to nourish our bodies. I don’t understand what the FDA are trying to do allowing the drug companies to over flow us with chemicals. Get off our backs and let us take charge of our own health. I’ve been on different meds for blood pressure. Nothing works,you know I am going natural now.
HERE IS A SIMPLE REPLY. As John Lennon wrote,” Give power to the people”. We know what’s best for us AMERICANS,more than the government beaurocracies, including now the marriage of the FDA and the pharmeutical industry. A courtship that has been going on for years, and now are ONE. All their interested is, power and money, and not the public’s interest and well-being. That is not democracy, it’s socialism.
Remember the saying not broke don’t fix it? This is worse than before. Giving this much power to an agency starts always has grave consequences. Unfortunately, it is going to be the health of the people in the United States of America that will suffer. People are smart. We can make good decisions on what we need. We don’t need the FDA making those decisions for us. Putting a Big Brother watch is going to limit our freedoms. This new, broader FDA food detention authority opens the door for the FDA to abuse its power and hold any supplement they believe has not filed an NDI notification. I see abuse of power coming up. Lets stop this abuse of power before it actually happens.
do not take away our freedom to purchase healthy vitamin supplements and food instead of forcing us to use pharmaceutical drugs. do not take away our choices, we want to live healthy lives.
I don’t want the FDA telling me what supplements I can take and what to do and what not to do. We need our Freedom and where are our rights? We want our supplements and to choose which ones that will help our health.
I do not want the government or any so called “health agency” that does more harm than good to control what I take. The organic supplements and foods are better, leave them alone. If the public has any complaints they will tell you. Stop playing god and trying to control everyone’s lives. Your system is becoming more hazardous for the public than if we didn’t have any control.
I am completely shocked and disgusted with this NDI guidance being proposed. It goes against the original purpose of why the FDA was created to begin with. The health and well being of the American citizens is the only purpose of FDA. The profits of the pharmacuetical and big aggiculture industries are not your puroose or your duty. The actions taken by the FDA are hostile to the health and well being of AMERICAN citizens. If you cannot serve America then this agency needs to be completely overhaled so it can get back to the original purpose for its creation. I wonder if you people at the FDA have any conscience at all. Do you not care about the American citizens?
People have the right to take care of themselves and eat healthy and be proactive in their mind/body health. We have the right to choose.
i should,in this country be able to buy supplements,herbs and any other food product that comes from the earth!Instead it seems i have the right to buy chemical compounds that may harm me over time becuase there is more of a profit to be made ,this is sad.We should at least have the right to choose which to buy chemical or supplements/natural holistic products or not.It should be our choice not yours.
We have a right to protect our families from what the government allows to be placed in our food and our bodies. PLEASE STOP THE GOVERNMENT FROM CONTROLLING OUR SUPPLEMENTS AND OUR HEALTH !!!! Please our families fought all these years for our freedom. Then have those very freedoms that they died for striped away from us? This is so sad no words for this at all. This is USA this stands for freedom !!!!!!!!!!
I find it laughable that the FDA is going to start quashing supplements yet allows the massive pharmaceutical machine to continually advertise to sell drugs most don’t need and often have side effects that are worse than the original problem. If the FDA were truly serious about protecting the public’s health, they would have banned tobacco decades ago. Leave my supplements alone and re-regulate drug advertising!
Are you seriously thinking this is a good move? You approve GARBAGE food for us to consume that have almost NO nutritional value and you want to take away what we can take/do to help us get the nutritional value we should have??? PLEASE tell me where does this make sense????!!!!!
I feel better by the choice of my supplements, etc. Please do not regulate what that choice is.
Please, please, leave our supplements alone!
NO! to NDI draft guidance. NO! to FDA excepting funds from pharmaceutical companies.
Not allowing people to make informed decisions ties our hands as individuals. As a society, people have been making up their own minds for centuries, even before science or religion. It’s an unfunny joke to allow this corporate mindset to drive our ideals and feelings towards the planet and each other.