How to Determine Quality in Supplements, Part 3

Hopefully by this time I have already established in my first two posts on this subject that there are some serious problems in terms of quality in the supplement industry. To verify some of those assertions, consider the following list of just a few of the common problems that exist in dietary supplements:

• Inaccurate label claims of herbal products. Monmaney T. Labels’ potency claims often inaccurate, analysis finds. Los Angeles Times, August 31, 1998.
  
• Lactobacillus products mislabeled and contaminated. Hughes, et al. Microbiologic characteristics of Lactobacillus products used for colonization of the vagina. Obstet Gyneocol 1990;75:244.
  
• Herbs seriously contaminated with heavy metals and pathogens. Bateman, J. Possible toxicity of herbal remedies. Scottish Med J 1998;4:7-15.
  
• Nutrient interactions inhibit mineral absorption from multiple vitamin-mineral supplements. Shils, et al. Modern Nutrition in Health and Disease Vol 1.8th ed. Philadelphia: Lea & Febiger; 1997. pp. 216-217.
  
• Calcium supplements contaminated with lead. Bourgoin B, et al. Lead Content in 70 Brands of Dietary Calcium Supplements. Amer J Pub.Hlth. August 1993, Vol. 83, No.8
  
• Herbal weight loss products cause lethal side effects because of being tainted with dangerous drugs. August 2002, Media Inquiries: 301-827-6242
  
• Herbs contaminated with mold. Halt M. Moulds and mycotoxins in herb tea and medicinal plants. Eur J Epidemiology 1998;14:269-74
  
• Liver failure and serious liver injury occur with herbs contaminated with drugs. U. S. Food and Drug Administration Center for Food Safety and Applied Nutrition Office of Nutritional Products, Labeling, and Dietary Supplements November 19, 2001

So how can you know if a supplement company is in the health science business rather than in the business of selling pills? Here are some things to look for:

1. GMP certification. Like I mentioned in my first post, this is the ONLY way to know if a company is just tooting their own horn or if the quality of the company has been analyzed by a reputable third-party placing their stamp of approval on their manufacturing systems.

2. Assays. An assay is an analysis of finished products and their individual ingredients. Most companies do not perform assays because they are not required by the FDA and they are expensive. But this is the only way to tell if a batch is contaminated with mold, fungus, heavy metals, pharmaceutical agents, or other foreign substances. Many companies that do perform assays do them randomly, perhaps one batch out of every 10 or 20. However, responsible quality control demands that assays be performed on every batch because purity is not guaranteed with every batch of new raw material.

3. Human evaluations for safety and efficacy. Unfortunately, this is a rarity in the supplement industry. Most companies base the safety and efficacy of their products upon third-party research done on various individual ingredients, but they do not test the actual products themselves in a clinical setting. It cannot be assumed that just because the third-party research on Echinacea, for example, showed a certain degree of safety and efficacy does not mean that once the Echinacea is manufactured into a product in a particular facility that it is then going to pass stringent QC/QA measures and that it will have that same effect in the clinical setting. This is especially true when the ingredient is combined with other agents. Most third-party research is done on individual ingredients, not on combinations. So most supplement manufacturers produce products simply assuming that if the research on Echinacea shows benefit in immunity, and the research on Goldenseal shows similar benefit, then why not combine them for an even better result? While that works out sometimes, at other times ingredients can actually compete with one another and cancel each other out. So it is important that there be a system in place that provides human safety and efficacy studies on the finished products to be able to provide a high level of predictability.

4. Extensive scientific Team. Most companies, if they have scientists on staff at all, have maybe 2 or 3 overseeing the entire operation. I find it difficult to believe that 2 or 3 scientists, or even a half dozen, could efficiently oversee the formulation, manufacture, and testing of thousands of bottles per month of product while also keeping abreast of the latest research. I didn’t say it couldn’t be done. I just said I find it difficult to believe that it could be done efficiently. I tend to trust a broader range of expertise which incorporates botanists, professional wild crafters of herbs, PhDs, MDs, chiropractors, clinical nutritionists, and naturopaths all working together to pioneer breakthroughs in the nutritional industry, to produce nutriceuticals that pass the scrutiny of all the various disciplines involved, to stay abreast of all the latest research, and to oversee the operations. If I needed a heart operation, I would want at least two qualified heart surgeons on hand, several nurses, an anesthesiologist, etc, rather than trusting my health to just a couple of guys with stethoscopes. Nutritional products are no different. We take them into our bodies. They affect our biochemistry, and I want mine to be produced by the most extensive scientific team with the most years of experience possible.

5. State of the Art Facilities. This goes back to GMP certification. A manufacturer can throw a few scientific-sounding terms your way to make their operations sound impressive, but you really have no idea what their operations involve without a third-party analysis of their facility and operational system. I had one doctor tell me that he toured the facility of a doctor’s line supplement company who I will leave nameless, and he said that it really wasn’t anything more than a big dank warehouse with a few machines. And yet somehow they were still proud enough of the place to give tours of it. That’s not what you want to see from a supplement company, especially one that is marketing their goods to doctors.

