Use Food for Healing? Not if the FDA Can Stop It!

October 15, 2013
Category: Uncategorized

doctor discussing with patientThis is especially true when they’re “medical foods” that directly compete with drugs—it appears FDA is trying to kill them, with stringent new rules they’re illegally enforcing before the comment period is even over. Urgent Action Alert—MUST BE IN BY OCTOBER 15 (TODAY)!

In complete violation of due process, the FDA has warned at least one maker of medical foods that their products are misbranded, unapproved drugs. Although this might eventually be true under the FDA’s new draft guidance on medical foods (which we wrote about in August), the guidance has not been finalized and the guidance they are trying to enforce is not yet law. Meanwhile, comments from the public are being accepted only through today (October 15).

The FDA pulled a similar stunt in May 2012, when it tried to enforce its guidance on New Dietary Ingredients while it was still in the draft stage. It’s a disturbing pattern: the FDA increasingly uses guidance as if it were law in an attempt to circumvent the regulatory process.

“Medical food” doesn’t sound very appetizing, but if properly constructed it has a role to play. It’s a blend of fats, carbohydrates, proteins, and supplements designed to address the nutritional needs of people with a specific illness or condition, beyond what ordinary food can provide. It’s the one kind of nutritional supplement that is still allowed to make claims about treating disease, so without medical foods, the world of disease claims and treatment would be reserved exclusively for Big Pharma, which is exactly what the FDA wants. After all, it is Big Pharma that pays the FDA’s bills, including many staff salaries.

Currently, there are medical foods available that treat a wide range of diseases and conditions. But the new draft guidance narrows the definition of medical foods to just those that treat “inborn errors of metabolism” (IEM), as we mentioned in previous coverage of the issue. IEM are inherited disorders in which absence of an enzyme interferes with the metabolism of protein, fats, or carbohydrates, and clearly comprises a very small percentage of unwell people. There is no rational basis for this restriction. It is clearly meant to enforce drug monopolies.

By statute, medical food means “dietary management of a disease or condition, for which distinctive nutrition requirements, based on recognized scientific principles, are established by medical evaluation.” Of course, many diseases other than IEM have distinct nutritional needs, such as diabetes, which the guidance specifically excludes! Medical foods can also address the nutritional deficiencies that can occur from taking pharmaceutical drugs. Disease states associated with nutritional deficiencies include:

  • Early-Onset Genetic Abnormalities such as amino acid processing mutations, lipid processing mutations, and glucose transport deficiencies. For example, pancreatic insufficiency is associated with reduced amounts of digestive enzymes, so dietary management of this condition requires a reduced fat diet (to assist food absorption) and enzyme replacement.
  • Late-Onset Genetic Abnormalities: These include diabetes, cardiovascular disease, renal disease, and osteoporosis.
  • Lifestyle-Influenced Abnormalities such as diabetes, cardiovascular disease, arthritis, wasting syndrome, and respiratory diseases.
  • Drug-Induced Abnormalities: These abnormalities arise from autoimmune, oncology, and gastrointestinal treatments. For example, Methotrexate (used to treat rheumatoid arthritis, lupus, and inflammatory bowel disease) can cause a deficiency in folate, while Isoniazid (an antibiotic used to treat tuberculosis) can deplete B6.


The FDA is also proposing that medical foods no longer require a doctor’s prescription. They are doing this because there will be so few medical foods under such tight restrictions that they will no longer pose any competition for drugs, and by removing the prescription requirement it can appear that the rules are being “liberalized.”

It is worth noting that there has been no instance of harm from the wider list of medical food previously allowed. Medical food manufacturers are also required to abide by Current Good Manufacturing Practices (CGMPs) for dietary supplements.

As a general rule, these products are safer than drugs. They are composed of ingredients that are either generally recognized as safe (GRAS) or are on an approved additive list. The FDA will approve toxic drugs with serious side effects, while they would never allow food ingredients with the same side effects.

Look, for example, at Flavocoxid, a medical food created for the management of osteoarthritis. It was formulated to be safer and have fewer side effects than its prescription drug equivalent, nonsteroidal anti-inflammatory drugs (NSAIDS), which are associated with gastrointestinal bleeding and even kidney failure. Like so many others, this medical food would disappear under the proposed new rules.

You may be interested to read the formal comments ANH-USA is submitting about this whole medical foods guidance fiasco. We are alleging that the FDA took the requirements by which a medical food can be exempt from labeling (as set forth in the Nutrition Labeling and Education Act) and is acting as if they are prerequisites for being a medical food legally. What a bait-and-switch! This new definition differs from the definition of medical foods in the Orphan Drug Act, where it originated. This new definition basically holds that if a disease can be treated with regular food, there can be no medical food legally available for that condition. We are alleging, among other things, that this guidance is a violation of the Administrative Procedures Act (APA), because the FDA is, for all intents and purposes, creating a new rule without following APA rulemaking requirements. We’re also charging that the guidance violates the First Amendment because it prohibits truthful claims about medical foods.

