FDA Attempting to Restrict Medical Foods

August 20, 2013
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medical foodsWant to manage your diabetes this way? FDA says no. Action Alert!

“Medical foods,” by federal definition, aren’t simply a diet plan prescribed by a doctor. They are foods that are specifically formulated and processed for a sick patient. They form a separate category from conventional foods and dietary supplements in that they are intended to meet specific nutritional requirements for the management of a disease or condition, and are used under medical supervision. These foods can be consumed orally or through a feeding tube.

Medical foods do not require FDA premarket approval. Manufacturers of such foods can make disease claims, which means they are exempt from the labeling requirement for health claims with its demand for random controlled trials. Medical foods do, however, have to follow current good manufacturing practices (cGMPs), facility registration, and other normal safety requirements.

The FDA has just issued an updated draft guidance on medical foods, and this new version drastically limits the number of medical conditions that medical foods can be used to manage. The guidance now uses “inborn errors of metabolism” (IEMs) to determine which diseases or conditions are included on the list. For example, inherited biochemical disorders in which absence of an enzyme interferes with the metabolism of protein, fats, or carbohydrates would be treatable with medical foods. The guidance excludes diseases resulting from essential nutrient deficiencies like scurvy and pellagra.

Outrageously, the guidance specifically excludes diabetes—both type 1 and type 2, as well as gestational diabetes—because, according to the FDA, diabetes can be controlled by simply managing or tweaking one’s normal diet (along with taking FDA-approved drugs, of course). According to the FDA, type 1 diabetics should use carbohydrate counting or the carbohydrate exchange system to match their insulin dose to their carbohydrate intake. And type 2 diabetes patients should simply restrict calories, eat regularly, increase fiber intake, and limit their intake of refined carbohydrates and saturated fats—in addition to taking prescribed drugs.

This is consistent with the usual FDA stance, which wants there to be as little competition as possible for approved drugs. By contrast, nearly all integrative physicians and even many conventional doctors would argue that diabetes requires very aggressive nutritional intervention, and medical foods can be a vital part of the treatment plan.

Merely tweaking one’s normal diet is not sufficient to provide enough nutrients to correct the condition. Leaving aside our nutrient-depleted soil, there’s the fact that many (or even most) people have extremely poor eating habits. Perhaps it’s because they haven’t been clearly taught about a proper diet for their disease, or perhaps they lack the discipline required to monitor their eating so carefully. Whatever the reason, making a few changes to the standard American diet will almost certainly not be enough to manage conditions like diabetes or nutrient-deficient diseases, whereas medical foods may.

For example, this ingredient list for the medical food for diabetes provides many of the essential nutrients required—including a number of specific vitamins, cinnamon, and plant sterols—all of which are essential toward managing diabetes.

Another problem with the FDA’s guidance is that since medical foods are, by definition, administered under medical supervision, the patient’s physician is fully qualified to decide whether the medical food is required or not. The FDA doesn’t need to override doctors’ judgment and tell them what’s necessary for their patient! Yes, doctors are often remarkably lacking in nutrition knowledge. But if so, the FDA is even more lacking.

Besides, medical foods can be used in addition to an overall treatment plan. We should therefore be encouraging consumer access to as many treatment options as possible. By narrowly limiting the conditions that medical foods can be used for, FDA is reducing patient access to nutritional interventions for disease—something the FDA seems to be doing on a regular basis. Famed health and constitutional law firm Emord & Associates put it this way:

The problem with FDA’s approach is that it eliminates beneficial products from the marketplace, requiring them to either proceed through the drug approval process or be marketed as dietary supplements with limited structure/function claims, thus depriving consumers of valuable information that can improve their health. Although some diseases and conditions that have special nutritional requirements can be managed through diet modifications alone, not all consumers are willing or able to make drastic diet modifications. If FDA’s new position stands, companies could resort to the DSHEA’s health claims provisions to spread information concerning a nutrient’s relationship with certain disease states.

We expect to see some serious pushback from manufacturers on this guidance. Several companies, such as Abbott Labs and Metagenics, are either manufacturing ingredients aimed at medical foods for diabetes, or have complete medical food products already on the market. As one spokesperson put it, “They are drawing a line in the sand which, especially in regard to diabetes, might not be that easy. This is more of a physician question; what if a patient is trying to modify their diet and it’s not working?”