6. Product Innovation. One of the elements that a sophisticated product line should possess is unique product innovation and industry firsts. A true science-based company that is helping to blaze new trails in nutritional medicine will invest in the process of scientific discovery and well-designed research to bring previously undiscovered compounds and new applications for already-known compounds to the market. Honestly, most nutritional companies even in the professional market are what I call “me too” companies, meaning that they piggy-back off the research and product innovation that other companies have already pioneered and create their own spin-off products with slight variations and cheaper price tags. In a free market system that is certainly a legitimate way to forge a business. However, if enough practitioners patronize me-too companies based upon getting what they hope will be the same kinds of products for less money, eventually all the companies who actually invest in research will no longer be in business, or at least not be able to do the research any longer.

As you can see, there is a lot to producing supplements that are of true quality, more than most people could ever imagine. Just looking at the ingredients on a label and checking to see if “quality” is somewhere in the marketing is not a good way to determine the quality of your supplements, and neither is looking for less expensive products necessarily. True quality costs money, and a more sophisticated line will usually reflect that in their prices. That is true of organic food, it’s true in the extent of training that certain doctors receive and the services they offer, it’s true in the automobile industry, it’s true in the clothing industry, and every industry under the sun. And it’s certainly true in the supplement industry. You get what you pay for, and when patients understand that they are more inclined to comply with the practitioner’s recommendations instead of going down to the local franchise pharmacy to purchase their supplements.

In conclusion, practitioners should help their patients understand the difference between companies that are in the health business and those that are in the business of selling pills. Those that are in the health business will adhere to the standards discussed in this and the previous posts, because as as Dr. Jeffrey Bland likes to say, “The most expensive supplement is the one that doesn’t work.”

How To Determine Quality in Supplements, Part 2

A good share of doctors who are evaluating a supplement line and/or a specific product do it like this: They will look at the label and check for certain ingredients. All done. If they like what they see in terms of ingredients, that is all they think they need to know.

Allow me ask this question: If a healthcare consumer were looking through the yellow pages for a good holistic practitioner, would you say that they have investigated their choices thoroughly by simply looking at the educational degrees of the various practitioners and the services offered? I think you would agree that just because someone has certain letters behind their name and offers a particular service does mean that their level of expertise is what you are after. I heard a joke that illustrates this point. “Do you know what you call a medical student who graduates with a C average? Answer: Doctor.”

I have been adjusted by chiropractors who I will never let touch me again, but others seem to have a magic touch. I have met self-proclaimed nutritional gurus who are so “out there” in their philosophies that I wonder how they ever got be doctors, but I would trust my own family to others. If you are like me, you don’t want just anyone with his/her name on a shingle adjusting your spine or overseeing your medical care.

Shouldn’t we be just as scrutinizing with the supplements that we are taking on a daily basis, and shouldn’t doctors be even more scrutinizing when it comes to supplements with which they trust their livelihoods?

If you believe that a supplement line merely calling themselves “professional” and talks quality and markets themselves to doctors automatically makes them a company turning a quality product, then I have some beachfront property in Kansas I would like to sell you. :-)

Everyone Talks Quality
When was the last time you saw an advertising line like this: “Our quality control is above average.” Never, right? Nearly every supplement manufacturer will provide you with full-color advertising showing people in white lab coats looking at samples in a test tube or through a microscope. Everyone says that they are second to none in terms of quality, just like every restaurant says that they maintain a clean kitchen, just like every car manufacturer wants you to believe that their brand of car is the safest and most reliable on the road, etc. So how do you differentiate effective marketing from true quality?

Unfortunately, there IS a big problem with quality in dietary supplements. Bear in mind that the supplement industry is not regulated by the FDA, and that means that standards of quality are self-imposed. In other words, it is up to each individual company how much money they want to spend on quality measures. And that is perhaps why there are not more companies that are GMP certified (see my last post).

There is much more to determining the quality of a product or supplement line than just looking at the ingredients of a label, because there are some serious problems that exist in the supplement industry regarding quality that I’ll talk more about in the next post. For today’s post, however, I want to focus on the difference between what’s on a label and what is actually represented in a product.

Analyzing Raw Materials
Nearly all supplement companies get their raw materials from third-party suppliers. Remember, there are no FDA standards to guide supplement companies in how they select their raw materials, so most of the time companies make their decisions based upon price and based upon the claims of the raw material suppliers. If the companies selecting these raw materials don’t analyze what they are buying prior to the purchase, then they really have no idea what they are getting.

For example, the therapeutic parts of the herb, Echinacea, are in the flowering bud, not the stem or the roots. Yet a supplement company can buy a batch of Echinacea from a third-party supplier not knowing that most of the raw material is stems and roots and possessing almost no therapeutic benefits.

