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What are the most important things I need to know to have success with taking Daily Essential Nutrients?
Understanding these 3 important factors will make all the difference in your success using our broad-spectrum micronutrients, Daily Essential Nutrients (DEN) or Optimal Balance.
The brain and body need optimal nutrition to function correctly. Consistent and regular intake of DEN ensures that your nutritional foundation is solid.
Gut health is critically important. Without adequate gut health, you won’t properly absorb the nutrients you need. Take this quiz to determine if you might have a gut balance issue.
Many medications significantly interfere with the positive effects of nutrients. For best results, it’s ideal to replace certain medications with nutrients over time. DEN is powerful enough to gradually reduce or eliminate your need for many medications. Another reason for this is the fact that powerful broad-spectrum micronutrients can potentiate medications, causing them to be stronger in your system.
How soon should I expect to see results?
Some individuals see dramatic results within a few days; however, Daily Essential Nutrients (DEN) typically produces results gradually over a period of several months (and sometimes longer for certain conditions). Dozens of medical journal publications have reported impressive results in people who took our product at recommended levels for at least 8 weeks. But it’s safe to say that no one will see the full benefits of DEN in just 8 weeks— many people continue to report subtle improvements for years after.
How much do I need to take?
The recommended dose of our clinical strength formula, Daily Essential Nutrients—4 capsules, 3 times per day, with meals, or 1 scoop of powder, 3 times per day—is based on extensive experience addressing various symptoms in thousands of people, including adults, adolescents, and children. Independent university research has shown that people respond best, particularly in the first few months, by consistently taking the recommended dose. However, some individuals have reported significant benefits from taking less. For best results, work your way up to the full dose, and then reduce down to the level that sustains your improvements.
The recommended dose of our regular strength formula, Optimal Balance, is 3 capsules, twice per day.
How much do children need to take?
In general, we recommend the following initial dosages of Daily Essential Nutrients for children diagnosed with psychiatric conditions, based on published research and clinical experience:
2-3 years: Work up to 4 capsules/day (with food).
4-5 years: Work up to 8 capsules/day (with food).
6 years or older: Work up to 12 capsules/day (with food).
(1 level scoop of Daily Essential Nutrients Powder is equivalent to 4 capsules).
For individual cases, the dose required to address mood, anxiety, behavioral, and other symptoms may be slightly higher or lower than the initial recommended doses listed above. Optimal dosing of Daily Essential Nutrients appears to be more dependent on individual nutrient needs than on age or body weight.
Based on clinical experience, individuals who are experiencing psychiatric symptoms have significantly higher nutrient needs than most others of the same age and weight. Also, children and adolescents who are growing quickly may actually have higher nutrient needs than many adults.
Children taking Daily Essential Nutrients should be monitored by a medical doctor.
The recommended dose of our regular strength micronutrient formula, Optimal Balance, is 3 capsules, twice per day.
How do I get started?
The simplest way is to take 1 capsule 3 times per day the first day, two capsules 3 times per day the second day, and so on. By the fourth day, you’ll be taking the full recommended dose of 4 capsules 3 times per day. Most people have no problem tolerating Daily Essential Nutrients when they gradually introduce it in this way. Those who may be sensitive can choose to increase the dose more gradually (for example, increasing their dose by one capsule per day so it takes 12 days to reach the recommended therapeutic dose of 12 capsules per day). Here is a helpful video that will walk you through the process.
Can I stop taking Daily Essential Nutrients once I’ve seen a positive response?
Supplying your body with nutrients on a regular daily basis will ensure your body gets the critical and essential ingredients it needs for maximum wellness and optimal results. Consistently eating nutrient-rich food is also very important, but even if you’re carefully choosing your diet, it’s still very difficult to get all the nutrition you need from food alone. This is especially true for anyone with mood or anxiety issues, because according to research, these people often have higher-than-average nutrient needs.
Over the years, researchers have documented many cases where people with mood, anxiety, or behavioral issues responded favorably to our nutrient therapy and then stopped taking it, thinking they didn’t need it anymore. The unfavorable symptoms returned. Restoring the nutrients improved their symptoms dramatically again. Most people who experience this contrast decide that it’s worth taking Daily Essential Nutrients regularly to enjoy the stability it provides.
Can I reduce my dosage of Daily Essential Nutrients after I’ve seen a positive response?
Some have found that they can maintain stable health on a little less than the full therapeutic dose of 12 capsules per day after their symptoms have been eliminated for a few months. It’s important to find a threshold that works for you, keeping in mind that if you take too little, your symptoms may eventually return. Daily Essential Nutrients is like food for a starving brain.
Why do I have to take so many pills?
Think of Daily Essential Nutrients as a part of your daily food intake. Taking 4 capsules per meal is like getting a single spoonful of food packed with nutrients to compensate for empty calories (or for some people, simply to meet a higher-than-average need for certain nutrients that can be determined by genetics and other factors).The average person in the United States consumes enough added sugars to make up one-sixth of total daily calories! That’s one-sixth of our food that contains NO essential nutrients at all! Bruce Ames, a renowned nobel prize winning scientist stated: “We are starving! Even though we’re all getting fat, we’re starving for vitamins and minerals.”
The reason for our recommended dosage is that we’re focused on helping individuals achieve real-life results! Extensive scientific research has shown that the recommended dosage delivers the most consistent and marked improvements for serious mood and anxiety-related disorders. This research includes careful safety monitoring which showed no safety concerns at the therapeutic equivalent of the recommended 12 capsule per day dosage.
