Q: When is a food not a food? A: When the FDA twists an old law to its own ends. Action Alert!
According to the Food Drug and Cosmetics Act (FD&C), originally passed in 1938 and amended many times since, any “article (other than food) intended to affect the structure or any function of the body” is considered a drug.
In the FDA’s recent guidance on new drugs (INDs) that we’ve been telling you about, the agency has come to the rather bizarre conclusion that conventional foods (including medical foods) may only make structure/function claims under limited circumstances. Specifically, the structure/function claim must be related to the product’s “taste, aroma, or nutritive value.”
This tortured definition is presumably supposed to rein in food or medical food producers from talking about weight loss, for example, since such a claim would not be about taste, aroma, or nutritive value. The agency cites a thirty-year-old court case to defend itself from the valid charge that it is trying to legislate on its own without congressional approval.
We have discussed the importance of structure-function claims many times. They are one of the few and very important avenues by which the public can learn about the health benefits of foods.
That the FDA is particularly targeting weight loss, may be inferred from this passage in the guidance:
If an edible product that might otherwise be a conventional food is intended for a use other than providing taste, aroma, or nutritive value, such as blocking the absorption of carbohydrates in the gut, the product becomes a drug because the primary purpose of consuming it has changed. In other words, the product is no longer being consumed as a food—primarily for taste, aroma, or nutritive value—but used as a drug for some other physiological effect.
By way of further example, the FDA explains that a study of the effect of soy on bone metabolism would require the manufacturer to file an Independent New Drug (IND) application. This means that products such as coffee or prune juice may be studied for their impact on digestion, but in order to do so, an IND would now be required. In this way, soy, coffee beans, and prunes would magically be transformed into drugs.
As FDA Law Blog points out, the FDA’s reliance on the very narrow interpretation of the phrase “other than food” is in direct conflict with other case law—and the opinion of the Seventh Circuit Court:
Case law establishes that, in the view of the courts, a “food” may properly make any claim in labeling that is truthful and nonmisleading about a “physiological effect” of the food, including a physiological effect of a component of the food, on the structure or function of the human body, provided that the claim does not represent that the product is intended to cure, treat, mitigate, or prevent disease (which would create “drug” status for the product), and does not “characterize the relationship” between a “substance” and “disease,” “damage,” or “dysfunction” of the body (which would meet the definition of a “health claim” and create separate requirements).
In addition, Congress explicitly legislated a “food” exemption for structure/function claims for a reason. The law’s clear intention is that foods can legitimately make structure/function claims.
This strange interpretation in the IND guidance, combined with the provision in the guidance that we discussed previously—the one that requires companies to start the drug approval process if a nutrient is to be studied for its potential disease prevention or treatment, even if the food or supplement won’t make any related health claims or be marketed as a drug—will ensure an increase in INDs for food, dietary supplement, and medical food research.
INDs are wildly inappropriate for food and supplement research. They are costly (as we have mentioned before, the cost of an IND application is currently about $2.3 million, which then leads to billions more for approval). They’re also incredibly burdensome, requiring:
- A general investigational plan;
- Information and completed forms about the investigators;
- Study protocols;
- Chemistry, manufacturing, and controls (CMC) information about the drug substance and the drug product; and
- Animal pharmacological and toxicological studies and any prior human experience.
Much food and supplement research has been done by university labs. That would no longer be feasible if the FDA has its way.
Furthermore, as we have pointed out repeatedly, foods and supplements (unlike drugs) do not expose the public to the kind of risk that would justify such tight control and monitoring under an IND (e.g., submission of animal and toxicological studies to FDA). Foods and supplements are complex mixtures of many compounds which are impossible to characterize in the way FDA expects for an IND, unlike drug products that consist of a single active compound (and a few other well-characterized compounds).
Even more importantly, no one has ever alleged that food and nutrition research was posing any danger to patients or consumers—and yet this very research is now endangered by the FDA’s guidance. Remember, once an IND for a nutrient has been filed, it may preclude that ingredient from being used as a food or dietary supplement at a later stage.