Even the true therapeutic parts of the plants can vary from batch to batch, and that’s why comprehensive lab analysis are important to verify the different constituents of the plant.

The herb, St. John’s Wort, for example, contains hyperforin and hypericins that give the herb the therapeutic benefits. In a recent analysis of four different suppliers of St. John’s Wort, all varying in price, the lab analysis showed the following:

The first three samples, ranging in price from $12.32/kg to $19.00/kg, all had incomplete assay information and/or had incorrect assay methods. There was no detectable hyperforin in any of them, and although there were adequate levels of hypericins, all three samples had suspect adulteration with synthetic hypericin. All three samples also had heavy metal contamination.

In contrast, the fourth sample of St. John’s Wort – by far the most expensive of the four at $36.00/kg – was identity confirmed with a complete and correct assay method, had therapeutic amounts of hyperforin at 3.0%, and therapeutic amounts of natural, unadulterated hypericins at 0.3%. Likewise, there was not any heavy metal contamination.

A scrutinizing supplement company would know what to look for in all four samples, so they would first of all have to know what a correct and complete assay method looks like to be able to determine if the information presented in the assay report actually means anything. It’s not enough to just have an assay. You have to know the correct assay methods. Secondly, the scrutinizing company would know what levels of the therapeutic agents to look for, as well as levels and types of possible adulteration. Thus, a company that is truly in the health business will choose, in this case, sample #4 even though it is three times more expensive than some of the other samples.

As a last point, what do you think the suppliers of samples 1, 2, and 3 do after a company with high standards rejects their raw materials? You guessed it. They just take their shoddy raw material and go sell it to another supplement company who either doesn’t do any raw material analysis at all, or one who doesn’t perform the proper methods of evaluation.

So price is definitely not the way a responsible consumer, whether it be a practitioner or a patient, should be choosing their supplements.

In my last and final post on this subject, I’ll address six other markers of true quality in supplements. Stay tuned.

How to Identify a Quality Supplement Line

The food supplement industry is one of the fastest growing industries in America and abroad. It is little wonder that new supplement lines are sprouting up all over the place.

For scrutinizing practitioners who want and need to provide the absolute best for their patients, how does one wade through the marketing to determine quality that is worthy of the clinical setting?

As I embark upon this subject, let me say up front that you should not take my word for any of what I’m about to tell you. I have worked in the supplement industry for 15 years now and have been privy to information to which most practitioners are not exposed. But in that I could rightfully be accused of having biases because of my associations, I encourage you to check out my claims for yourself.

Good Manufacturing Practices (GMP)
One of the most important markers of quality in supplement manufacturing that a scrutinizing practitioner needs to know about is Good Manufacturing Practices (GMP). There are three entities that offer GMP certifications. They are the Natural Products Association (NPA), the Therapeutic Goods Association (TGA), and the National Sanitation Foundation (NSF). These organizations are reliable third-party sources of gold standard analysis on the quality of supplement manufacturing. Their analysis involves random audits that scrutinize areas that most practitioners would not even know to ask about, such as determining if the kind of paint used on the walls is producing off-gassing, whether or not the water is ultra-purified, analyzing the joining of walls to the floor to make sure that there is a gradual and sloped transition so that no dust can gather in the corners, analyzing the machinery and the operating systems, and testing the knowledge of the people running machines to make sure that each person’s procedures matches GMP standards.

This is merely a partial list, as a GMP audit usually takes up to two weeks to complete, and companies seeking GMP certification do not know when the audit is going to take place. The auditors simply show up unannounced, so the company had better be operating according to those standards 24/7 to score a passing grade.

The primary goal of GMP is to ensure that the manufacturing processes operate in a state of control. This state of control acts as a filter to help eliminate product contamination, mix-ups, and errors. GMP certification offers health professionals and their patients a basis for trust that the supplements they are using are safe and match label claim.

GMP is Good Business
GMP certification is good business for both the company in question and the doctors and patients using their products because it reduces exposure to potential product liability issues. Remember, in today’s culture anyone can sue anyone for almost anything. If a patient ever sought legal actions against a doctor for his or her administration of a certain nutritional product, the backing of GMP certification that is consistent with how drug companies manufacture their products could help protect both the doctor and the supplement company.

Also, GMP certification reduces exposure to regulatory enforcement actions.

I have included the GMP framework at the end of this post for those interested in learning more.

Aren't All Supplement Lines Operating with High Standards?

It takes multiple millions of dollars to get a manufacturing system and facility up to the very stringent GMP standards, but the certification itself costs only $200. Many companies claim that they are “GMP compliant,” or “operate according to GMP standards,” but these claim beg an important question. If a company has already spent the millions of dollars it takes to get up to GMP standards, why would they not spend another $200 to validate their quality claims by getting certified? As it appears to me (for whatever my opinion is worth), the companies who are not certified remain that way because either they know up front that they cannot pass the audits, or because they have already attempted to get certified but failed the stringent auditing process.