What makes Daily Essential Nutrients more bulky than other multivitamin-mineral products?
Does Daily Essential Nutrients have any side effects at our recommended levels?
Are there any medical conditions that would prevent a person from taking Daily Essential Nutrients?
Yes. People with certain rare medical conditions or severe sensitivity to a particular ingredient may not be able to take Daily Essential Nutrients. Feel free to call us to talk about your situation. We’re also happy to talk with your doctor or other health professional. These decisions are best made in consultation with a qualified healthcare professional. For more information, you may want to review the Possible Limiting Factors guide from our Clinical References with your doctor.
Can I add extra vitamins or minerals to Daily Essential Nutrients?
Can I take other supplements (besides vitamins and minerals) while I’m taking Daily Essential Nutrients?
Will Daily Essential Nutrients ever stop working?
What factors might increase a person’s nutrient requirements?
Gut Health and Absorption
What does my gut health have to do with my brain?
How do I know if Olive Leaf Extract is working?
How long do I need to take Olive Leaf Extract?
Is there any way to kill the yeast and avoid all the nasty flu-like symptoms?
How will taking antibiotics affect my response to Daily Essential Nutrients?
Using Micronutrients and Medications
Is it safe to take Daily Essential Nutrients with medications?
The short answer is yes – if you follow the guidelines we give! We encourage all individuals who are currently taking medications to work closely with their doctor, because all medication levels should be monitored while using Daily Essential Nutrients. The main reason is that people who take Daily Essential Nutrients have a reduced need for most medications over time – especially psychiatric medications. As the nutrients begin to normalize body chemistry, people feel over-medicated until they reduce their psychiatric medication doses.
In his comprehensive review of micronutrient therapy in psychiatry, published in the peer-reviewed journal Child and Adolescent Psychiatric Clinics of North America in 2014, Dr. Charles Popper of Harvard University’s McLean Hospital discussed among other things the interplay between micronutrients and conventional medications.
One of the things he considered “particularly impressive in reviewing the reports on broad-spectrum micronutrient effects on mood disorders” was “the ability of most patients to discontinue their previous psychiatric medications entirely or at least reduce their doses.”
On the other hand, he identified as one of the “disadvantages of this treatment” that “drug-nutrient interactions are a challenge to patients when transitioning from conventional medications to [micronutrients]…” He clarified further by saying that the transition away from medications can be especially difficult “if withdrawal syndromes result from tapering of long-term treatments with benzodiazepines, SSRIs, or some antipsychotic agents” and he asserted that most physicians “need consultation or training when learning to conduct these transitions” beyond their standard, formal education.
At Hardy Nutritionals®, we have had enough feedback from doctors and patients using our micronutrients to know exactly what Dr. Popper is talking about, but the concept of drug-nutrient interactions is neither new nor alarming. It is well-known that significant diet changes can create a need to adjust medication dosing, and even simply eating a grapefruit can throw an otherwise well-dosed medication out of whack.
Our experience is that while Daily Essential Nutrients can initially be taken safely with most medications, both you and your doctor should expect that most types of medications will need to be adjusted or gradually eliminated while using Daily Essential Nutrients. An optimally functioning, healthy body has no need for medications, so it should be no surprise that using a natural intervention as powerful and comprehensive as Daily Essential Nutrients might eliminate the need for certain medications or at least require dose reductions.
If you are taking any medication of any kind, it is strongly recommended that you are monitored by a physician who is familiar with micronutrient therapy and the medications that you are taking. The knowledgeable Product Specialists and scientists at Hardy Nutritionals® can direct both you and your doctor to resources that can help.
Why is it so important to understand your medication side effects if you are taking micronutrients and medications?
If you are taking medications, frequently review their potential side effects, using a resource such as Drugs.com, RxList.com, or WebMD.com. As your body responds to the nutrients, you may need less medication; increased side effects may indicate that medications need to be reduced. We strongly recommend that you consult with your doctor when altering your treatment regimen and before adjusting your medication dosing.
When taking medications simultaneously with Daily Essential Nutrients, how will I know if my medication dose needs to be reduced?
Nutrient-drug interactions vary widely, but as a general rule over medication will cause an increase in the severity, the frequency, or the number of the side effects of the drug. If your medication side-effects increase in severity or frequency this is an indicator that the medication dose should be reduced.
Published lists of the side effects, interactions, and warnings for almost any drug can be found on a simple, user-friendly online database such as Drugs.com, RxList.com, or WebMD.com.
What does over-medication feel like?
How can I successfully transition from psychiatric medications to Daily Essential Nutrients?
When and how should I start reducing my medications?
How soon can I reduce my medications again?
How do I know if I am experiencing drug withdrawal and how can I manage it?
What products can I take to help with withdrawal symptoms?
Do antibiotics interfere with the effectiveness of Daily Essential Nutrients?
Adding a probiotic and prebiotic combination (such as Hardy Nutritionals Greens & Probiotics) during antibiotic treatment and for one to two weeks after completion is also recommended.
If an individual has a history of fungal or microbial infections a strong anti-fungal agent (such as Hardy Nutritionals Olive Leaf Extract or a prescription if warranted) is recommended for the duration of antibiotic treatment and for a short time thereafter.
(1) Ly D, DeLisi LE. Can antibiotics cause a psychosis?: Case report and review of the literature. Schizophr Res. 2017 Nov;189:204-207. PubMed PMID: 28185785.
What else do I need to know about taking medications with Daily Essential Nutrients?
