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I have recently been spending some time listening to the radio, especially when my show When Your Health Matters is airing. For those of you who do not know, I have a weekly radio show where I discuss information related to health issues of the month so that you can get a dose of healthful information even if you are unable to make it to the office on a regular basis. This way you can continue to support yourself and your health with the information provided. The show airs every Saturday at 9 am on any of the following 2 AM Stations (1260 AM and 1420 AM). I also air on Saturday mornings at 9am on WKIP 1450 AM as well as Q 92.1. Sunday mornings we are heard at 6:30 am on WRWD 107.3 FM. I would welcome your listening and love some feedback and your input to topics that are important to you. You can always e-mail me at firstname.lastname@example.org or simply call the office at (845)561-BACK or 561-2225.
So after listening to the radio and hearing some commercials about something I discuss all the time in the office, I felt it important to do some research to determine if what is being said is accurate. So I went to the website associated with the product, www.digestiveadvantage.com and looked at what they have posted. What I came away thinking is they have some great marketing people and impressive layouts to the site and even have some research abstracts related to their product. Again, all very impressive to the average consumer. AND since Probiotics have been a topic that is near and dear to my digestive health, as well as my heart for the past 20 years, I thought I would look a little deeper into the information. After all, the average consumer does not know what to believe and what not to believe. So some of the claims being made I will discuss and give you more complete information and of course my opinion on the matter.
The site offers the following:
Digestive Advantage Irritable Bowel Syndrome, Lactose Intolerance, Children's Lactose Intolerance, Gas Defense Formula, Daily Constipation Formula and Colon Care Formula. They are even nice enough to offer you a Special TV Offer for their daily Probiotic called Sustenex. So I did some research related to their different products by looking on their site and followed that up by calling the manufacturer's 800 number. After being on hold for 36 plus minutes, the call center lady answered and was extremely helpful from the standpoint that she told me she works at a call center to answer the phone and answers questions "based on the information on the screen in front of me." I asked her what does she do with the medical questions above her understanding, and she said she refers them to their Medical Doctor. She was then nice enough to give me a second phone number for the manufacturer.
Upon calling that 800 number, I was able to speak to the Vice President of Scientific Studies for the manufacturer Ganeden Biotech. This is the company that manufactures the Sustenex as well as all the other Digestive Advantageproducts found on the website. I asked about the labeling and the concentration of bacteria found in each dosage. He said that because their product is considered a "Medical Food" and not a supplement, the rules and regulations enforced by the Food and Drug Administration doesn't require they put on the label information related to the dosage per serving. Only food supplements or food (of a non-medical type) are required to put information related to concentration, % of Daily Value, serving size etc. I wasn't aware of that, so getting that information related to the different standards for labeling was well worth the time it took to get it.
So I went to the Food and Drug Administration to investigate this by calling their 800 number. And after 36 minutes and 46 seconds of being on hold, I was able to speak to a woman who was not comfortable giving her name. She was quite helpful though. She helped me to navigate their website and directed me to the place where it discusses the term "Medical Food."
No. Medical foods are exempted from the labeling requirements for health claims and nutrient content claims under the Nutrition Labeling and Education Act of 1990 (see 21 U.S.C. 343 (q) (5) (A) (iv)).
Following that recommendation and again being helped by the woman, who shall remain nameless, was directed to the following information:
Exempts from the labeling requirements food: (1) sold for immediate consumption in restaurants, or sold to restaurants for sale or use in restaurants; (2) processed and prepared primarily in a retail establishment and not for immediate consumption in the establishment; (3) including certain infant formulas; (4) which is a medical food; (5) which is customarily processed, labeled, or repacked in substantial quantities at establishments other than those where it was originally processed or packed; (6) in small packages containing no nutrition information; (7) which contains insignificant amounts of all the nutrients and does not make any claim with respect to the nutritional value of the food; (8) sold by certain small businesses, unless the label provides nutrition information or makes a nutrition claim; and (9) sold by a distributor to restaurants or certain other establishments. Allows the Secretary to require, if a food contains insignificant amounts of more than half the nutrients required to be included in the labeling, that the amounts of such nutrients be stated in a simplified form.
So what the Vice President of Scientific research said was indeed true and accurate. If you are manufacturing "Medical Foods," you do not have to post the specific nutritional information based on the FDA Rules and Regulations.