As it currently stands, there are only two doctor’s lines that maintain GMP status, and there is still only one doctor’s line that is certified on all three levels.

Yeah, but…
One common argument against GMP certification used by non-GMP companies is that the GMP process doesn’t take into consideration ingredient selection. In other words, an aspirin or calcium carbonate product can be GMP certified. So ingredient selection and product design certainly play an important role.

I agree that GMP is not an all-encompassing standard of what differentiates a quality line from those that are not. However, GMP is like a doctor who has a certified degree offering treatment versus someone like myself who has some knowledge of healthcare but has no license. A scrutinizing patient would and should raise an eyebrow at a person who said, “Well, I have all the knowledge that any other practitioner has, I just never got my license. But you can trust me because I offer the same care that any licensed practitioner would.” In order to validate the knowledge, training, and skill of any person offering healthcare, a license or certification must be in hand.

Similarly, a scrutinizing practitioner should also raise an eyebrow at a company who claims to operate according to GMP standards but never bothered to get certified. A product line can be making great choices in terms of their ingredient selection but then fail in other vital quality procedures. What good is the best Ginko raw material, for example, if the manufacturing process fails in many important markers of quality determined by the GMP certification process? If a company will not invest the $200 it takes to get GMP certified, then it should not be assumed that that company is operating on that level of quality in spite of what they claim. Nor should it be assumed that that company is doing the due diligence in other areas of quality not analyzed by GMP.

Remember, every supplement company is in business to make money, and talk is cheap. A practitioner really has no idea what goes on behind closed doors unless the system in place is analyzed, scrutinized, and certified by a reliable and recognized third-party placing their stamp of approval on the operating system. And that’s why GMP is important.

In the next post, I’ll address a few other important determinants of quality.

________________________

The GMP framework involves:
Technical Controls
-Materials
-Buildings
-Equipments
Operational Controls
-Policies
-Procedures
-Records
Relational Controls
-People (Employees and Suppliers)

GMP controls include the use of procedures that control each step and records that confirm procedures were followed and provide traceability in the following areas:
· Receipt and storage of raw materials, in-process materials and finished product.
· Manufacturing process
· Testing (raw materials, in-process and finished product)
· Filling, labeling and packaging
· Finished product approval
· Document Review
· Release and distribution
· Change control

Why Food Matters

In the 15 years that I have supported doctors in their use of clinical nutrition, I have always tried to take a balanced perspective and emphasize the fact that even the most sophisticated supplements should not be expected to take the place of a healthy diet. Diet lays the foundation for health and vitality, and supplements are just that – they supplement the diet.

But therein lies a big problem.

Here in the Midwest the concept of what eating healthier looks like is almost amusing. A lot of people seem to think that as long as their Wendy’s hamburger has some iceberg lettuce and a slice of tomato they are eating healthy. But the problem doesn’t seem to be isolated to the Midwest. Current statistics from the NHANES study show that two thirds of the U.S. population are overweight, with a third of those classified as obese. Likewise, a Surgeon General report indicates that 7 out of 10 leading causes of death in the U.S. are preventable and diet-related.

In caring for the chronic health concerns of patients, it is imperative, of course, to coach them on their diet and why the diet is so important. One of the concepts to attempt to get across to patients is the fact that each bite of food carries a message to the cells of the body. What message is being communicated depends on what kind of food is being ingested.


Think of it this way: If your automobile requires diesel fuel, but you put in regular unleaded, it won’t take very long at all for the automobile to respond negatively. While our bodies are far more sophisticated and intricate than an automobile, the same concept still applies nevertheless. The human body was not designed to function on chemical concoctions like bologna and chips and Velveeta cheese and Lucky Charms and the endless assortment of man-made food stuffs. While the human body has the innate ability to make adjustments and function somewhat normally on junk food diets for long stretches of time in some cases, eventually system failures begin to occur.

When system failure does occur, instead of changing the fuel that caused the breakdown in the first place, what most Americans tend to do is put duct tape on the engine light, so to speak, by suppressing symptoms with one or more drugs.

We absolutely must begin to help people understand that heart disease, for example, is not a result of statin drug insufficiencies. Depression is not a Prozac deficiency. Arthritis is not due to not having enough COX-2 inhibiting drugs. These drugs have their place and benefit when used appropriately, but they do not lead to better health.

A Diagram of a Protein Kinase

Achieving better health is contingent upon changing the messages to the cells. Recall that our biochemistry is a complex system of signals involving kinases, hormones, and a delicate balance of other intracellular messengers. These signals can become altered due to the kind of messages being sent from the food we eat. Bad food equals bad messages resulting in poor function. Good food equals good messages resulting in improved and optimal function. It’s as simple as that. The human body in spite of its Divine design cannot function optimally for very long when the signals are destructive, and this is a concept most Americans have yet to understand and that most doctors have yet to communicate effectively to their patients.