We spoke with Matthew Vukovich, PhD, who chairs the Department of Health and Nutritional Sciences at South Dakota State University. He believes that INDs should not be required at all for food research. He says his department is delaying research while they try to seek clarification on the FDA’s requirements.
A number of researchers are trying to convince the FDA that the guidance needs to be changed. They too say it has severely hindered their ability to conduct food research.
It is bad enough that food and supplements, the cutting edge of health science, cannot make any medicinal claims. But for the FDA to try to stamp out research on food and supplements is an outrage.
Action Alert! If you have not done so already, please contact the FDA and tell them to stop trying to halt food and supplement research! Tell them—and your legislators—that food nutrition research has no part in the drug approval regime. Their guidance is stopping scientific research in its tracks, at a time when we desperately need more research, not less. Send your message today!
It is the big drug companies that are paying to get this passed. Nutrition, supplements keep people healthier and cut into the potential bottom line. We are not fodder for the profit machines!
Food is our medicine … or poison depending on what you CHOOSE to eat … FDA … you have to be kidding!!
80% of ALL Disease is totally preventable by choosing a healthier lifestyle!!
Prevention and Education is ALWAYS better than cure … but there is no money in prevention now is there … if as much money was spent on prevention and education we would have a healthy world of people, but that would not benefit the FDA and their pharmaceutical buddies now would it!
What Criminals! Who is worse the FDA, FCC, the FED or Washington? All the same!
We as Americans are being Lied to and Scammed by our Government!
Our Government hides so much from the people that pay their salaries and we as Americans need a Revolt to get the facts from our corrupt lying Government!
Note: This post has been edited by a moderator to avoid potentially offensive language. We share in the anger and frustration though!
You just don’t want any competition to Big Pharma, who owns you and therefore tells you what to do, what to approve, and who to block. Food Nutrition research has no part in the drug approval regime. You are stopping scientific research in its tracks at the bidding of your corporate masters and hoping we won’t notice….
Please do not take our basic right to food away.
One has to seriously wonder how exactly they will teach history lessons about the ailments affecting the sailors in olden times, who contracted SCURVY because they could not get Vitamin C-containing citrus fruits on a sea voyage.
Dehydration, which can literally kill people, apparently makes water a drug, if we drink it to solve a dehydration problem!
All foods have medicinal value, even when consumed as food. Whether we say so or not, the food is doing what it is supposed to do: supply particular nutrients to fuel and heal the body.
The FDA must seriously be running out of things to do to annoy us all, if they are sinking so low! Time for everyone to make their opinion known… to the FDA itself. Tweet, FaceBook, share, share, and share some more…. ’tis the season, after all…
And for God’s sake, don’t anyone tell them that turkeys are a terrific source of L-Tryptophan, or we’ll all have to suffer with ham….
I think it is useless to contact the FDA. This outlaw illegal agency must be abolished.
This issue is huge, and cannot be overstated. In 2013, fully 40% of all warning letters issued from the FDA were written to food, dietary supplement, and even pharmacy companies making “health claims”. Not one letter addressed allegations that the claims were false. Rather, the FDA addressed in all cases that they were not FDA approved drugs, and therefore claims, whether truthful or otherwise, were banned from websites, labels, literature, etc.
Keep up the great work of keeping us informed, ANH!
Since food is used to not only provide energy to survive but to provide particular nutrients to make our body processes synergistic, it would follow that scientists should be sanctioned to research foods as well to determine what foods prevent, control or reverse diseases would be not only logical but imperative.