This journey can feel a bit rocky at times, but educating yourself will help immensely to make your way smoother. Always remember that many others have travelled this road before you and that they have found a very fulfilling and productive life after mental illness by providing their bodies with the nourishing essential nutrients they need.
Reducing medications in the right way is essential to your success when you are taking Daily Essential Nutrients.
In addition to the obvious case of psychiatric medications, many other drugs, recreational substances, and certain herbal preparations all have psychoactive effects. Alcohol, recreational drugs, caffeine, and even certain types of over-the-counter cold & flu antihistamines can be mood and mind altering, and their use should be minimized or eliminated during micronutrient therapy. General anesthesia and many pain killers also have psychotropic effects, and should be used judiciously if at all.
Finally, oral contraceptives and hormone replacement therapy may create mood swings in spite of the mood-stabilizing effects of Daily Essential Nutrients.
Anti-nutritional medications include oral antibiotics and antacids. Both reduce the body’s ability to extract nutrients from food by interfering with either acidic digestion or microbial digestion, and therefore a higher dose of Daily Essential Nutrients may be necessary if you are taking antacids or antibiotics.
Examples of medication interactions with a specific ingredient in Daily Essential Nutrients include folate interacting with certain cancer medications, iodine with certain thyroid medications, and vitamin K with certain anticoagulant medications. Such problems can usually be managed by appropriately adjusting the dose of the medication. Consult with a physician trained in micronutrient therapy before taking any medications simultaneously with Daily Essential Nutrients.
Where can my doctor and I get more information about using Daily Essential Nutrients?
Based on published research, our own extensive experience, and feedback from healthcare professionals who have worked with thousands of people like you, we have compiled detailed clinical reference materials to help your doctor understand how to help you transition safely from psychiatric medications to Daily Essential Nutrients.
We have helped thousands successfully introduce our nutrients to their diets and simultaneously wean off their medications. We are happy to answer any questions you or your health professional might have about this.
You or your doctor are welcome to reach us toll free in the USA or Canada at 1-855-955-1110. For overseas or international calls use 1-587-271-1110. We are open from Monday to Friday 9:00 am to 5:00 pm Mountain Standard Time (MST). We look forward to hearing from you.
Things To Discuss With Your Doctor
Why is the recommended therapeutic dose of Daily Essential Nutrients 12 capsules per day?
At Hardy Nutritionals® we’re focused on helping individuals achieve real-life results. Extensive scientific research at more than 17 universities and medical clinics around the world has shown that the equivalent of this dosage delivers the most consistent results and marked improvements in both adults and children. This research has included careful safety monitoring which showed no safety concerns at the equivalent of the 12 capsules per day dosage. However, some individuals have reported seeing improvements in certain mood-related symptoms at a lower dose. The important thing is to find the dose that works best for you while keeping in mind that the full dose will most likely provide the best results. As our founder, David L. Hardy said, "Don't cheat yourself out of a full response."
What makes Daily Essential Nutrients so bulky?
Why does Daily Essential Nutrients contain high vitamin levels compared to the RDA?
Can I take Daily Essential Nutrients with other supplements?
Can I take additional iron with Daily Essential Nutrients?
Can I take Daily Essential Nutrients with psychiatric medications?
Can I take Daily Essential Nutrients with heart medications?
Can I take Daily Essential Nutrients with other medications?
Can I use Daily Essential Nutrients if I have a special medical condition?
Will digestive problems reduce the effectiveness of Daily Essential Nutrients?
Why Daily Essential Nutrient Works?
What makes Daily Essential Nutrients outperform other vitamin-mineral supplements?
What is NutraTek™ mineral delivery technology?
How does NutraTek™ technology compare with amino acid chelation?
Why is the completeness of Daily Essential Nutrients important?
Why is the nutrient balance in Daily Essential Nutrients important?
Product Safety & Quality
How safe is Daily Essential Nutrients?
What makes Daily Essential Nutrients a quality product?
How does Daily Essential Nutrients exceed quality standards?
Hardy Nutritionals® is committed to bringing you high-quality products. In order to bring you products that meet our high standards, we use a manufacturing facility in the United States that maintains rigorous Good Manufacturing Practice (GMP) standards. Our facility is registered with and inspected by the FDA, the Department of Health and Human Services, and by NSF international. NSF international is a third-party not-for-profit company that provides GMP audits, safety audits, and certifications for a wide range of consumer products. These standards, along with our commitment to quality, are why you can depend on the quality, potency and purity of our products. Learn more.
Can children take Daily Essential Nutrients?
What are Good Manufacturing Practices (GMPs)?
How long can I take Daily Essential Nutrients?
Can I take a full daily dose of Daily Essential Nutrients at once?
Is it normal that Daily Essential Nutrients has changed the color of my urine?
Yes. Daily Essential Nutrients contains riboflavin (vitamin B2), which can make your urine more intense in color.
Is it harmful to take expired Daily Essential Nutrients?
No, there is no safety concern. However, we can’t guarantee that all the ingredients listed on the label will have their original potency beyond the expiration date. The best way to keep your micronutrients fresh is by storing them in a cool, dry, place. You may also freeze or refrigerate them.
Can I take Daily Essential Nutrients if I am lactose intolerant?
Does Daily Essential Nutrients contain gluten?
Does Daily Essential Nutrients contain caffeine?
Is titanium dioxide safe?
Titanium dioxide is the naturally occurring oxide of titanium, chemical formula TiO2. It is used to provide whiteness and opacity to foods and medicines, and in our case, the veggie capsule.