In the Christian circles in which I grew up and am still a part it was and is popular to refer to the human body as a temple, a Biblical reference. The concept being communicated is that we need to respect our bodies and not abuse them with drugs and alcohol and cigarettes. I couldn’t agree more. However, it is not uncommon even in Christian circles in America to avoid these vices yet still over-indulge on a daily basis with every nutrient-deficient, chemical and sugar-laden junk food under the Milky Way. And somehow many people remain blind to this double-standard.

Since I’m picking on my church-going brethren a little, allow me to use an historical and Biblical reference to illustrate my point.

In the book of Proverbs, chapter 23, verses 1 through 3, it says:

“When you sit to dine with a ruler, note well what is set before you, and put a knife to your throat if you are given to gluttony. Do not crave his delicacies, for that food is deceptive.”

This passage was written approximately 4,000 years ago in the Middle East. In that time and place, it was only the rulers and dignitaries – the wealthy of the culture – that ate calorie-rich, nutrient deficient foods. Refined foods, animal fat, and copious amounts of alcohol were daily indulgences. However, the commoners subsisted on wild game and fresh fruits, vegetables, and grains that they farmed themselves. As a result, the “diseases of kings and queens,” as they became known, were common among the elite of the culture, but very uncommon among the working class. What were the diseases of kings and queens? Heart disease, obesity, arthritis, and other degenerative maladies were the afflictions of the rich of that time. And today America is an entire nation of people who know such endless abundance that the entire population is suffering from the diseases of kings and queens. That’s why the writer of Proverbs warns against excessive food indulgences and encourages self control.

By the way, I think the last phrase of Proverbs 23:3 is interesting. It says that that food can be deceptive. What is “deceptive” food? I believe the message is clear. It’s food that looks good and tastes good and thus promises pleasure, but in the end it robs one of life and vitality. It deceives those who excessively indulge in it.

Inspiring Behavior Modification in Patients
Inspiring behavior modification in patients remains problematic for many practitioners because of time constraints in the ability to offer patient education. There are some fantastic resources, however, to aid in this endeavor.

First, there is a new movie due out anytime called, Food Matters. Click here to view the trailer. This will be an eye-opening and educational movie that can inspire your patients toward change.
Likewise, the movie, Super-Size Me, a documentary about a man who ate nothing but fast food for 30 days and almost didn’t live to tell about it, sheds some sickening light upon the fast food industry and what kind of health consequences it is having on America.

Lastly, there is a certification course called, First Line Therapy, which is a three and a half day training on Therapeutic Lifestyle Changes (TLC) that can aid practitioners in helping patients to undergo the necessary changes to transform their health. The patient education tools and program guides that this program offers make it easy to inspire and guide patients in taking control of their own health.

Not to minimize the importance of supplements, it is true that supplements can often bring about dramatic improvement without lifestyle changes. But I believe the most profound health benefits will be realized when diet and physical activity form the foundation and supplements are used to support these efforts.

The Truth about Sucralose (Splenda)

Sucralose is the new rave in artificial sweeteners. Many believe it to be a healthy alternative to proven neurotoxic substances like aspartame. But not so fast. One cannot base one's opinion on the healthfulness of an artificial sweetener (or anything else, for that matter) based upon the marketing hype of the manufacturer.

I'm offering today's post with the help of my friend, Dr. Ed Zimmer, who wrote an excellent detailed article on this some time ago. What you see here are excerpts from Dr. Zimmer's article.

From the article:

I have read the FDA’s multi-page final ruling for the approval for Splenda® (sucralose) and am deeply disturbed. There is an old saying: “What you don’t know can’t hurt you.” Splenda® is a great example of how this statement could not be further from the truth. So, I am going to give you facts about Splenda® and the man-made chemical, sucralose, and allow you to come to your own conclusion as to whether you think it is a good idea to allow yourself, your children, or anyone you care about to be dosed with this chemical on a regular basis.

Understanding The Chemistry
The first thing that you need to know is that sucralose is not a natural molecule. All you need to do is to take a look at the chemical name for sucralose to understand that it is not natural (see diagram). It is a man-made chemical that falls into the class of chemicals known as chlorinated hydrocarbons. Other chemicals that fall into this same category include many dangerous pesticides like dioxin and DDT. The chlorinated monosaccharide, 6chloro-6-deoxy-D-glucose is a known neurotoxin. Thus, sucralose falls into a category of molecules that should immediately raise serious questions about potentially deadly health concerns.

To be fair, however, you need to know that not all chlorinated molecules are toxic to humans. We cannot, in good faith, immediately make the connection that sucralose is a toxin just because it is a chlorinated hydrocarbon.

Not So Splendid...
To be a little more specific about how sucralose is made, man has taken a natural sugar molecule and forced three chlorine groups to be unnaturally added. The addition of these three chlorine groups causes the body to not recognize the molecule as sugar any longer. The benefit of this for the marketplace is that it creates a molecule about 600 times sweeter than sugar that is not used by the body to make energy. Thus, it has no calories.