For the FDA to make such studies onerous to place obstacles to prevent or impede studies to determine food and common supplements on the market medicinal value is troubling and runs counterintuitive to the mission of your agency. It would seem that such stalwart end runs around laws to prevent people from learning about affordable alternatives to consume foods, herbs, spices and supplements rather than synthetic pharmaceutical to control, prevent or reverse disease, is rooted in an agenda that suggests collusion with fiduciary interests surrounding pharmaceutical companies. This agency was suppose to protect citizens from companies hocking their medicine that put people at risk, not keeping folks from eating foods and other naturally available herbs, spices and supplements that could potentially cure illnesses. It seems the FDA is instituting these research criteria to protect pharmaceutical companies from competition i.e. if people reverse illnesses just by eating a particular food, pharmaceutical companies would lose their relevance and monopoly treating diseases and chronic conditions.
Make it possible that we as consumers can have healthier alternatives to treat illnesses rather than rely on dangerous pharmaceuticals.
I filled out the take action form regarding FDA and food, but there was no send or submit button so I don’t think the message got through.
I don’t know what is happening but when I try to take action my computer automatically leaves the site and goes to a generic site. I cannot do anything about taking action, I don’t know if it is my computer or what the problem is.
Thank you for reaching out to ANH about this issue. We’re aware that some of our members are misdirected when trying to take action, and we hope to have this completely remedied with a new forthcoming website. In the meantime, we’ve been told that clearing your browser cache or trying a different browser will give you access. Thanks so much for your patience and supporting our efforts!
When you have the fox guarding the hen house what can you expect? No one in the FDA should have ties with the White house, no vested interest in the pharmaceutical industry, and no toxic chemicals industry , just people like the common American housewife feeding their family. It is interesting the first family only eats organic something the rest of us can not afford. It infringes on our right to freedom of the press and freedom of speech not to label our food with GMO labels and recommendations of food to alleviate disease. Instead we are told we must follow the foot dragging associations biased views on labeling and make anything illegal that does not benefit them.
Supplements should be exempt from INDs. They are not food. They are not drugs. They are supplements to be used in addition to food. Why do we always take things from one extreme to the other. See this for what it is. Another attempt to regulate unnecessary things. Anything is bad in excess. Taken reasonably there is no harm.
It’s past time to cease and desist your foolishness and do the job you are paid to do.
Perhaps it is time to drastically change the way the FDA conducts “business”! They should not receive what I consider “kick backs” from the drugs they accept for public consumption. In all other parts of government, this form of bribery would be prosecuted! Nothing is done to those who accepted the deadly drugs that had to eventually be yanked off the shelves!
Mandating and even calling GMO products “food” without in depth study on the physiological effects of long term studies is another sign of the unconscionable hold that big Pharma and corporations have on them!
Food is a natural product that other cultures such as India have used as natural medicine to aid the discomforts and infirmities of man since time immemorial. To now assign a careful script of what claims can and cannot be made is ludicrous! Further showing the stranglehold of greedy corporations.
We have the right to know what we are eating. Americans want the right to know if there are GMO in our food and supplements. GMO are the root cause of a lot of health issues with humans and animals.
folks.. regarding “take action” on ndi for food research takes you to site “secure3.convio.net”. Have not been able to take action. please advise. I will keep you anh-usa post for a few days and keep trying to take action. Thanks, Anthonie
Thank you for reaching out to ANH about this issue. We’re aware that some of our members are misdirected when trying to take action, and we hope to have this completely remedied with a new forthcoming website. In the meantime, we’ve been told that clearing your browser cache or trying a different browser will give you access. Thanks so much for your patience and supporting our efforts.
Stop trying to halt food and supplement research. Food nutrition research has no part in the drug approval regime.
Best regards
Marit Pettersen
food nutrition research has no part in the drug approval regime. Their guidance is stopping scientific research in its tracks, at a time when we desperately need more research, not less.
Foods, herbs and anything else that grows have no place in regulations.
Nutrition is preventative. Please consider the people that would benefit the most. Those of us lower income. Must be more nutritionally sound. Do not placate the pharmaceutical industry
Apparently their concerns are conflicted and not in the best interest of your/our public.