The US Code of Federal Regulations Title 21 (revised April 2014) states;
(c) Uses and restrictions. The color additive titanium dioxide may be safely used for coloring foods generally, subject to the following restrictions:
(1) The quantity of titanium dioxide does not exceed 1 percent by weight of the food.
(2) It may not be used to color foods for which standards of identity have been promulgated under section 401 of the act unless added color is authorized by such standards.
(d) Labeling. The label of the color additive and any mixtures intended solely or in part for coloring purposes prepared therefrom shall conform to the requirements of 70.25 of this chapter.
(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act. 
The most current evidence indicates that titanium dioxide is not toxic and is relatively inert in biological systems. [2,3,4] Nanoscale range particles have different physical properties and are not suitable as a pigment. Nanoscale titanium dioxide is not currently approved as a food additive.
It is very clear from the literature that there is a distinction in health effects between nano-sized mineral oxides, including titanium dioxide, and larger sized particles of the exact same material.
Nano-particles of many different mineral oxides--including iron oxide, magnesium oxide, copper oxide, silicon dioxide, manganese oxide, etc. can pass through cell membranes undigested remaining predominantly as inorganic oxides and not as mineral ions or ions chaperoned by other organic molecules. This distinction also applies to certain non-mineral ingredients as well. For example, nanoparticles of microcrystalline cellulose  are clearly harmful while the larger particle sizes are not.
Many of the inorganic mineral oxides cause oxidative stress when they are nano-sized. Yet the same substances are not harmful if the particles are large enough that they would normally pass through the bowel and do not enter the cell undigested.
Thus, the dangers to health are due to the size rather than the substance and titanium dioxide is not unique in this.
Titanium dioxide content is less than or equal to 1% of the weight of the empty capsule. We use the titanium dioxide for one reason and that is because the raw materials we use can sometimes have varying shades of color depending on harvesting, original moisture content etc. and it distresses individuals when the color is different between batches, even if it does not change the nutritional content. We also regularly evaluate the state of the evidence for many ingredients and make changes or improvements accordingly.
There is a lot of recent press on titanium dioxide. It appears that origins of the carcinogenic findings come from a 2010 publication of the International Agency for Research on Cancer (IARC), a branch of the World Health Organization. 
The IARC found that all the human studies analyzed do not suggest an association between occupational exposure to titanium dioxide as it occurred in recent decades in Western Europe and North America and risk for cancer. There was no evidence of an exposure–response relationship.
In animal studies oral, subcutaneous and intraperitoneal administration did not produce a significant increase in the frequency of any type of tumor in mice or rats. Inhalation studies did show an increase in lung tumors in rats breathing fine titanium dioxide dust at a concentration of 250 mg/m3 for two years. That is equal to breathing in and average of 30 grams of the particulate over two years.
The IARC concluded;
“Cancer in Humans: There is inadequate evidence in humans for the carcinogenicity of titanium dioxide.
Cancer in experimental animals: There is sufficient evidence in experimental animals for the carcinogenicity of titanium dioxide.
Overall evaluation: Titanium dioxide is possibly carcinogenic to humans (Group 2B).”
There are four IARC classification groups. 
Group 1: carcinogenic to humans (currently – 118 agents). There is enough evidence to conclude that it can cause cancer in humans.
Group 2A: probably carcinogenic to humans (currently – 79 agents). There is strong evidence that it can cause cancer in humans, but at present it is not conclusive.
Group 2B: possibly carcinogenic to humans (currently – 290 agents). There is some evidence that it can cause cancer in humans but at present it is far from conclusive.
Group 3: not classifiable as to carcinogenicity in humans (currently – 501 agents). There is no evidence at present that it causes cancer in humans.
Group 4: probably not carcinogenic to humans (currently – 1 agent). There is strong evidence that it does not cause cancer in humans.
There are two items to point out. First, the conclusion that titanium dioxide is possibly carcinogenic to humans comes from experimental animals exposed to incredibly high doses of inhaled material. Ingestion, or eating, did not increase the frequency of any types of cancer.
It is almost like saying that rats died when breathing in water therefore water is possibly harmful to humans. The statement may be accurate but it is very ambiguous.
Second, the categories are all worded in such way that cancer is a certainty or a probability. This too is ambiguous.
To be fair if humans breathed in the equivalent amount of titanium dust we would likely get lung tumors also. The human equivalent would be 2.1 kg or 4.6 pounds over two years.
On October 26, 2015, the IARC reported that consumption of processed meat (e.g., bacon, ham, hot dogs, sausages) was a Class 1 carcinogen, and that red meat was a Class 2A carcinogen ("probably carcinogenic to humans"). 
Therefore based on their own criteria titanium dioxide carries less cancer risk than red meat and far less risk than processed meats.
 Skocaj M, Filipic M, Petkovic J, Novak S. Titanium dioxide in our everyday life; is it safe? Radiol Oncol. 2011 Dec;45(4):227-47.
 Ophus EM, Rode L, Gylseth B, Nicholson DG, Saeed K. Analysis of titanium pigments in human lung tissue. Scand J Work Environ Health. 1979 Sep;5(3):290-6.
 Lindenschmidt RC, Driscoll KE, Perkins MA, Higgins JM, Maurer JK, Belfiore KA. The comparison of a fibrogenic and two nonfibrogenic dusts by bronchoalveolar lavage. Toxicol Appl Pharmacol. 1990 Feb;102(2):268-81.