Then my "nameless" friend of the FDA directed me to the definition of a Medical Food from their site www.fda.org which I found interesting. It stated the following:
(8) Medical foods as defined in section 5(b) of the Orphan Drug Act (21 U.S.C. 360ee(b)(3)). A medical food is a food which is formulated to be consumed or administered enterally (by feeding tube) under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation. A food is subject to this exemption only if:
(i) It is a specially formulated and processed product (as opposed to a naturally occurring foodstuff used in its natural state) for the partial or exclusive feeding of a patient by means of oral intake or enteral feeding by tube;
(ii) It is intended for the dietary management of a patient who, because of therapeutic or chronic medical needs, has limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs or certain nutrients, or who has other special medically determined nutrient requirements, the dietary management of which cannot be achieved by the modification of the normal diet alone;
(iii) It provides nutritional support specifically modified for the management of the unique nutrient needs that result from the specific disease or condition, as determined by medical evaluation;
(iv) It is intended to be used under medical supervision; and
(v) It is intended only for a patient receiving active and ongoing medical supervision wherein the patient requires medical care on a recurring basis for, among other things, instructions on the use of the medical food.
So my understanding at that point says the website selling these products are in fact not legal and as my "friend" from the FDA recommended, "You should never buy anything claiming to be a 'medical food' on the internet because it has to be used with "Medical Supervision." In other words, Digestive Advantage should not be able to be sold directly to the consumer, even if they have a diagnosis related to a digestive concern. The Supervising Doctor is supposed to administer the "Medical Food."
So I continued investigating the products available (illegally?) through the Digestive Advantage website and the website of Ganeden Biotech. When I called the 800 number for the website for a second time, I was able to speak to an operator who told me "the product is available for anyone who has these conditions stated on the labels for the different products." I asked her if I needed a prescription for obtaining any of these products and she told me "No." So I asked if I needed to be under a doctor's supervision to buy the products. And I was told if I had medical questions to direct them to a doctor, but I didn't need a doctor to purchase the products. In other words, the "Medical Food" is being distributed without adhering to the Guidelines for the Medical Food as stipulated in the FDA Rules and Regulations.
Choosing to look deeper into the Medical Food being offered and upon further review, I found the following:
The information available on their products is incomplete. But is that an issue? My understanding is the information is incomplete by label standards for foods and supplements because "Medical Foods" do not need to adhere to the label requirements of foods or supplements. They are a distinct category not subject to the same rules and regulations, as stated above. AND that still doesn't sit well with me, but it gets better later on. Please keep reading.
I continued to research the information on the FDA Rules and Regulations for "Medical Food." I came across the following rule, which I found completely intriguing.
Do Medical Foods Have To Be Approved or Registered With the FDA?
NO! Medical foods do not have to undergo pre-market review or approval by FDA and individual medical food products do not have to be registered with FDA.
That is what it says at the FDA website as posted at www.fda.org
What I take away from that statement is any Medical Doctor can formulate anything they choose and administer it to his or her patient(s) without any approval from the FDA or any governing body. Does anyone else reading this have an issue with that?
Then what naturally follows is par for the course.
They also make claims that are not based in any logic. For instance, the following is information on their biggest seller, Sustenex. It says the following related to how it helps immunity within the body:
Sustenex with GanedenBC30 boosts your immune system by replenishing your digestive tract with beneficial bacteria cells, otherwise known as probiotics. These probiotics help boost your immune system by keeping the levels of beneficial and harmful bacteria balanced, creating an optimal environment in which the immune system can function.
The only problem with that statement is you do not want your beneficial and harmful bacteria to be balanced, nor does it say how it does the balancing. Ideally, you want next to no harmful bacteria and plenty of beneficial bacteria to keep the yeast and Candidia in balance. This prevents Leaky Gut Syndrome from occurring which strengthens the Immune System. When you have too much Yeast and Candidia, you get the condition of Leaky Gut and this keeps undigested proteins, due to a lack of healthy bacteria, from breaking down in your digestive system causing foreign proteins to "leak" across the digestive system wall creating an Immune Response and causing weakness over time. Not ideal if you are interested in increasing your overall health.
I was able to find this label from their website and wanted to point some things out.
Active Ingredient: GanedenBC30 (Bacillus coagulans GBI-30, 6086)
Other Ingredients: Calcium (calcium carbonate), vegetarian capsule shell (hypromellose, water, titanium dioxide (color), chlorophyll), microcrystalline cellulose, magnesium stearate and silicon dioxide.
Allergy Warning: Sustenex may contain trace amounts of casein (milk protein).
Sustenex is lactose free
Under Active Ingredients, they list their special patented bacteria formulation Ganeden BC30 and then list it as Bacillus coagulans GBI-30, 6086. What makes it special is it contains a protective 'spore' within the capsule which, according to what they say, is able to sustain the harsh acids of the stomach. This is a good thing, as we'd like the bacteria to make it to the place where it is needed, the intestines. So far, no problems with the product.
Now we'll go to Other Ingredients. The first of which is Calcium listed as Calcium Carbonate. Knowing a little about nutrition and physiology and a healthy response within the body, Calcium Carbonate is an excretory product the body produces from the ideal form of calcium for the body, Calcium Bicarbonate. In other words, it is a waste product for the body. Therefore, having Calcium Carbonate seems like a waste of an ingredient, since the body will simply excrete it.