The logical question to ask next is how the addition of these three chlorine groups affects the natural sugar molecule. The only way to assess what this new, unnatural molecule will do to humans is to perform studies. This is where the scary part begins.

You would assume that in order to gain FDA approval there would have to be numerous independent studies done to prove the safety of this chemical. You would also assume that if the studies performed raised any questions about potential health concerns that the FDA would err on the side of safety and would not approve a questionable chemical as being safe for consumption.

You assume too much!

As you read about the following information, remember that McNeil is extremely proud of the studies they have done on sucralose.

The Testing of Splenda®
As is common with the FDA approval process, the only testing and studies supplied for consideration were done by the very same company that had financial interests in the product. The truth is that if their study results were negative in nature they would stand to lose billions of dollars. This is quite a motivation to design studies in a way that would decrease the chances of negative results. And, as you will soon see, any negative results were vigorously defended and explanations were quickly formulated.

The studies supplied to the FDA by McNeil (the maker of Splenda®) addressed a number of concerns including but not limited to:

• Fetal Toxicity • Reprodcutive Toxicity • Cancer Causing Potential • Immune System Toxicity • Brain Toxicity • Kidney Toxicity • Diabetic Effects • Environmental Effects

As I stated earlier, you would expect that the results from these studies would have shown no real concerns, as the FDA did approve sucralose for human consumption. This, unfortunately, was not the case and the FDA went out of its way to defend the negative study results instead of erring on the side of safety for consumers.

What The Studies Revealed...
All of the studies submitted to the FDA for approval were animal studies. So, we really do not know what sucralose does to humans from these studies. The studies submitted by McNeil revealed some very disturbing findings. I will use direct quotes from the FDA Final Report so that you can see exactly what the results were. The partial list of negative findings follows.

The testing for gene toxicity (cancer potential) revealed:

“...sucralose and its hydrolysis products showed weakly genotoxic responses in some of the genotoxicity tests.”

“Tests for clastogenic (capable of causing breaks in chromosomes) activity of sucralose in a mouse micronucleus test and a chromosomal abberration test in cultured human lymphocytes were inconclusive. Sucralose was weakly mutagenic in a mouse lymphoma mutation assay.”

“Results of three other genotoxic tests were inconclusive: The chromosomal abberration assay in cultured human lymphocytes, the sex-linked recessive lethal assay in Drosophila melangaster, and the covalent DNA binding potential study in rates. 1-6DCF (a by-product of sucralose) was weakly mutagenic in the Ames Test and the L5178Y TK+/- assay.”

So, sucralose and its by-products did show some toxicity to genes. This is not a good thing as it could potentially lead to the development of cancer. The FDA simply dismissed these finding stating that the 2 year cancer studies done in rats were negative and thus, the findings of gene toxicity were insignificant. This was quite a leap of faith taken by the FDA. In other words, The FDA suggested that since limited tests done in rats did not show any increased cancer rates, the actual finding of gene toxicity should be completely dismissed. And, they were.

I ask you to think about how cancer develops in people who are exposed to cancer-causing toxins. Take asbestos exposure for example. When did people exposed to this toxin develop cancer? Did it take months, a couple of years, or many years? The answer is many years. Most people did not develop cancer for over a decade.

So, how can the FDA simply dismiss findings of gene toxicity through a two-year rat study and conclude that sucralose will not cause cancer in the long-term?

The testing for immune toxicity revealed that sucralose caused damage to the immune system:
“...when rats were fed sucralose in a 4 to 8 week range finding study the following effects were noted: Decreased thymus and spleen weights (immune tissues) , lymphocytopenia (reduced white blood cells), and cortical hypoplacia of the spleen and thymus.”

In an effort to reduce the negative impact of these findings, McNeil then followed this up with a study that only lasted 28 days. This new study again showed disruptions in immune functions at higher dose sucralose fed rats, but not in lower dose groups. The FDA found this 28 day study to be sufficient in defining the safety of sucralose for dosing in humans to not cause immune function disruptions. The bottom line is that the studies conclusively showed that sucralose could have a negative effect on the immune system.

One of the more disturbing findings revealed through the FDA Final Report concerned the testing to determine the neurotoxicity (brain toxicity) of sucralose. Remember that sucralose is of the same family of chlorinated hydrocarbons as are many dangerous pesticides. The question of neurotoxicity is a big one.

McNeil conducted two neurotoxicity studies, one in mice and one in monkeys. The tests were performed for only 21 and 28 days, respectively. How in the world would a 28 day study give the FDA enough comfort to make their conclusion that sucralose is not neurotoxic for long-term use by humans?

Interestingly enough, a 2006 peer-reviewed study in the journal of Headache presented a case study where sucralose was a trigger for migraine headaches (Headache. 2006 Sep,46(8): 1303-4.)

But wait, the FDA stated that sucralose was not neurotoxic. Testing for brain toxicity was done in monkeys for only 28 days! Could they have been wrong?