 Pelclova D, Zdimal V, Kacer P, Fenclova Z, Vlckova S, Syslova K, Navratil T, Schwarz J, Zikova N, Barosova H, Turci F, Komarc M, Pelcl T, Belacek J, Kukutschova J, Zakharov S. Oxidative stress markers are elevated in exhaled breath condensate of workers exposed to nanoparticles during iron oxide pigment production. J Breath Res. 2016 Feb 1;10(1):016004. PMID: 26828137
 Mangalampalli B, Dumala N, Perumalla Venkata R, Grover P. Genotoxicity, biochemical, and biodistribution studies of magnesium oxide nano and microparticles in albino wistar rats after 28-day repeated oral exposure. Environ Toxicol. 2018 Apr;33(4):396-410. PMID: 29282847
 Xu P, Xu J, Liu S, Yang Z. Nano copper induced apoptosis in podocytes via increasing oxidative stress. J Hazard Mater. 2012 Nov 30;241-242:279-86. PMID: 23063557
 Passagne I, Morille M, Rousset M, Pujalté I, L'azou B. Implication of oxidative stress in size-dependent toxicity of silica nanoparticles in kidney cells. Toxicology. 2012 Sep 28;299(2-3):112-24. PMID: 22627296
 Sárközi K, Papp A, Horváth E, Máté Z, Hermesz E, Kozma G, Zomborszki ZP, Kálomista I, Galbács G, Szabó A. Protective effect of green tea against neuro-functional alterations in rats treated with MnO2 nanoparticles. J Sci Food Agric. 2017 Apr;97(6):1717-1724. PMID: 27435261
 Endes C, Camarero-Espinosa S, Mueller S, Foster EJ, Petri-Fink A, Rothen-Rutishauser B, Weder C, Clift MJ. A critical review of the current knowledge regarding the biological impact of nanocellulose. J Nanobiotechnology. 2016 Dec 1;14(1):78. PMID: 27903280
Can I take Daily Essential Nutrients if I am pregnant or breastfeeding?
What are the benefits to taking Daily Essential Nutrients while breastfeeding?
Can Daily Essential Nutrients help with symptoms related to my menstrual cycle?
Health Benefits of Micronutrients
What are some of the health benefits I can expect by supplementing with Daily Essential Nutrients?
Taking Daily Essential Nutrients can prevent health problems by ensuring that you get the essential nutrients your body needs. Daily Essential Nutrients has been clinically proven to help improve mood, focus, mental clarity, emotional stability, and sleep quality.*
Why is the multi-nutrient approach of Daily Essential Nutrients essential for my health?
What are vitamins?
Can Daily Essential Nutrients help to promote healthy metabolism?
Yes. The ingredients in Daily Essential Nutrients are shown to:
Why are vitamins important?
Can Daily Essential Nutrients help maintain healthy skin and other tissues?
Yes. The ingredients found in Daily Essential Nutrients are shown to:
What are minerals?
Can Daily Essential Nutrients help in growth and development?
Yes. The ingredients in Daily Essential Nutrients have been shown to:
Can Daily Essential Nutrients help to prevent vitamin deficiencies?
Yes. The ingredients in Daily Essential Nutrients are shown to:
Why are minerals important?
What does DRI mean?
Can Daily Essential Nutrients help to prevent mineral deficiencies?
Can Daily Essential Nutrients support brain health?
What does RDA mean?
What does AI mean?
Can Daily Essential Nutrients help with my daily stress and mood?
What does EAR mean?
Can Daily Essential Nutrients make up for unhealthy eating?
Can Daily Essential Nutrients help to control my weight?
What does UL mean?
How can Daily Essential Nutrients reduce my healthcare costs?
What does NOAEL mean?
What does LOAEL mean?
What is magnesium stearate and why is it used?
Magnesium stearate has come under some very negative
scrutiny of late. There are numerous statements which indicate that magnesium
stearate is bad for you, magnesium stearate harms the immune system, and that quality
supplements do not contain magnesium stearate.
These strongly worded positions lacked
adequate references and the few that provided references cited one primary
source, which will be reviewed in this comprehensive examination. Statements
like these can be very concerning and we determined to find where they were
coming from. What we found was that none of the comments had any cogency or
Stearic Acid and Magnesium Stearate
Stearic acid is one of the most common saturated fatty
acids found in nature and occurs in many animal and vegetable fats and oils.
Cocoa butter and shea butter have the highest stearic acid content at 28–45%.
Magnesium stearate is used as a lubricant in the
manufacture of medical and supplemental tablets, capsules and powders. Studies
have shown that magnesium stearate may affect the release time of the active
ingredients in tablets, etc., but that it does not reduce the overall bioavailability
of those ingredients. [4,5]
The few milligrams of magnesium stearate in a supplement
capsule represent 0.069% of the average daily dietary intake of stearic acid. In
other words, based on average daily intake, 99.83% of stearic acid comes from
all the other foods we eat every day, even the “healthy” foods.
Making dietary supplements in a high quality way is far
more complex than most people realize.
There are several variables involved with nutrients that affect flowing
and sticking. These include particle
size of the ingredient, moisture content, chemical nature, solubility, and
cohesive nature. These factors vary
based on the ingredients in any product and become more complex as the number
of different ingredients in the product increases. We use USP grade stearates
derived from vegetable sources.
Did you know?
According to USDA National Health and Nutrition
Examination Survey (NHANES 2001-2002) the average intake of stearic acid is 5.7
g/day (8.1% of total fat) for women and 8.2 g/day (8.4% of total fat) for men
from all dietary sources. 
Stearic acid, or stearate, intake is second only to
palmitic acid which accounts for 54.2% of saturated fatty acids (SFAs) (5.8% of
total calories) for females and 54.5% of SFAs (6.0% of total calories) for
In 95% lean ground beef, 37% of the
saturated fat is stearic acid. 
