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Frequently Asked Questions

In general, it’s safer to take Daily Essential Nutrients than not to take it!* Those taking medications and those with special medical needs should consult with a physician before use. Learn more. Our products are rigorously tested for heavy metals and are not released for sale unless they meet United States Pharmacopeia (USP) and US Environmental Protection Agency (EPA) standards.

Daily Essential Nutrients is backed by over 35 years of applied nutritional science. The proprietary mineral blend in Daily Essential Nutrients has been extensively studied by independent researchers and refined in clinical practice for over 15 years. Through this test of time, it has produced never-before-seen results that have been published around the world in medical journals.* Learn more.

Hardy Nutritionals® is committed to bringing you high-quality products. In order to bring you products that meet our high standards, our products are manufactured in an NSF/ANSI GMP 455-2 certified facility which is also registered with and inspected by the FDA and the Department of Health and Human Services. These standards, along with our commitment to quality, are why you can depend on the quality, potency and purity of our products. Learn more.

Yes. Daily Essential Nutrients has shown impressive results in children with a variety of mood, anxiety, and behavioral disorders.* Learn more.
Daily Essential Nutrients can be taken at recommended doses on a daily basis in perpetuity - just like food.* Learn more.
Good Manufacturing Practices (GMPs) help to safeguard the health of the consumer as well as ensure high quality products in accordance with dietary supplement regulations. GMP involves testing of products during the manufacturing process to ensure that ingredients are uncontaminated and in the correct amounts (as indicated on the product label), and that the expiration date is based on real and accelerated stability measurements. Learn more.
Yes. There’s no danger in this. However, we recommend that you split your daily dose of Daily Essential Nutrients into 3 doses in order to increase absorption and ensure that your body has the nutrients it needs throughout the day.*

Yes. Daily Essential Nutrients contains riboflavin (vitamin B2), which can make your urine more intense in color.

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.

Daily Essential Nutrients may contain an insignificant amount of lactose. Lactose intolerant individuals have been able to tolerate small quantities of lactose. Consult a physician if you have any questions.
Daily Essential Nutrients may contain an insignificant amount of gluten. Although we do not add any gluten to our products, we cannot guarantee that all raw materials are 100% gluten-free.
No, Daily Essential Nutrients contains no caffeine or any natural sources of caffeine.

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. [1]

 

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[5], magnesium oxide[6], copper oxide[7], silicon dioxide[8], manganese oxide[9], 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 [10] 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. [11]

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. [12]

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"). [13]

Therefore based on their own criteria titanium dioxide carries less cancer risk than red meat and far less risk than processed meats. 

 

References

[1] http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=73.575

[2] 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.

[3] 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.

[4] 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.

[5] 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

[6] 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

[7] 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

[8] 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

[9] 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

[10] 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

[11] http://monographs.iarc.fr/ENG/Monographs/vol93/

[12] http://monographs.iarc.fr/ENG/Classification/

[13] http://www.iarc.fr/en/media-centre/pr/2015/pdfs/pr240_E.pdf