Are you comfortable with the conclusion that sucralose has no neurotoxicity? Instead of rushing to approve this chemical, why didn’t the FDA call for longer term human trials? Again, is the FDA looking out for you, or for the company?

Because of space restraints, I will summarize the other negative findings from this FDA report. The FDA dismissed all of these findings as not having been substantive.

• Enlarged liver and kidneys • Reduced growth rates • Decreased red blood cell count • Extension of pregnancy periods • Decreased fetal body weights • Subcutaneous Fetal edema (swelling of the fetus) • Increase in HbA1C (Hemaglobin A1C a marker for bad sugar control)

The bottom line is that the limited amount of studies performed on sucralose have raised serious questions about this chemical’s negative effects on immune system function, brain function, fetal toxicity, and the increased risk for cancer. These are not conspiracy theories. These facts are found in the FDA’s own report. The FDA simply doesn’t think these facts are important.

McNeil, for obvious reasons, wants you to believe that their product is safe. I am frightened by what I have learned and am far from convinced.

As you sort through the data I have provided for you in this article I would like you to consider a number of important questions.

Is sucralose natural in any way? My answer: No, it is a man-made chemical in the same class as many pesticides.

Is Splenda® (sucralose) good for you in any way? My answer: No. Your body can’t even use it to make energy.

Have there been legitimate questions raised regarding the safety of Splenda® for human consumption? My answer: You bet there have!

When those questions are raised, do you feel that the FDA errs on the side of safety for consumers? My answer: Not by a long-shot! Why not call for additional INDEPENDENT long-term studies to completely answer the legitimate questions that have been raised?

Have there been any human studies completed with Splenda® to address these major concerns?
My answer: None after 8 years!

Knowing about the potential negative effects on the immune system and the nervous system would you give this chemical to your children or to the child growing in your womb? My answer: No way!

Final Thoughts
Most of us have an inherent trust that our health care system, as a whole, is looking out for our best interests. In general, I have to say that I do not necessarily disagree with this statement. However, you should not be blinded by the fact that many aspects of our health care delivery system regard profit over your well-being. In my opinion, the FDA too many times is one of those organizations.

I am dismayed by how many of my patients and my close friends dismiss any negative information about a product if it has been approved by the almighty FDA. I urge you as a consumer of health care to guard against falling into a false sense of security simply because something has FDA approval. There are hundreds of drugs that have been approved by the FDA only to have been removed from the market many years and many deaths later. (This concludes Dr. Zimmer's article.)

My Concluding Remarks

Some alternative natural sweeteners to consider are Stevia and Xylitol, fructose and honey. But steer clear of anything that was made in a laboratory and that is a chemical. I would encourage you to check the labels of your chewing gums, commercial teas and colas, and anything packaged, because nearly all commercial products that don't contain sugar contain at least one chemical sweetening agent.

Again, I would like to thank Dr. Zimmer for thoroughly researching this issue.

Dr. Zimmer received his undergraduate degree in Chemistry from DePauw University in Greencastle, Indiana. His Masters work in Nutrition was completed at Bridgeport University in Connecticut. He graduated Summa Cum Laude from the National College of Chiropractic and was voted outstanding graduate by the faculty. He and his wife, Sherri, have five children.

Natural Modulation of Detoxification Pathways

Recall from my last post that the liver has two major pathways – Phase 1 and Phase 2 -- that are involved in transforming toxins into water soluble substances for excretion. These pathways are dependant upon specific micronutrients for their function, and certain natural compounds can positively affect their efficiency.

Green tea catechins, for example, have been shown to stimulate the detoxification systems through selective induction of both Phase 1 and Phase 2 metabolic enzymes. Likewise, watercress, artichoke, milk thistle, and the ellagic acid found in pomegranate have all been shown to provide modulation of the Phase 1 pathways and support for Phase 2 conjugation activity.

Certain micronutrients, too, play a vital role. N-Acetylcysteine (NAC) promotes detoxification by acting directly on reactive oxygen radicals. NAC is currently the “gold standard” for management of acetaminophen poisoning.

The methyl donors, choline, methionine, and folate play an important role in balanced detoxification by providing cofactors for Phase 2 conjugation reactions.

These pathways are also dependant upon sufficient macronutrients for their function. Adequate protein, quality carbohydrates and fats, and fiber are important in supporting these pathways and maintaining healthy metabolism during a detoxification program.

To that end, the two formulas in particular that provide the foundation for nutrient-tailored detoxification are the liver supporting nutriceutical and the detoxification medical food.