One cup of Brazil nuts contains 8.305g of
stearate (38.7% of SFAs). 
One cup of cashew nuts, dry roasted no salt,
contains 4.072 g of stearate. 
One tablespoon of olive oil contains 0.264 g
(264 mg) of stearate. 
Generally Recognized as Safe
Food and Drug Administration
FDA's GRAS (generally recognized as safe) Substances
(SCOGS) review states, "There is no evidence in the available information
on ... magnesium stearate ... that demonstrates, or suggests reasonable grounds
to suspect, a hazard to the public when they are used at levels that are now
current and in the manner now practiced, or which might reasonably be expected
in the future." 
World Health Organization
Magnesium stearate has been the subject of study by the
Joint FAO/WHO Expert Committee on Food Additives and industry manufacturers for
over forty years. The 80th meeting of the Expert Committee was held in Rome,
Italy and the technical report was published in 2016. In their report they
summarized the history of the review of magnesium stearate.
“At the seventeenth meeting
(in 1973), the Committee evaluated salts of palmitic and stearic acids and
established ADIs* “not limited”, with notes that palmitic and stearic acids are
normal products of the metabolism of fats and that their metabolic fate is well
established. Provided that the contribution of cations such as magnesium does
not add excessively to the normal body load, there would be no need to consider
the use of these substances in any different light to that of dietary fatty
“At its twenty-ninth
meeting (in 1985), the Committee was of the opinion that “ADIs for ionizable
salts should be based on previously accepted recommendations for the constituent
cations and anions”. The Committee listed ADIs for a number of combinations of
cations and anions, including those of magnesium stearate and magnesium
palmitate (ADI “not specified”). The Committee was concerned that dietary
exposure resulting from the use of magnesium salts as food additives may have a
laxative effect. The Committee stated that fatty acids are normal constituents
of coconut oil, butter and other edible oils and that they do not represent a
toxicological problem. As the Committee had no information on the manufacture
or use of the food-grade materials at that time, an ADI for magnesium stearate
was not established.”
“At its forty-ninth meeting (in 1997), the Committee evaluated the safety of palmitic acid and stearic acid when used as flavouring agents and concluded that they would not present a safety concern under the proposed conditions of use.”
“In 2010, at the
Forty-second Session of CCFA, the deletion of magnesium salts of fatty
acids from the INS had been proposed. The International Alliance of
Dietary/Food Supplement Associations offered technological justification for
the use of this additive.”
The Committee “at its
Forty-third Session in 2011 assigned the new INS number 470(iii) to magnesium
stearate and asked the Committee to conduct a safety assessment, assess dietary
exposure and set specifications for magnesium stearate”
“At its seventy-sixth
meeting (in 2012), the Committee established an ADI* “not specified” for a
number of magnesium-containing food additives and recommended that total
dietary exposure to magnesium from food additives and other sources in the diet
should be assessed. This was in the context of the evaluation of magnesium
dihydrogen diphosphate, in which the estimated chronic dietary exposure to magnesium
from the proposed uses was up to twice the background exposures from food
previously noted by the Committee and may be in the region of the minimum
laxative effective dose. For the present evaluation, a range of published
studies together with three reports on genotoxicity testing of magnesium
stearate were submitted to the Committee.”
For the current 2015-2016 evaluation, a range of
published studies together with three reports on genotoxicity testing of
magnesium stearate were submitted to the Committee. The Committee concluded that there are no differences in
the evaluation of the toxicity of magnesium stearate compared with other
magnesium salts and confirmed the ADI* “not specified” for magnesium salts of
stearic and palmitic acids.
*ADI (Allocation of Acceptable Daily Intakes) ‘not
specified’ is a FAO-WHO term for a substance with very low toxicity for which
no safe upper-limit of intake is established, or deemed necessary, on the basis
of available biochemical, chemical, and toxicological data. 
Stearic Acid may have Health Benefits
In a systematic review  and a meta-analysis of 60
controlled trials  in humans the data clearly (referenced back to 1957)
indicate that stearic acid (or its conjugate base stearate) has no effect on
cholesterol levels compared to other long-chain saturated fatty acids. In fact the authors of the 2010 systematic review
concluded that “LDL cholesterol decreased as dietary stearic acid increased in
a statistically significant dose-response relation.”
Researchers from the Netherlands even evaluated hydrogenated
linoleic acid (to produce stearic acid) and found that there was no difference
in the serum lipid profiles compared to “natural” stearic acid. 
Molecular basis for the immunosuppressive action of
stearic acid on T cells
The common reference used to demonstrate harm caused by magnesium
stearate was published in 1990. The experiment entitled “Molecular basis for
the immunosuppressive action of stearic acid on T cells”  is research that
many people have used as evidence that magnesium stearate is harmful to human T
It is clear that anyone referring to this study to claim
magnesium stearate is toxic to humans hasn’t actually read it.
The researchers were specifically looking to determine
the mechanism by which stearic acid (stearate) causes T cell suppression in
mice, but in order for the experiment to work the scientists had to remove the
immune cells from mice. The T cells then had to be incubated on rabbit
anti-mouse immunoglobulins in order to be isolated and purified. The
lymphocytes were cultured in medium containing 0.2% NaHCO3, penicillin,
streptomycin and 5% fetal bovine serum.
The T cells were then stimulated with phytohaemagglutinin
or with lipopolysaccharide. These are plant and bacterial factors that start
the process of activating the T cells (mitosis).