Next we have Hypromellose which is hypromellose /hy•pro•mel•lose/ (hi-pro´mĕ-lôs) a propylene glycol ether of methylcellulose, supplied in differing degrees of viscosity; used as a suspending and viscosity-increasing agent and tablet binder, coating, and excipient in pharmaceutical preparations, and applied topically to the conjunctiva to protect and lubricate the cornea. Basically it is a binder for formulating a capsule.
Then we have Titanium Dioxide. Titanium dioxide has recently been classified by the International Agency for Research on Cancer (IARC) as an IARC Group 2B carcinogen ''possible carcinogen to humans''. Titanium dioxide accounts for 70% of the total production volume of pigments worldwide. It is widely used to provide whiteness and opacity to products such as paints, plastics, papers, inks, foods, and toothpastes. It is also used in cosmetic and skin care products, and it is present in almost every sun block, where it helps protect the skin from ultraviolet light. Pretty sure I do not choose to put that in my body on a regular basis, as it is classified as a possible carcinogen in humans.
After that we have microcrystalline cellulose which compacts well under minimum compression pressures, has high binding capability, and creates tablets that are extremely hard, stable, yet disintegrate rapidly. Microcrystalline Cellulose is basically cellulose and is derived from high quality wood pulp. No real issue there, as they break it down so much that your body doesn't have to work hard to handle it. My question is what is the process for preparing it for use? Is there bleach used in the process? Do you choose to eat bleach?
Then we have Magnesium stearate, made by hydrogenating cottonseed or palm oil, and is used throughout the supplements industry as a lubricant. It is added to the raw materials in supplements so that production machinery will run at maximum speeds. This fatty substance coats every particle of the nutrients, so the particles will flow rapidly. This ensures that production schedules will meet profit targets.
Cottonseed oil has the highest content of pesticide residues of all commercial oils; cotton crops are heavily sprayed. In the hydrogenation process, the oil is subjected to high heat and pressure in the presence of a metal catalyst for several hours, creating a hydrogenated saturated fat. Hydrogenated vegetable fats contain altered molecules derived from fatty acids that may be toxic. The metal catalyst used in the hydrogenation process may also contaminate the stearates produced. Pretty sure I would choose to go without putting that into my body.
Finally, we have silicon dioxide. Most multivitamin or combination supplement products I've come across use silicon dioxide (or silica, SiO2) as an excipient. Recent research has shown that silicon dioxide nanoparticles (size 1-1000nm) can be cytotoxic (i.e. kill mammalian cells) but I'm not sure as to whether "larger" silica particles have this property. What is unclear to me is whether the silicon dioxide used as excipients in nutritional supplement products are formulated in larger pieces (which would not be expected to be absorbed by the GI tract) or if they are indeed being added as nanoparticles instead (which could potentially be much more harmful).
While nanoparticles are a very recent and emerging field and much of the research is preliminary, because of their higher surface area, it has been suggested that they can be more reactive, catalytic, or harmful to mammalian cells than "larger" particles (of the same molecular formula). For this reason I choose not to put this into my body.
Now appreciate that each of these ingredients are part of the capsule for the GanedenBC30 (Bacillus coagulans GBI-30, 6086). What that means is you would be ingesting these ingredients every day. AND over time this would lead to accumulation within the body and potential health issues could result. You get to make that choice for yourself. Personally, I choose not to do the active ingredient and therefore do not have to worry about the package it comes in.
I personally use UltraFlora Balance Probiotic made by a company I deal with which is also a Medical Food and does not sell directly to consumers. They adhere to the principle of requiring you to go to a health care practitioner and to be monitored regularly. And since I know the benefits of taking this probiotic every day, as I have been using this specific product for the past 27 plus years, I can highly recommend and do highly recommend this product to every one of my patients.
If you have digestive related issues, or have health issues in general, you may also choose to consider what has been said here. Being able to purchase Medical Food without the direct recommendation or supervision for the product is not legal, nor very smart. Taking any health related product without proper supervision is simply irresponsible. And thinking I can get it cheaper at a different store that is cheaper but not regulated is equally irresponsible. As long as health related issues continue to plague society, don't you think it is time you gained the understanding you require in order to fully restore your health? And if you invest the time and money, shouldn't you finish the process by going to the source for your healthcare needs?
If you have any questions related to this or another health related topic, please feel free to contact me through my office at (845)561-BACK or 561-2225. I thank you for your consideration and for your time.
Click the link for a description of this week's show and a link to the podcast from:
Advanced Alternative Medicine Center
Serving All Your Heath Care Needs ... Naturally!
Dr. Richard A. Huntoon