Urgent Action Alert! Tell the 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, including medical foods with more natural ingredients, not the elimination of them. Also, the comment period, which ends TODAY, October 15, 2013, should be extended to allow concerned citizens such as yourself time to address the agency’s latest egregious violation of the law. Please send FDA your comments immediately, and we’ll send a copy to your senators and congressional representative!

Take-Action1

12 responses to “Use Food for Healing? Not if the FDA Can Stop It!”

  1. j.michael carney says:

    we’re getting every freedom stripped one by one , we are going to need the police or a doctor to start paying attention to us ,,, your going way to far … I am hoping this country blows up ….

  2. C McDonald says:

    Yahoo seems to be blocking me from taking action,…

  3. Christine Rumpf says:

    I want to be educated enough to know what is in the food I eat! I have the right over my body and choice to choose what I will and will not eat. I want everything labeled and I do not believe in GMO’s.

  4. Christine Rumpf says:

    Furthermore, I should be the one that decides to use whatever food I want to heal my body.

  5. Julianna Sauber says:

    Food has healed me, and should not be denied of others. As we fight over healthcare crisis, food has the geese ability to solve or exacerbate this issue, but it can only help the issue if it is ALL available to people. Don’t let big pharma win over human beings and common sense, compassion and respect!

  6. Gary Beachum says:

    To Whom It May Concern,
    I am a lymphoma patient and a science educator with a medical background. Medical foods should not be restricted. They should be administered with the informed consent of the patient. I have used these as an adjunct to conventional treatment. I definitely have benefited from their use. This is not a placebo effect, as some would charge due to the fact that I didn’t believe they would work initially. However, I have been forced to change my mind in this regard. Please do not jeopardize my life by restricting access to these from informed medical providers.

  7. Michael Tuttle says:

    “Someone” is messing with the Take Action page. It only comes up for a split-second.
    Thanks!

  8. felicia kandel says:

    Stop hamring the people!!

  9. judy edmands says:

    Dear Sirs,
    Why are you considering violating the Administrative Procedure Act. It works.
    We want safe care.We do not want Big Pharma taking away any more of our
    rights .The side effects are horrible . Medical food saves lives….Big Pharma
    destroys lives. It is that simple. Think of your own children, your own families.
    Do no harm..Let that motto stand.
    Please have mercy on the good citizens of this country.
    W e are trusting you to help us. And we are counting on you to protect us
    Sincerely,
    judy edmands

  10. Jack Edmands says:

    Dear Sirs,
    Why are you considering violating the Administrative Procedure Act. It works.
    We want safe care.We do not want Big Pharma taking away any more of our
    rights .The side effects are horrible . Medical food saves lives….Big Pharma
    destroys lives. It is that simple. Think of your own children, your own families.
    Do no harm..Let that motto stand.
    Please have mercy on the good citizens of this country.
    W e are trusting you to help us. And we are counting on you to protect us
    Sincerely,
    Jack Edmands

  11. Brendan McDaid says:

    Why does FDA regard people eating healthy food that has medicinal properties as a threat? Whose side are they on? The side of ordinary citizens, or sthe side of powerful élite’s whose profits are threatened when we take our health into our own hands.

  12. Mark Thorson says:

    The current status is that medical foods cannot be purchased without a prescription. When I was interested in getting Axona (pure synthetic medium-chain triglycerides for combatting Alzheimer’s disease) for my mother, that was a major roadblock. I’d need to convince her doctor that this product was worth trying and get her to write a prescription for it.
    After reviewing the evidence more thoroughly, I think the evidence for Axona is too scant and the proposed mechanism of action is too shaky though not unreasonable. Nevertheless, I think anybody who wants to buy Axona should be able to do so without a prescription. There is no significant risk from using it, even if you don’t have Alzheimer’s disease. It shares the putative mechanism against Alzheimer’s that coconut oil has, but without the strong cholesterol-raising effect that coconut oil has. Axona is much less risky than the unregulated alternative (coconut oil), so there would be a reduction in the possible harm to the public if Axona were made available without a prescription.
    If the makers of Axona were prohibited from distributing the data from the clinical trial of the product, that would also be bad. The evidence is not great, but there does seem to be a positive result in the small trial which has been performed. I don’t think that trial results should be suppressed, but there should be a requirement for a disclaimer to inform the public when the trial has insufficient statistical power to make strong claims (as is the case with Axona) or when the data comes from animal models or (worse yet) cell suspension studies. I don’t think most of the public appreciates the large differences in the quality of data from clinical studies, animal studies, ex vivo studies, and in vitro studies.

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