At this point stearic acid combined with bovine serum
albumin and diatomaceous earth (80-90% silica, 2-4% aluminum oxide, and 0.5-2%
iron oxide) were added to the T cells. The T cells began to incorporate
stearate into their membranes which resulted in inactivation of the T cell. B
cells, also from mice, examined in the same way had no issues because they have
an enzyme that desaturates the stearate molecule.
Yes, this experiment worked in mouse T cells. However,
it had to be done in a petri dish (in vitro) to create the environment where it
could happen. To quote directly from the authors; “If the effects of 18:0
(stearate) on T cells could be retained in vivo (in the living organism), the
fatty acid could effectively and rapidly immunosuppress cell-mediated
responses, but without the serious side-effects of cyclosporin.” In other
words, the effect is not observed in the living mouse.
The researches were trying to see if there was a way
that stearate could be used as a potential immune suppressing drug, but could
only get it to work in conditions far removed from normal physiological
conditions. Human T lymphocytes have a desaturase enzyme unlike the
mouse T cell.  This means that human T cells can modify stearate by
enzymatic desaturation and cannot be inactivated by stearate consumption.
Beare-Rogers, J.; Dieffenbacher, A.; Holm, J.V. (2001). "Lexicon of lipid
nutrition (IUPAC Technical Report)". Pure and Applied Chemistry 73 (4):
D. Søndergaarda, O. Meyera and G. Würtzena (1980). "Magnesium stearate
given peroprally to rats. A short term study". Toxicology 17 (1): 51–55.
doi:10.1016/0300-483X(80)90026-8. PMID 7434368
"Magnesium stearate" by Edgar181 - Own work. Licensed under Public
Domain via Wikimedia Commons - http://commons.wikimedia.org/wiki/File:Magnesium_stearate.png#/media/File:Magnesium_stearate.png
Alija Uzunović, Edina Vranić; "Effect Of Magnesium Stearate Concentration
On Dissolution Properties Of Ranitidine Hydrochloride Coated Tablets";
Bosnian Journal Of Basic Medical Sciences, 2007, 7(3): 279-283.
Natalie D. Eddington, Muhammad Ashraf, Larry L. Augsburger, James L. Leslie,
Michael J. Fossler, Lawrence J. Lesko, Vinod P. Shah, Gurvinder Singh Rekhi;
"Identification of Formulation and Manufacturing Variables That Influence
In Vitro Dissolution and In Vivo Bioavailability of Propranolol Hydrochloride
Tablets"; Pharmaceutical Development and Technology, Volume 3, Issue 4
November 1998 , pages 535–547.
U.S. Department of Agriculture, Agricultural Research Service. What We Eat in
America, NHANES 2001-2002, individuals 2 years and over (excluding breast-fed
children). Nutrient Intakes: Mean Amount Consumed Per Individual, One Day.
U.S. Department of Agriculture, Agricultural Research Service, 2006. USDA
Nutrient Database for Standard Reference, Release 19.
U.S. Department of Agriculture, Agricultural Research Service, 2014. USDA
National Nutrient Database for Standard Reference. Release 27.
FDA's SCOGS Database; Report No. 60; ID Code: 557-04-0;
Hunter JE, Zhang J, Kris-Etherton PM. Cardiovascular disease risk of dietary
stearic acid compared with trans, other saturated, and unsaturated fatty acids:
a systematic review. Am J Clin Nutr. 2010 Jan;91(1):46-63. Review. PubMed PMID: 19939984.
Mensink RP, Zock PL, Kester AD, Katan MB. Effects of dietary fatty acids and
carbohydrates on the ratio of serum total to HDL cholesterol and on serum
lipids and apolipoproteins: a meta-analysis of 60 controlled trials. Am J Clin
Nutr. 2003 May;77(5):1146-55. PubMed PMID: 12716665.
Zock PL, Katan MB. Hydrogenation alternatives: effects of trans fatty acids and
stearic acid versus linoleic acid on serum lipids and lipoproteins in humans. J
Lipid Res. 1992 Mar;33(3):399-410. PubMed PMID: 1569387.
Tebbey PW, Buttke TM. Molecular basis for the immunosuppressive action of
stearic acid on T cells. Immunology. 1990 Jul;70(3):379-84. Erratum in:
Immunology 1990 Oct;71(2):306.
 Anel A, Naval J, González B, Uriel J, Piñeiro A.
Fatty acid metabolism in human lymphocytes. II. Activation of fatty acid
desaturase-elongase systems during blastic transformation. Biochim Biophys
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What is titanium dioxide and why is it used?
What is nickel and why is it used?
Nickel, as well as magnesium, is an activator of an enzyme called calcineurin, which in turn activates another enzyme called calmodulin. Together these enzymes move calcium into cells. This action has influences in the immune response and inflammation, metabolism, apoptosis, smooth muscle contraction, intracellular movement, short-term and long-term memory, and helps modulate neuronal development and plasticity. 
Nickel serves as a cofactor or structural component of specific metalloenzymes of various functions, including hydrolysis and redox reactions and gene expression (Andrews et al., 1988; Kim et al., 1991; Lancaster, 1988; Przybyla et al., 1992). Nickel also serves as a cofactor facilitating ferric iron absorption or metabolism (Nielsen, 1985). Nickel is an essential trace element in animals, as demonstrated by deficiency signs reported in several species. Rats deprived of nickel exhibit retarded growth, low hemoglobin concentrations (Schnegg and Kirchgessner, 1975), and impaired glucose metabolism (Nielsen, 1996). Nickel may interact with the vitamin B12- and folic-acid dependent pathway of methionine synthesis from homocysteine (Uthus and Poellot, 1996). 