Action Alert! Tell FDA they need to broaden their list of diseases and conditions for which medical foods may be administered, not restrict it! Especially let them know that diabetes patients need this kind of targeted nutrition therapy, and merely tweaking their regular diet is not enough. What we need are better medical foods, not the elimination of them. Another good idea would be to let supplement companies make medical foods, rather than just drug and medical products companies. Please send FDA your comments today!

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34 Responses to “FDA Attempting to Restrict Medical Foods”

  1. Jo Dornak says:

    Yes I agree that many prescription drugs should and have been eliminated due to the fact that they have injured and even killed rather than cured. I have used vitamins and minerals for many years to supplement my diet. I am almost 87 years old, had cervical surgery a year ago, and did not need any blood transfusions. The Surgeon was amazed that my blood was perfect. However a Naturopathic Dr using natural foods and supplements can take the credit for my good health. If the FDA gets away with telling us what we can put in our bodies it is just another socialistic way of destroying our freedom. I have had many issues that prescription drugs did not help. But I am a living proof to say that natural medical foods came to the rescue. If there is any way that we can convince our congressmen to take action to stop this assult on our lives and health let us please get a petition going. I am not a computer whiz at this, but I am willing to sign one if it will help.

    Jo in S.A. Texas

       4 likes

    • michelle forus says:

      God blessed you! You grew up in an era that you were allowed to decide what to feed yourself. I am realizing that its we the people who have got to stop blaming them for what they do and start taking action in what we do. Years ago every county had a common law Grand Jury, not many people willing these days, just wieners and complainers, big babies!!
      People had better start reading their Constitutions and I mean the original that serves us not them! If not were doomed!!
      Join your local Citizens Grand Jury and clean house already people before its to late for us all!!!
      We have a country not by majority but by majority who participate, Ben Franklyn

         0 likes

    • Flora says:

      Jo, I’m with you! I suffered many horrifying side-effects from prescribed pharmaceuticals after surgery last year… stopped taking them all and found a healthy-food/nutrition genius who has led me to a state of well-being, and I feel better than I ever did throughout my lifetime. Good food IS good medicine!

         0 likes

  2. franny lee says:

    I am wondering if this latest attack by the FDA aginst what they are calling medical foods will also attemt to include what are known as super foods which do not make the same sort of specific claims as formulated products like this GlycemX the article uses as an example of medical food. I am referring to foods like maca and blue-green agae.

       3 likes

  3. Barb Eaton says:

    No surprise here. Read this article and you will see that Monsanto ex-employees are running the FDA, USDA and other big agencies that make decisions about what we’ll be allowed to eat. Yep, if you had any doubts about it, forget it. They’re in with the help of this administration. Turns my stomach!!!

    http://gmoinside.org/news/the-secrets-out-monsanto-is-big-ags-top-spender-on-lobbying-spending-nearly-8-7-million-annually-on-seed-patents/

       2 likes

  4. Caroline says:

    The screw ups by the FDA are many. For one thing, who convinced them that foods containing grown in insect killers are good for human or animal consumption? Who, besides”Big Business” and “Big Pharma”?? Do you all feed your families this insect intestinal tract rupturing food? Please label GMO foods, so I can choose what I want to eat.. Stop trying to rule common old vitamin supplements and food. The US is way behind in rational thinking. I believe Big Money gets into the brains [ and pockets] of agencies such as FDA.

       7 likes

  5. Barbara Viken says:

    I’ve known that the FDA isn’t doing their job since I was a teenager. And I’m a senior now!
    I’ve thought for years the FDA should be abolished, especially since now they’re increasingly being influenced by the chemical companies. ‘They OK too many toxins in food and OK the use of ever-more toxic chemicals used on food plants. All food should be grown organically, unless we all want to go the way of Easter Island (which is extinction).

       3 likes

    • Reta says:

      The F D A is not influenced by big business, it’s owned by them. Dr Mercola has a chart showing the revolving door between them and Mon san to. Judge Clarence Thomas worked for Mon san to and wrote the deciding vote allowing companies to patent seeds in 2001. Tom Vilsack, head of the USDA is and has been in big business pocket for a long time.