The medical food provides a broad-spectrum blend of both micro and macro nutrients for support of the detoxification pathways. The first product of its kind, this formula is the only such nutritional product that meets the FDA’s criteria for “medical foods,” and enjoys more than 20 years of research. In study after study, the medical food shows dramatic improvement – more than 200% in most cases -- in Phase 1 enzyme activity, as well as the Phase 2 pathways glucaronidation, sulfation, and glycine conjugation. All these pathways are absolutely necessary in the liver’s ability to clear toxins. (see graphs below)

Phase 1 Caffeine Clearance

221% Improvement in Phase 2 Conjugation 200% Improvement in Glucaronidation

283% Improvement in Phase 2 Sulfation
In other clinical trials evaluating the medical food's effect on symptoms associated with Fibromyalgia, chronic fatigue, chemical sensitivities, allergies, and migraines, the use of the medical food along with a modified elimination diet brought dramatic relief within two weeks and almost complete eradication of symptoms after only six weeks.

As a complement to the medical food, the encapsulated formula provides several compounds listed above that could not be included in a medical food because of the taste factor. Ellagic acid, watercress, silymarin, and artichoke are compounds that provide powerful bifunctional modulation of the liver pathways.

Used together, these formulas provide complete therapeutic nutrition for the elimination of synthetic chemicals.

As a stand-alone regime, the medical food would need to be used at no less than 2 scoops 3 times per day along with the modified elimination diet provided in the accompanying detoxification patient guide. One could modify the dose by adding 4-6 capsules per day of of the encapsulated formula.

For even more complete and aggressive support, one could consider the use of the nutriceutical for the kidneys. Featuring even higher levels of NAC along with cordyceps and Chinese Salvia root, this formula supports kidney function, provides great antioxidant protection, and promotes the final stage of toxin elimination, which is through the kidneys.

This three-tiered program is what I used to treat my toxicity sickness that I talked about in my last post, with unforgettable results.

Nutrient-Tailored Detoxification: Battling the Toxins that Make us Sick

It was the first week of December and I was overdue in putting the finishing touches on the painting I had begun months before. In a swell of motivation, I decided to get all the work done in one weekend, taking down all the doors in the house and transporting them to my garage. Since it was December it was cold outside, and being the manly man that I am (smirk) I didn’t give any thought to the possible damage that breathing the noxious fumes of oil-based paint might cause. I feverishly painted and sanded and painted some more for two straight days, proud of all that I had accomplished when the doors were re-hung.

At first I felt fine, but in a few days I began having severe flu symptoms. Because of the delayed reaction, I did not attribute my sickness to the paint, but thought I had simply come down with a winter flu. I pounded my stash of immune-support herbs and vitamins that usually work so wonderfully, but this time nothing happened. A week went by and I was no better, and curiously there was no fever and no swollen glands. But I had the same aches, pains, and fatigue that are usually associated with influenza.

Six weeks went by and my symptoms persisted. I sought advice from several practitioners but nothing was helping until a doctor friend of mine examined me and suggested that I was toxic. I knew how I ate and took care of myself, so his suggested surprised me….until I remembered my weekend of painting with no ventilation. Dumb!

My friend suggested a four-product detoxification program for me that almost immediately began to affect my symptoms. The first day I was slightly better. By the fourth day I was feeling significantly better, and by the eighth day I was symptom free. While I didn’t enjoy my sickness, it was great to personally experience the power of the same nutrient-tailored detoxification regime that I had been detailing my clients on for so many years.

A Brief Biochemistry Lesson…Just to Refresh Your Memory
One of the body’s primary methods of getting rid of toxins is through a conversion process in the liver. This is how it works:

Upon exposure the Phase 1 liver pathway, known as the Cytochrome P-450, goes to work to convert the fat-soluble toxin into an intermediate metabolite. I’ll spare you the specific chemical reactions, but substances that are fat soluble cannot be eliminated in that form. The liver’s job is to convert them into molecules that can be excreted. After the first step is complete, the phase 2 enzyme pathways kick in to further convert the newly-created intermediate into a water soluble substance. This process is known as biotransformation.

Overload Leads to Imbalanced Pathway Activity
In order for biotransformation to work properly, the two pathways have to work in concert. The primary reason is that the intermediate metabolites created by the Cytochrome P-450 pathways are actually MORE toxic than the original substance. So the Phase 2 pathways must be able to keep up so that these noxious chemicals can be readily excreted.

Therein lies the rub.

Because of massive amounts of toxic insults that people living in industrialized nations absorb, the system of biotransformation cannot keep up. The Phase 1 pathways stay locked in overdrive transforming all the toxins into intermediates, but the Phase 2 pathways bog down attempting to make the necessary conversions for excretion. And because of the log jam of intermediate metabolites that ensues, a huge amount of oxidative stress sets in because of the toxic nature of these metabolites that are not getting excreted. The toxins, however, have to go somewhere, so the body tries to hide them away in the fat cells in an attempt to protect the vital tissues and organs. In doing so, the neurological system is often affected because of the large amount of fatty tissue in the brain and nerves.

It has been proven that there is often a link between toxic exposures and neurological impairments. Just as compelling, though, are the studies proving that if caught in time, neurological impairment is reversible with nutrient-tailored detoxification therapy.

In the next post I'll go into more detail about specific condition applications, protocols, etc. So stay tuned.