The superoxide ion, (O2-) is generated in biological systems by reduction of molecular oxygen. It has an unpaired electron, so it behaves as a free radical. It is a powerful oxidising agent. These properties render the superoxide ion very toxic and are deployed to advantage by phagocytes to kill invading microorganisms. Otherwise, the superoxide ion must be destroyed before it does unwanted damage in a cell. The superoxide dismutase enzymes perform this function very efficiently. 
In biology this type of reaction is called a dismutation reaction. It involves both oxidation and reduction of superoxide ions. The superoxide dismutase group of enzymes, abbreviated as SOD, increase the rate of reaction to near the diffusion limited rate. The key to the action of these enzymes is a metal ion with variable oxidation state which can act as either an oxidizing agent or as a reducing agent. 
In human SOD the active metal is copper, as Cu2+ or Cu+, coordinated tetrahedrally by four histidine residues. This enzyme also contains zinc ions for stabilization and is activated by copper chaperone for superoxide dismutase (CCS). Other isozymes may contain iron, manganese or nickel. Ni-SOD is particularly interesting as it involves nickel (III), an unusual oxidation state for this element. The active site Ni geometry cycles from square planar Ni (II), with thiolate (Cys2 and Cys6) and backbone nitrogen (His1 and Cys2) ligands, to square pyramidal Ni (III) with an added axial His1 side chain ligand. 
Calcineurin is a protein phosphatase  consisting of a catalytic subunit, calcineurin A, which contains an active site dinuclear metal center, and a tightly associated, Ca (2+)-binding subunit, calcineurin B. This enzyme has a wide variety of biological responses including Ca (2+) and calmodulin* dependent signal transduction, lymphocyte activation, neuronal and muscle development, neurite outgrowth, and morphogenesis of vertebrate heart valves.  Research dating to the early 1980’s has identified that nickel is an activator of the calcineurin enzyme. [8-14]
*Calmodulin is a calcium binding protein that mediates many crucial processes such as inflammation, metabolism, apoptosis, smooth muscle contraction, intracellular movement, short-term and long-term memory, and the immune response. Calmodulin is expressed in many cell types and can have different subcellular locations, including the cytoplasm, within organelles, or associated with the plasma or organelle membranes. Many of the proteins that Calmodulin binds are unable to bind calcium themselves, and use Calmodulin as a calcium sensor and signal transducer.
 Wayman GA, Lee YS, Tokumitsu H, Silva AJ, Soderling TR. Calmodulin-kinases: modulators of neuronal development and plasticity. Neuron. 2008 Sep 25;59(6):914-31. PMID: 18817731
 Food and Nutrition Board, Institute of Medicine. Dietary Reference Intakes: Vitamin A, Vitamin K, Arsenic, Boron, Chromium, Copper, Iodine, Iron, Manganese, Molybdenum, Nickel, Silicon, Vanadium, and Zinc. National Academy Press, Washington, D.C., 2001.
 Packer, L. (editor) (2002). Superoxide Dismutase: 349 (Methods in Enzymology). Academic Press. ISBN 0-12-182252-4.
 Heinrich, Peter; Georg Löffler; Petro E. Petrides (2006). Biochemie und Pathobiochemie (Springer-Lehrbuch) (German Edition). Berlin: Springer. pp. 123.
 Barondeau, D.P.; Kassmann C.J.; Bruns C.K.; Tainer J.A.; Getzoff E.D. (2004). "Nickel superoxide dismutase structure and mechanism". Biochemistry 43 (25): 8038–8047.
 Liu L, Zhang J, Yuan J, Dang Y, Yang C, Chen X, Xu J, Yu L. Characterization of a human regulatory subunit of protein phosphatase 3 gene (PPP3RL) expressed specifically in testis. Mol Biol Rep. 2005 Mar;32(1):41-5.
 Rusnak F, Mertz P. Calcineurin: form and function. Physiol Rev. 2000 Oct;80(4):1483-521. Review.
 King MM, Huang CY.; Activation of calcineurin by nickel ions. Biochem Biophys Res Commun. 1983 Aug 12;114(3):955-61.
 Raos N, Kasprzak KS.; Allosteric binding of nickel(II) to calmodulin. Fundam Appl Toxicol. 1989 Nov;13(4):816-22.
 Mukai H, Ito A, Kishima K, Kuno T, Tanaka C.; Calmodulin antagonists differentiate between Ni(2+)- and Mn(2+)-stimulated phosphatase activity of calcineurin. J Biochem (Tokyo). 1991 Sep;110(3):402-6.
 Pallen CJ, Wang JH.; Stoichiometry and dynamic interaction of metal ion activators with calcineurin phosphatase. J Biol Chem. 1986 Dec 5;261(34):16115-20.
 Matsui H, Pallen CJ, Adachi AM, Wang JH, Lam PH.; Demonstration of different metal ion-induced calcineurin conformations using a monoclonal antibody. J Biol Chem. 1985 Apr 10;260(7):4174-9.
 Mancinella A.; Nickel, an essential trace element. Metabolic, clinical and therapeutic considerations. Clin Ter. 1991 Aug 15-31;138(3-4):159-65.
 Pallen CJ, Wang JH.; Regulation of calcineurin by metal ions. Mechanism of activation by Ni2+ and an enhanced response to Ca2+/calmodulin. J Biol Chem. 1984 May 25;259(10):6134-41.