      However, this site is dead wrong touting the ingredient list for the ‘medical food for diabetes’ above. It is predominately soy, and fructose is at the top of the list as well.

         1 likes

  6. Suzanne Myers says:

    The FDA needs to stay out of our lives and let us make our own choices.

    I am 52, since I was a little girl,I have had severe allergies. For years I have “tweaked” my food choices to stay healthy…it has been a science, but it does keep me from getting sick: it keeps my joint inflammation away, keeps my asthma away, keeps my histamine levels balanced, keeps my depression away, and now special food choices are correcting my digestive/enzyme issue…with great success!
    So don’t tell me that food choices don’t make a difference, I and the government should have no say as to how I run my life…that is absurd!

    Suzanne

       5 likes

  7. Patrick E Richardson says:

    I have two adult children who are now type 2 diabetic thanks to prescription medication.
    The Fraud Deception Agency cares less about the general health of Americans.

       19 likes

    • Eric Matthews says:

      What prescription drug causes type 2 diabetes?

         0 likes

    • Daniel Murray says:

      You must take all foods containing High Fructose Corn syrup from their diet.(HFCS)

      No soft drinks, no fruit drinks, no jams, jellies, no sweet pickles, no ketchup with HFCS!!!!!

      This sweetener has been linked to type 2 diabetes, heart disease, non-fatty liver diseases.

      Life Extension Foundation had an article in their magazine in 2011 I believe.

      Fructose cannot be used for energy in the presence of any caffeine.

      Daniel

         3 likes

    • deborah gesser says:

      monsanto won. does my vote really count.

         2 likes

  8. Joe Galva says:

    The FDA should be abolished. They are constantly sticking their nose into peoples lives. They are a bloated waste off taxpayer money. It is my body and I will put what I think is good for me. I don’t need someone from the government telling me how to live, what medicine I can take. Defund the FDA. I am no way a tea party person, just a democrat trying to live with such absurd laws and rules.

       26 likes

    • karen says:

      Try to take away good food and vitamins , yeah right, but let everyone smoke pot because they need medication.

         0 likes

    • TIm Wallace says:

      I was under the impression that the FDA receives mos of its funding from the pharmaceutical industry and the taxpayer funding was relatively insignificant. THe majority of FDA pronouncements are promoting Big Pharma, and trying to suppress and prohibit the use of Natural substances that promote elemination of disease, Big Pharma is only interested in hiding symptoms of disease, not finding the source of those symptoms and curing the disease. How else can they continue to sell products that have serious side effects that need additional drugs, and thus more revenues for them, to suppress the side effects

         3 likes

  9. Violet Sunderland says:

    It is dangerous folly to manipulate treatment of health issues. What single remedy or combination of substances work for one patient does not work for everybody. Then there is the age, size and gender issues that steer a health care provider in one direction or another. Even providers don’t always agree on what treatment is best.

    Just like prohibition of alcohol and drugs, the outlawing of anything always goes underground, the cost of which could be excessive. Leave things well enough alone.

       14 likes

  10. HOWARD KIRSHENBAUM says:

    The FDA has been screwing up our foods and medicines for so long. They have allowed drugs that kill and foods that are so full of chemicals that they have no idea what the long term effects are. Obesity, I believe, is a direct result of the FDA idea of the food pyramid we lived with for so many years. They allow Roundup ready corn for consumption. They have no business trying to regulate foods that are prescribed by doctors that are in their very nature, benign for ingestion.

       21 likes

  11. Miloui says:

    The FDA need to stop letting Big Business and Pharmaceutical Companies dictate their decisions. The FDA guidelines seem to to be based only on money.

       20 likes

  12. Dear Alliance for Natural Health;
    Even better than special food for diabetcs would be to not come down with the disease in the first place.
    I suspect that a poison, capsaicin in chili pepper, is one of the causes of diabetes, especially in combination with a copper deficiency. I have published this in the 2008 Medical Hypotheses 71 p 323-324, entitled “Does capsaicin in chili cause diabetes?”. You may also see some discussion of this in http://charles_w.tripod.com/diabetes.html . So it would be a good idea not to recommend chili in diets until such time as the matter is established on animal experiments, or to use capsaicin as a medicine. It is not impossible that capsaicin causes other problems as well.
    Dr. Beale speaks of having a worm that one can do experiments involving diabetes on. Maybe one of your students could use such a technique. His URL is http://www.ttuhsc.edu/som/cbb/faculty/beale.aspx .
    You may see how to increase copper in the diet in http://charles_w.tripod.com/copper3.html (chili probably operates synergistically with a copper deficiency).
    You also may find a book about potassium nutrition as it relates to heart disease, gout, rheumatoid arthritis, high blood pressure, and diabetes, useful for your library. Its availability through Paypal along with its introduction and table of contents may be accessed in http://charles_w.tripod.com/book.html .
    Sincerely, Charles Weber

       3 likes

  13. MareCadTITANIC says:

    f d a stay our of our lives now !!!

       2 likes

  14. FDAisCorruptedbyDrugCompanies says:

    It seems that we can almost always count on our anti-scientific, corrupt, corporate-drunk Washington institutions and Washington agencies to attempt to destroy our collective health and well being.

       10 likes

  15. Terry Morgan says:

    It sounds like the FDA has no authority over medical foods. “Medical foods do not require FDA premarket approval. ” Why are you bargaining with them as if they have been granted authority to regulate medical foods, as if the most you can achieve is to get them to expand their list of conditions? You should be issuing an action alert getting signers for a petition to Congress to reign in the FDA. If the FDA has no jurisdiction over medical foods, we should be acting to remind them of that. What gives?

       12 likes

  16. “Let thy food be thy medicine and thy medicine be thy food”…organic, of course! We are waking up to the insanity of big pharma meds ~ all you have to do is watch one commercial on the side effects, which are way worse than what you are trying to fix, and you can easily figure out the scam.

       9 likes

  17. megan says:

    Please let people keep the freedom to choose what foods to eat !

       2 likes

  18. Cindy Bye says:

    Please do not restrict people on the way the find best to improve their health. We are Americans just trying to live our lives in peace.

       2 likes

  19. “Manufacturers of such foods can make disease claims” — are you sure? If Cheerios cannot say it lowers cholesterol, then how can non-FDA approved medical foods make disease claims? If they did, they would be considered “drugs” and the FDA would regulate them. Am I mistaken?

       2 likes

  20. Tony Fichera says:

    I take several vitamins/supplements because I can no longer receive them in foods .Those foods contain GMOs/preservatives and chemicals that I do not want to put into my body.Getting optimal nutrition,including foods that have proven track records to aid in the treatment of diseases,should always come from the most natural source–food. It stands to reason that medical foods should be “made” by food companies and not drug companies.I currently treat a chronic medical condition with diet and supplements. I no longer take drugs which produced distressing side effects.It’s all about being provided the freedom and opportunity to choose..

       9 likes

  21. Craig Terrell says:

    I opposed this measure to restrict medical foods. People should be allowed to eat what they want, especially if it is healthy

       7 likes

  22. Shasha says:

    Hi, No gluten/dairy/soy/sugar…vitamins/good oils and LDN may help Diabetics not just lowering carbs. Gluten is wheat/barley/rye…oats. GMO food may also hurt them. I hope people will always be able to get things they need to stay well on this earth.

       6 likes

  23. tony young says:

    The FDA needs to broaden their list of diseases and conditions for which medical foods may be administered, not restrict it!

    Diabetes patients need targeted nutrition therapy. Merely tweaking their regular diet is not enough. What we need are better medical foods, not the elimination of them. An excellent idea would be to let supplement companies make medical foods, rather than just drug and medical products companies.

       5 likes

  24. Julie Amato says:

    I am not happy with the new rules by the FDA….
    The FDA needs to broaden their list of diseases and conditions for which medical foods may be administered, not restrict it! Especially diabetes patients need this kind of targeted nutrition therapy, and merely tweaking their regular diet is not enough. What we need are better medical foods, not the elimination of them. Another good idea would be to let supplement companies make medical foods, rather than just drug and medical products companies. Please rethink this strategy….there are much better solutions, I’m sure….thank you.
    Julie

       2 likes

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